Lay health workers in primary and community health care (Review)

Lay health workers in primary and community health care (Review) Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, van Wyk B, Bosch-Capblanch X, Patrick M This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2007, Issue 4 http://www.thecochranelibrary.com 1

T A B L E O F C O N T E N T S ABSTRACT...................................... PLAIN LANGUAGE SUMMARY.............................. BACKGROUND.................................... OBJECTIVES..................................... CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW.................. SEARCH METHODS FOR IDENTIFICATION OF STUDIES................... METHODS OF THE REVIEW............................... DESCRIPTION OF STUDIES............................... METHODOLOGICAL QUALITY.............................. RESULTS....................................... DISCUSSION..................................... AUTHORS CONCLUSIONS............................... POTENTIAL CONFLICT OF INTEREST........................... ACKNOWLEDGEMENTS................................ SOURCES OF SUPPORT................................. REFERENCES..................................... TABLES....................................... Characteristics of included studies............................. Characteristics of excluded studies............................. ADDITIONAL TABLES.................................. Table 01. Methodological quality assessment using EPOC criteria for included studies........... Table 02. Methodological quality summary scores for all included studies............... Table 03. Primary objective of LHW intervention for all included studies............... Table 04. LHWs to promote breast cancer screening uptake compared with usual care........... Table 05. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care........ Table 06. LHW to promote breastfeeding (2 weeks-6 months) postpartum comp. with usual care....... Table 07. LHWs to promote immunization uptake compared with usual care.............. Table 08. LHWs to reduce morbidity/mortality from infections compared with usual care.......... Table 09. LHWs to improve hypertension treatment compared with usual care............. Table 10. LHWs to promote mother-child interaction compared with usual care............. Table 11. LHWs providing support for alcoholics compared with office support / usual care......... Table 12. LHWs providing support for mothers of sick children compared with usual care......... Table 13. LHWs providing home aide services for the elderly compared with day care / usual......... Table 14. LHW interventions not grouped by intention..................... ANALYSES...................................... Comparison 01. LHW interventions to promote breast cancer screening uptake compared with usual care.... Comparison 02. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care..... Comparison 03. LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care.. Comparison 04. LHW interventions to promote immunization uptake compared with usual care....... Comparison 05. LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care... INDEX TERMS.................................... COVER SHEET.................................... GRAPHS AND OTHER TABLES.............................. Analysis 01.01. Comparison 01 LHW interventions to promote breast cancer screening uptake compared with usual care, Outcome 01 Breast cancer screening uptake..................... Analysis 02.01. Comparison 02 LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care, Outcome 01 Breastfeeding up to 2 weeks postpartum.................... Analysis 03.01. Comparison 03 LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care, Outcome 01 Breastfeeding between 2 weeks and 6 months postpartum.......... Analysis 04.01. Comparison 04 LHW interventions to promote immunization uptake compared with usual care, Outcome 01 Immunization uptake.......................... 1 2 2 2 3 4 4 6 9 9 10 11 12 12 12 13 24 24 50 54 54 56 59 61 62 66 69 73 73 76 83 84 87 90 100 100 100 100 100 100 100 100 102 102 103 103 104 i

Analysis 05.01. Comparison 05 LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care, Outcome 01 Morbidity and mortality....................... 105 ii

Lay health workers in primary and community health care (Review) Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, van Wyk B, Bosch-Capblanch X, Patrick M This record should be cited as: Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, van Wyk B, Bosch-Capblanch X, Patrick M. Lay health workers in primary and community health care. Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004015. DOI: 10.1002/14651858.CD004015.pub2. This version first published online: 24 January 2005 in Issue 1, 2005. Date of most recent substantive amendment: 08 November 2004 A B S T R A C T Background Lay health workers (LHWs) are widely used to provide care for a broad range of health issues. However, little is known about the effectiveness of LHW interventions. Objectives To assess the effects of LHW interventions in primary and community health care on health care behaviours, patients health and wellbeing, and patients satisfaction with care. Search strategy We searched the Cochrane Effective Practice and Organisation of Care and Consumers and Communication specialised registers (to August 2001); the Cochrane Central Register of Controlled Trials (to August 2001); MEDLINE (1966- August 2001); EMBASE (1966-August 2001); Science Citations (to August 2001); CINAHL (1966-June 2001); Healthstar (1975-2000); AMED (1966-August 2001); the Leeds Health Education Effectiveness Database and the reference lists of articles. Selection criteria Randomised controlled trials of any intervention delivered by LHWs (paid or voluntary) in primary or community health care and intended to promote health, manage illness or provide support to patients. A lay health worker was defined as any health worker carrying out functions related to health care delivery; trained in some way in the context of the intervention; and having no formal professional or paraprofessional certificated or degreed tertiary education. There were no restrictions on the types of consumers. Data collection and analysis Two reviewers independently extracted data onto a standard form and assessed study quality. Studies that compared broadly similar types of interventions were grouped together. Where feasible, the results of included studies were combined and an estimate of effect obtained. Main results Forty three studies met the inclusion criteria, involving more than 210,110 consumers. These showed considerable diversity in the targeted health issue and the aims, content and outcomes of interventions. Most were conducted in high income countries (n=35), but nearly half of these focused on low income and minority populations (n=15). Study diversity limited meta-analysis to outcomes for five subgroups (n=15 studies) (LHW interventions to promote the uptake of breast cancer screening, immunisation and breastfeeding promotion [before two weeks and between two weeks and six months post partum] and to improve diagnosis and treatment for selected infectious diseases). Promising benefits in comparison with usual care were shown for LHW interventions to promote immunisation uptake in children and adults (RR=1.30 [95% CI 1.14, 1.48] p=0.0001) and LHW interventions to improve outcomes for selected infectious diseases (RR=0.74 [95% CI 0.58, 0.93) p=0.01). LHWs also appear promising for breastfeeding promotion. They appear to have a small effect in promoting breast cancer screening uptake when compared with usual care. For the remaining subgroups (n=29 1

studies), the outcomes were too diverse to allow statistical pooling. We can therefore draw no general conclusions on the effectiveness of these subgroups of interventions. Authors conclusions LHWs show promising benefits in promoting immunisation uptake and improving outcomes for acute respiratory infections and malaria, when compared to usual care. For other health issues, evidence is insufficient to justify recommendations for policy and practice. There is also insufficient evidence to assess which LHW training or intervention strategies are likely to be most effective. Further research is needed in these areas. P L A I N L A N G U A G E S U M M A R Y Consumers, who are not certified health care professionals, may be trained to promote health and provide health care services. To determine whether these lay health worker programmes are effective, 43 studies were found and analysed. The studies took place mostly in USA, Canada and the UK. Overall, lay health worker programmes appear to be effective for some kinds of healthcare, but there is not yet enough evidence to say that this is true for all or most kinds of healthcare. Compared to usual care,lay health worker programmes to increase immunization (vaccination) in children and adults and programmes to improve health in people with lung infections and malaria may be effective. These programmes may also be effective in increasing breastfeeding, and in decreasing death in the elderly through providing home aide services. They may also have a small effect in increasing the uptake of breast cancer screening. There is not enough evidence to show whether lay health worker programmes are effective for other health care problems (for example, for managing high blood pressure or supporting alcoholics or mothers of sick children). It is also not known how best lay health workers should provide services and how much training they need to be effective. B A C K G R O U N D The 1970s saw the initiation and rapid expansion of lay health worker (LHW) programmes in low and middle income settings, stimulated by the primary health care approach adopted by the WHO at Alma-Ata (Walt 1990). LHW programmes also became more widespread in high income settings (Rosenthal 1998). Economic recession and political and policy changes throughout the developing world in the 1980s led to reduced investments in primary health care, including LHW programmes. By the mid-1980s the effectiveness and cost of such programmes was being questioned, particularly at a national level in developing countries, and several evaluations were conducted (Walt 1990; Frankel 1992). However, most of these were uncontrolled case studies that could not produce robust assessments of effectiveness due to selection bias and confounding. Interest in community or lay health worker programmes in low and middle income countries became more prominent again in the 1990s prompted by the AIDS epidemic; the resurgence of other infectious diseases; and the failure of the formal health system to provide adequate care for people with chronic illnesses such as cancer, epilepsy and mental illness (Maher 1999; Hadley 2000). The growing emphasis on decentralisation and partnership with community based organisations was also important. In industrialised settings, a perceived need for mechanisms to deliver health care to minority communities and to support consumers for a wide range of health issues (Witmer 1995) also led to the growth of a wide range of LHW interventions. For example, a national survey in 1998 in the United States documented 12,500 LHWs in a large number of programmes (Rosenthal 1998). Overall, however, this growth of interest in LHWs developed in the absence of robust evidence of their effects. Five systematic reviews have examined interventions with a lay health worker component, these focusing on breast cancer screening (Bonfill 2004); breastfeeding (Sikorski 2004); support during pregnancy (Hodnett 2004a; Hodnett 2004b); and the effectiveness of community health workers in the United States (Swider 2002). However, no reviews have attempted to examine the global evidence for the effects of LHWs, as compared to other interventions, for all conditions and types of interventions in primary and community health care. As new LHW programmes, for example in home-based care and treatment support, are developed (Foster 1996; Masood 1999; Unaids 1999), reliable reassurance should be sought that these interventions do more good than harm. Such interventions also have considerable direct and indirect costs. This systematic review therefore examines the effects of lay health worker (paid and voluntary) interventions in primary and community health care on health care behaviours, people s health and wellbeing, and their satisfaction with care. O B J E C T I V E S We address the following question: 2

Are lay health workers effective in improving the delivery of health care and health care outcomes? To answer this question, we attempted to address the following comparisons: LHW interventions compared to no intervention. LHW interventions involving activities not now undertaken by health professionals and delegated to LHWs compared to no intervention. LHW interventions involving activities not now performed adequately by health professionals and delegated to LHWs compared to no intervention. LHW interventions involving activities now performed by health professionals but delegated to LHWs to reduce resource consumption compared to the same activities performed by health professionals. The effectiveness of the lay health worker intervention related to intensity of training. C R I T E R I A F O R C O N S I D E R I N G S T U D I E S F O R T H I S R E V I E W Types of studies Randomised controlled trials. Types of participants Types of health care providers: Any lay health worker (paid or voluntary) including community health workers, village health workers, cancer supporters, birth attendants etc. For the purposes of this review, a lay health worker was defined as any health worker: carrying out functions related to health care delivery trained in some way in the context of the intervention having no formal professional or paraprofessional certificated or degreed tertiary education. Exclusions: Interventions in which a health care function was performed as an extension to a participants profession, where profession refers to work done for pay and which required a formal tertiary education (e.g. teachers provided health promotion in Schools - also see below). Formally trained nurse aides, medical assistants, physician assistants, paramedical workers in emergency and fire services and other self-defined health professionals or health paraprofessionals. LHWs included in this review from industrialised or less industrialised settings may have received training recognised by a Ministry of Health or other certifying education, but this training did not form part of a tertiary education certificate or degree. Interventions involving patient support groups only as these interventions were seen as different to LHW interventions. Another review (now at the protocol stage in the Consumers and Communication Review Group) will examine this area. Interventions involving teachers delivering health promotion or related activities in schools as this large and important system of LHWs constitutes a unique group (teachers) and setting (schools) which would be better addressed in a separate review. Interventions involving peer health counselling programmes in schools in which peers [pupils] teach other pupils about a health issue as part of the curriculum. Again, this constitutes a unique group and setting which would be better addressed in a separate review. LHWs in non-primary level institutions (e.g. referral hospitals) because of the focus of the review on primary and community health care. RCTs of interventions to train self-management tutors who were not lay persons (i.e. they were health professionals). Furthermore, RCTs simply comparing lay self-management with other forms of management (i.e. do not focus on the training of tutors etc.) were also excluded because they are concerned with the effects of empowering people to manage their own health issues rather than with the effects of interventions by LHWs who are providing services to others. Our review is primarily concerned with the latter. The former is being addressed by a review lay self-management review (now at the protocol stage in the Consumers and Communication Review Group). RCTs of interventions to train selfmanagement tutors who were themselves lay persons were eligible for inclusion in this review. Studies which measured only consumers knowledge, attitudes or intentions, for example knowledge of what constitutes a healthy diet or attitudes towards people with HIV/AIDS. These measures were not considered useful indicators of the effectiveness of LHW interventions. Types of consumers: There were no restrictions on the types of patients / recipients for whom data was extracted. Types of intervention Any intervention delivered by lay health workers and intended to promote health, manage illness or support people. An intervention was included if the description of the intervention was adequate to allow reviewers to establish that it was a lay health worker intervention (see definition above). 3

RCTs comparing one form of LHW intervention with another were not excluded from this review. However, these studies (n = 5) have not yet been analysed and will be considered in the next update of this review. Types of outcome measures Studies were included if they assessed any outcome measures within the following groups: (1) Utilisation of lay health worker services (2) Consultation processes (3) Consumer satisfaction with care (4) Health care behaviours such as types of care plans agreed, adherence to care plans (medication, dietary advice etc), attendance at follow-up consultations and health service utilisation (5) Health care outcomes, as assessed by a variety of measures including physiological measures such as blood pressure or blood glucose levels, patient self-reports of symptom resolution or quality of life and patient self-esteem (6) Cost (7) Social development measures such as the creation of support groups or the promotion of other community activities. S E A R C H M E T H O D S F O R I D E N T I F I C A T I O N O F S T U D I E S See: methods used in reviews. The following electronic databases were searched: MEDLINE (1966 - August 2001) CENTRAL and specialised Cochrane Registers (EPOC and Consumers and Communication Review Groups) (to August 2001) Science Citations (to August 2001) Embase (1966 -August 2001) CINAHL ( 1966 - August 2001) Healthstar (1975-2000) AMED (1966- August 2001) Leeds Health Education Effectiveness Database (http:// www. hubley.co.uk) We retrieved documents that included both one or more terms relating to lay health workers and one or more terms suggesting a RCT. Search strategies were tailored to each database. The strategy for MEDLINE is presented as an example. Bibliographies of studies assessed for inclusion were also searched and all contacted authors were asked for details of additional studies. MEDLINE search strategy 1.controlled clinical trial.pt 2.randomized controlled trial.pt 3.randomized controlled trials/ 4.random allocation/ 5.double blind method/ 6.single blind method/ 7.or/1-6 8.clinical trial.pt 9.exp clinical trials/ 10.(clin$ adj25 trial$).ti,ab. 11.((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 12.placebos.sh 13.placebo$.ti,ab 14.random$.ti,ab. 15.research design.sh 16. or/8-15 17. 7 or 16 18.animal/ 19.human/ 20.18 not 19 21.17 not 20 22.community health aides/ 23.home health aides/ 24.exp voluntary workers/ 25.home nursing/ 26.community networks/ 27.(lay adj5 (worker? or visitor? or attendant? or aide? or support$ or personnel)).tw. 28.(birth adj1 attendant?).tw. 29.monitrice?.tw. 30.(train$ adj1 volunteer?).tw. 31.paraprofessional.tw. 32.((health or care or healthcare) adj1 worker?).tw 33.((health or medical or care or nurs$ or psychiatric) adj1 (aide or aides)).tw. 34.((health or medical or care or nurs$ or psychiatric) adj1 attendant?).tw. 35.((nurs$ or care or home) adj1 support).tw 36.(support adj1 (program$ or service? or social)).tw. 37.or/22-36 38.21 and 37 M E T H O D S O F T H E R E V I E W Selection of trials: Two reviewers independently assessed the potential relevance of all titles and abstracts identified from the electronic searches. Full text copies of all articles that were identified as potentially relevant by either reviewer were retrieved. As assessment of the eligibility of interventions can vary between reviewers, each full paper was assessed independently for inclusion 4

by at least two reviewers. When reviewers disagreed the decision was referred to a third reviewer. If agreement could still not be reached, the decision was referred to the entire group to resolve by consensus. Where necessary, the study authors were asked for further information. Studies that were so flawed in their design or execution as to be unlikely to provide reliable data were excluded. Such exclusions are explained in the table of excluded studies. Assessment of methodological quality: Two reviewers independently assessed the quality of all eligible trials using the methodological quality criteria for RCTs listed in the Cochrane EPOC Review Group module (see ADDITIONAL INFORMATION, ASSESSMENT OF METHODOLOGICAL QUALITY under GROUP DETAILS). Studies were assessed as high quality if they reported allocation concealment, higher than 80% patient follow up and intention to treat analysis. Studies were assessed as low quality if they did not meet these criteria or if they did not report the information necessary for assessment. Data extraction: Two reviewers independently extracted data from all included studies on to a standard form. The data were then checked against each other and, if necessary, reference was made to the original paper. Any outstanding discrepancies between the two data extraction sheets were discussed by the data extractors and resolved by consensus. If necessary, other members of the review team considered these discrepancies. Attempts were made to contact study authors to obtain any missing information. Data relating to the following was extracted from all included studies: (1) participants (LHWs and consumers). For LHWs this included information on the term/s used to describe the LHW, selection criteria, basic education, tasks performed. For consumers, this included the health problems / treatment received, their age and demographic details and their cultural background. (2) health care setting (home, primary care facility or other); geographic setting (rural, formal urban or informal urban settlement) and country. (3) study design and the key features of studies (e.g. whether allocation to groups was at the level of individual health care provider or village/suburb). (4) intervention (specific training and ongoing monitoring and support [including duration, methods, who delivered by etc.] and the health care tasks performed with consumers). A full description of the intervention was also extracted. (5) the number of LHWs that were approached, trained and followed up; the number of consumers enrolled at baseline and the number and proportion followed up. (6) outcomes assessed and timing of outcome assessment. (7) results (effects), organised into 7 areas (consultation processes, utilisation of lay health worker services, consumer satisfaction with care, health care behaviours, health status and well being, social development measures and cost). (8) consumer involvement in the selection, training and management of the LHW interventions. Data synthesis: We grouped together studies that compared broadly similar types of interventions (n = 32), as listed below. The remaining eleven studies were very diverse and could not be usefully grouped. (1) LHW interventions to promote the uptake of breast cancer screening compared with usual care. (2) LHW interventions to promote breastfeeding compared with usual care. (2.1) LHW interventions to promote breastfeeding up to 2 weeks post partum compared with usual care. (2.2) LHW interventions to promote breastfeeding between 2 weeks and 6 months post partum compared with usual care. (3) LHW interventions to promote immunization uptake in children and adults compared with usual care. (4) LHW interventions to reduce morbidity and mortality from acute respiratory infections and malaria compared with usual care. (5) LHW interventions to improve hypertension treatment compared with usual care. (6) LHW interventions to provide support for recovering alcoholics compared with usual care or office based support. (7) LHW interventions to provide support for mothers of sick children compared with usual care. (8) LHW interventions to provide home aide services for the elderly compared with usual care or day care services (9) LHW interventions to promote mother-child interaction / health promotion compared with usual care. The comparisons made in the included studies did not allow us to address the other comparison groups listed under Objectives. Where feasible, the results of included studies were combined and an estimate of effect obtained. This was possible for the following four study subgroups: LHW interventions to promote the uptake of breast cancer screening; to promote breastfeeding; to promote immunization uptake; and to provide health care and treatment. Outcomes comparisons for LHW interventions to promote the uptake of breast cancer screening, breastfeeding and immunization are expressed as adherence to a beneficial health behaviour. Outcomes for the LHW interventions to reduce morbidity and mortality from acute respiratory infections and 5

malaria comparison are expressed as number of events (mortality and morbidity). Primary outcome measures were entered for all studies except Johnson 1993, where we selected a single relevant outcome (immunization status) from those measured. Only dichotomous outcomes were included in meta-analysis owing to the methodological complications involved in combining and interpreting studies using different continuous outcome measures and because of missing data in some studies. Differences in baseline variables were rare and not considered influential. Data were reanalysed on an intention-to-treat basis where possible. Adjustment for clustering was made where necessary, assuming an intracluster correlation coefficient (ICC) of 0.02 which is typical of primary and community care interventions (Campbell 2000). Log relative risks and standard errors of the log relative risk were then calculated for both individual and adjusted cluster RCTs and analysed using the generic inverse variance method in Review Manager 4. Relative risks were preferred to odds ratios because event rates were often high and, in these circumstances, odds ratios can be difficult to interpret (Altman 1998). Random effects metaanalysis was preferred because the studies were heterogenous. For the remaining five study subgroups (LHW interventions to improve hypertension treatment ; to provide support for recovering alcoholics; to provide support for mothers of sick children; to provide home aide services for the elderly; and to promote mother-child interaction / health promotion), the outcomes assessed and the settings in which the studies were conducted were very diverse. We therefore judged it inappropriate to combine the results of included studies quantitatively, as an overall estimate of effect would have little practical meaning. We therefore present a brief descriptive review of these subgroups. The diversity of studies, the small number of studies in each subgroup and the limited intervention descriptions precluded examination of the relations between the characteristics of the interventions and their effects. The feasibility of such analysis will be re-assessed when the review is updated. D E S C R I P T I O N O F S T U D I E S Searching Electronic searching identified 8,637 titles or abstracts written both in English and foreign languages. Approximately 400 of these studies were considered potentially eligible for inclusion and full text articles were ordered. 43 studies fully met our inclusion criteria including 33 individual randomised controlled trials and 10 cluster randomised control trials (Caulfield 1998; Chongsuvivat 1996; Duan 2000; Haider 2000; Kidane 2000; Lin 1997; Morrow 1999; Mtango 1986; Ramadas 2003; Voorhees 1996). All included studies were published in English language journals. The majority of included studies (n = 27) compared a LHW intervention arm against a control arm receiving either no intervention or usual care but three studies (Leigh 1999; Olds 2002; Tudiver 1992) compared a LHW system of care against a professional system. A further thirteen studies examined more than one intervention arm, but in all cases a control group receiving no intervention services was included for comparison. Searching also identified five studies comparing different types of LHW intervention only and three studies that examined LHWs as part of a wider range of interventions. These studies were not included in this review because they do not allow the specific assessment of LHW success when compared against usual or professional care systems. The included studies show considerable heterogeneity in terms of their setting; the health issues on which they focused; the aims, format and content of interventions; and the outcomes measured. Setting Fourteen different countries were represented in the included studies. Most trials took place in North America, 24 in the U.S.A. and four in Canada. A further four studies were based in the United Kingdom and one in Ireland. In the Southern hemisphere further studies were included from New Zealand (Bullock 1995), Australia (Heller 1995), Tanzania (Mtango 1986) and South Africa (Zwarenstein 2000) and in the Northern hemisphere from Thailand (Chongsuvivat 1996), Mexico (Morrow 1999), Ethiopia (Kidane 2000), India (Ramadas 2003), Bangladesh (Haider 2000) and Taiwan (Lin 1997). In 28 studies the intervention was delivered to patients based in their homes. Four interventions were based solely in a primary care facility (Barnes 1999; Caulfield 1998; Komaroff 1974; Von Korff 1998). A further nine studies involved a combination of home, primary care and community based interventions (Andersen 2000; Ireys 1996; Ireys 2001; Krieger 1999; Leigh 1999; Silver 1997; Wan 1980; Weinberger 1989; Wertz 1986). One study (Lapham 1995) took place in purpose run transitional housing facilities and one study (Voorhees 1996) was organised from and conducted using local church facilities. Intervention characteristics Objective of the interventions Studies were grouped into three broad categories based upon the primary health care intention of the intervention. The first category contained interventions designed to provide or to improve treatment for a health related condition (n=11). Included in this category were two studies using LHWs to detect and treat acute respiratory infections (Chongsuvivat 1996; Mtango 1986). One study (Kidane 2000) examined the use of similar LHW services to detect and treat malaria, including the monitoring and provision of chemotherapy. Three studies focused on hypertension control through approaches that included physician assistant care (Komaroff 1974); screening and referral for treatment (Krieger 1999); and lifestyle education (Lin 1997). Other studies in the group used LHWs to screen and refer the elderly to formal health 6

care (Carpenter 1990); to screen for oral cancer (Ramadas 2003); to provide therapy and care for aphasic patients (Wertz 1986); to improve existing treatment procedures for osteoarthritis (Weinberger 1989); to supervise directly observed therapy for tuberculosis patients (Zwarenstein 2000). Interventions intended to change people s health related knowledge, attitudes or behaviours constituted a second category (n= 20). Within this diverse grouping were four interventions promoting breast feeding practices (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999). Another four provided counselling to promote the uptake of breast and cervical cancer screening services (Andersen 2000; Duan 2000; Hoare 1994; Sung 1997) and three attempted to increase immunization uptake through outreach and follow up services (Barnes 1999; Johnson 1993; Krieger 2000). Six studies evaluated the impact of LHW visiting and education programmes on mother-infant interaction and health behavioural outcomes (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980). Other studies in this category offered telephone support and advice for coronary heart disease patients (Heller 1995); AIDS primary prevention strategies (Tudiver 1992); self treatment education for back pain sufferers (Von Korff 1998); and smoking cessation strategies (Voorhees 1996). The third category includes interventions in which the LHWs primary purpose was to provide psycho-social support (n=6). However, it should be noted that, in some studies, the intervention had the subsidiary effect of changing people s behaviour. For instance two studies evaluated LHW support to recovering substance users enrolled in treatment programmes (Lapham 1995; Leigh 1999). Three studies assessed social support for mothers of children with chronic health problems (Ireys 1996; Ireys 2001; Silver 1997) and one study providing practical and emotional support for new mothers (Morrell 2000). Multifaceted interventions were included in a fourth category if they aimed explicitly to provide more than one type of service in roughly equal measure. Four studies provided in home services for the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992); one intervention was directed at improving growth and development among children with non-organic failure to thrive (NOFTT) (Black 1995); and one used LHW home visiting to help reduce the incidence of low birth weight babies (Graham 1992). These intervention groups were further divided for meta-analysis, as described above. Mode of delivery There was great variety in the mode of intervention delivery adopted in different studies. Some trials used very specific delivery techniques, often tailored to the individual recipient. Some studies used face-to-face contact together with some form of telephone campaign whereas others set up community meetings and activities, such as themed bingo nights (Andersen 2000). However, no trials examined the passive delivery of health education, neither through the media nor through other activities like pamphlet distribution. In one study LHWs mailed educational brochures (Andersen 2000) but this was done together with numerous other interventions. In two studies (Tudiver 1992; Von Korff 1998) volunteers held educational meeting sessions at which messages about self care health behaviour were delivered. In total eleven studies examined interventions that involved some form of telephone contact. In certain studies the intervention was delivered entirely by telephone (Heller 1995) but in others telephone counselling was part of a more complex intervention and in some it was compared against personal contact methods (Barnes 1999). Twenty two studies used home visits to deliver at least part of the intervention and six studies used primary care facilities as a base for face-to-face contact. Other methods of intervention delivery included community meetings and discussion sessions (n=6), video presentations (Caulfield 1998) and family orientated activity sessions (Ireys 2001). One study (Voorhees 1996) used church meetings and facilities to deliver coronary heart disease education and a smoking cessation strategy respectively. Another (Duan 2000) used church volunteers to contact parishioners with an intervention promoting breastfeeding. Other characteristics A few trial reports gave information about the organisational base of the intervention. In fourteen studies a non-governmental organisation, charitable organisation or community group was responsible for elements of the intervention including organisation, training and delivery. Consumer involvement was integral to the intervention in eleven studies (Duan 2000; Heller 1995; Ireys 1996; Ireys 2001; Kidane 2000; Lapham 1995; Silver 1997; Tudiver 1992; Von Korff 1998; Wertz 1986; Zwarenstein 2000). Most often, former sufferers of a particular health condition were recruited to deliver the intervention to current sufferers. No study recorded that patients had been involved in the selection of LHWs. However, a number of trials recruited LHWs from participant communities, often to represent its demographic characteristics. Participants Lay health workers There were considerable differences in the number of LHWs employed to deliver the interventions (range = 2 (Graham 1992) to 150 (Chongsuvivat 1996)). It is difficult to group trends in the selection and training of lay health workers. Individuals were sometimes recruited because they were familiar with a target community or because they had experience of a particular health condition. In other studies (Carpenter 1990; McNeil 1995), volunteers were recruited but no selection process appeared to be used. For some trials selection criteria were not described. The amount of training afforded lay health workers varied greatly between trials. In some the training consisted only of an hour long introduction to the aims and principles of the intervention (Car- 7

penter 1990), or a 2½ hour orientation session (Dennis 2002). More complex interventions however could be preceded by longer training periods. For example, two studies reported 100 hours of training (Barth 1991; Krieger 1999), while others reported eight theoretical and practical sessions (Black 1995), eight weeks of national vocational level training (Morrell 2000) or specific health condition training lasting months (Kidane 2000; Olds 2002; Morrow 1999; Ramadas 2003; Siegel 1980; Sung 1997; Wertz 1986). Recipients A total of 210110 individuals were targeted in the 43 studies. Nineteen studies targeted interventions towards children and five delivered interventions specifically to the elderly. A large group of studies (n=15) recruited families, or mothers, of children with a specific health problem. Included in this group were studies aimed at breastfeeding mothers (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999) and studies that attempted to improve the mother-infant relationship for mutual benefit (Barth 1991; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980; Ireys 1996; Ireys 2001; Morrell 2000; Silver 1997; Black 1995; Graham 1992). Only one intervention was designed specifically for men. This was an education programme about high risk sexual practices delivered to homosexual men in Canada (Tudiver 1992). Nearly half the interventions focused on low income and minority populations (n= 19), especially those studies set in inner city U.S.A. and in middle and low income countries. Outcomes Most studies reported multiple measures of effect and many did not specify a primary outcome. For example, many different psychometric scoring systems were used and generally different trials chose to measure different aspects of psychosocial health. 1. Morbidity and mortality Five studies recorded morbidity and mortality data as primary outcomes in evaluating LHW interventions to improve diagnosis and treatment for acute respiratory infections (ARI) and malaria (Chongsuvivat 1996; Kidane 2000; Mtango 1986) and screening for oral cancer (Ramadas 2003). Three of these trials used measures specific to children under the age of five while the oral cancer screening trial recorded adult mortality. In response to an education program for sufferers of back pain, Von Korff 1998 recorded pain intensity, disability and mental health indicators. 2. Treatment assessment measures Six studies assessed the effect of LHWs on successful treatment of a particular health condition. Three of these studies (Komaroff 1974; Krieger 1999; Lin 1997) evaluated hypertension management practices, recording the successful completion of treatment and referral, patient and practitioner satisfaction as well as knowledge scores and blood pressure. A theoretically similar intervention (Weinberger 1989) aimed at osteoarthritis sufferers also measured consumer satisfaction with health care, compliance with medication and the impact of their arthritis on sufferers. Zwarenstein 2000 recorded successful treatment rates for tuberculosis patients. One study (Carpenter 1990) did not focus on a single health condition and evaluated the time elderly patients spent in health care institutions and used an activities of daily living scale to assess quality of life. 3. Health service uptake Five studies (Caulfield 1998; Dennis 2002; Haider 2000; Morrell 2000; Morrow 1999) promoted breastfeeding, evaluating initiation, duration and type of the adopted practice. One study also recorded maternal satisfaction and diarrhoea incidence in infants (Morrow 1999). Three studies (Barnes 1999; Johnson 1993; Krieger 2000) assessed the effect of a LHW intervention on immunization uptake by recording individual immunization status in the study population. 4. Behaviour change Two studies (Heller 1995; Voorhees 1996) recorded changes in cigarette smoking behaviour, in the first study as an indicator of lifestyle practices and in the second as a direct measure of a smoking cessation strategy. Tudiver 1992 assessed the effect of an education program on AIDS risk knowledge score and sexual practices. 5. Psycho-social measurements and assessment of quality of life Many studies used psychological tests and mental health scoring systems to assess the effects of the intervention. Measures of infant-parent well being and interaction were common to six studies (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980), some of which also recorded maternal drug use, satisfaction scales and child nutritional status. Four studies (Ireys 1996; Ireys 2001; Morrow 1999; Silver 1997) combined psychological measurement with an assessment of both the perceived and the actual availability of support to mothers. Four studies providing home aide services to the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992) combined psychological health and contentment scores with formalised activities of daily living scales and measures of physical health, such as aerobic capacity and number of admissions to health care institutions. 6. Drug rehabilitation Two studies (Lapham 1995; Leigh 1999) supported recovering substance users. Efficacy of the intervention was measured by recent drug and alcohol use as well as study attrition and treatment attendance. 7. Child physical health Black 1995 measured infant growth and development and parent-child interaction among children with non-organic failure to thrive. Graham 1992 recorded the proportion of low birth weight babies born to high risk mothers following an intervention during pregnancy. Included studies recorded both dichotomous and continuous outcomes. Dichotomous measures were presented in studies (n=14) examining the treatment of ARI and malaria, promoting the uptake of breast and oral cancer screening, breastfeeding and immu- 8

nization. Continuous outcomes were generally reported in studies promoting parent-child health, supporting mothers of sick children, supporting substance users and providing home aide services for the elderly. M E T H O D O L O G I C A L Q U A L I T Y Assessments of the methodological quality of included studies are shown in Additional Tables 1 and 2. Fifteen studies were assessed as high quality, with low susceptibility to bias. The remaining 29 studies were considered low quality, meaning that bias was of greater concern. Allocation concealment was done in 32 studies and in the all of the remainder it was scored unclear. Loss to follow was scored done in 21 studies (i.e. more than 80% of patients followed up), unclear in twelve studies and not done in ten studies. Intention to treat analysis was performed in 27 studies, in twelve the procedure was not described and in four it was not done. The grouping of studies according to methodological quality is not intended as a platform for deciding which studies should be included in the meta analysis. It is rather intended to illustrate the quality range for research on the effects of LHW interventions. R E S U L T S Lay health workers have been employed to deliver a very wide variety of interventions in many different health care settings. Trying to group studies by intervention type is therefore problematic and a more useful discussion can be generated by concentrating on the intended outcome or objective of each study. For the purposes of discussion and meta-analysis 32 studies have been organised into ten groups, each group containing studies that used broadly similar methods to influence a single health care outcome. Metaanalysis was performed on five of the ten groups, including a total of fifteen studies. In the others, outcomes were considered too diverse to be usefully pooled. In the majority of cases it is the primary study outcome that has been included in the analysis. The additional tables list all of the study outcomes. The effects described in this section all favour the intervention arm of the trials, unless stated otherwise. LHW interventions to promote breast cancer screening compared with usual care (see meta view) Four studies (Andersen 2000; Duan 2000; Hoare 1994; Sung 1997) employed LHWs to increase the uptake of breast cancer screening services. Duan 2000 analysed separately the effect on users and non users at baseline. The pooled RR for the five comparisons was 1.05 [95% confidence intervals (CI) 0.99, 1.12], providing little evidence for a beneficial effect of the intervention [p= 0.10]. Heterogeneity between study outcomes was extremely low [p=0.86; I 2 =0%]. LHW interventions to promote breastfeeding up to 2 weeks post partum compared with usual care (see meta view) Four studies (Caulfield 1998; Dennis 2002; Haider 2000; Morrow 1999) examined the short term post partum effects of LHW interventions to promote breastfeeding. Meta-analysis indicated that breastfeeding promotion may increase the uptake of breastfeeding practices (RR=1.69 [95% CI 0.91, 3.12] p=0.10). The heterogeneity of the studies outcomes raises doubts about the suitability of a pooled estimate (p<0.00001; I 2 =89.6%). LHW interventions to promote breastfeeding between two weeks and six months post partum compared with usual care (see meta view) The pooled RR for the four studies that examined the longer term influence of breastfeeding promotion interventions (Dennis 2002; Haider 2000; Morrell 2000; Morrow 1999) was 2.93 [95% CI 0.88, 9.71] p=0.08). This result should be interpreted with some caution as individual study estimates ranged from 1.06 [0.64, 1.75] (Morrell 2000) to 11.64 [7.09, 19.09] (Haider 2000). Although between study heterogeneity was substantial (p<0.00001; I 2 =95.7%), the effect is large and the individual study results all favour the intervention. A possible explanation for the observed variation could be the extensive differences in the intensity of the intervention between studies. The extremely large RR in Haider 2000 coincides with an extremely intensive, one to one intervention strategy. Another influential factor may be the prevailing breastfeeding practices within the study areas: for example, Haider 2000 was done in a region where exclusive breastfeeding is very rare. It may also be problematic to combine exclusive breastfeeding and any breastfeeding measures. LHW interventions to promote immunisation uptake in children and adults compared with usual care (see meta view) Three studies (Barnes 1999; Johnson 1993; Krieger 2000) provide strong evidence that LHW based promotion strategies can increase the uptake of immunisation in both adults and children (RR=1.30 [95% CI 1.14, 1.48] p=0.0001). There was little heterogeneity (p=0.95; I 2 =0%). LHW interventions to provide health care and treatment specific to a medical condition compared with usual care (see meta view) Two studies (Chongsuvivat 1996; Mtango 1986) used LHWs to diagnose and treat acute respiratory infection (ARI) in children under five years old and one study (Kidane 2000) used LHWs to treat malaria episodes in children of the same age. Two of the studies (Kidane 2000; Mtango 1986) recorded all cause mortality outcome data whereas Chongsuvivat 1996 recorded morbidity data for ARI. The pooled RR for mortality for the two studies was 0.69 [95% CI 0.51, 0.94] (p=0.02). When morbidity data were included the pooled RR remained significant (RR=0.74 [95% CI 0.58, 0.93) p=0.01) although heterogeneity affected both the mor- 9

tality RR (p=0.02; I 2 =81.4%) and the mortality and morbidity combined RR (p=0.02; I 2 =75.8%). LHWs interventions to improve treatment of hypertension compared with usual care Evidence from the three studies using LHWs to treat hypertension (Lin 1997; Komaroff 1974; Krieger 1999) was mixed: one study reported that LHWs could significantly lower both systolic and diastolic blood pressure (Lin 1997) but another (Komaroff 1974) found no significant differences. Krieger 1999 found that significantly more patients receiving the LHW intervention (p=0.001) completed follow-up appointments with health care providers within 90 days of referral. LHW interventions to promote mother-infant interaction / health promotion compared with usual care Six studies examined the effect of LHWs on mother-child health promotion (Barth 1991; Bullock 1995; Johnson 1993; Olds 2002; Schuler 2000; Siegel 1980). The results of these studies were highly variable, with many of the studies reporting multiple outcome measures. The effects could therefore not be summarised and results for individual studies are presented in Additional Table 10. LHWs providing support for recovering alcoholics compared with office based support or usual care The effect of LHW support on recovering alcohol users was examined in two studies (Lapham 1995; Leigh 1999). Neither found a significant effect on any of the alcohol use measures reported. Nor were there any significant differences in the employment or housing status, nor social stability and the use of leisure, nor the average income of participants in the control and treatment groups. However, Leigh 1999 noted that physical health and emotional function were significantly more improved in a control arm receiving office-based rather than LHW support. LHWs providing support to mothers of sick children compared with usual care Three studies (Ireys 1996; Ireys 2001; Silver 1997) reported maternal health outcomes following interventions to provide support for mothers of sick children. Two studies (Ireys 2001; Silver 1997) reported that maternal anxiety was lower in the intervention group but this was the only significant outcome of many reported. The same two studies also reported child mental health scores. Three scores (hostility; anxiety/depression; summary score of mental health) favoured the intervention group in one study (Ireys 2001). Other differences were not significant. LHWs providing home aide services for the elderly compared with day care services or usual care Four studies examined home aide services for the elderly (McNeil 1995; Nielsen 1972; Wan 1980; Williams 1992) and assessed mental and physical functioning. Multiple outcomes were reported and results were very variable. Two studies recorded general mortality in the elderly: Nielsen 1972 found no significant impacts of the intervention but Wan 1980 measured significant impacts for the LHW intervention compared to control. Owing to the range of interventions described and outcomes measured, eleven studies could not be assigned to subgroups. The outcomes for individual studies are reported in Additional Table 14. D I S C U S S I O N This review identified 43 RCTs evaluating the effects of LHW interventions in primary and community health care. The diversity of included studies limited meta-analysis to outcomes for five study subgroups (n = 15 studies in total). Of these, LHW interventions to promote immunization uptake in children and adults and to improve outcomes for ARI and malaria show promising benefits, when compared with usual care. There is also evidence that they may be effective in promoting the uptake of breastfeeding and of a small, non-significant effect of LHW interventions in promoting the uptake of breast cancer screening. The effect size for LHW interventions to promote breast cancer screening uptake was comparable to that demonstrated elsewhere (Bonfill 2004). However, recent reviews suggest that mass cancer screening may not result in survival benefit (Olsen 2004). For interventions to promote any breastfeeding, our effect estimates are a little larger than those previously reported (Sikorski 2004), probably because of differences in both the studies and outcomes included in these analyses. The remaining subgroups (LHW interventions to improve hypertension treatment; promote parent-child interaction and health; provide support for mothers of sick children; provide support for recovering alcoholics; and provide home aide services for the elderly), including 18 studies, reported many continuous and dichotomous outcomes using a wide range of indicators and measures. These outcomes were considered too diverse to allow meaningful statistical pooling. One study examining LHWs providing home aide services for the elderly suggest that these may significantly reduce mortality (Wan 1980). This promising effect needs confirmation. For the other subgroups, it is difficult to draw any conclusions on the effectiveness of interventions. The meta-analysis findings need to be interpreted with caution for several reasons. All subgroups included few studies and many of these had small sample sizes. Furthermore, three subgroups (LHW interventions to increase breastfeeding in the first 2 weeks post-partum and between 2 weeks and 6 months post-partum and LHW interventions to improve treatment of ARI and malaria) showed significant statistical heterogeneity. Caution is also needed in extrapolating the meta-analysis findings to large scale programmes. LHWs in experimental studies may be more carefully selected; receive substantial training and support 10

from highly motivated project leaders; and work with carefully selected consumer groups. Furthermore, most trials did not measure the effectiveness of LHW programmes over long periods. These factors may be important to the long term success and sustainability of large routine LHW programmes (Berman 1987; Walt 1989), although such hypotheses need further evaluation. In addition, few studies described how LHW-provided services linked with other health system components, creating difficulties or at least uncertainties for scaling up. Most studies in this review did not compare LHW interventions with similar services delivered by professionals (substitution), but rather compared LHW interventions with usual care. The few studies that compared LHW programmes with similar services delivered by professionals (e.g. Leigh 1999; Olds 2002; Tudiver 1992) reported mixed findings, with different outcomes favouring professional or LHW interventions. It is therefore possible that replacing professional care with LHWs may in some circumstances do harm and this should be considered more carefully in future studies. However, any such inferences must be viewed with caution given the diversity of the studies and the multiple outcomes reported. We would suggest that the available data allow no overall conclusions to be drawn regarding the effectiveness of LHWs in substituting for professional providers. Only four studies reported cost data (Carpenter 1990; Krieger 2000; Morrell 2000; Olds 2002). These included the running costs of the intervention (Carpenter 1990); the marginal costs per additional person immunized (Krieger 2000); cost effectiveness (Morrell 2000); and the costs of the programme (Olds 2002). We are therefore unable to draw any conclusions regarding the cost of LHW interventions compared to similar interventions delivered by health professionals. Although participants were very varied, fewer than 50% of included studies explicitly stated that they were targeting low income or minority consumer groups. This suggests that, at least for experimental programmes, LHWs are not being used only to provide services to poorer populations. Few studies reported involving consumers in the development of the interventions; the selection of LHWs; or the support of the LHW programmes and we therefore could not assess the impacts of such involvement on intervention effectiveness. The review identified a number of methodological problems. Firstly, there are significant difficulties in locating RCTs of LHW interventions due to the poor indexing of the term lay health worker within the major health literature databases and the large number of other terms used in the literature to describe LHWs. We identified over forty such terms in the course of this review. Secondly, there is no single widely accepted definition of this cadre of health workers (Love 1997; Witmer 1995). Furthermore, applying any definition to published studies is difficult as many do not describe adequately the training and background of health workers. Thirdly, poor descriptions of the LHW interventions, particularly with regard to the training and support, precluded assessment of the relationship between health outcomes and the type and intensity of LHW training and support (Ward 2004). Information on this relationship would help those designing LHW programs. Inadequate intervention descriptions also make difficult the development of a typology of LHW training interventions, which could be useful for grouping studies for analysis. Finally, poor intervention descriptions create difficulties in exploring the interrelationships between different elements of these complex interventions (Campbell 2000), which may include provision of information, support and treatment. Fourthly, many studies did not clearly specify a primary outcome creating difficulties in deciding which outcomes should be included in meta-analysis (Chan 2003). Some studies assessed large numbers of outcomes, increasing the probability of finding statistically significant differences by chance. Furthermore, the diversity of the psychometric and other outcome measures used made statistical pooling of outcome data difficult. Finally, a number of cluster randomized studies reported outcomes for individual participants without adjusting for the possible effects of clustering. A U T H O R S Implications for practice C O N C L U S I O N S LHW interventions show promising benefits in promoting the uptake of immunization in children and adults and for improving outcomes for malaria and ARI in children, when compared with usual care. Health planners could consider including LHW interventions as components of health service strategies in these areas, particularly where other effective and feasible interventions do not exist. LHWs also appear promising for breastfeeding and may also reduce mortality in the elderly. They appear to have a small, and probably not clinically relevant, effect for breast cancer screening. For other health issues, evidence of the effectiveness of LHW interventions is so far insufficient to allow recommendations for policy and practice. There is also insufficient evidence to assess which LHW training or intervention strategies are likely to be most effective. However, LHWs are most likely to be useful as a cadre of health care providers when they have an effective health care intervention to deliver. LHWs could also potentially reduce the costs of health care if substituted for professionals, by providing care at a level closer to consumers, but evidence for this is currently lacking. Given the growing interest in the use of LHWs for a range of health issues, for example in the delivery of home care for people with HIV/AIDS (Farmer 2001, Loewenson 2004), policy makers, 11

funders and researchers need to be encouraged to use rigorous designs in evaluating these programs. Implications for research For a wide range of health issues, further rigorous research on the effectiveness of LHW interventions is needed. Greater attention needs to be paid to the quality of study designs, particularly where cluster randomisation is used. Also, investigators should specify a primary outcome; consider whether the measurement of large number of related outcomes is useful; describe more thoroughly the training and support strategies used, any co-interventions and health care organisation and system issues; and assess possible harms of the interventions. For health issues where LHW interventions demonstrate benefits, research needs to shift to understanding which components of these often multifaceted interventions are most effective. Further research should also explore the transferability of these findings to other settings and consumer groups and the effectiveness of different approaches to the training of LHWs and the delivery of LHW-led services. Given the wide range of health issues, consumers, settings, training strategies and delivery mechanisms for LHW interventions, there is an urgent need for the development of a coherent typology of LHW interventions that could help to guide research and practice in this field. While the RCTs included in this review cover a wide range of health issues, researchers in these fields appear to be working largely in isolation from one another, as evidenced by the failure to date to attempt to assemble the global evidence on the effectiveness of these interventions. The absence of a widely accepted definition of LHWs as well as the poor conceptualisation of the field (Love 1997) contribute to this problem. There may be potential for better sharing of knowledge across hitherto isolated health specialty areas if a coherent typology of LHW interventions was developed. Such a typology would allow LHW interventions to be conceptualised in terms of their lay component rather than in terms of the specific health issues on which they focus. Greater efforts need to be made to involve consumers in the planning and support of studies of the effectiveness of LHW programs. The effects of consumer involvement also require further research. Economic studies should accompany trials to establish the costeffectiveness of different LHW interventions. Studies are needed to evaluate the effectiveness of LHWs as compared to professional health care providers in delivering interventions in the fields of health education, promotion and the management of disease. P O T E N T I A L I N T E R E S T None known. C O N F L I C T O F A C K N O W L E D G E M E N T S Our thanks to the many study authors who gave us additional information regarding study designs and interventions. Past and present staff at the editorial bases for the Cochrane Effective Practice and Organisation of Care and Consumers and Communication Review Groups also provided considerable assistance and support: Hilda Bastian, Cynthia Fraser, Sophie Hill, Laura McAuley, Jessie McGowan and Graham Mowatt. Particular thanks to our contact editor, Andy Oxman, for his ongoing support and advice; to Craig Ramsay for statistical advice; and to Marina Clarke for assisting with inclusion assessments. Administrative support was ably provided by Sylvia Louw at the Medical Research Council, South Africa and Anna Gaze at the London School of Hygiene and Tropical Medicine. Our thanks also to Simon Goudie for assistance with graphics and editing. We are also grateful for the comments of several consumer representatives; several anonymous peer-reviewers; and many others who shared with us their insights into lay health worker programs. Funding for this review was provided by German Technical Development (GTZ) (95.2068.5-001.00); WHO (M12/370/1); and the European Union funded AFDOT project (ICFP500A4PRO2). Additional funding for members of the review team was provided by the Medical Research Council of South Africa. Our thanks to Andy Haines at the London School of Hygiene and Tropical Medicine for his support in obtaining funding to complete the review. S O U R C E S O F S U P P O R T External sources of support German Technical Co-operation (GTZ) GERMANY World Health Organisation SWITZERLAND Internal sources of support Medical Research Council SOUTH AFRICA 12

R E F E R E N C E S References to studies included in this review Andersen 2000 {published data only} Andersen, M.R. Yasui, Y Meischke, H. Kuniyuki, A. Etzioni, R. Urban, N. The Effectivness of Mammography Promotion by Volunteers in Rural Communities. Am J Prev Med 2000;18(3):199 207. Barnes 1999 {published data only} Barnes, K. Friedman, S.M. Namerow, P.B. Honig, J. Impact of Community Volunteers on Immunization Rates of Children Younger than 2 Years. Arch Pediatr Adolesc Med 1999;153(5):518 524. Barth 1991 {published data only} Barth, R.P. An Experimental Evaluation of In-Home Child Abuse Prevention Services. Child Abuse and Neglect 1991;15:363 75. Barth, R.P. Hacking, S. Ash, J.R. Preventing Child Abuse: An Experimental Evaluation of the Child Parent Enrichment Project. Journal of Primary Prevention 1988;8(4):201 217. Black 1995 {published data only} Black, M.M, Dubowitz, H, Hutcheson, J, Berenso-Howard, J, Staar, R.H. Randomized Clinical Trial of Home Intervention for Children with Failure to Thrive. Pediatrics 1995;95(6):807 814. Hutcheson, J.H, Black, M.M, Talley, M, Dubowitz, H, Howard, J.B, Starr, R.H, Thompson, B.S. Risk Status and Home Intervention Among Children with Failure-to-Thrive: Follow-Up at Age 4. Journal of Pediatric Psychology 1997;22(5):651 668. Bullock 1995 {published data only} Bullock, LFC. Wells, JE. Duff, GB. Hornblow, AR. Telephone Support for Pregnant Women: Outcome in Late Pregnancy. New Zealand Medical Journal 1995, (November):476 478. Carpenter 1990 {published data only} Carpenter, G.I. Demopoulos, G.R. Screening the Elderly in the Community: Controlled Trial of Dependency Surveillance Using a Questionnaire Administered by Volunteers. BMJ 1990;May:1253 1256. Caulfield 1998 {published data only} Caulfield, L.E.Gross, S.M.Bentley, M.E, et al. WIC-Based Interventions to Promote Breastfeeding among African-American Women in Baltimore: Effects on Breastfeeding Initiation and Continuation. J Hum Lact 1998;14(1):15 22. Chongsuvivat 1996 {published data only} Chongsuvivatwong, V. Mo-Suwan, L. Tayakkanonta, K. Vitsupakorn, K. McNeil, R. Impacts of Training of Village Health Volunteers in Reduction of Morbidity from Acute Respiratory Infections in Childhood in Southern Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 1996;27(2):333 339. Dennis 2002 {published data only} Dennis, C.L, Hodnett, E, Gallop, R, Chalmers, B. The effect of peer support upon breast-feeding duration among primiparous women: a randomized controlled trial. CMAJ 2002;166(1):21 28. Dennis, CL. Breastfeeding Peer Support: Maternal and Volunteer Perceptions from a Randomized Controlled Trial. Birth 2002;29(3): 169 176. Duan 2000 {published data only} Derose, K.P, Reigadas, E, Hawes-Dawson, J. Church-Based Telephone Mammography Counseling with Peer Counselors. Journal of Health Communication 2000;5(2):175 188. Duan, N, Fox, S.A, Derose, K.P, Carson, S. Maintaining Mammography Adherence Through Telephone Counseling in a Church-Based Trial. American Journal of Public Health 2000;90(9):1468 71. Pitkin Derose, K, Hawes-Dawson, J, Fox, S.A, Maldonado, N, Tatum, A, Kington, R. Dealing with Diversity: Recruiting Churches and Women for a Randomized Trial of Mammography Promotion. Health Education and Behaviour 2000;27(5):632 48. Stockdale, S.E, Keeler, E, Duan, N, Pitkin Derose, K, Fox, S.A. Costs and Cost-Effectiveness of a Church-Based Intervention to Promote Mammography Screening. Health Services Research 2000;35(5 (Part 1)):1037 57. Graham 1992 {published data only} Graham, AV. Frank, SH. Zyzanski, SJ. Kitson, GC. Reeb, KG. A Clinical Trial to Reduce the Rate of Low Birth Weight in an Inner- City Black Population. Fam Med 1992;24(6):439 46. Haider 2000 {published data only} Haider, R. Ashworth, A. Kabir, I. Huttly, S.R.A. Effects of Community-Based Peer Counsellors on Exclusive Breastfeeding Practices in Dhakar, Bangladesh: A Randomised Controlled Trial. The Lancet 2000;356(Nov 11):1643 1647. Heller 1995 {published data only} Heller, R.F. A Randomized Controlled Trial of Community Based Counselling Among Those Discharged from Hospital with Ischaemic Heart Disease. Aust NZ Med 1995;25:362 364. Hoare 1994 {published data only} Hoare, T. Thomas, C. Biggs, A. Bradley, S. Friedman, E. Can the Uptake of Breast Cancer Screening by Asian Women be Increased? A Randomized Controlled Trial of a Linkworker Intervention. Journal of Public Health Medicine 1994;16:179 185. Ireys 1996 {published data only} Chernoff, R.G, Ireys, H.T, DeVet, K.A, Young, K.J. A Randomized Controlled Trial of a Community-Based Support Program for Families of Children With Chronic Illness: Pediatric Outcomes. Arch Pediatr Adolesc Med 2002;156:533 39. Ireys, H.T, Sills, E.M, Kolodner, K.B. A Social Support Intervention for Parents of Children with Juvenile Rheumatoid Arthritis: Results of a Randomized Trial. J Pediatr Psychol 1996;21(5):633 641. Ireys 2001 {published data only} Ireys, H. Chernoff, R. De Vet, KA. Kim, Y. Maternal Outcomes of a Randomized Controlled Trial of a Community-Based Support Program for Families of Children with Chronic Illness. Arch Pediatr Adolesc Med 2001;155:771 776. Johnson 1993 {published data only} Johnson, Z. Howell, F. Molloy, B. Community Mother s Programme: Randomised Controlled Trial of Non-Professional Intervention in Parenting. BMJ 1993;306(29 May):1449 1452. 13

Kidane 2000 {published data only} Kidane, G. Morrow, R. H. Teaching Mothers to Provide Home Treatment of Malaria in Tigray, Ethiopia: A Randomized Trial. The Lancet 2000;356(August):550 555. Komaroff 1974 {published data only} Komaroff, A.L, Black, W.L, Flatley, M, Knopp, R.H, Reiffen, B, Sherman, H. Protocols for Physician Assistants: Management of Diabetes and Hypertension. The New England Journal of Medicine 1974; 290(6):307 12. Krieger 1999 {published data only} Krieger, J. Collier, C. Song, L. Martin, D. Linking Community- Based Blood Pressure Measurements to Clinical Care: A Randomized Controlled Trial of Outreach and Tracking by Community Health Workers. American Journal of Public Health 1999;89(6). Krieger 2000 {published data only} Krieger, JW. Castorina, JS. Walls, ML. Weaver, MR. Increasing Influenza and Pneumococcal Immunization Rates: A Randomized Controlled Study of a Senior Center-Based Intervention. Am J Prev Med 2000;18(2):123 131. Lapham 1995 {published data only} Lapham, S.C, Hall, M, McMurray-Avila, M, Beaman, H. Residential Care: Alburquerque, Evanston/VA, Los Angeles. Alcoholism Treatment Quarterly 1993;10(3-4):139 54. Lapham, SC. Hall, M. Skipper, BJ. Homelessness and Substance Use Among Alcohol Abusers Following Participation in Project H&ART. J Addict Dis 1995;14(4):41 55. Leigh 1999 {published data only} Leigh, G. Hodgins, D.C. Milne, R. Volunteer Assistants in the Treatment of Chronic Alcoholism. American Journal of Drug and Alcohol Abuse 1999;25(3):543 559. Lin 1997 {published data only} Lin, T Chen, C. Chou, P. A Hypertension Control Program in Yu- Chi, Taiwan: Preliminary Results. J Formos Med Assoc 1997;96(8): 613 621. McNeil 1995 {published data only} McNeil, J.K. Effects of Nonprofessional Home Visit Programs for Subclinically Unhappy and Unhealthy Older Adults. Journal of Applied Gerontology 1995;14(3):333 42. Morrell 2000 {published data only} Morrell, C. J. Spiby, H. Stewart, P. Walters, S. Morgan, A. Costs and Effectiveness of Community Postnatal Support Workers: Randomized Control Trial. British Medical Journal 2000;321(September): 593 598. Morrow 1999 {published data only} Morrow, A.L. Guerrero, M.L. Shults, J. Calva, J.J. Lutter, C. Bravo, J, et al. Efficacy of Home-Based Peer Counselling to Promote Exclusive Breastfeeding: A Randomized Controlled Trial. Lancet 1999;353: 1226 31. Mtango 1986 {published data only} Mtango, F.D.E. Neuvians, D. Acute Respiratory Infections in Children Under Five Years. Control Project in Bagamoyo District, Tanzania. Transactions of the Royal Society of Tropical Medicine and Hygiene 1986;80:851 858. Nielsen 1972 {published data only} Nielsen, M. Blenker, M. Bloom, M. Downs, T. Beggs, H. Older Persons after Hospitalization: A Controlled Study of Home Aide Service. AJPH 1972;62(8):1094 1101. Olds 2002 {published data only} Korfmacher, J, O Brien, R, Hiatt, S, Olds, D. Differences in Program Implementation Between Nurses and Paraprofessionals Providing Home Visits During Pregnancy and Infancy: A Randomized Trial. American Journal of Public Health 1999;89(12):1847 51. Olds, D.L, Robinson, J, O Brien, R, Luckey, D.W, Pettitt, L.M, Henderson, C.R, Ng, R.K, Sheff, K.L, Korfmacher, J, Hiatt, S, Talmi, A. Home Visiting by Paraprofessionals and by Nurses: A Randomized Controlled Trial. Pediatrics 2002;110(3):486 496. Ramadas 2003 {published data only} Ramadas, K, Sankaranarayanan, R, Jose Jacob, B, Thomas, G, Somanathan, T, Mahe, C, Pandey, M, Abraham, E, Najeeb, S, Mathew, B, Parkin, D.M, Krishnan, N. Interim results from a cluster randomized controlled oral cancer screening trial in Kerala, India. Oral Oncology 2003;39:580 88. Sankaranarayanan, R, Mathew, B, Jacob, B.J, Thomas, G, Somanathan, T, Pisani, P, Pandey, M, Ramadas, K, Najeeb, K, Abraham. E. Early Findings from a Community-Based, Cluster-Randomized, Controlled Oral Cancer Screening Trial in Kerala, India. Cancer 2000;88(3):664 73. Schuler 2000 {published data only} Schuler, M.E. Nair, P. Black, M. M. Kettinger, L. Mother-Infant Interaction: Effects of a Home Intervention and Ongoing Maternal Drug Use. Journal of Clinical Child Psychology 2000;29(3):424 431. Siegel 1980 {published data only} Siegal, E. Bauman, E.K. Schaefer, E.S. Saunders, M.M. Ingram, D. Hospital and Home Support During Infancy: Impact on Maternal Attachment, Child Abuse and Neglect, and Health Care Utilization. Pediatrics 1980;66(2):183 190. Silver 1997 {published data only} Silver, E, Ireys, H.T, Bauman, L.J, Stein, R.E. Psychological Outcomes of a Support Intervention in Mothers of Children with Ongoing Health Conditions. The Parent-to-Parent Network. Journal of Community Psychology 1997;25(3):249 264. Sung 1997 {published data only} Sung, JF. Blumenthal, DS. Coates, RJ. Effect of a Cancer Screening Intervention Conducted by Lay Health Workers Among Inner-City Women. American Journal of Preventive Medicine 1997;13(1):51 56. Tudiver 1992 {published data only} Tudiver, F.Myers, T.Kurtz, R.G.Orr, K.Rowe, C.Jackson, E.Bullock, S.L. The Talking Sex Project. Evaluation & The Health Professional 1992;15(4):26 42. Von Korff 1998 {published data only} Von Korff, M. Moore, J.E. Lorig, K. Cherkin, D.C Saunders, K. Gonzalez, V.M. Laurent, D. Rutter, C. Comite, F. A Randomized Trial of a Lay Person-Led Self-Management Group Intervention for Back Pain in Primary Health Care. Spine 1998;23(23):2608 2615. Voorhees 1996 {published data only} Stillman, FA. Bone, LR. Rand, C. Levine, DM. Becker, DM. Heart, Body and Soul: A Church Based Smoking Cessation Program for Urban African Americans. Preventative Medicine 1993;22:335 49. 14

Voorhees, C.C, Stillman, F.A, Swank, R.T, Heagerty, P.J, Levine, D.M, Becker, D.M. Heart, Body and Soul: Impact of Church-Based Smoking Cessation Interventions on Readiness to Quit. Preventative Medicine 1996;25:277 85. Wan 1980 {published data only} Wan, T.T.H. Weissert, W, G. Livieratos, B.B. Geriatric Day Care and Homemaker Services: An Experimental Study. Journal of Gerontology 1980;35(2):256 274. Weinberger 1989 {published data only} Rene, J. Weinberg, M. Mazzuca, S.A. Brandt, K.D. Katz, B.P. Reduction of Joint Pain in Patients with Knee Osteoarthritis who have Recieved Monthly Telephone Calls from Lay Personnnel and Whose Medical Treatment Regimens have Remained Stable. Arthritis and Rheumatism 1992;35(5):511 515. Weinberger, M, Tierney, W.M, Booher, P, Katz, B.K. Can the Provision of Information to Patients with Osteoarthritis Improve Functional Status? A Randomised Controlled Trial. Arthritis and Rheumatism 1989;32(12):1577 1583. Weinberger, M. Tierney, W.M. Booher, P. Katz, B.P. The Impact of Increased Contact on Psychosocial Outcomes in Patients with Osteoarthritis: A Randomized Controlled Trial. The Journal of Rhematology 1991;18(6):849 854. Wertz 1986 {published data only} Wertz, R. Weiss, D.G. Aten, J.L. Brookshire, R.H. Garcia-Bunuel, L. Holland, A.L. Kurtzke, J.F. La Pointe, L.L. Miliant, F.J. Brannegan, R. Greenbaum, H. Marshall, R.C. Vogel, D. Carter, J. Barnes, N.S. Goodman, R. Comparison of Clinic, Home, and Deferred Language Treatment for Aphasia. Arch Neurol 1986;43(July):653 658. Williams 1992 {published data only} Williams, E.I. Greenwell, J.Groom, L.M. The Care of People Over 75 Years and Older After Discharge from Hospital: An Evaluation of Timetabled Visiting by Health Visitor Assistants. J Public Health Med 1992;14(2):138 144. Zwarenstein 2000 {published data only} Zwarenstein, M. Schoeman, J.H. Vundule, C. Lombard, C.J Tatley, M. A Randomized Controlled Trial of Lay Health Workers as Direct Observers for Treatment of Tuberculosis. Int J Lung Dis 2000;4(6): 550 554. References to studies excluded from this review Akram 1997 Akram, D.S. Agboatwalla, M. Shamshad, S. Effect of Intervention on Promotion of Exclusive Breast Feeding. J Pak. Med. Assoc 1997; 47(2):46 48. Anderson 1998 Anderson. S. E. Brewer, B.S. Stein, M. Closing the Distance. Nursing Management 1998;November:44 48. Andresen 1992 AndresenP.A, Telleen, S.L. The realtionship between social support and maternal behaviours and attitudes: a meta-analytic review. American Journal of Community Psychology 1992;20(6):753 774. Arlotti 1998 Arlotti, JP. Cottrell, BH. Lee, SH. Curtin, J. Breastfeeding among Low-Income Women with and without Peer Support. J Commun Health Nurs 1998;15:163 178. Armstrong 1999 Armstong,.L. Fraser, J.A. Dadds, M.R. Morris, J. A Randomized Controlled Trial of Nurse Home Visiting to Vulnerable Families with Newborns. J.Paediatr. Child Health 1999;35:237 244. Ashworth 1992 Ashworth, C.S, Durant, R.H, Newman, C, Gaillard, G. An Evaluation of a School Based AIDS/HIV Education Programme for High School Students. Adolesc Health 1992;13(7):582 8. Assar 2000 Assar, D, Chamberlain, D, Colquhoun, M, Donnelly, P, Handley, H.J, Leaves, S, Kern, K.B. Randomised Controlled Trials of Staged Teaching for Basic Life Support (1) Skill Aquisition at Bronze Stage. Resuscitation 2000;47:7 15. Ayele 1993 Ayele, F. Desta, A. Larson, C. The Functional Status of Community Helth Agents: A Trial of Refresher Courses and Regular Supervision. Health Policy and pplanning 8(4):379 384. Bailey 1996 Bailey, J.E. Coombs, D.W. Effectiveness of an Indonesian Model for rapid Training of Guatemalan Health Workers in Diarrhea Case Management. Journal of Community Health 21(4):269 276. Bang 1993 Bang, A.T.Bang, R.A.Morankar, V.P.Sontakke, P.G. Solanki, J.M. Pneumonia in Neonates:Can it be Managed in the Community?. Archives of Disease in Childhood 1993;68:550 556. Bang 1994 Bang, A. T. Bang, R. A. Sontakke, P. G. & the Search Team. Management of Childhood Pneumonia by Traditional Birth Attendants. Bulletin of the World Health Organization 1994;72(6):897 905. Bang 1999 Bang, A.T. Bang, R.A. Baitule, S.B. Reddy, M.H. Deshmukh, M.D. Effect of Home-Based Neonatal Care and Management of Sepsis on Neonatal Mortality: Feild Trial in Rural India. The Lancet 1999;345: 1955 1961. Berry 1991 Berry, G.L. Zarit, S. Rabatin, V.X. Caregiver Activity on Respite and Nonrespite Days: A Comparison of Two Service Approaches. The Gerontologist 1991;31(6):830 835. Bester 1991 Bester, F. C. J. Weich, D. J. V. Albertyn, E. W. Socio-Economic Circumstances and Functional Abilites of Elderly Black Persons in the Orange Free State. South African Medical Journal 1992;82:110 113. Bhattacharya 1988 Bhattacharya, R. Kaur, P. Reddy, C.S. 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Gray 1980 Gray, S.W. Ruttle, K. The Family-Oriented Home Visiting Programe: A Longitudinal Study. Genetic Psychology Monographs 1980;102:299 316. Greenwood 1989 Greenwood, B.M. Greenwood, A.M. Snow, R.W. Bypass, P. Bennett, S. Hatib-N Jie. The Effects of Malaria Chemoprophylaxis given by Tradtional Birth Attendants on the Course and Outcome of Pregnancy. Transactions of the Royal Society of Tropical Medicine and Hygiene 1989;83:589 594. Gunnell 2000 Gunnell, D. Coast, J. Richards, S.H. Peters, T.J. Pounsford, C. How great a burden does early discharge to hospital-at-home impose on carers? A randomized controll trial. Age and Ageing 2000;29:137 142. Gupta 1992 Gupta, P.C. Meth, F.S. Pindborg, J.J. Bhonsle, R.B. Murti, P.R. Daftary, D.K. Aghi, M.B. Primary Prevention Trial of Oral Cancer in India: A 10-year Follow-up Study. J Oral Pathol Med 1992;21(10): 433 9. Haider 1997 Haider, R. Kabir, I. Hamadani, J.D. Habte, D. Reasons for Failure of Breast-Feeding Counselling: Mother s Perspectives in Bangladesh. Bulletin of the World Health Organization 1997;75(3):191 196. Hamalainen 1992 Hamalainen, S. Keinanen-Kiukaanniemi, S. A Controlled Study of the Effects of One Lesson on the Knowledge and Attitudes of School Children Concerning HIV and AIDS. Health Education Journal 1992, (51):3. Hampson 1980 Hampson, R.B. Relative Effectiveness of Behavioural and Reflective Group Training With Foster Mothers. Journal of Consulting and Clinical Pschology 1980;48(2):294 295. Havas 1991 Havas, S. Koumjian, L. Reisman, J. Hsu, L. Wozenski, S. Results of the Massachusetts Model System for Blood Cholesterol Screening Project. JAMA 1991;266(3):375 381. Heikens 1993 Heikens, G.T. Schofield, W.N. Dawson, S. [The kingston Project. II. The effects of high energy supplement and metronidazole on malnourished children rehabilitated in the community: anthropometry]. European Journal of Clinical Nutritionh 47:160 173. Heins 1987 Heins, HC. Nance, NW. Ferguson, JE. Social Support in Improving Perinatal Outcome: The Resource Mothers Program. Obstet Gynecol 1987;70(2):263 6. Helgeson 2001 Helgeson, V.S, Cohen, S, Schulz, R, Yasko, J. Long-Term Effects of Educational and Peer Discussion Group Interventions on Adjustment to Breast Cancer. Health Psychol 2001;20(5):387 92. Hernandez 2000 Hernandez, M.T.E. Rubio, T.M. Ruiz, F.O. Riera, H.S. Gil, R.S. Gomez, J.C. Results of a Home-Based Training Program for Patients with COPD*. Clinical Investigations 106 114. Hill 1999 Hill, M.N, Bone, L.E, Hilton, S.C, Roary, M.C, Kelen, G.D, Levine, D.M. A Clinical Trial to Improve High Blood Pressure Care in Young Urban Black Men. American Journal of Hypertension 1999;12:548 554. Hill 2000 Hill, A.G MacLeod, W.B Joof, D. Gomez, P. Ratcliffe, A.A Walraven, G. [Decline of Mortality in Children in Rural Gambia: The Influence of Village-Level Primary Health Care]. Tropical Medicine and International Health 2000;5(2):107 118. Hodnett 1989 Hodnett, E.D, Osborn, R.W. A Randomized Trial of the Effects of Monitice Support During Labor: Mothers Views Two to Four Weeks Postpartum. Birth 1989;16(4):177 183. Hodnett, ED. Osborn, RW. Effects of Continuous Intrapartum Professional Support on Childbirth Outcomes. Res Nurs Health 1989; 12(5):289 97. Hughes 1992 Hughes SL, Cummings J, Weaver F, Manheim L, Braun B, Conrad K. A randomized trial of the cost effectiveness of VA hospital-based home care for the terminally ill. Health Services Research 1992;26: 801 817. Jepson 1999 Jepson, C. McCorkle, R. Adler, D. Nuamah, I. Lusk, E. Effects of Home Care on Caregiver s Psychological Status. Image:Journal of Nursing Scholarship 1999;31(2):115 119. Jessop 1991 Jessop, D.J. Stein, R.E.K. Who Benifits From a Pediatric Home Care Program?. Pediatrics 1991;88(3):497 505. Johansson 1999 Johansson, B. Berglund, G. Gilmelius, B. holmberg, L. Sjoden, P. Intensified Primary Cancer Care: A Randomized Study of Home Care Nurse Contacts. Journal of Advanced Nursing 1999;30(5):1137 1146. Johnstone 2000 Johnstone, B. Wheeler, L. Deuser, J. Sousa, K.H. Outcomes of the Kaiser Permanent Tele-Home Health Research Project. Arch. Fam.Med 2000;9:40 45. Kaag 1996 Kaag, M.E.C. Wijkel, D. De Jong, D. Primary Health Care Replacing Hospital Care- The effect on Quality of Care. International Journal for Quality Health Care 1996;8(4):367 373. Kamolratanakul 1999 Kamolratanakul, P, Sawert, H, Lertmaharit, Kasetjaroen, Y, Akksilp, S, Tulaporn, C, Punnachest, K, Na-Songkhla, S, Payananadana, V. Randomized controlled trial of directly observed treatment (DOT) for patients with pulmonary tuberculosis in Thailand. Transactions of the Royal Society of Tropical Medicine and Hygiene 1999;93:552 557. Kent 1997 Kent, R.M. Chandler, B. A Comparison of Community Care Services Provided for Younger and Elderly Disabled People. Clinical Rehabilitation 1997;11:265 270. 17

Kidorf 1997 Kidorf, M. Brooner, R. King, VL. Motivatring Methodone Patients to Include Drug-Free Significant Others in Treatment: A Behavioral Intervention. Journal of Substance Abuse Treatment 14(1):23 28. King 1991 King, A.C. Haskell, L. Barr Taylor, C, Kraemer, H.C. DeBusk, R.F. Group-vs Home-Based Exercise Training in Health Older Men and Women. JAMA 1991;266(11):15351542. Kitzman 1983 Kitzman, H. Olds, D.L. Sidora, K. Henderson, C.R. Hanks, C. Cole, R. Luckey, D.W. Bondy, J. Cole, K. Glazener, J. Enduring Effects of Nurse Home Visitation on Maternal Life Course: A 3-Year Followup of a Randomized Trial. JAMA 1983;283(15). Kules 1995 Kules, A.R. Axelrod, A. Utilizing Effective Group Models for Prostate Cancer Patients and their Famlies. Cancer Supplement 1995;75(7): 1892 1896. Kumar 1998 Kumer, M.S Mudaliar, S.Daniels, D. Community-Based Outreach HIV INtervention for Street-Recruited Drug Users in Madras,India. Public Health Reports 1998;113(Supplement 1):58 66. 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Barnes 1999 Barnes K, Friedman SM, Brickner Namerow P, Honig J. Impact of community volunteers on immunization rates of children younger than two years. Arch Pediatr Adolesc Med 1999;153(5):518 524. Berman 1987 Berman, P.A, Gwatkin, D.R, Burger, S.E. Community-based health workers: head start or false start towards health for all?. Soc Sci Med 1987;25(5):443 59. Black 1995 Black, M.M. Dubowitz, H. Hutcheson, J. Berenso-Howard, J. Staar, R.H. A Randomized Clinical Trial of Home Intervention for Children with Failure to Thrive. Pediatrics 1995;95(6):807 814. Bonfill 2004 Bonfill, X, Marzo, M, Pladevall, M, Marti, J, Emparanza, J.I. Strategies for increasing the participation of women in community breast cancer screening (Cochrane Review). The Cochrane Library 2004; Issue 1. Campbell 2000 Campbell, M.K, Grimshaw, J.M, Steen, I.N. Sample size calculations for cluster randomised controlled trials. J Health Serv Res Policy 2000; 5:12 16. Chan 2003 Chan A-W, Altman, D. Discrepancies between protocols and publications: evidence of outcome reporting bias in randomised trials. Paper presented at the XI Cochrane Colloquium: Evidence, health care and culture. Barcelona, Spain: 26-31 October 2003. Dick 1997 Dick J, Clarke M, Tibbs J, Schoeman H. Combating tuberculosislessons learnt from a rural community project in the Klein Drakenstein area of the western Cape. South African Medical Journal 1997; 87(8):1042 1047. Dick 1998 Dick, J, Henchie, S. A cost analysis of the tuberculosis control programme in Elise River, Cape Town. S Afr Med J 1998;88(3 Suppl): 380 83. Farmer 2001 Farmer, P, Leandre, F, Mukherjee, J, Gupta, R, Tarter, L, Kim, J.K. Community-based treatment of advanced HIV disease: introducing DOT-HAART (directly observed therapy with highly active antiretroviral therapy). Bull World Health Organ 2001;79(12):1145 51. Fedder 2003 Fedder, D.O, Chang, R.J, Curry, S, Nichols, G. The effectiveness of a community health worker outreach program on healthcare utilization of west Baltimore City Medicaid patients with diabetes, with or without hypertension. Ethn Dis 2003;13(1):22 7. Foster 1996 Foster G, Mafuka C, Drew R, Kambeu S, Saurombe K. Supporting children in need through a community-based orphan visiting programme. Aids Care 1996; Vol. 8, issue 4:389 403. Frankel 1992 Frankel S. The community health worker: effective programmes for developing countries. Oxford: Oxford University Press, 1992. Hadley 2000 Hadley M, Maher D. Community involvement in tuberculosis control: lessons from other health care programmes. International Journal of Tuberculosis and Lung Disease 2000;4(5):401 408. Hodnett 2004a Hodnett, E.D, Fredericks, S. Support during pregnancy for women at increased risk of low birthweight babies (Cochrane Review). Cochrane Library 2004;Issue 1. Hodnett 2004b Hodnett, E.D, Gates, S, Hofmeyr, G.J, Sakala, C. Continuous support for women during childbirth (Cochrane Review). Cochrane Library 2004;Issue 1. Loewenson 2004 Loewenson, R, McCoy, D. Access to antiretroviral treatment in Africa. New resources and sustainable health systems are needed. BMJ 2004;328:241 42. Love 1997 Love, M.B, Gardner, K, Legion, V. Community Health Workers: who are they and what do they do?. Health Education and Behaviour 1997;24(4):510 22. Maher 1999 Maher D, van Gondrie PCFM, Raviglione M. Community contribution to tuberculosis care in countries with high tuberculosis prevalence: past, present and future. The International Journal of Tuberculosis and Lung Disease 1999;3(9):762 68. Masood 1999 Masood, S. A plea for a worldwide volunteer cervical cancer education and awareness programme. A proposal from the International Academy of Cytology Committee on Cancer Detection for Medically Underserved Women. Acta Cytol 1999;43(4):539 543. Olsen 2004 Olsen O, Gøtzsche PC. Screening for breast cancer with mammography (Cochrane Review). The Cochrane Library 2004, Issue 2. Art. No.: CD001877. DOI:10.1002/14651858.CD001877.pub2. Rosenthal 1998 Rosenthal, E.L. A Summary of the National Community Heath Advisor Study. Annie E. Casey Foundation 1998. Sikorski 2004 Sikorski, J, Renfrew, M.J, Pindoria, S, Wade, A. Support for breastfeeding mothers (Cochrane Review). The Cochrane Library 2004; Issue 1. Sinanovic 2003 Sinanovic, E, Floyd, K, Dudley, L, Azevedo, V, Grant, R, Maher, D. Cost and cost-effectiveness of community-based care for tuberculosis in Cape Town, South Africa. Int J Tuberc Lung Disease 2003;7(9 Suppl 1):S56 62. Swider 2002 Swider S, M. Outcome effectiveness of community health workers: an integrative literature review. Public Health Nurs 2002;19(1):11 20. Unaids 1999 Unaids. Comfort and Hope. Six case studies on mobilizing family and community care for and by people with HIV/AIDS. Unaids Best Practice Collection 1999; Vol. June. 23

Walt 1989 Walt, G, Perara, M, Heggenhougen, K. Are large-scale volunteer community health worker programmes feasible?. Soc Sci Med 1989; 29(5):599 608. Walt 1990 Walt G. Community health workers in national programmes: just another pair of hands?. Milton Keynes: Open University Press, 1990. Ward 2004 Ward, D, Severs, M, Dean, T, Brooks, N. Care home versus hospital and own home environments for rehabilitation of older people (Cochrane Review). The Cochrane Library 2004;Issue 1. Wilkinson 1997 Wilkinson, D, Floyd, K, Gilks, C.F. Costs and cost-effectiveness of alternative tuberculosis management strategies in South Africa - implications for policy. S Afr Med J 1997;87(4):451 5. Witmer 1995 Witmer, A, Seifer, S.D, Finocchio, L, Leslie, J, O Neil, E.H. Community health workers: integral members of the health care work force. Am J Public Health 1995;85(8 Pt 1):1055 58. Zwarenstein 2000 Zwarenstein M, Schoeman JH, Vundule C, Lombard CJ, Tatley M. A randomised controlled trial of lay health workers as direct observation for treatment of tuberculosis. International Journal of Tuberculosis and Lung Disease 2000;4(6):550 554. Indicates the major publication for the study T A B L E S Characteristics of included studies Study Andersen 2000 Methods Participants Interventions RCT LHW: lay health workers were recruited by mail from participating community. TRAINING: trained by field workers, organised by Community Trial of Mammography Promotion. PATIENTS: women aged 50-80 years. 37% had completed high school and 21% reported incomes <$15,000 per year. TOTAL=9484; INTERVENTION 1=2369; INTERVENTION 2=2376; INTERVENTION 3=2369; CONTROL=2370. OBJECTIVE: to promote mammography uptake among women. INTERVENTION 1: individual telephone counselling (ITC). INTERVENTION 2: community activities. INTERVENTION 3: ITC and community activities. CONTROL: no intervention. MODE OF DELIVERY: LHWs delivered barrier specific telephone counselling (BSTC) to individuals and mailed brochures. Community activities included the showing of videos, themed bingo nights and beauty shop promotions, designed to present the benefits of mammography. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. 24

Characteristics of included studies (Continued) GEOGRAPHICAL SETTING: Rural U.S.A. HEALTH CARE SETTING: home and community. Outcomes Notes Allocation concealment HEALTH CARE BEHAVIOURS: frequency of mammography use. FOLLOW UP TIME: 3 years after intervention. Three intervention arms: individual telephone counselling, community activities, both. A Adequate Study Barnes 1999 Methods Participants RCT LHW: most of the volunteers were bilingual. TRAINING: not described. PATIENTS: children <2 years of age who enrolled in one of two ambulatory clinics and were not immunized. Predominantly Hispanic low income children, part of a highly mobile immigrant community from the Dominican Republic. TOTAL=434; INTERVENTION=218; CONTROL=216. Interventions OBJECTIVE: to increase rate of immunization in children <2 years of age. INTERVENTION: immunization outreach, tracking and follow up. CONTROL: no intervention. MODE OF DELIVERY: LHWs contacted participants offering basic immunization education and referral, reminders of upcoming vaccinations and contact to ensure that vaccination was received. They also provided support/assistance to obtain immunization services eg clinic contact, escort for appointments. Control families were informed of child s immunization record and told to reschedule missed appointments. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: primary care facility. Outcomes Notes Allocation concealment HEALTH CARE BEHAVIOURS: immunization status (up to date/due/late). FOLLOW UP TIME: minimum of 5 months follow up. B Unclear Study Barth 1991 Methods Participants Interventions RCT LHW: all parenting consultants were either mothers or had significant experience of bringing up infants and were recrutied to represent ethnic and geographical communities in the service area. TRAINING: volunteers were trained for over 100 hours about the perinatal period, community resources, child abuse, and child abuse reporting and team building. They were also taught the basics of a task centered approach which focuses on the identification of goals for self improvement and child care, and enhances the client s ability to identify and complete tasks that forward goal attainment. Training organised by Child Parent Enrichment Project (CPEP), a community based, private, non profit agency. PATIENTS: mainly white women with a high school education and a mean age of 22.4 years. Most had one child already and 72% had a family income <$10,000 per year. The mean duration of pregnancy on recruitment was 5 months. TOTAL=65; INTERVENTION=29; CONTROL=36. OBJECTIVE: to prevent abuse in children using a perinatal prevention program involving pre-natal education and support; early/extended post partum contact; parent education; home visitation by professionals, paraprofessionals or volunteers. INTERVENTION: parenting consultants. CONTROL: no intervention. 25

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment MODE OF DELIVERY: Services were provided for 6 months and home visits occurred approximately twice a month. Consultants saw approximately 10 families and worked for 20 hours per week. LHWs assisted mothers to identify goals for improved self and child care; enhanced the mothers ability to identify and complete tasks that forward goal attainment; tasks were recorded on sheets for clients and LHWs and accountability of task achievement; tasks included preparing a clean room for the infant to come home to, visiting the labor room prior delivery, etc. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: CPEP. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: psychological measures of parent and infant well being. FOLLOW UP TIME: 6 months after birth of infant. B Unclear Study Black 1995 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: 3 lay home visitors were recruited. Each had experience with children, interpersonal skills and community knowledge. TRAINING: visitors received an 8 session training program featuring lectures, discussions on children s health/nutrition, infant/toddler development, activities to promote child s development, parentchild interaction, behavior management, relationship building, family relationships, child/family advocacy, problem solving strategies, community resources and services. Training organised by university growth and nutrition clinic and community based agency. PATIENTS: children <25 months of age. Weight for age below the 5th percentile based on National Centre for Health statistics growth charts; gestational age of at least 36 weeks; birth weight appropriate for gestational age; no significant history of perinatal complications, no congenital disorders. Patients were recrutied from clinics serving low income families. TOTAL=130; INTERVENTION=64; CONTROL=66. OBJECTIVE: to improve growth and development among children with non-organic failure to thrive (NOFTT). INTERVENTION: home visits and clininc services. CONTROL: clinic services. MODE OF DELIVERY: The home visiting program involved a mean number of visits = 19.2 (SD = 11.5) lasting for approximately 1 hour at a time. Home visits using an individualized family service plan to assist the formation of a therapeutic alliance/support to the mother s familial, personal and environmental needs. The Hawaii Early Learning Program was used as curriculum and home visitors demonstrated developmentally appropriate activities to facilitate parent-child interaction and supported recommendations from clinic nutritionist. CHARACTERISTICS OF TRAINING ORGANISATION: CONSUMER INVOLVEMENT IN DESIGN/DEVLOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: growth, cognitive development, motor development, language development, parent-child interaction, home environment. FOLLOW UP TIME: 12 months after intervention. Home visitors were supervised by a community health nurse and accompanied on some visits by an off-duty police officer.both intervention and control groups received nutrition information/support from the clinic. A Adequate Study Bullock 1995 Methods RCT 26

Characteristics of included studies (Continued) Participants Interventions Outcomes Notes Allocation concealment LHW: 19 volunteers were recruited although the procedure is not described. TRAINING: intial training included information about the research program, research methods, communication techniques and general information about normal occurrences in antenatal/prenatal periods. It was followed by periodic meetings to give information/support to the volunteers. PATIENTS: antenatal women who were either single/in relationship where partner was unemployed (53% single; 18% married; 21% de facto married: 8% separated). Mean age = 24 years. TOTAL=131; INTERVENTION=65; CONTROL=66. OBJECTIVE: to provide support for pregnant women. INTERVENTION: telephone support. CONTROL: no intervention. MODE OF DELIVERY: weekly telephone calls unto 12 weeks after birth of baby. 8 check-off questions to be asked weekly. Referred women to health care provider if there was medical problem and encouraged women to seek assistance from community agencies. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban New Zealand. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: smoking, drinking, marijuana use, nutrition, utilization of community resources. HEALTH STATUS AND WELL BEING: stress, social support from partner, social support from others, self esteem, anxiety. FOLLOW UP TIME: 34 weeks after gestation. A Adequate Study Carpenter 1990 Methods Participants Interventions Outcomes Notes RCT LHW: 41 volunteers were recruited through mother/toddler groups or as students. TRAINING: one hour training session, during which the principles/aims of project were explained and they were introduced to questionnaire. 4 monthly meetings were then held to maintain interest/exchange information. PATIENTS: 467 participants aged 75-84 years and 72 participants aged >85 years. TOTAL=539; INTERVENTION=272; CONTROL=267. OBJECTIVE: to improve referral of elderly persons to care institutions. INTERVENTION: screening interviews. CONTROL: no intervention. MODE OF DELIVERY: volunteers administered scored activity of daily living questionnaires using the Winchester Disability Rating Scale. A daily living test score used to cover home conditions and companionship. Individuals with an increase in score of 5 or more were referred to GPs for further action. Specific requests were also referred. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.K. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: admissions and referrals to care institutions. HEALTH STATUS AND WELL BEING: change in activities of daily living score, mortality. CONSUMER SATISFACTION WITH CARE: general opinions. COSTS: running costs of the project. FOLLOW UP TIME: 39 months after start of intervention. 27

Characteristics of included studies (Continued) Allocation concealment A Adequate Study Caulfield 1998 Methods Participants Interventions Outcomes Notes Allocation concealment Cluster RCT LHW: peer counsellors were former women, infants and children (WIC) clinic clients who had successfully breast fed at least one child. TRAINING: all counselors completed a 5-week training programme adapted from a WIC Manual and administered by the study investigators and staff. PATIENTS: pregnant women who were before 24 weeks gestation and were WIC eligible, carrying single pregnancy, planning to keep the baby, remain in clinic s catchment area. Women were excluded if pregnancy was contra-indicated. 64-86% of women had <high school education; 82-89% were single; 23-37% <18 years of age; 40-53% 18-25 years; 20-27% >25 years of age. TOTAL=548. OBJECTIVE: to promote and support breastfeeding. INTERVENTION 1: peer counsellors. INTERVENTION 2: video education. INTERVENTION 3: peer counsellors and video education. CONTROL: no intervention. MODE OF DELIVERY: peer counsellors followed up those women interested in breastfeeding three or more times during pregnancy and then weekly to 16 weeks postpartum as long as they continued to breastfeed. One clinic in the study received a video based intervention as well. A random quality assurance visit was made to one clinic each week during the study. A checklist was completed to assess whether the intervention was being delivered as planned and any problems were rectified. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: WIC clinics. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: primary care facility (WIC clinics). HEALTH CARE BEHAVIOURS: initiated breastfeeding, still breastfeeding at 7-10 days. FOLLOW UP TIME: 7-10 days post partum. Three intervention arms: peer counsellors, video, both. B Unclear Study Chongsuvivat 1996 Methods Participants Interventions Cluster RCT. LHW: there were approximately 10 volunteers for each of the 15 villages included in the study. TRAINING: health workers trained by pediatricians at regional hospital conducted 2 day training workshop for health volunteers from intervention villages. Training included a video program, lecture, demonstration and simulation, was conducted in Thai/local Malay dialect. The curriculum/media for training was modified from those developed by WHO PATIENTS: children <5 years of age. Mean age = 2.0 years in intervention group and 2.2 years in control control group. There were slightly more males than females. TOTAL=1313; INTERVENTION=664; CONTROL=649. OBJECTIVE: to improve detection of serious acute respiratory infection (ARI). INTERVENTION: village health volunteers. CONTROL: no intervention. MODE OF DELIVERY: volunteers detected serious ARI, gave initial care by sponging and advised referral of cases to a health centre where antibiotics could be given and made a referral to hospital if necessary. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY OF INTEVENTION: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. 28

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment GEOGRAPHICAL SETTING: rural Thailand. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOUR: health care utilization in past week. HEALTH STATUS AND WELL BEING: ARI event in the last week, severity of ARI attack. FOLLOW UP TIME: up to a maximum of 19 weeks. B Unclear Study Dennis 2002 Methods Participants Interventions Outcomes Notes Allocation concealment LHW: 58 volunteer mothers, with minimum of 6 months previous breast feeding experience and a positive breast feeding attitude, were recruited into the participating community organization specifically for the trial. 86.9% had post secondary education. TRAINING: mothers completed a 2.5 hour orientation session. The focus of the orientation session was to develop the peer volunteers telephone support and referral skills; role playing and the verification of problemsolving skills were important components of the session. PATIENTS: mothers with singleton births at 37 weeks gestation or greater. All participants >16 years of age. Majority (75%) aged 25-34 years; approximately 90% married; >60% had college or undergraduate university training; approximately 40% had an annual household income of 40000-79999 Can$. TOTAL=258; INTERVENTION=132; CONTROL=126. OBJECTIVE: to provide peer support to increase breastfeeding duration. INTERVENTION: peer support by volunteers. CONTROL: no intervention. MODE OF DELIVERY: volunteers contacted a new mother by telephone within 48 hours after hospital discharge and as frequently thereafter as the mother deemed necessary: 97% telephone interactions; 3% faceto-face meetings. The mean duration of contact: 53.1 days and 96% contacts made within the first week post partum. Volunteers provided peer support, defined as specific type of social support that incorporates informational, appraisal (feedback) and emotional assistance. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban Canada. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: self reported breast feeding (exclusive, almost excluse, high, partial, token, bottle feeding). LENGTH OF FOLLOW UP: 12 weeks post partum. A 43-page handbook was distributed to all peer volunteers. The handbook outlined provisional services available for referral and was to be used as a reference guide. A Adequate Study Duan 2000 Methods Participants Interventions Cluster RCT LHW: 45 peer counsellors hired from participating churches. Potential candidates were evaluated through telephone interviews, group orientation sessions, written applications and personal references. TRAINING: involved approximately 8-12 hours of workshop training and at least 8-12 hours of additional on-site training at the phone centres. PATIENTS: women from participating churches. 56-61% aged 50-64 years (vs 65-80 years); 55-60% married or cohabiting; >90% had health insurance; >80% had high school or more; >83% had income >$10000. TOTAL=1113 OBJECTIVE: to increase the uptake of mammographic screening for breast cancer. 29

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment INTERVENTION: telephonic mammography counselling. CONTROL: no intervention. MODE OF DELIVERY: counsellors called participants from churches to provide mammography counselling over the phone. The intervention was based on the Health Belief Model which advocates increasing awareness of vulnerability as well as cues to action. The counselling was individualized to address barriers. Women were informed about their risk status and about breast cancer prevalence rates. They were also encouraged to ask their physicians for a referral and information about convenient screening facilities. Counsellors were asked to commit to a minimum of 6 hours of phone work over a 3-4 week period. Selected counsellors received small stipends and transport allowances. Some received token gifts at dinners held during each intervention year. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: participating churches provided volunteers and facilities for delivery. ORGANISATIONAL BASE OF THE INTERVENTION: participating churches. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: maintenance of adherence to mammography screening; conversion of adherence to mammography screening. LENGTH OF FOLLOW UP: 1 year. Materials available to counsellors: barrier specific telephone counseling script; counselling questionnaire; mammography resources guide; call record and counseling record; counselor self-evaluation. Survey firm hired to collect baseline data on the participants B Unclear Study Graham 1992 Methods Participants Interventions Outcomes Notes RCT LHW: 2 home visitors were non-professional Black women who demonstrated rapport with patients from clinic population and had children of their own. TRAINING: specific training was in childbirth education, community resources, and nutrition during pregnancy. The training included reading, discussion groups, weekly meetings, and attendance at hospital prenatal classes. PATIENTS: low income, Black inner city mothers at risk of low birth weight babies. Mean age was 24 years with 21% being between 14 and 20 years and 4% over the age of 35 years. Mothers lived within a 5 mile radius of the hospital. Only high risk participants, initially identified by a medical/psychosocial screening questionnaire, were randomized; a low risk category formed another, non-randomized control population. TOTAL=232; 4 HOME VISITS=87; SOME HOME VISITS=87; CONTROL=58. OBJECTIVE: to reduce the incidence of low birth weight babies (<2500g) among high risk mothers. INTERVENTION: non professional home visitors. CONTROL: no intervention. MODE OF DELVIERY: 4 x 1 hour home visits at 2 to 4 week intervals. Intervention was family focused with goal of strengthening intrafamilial interpersonal support system. Home visitors provided psychosocial support, made efforts to reduce family stress, provided information on health risks during pregnancy (smoking, drinking cessation techniques), provided nutrition education/information for prenatal/childbirth and gave a small gift at each visit. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: frequency of clinic attendance. HEALTH STATUS AND WELL BEING: proportion of low birth weight babies born to high risk mothers. LENGTH OF FOLLOW UP: not described. 30

Characteristics of included studies (Continued) Allocation concealment A Adequate Study Haider 2000 Methods Participants Interventions Outcomes Notes Allocation concealment Cluster RCT LHW: counsellors were local mothers with personal breastfeeding experience, at least 4 years schooling, a willingness to help other mothers and residence in the intervention areas. TRAINING: 40 hours (4 hours x 10 days) by demonstrators and role play using WHO/UNICEF breastfeeding counseling course and King s book (1992). 2 week pilot where volunteers practiced with pregnant mothers and mothers with newborns. Performance monitored at least 3 times during study by breast feeding supervisors. PATIENTS: pregnant women of lower-middle and lower socioeconomic status, aged 16-35 years, with 3 living children or less or parity 5. TOTAL=726; INTERVENTION=363; CONTROL=363. OBJECTIVE: the promotion of exclusive breastfeeding among pregnant women. INTERVENTION: community based peer counsellors. CONTROL: no intervention. MODE OF DELIVERY: one counsellor responsible for 12-25 mothers residing in the same zone. During 15 visits (20-40 mins long) over 5 months counsellors explained the benefits of exclusive breastfeeding for 5 months. Prenatally, mothers were encouraged to eat more and avoid exhaustion. Mothers were also encouraged to hold babies within a few minutes of delivery, and initiate breast feeding within one hour of delivery. Prelacteal and postlacteal foods were discouraged. 15 homebased counselling visits were scheduled, with 2 visits in the first trimester, three in early post partum and the 2/52 until the infant was 5 months old. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: WHO/UNICEF breastfeeding counselling course. GEOGRAPHICAL SETTING: informal urban Bangledesh. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: holding infants after delivery, breastfeeding initiation, exclusive breastfeeding, use of prelacteal foods, use of post lacteal foods. LENGTH OF FOLLOW UP: 5 months. A Adequate Study Heller 1995 Methods Participants Interventions RCT LHW: members of the Australian Cardiacs Association (ACA), a community based non medical intervention whose members have suffered from heart disease. TRAINING: no details given. PATIENTS: aged 25-74 years discharged from hospital with diagnosis of ischaemic heart disease or MI. Patients were excluded if unable to speak English, aphasic, confused or too ill to be disturbed. TOTAL=424; INTERVENTION=202; CONTROL=222 OBJECTIVE: to provide support to patients after cardiac surgery. INTERVENTION: telephone calls from members of the ACA. CONTROL: no intervention. MODE OF DELIVERY: based on nurse advice program. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: ACA members have themselves suffered from heart disease. ORGANISATIONAL BASE OF THE INTERVENTION: ACA, a community-based non-medical organisation. GEOGRAPHICAL SETTING: urban Australia. 31

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: changes in cigarette smoking and diet. HEALTH STATUS AND WELL BEING: quality of life factors - emotional, physical, social. LENGTH OF FOLLOW UP: 6 months after discharge. A Adequate Study Hoare 1994 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: 2 linkworkers able to speak Pakistani and Bangladeshi. TRAINING: only describe as appropriate. PATIENTS: Pakistani and Bangladeshi women aged 50-64 years who were registered with a general practitioner and eligible for NHS Breast Screening Programme. TOTAL=498; INTERVENTION=247; CONTROL=251 OBJECTIVE: to encourage uptake of breast screening for the early detection of breast cancer. INTERVENTION: home visits by linkworkers. CONTROL: no intervention. MODE OF DELIVERY: followed up of women; carried out interviews in the appropriate language using a semi-structured questionnaire; gave a short explanation about breast screening. Home visits featured information and encouragement. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.K. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: breast screening attendance. LENGTH OF FOLLOW UP: continuous. A Adequate Study Ireys 1996 Methods Participants Interventions RCT LHW: 5 mothers (mentors) with children aged 18 to 24 who had juvenile rheumatoid arthritis (JRA) since childhood. TRAINING: the mentors participated in a 30 hour training programme. The programme focused on enhancing three types of social support: (1) informational support (2) affirmational support (3) emotional support. No information on methods used. PATIENTS: mothers who had been active patients of the pediatric rheumatology clinic at Johns Hopkins Hospital. 87.2% were married; 91.7% had at least high school education; 64.6% worked outside of home at least part-time. Children with (JRA). Mean age = 7.7 years; 75% were female; 76% of the children had had JRA for 3 years or more. TOTAL=45; INTERVENTION=25; CONTROL=20. OBJECTIVE: to provide social support for mothers with children who have juvenile rheumatoid arthritis (JRA). INTERVENTION: A-PLUS mentors. CONTROL: no intervention. MODE OF DELIVERY: the mentors aimed to enhance social support (informational, affirmational and emotional) and overall mental health. Their protocol specified that they should (1) make telephone contacts of 5 minutes or more with each assigned mother every 2 weeks (2) meet individually with each mother every 6 weeks (3) hold occasional special events such as picnics. Weekly supervision was provided by the programme 32

Characteristics of included studies (Continued) coordinators - a psychologist and a social worker. Each mentor also met individually with the social worker once a month to review all assigned families. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from JRA. ORGANISATIONAL BASE OF THE INTERVENTION: A-PLUS (Arthritis Parents: Learning, Understanding Sharing) mentors, a commnuity based scheme. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home and community. Outcomes Notes Allocation concealment HEALTH STATUS AND WELL BEING: maternal mental health, perceived availability of social support. LENGTH OF FOLLOW UP: 15 months after intervention. A Adequate Study Ireys 2001 Methods Participants Interventions RCT LHW: 39 veteran mothers or experienced mothers with young adult children affected by chronic disease (diabetes, sickle cell anaemia, moderate to severe asthma and cystic fibrosis). The Network Mothers (NM) were recruited by asking directors and staff of speciality clinics to nominate suitable mothers whose affected child was 18 years or older. TRAINING: network mothers: 30 hour training program, focusing on enhancing skills in listening, reflecting and story swapping. Role plays, videotaped interviews, and in-class practice interviews were used. Successful graduates of the training were invited to participate in the programme and then underwent an additional 20 hours of training along with the child life specialists to reinforce the team aspects of the program and to review operational procedures. The network mothers and child life specialists met together weekly with a paediatrician and a social worker to ensure that the intervention was being delivered as planned. These meetings served to co-ordinate efforts within and across teams, address ongoing problems, and review issues related to recent or upcoming contacts or special events. PATIENTS: Women with children aged 7 to 11 years with one of the following chronic illnesses: diabetes (40%), sickle cell anaemia (19%), cystic fibrosis (9%), moderate to severe asthma (32%). 29% were single mothers of whom 35% only had high school education or less. 70% of mothers had some form of employment. TOTAL=161; INTERVENTION=86; CONTROL=75. OBJECTIVE: to provide social support for mothers of children suffering from chronic illness. INTERVENTION: social support from network mothers. CONTROL: mothers were given a telephone number through which they could reach an experienced parent is they so wished. The experienced parent did not go through any training and did not initiate telephone calls. MODE OF DELIVERY: volunteer mothers performed the following tasks. 7 visits of 60 to 90 minutes to each assigned family, either alone or with the child life specialist; biweekly telephone contacts of at least 5 minutes to build and maintain support, follow up on issues previously discussed or plan future meetings; participation in 3 special events, such as bowling parties or small-group lunches that would allow program parents to meet each other in a nonstressful venue. Through these interventions, the LHWs provided 3 types of support. 1/ informational support, by linking families with existing health and community resources and by sharing information among mothers about child behaviour, parenting and coping. 2/ affirmational support, by enhancing a mother s confidence in parenting and by reassuring her that her concerns and issues were appropriate. 3/ emotional support, by being available to listen to a parent s concerns, demonstrating a continued interest in the mother s viewpoints and experiences, and effectively communicating an understanding of the mother s feelings and concerns. Each network mother had 1 to 7 assigned families and was paid hourly for all program-related efforts. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from a chronic illness. ORGANISATIONAL BASE OF THE INTERVENTION: not described. 33

Characteristics of included studies (Continued) GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home and community. Outcomes Notes Allocation concealment HEALTH STATUS AND WELL BEING: maternal physical health, maternal anxiety, maternal depression, stressful life events, child psychological adjustment, child depression, child report of general anxiety, child self esteem. CONSULTATION PROCESS: number of contact minutes. Child life specialists: this component was designed to enhance the mental health, adjustment and self-esteem of children with selected conditions and was delivered by professionals. It was analysed separately. A Adequate Study Johnson 1993 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: community mothers living in disadvantaged areas who were identified by a local public nurse and interviewed by regional family development nurse to assess suitability. Community leaders/self promoting individuals were generally excluded. TRAINING: four weeks of training, during which the concepts of the programme are explained. Community mothers also meet, exchange ideas and explore ways of delivering the programme. PATIENTS: First time mothers with infant <1 year old. In the control group mean age=23.1 years and in the intervention group mean age=24.1 years. 56% were single; 17% (control) to 29% (intervention) employed; 12% social class I, II, IIINM; 88% social class IIIM,IV,V; 40% live in private hosuing; 60% live in local authority housing; 42% of fathers employed. TOTAL=262; INTERVENTION=141; CONTROL=121. OBJECTIVE: to deliver a child development programme (early reading as a child, language development, cognitive development through play) to disadvantaged mothers. INTERVENTION: non professional community mothers. CONTROL: no intervention. MODE OF DELIVERY: one volunteer mother supports 5 to 15 first time parents with guidance on health/ development. After training, each community mother works under the guidance of a family development nurse, who serves as a resource person, confidante, and monitor. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: based upon the principles inherent in the Early Childhood Development Unit in the University of Bristol. GEOGRAPHICAL SETTING: urban Ireland. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: immunizations, dietry nutrition intake, number of mothers who read to their children, the extent to which mothers use nursery rhyme and song with their children. HEALTH STATUS AND WELL BEING: mother s self esteem, relative risk of having an accident, mother s feeling in year since child was born, hospital admissions. LENGTH OF FOLLOW UP: one year. A Adequate Study Kidane 2000 Methods Participants Cluster RCT LHW: mother coordinators chosen by neighborhood groups of 10-44 households. TRAINING: 2 months of malaria specific training from Malaria Control Program (MCP) including how to teach neighborhood mothers to recognize symptoms of malaria in children <5 years; give appropriate course of treatment; recognize adverse drug reactions, share chloroquine appropriately. PATIENTS: children <5 years and their mothers. 34

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment TOTAL=13677 children in 24 tabias; INTERVENTION=6383 children in 12 tabias; CONTROL=7294 children in 12 tabias. OBJECTIVE: to recognize malaria symptoms in children <5 years old, give appropriate course of treatment, recognize adverse drug reactions and share chloroquine appropriately. INTERVENTION: mother coordinators deliver malaria specific services as well as keep check on births/ deaths and have information on where to refer sick children. CONTROL: coordinators but no malaria specific services. MODE OF DELIVERY: mother coordinators were supplied with drugs for distribution to all households and were responsible for monitoring/replenishing drugs (using pictorial treatment charts to calculate dosage by age). They refered children for further treatment if no improvement in 48 hours. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: households within the villages selected their mother coordinators. ORGANISATIONAL BASE OF THE INTERVENTION: Malaria Control Program (MCP), organised by the department of health. GEOGRAPHICAL SETTING: rural Ethiopia. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: mortality rate in children <5 years old, number of possible malaria deaths in children <5 years old. LENGTH OF FOLLOW UP: one year after intervention. A Adequate Study Komaroff 1974 Methods Participants Interventions Outcomes RCT LHW: physician assistants who had completed high school; none had past work experience of consequence in the health field. Selected for their apparent sensitivity, poise and warmth. Intelligence, willingness and ability to perform repetitive tasks and dexterity. TRAINING: 4 weeks concentrating on protocol skills and psychological aspects of patient care, using a training manual on the pathophysiology of hypertension and diabetes. PATIENTS: diabetes and hypertension patients. Many of the hypertensive patients were also diabetic. Patients included those considered suitable for protocol management by a physician.the typical patient was poor, black, 55 years old women, requiring insulin. TOTAL=137; INTERVENTION=84; CONTROL=53 OBJECTIVE: to make more efficient the care of patients already diagnosed with hypertension or diabetes. INTERVENTION: health care assistants. CONTROL: normal physician care. MODE OF DELIVERY: assistants took patient history; conducted a limited physical examination; ordered lab tests (all guided by computer protocol); encouraged patients to reveal additional symptoms and recorded additional clinical observations. Patients usually saw the same health assistant and each session lasted an average of 25 minutes. Physicians assessed the performance of LHW in the application of the protocols with real patients. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: physician clinical practices. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: primary care facility. CONSULTATION PROCESS: physician acceptance. UTILIZATION OF LHW: physician visit saving. CONSUMER SATISFACTION WITH CARE: patient acceptance. HEALTH STATUS AND WELL BEING: serum glucose levels; blood pressure. LENGTH OF FOLLOW UP: assessments made at following patient visit. 35

Characteristics of included studies (Continued) Notes Allocation concealment B Unclear Study Krieger 1999 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: community health workers who were generally Black (12/14) and all came from low-income neighborhoods similar to intervention site. TRAINING: 100 hours of training on hypertension; the cardiovascular system; risk factors for cardiovascular disease; community resources; research methods; stress management; and alcohol and other drugs. They were also certified as blood pressure measurement specialists. PATIENTS: mainly middle aged, Black, male, poor and unlikely to have received education beyond high school. TOTAL=421: INTERVENTION=209; CONTROL=212. OBJECTIVE: to improve the medical follow up (screening and referral for treatment) of people with elevated blood pressure. INTERVENTION: community health workers assisted referral to blood pressure treatment services. CONTROL: no intervention. MODE OF DELIVERY: community health workers conducted blood pressure (BP) measurements at social service agencies, food banks, shops, shelters, libraries etc. Persons with elevated BP were detected. Those randomized to CHW were then provided with the following services: (1) referral to medical care and, if necessary, assistance in locating a provider; (2) an appointment, or telephone follow-up with clients who preferred to make their own appointment to check that this had been made; (3) an appointment reminder letter; (4) follow-up to determine whether the appointment was kept; (5) a new appointment for each missed appointment (6) assistance in reducing barriers to care through referral to community transportation, child care or other services. Contact activities were monitored with a computerised tracking system. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: primary care facility and community. HEALTH CARE BEHAVIOURS: completion of follow up appointment with health care professional (HCP). LENGTH OF FOLLOW UP: 3 months after enrolment. A Adequate Study Krieger 2000 Methods Participants Interventions RCT LHW: peer to peer outreach volunteers were predominantly African-American senior centre members. TRAINING: 4 hours training including role play sessions. PATIENTS: participants were aged >65 years and resident in targeted ZIP code areas. Ethnically diverse; most low income; most had no complete college. TOTAL=1246; INTERVENTION=622; CONTROL=624 OBJECTIVE: to encourage immunization against influenza and pneumonia. INTERVENTION: Peer to peer outreach volunteers. CONTROL: no intervention. MODE OF DELIVERY: each volunteer contacted 20-25 intervention group participants and used script to encourage immunization of defaulters (receipt of immunization/address barriers to immunization); mailing of educational material. Intervention lasted for 6 weeks. If volunteer could not reach participant after 5 attempts then alternative contact person phoned. Volunteers were assisted by an on site project coordinator. 36

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were predominantly senior citizens. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: influenza and pneumococcal immunization. COST: cost and cost effectiveness. OTHER: change in knowledge, perceived barriers to immunization, appraisal of the intervention. LENGTH OF FOLLOW UP: three months after intervention. B Unclear Study Lapham 1995 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: recovering alcoholics/addicts with at least one year of sobriety. TRAINING: not described. PATIENTS: homeless persons with alcohol related problems. Median age = 37 years (range 18-67); 87% male; non-hispanic whites had somewhat higher education levels. Almost half of the participants identified their profession as skilled labour ; 25% were clerical workers or semi- to unskilled labourers. 49% unemployed over previous 12 months. Those with dependent children, serious mental illness or organic brain syndrome were not considered eligible. TOTAL=469; INTERVENTION 1=161; INTERVENTION 2=164; INTERVENTION 3=92; CON- TROL=52. OBJECTIVE: to encourage positive group interactions and peer group support systems to assist recovering addicts/alcoholics. INTERVENTION 1: case management; substance abuse counseling services; 4 months of transitional housing. INTERVENTION 2: 4 months of transitional housing. INTERVENTION 3: 4 months of housing. MODE OF DELIVERY: case manager and volunteer staff performed therapy/provided education orientated groups, staff transitional housing, provided peer support. The expectation was that participants, with assistance from residence managers, will become motivated to develop group support systems within their respective housing units. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were recovering addicts/alcoholics with at least one year sobriety. ORGANISATIONAL BASE OF THE INTERVENTION: care homes organised by the H&ART project. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: transitional housing. HEALTH CARE BEHAVIOURS: study attrition. HEALTH STATUS AND WELL BEING: drug and alcohol use. LENGTH OF FOLLOW UP: 10 months after intervention. A Adequate Study Leigh 1999 Methods Participants RCT LHW: 69 volunteers recruited through community advertising. TRAINING: after initial screening, three training sessions and then a second interview and 2 psychometric tests before signing a 4 month contract. PATIENTS: chronic alcoholics with a mean age of 30-40 years. 37

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment TOTAL=106; INTERVENTION=52; CONTROL=54. OBJECTIVE: to support recovering alcoholics attending therapy. INTERVENTION: volunteer aides. CONTROL: no intervention. MODE OF DELIVERY: volunteers attended all but client s first treatment session and spent 4-6 hours with each client, each week, in the community. Attempt made to match clients/volunteers on age, sex, educational background. At each session volunteer and client reported on shared activities, planned for future ones and discussed with the therapist best way to achieve client s goals. Volunteer and client agreed to meet each other in the community to work on these goals. Clients could spend part of their session alone with the therapist if they so requested. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban Canada. HEALTH CARE SETTING: community. HEALTH CARE BEHAVIOURS: mean number of drinking days per month, medium number of weeks attended. HEALTH STATUS AND WELL BEING: physical health, emotional function. LENGTH OF FOLLOW UP: 12 months post intervention. B Unclear Study Lin 1997 Methods Participants Interventions Outcomes Notes Allocation concealment Cluster RCT LHW: 24 volunteers selected from the community. TRAINING: volunteers received a 2 day training course from the staff of a local Health Station (clinic). This training included how to measure blood pressure and body weight and the required knowledge related to hypertension and cardiovascular complications. PATIENTS: some participants were diagnosed with hypertension but others had no specific health problems. Average age was approximately 60 years; 47% were male; 85% were married and approximately 12% widowed or divorced, 40% illiterate and 40% had elementary school education; 40-47% were farmers and fisherman, approximately 20% housewives, 15-19% unemployed, 9-19% businessmen or laborers. TOTAL=1102; INTERVENTION=582; CONTROL=520. OBJECTIVE: to improve the follow-up and education of consumers with regard to blood pressure and healthy lifestyle. INTERVENTION: volunteer home visits. CONTROL: no intervention. MODE OF DELIVERY: During home visits, the volunteers measured blood pressure and body weight; conveyed health information related to hypertension, regular blood pressure checks, weight reduction, reduction of alcohol consumption, and physical exercise; encouraged compliance with antihypertensive drug therapy, where appropriate. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: local health station and local Health Promotion Committee. GEOGRAPHICAL SETTING: rural Taiwan. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: hypertension related knowledge and behaviour. HEALTH STATUS AND WELL BEING: blood pressure. LENGTH OF FOLLOW UP: 6 months after intervention. A Adequate 38

Characteristics of included studies (Continued) Study McNeil 1995 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: nonprofessional volunteers who were undergraduate students in psychology, often organized by local church, community or senior groups. TRAINING: not described. PATIENTS: older persons with mild depression. 26 females and 4 females with mean age = 72.5 years; mean education level = 9.2 years. 30% were married; 10% single, divorced or separated. SES was evenly distributed between laborer/homemaker, clerical worker/small business owner, manager/professional. TOTAL=30. OBJECTIVE: to relieve depression in older persons. INTERVENTION 1: accompanied walking. INTERVENTION 2: conversation. CONTROL: no intervention. MODE OF DELIVERY: accompanied walking demonstrated positive effects of aerobic exercise/well being of the elderly, mobility, urine control, balance, exercise endurance. Twice per week, and one alone for 20 minutes. Increase to 40 minutes later. Conversation with OP twice weekly visits for 20 minutes. Increase to 40 minutes. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban Canada. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: subjective health, psychological well being, depression, psychological symptoms score, somatic symptoms score, aerobic capacity. LENGTH OF FOLLOW UP: 6 weeks after intervention. A Adequate Study Morrell 2000 Methods Participants Interventions Outcomes RCT LHW: not described. TRAINING: National vocational qualification (level 2) postnatal care award, endorsement units for domiciliary care award and competence in the care of young children through an 8 week training programme. PATIENTS: women >17 years old who delivered live baby. Mean age was approximately 28 years. TOTAL=623; INTERVENTION=311; CONTROL=312. OBJECTIVE: to provide practical and emotional post-natal support for mothers, including help in gaining confidence in caring for baby and reinforcement of midwifery advice on infant feeding. INTERVENTION: community post natal support workers. CONTROL: no intervention. MODE OF DELIVERY: the intervention group were offered 10 visits from a support worker for up to 3 hours per day in the first 28 postnatal days. Most women received 6 visits and 15% received 10 visits. The length of visits ranged from 10-375 minutes. Time was spent on: housework (38%); talking with the mother (23%); dealing with the baby (9%); dealing with other siblings (8%); bottle feeding (7%); talking about the baby (6%); discussing breast feeding (3%). CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.K. HEALTH CARE SETTING: home. CONSUMER SATISFACTION WITH CARE: consumer satisfaction with midwife, health visitor and general practioner. 39

Characteristics of included studies (Continued) Notes Allocation concealment HEALTH STATUS AND WELL BEING: general health perception, depression, social support, breastfeeding rates. COST: NHS costs, use of social services, personal expenditure. LENGTH OF FOLLOW UP: 6 months after intervention. A Adequate Study Morrow 1999 Methods Participants Interventions Outcomes Notes Allocation concealment Cluster RCT LHW: counselors who previously worked for Instituto National de la Nutrician as field data collectors, lived in the study neighbourhood, were aged 25-30 years, had a high-school education and a commitment to breastfeeding, although did not necessarily have previous personal breastfeeding experience. TRAINING: peer counselors were trained and supervised by staff of La Leche League of Mexico and the physician study coordinator, who was also trained in lactation management. The peer-counsellor training consisted of 1 week of classes, 2 months in lactation clinics and with mother-to-mother support groups, and 1 day of observation and demonstration by visiting experts. Peer counselors also practiced in a non-study neighbourhood for 6 months before the trial and refined the content of messages and their problem solving skills. PATIENTS: all women residing in the periurban study area. Majority had primary or no schooling and were married. Few (7-15%) were employed outside the home. 27% of mothers were primiparous and 31% gave birth by caesarian section. TOTAL=130; INTERVENTION 1=44; INTERVENTION 2=52; CONTROL=34. OBJECTIVE: to promote breastfeeding among pregnant and lactating women. INTERVENTION 1: six home visits. INTERVENTION 2: three home visits. CONTROL: no home visits. MODE OF DELIVERY: Home visits to pregnant women focused on the benefits of exclusive breastfeeding; basic lactation anatomy and physiology; infant positioning; common myths; typical problems and solutions; and preparation for birth. Postpartum visits focused on establishing a healthy breastfeeding pattern; addressing maternal concerns; and providing information and social support. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: support provided by staff of La Leche League, Mexico. GEOGRAPHICAL SETTING: informal urban Mexico. HEALTH CARE SETTING: home. CONSUMER SATISFACTION WITH CARE: maternal satisfaction. HEALTH CARE BEHAVIOURS: exclusive breastfeeding in previous week at 2 weeks and 3 months, practice of exclusive breastfeeding at all five measurement times, duration of any breastfeeding, incidence of diarrhoea in children >3 months of age. LENGTH OF FOLLOW UP: up to 3 months post partum. A Adequate Study Mtango 1986 Methods Participants Cluster RCT LHW: village health workers. TRAINING: courses on Acute Respiratory Infections (ARI). PATIENTS: 18% of children in villages in Bagamoya District were aged <5 years, predominantly Muslim and mainly of Bantu descent. The district s economic base is mainly agricultural, income per capita is among lowest in Tanzania. 40

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment TOTAL=16126 (YEAR 1); 19014 (YEAR 2); INTERVENTION=8028 (YEAR 1); 9099 (YEAR 2); CON- TROL=8098 (YEAR 1); 9915 (YEAR 2). OBJECTIVE: to improve diagnosis, referral and treatment of ARI. INTERVENTION: village health workers (VHW). CONTROL: no intervention. MODE OF DELIVERY: utilization of VHWs to include higher levels of primary care by visiting each household with child <5 years every 6-8 weeks, giving health education to mothers about childhood symptoms/ signs of ARI, treating pneumonia immediately with Cotrimoxazole and referring severe cases to nest higher level of care. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: rural Tanzania. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: mortality rate for children <5 years of age. LENGTH OF FOLLOW UP: 2 years. A Adequate Study Nielsen 1972 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: employees of commercial home aide service given no previous special training. TRAINING: not described. PATIENTS: older persons discharged from hospital. All were 60 years of age or older (median age=74) and 2/3 were female. TOTAL=100; INTERVENTION=50; CONTROL=50. OBJECTIVE: geriatric rehabilitation. INTERVENTION: home aide service. CONTROL: no intervention. MODE OF DELIVERY: home aide service was orientated towards helping the older person carry out the tasks that he would ordinarily do for himself if he were able, or that a family member, if he had one, might do for him. These tasks included house cleaning, meal planning, grocery shopping, bathing, dressing and exercising assistance, escort services, reading to and writing for older participants. The home aides were supervised by mature and experienced paraprofessional workers who were in turn supervised and directed by a social worker and a nurse. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: commercial home aide service. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. CONSUMER SATISFACTION WITH CARE: self assessed/evaluator assessed contentment score. HEALTH CARE BEHAVIOURS: number of admissions/days spent in short and long stay institutions. HEALTH STATUS AND WELL BEING: mortality. LENGTH OF FOLLOW UP: one year. A Adequate Study Olds 2002 Methods Participants RCT LHW: paraprofessional home visitors were required to have high school education but excluded if they had college preparation in the helping disciplines or a bachelor s degree in any discipline as well as strong people skills. Preference was given to those who had previously worked in human services agencies. 41

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment TRAINING: one month intensive training. Volunteers then served 2 families in a pilot program to gain experience with the model and performed regular in service training to cover aspects of MCH/development. PATIENTS: low income women from from 21 antepartum clinics in the Denver metropolitan area, who had no previous live births and who qualified for Medicaid or had no private health insurance. Mean age=19.76 years; 84% of whom were unmarried; had a mean=11 years education; no previous live births; qualified for Medicaid/no private insurance. TOTAL=735; INTERVENTION 1=245; INTERVENTION 2=235; CONTROL=255. OBJECTIVE: child and maternal health promotion to 1) improve maternal/fetal health during pregnancy; 2) improve health/development of child by helping parents provide more competent care; 3) enhance parent s personal development, planning future pregnancies, further education and find work. INTERVENTION 1: paraprofessional home visits. INTERVENTION 2: nurse home visits. CONTROL: no intervention. MODE OF DELIVERY: each visitor managed a case load of 25 families. There were 2 supervisors for 10 visitors. 3/10 visitors left the study and replacements were hired. Paraprofessionals completed approximately 6.3 home visits during pregnancy and 16 visits during infancy. By the end of the program 48% of the paraprofessional visited families had discontinued the program. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. CONSULTATION PROCESS MEASURES: length of visit, family members participating, % time devoted to different progress areas, attempted visits not completed. UTILIZATION OF LHW: program drop out, relationship continuity. CONSUMER SATISFACTION WITH CARE: mother s rating of helping relationship. COST: cost of program or 2 or 5 years service per family. HEALTH CARE BEHAVIOURS: number/timing of subsequent pregnancies, mother-infant interaction, use of psychoactive substances, use of nicotine, marijuana or cocaine, change in tobacco use. HEALTH STATUS AND WELL BEING: child emotional, mental and behavioural development, language development. LENGTH OF FOLLOW UP: up to 24 months. A Adequate Study Ramadas 2003 Methods Participants Interventions Cluster RCT LHW: health workers were biology or social science graduates. TRAINING: 3 month training period organized by the Community Oncology Division of the Regional Cancer Centre (RCC). Taught oral cancer theory including risk factors, natural history, diagnosis, treatment, audio/visual prognosis; trained in field. Control HWs also trained (2 for each panchayath) but not in oral screening techniques. PATIENTS: residents of Kerala who were all over 35 years old. TOTAL=153708; INTERVENTION=78969; CONTROL=74739. OBJECTIVE: to reduce oral cancer mortality through screening. INTERVENTION: health workers delivered a variety of services including oral cancer screening. CONTROL: health worker delivered a variety of services but did not screen for oral cancer. MODE OF DELIVERY: during home visits health workers conducted oral examination and recorded weight, blood pressure and respiratory peak flow measurement; enumerated households and record all their residents; interviewed eligible subjects with respect to socio-demographic factors, personal habits, diet and medical history. Recorded information on structured form; measured height, weight, blood pressure, respiratory peak 42

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment flow; conducted oral/visual inspection to identify anatomic lesions, benign lesions, leukoplakia, oral sub mucous fibrosis and oral cancer. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: Community Oncology Division of the Regional Cancer Centre (RCC). GEOGRAPHICAL SETTING: rural India. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: number of incident oral cancers, number of deaths among oral cancer patients. OTHER: program sensitivity, specificity and positive predictive value. LENGTH OF FOLLOW UP: 1995-2002. B Unclear Study Schuler 2000 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: lay visitors were two middle aged African-American women who had previous experience of making home visits and were familiar with the community where the mothers lived. TRAINING: trained to persue HELP at Home (Hawaii Early Learning Profile, 1991). PATIENTS: women with mean age=27 years. 97.7-100% unemployed; 91.7-96.4% single. TOTAL=171; INTERVENTION=84; CONTROL=87. OBJECTIVE: to increase maternal empowerment and infant development. INTERVENTION: home visitors. CONTROL: no intervention. MODE OF DELIVERY: home visitors delivered a developmentally orientated intervention based on program used by IHDP, providing information on drug use/treatment to increase maternal empowerment and infant development. Home visitors modeled behavior/activity on a sheet. Weekly visits in the first 6 months (mean= 8.9) of mean length=30.1 mins CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: cocaine/heroin, marijuana, alcohol use. HEALTH STATUS AND WELL BEING: mother infant interaction (maternal responsiveness and infant warmth). LENGTH OF FOLLOW UP: 6 months post intervention. A Adequate Study Siegel 1980 Methods Participants RCT LHW: paraprofessional infant care workers. TRAINING: 200 hours of pre-service training including 3 months of multi-method classroom learning experiences and field work during last month of training. Began with orientation to research project then covered mother-infant attachment, child care/development, importance of play/stimulation, special needs of mothers/infants, use of community resources, skills in relating to mothers. Continuous supervision provided by project field director who had a degree in child development. Public health nurses participated in training and served as continuing resources to infant care workers, the relationship was facilitated by the health department PATIENTS: women in third trimester of pregnancy who received care at public prenatal clinic. 43

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment TOTAL=202; INTERVENTION 1=47; INTERVENTION 2=50; INTERVENTION 3=53; CONTROL= 52. OBJECTIVE: to promote mother s involvement with children and support mothers coping with situational stresses. INTERVENTION 1: home visits and extended contact in hospital. INTERVENTION 2: extended contact in hospital only. INTERVENTION 3: home visits only. CONTROL: normal hospital care (approximately 2 ½ hours of routine contact per day). MODE OF DELIVERY: infant care workers first visited mothers in hospital then made 9 visits during first 3 months of infant s life. Hospital contact consisted of at least 45 mins during first three hours after delivery and then at least 5 additional hours each day during hospital stay. During first 6 months of intervention workers met as a group with field director for three hours twice a week (once a week after 6 months). CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: acceptance, interaction/stimulation, consoling, infant positive/negative behaviour. HEALTH STATUS AND WELL BEING: reports of child abuse and neglect. OTHER: health care utilization by infants. LENGTH OF FOLLOW UP: up to 12 months. A Adequate Study Silver 1997 Methods Participants Interventions RCT LHW: 3 lay counselors were were recruited through advertisements in neighborhood newspapers. They were all women who had raised children with ongoing health conditions. Further selection of counselors occurred, but no information provided on how this occurred. TRAINING: 40 hour training programme focusing on listening, reflection and communication skills and on the issues that mothers of children with ongoing conditions experience. A second intensive training programme covered home visiting, coordinating schedules and how to describe the programme to participants. 10 women received 40 hour training program. 6 proceeded to further training and 3 women accepted jobs as lay interveners. PATIENTS: mothers and children with a variety of ongoing health conditions.mothers had an average age of approximately 34 years; one-third were high school graduates, one-third had attended some college and 20% had less than high school education; approximately 40% of mothers were employed; just under half of families were on welfare. Children had an average age of approximately 7 years; on average had been diagnosed for 5 years; both parents were present in fewer than half of households. TOTAL=265; INTERVENTION=183; CONTROL=182. OBJECTIVE: to provide social support and increased access to relevant information, services and knowledgeable advisors for mothers of children with ongoing health conditions. INTERVENTION: support and information from lay counselors. CONTROL: no intervention. MODE OF DELIVERY: through face-to-face home meetings and biweekly telephone calls and group activities the project attempted to 1. Link mothers with community support/resources; 2. Share information about child health/behavior; 3. Enhance maternal confidence in parenting; 4. Provide source of emotional support; 5. Help identify support among mothers naturally occurring network of friends/family. Lay intervenors worked approximately 21 hours per week and were supervised by a clinical psychologist and a social worker. 44

Characteristics of included studies (Continued) CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: social support provided by mothers with older children who had previously suffered from on going health conditions ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home and community. Outcomes Notes Allocation concealment UTILIZATION OF LHW: program participation. HEALTH STATUS AND WELL BEING: children s illness related functional impairment, stressful life events. OTHER: maternal capacity to provide care. LENGTH OF FOLLOW UP: 12 months after intervention. A Adequate Study Sung 1997 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: 20 para-professional home visitors had experience of working in community as self-help support group leader for NBWHP. TRAINING: 10 weeks in interviewing and health education topics. PATIENTS: inner city, low income, African-American women who were recruited from public/senior citizen housing projects, inner-city business settings and by referrals from a health orientated, self help organization. TOTAL=221; INTERVENTION=163; CONTROL=158. OBJECTIVE: to promote breast/cervical screening among inner city African-American women. INTERVENTION: culturally sensitive home education program about cancer prevention. CONTROL: no intervention. MODE OF DELIVERY: women were interviewed using a standard questionnaire and then LHWs visited homes of intervention group. 2 home visits one month apart and booster session 2 months later. The second sessions included 1)Information about breast and cervical cancer screening procedures and video; 2)Information about reproductive health and printed materials. The intervention was delivered over 11 weeks. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: the National Cancer Institute (NCI) supported the study. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: change in screening uptake for pap smear, breast self examination, breast clinical examination, mammography. LENGTH OF FOLLOW UP: 6 months post intervention. B Unclear Study Tudiver 1992 Methods Participants Interventions RCT LHW: volunteers from the gay community. TRAINING: volunteer training was an intensive one-day session on group process and the curriculum for the programme. PATIENTS: gay and bisexual men with a mean age of 32 years (range 14-72); 97% first language English; 83% had some college or university education; 88% were employed; 18% had annual earnings >$40000. 72% had lived in Canada all their lives TOTAL=626; INTERVENTION 1=252; INTERVENTION 2=111; CONTROL=263. OBJECTIVE: to promote AIDS reduction strategies. 45

Characteristics of included studies (Continued) Outcomes Notes Allocation concealment INTERVENTION 1: volunteer led group eduaction seesions. INTERVENTION 2: professional led group education sessions. CONTROL: no intervention. MODE OF DELIVERY: volunteers led highly structured 3 hour education session in one of the participants homes for 8-12 gay and bisexual men on AIDS risk reduction. Each pair of volunteers led several different sessions. These included (1) introduction and goal setting (2) establishment of group rapport (3) the impact of AIDS on individuals and the community (4) safer sex guidelines and risk clarification (5) condom demonstration (6) difficulties with safer sex practices (7) sexual scenario role-play (8) safer sex fantasies and scenarios. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: volunteers were from the gay community. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban Canada. HEALTH CARE SETTING: home. HEALTH CARE BEHAVIOURS: knowledge of AIDS risk score, knowledge of risk score for anal intercourse, impulse control awareness, condom efficacy, sexual practices. LENGTH OF FOLLOW UP: 3 months after intervention. Intervention 2 does not appear to have a lay health worker componant but we are awaiting confirmation from the authors. B Unclear Study Von Korff 1998 Methods Participants Interventions Outcomes Notes RCT LHW: 8 lay leaders who had experienced chronic/recurrent back pain and were willing and able to lead groups according to a highly structured protocol. TRAINING: 2 days of formal training by one of the co-authors (KL). PATIENTS: patients aged 25-70 with back pain who were largely well educated, employed full-time or parttime, married and white with a mean age =50 years. TOTAL=255; INTERVENTION=129; CONTROL=126. OBJECTIVE: to assist patients with chronic back pain with methods of self care regarding exercise programs, posture, etc. INTERVENTION: weekly education classes on self help methods for treating back pain. CONTROL: consumers received a commercial book on back pain care. MODE OF DELIVERY: volunteers led four 2-hour classes, held once a week totaling 16 hours of patient education (information and problem solving skills) and supplemented by written information and videotapes. Classes aimed to teach skills in appropriate pacing of exercise and activity, positive and negative self talk in managing back pain, handling of flare-ups and working with health providers. The classes were conducted according to a fully structured protocol. Self-care materials developed for this study were provided to study participants at the end of the first class session. These materials included a book and two professionally produced videotapes: a 40-minute videotape on back pain self-management and a 25-minute videotape demonstrating exercises. Intervention subjects who did not attend any of the group sessions were not given these educational materials. There were 2 volunteers to 10-15 patients. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: trainers were patients who had recurrent or chronic back pain. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: primary care facility. HEALTH STATUS AND WELL BEING: pain intensity and interference, disability rating, mental health. OTHER: attitudes towards back pain self care, back pain worries. LENGTH OF FOLLOW UP: up to 12 months after intervention. 46

Characteristics of included studies (Continued) Allocation concealment A Adequate Study Voorhees 1996 Methods Participants Interventions Outcomes Notes Allocation concealment Cluster RCT LHW: 29 smoking cessation lay volunteers. TRAINING: a 4 session training programme in understanding smoking behaviour, nicotine addiction and the process of withdrawal. They were also trained to assist people through individual and small group methods PATIENTS: smokers with an average age of approximately 46 years; 68-75% female; 67-81% had more than 12 years of education; 74-78% belonged to Baptist churches. TOTAL=340; INTERVENTION (FOLLOWED UP)=199; CONTROL (FOLLOWED UP)=93; OBJECTIVE: to encourage smokers to quit smoking. INTERVENTION: culturally specific smoking cessation strategies. CONTROL: smoking cessation pamphlet. MODE OF DELIVERY: smoking cessation strategies included assisting registration, carbon monoxide measurement, administration of questionnaires used to assess smoking prevalence, diabetes and coronary disease risk. There were also one to four pastoral sermons on smoking; testimony during church services from individuals going through the quit process; baseline and follow-up health fairs, including voluntary health assessment. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: Baptist churches. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: church facilities. HEALTH CARE BEHAVIOURS: quit rate among smokers, shifts in stages change among smokers. LENGTH OF FOLLOW: one year after baseline. Further additional materials were provided to the intervention group. These included One day at a time book of devotions to assist smokers; Stop Smoking inspirational audiotape; smoking cessation specialist s manual. A Adequate Study Wan 1980 Methods Participants Interventions RCT LHW: homemakers. TRAINING: no details given of training or support. PATIENTS: the elderly who might otherwise need long term care. 48% over the age of 75. Mixed gender with 80% of sample being classified as White. About ¼ of sample lived alone. Over half were severely dependent. TOTAL=1871; INTERVENTION 1=307 (CONTROL=323); INTERVENTION 2=194 (CONTROL= 190); INTERVENTION 3=59 (CONTROL=80). OBJECTIVE: to provide day care and homemaker services for the elderly. INTERVENTION 1: homemaker services. INTERVENTION 2: day care services. INTERVENTION 3: both homemaker and day care services. CONTROL: no services for all three interventions. MODE OF DELIVERY: homemaker services included cooking, cleaning, laundry, ironing, assistance with activities such as eating, walking, dressing, bathing etc, shopping, health care management, accompanying the patient to the health services, assisting visiting health professionals. Day care services included nursing, social services, meals, transportation, patient activities, occupational therapy, speech therapy, eye, ear and podiatric therapy. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. 47

Characteristics of included studies (Continued) HEALTH CARE SETTING: home and primary care facility/community. Outcomes Notes Allocation concealment HEALTH STATUS AND WELL BEING: activites of daily living, mental health status, contentment, activity scale, mortality. LENGTH OF FOLLOW UP: 12 months. A Adequate Study Weinberger 1989 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: 21 non medical personel. TRAINING: not described. PATIENTS: osteoarthritis patients from the Regenstrief Medical Record System with a mean age=62.3 years; 87.7% were women; 23.2% were currently married; average years of education =9.3; 65.6% reported annual family incomes below US$6000. TOTAL=439; INTERVENTION 1=109; INTERVENTION 2=109; INTERVENTION 3=109; CON- TROL=112. OBJECTIVE: to improve the treatment of patients with osteoarthritis. INTERVENTION 1: telephone contact. INTERVENTION 2: clinic contact. INTERVENTION 3: telephone and clinic contact. CONTROL: regular treatment. MODE OF DELIVERY: telephone group - called monthly except when called one week before scheduled clinic visit to remind patients of appointment. Schedule then shifted to return to monthly calls. Clinic group - intervention interview delivered at all scheduled visits to GMP. At each contact interview, the following items were discussed. 1) Problems with joint pain; 2) Medications (i.e. compliance, whether the supply was sufficient to last until the next appointment); 3) Gastrointestinal and other symptoms; 4) Presence of early warning signs for hypertension, heart disease, diabetes and chronic obstructive pulmonary disease; 5) Date of the next scheduled outpatient visit; 6) An established mechanism whereby patients could telephone a physician during evenings and weekends; 7) Barriers to keeping appointments. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF CARE: Regenstrief Medical Record System. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home and primary care facility. UTILIZATION OF LHW: mean number of contacts between patients and LHWs. CONSUMER SATISFACTION WITH CARE: Rand Corporation satisfaction with health care scale. HEALTH CARE BEHAVIOURS: compliance with medication over preceding week. HEALTH STATUS AND WELL BEING: arthritis impact measurement including psychological health, physical health and pain scores, Philedelphia Geriatric Centre Morale Scale. OTHER: perceived availability of social support. LENGTH OF FOLLOW UP: 11 months after enrolment. A Adequate Study Wertz 1986 Methods Participants RCT LHW: volunteers friends/familiy members of patients with no previous experience in health care. TRAINING: volunteers received 6-10 hours training weekly for 12 weeks: information on aphasia, observing treatment of aphasia on videotape, practicing techniques to use. Speech pathologist trained the home therapist volunteers and developed treatment programs they administered. 48

Characteristics of included studies (Continued) Interventions Outcomes Notes Allocation concealment PATIENTS: aphasic patient 2-24 weeks after stroke who were75 years or younger and could read/write in English. TOTAL=121; INTERVENTION 1=38; INTERVENTION 2=43; CONTROL=40. OBJECTIVE: to provide home treatment for aphasic patients. INTERVENTION 1: treatment in clinic following stroke. INTERVENTION 2: treatment at home following stroke. CONTROL: no treatment in first 12 weeks following stroke. MODE OF DELIVERY: LHWs administered programs of stimulus response designed by speech therapists. Individual programs were customized by speech therapist to the patient s needs and each patient received 8-10 hours of treatment. Every 2 weeks volunteer-patient pairs were videoed and approach was discussed by therapist after she had reviewed tape. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: consumer s family/friends selected to deliver the intervention. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.S.A. HEALTH CARE SETTING: home and primary care facility (clinic). HEALTH STATUS AND WELL BEING: comprehension, reading, writing and speaking ability. LENGTH OF FOLLOW UP: up to 24 weeks post intervention. A Adequate Study Williams 1992 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: health visitor assistants (HVA). TRAINING: not described. PATIENTS: aged >75 years who were discharged from hospital during study and returned to their own/ relatives houses but did not require district nursing. TOTAL=470; INTERVENTION=231; CONTROL=239. OBJECTIVE: to provide support and treatment to elderly patients in the year following discharge from hospital. INTERVENTION: health visitor assistants. CONTROL: no intervention. MODE OF DELIVERY: HVAs visited consumers following discharge from hospital according to the following schedule - 2 x 2 weeks following discharge 3 x monthly visits; 3 x 2 monthly visits (8 visits per year). They initiated actions including medication; heating; housing; mobility; sight; hearing; eating; sleeping; incontinence; mental state; loneliness; shopping; cooking; cleaning; laundry; appearance; feet; aids and appliances; financial benefits and carer relief; counseling support or advice. They were supported by a community based registered general nurse. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: not described. ORGANISATIONAL BASE OF THE INTERVENTION: not described. GEOGRAPHICAL SETTING: urban U.K. HEALTH CARE SETTING: home. CONSULTATION PROCESS: number of patients who had full 8 visits, recorded actions at each visit. HEALTH STATUS AND WELL BEING: physical status, disability level, mental status. OTHER: discharge from hospital, home circumstances, informal support, use of social and nursing services, need for help from social services, need for information on financial benefits. LENGTH OF FOLLOW UP: one year after discharge from hospital. A Adequate 49

Study Zwarenstein 2000 Methods Participants Interventions Outcomes Notes Allocation concealment RCT LHW: many of the lay health workers (LHW) were previous TB patients, or had TB in the family. TRAINING: 5 mornings of interactive health promotion education. The rationale was that the process of training the LHW volunteers would increase knowledge of the disease in the community. PATIENTS: pulmonary tuberculosis patients of whom 49% <35 years of age; 58% male; 69% single; 89% living in formal housing; 11% employed; 22% had >11 years of schooling. TOTAL=156; INTERVENTION 1=54; INTERVENTION 2=44; CONTROL=58. OBJECTIVE: to improve tuberculosis (TB) treatment outcomes for pulmonary TB. INTERVENTION 1: observation of TB treatment taking by lay health workers. INTERVENTION 2: self observed TB treatment taking. CONTROL: nurse observed TB treatment taking at a clinic MODE OF DELIVERY: LHW supervises the daily dose of anti-tuberculosis medication. The TB patient came to the LHW s house each day, and the LHW administered the medication from the supplies that they held. They then monitored this on a compliance record. If the patient missed a day s treatment, the LHW visited the patient s home. If the LHW could not solve the problem, a staff member of the managing NGO visited the patient. CONSUMER INVOLVEMENT IN DESIGN/DEVELOPMENT/DELIVERY: many LHWs were previous TB patients who family members of TB patients. ORGANISATIONAL BASE OF THE INTERVENTION: SANTA, a TB NGO. GEOGRAPHICAL SETTING: urban South Africa. HEALTH CARE SETTING: home. HEALTH STATUS AND WELL BEING: successful TB treatment completion (patients cured and patients completely cured), successful treatment in new patients, sucecssful treatment in recurrent patients, successful treatment in female patients, successful treatment in male patients. LENGTH OF TREATMENT: 6 months. A Adequate Characteristics of excluded studies Study Akram 1997 Anderson 1998 Andresen 1992 Arlotti 1998 Armstrong 1999 Ashworth 1992 Assar 2000 Ayele 1993 Bailey 1996 Bang 1993 Bang 1994 Bang 1999 Berry 1991 Bester 1991 Reason for exclusion Not a RCT Not a RCT Review article Not a RCT Not a RCT Education programme delivered in schools Study compares two types of LHW Not an RCT, view as a CBA. Both groups intervention and control have CHA Not an RCT, not an CHW. This study compared 2 ways of training LHW Controlled field study Field trial Not a RCT Not a RCT Descriptive study not an RCT. 50

Bhattacharya 1988 Bird 1998 Boucher 1987 Brennan 1991 Brook 1989 Brownstein 1992 Bullough 1989 Chamberlain 2001 Charles 1974 Chen 1999 Christopher 1990 Corrado 2000 Cox 1998 Dalby 2000 Davies-Adetugbo 1997 Davis 1994 Delacollette 1996 Dennis 1997 DiCenso 1997 DiClemente 1989 Dick 1997 Durand 1992 Durlak 1981 Gerson 1976 Goodburn 2000 Graham 2002 Grande 1999 Gray 1980 Greenwood 1989 Gunnell 2000 Gupta 1992 Haider 1997 Hamalainen 1992 Hampson 1980 Havas 1991 Heikens 1993 Heins 1987 Helgeson 2001 Hernandez 2000 Hill 1999 Hill 2000 Hodnett 1989 Hughes 1992 Quasi randomization,? systematic. Not CHW intervention. Training for mothers and family members. Not a RCT. Not a RCT or LHW RCT but not achw Not a RCT Review article Both groups have CHW involement Study compares two types of LHW Not a RCT or LWH study RCT but not LHW Not a RCT Not a RCT Not a LHW study Not a LHW study Controlled before and after Not a RCT Not a RCT. Not LHW study Not LHW study Intervention delivered by teachers Not a RCT Not a RCT NOT a RCT RCT but nor a LHW project Not a RCT School based, teacher led intervention RCT but not CHW Professional staff who administer the intervention Not LHW study Randomized but not CHW intervention. Not a LHW studt Not a RCT Formal education setting RCT not a LHW project Not a RCT RCT but not CHW. Both groups provided with care. Not a RCT Not LHW study RCT but not CHW. Not LHW study Not a RCT Not LHWs but midwives in training to become professional RCT but not a CHW. 51

Jepson 1999 Jessop 1991 Johansson 1999 Johnstone 2000 Kaag 1996 Kamolratanakul 1999 Kent 1997 Kidorf 1997 King 1991 Kitzman 1983 Kules 1995 Kumar 1998 Larson 1980 Lasater 1996 Lefeber 1997 Lin,T 1997 Lindsay 1993 Linn 1977 Mallams 1982 Mandelblatt 1996 Margolis 1998 May 1986 Mc Farlane 1997 McCosker 1997 McCurren 1999 McInnes 2000 Menendez 1994 Menendez,C Mercier 1992 Moongtui 2000 Mowles 1982 Muijen 1992 Nations 1997 Neittaanmaki 1980 Newcomer 1999 Newell 1993 Nikodem 2001 Pai 1982 Pai 1983 Paulson 1999 Radentz,W.H Rettig,B 1986 RCT but not a CHW Not LHW study Not LHW study RCT but not an CHW Not LHW study Within intervention arm allocation to LHW or professional supervision was not random Not a RCT Not a RCT Not LHW study Not LHW study Not a RCT Controlled field study Not RCT, visits by undergraduate students Not LHW study Not a RCT Controlled before and after Not a RCT Institutionalised professional care Patient support group intervention Not a RCT Not a RCT Not a RCT Not a RCT Not a RCT Insitutionalised care This study is a CCT not a RCT Not LHW study Study measuring effectivness Not a RCT or a LHW project Not LHW study Not a RCT RCT but not a LHW project Not a RCT Not a RCT RCT but not a LHW intervention. Not an RCT Institutionalised care Used trained nurses Not a LHW project Not a RCT Tested the use of an audiovisual health education program Not LHW study 52

Robinson 1988 Rotheram-Borus 1991 Rubenstein 1978 Samman 1999 Saylor 1983 Scarano 1987 Schafer 1998 Schardin 1994 Searle 1999 Shaughnessy 1996 Shaw 1999 Small 1987 Smith 2000 Smith, JB 2000 Spiby 1999 Stephens 1996 Stephenson 1998 Stewart 1999 Strawczynski 1973 Stricklin 2000 Sullivan 1999 Susser 1998 Terefe 1993 Teri 1999 Tessaro 1997 Thomas 1985 Thouw 1992 Tinetti 1993 Tinetti 1999 Toobert 2000 Townsend 1976 Tramarin 1992 Tuckman 1994 Tudiver, F 1992 Uphold 2000 Victora 1994 Walraven 1995 Walton 1993 Wanlass 1983 Watts 1995 Weiler 1993 Weinberger 1988 RCT but both groups have CHW s. Family caregivers intervention is training to CHW Not a RCT Not a RCT Not LHW study Not a RCT Not a RCT Controlled before and after Not a RCT RCT but not a LHW project Not a RCT Not a RCT Comparison of two types of LHW Not LHW study Not a RCT Not a RCT Not a RCT Health education intervention administered in schools Not a RCT Not a LHW project Not a LHW, not a RCT Not LHW study Not a LHW project RCT but both groups have CHW involvement. The intervention was husband involvement Not a RCT Not a LHW study Intervention delivered by public health nurses or health education teachers Not a RCT RCT but not CHW Not LHW study Not LHW study Not LHW Not LHW study Not a RCT RCT but not a LHW study Not a LHW project or a RCT Not LHW study Not LHW study RCT but not CHW Not LHW study Review article; not LHW study Not an RCT or LHW study Not LHW study 53

Characteristics of excluded studies (Continued) Wenger 1992 Weuve 2000 Williams, EI 1992 Wolf 1985 Not LHW study Randomized but probably not CHW intervention. Both groups had family caregivers Not LHW study Intervention used Visiting Nurse Association A D D I T I O N A L T A B L E S Table 01. Methodological quality assessment using EPOC criteria for included studies Study Andersen 2000 Barnes 1999 Barth 1991 Bullock 1995 Carpenter 1990 Caulfield 1998 Chongsuvivatwong 1996 Dennis 2002 Duan 2000 Graham 1992 Haider 2000 Heller 1995 Hoare 1994 Allocation procedure Level of allocation Baseline measure Primary outcome Loss to follow up Contamination Assessors blind Intention to treat Unit analysis error Done Done Done Done Done Done Done Done Yes, adjustment unclear Unclear Done Done Done Unclear Done Not done Unclear No Unclear Done Done Done Not done Unclear Unclear Unclear No Done Done Done Done Done Done Unclear Done Yes, adjustment unclear Done Done Done Unclear Not done Done Not done Unclear Unclear Done Unclear Unclear Not done Unclear Not done Unclear Yes, adjustment unclear Unclear Done Done Done Done Unclear Unclear Done Yes, adjustment made Done Done Done Done Done Done Done Done No Unclear Done Done Unclear Unclear Unclear Not done Unclear Yes, adjustment unclear Done Done Done Done Unclear Unclear Unclear Done No Done Done Done Done Done Unclear Not done Unclear Yes, adjustment made. Done Done Done Done Not done Done Not done Done No Done Done Done Done Not done Not done Unclear Done No Hutche- Done Done Done Done Done Done Done Unclear No 54

Table 01. Methodological quality assessment using EPOC criteria for included studies (Continued) Study Allocation procedure Level of allocation Baseline measure Primary outcome Loss to follow up Contamination Assessors blind Intention to treat Unit analysis error son 1997 Ireys 1996 Done Done Unclear Unclear Done Unclear Unclear Unclear No Ireys 2001 Done Done Done Done Done Done Done Done No Johnson 1993 Kidane 2000 Komaroff 1974 Krieger 1999 Krieger 2000 Lapham 1995 Leigh 1999 Done Done Unclear Unclear Done Unclear Not done Unclear No Done Done Done Done Done Unclear Done Done Yes, adjustment made Unclear Done Done Done Unclear Not done Unclear Unclear No Done Done Done Done Not done Done Done Not done No Unclear Done Done Done Done Unclear Unclear Not done No Done Done Done Done Unclear Unclear Done Done No Unclear Done Done Done Not done Unclear Done Unclear No Lin 1997 Done Done Done Unclear Not done Done Done Unclear Yes, adjustment unclear McNeil 1995 Morrell 2000 Morrow 1999 Mtango 1986 Nielsen 1972 Done Done Done Done Unclear Done Unclear Done No Done Done Done Done Done Unclear Not done Done No Done Done Done Unclear Done Done Not done Done Yes, adjustment made Done Done Not done Not done Unclear Unclear Unclear Done Yes, adjustment unclear Done Done Done Done Done Unclear Unclear Done No Olds 2002 Done Done Done Unclear Done Done Done Done No Sankanarayanan 2000 Unclear Done Done Done Unclear Done Unclear Done Yes, adjustment unclear Schuler Done Done Done Unclear Done Done Done Done No 55

Table 01. Methodological quality assessment using EPOC criteria for included studies (Continued) Study Allocation procedure Level of allocation Baseline measure Primary outcome Loss to follow up Contamination Assessors blind Intention to treat Unit analysis error 2000 Siegel 1980 Silver 1997 Done Done Done Done Unclear Done Done Done No Done Done Unclear Unclear Done Unclear Done Done No Sung 1997 Unclear Done Done Done Unclear Unclear Not done Done No Tudiver 1992 Van Korff 1998 Voorhees 1996 Unclear Done Done Done Unclear Not done Not done Done No Done Done Done Done Done Unclear Done Done Yes, adjustment made Done Done Done Done Done Done Done (biochemical measure only) Wan 1980 Done Done Done Unclear Not done Unclear Unclear Not done No Weinberger 1989 Wertz 1986 Williams 1992 Zwarenstein 2000 Done Done Done Done Done Done Unclear Done Done No Done Done Done Done Unclear Done Done Done No Done Done Done Done Not done Unclear Unclear Not done No Done Done Done Done Done Unclear Unclear Done No Yes, adjustments made Table 02. Methodological quality summary scores for all included studies Study Andersen 2000 Barnes 1999 Barth 1991 Bullock 1995 Carpenter 1990 Caulfield 1998 Summary score H (High) L (Low) L H L L 56

Table 02. Methodological quality summary scores for all included studies (Continued) Study Chongsuvivatwong 1996 Dennis 2002 Duan 2000 Graham 1992 Haider 2000 Heller 1995 Hoare 1994 Hutcheson 1997 Ireys 1996 Ireys 2001 Johnson 1993 Kidane 2000 Komaroff 1974 Krieger 1999 Krieger 2000 Lapham 1995 Leigh 1999 Lin 1997 McNeil 1995 Morrell 2000 Morrow 1999 Mtango 1986 Nielsen 1972 Olds 2002 Ramadas 2003 Schuler 2000 Siegel 1980 Silver 1997 Sung 1997 Tudiver 1992 Van Korff 1998 Summary score L H L L L L L L L H L H L L L L L L L H H L H H L H L H L L H 57

Table 02. Methodological quality summary scores for all included studies (Continued) Study Voorhees 1996 Wan 1980 Weinberger 1989 Wertz 1986 Williams 1992 Zwarenstein 2000 Summary score H L H L L H 58

59 Table 03. Primary objective of LHW intervention for all included studies Objective of LHWs Study Details 1. Delivery of treatment/medical service (this category includes interventions that actively treat, or improve the current treatment of, a health related condition). 2. Changing knowledge, attitudes and behaviour (this category includes any intervention that provides information, education or support intended to change the consumer s knowledge, attitude or behaviour towards a health related issue). 1. Carpenter 1990 2. Chonsuvivatwong 1996 3. Kidane 2000 4. Komaroff 1974 5. Krieger 1999 6. Lin 1997 7. Mtango 1986 8. Ramadas 2000 9. Weinberger 1989 10. Wertz 1986 11. Zwarenstein 2000 1. Andersen 2000 2. Barnes 1999 3. Barth 1988 4. Bullock 1995 5. Caulfield 1998 6. Dennis 2002 7. Duan 2000 8. Haider 2000 9. Heller 1995 10. Hoare 1994 11. Johnson 1993 12. Krieger 2000 13. Morrow 1999 14. Olds 2002 15. Schuler 2000 16. Siegel 1980 17. Sung 1997 18. Tudiver 1992 19. Von Korff 1998 20. Voorhees 1996 1. Screening interviews for the elderly to improve referral for treatment 2. Detection of serious ARI infections 3. Recognition/treatment of malaria symptoms in children <5 years of age 4. Care of patients diagnosed with hypertension/diabetes 5. Blood pressure screening and referral for treatment 6. Follow up/education to promote healthy lifestyle and lower blood pressure 7. Diagnosis/referral/treatment of ARI 8. Screening for oral cancer 9. Improve treatment of OA patients 10. Home treatment for aphasic patients 11. Directly observed therapy for TB patients 1. Counselling to promote mammography uptake among women 2. Increase immunization uptake by education outreach/tracking and follow up. 3. Education/support/contact to prevent child abuse 4. Psychological support for pregnant women 5. Breastfeeding promotion and support 6. Peer support to improve breastfeeding duration 7. Telephone mammography counselling 8. Promotion of exclusive breastfeeding among pregnant women 9. Telephone support/advice for CHD patients 10. Encourage uptake of breast screening in Pakistani and Bangladeshi women 11. Support/education to encourage child development programs 12. Peer outreach to encourage pneumonia and influenza immunization 13. Home visits to promote breastfeeding 14. Child and maternal health promotion 15. Increase maternal empowerment and infant development 16. Promote mother s involvement with child 17. Promote breast/cervical cancer screening 18. Promotion of AIDS reduction strategies 19. Self care treatment of back pain education 20. Smoking cessation strategies

Table 03. Primary objective of LHW intervention for all included studies (Continued) Objective of LHWs Study Details 3. Psycho-social support (this category includes interventions where the primary intention is to provide support. Interventions that change behaviours as a result of support are included in category 2). 4. Multifaceted interventions (this category includes interventions that explicitly combine two or more of the objectives listed above). 1. Ireys 1996 2. Ireys 2001 3. Lapham 1995 4. Leigh 1999 5. Morrell 2000 6. Silver 1997 1. Black 1995 (1,2,3) 2. Graham 1992 (1,2,3) 3. McNeil 1995 (1,3) 4. Nielsen 1972 (1,3) 5. Wan 1980 (1,3) 6. Williams 1992 (1,3) 1. Social support for mothers whose children have JRA 2. Social support for mothers whose children have a chronic illness 3. Transitional housing/support to assist recovering addicts/alcoholics 4. Support for recovering alcoholics attending therapy 5. Practical and emotional support for new mothers 6. Social support and information access for mothers whose children have ongoing health conditions 1. Improve growth/development among children with NOFTT 2. Home visiting and support to prevent LBW babies 3. Physical activity and companionship to relieve depression in the elderly 4. Home aide service for the elderly 5. Day care and homemaker services 6. Support/treatment for the elderly following hospital discharge 60

Table 04. LHWs to promote breast cancer screening uptake compared with usual care Study Outcome type Control group Intervention group Statistical sig. Andersen 2000 Health care behaviours % mammography use (new users) = 0.578 % mammography use (relapse) = 0.922 Duan 2000 Health care behaviours Year 1 mammography nonadherence 1/ maintenance (maintaining adherence): n=258 (23.3%) 2/ conversion (becoming adherent): n=139 (37.4%) Hoare 1994 Health care behaviours Breast screening attendance 1/ All women 117 (47%) 2/ Pakistani women 79 (51%) 3/ Bangladeshi women 38 (40%) Sung 1997 Health care behaviours % change in screening uptake: 1/ Pap smear 10.2% 2/ Breast self Exam -0.1% 3/ Clinical Breast Exam 3.8% 4/ Mammography 5.1% CA: % mammography use (new users) = 0.599 IC: % mammography use (new users) = 0.606 CA+IC: % mammography use (new users) = 0.604 CA: % mammography use (relapse) = 0.951 IC: % mammography use (relapse) = 0.918 CA+IC: % mammography use (relapse) = 0.936 Year 1 mammography nonadherence 1/ maintenance (maintaining adherence): n=264 (15.8%) 2/ conversion (becoming adherent): n=152 (34.8%) Breast screening attendance 1/ All women 122 (49%) 2/ Pakistani women 83 (54%) 3/ Bangladeshi women 39 (42%) % change in screening uptake: 1/ Pap smear 8.4% 2/ Breast self exam -1.1% 3/ Clinical Breast Exam 8.7% 4/ Mammography 14.9% p = 0.40 (interventions combined) p = 0.30 (interventions combined) 1/ p=0.029 (one sided) 2/ p=0.324 (one sided) 1/ p=0.53 2/ p= 0.56 3/ p=0.79 Mean differences and 95% CIs: 1/ Difference -1.8% (-8.0,4.4) 2/ Difference -1% (-6.1, 4.1) 3/ Difference 4.9% (-0.4, 10.2) 4/ Difference 9.8% (2.9, 16.7) 61

62 Table 05. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care Study Outcome type Control group Intervention group Statistical sig. Caulfield 1998 Health care behaviours All values given are percentages. 1/ Intention to breastfeed at enrolment= 23 at 34 weeks=14 2/ Initiated breastfeeding = 26 3/ Still breastfeeding at 7-10 days postpartum = 14 4/ Breastfeeding initiation by intention at enrolment Breastfeed=62 Artificial milk=16 5/ Breastfeeding at 7-10 days postpartum by intention at enrolment Breastfeed=63 Artificial milk=43 All values given are percentages. Intervention 1: LHW 1/ Intention to breastfeed at enrolment= 53 at 34 weeks=38 2/ Initiated breastfeeding = 50 3/ Still breastfeeding at 7-10 days postpartum = 32 4/ Breastfeeding initiation by intention at enrolment Breastfeed=77 Artificial milk=21 5/ Breastfeeding at 7-10 days postpartum by intention at enrolment Breastfeed=77 Artificial milk=17 Intervention 2: video 1/ Intention to breastfeed at enrolment= 53 34 weeks=42 2/ Initiated breastfeeding = 62 3/ Still breastfeeding at 7-10 days postpartum = 38 4/ Breastfeeding initiation by intention at enrolment Breastfeed=86 Artificial milk=35 5/ Breastfeeding at 7-10 days postpartum by intention at enrolment Breastfeed=68 Artificial milk=44 LHW and video intervention 1/ Intention to breastfeed at enrolment= 44 34 weeks=41 2/ Initiated breastfeeding = 52 3/ Still breastfeeding at 7-10 days LHW: Initiated breastfeeding OR (CI) = 3.84 (1.44, 10.21) Still breastfeeding at 7-10 days OR (CI) = 1.11 (0.34, 3.61) Video: Initiated breastfeeding OR (CI) = 1.36 (0.52, 3.54) Still breastfeeding at 7-10 days OR (CI) = 0.79 (0.25, 2.52) LHW + Video: Initiated breastfeeding OR (CI) = 1.92 (0.78, 4.76) Still breastfeeding at 7-10 days OR (CI) = 1.52 (0.50, 4.59)

63 Table 05. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Dennis 2002 Health care behaviours 1.1 Self-reported breastfeeding within the 24 hours preceding the (a) 4 = 104 (83.9%) (b) 8 = 93 (75.0%) (c) 12 = 83 (66.9%) week telephone interview 2.1 Type of breastfeeding: No. (%) at 4 weeks: - exclusive = 78 (62.9) - bottle feeding = 20 (16.1) 2.2 Type of breastfeeding: No. (%) at 8 weeks: - exclusive = 68 (54.8) - bottle feeding = 31 (25.0) 2.3 Type of breastfeeding: No. (%) at 12 weeks: - exclusive = 50 (40.3) - bottle feeding = 41 (33.1) Haider 2000 Health care behaviours 1/ Time holding babies median=1 hr range=0-33 2/ Time of breastfeeding initiation median=1 hr postpartum = 38 4/ Breastfeeding initiation by intention at enrolment Breastfeed=83 Artificial milk=27 5/ Breastfeeding at 7-10 days postpartum by intention at enrolment Breastfeed=79 Artificial milk=40 1.1 Self-reported breastfeeding within the 24 hours preceding the (a) 4 weeks = 122 (92.4%) (b) 8 = 112 (84.8%) (c) 12 = 107 (81.1%) week telephone interview 2.1 Type of breastfeeding: No. (%) at 4 weeks: - exclusive = 98 (74.2) - bottle feeding =10 (7.6) 2.2 Type of breastfeeding: No. (%) at 8 weeks: - exclusive = 83 (62.9) - bottle feeding = 20 (15.2) 2.3 Type of breastfeeding: No. (%) at 12 weeks: - exclusive = 75 (56.8) - bottle feeding = 25 (18.9) 1/ Time holding babies median=2 hrs range=0-66 2/ Time of breastfeeding initiation median=9hrs 1.1 (a) RR (95% CI) = 1.10 (1.01-2.72) p=.03 (b) RR (95% CI) = 1.13 (1.00-1.28) p=.05 (c) RR (95% CI) = 1.21 (1.04-1.41) p= 0.01 1.2 (a) 4 week OR (95% CI) = 2.5 (1.04-6.00) p=.04 (b) 8 weeks OR (95% CI) = 2.4 (1.15-4.83) p=.01 (c) 12 weeks OR (95% CI) = 2.5 (1.33-4.78) p=<.001 2.1 Type of breastfeeding: at 4 weeks: - exclusive p=.03 - bottle feeding p=.03 2.2 Type of breastfeeding: at 4 weeks: - exclusive p=.08 - bottle feeding p=.03 2.3 Type of breastfeeding: at 4 weeks: - exclusive p=.01 - bottle feeding p=0.01 1/ p<0.0001 2/ p<0.0001 3/ first 4 days: p<0.0001 on day 4: p<0.0001 at month 5: p<0.0001

64 Table 05. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. range=0-49 206 (64%) within first hour 3/ Exclusive breastfeeding: first 4 days n=9 (3%) on day 4 n=99 (30%) at month 5 n=17 (6%) 4/ Use of prelacteal foods n=294 (89%) 5/ Use of postlacteal foods n=75 (23%) range=0-95 51 (15%) within first hour 3/ Exclusive breastfeeding first 4 days n=180 (56%) on day 4 n=273 (83%) at month 5 n=202 (70%) 4/ Use of prelacteal foods n=101 (31%) 5/ Use of postlacteal foods n=156 (47%) Morrow 1999 Consumer satisfaction 83/85 consumers said counselor was helpful and supportive Health care behaviours 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 8/34 (24%) - 3 months = 4/33 (12%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 4/33 (12%) 3/ Duration of any breastfeeding - overall: no data provided - 3 months = 28/33 (85%) - 6 months = 22/29 (76%) 4/ Incidence of diarrhoea in infants 0-3 months of age = 9 6 visits group 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 35/44 (80%) - 3 months = 28/42 (67%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 21/42 (50%) 3/ Duration of any breastfeeding (for intervention groups combined) - overall: no data provided - 3 months = 87/92 (95%) - 6 months = 65/75 (87%) 4/ Incidence of diarrhoea in infants 0-3 months of age = 8 3 visit group 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 32/52 (62%) - 3 months = 25/50 (50%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 19/50 (38%) 4/ p<0.0001 5/ p<0.0001

Table 05. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. 4/ Incidence of diarrhoea in infants 0-3 months of age = 4 65

66 Table 06. LHW to promote breastfeeding (2 weeks-6 months) postpartum comp. with usual care Study Outcome type Control group Intervention group Statistical sig. Dennis 2002 Health care behaviours 1.1 Self-reported breastfeeding within the 24 hours preceding the (a) 4 = 104 (83.9%) (b) 8 = 93 (75.0%) (c) 12 = 83 (66.9%) week telephone interview 2.1 Type of breastfeeding: No. (%) at 4 weeks: - exclusive = 78 (62.9) - bottle feeding = 20 (16.1) 2.2 Type of breastfeeding: No. (%) at 8 weeks: - exclusive = 68 (54.8) - bottle feeding = 31 (25.0) 2.3 Type of breastfeeding: No. (%) at 12 weeks: - exclusive = 50 (40.3) - bottle feeding = 41 (33.1) Haider 2000 Health care behaviours 1/ Time holding babies median=1 hr range=0-33 2/ Time of breastfeeding initiation median=1 hr range=0-49 206 (64%) within first hour 3/ Exclusive breastfeeding: first 4 days n=9 (3%) on day 4 n=99 (30%) at month 5 n=17 (6%) 4/ Use of prelacteal foods 1.1 Self-reported breastfeeding within the 24 hours preceding the (a) 4 weeks = 122 (92.4%) (b) 8 = 112 (84.8%) (c) 12 = 107 (81.1%) week telephone interview 2.1 Type of breastfeeding: No. (%) at 4 weeks: - exclusive = 98 (74.2) - bottle feeding =10 (7.6) 2.2 Type of breastfeeding: No. (%) at 8 weeks: - exclusive = 83 (62.9) - bottle feeding = 20 (15.2) 2.3 Type of breastfeeding: No. (%) at 12 weeks: - exclusive = 75 (56.8) - bottle feeding = 25 (18.9) 1/ Time holding babies median=2 hrs range=0-66 2/ Time of breastfeeding initiation median=9hrs range=0-95 51 (15%) within first hour 3/ Exclusive breastfeeding first 4 days n=180 (56%) on day 4 n=273 (83%) at month 5 n=202 (70%) 4/ Use of prelacteal foods n=101 (31%) 1.1 (a) RR (95% CI) = 1.10 (1.01-2.72) p=.03 (b) RR (95% CI) = 1.13 (1.00-1.28) p=.05 (c) RR (95% CI) = 1.21 (1.04-1.41) p= 0.01 1.2 (a) 4 week OR (95% CI) = 2.5 (1.04-6.00) p=.04 (b) 8 weeks OR (95% CI) = 2.4 (1.15-4.83) p=.01 (c) 12 weeks OR (95% CI) = 2.5 (1.33-4.78) p=<.001 2.1 Type of breastfeeding: at 4 weeks: - exclusive p=.03 - bottle feeding p=.03 2.2 Type of breastfeeding: at 4 weeks: - exclusive p=.08 - bottle feeding p=.03 2.3 Type of breastfeeding: at 4 weeks: - exclusive p=.01 - bottle feeding p=0.01 1/ p<0.0001 2/ p<0.0001 3/ first 4 days: p<0.0001 on day 4: p<0.0001 at month 5: p<0.0001 4/ p<0.0001 5/ p<0.0001

67 Table 06. LHW to promote breastfeeding (2 weeks-6 months) postpartum comp. with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. n=294 (89%) 5/ Use of postlacteal foods n=75 (23%) 5/ Use of postlacteal foods n=156 (47%) Morrell 2000 Consumer satisfaction No difference in satisfaction with midwife, health visitor or GP. More women in the intervention group reported that their partner was supportive (p=.04) Health status and wellbeing At 6 weeks: 1/ SF-36 general health perception score 76.7 (18.6) 2/ Physical functioning 89.1 (15.4) 3/ Social functioning 80.2 (23.8) 4/ Role limitation-physical 73.2 (38.8) 5/ Role limitation-emotional 77.4 (63.6) 6/ Mental health 72.7 (17.8) 7/ Vitality 50.3 (20.9) 8/ Pain 73.8 (24.9) 9/ Health change 65.6 (26.2) 10/ Duke functional social support 16.6 (7.4) 11/ Edinburgh postnatal depression 6.7 (5.5) At 6 months: 1/ SF-36 physical functioning 91.2 (15.1) 2/ Social functioning 84.0 (23.6) 3/ Role limitation - physical 82.1 (32.6) 4/ Role limitation emotional 79.5 (35.5) 5/ Mental health 74.0 (17.5) 6/ Vitality 54.7 (21.3) 7/ Pain 82.8 (23.2) 8/ General health perception 76.9 (20.4) 9/ Health change 64.8 (24.2) 10/ Duke functional social support 16.7 At 6 weeks: 1/ SF-36 general health perception score 75.1 (18.4) 2/ Physical functioning 86.9 (16.0) 3/ Social functioning 76.4 (24.1) 4/ Role limitation-physical 65.2 (39.4) 5/ Role limitation-emotional 77.3 (35.3) 6/ Mental health 72.0 (17.5) 7/ Vitality 49.7 (21.3) 8/ Pain70.7 (24.3) 9/ Health change 63.9 (26.1) 10/ Duke functional social support 16.7 (6.7) 11/ Edinburgh postnatal depression 7.4 (5.2) At 6 months 1/ SF-36 physical functioning 89.8 (16.8) 2/ Social functioning 83.6 (22.0) 3/ Role limitation - physical 80.2 (32.5) 4/ Role limitation emotional 82.4 (31.7) 5/ Mental health 72.8 (17.3) 6/ Vitality 56.1 (21.1) 7/ Pain 81.0 (22.7) 8/ General health perception 76.0 (19.4) 9/ Health change 67.4 (23.0) 10/ Duke functional social support 17.1 (6.8) 1/ mean diff = 1.6 (-4.7-1.4) p=.22 2/ -2.2 (-4.6-0.5) 3/ -3.8 (-7.7-0.3) 4/ -7.9 (-14.6-0.9) 5/ -0.1 (-6.5-6.1) 6/ -0.7 (-3.8-2.2) 7/ -0.6 (-4.1-3.0) 8/ -3.0 (-6.9-1.1) 9/ -2.0 (-6.0-3.2) 10/ 0.0 (-1.3-1.3) 11/ 0.7 (0.2-1.6) 1/ -1.5 (-1.2-4.2) 2/ -0.4 (-4.7-4.0) 3/ -1.9 (-7.2-3.5) 4/ 2.8 (-3.4-8.3) 5/ -1.2 (-4.3-1.8) 6/ 1.4 (-2.5-5.1) 7/ -1.9 (-5.8-2.2) 8/ -0.9 (-4.5-2.7) 9/ 2.6 (-1.6-6.7) 10/ 0.4 (-0.9-1.8) 11/ -0.1-1.0-1.9)

Table 06. LHW to promote breastfeeding (2 weeks-6 months) postpartum comp. with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Cost (7.3) 11/ Edinburgh postnatal depression scale 6.7 (5.6) NHS costs a) Six weeks: 456.0 b) Six months: 638.9 11/ Edinburgh postnatal depression scale 6.6 (5.1) NHS costs a) six weeks: 635.0 b) six months: 815.2 1/ Differences are not significant Morrow 1999 Consumer satisfaction 83/85 consumers said counselor was helpful and supportive Health care behaviours 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 8/34 (24%) - 3 months = 4/33 (12%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 4/33 (12%) 3/ Duration of any breastfeeding - overall: no data provided - 3 months = 28/33 (85%) - 6 months = 22/29 (76%) 4/ Incidence of diarrhoea in infants 0-3 months of age = 9 6 visits group 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 35/44 (80%) - 3 months = 28/42 (67%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 21/42 (50%) 3/ Duration of any breastfeeding (for intervention groups combined) - overall: no data provided - 3 months = 87/92 (95%) - 6 months = 65/75 (87%) 4/ Incidence of diarrhoea in infants 0-3 months of age = 8 3 visit group 1/ Exclusive breastfeeding in the previous week at: - 2 weeks = 32/52 (62%) - 3 months = 25/50 (50%). 2/ Practice of exclusive breastfeeding at all 5 measurement times = 19/50 (38%) 4/ Incidence of diarrhoea in infants 0-3 months of age = 4 68

69 Table 07. LHWs to promote immunization uptake compared with usual care Study Outcome type Control group Intervention group Statistical sig. Barnes 1995 Health care behaviours Immunization status 1/ Up to date At enrolment 33 (39%) At last visit 41 (54%) 2/ Due At enrolment 14 (17%) At last visit 6 (8%) 3/ Late At enrolment 37 (44%) At last visit 29 (38) Johnson 1993 Health care behaviours 1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 65% (n=68) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 68% (n=71) 3/ Number of children in each trial arm admitted to hospital during the study: n= 21 (20%) 4/ Mean number of days spent in hospital for children: 1.3 days 5/ Mean length of stay in hospital in days: 7.0 6/ Length of time child kept on formula feeds: 28.0 weeks (SD 15.2) 7/ Proportion of mothers who gave their child cow s milk before 26 weeks: 47% (n=49) Immunization status 1/ Up to date At enrolment 24 (34%) At last visit 42 (75%) 2/ Due At enrolment 18 (25%) At final visit 4 (7%) 3/ Late At enrolment 29 (41%) At last visit 10 (18%) 1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 85% (n=108) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 77% (n=98) 3/ Number of children in each trial arm admitted to hospital during the study: n=24 (19%) 4/ Mean number of days spent in hospital for children: 2.6 days 5/ Mean length of stay in hospital in days: 14.0 days 6/ Length of time child kept on formula feeds: 38.1 (SD 13.5) weeks 7/ Proportion of mothers who gave their child cow s milk before 26 weeks: 19% (n=24) 8/ see control 1/ Up to date for immunisations p<0.05 2/ p value not reported 3/ Late for immunisations p<0.05 1/ p<0.001; RR 1.31; CI 1.12-1.54 2/ NS 3/ NS 4/ p=0.88 5/ p = <0.05 6/ 95%CI 6.4-13.8 weeks; p=<0.001 7/ RR = 0.40; 95%CI 0.27-0.61); p= <0.0001 8/ child: all significant in favour of the intervention at p=0.001 level (see page 1451) mother: all significant in favour of the intervention group at p=<0.01 level (see page 1451) 9/ p<0.0001; RR 1.81; 95% CI = 1.52-2.16 10/ Developmental score: -cognitive games: 95% CI = 1.65-2.60 (significant) -motor games: 95% CI: -0.13-0.28

Table 07. LHWs to promote immunization uptake compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Health status and well being 8/ 24 hour dietary nutrition intake: - child: 6 measures - mother: 6 measures. 9/ Number of mothers who read to their child: 54% (n=57) 10/ Developmental score: -cognitive games: mean=1.62 (SD 1.39) -motor games: mean=0.76 (SD 0.84) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=3.50 (SD3.24) 1/ Mothers self esteem - tired: yes = 90% (n=95); no = 10% (n= 10) -headaches: yes= 50% (n=52); no=50% (n=53) -miserable: yes=76% (n=80); no= 24% (n=25) -staying in: yes= 54% (n=57); no=46 (n= 48). 2/ Relative risk of having an accident: no data provided 3/ Mothers feelings in the year since their child was born\; - positive: mean=1.17 (SD 1.01) - negative: mean = 1.42 (SD 1.25) 9/ Number of mothers who read to their child: 98% (n=125) 10/ Developmental score: -cognitive games: mean=3.75 (SD 2.11) -motor games: mean=0.83(sd 0.76) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=7.74 (SD1.65) 1/ Mothers self esteem - tired: yes = 78% (n=99); no = 22% (n= 28) -headaches: yes= 49% (n=62); no=51% (n=65) -miserable: yes=57% (n=73); no= 43% (n=54) -staying in: yes= 31% (n=40); no=69 (n= 87). 2/ Relative risk of having an accident: no data provided 3/ Mothers feelings in the year since their child was born\; - positive: mean=2.61 (SD 1.28) - negative: mean = 0.93 (SD 0.87) (NS) 11/ nursery rhymes: 95% CI: 3.59-4.88. 1/ Mothers self esteem - tired: p=<0.01; RR=0.86 (95%CI 0.77-0.97) -headaches: p=0.92; RR=0.99 (95%CI 0.76-1.28) -miserable: p=<0.003; RR=0.75 (95%CI 0.63-0.90) -staying in: p=<0.001; RR=0.58 (95%CI 0.43-0.79) 2/ RR=0.3 (95%CI 0.08-1.14) 3/ Mothers feelings in the year since their child was born; - positive: diff in means=1.44 (95%CI = 1.14-1.75); p=<0.01 - negative: diff in means= -0.5 (95%CI = -0.77to -0.23); p=<0.01 70 Krieger 2000 Health care behaviours 1/ % receiving pneumonia vaccination All: baseline 40.5% 3 months 50.9% No previous immunization 112/363 (30.9%) 2/ % receiving influenza vaccination All: 1/ % receiving pneumonia vaccination All: baseline 41.7% 3 months 66.5% No previous immunization 170/327 (52.0%) 2/ % receiving influenza vaccination All: 1/ All: p<0.001 No previous immunization: IRR=1.68 (52.0/30.9) Rate difference 21.1% (52.0-30.9) 2/ All: p<0.0001 Previous immunization: p=0.005; RRI: 4% ; ARI: 4%; IRR: 1.04 No previous immunization: p=0.0002;

71 Table 07. LHWs to promote immunization uptake compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Cost Other baseline 83.0% 3 months 81.7% Previous immunization 414/437 (94.7%) No previous immunization 21/91 (23%) Pneumonia 1/ Subject belief in relation to the importance to the doctor that he/she gets immunized baseline 73.6% 3 months 78.8%* 2/ Belief that getting pneumonia is quite bad baseline 84.7% 3 months 82.7% 3/ Belief that the subject won t get pneumonia regardless immunization (% false) baseline 92.4% 3 months 93.4% Influenza 1/ Subject belief in relation to the importance to the doctor that he/she gets immunized baseline 80.7% 3 months 83.2% 2/ Belief that getting pneumonia is quite bad baseline 72.6% baseline 78.3% 3 months 88.2% Previous immunization 395/401 (98.5%) No previous immunization 51/102 (50%) Pneumonia: 124 or 205 (41 or 135 if replicated); Influenza 92 or 380 (88 or 283, if replicated) COMMENT: marginal cost depending on the strategy. If replicated, depending on the staff composition. Pneumonia 1/ Subject belief in relation to the importance to the doctor that he/she gets immunized baseline 75.4% 3 months 82.2%** 2/ Belief that getting pneumonia is quite bad baseline 85.4% 3 months 80.1%* 3/ Belief that the subject won t get pneumonia regardless immunization (% false) baseline 92.0% 3 months 95.1%* Influenza 1/ Subject belief in relation to the importance to the doctor that he/she gets immunized baseline 75.4% 3 months 83.6%** 2/ Belief that getting pneumonia is quite bad RRI: 117% ; ARI: 27% ; IRR: 2.17

Table 07. LHWs to promote immunization uptake compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. 3 months 78.1%* 3/ Belief that the subject won t get pneumonia regardless immunization (% false) baseline 93.0% 3 months 91.8% baseline 75.5% 3 months 70.5%* 3/ Belief that the subject won t get pneumonia regardless immunization (% false) baseline 92.6% 3 months 91.9% 72

Table 08. LHWs to reduce morbidity/mortality from infections compared with usual care Study Outcome type Control group Intervention group Statistical sig. Chongsuvivatwong 1996 Health care behaviours Attendance rates: 1/ health centre use 7.6/1000 2/ private clinic 13/1000 3/ community hospital 0.9/1000 4/ provincial clinic 8.6/1000 Attendance rates: 1/ health centre use 7.1/1000 2/ private clinic 18.6/1000 3/ community hospital 1.8/1000 4/ provincial clinic 40.1/1000 NB presumed rates calculated from OR and control rates OR for treatment group 1/ 0.93 2/1.43 3/ 2.01 4/ 4.71 Health status and well being 1/ Duration of illness 2/ Severity of illness: at least one episode of fever 160 (24%) 1/ max=118 days; mean=32.4 days 2/ Severity of illness: at least one episode of fever 140 (21%) 1/ p<0.001 2/ OR=0.45 Kidane 2000 Health status and well being 1/ <5 mortality rate = 50.2/1000 child years 2/ Number of possible malaria deaths in children <5 years = 68 (57%) 1/ <5 mortality rate = 29.8/1000 child years 2/ Number of possible malaria deaths in children <5 years = 13 (19%) 1/ p<0.003 (adjusted for clustering) 2/ p<0.001 Mtango 1986 Health status and well being 1/ Mortality Year 1: 40.1% (325) Year 2: 35.0% (347) 2/ Mortality from pneumonia Year 1: 14.3% Year 2: 12.2% 1/ Mortality Year 1: 32.4% (260) Year 2: 29.2% (266) 2/ Mortality from pneumonia Year 1: 11.6% Year 2: 10.0% Table 09. LHWs to improve hypertension treatment compared with usual care Study Outcome type Control group Intervention group Statistical sig. Komaroff 1974 Consultation process PHYSICIANS ACCEPTANCE. Accepted LHW decisions in 134/142 (94%). In the first 5 months physicians enter 10% of patients as suitable; 11 months later 40% Utilization of LHWs PHYSICIAN VISIT SAVING. 185 patients scheduled, of which 142 kept appointment of 73

Table 09. LHWs to improve hypertension treatment compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. which 53 (37%) did not need to see a physician. Consumer satisfaction Appointments failed: 25% 2.5% seek interim medical attention. Health status and well being Average serum glucose 12mg per 100 ml Decrease in diastolic blood pressure: no change Systolic blood pressure increased 4 mm more Krieger 1999 Health care behaviours % completion of followup appointment with health care professional (HCP) within 90 days of referral: 65.1% (95) Lin 1997 Health care behaviours 1/ Hypertension related knowledge and behaviour. 1.1 For hypertensives - awareness of condition: baseline n = 59; 6 months n = 62. - currently receiving treatment: baseline n = 36; 6 months n = 37. - BP controlled: baseline n = 20; 6 months n = 29. 1.2 Knowledge score: - normotensives: baseline = 0.94 1.26; 6 months = 1.46 1.39 - borderlines: baseline = 0.91 1.14; 6 months = 1.51 1.25 - hypertensives: baseline = 1.28 1.28; 6 months = 1.99 1.47 - overall: baseline = 1.01 1.24; 6 months = 1.60 1.38 1.3 Behaviour score: - normotensives: Appointments failed: 23% 2.2% seek interim medical attention Average serum glucose 8mg per 100 ml Decrease in diastolic blood pressure: 2 mm Systolic blood pressure decreased 5 mm % completion of followup appointment with health care professional (HCP) within 90 days of referral: 46.7% (77) 1.1 For hypertensives - awareness of condition: baseline n = 74; 6 months n = 88. - currently receiving treatment: baseline n = 40; 6 months n = 59. - BP controlled: baseline n = 20; 6 months n = 54. 1.2 Knowledge score: - normotensives: baseline = 1.04 1.28; 6 months = 1.47 1.25 - borderlines: baseline = 1.25 1.43; 6 months = 1.55 1.35 - hypertensives: baseline = 1.38 1.38; 6 months = 2.56 1.13 - overall: baseline = 1.17 1.34; 6 months = 1.73 1.33 1.3 Behaviour score: - normotensives: baseline = 1.31 0.93; 6 p=0.81 p=0.98 p=0.02 p=0.4 p=0.65 P = 0.001 Effect size for rate of follow up = 39.4% (14-71%), p = 0.001. No significant interactions between intervention and age, sex and race were present. Intervention therefore equally effective across ages, sexes, races. 1/ 1.1 Significant within group change for awareness, treatment and control in intervention group. Between group change not reported. 1.2 Knowledge score: improvement in score significantly greater for hypertensive subjects in intervention groups than for controls. P <.01 All other changes in knowledge scores NS. 1.3 Behaviour score: improvement in score significantly greater for hypertensive subjects in intervention groups than for controls. P <.001 All other changes in knowledge scores NS. 74

Table 09. LHWs to improve hypertension treatment compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. baseline = 1.11 0.98; 6 months = 1.55 0.98 - borderlines: baseline = 1.33 1.05; 6 months = 1.59 0.83 -hypertensives: baseline = 2.24 1.52; 6 months = 2.35 1.27 months = 1.53 0.88 - borderlines: baseline = 1.37 0.90; 6 months = 1.60 0.87 - hypertensives: baseline = 2.26 1.56; 6 months = 3.06 1.23 Health status and well being 1/ Blood pressure response: - Normotensive respondents: baseline systolic = 117+-12, 6 month systolic = 123+-13; baseline diastolic = 75+-8, 6 month diastolic = 76+-9. - Borderline respondents: baseline systolic = 138+ -12, 6 month systolic = 134+-17; baseline diastolic = 87+-5, 6 month diastolic = 83+-10. - Hypertensive: baseline systolic = 151+ -20, 6 month systolic = 146+-20; baseline diastolic = 95+-13, 6 month diastolic = 89+-12. -Overall: baseline systolic = 131+ -20, 6 month systolic = 132+-19; baseline diastolic = 83+-12, 6 month diastolic = 81+-11. 1/ Blood pressure response: - Normotensive respondents: baseline systolic = 117+-10, 6 month systolic = 121+-14; baseline diastolic = 75+-7, 6 month diastolic = 77+ -11 - Borderline respondents: baseline systolic = 142 +-9, 6 month systolic = 139+ -15; baseline diastolic = 86+-7, 6 month diastolic = 84+-10. - Hypertensive: baseline systolic = 149+ -20, 6 month systolic = 138+-18; baseline diastolic = 92+-12, 6 month diastolic = 83+-11. -Overall: baseline systolic = 130+ -19, 6 month systolic = 129+-18; baseline diastolic = 82+-11, 6 month diastolic = 80+-11. 1/ Blood pressure response: - Hypertensive: reduction in BP significantly greater for intervention than for control group. Systolic p<.01, diastolic p<.001. - Overall: reduction in BP significantly greater for intervention than for control group, for systolic pressure only. P<.05. - All other differences nonsignificant 75

76 Table 10. LHWs to promote mother-child interaction compared with usual care Study Outcome type Control group Intervention group Statistical sig. Barth 1988 Health care behaviours Prenatal care: 1/ Summary score for eating unhealthy items: mean = 8.28, SD = 2.88 2/ Summary score for eating healthy items: mean = 6.10, SD = 2.83 3/ Frequency of visit to doctor in 2nd and 3rd trimesters: mean = 9.73, SD = 3.48. Health status and wellbeing Parent well-being: 1/ The Center for Epidemiological Studies Depression Scale (CES-D): mean = 41.4, SD = 12.38 2/ The State-Trait Anxiety Inventory (STAI): mean = 40.41, SD = 13.23 3/ The Pearlin Mastery Scale: mean = 20.28, SD = 3.52 4/ The Child Abuse Potential Inventory (CAPI): mean = 93.37, SD = 46.61 5/ Goal level: mean = 2.98, SD = 1.02 Birth outcomes: 1/ Pregnancy problems (adverse events during delivery): mean = 1.36, SD = 1.09 2/ Total days mother and newborn were in hospital around delivery: mean = 9.80, sd = 4.57 3/ Birthweight (grams): mean = 3255, SD = 625 4/ Score of discrepancy between expected and actual discomfort during pregnancy and delivery: mean = 1.36, SD = 0.45 5/ Score of degree to which client worried about issues related to having a newborn: mean = 24.19, SD = 6.48 Child Temperament (subscales of Infant Temperament Questionnaires): 1/ Activity: mean = 50.18, SD = 8.75 2/ Mood: mean = 23.91, SD = 4.93 3/ Distractibility: mean = 24.59, SD = 6.44 Child welfare: 1/ Ratings of common illnesses experienced by child: mean = Prenatal care: 1/ Summary score for eating unhealthy items: mean = 8.12, SD = 2.38 2/ Summary score for eating health items: mean = 6.21, SD = 2.81 3/ Frequency of visit to doctor in 2nd and 3rd trimesters: mean = 9.90, SD = 3.17 Parent well-being: 1/ CES-D score: mean = 39.54, SD = 12.30 2/ STAI score: mean = 39.25, SD = 12.98 3/ Pearline score: mean = 19.98, SD = 3.73 4/ CAPI score: mean = 99.76, SD = 45.82 5/ Goal level: mean = 2.29, SD = 1.03 Birth outcomes: 1/ Pregnancy problems (adverse events during delivery): mean = 1.49, SD = 1.06 2/ Total days mother and newborn were in hospital around delivery: mean = 8.41, SD = 3.88 3/ Birthweight (grams): mean = 3396, SD = 683 4/ Score of discrepancy between expected and actual discomfort during pregnancy and delivery: mean = 1.31, SD = 0.19 5/ Score of degree to which client worried about issues related to having a newborn: mean = 25.04, SD = 7.55 Child Temperament (subscales of Infant Temperament Questionnaires): 1/ Activity: mean = 48.05, SD = 9.35 2/ Mood: mean = 22.05, SD = 4.54 3/ Distractibility: mean = 24.11, SD = 6.50 Child Welfare: 1/ Ratings of common illness experienced by child: mean = 5.62, SD = 2.92 2/ Whether the child s client has been removed from her care or p=ns for all measures p=ns for all measures

Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. 5.43, SD = 2.96 2/ Whether the child s client has been removed from her care or if a neighbour cared for the child because the mother did not: mean = 2.06, SD = 0.29 3/ Number of times the client has taken the newborn to emergency medical services: mean = 1.44, SD = 0.50 4/ Combined number of times that a baby has had check ups, DPT shots and polio shots: mean = 7.09, SD = 3.89 Social development measures Formal and informal support 1/ Community Resources Use Scale (CRUS): mean = 1.94, SD = 2.17 2/ Social Supports and Preparation Scale: mean = 2.44, SD = 1.99 3/ Inventory of Social Supportive Behaviours (ISSB): mean = 44.62, SD = 15.32 4/ Social Support Inventory: mean = 12.02, SD = 2.56 if a neighbour cared for the child because the mother did not: mean = 2.08, SD = 0.31 3/ Number of times the client has taken the newborn to emergency medical services: mean = 1.44, SD = 0.50 4/ Combined number of times that a baby has had check ups, DPT shots and polio shots: mean = 7.43, SD = 3.55 Formal and informal support: 1/ CRUS: mean = 2.0, SD = 1.86 2/ Social Supports and Preparation Scale: mean = 2.5, SD = 1.64 3/ ISSB: mean = 45.78, SD = 13.29 4/ Social Support Inventory: mean = 12.11, SD = 2.52 p=ns for all measures Bullock 1995 Health care behaviours 1/ smokers: baseline = 35 (56%); 34 weeks = 30 (48%) 2/ women drinking alcohol in last month: baseline = 17 (27%); 34 weeks = 18 (29%) 3/ >3 drinks on any one occasion: baseline = 7 (11%); 34 weeks = 6 (10%) 4/ marijuana use: baseline = 5 (8%); 34 weeks = 4 (6%) 5/ <3 meals/day: baseline = 23 (37%); 34 weeks = 23 (37%) 6/ Not utilizing any community resources: baseline = 45 (71%); 34 weeks = 35 (52%) 1/ smokers: baseline = 31 (53%); 34 weeks = 29 (49%) 2/ women drinking alcohol in last month: baseline =15 (25%); 34 weeks = 19 (32%) 3/ >3 drinks on any one occasion: baseline = 6 (10%); 34 weeks = 3 (5%) 4/ marijuana use: baseline = 4 (7%); 34 weeks = 2 (3%) 5/ <3 meals/day: baseline = 15 (25%); 34 weeks = 10 (17%) 6/ Not utilizing any community resources: baseline = 35 (59%); 34 weeks = 17 (29%) 5/ p = 0.03 6/ p = 0.02 77 Health status and wellbeing 1/ Stress: baseline =19.3; 34 weeks =18.4 2/ social support - partner: baseline =52.7; 34 weeks =52.7 3/ Social support- 1/ Stress: baseline =18.8; 34 weeks =16.5 2/ social support - partner: baseline =54.4; 34 weeks =56.9 3/ Social support- 1/ Stress: baseline p=0.02 2/ social support - partner: p=0.09 3/ Social support- other: p=0.49 4/ Self esteem:

78 Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. other: baseline =51.3; 34 weeks =49.7 4/ Self esteem: baseline =32.0; 34 weeks =32.5 5/ Depression (i) somatic: base =3.9; 34 =4.4 (ii) mood: base=7.2 34= 8.1 (iii) other: base=4.0; 34 = 4.1 (iv) overall: base =15.3; 34= 17.0 6/ State anxiety: base = 34.3; 34 = 34.1 7/ Trait anxiety: base =41.8; 34 =39.4 Johnson 1993 Health care behaviours 1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 65% (n=68) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 68% (n=71) 3/ Number of children in each trial arm admitted to hospital during the study: n= 21 (20%) 4/ Mean number of days spent in hospital for children: 1.3 days 5/ Mean length of stay in hospital in days: 7.0 6/ Length of time child kept on formula feeds: 28.0 weeks (SD 15.2) 7/ Proportion of mothers who gave their child cow s milk before 26 weeks: 47% (n=49) 8/ 24 hour dietary nutrition intake: - child: 6 measures - mother: 6 measures. 9/ Number of mothers who read to their child: 54% (n=57) 10/ Developmental score: -cognitive games: mean=1.62 (SD 1.39) -motor games: mean=0.76 (SD 0.84) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=3.50 (SD3.24) Health status and well being 1/ Mothers self esteem - tired: yes = 90% (n=95); no = 10% (n=10) - other: baseline =54.3; 34 weeks =52.5 4/ Self esteem: baseline =33.3; 34 weeks =34.9 5/ Depression (i) somatic: base =3.9; 34 =4.3 (ii) mood: base=7.2 34= 6.6 (iii) other: base=3.9; 34 = 4.4 (iv) overall: base =14.8; 34= 15.3 6/ State anxiety: base = 32.8; 34 = 30.0 7/ Trait anxiety: base =40.3; 34 =35.2 1/ Proportion of children who received all 3 shots of primary immunizations by first birthday: 85% (n=108) 2/ Proportion of children who received at least one shot of their primary immunization schedule who received the DPT vaccine: 77% (n=98) 3/ Number of children in each trial arm admitted to hospital during the study: n=24 (19%) 4/ Mean number of days spent in hospital for children: 2.6 days 5/ Mean length of stay in hospital in days: 14.0 days 6/ Length of time child kept on formula feeds: 38.1 (SD 13.5) weeks 7/ Proportion of mothers who gave their child cow s milk before 26 weeks: 19% (n=24) 8/ see control 9/ Number of mothers who read to their child: 98% (n=125) 10/ Developmental score: - cognitive games: mean=3.75 (SD 2.11) -motor games: mean=0.83(sd 0.76) 11/ The extent to which mothers used song and nursery rhyme with their child: mean=7.74 (SD1.65) 1/ Mothers self esteem - tired: yes = 78% (n=99); no = 22% (n=28) - p=0.008 5/ Depression (i) somatic: p= 0.86 (ii) mood: p =0.02 (iii) other: p= 0.84 (iv) overall: p=0.10 6/ State anxiety: p=0.05 7/ Trait anxiety: p=0.04 1/ p<0.001; RR 1.31; CI 1.12-1.54 2/ NS 3/ NS 4/ p=0.88 5/ p = <0.05 6/ 95%CI 6.4-13.8 weeks; p=<0.001 7/ RR = 0.40; 95%CI 0.27-0.61); p=<0.0001 8/ child: all significant in favour of the intervention at p=0.001 level (see page 1451) mother: all significant in favour of the intervention group at p=<0.01 level (see page 1451) 9/ p<0.0001; RR 1.81; 95% CI = 1.52-2.16 10/ Developmental score: -cognitive games: 95% CI = 1.65-2.60 (significant) -motor games: 95% CI: -0.13-0.28 (NS) 11/ nursery rhymes: 95% CI: 3.59-4.88. 1/ Mothers self esteem - tired: p= <0.01; RR=0.86 (95%CI 0.77-0.97) -

79 Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. headaches: yes= 50% (n=52); no=50% (n=53) -miserable: yes=76% (n=80); no= 24% (n=25) -staying in: yes= 54% (n=57); no=46 (n=48). 2/ Relative risk of having an accident: no data provided 3/ Mothers feelings in the year since their child was born\; - positive: mean= 1.17 (SD 1.01) - negative: mean = 1.42 (SD 1.25) Olds 2002 Consultation process 1/ length visit pregnancy 2/ length visit infancy 3/ Total visit time pregnancy 4/ Total visit time infancy 5/ Contact areas: a) Personal health pregnancy b) Personal health infancy c) Environ. health pregnancy d)environ. health infancy e) Life course development pregnancy f) Life course development infancy g) Parental care giving pregnancy h) parental care giving infancy i) Friends and family pregnancy j) Friends and family infancy headaches: yes= 49% (n=62); no=51% (n=65) -miserable: yes=57% (n=73); no= 43% (n=54) -staying in: yes= 31% (n=40); no=69 (n=87). 2/ Relative risk of having an accident: no data provided 3/ Mothers feelings in the year since their child was born\; - positive: mean= 2.61 (SD 1.28) - negative: mean = 0.93 (SD 0.87) Intervention 1: paraprofessionals 1/ length visit (pregnancy) = 85.24 2/ Length visit (infancy) = 78.49 3/ Total visit time (pregnancy) = 542 4/ Total visit time (infancy) = 1299 5/ Contact area scores: a) Personal health (pregnancy) = 26.56 b) Personal health (infancy) = 15.30 c) Environ. health (pregnancy) = 15.14 d) Environ. health (infancy) = 15.16 e) Life course development (pregnancy) = 15.43 f) Life course development (infancy) = 19.41 g) Parental care giving (pregnancy) = 23.70 h) Parental care giving (infancy) = 31.51 i) Friends and family (pregnancy) = 18.78 j) Friends and Family (infancy) = 18.39 Intervention 2: nurses 1/ length visit (pregnancy) = 77.25 2/ Length visit (infancy) = 71.82 3/ Total visit time (pregnancy) = 503 4/ Total visit time (infancy) = 1498 5/ Contact area scores: a) Personal health (pregnancy) = 38.11 b) Personal health (infancy) = 14.87 c) Environ. health (pregnancy) = 7.30 d) Environ. health (infancy) =7.93 headaches: p=0.92; RR=0.99 (95%CI 0.76-1.28) -miserable: p=<0.003; RR= 0.75 (95%CI 0.63-0.90) -staying in: p= <0.001; RR=0.58 (95%CI 0.43-0.79) 2/ RR=0.3 (95%CI 0.08-1.14) 3/ Mothers feelings in the year since their child was born\; - positive: diff in means= 1.44 (95%CI = 1.14-1.75); p=<0.01 - negative: diff in means= -0.5 (95%CI = -0.77to -0.23); p=<0.01 1/ p<0.001 2/ p<0.001 a) p<0.001 c) p<0.001 d) p<0.001 e) p<0.05 f) p<0.001 h) p<0.001 i) p<0.001 j) p<0.001

Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Utilization of LHWs 1/ Program dropout 2/ Relationship continuity 3/ No visits infancy 4/ Attempted visits pregnancy 5/ Attempted visits infancy 6/ Relationship disruption e) Life course development (pregnancy) = 13.97 f) Life course development (infancy) = 16.23 g) Parental care giving (pregnancy) = 25.03 h) Parental care giving (infancy) = 46.09 i) Friends and family (pregnancy) = 15.42 j) Friends and Family (infancy) = 14.76 Intervention 1: paraprofessionals 1/ Program dropout = 117 (48%) 2/ Relationship continuity = 6.32 3/ No visits infancy = 16.49 4/ Attempted visits pregnancy = 1.73 5/ Attempted visits infancy = 7.63 6/ Relationship disruption = 35% Intervention 2: nurses 1/ Program dropout = 89 (38%) 2/ Relationship continuity = 6.51 3/ No visits infancy = 21.34 4/ Attempted visits pregnancy = 1.33 5/ Attempted visits infancy = 5.25 6/ Relationship disruption = 11% 1/ p=0.004 2/ p=ns 3/ p<0.001 4/ p<0.05 5/ p<0.001 6/ p<0.001 Consumer satisfaction 1/ Mothers rating of relationship Intervention 1: paraprofessionals 1/ Mothers rating of relationship = 4.06 Intervention 2: nurses 1/ Mothers rating of relationship = 4.14 1/ p=ns 80 Health care behaviours 1/ Number/timing of subsequent pregnancies at 24 months = 41 2/ Mother-infant interaction = 98.99 home environment = 37.10 3/ Cotinine reduction = 12.32 Intervention 1: paraprofessionals 1/ Number/timing of subsequent pregnancies at 24 months = 33 2/ Mother-infant interaction 100.15 home environment = 37.40 3/ Cotinine reduction = 88.51 Intervention 2: nurses 1/ Number/ timing of subsequent pregnancies at 24 months = 29 2/ Mother-infant interaction = 100.31 home environment 1/ Mean difference 0.70 (0.46-1.06) p<0.1 2/ Mean difference 1.16 (-0.11-2.42) p<0.1 home environment 0.30 (-0.49-1.10) 3/ -76.19 (-302.21-149.82)

81 Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Health status and well being 1/ Child s language development = 99.49 2/ Mental Development Index (MDI) = 89.38 3/ Behaviour problems score = 45.26 = 37.79 3/ Cotinine reduction = 259.00 Intervention 1: paraprofessionals 1/ Child s language development = 99.89 2/ MDI = 89.45 3/ Behaviour problems score = 45.49 Intervention 2: nurses 1/ Child s language development = 101.22 2/ MDI = 90.13 3/ Behaviour problems score = 43.71 Other 1/ Educational achievement = 11.51 Intervention 1: paraprofessionals 1/ Educational achievement = 11.62 Intervention 2: nurses 1/ Educational achievement = 11.51 Schuler 2000 Health care behaviours % drug use: 1/ Cocaine/heroin 44.0 2/ Marijuana 37.8 3/ Alcohol 68.0 Health status and well being 1/ Maternal responsiveness score 3.3 2/ Infant warmth score 2.5 Other % use of services: 1/ AFDC 85.1 2/ medical assistance 93.1 3/ WIC 89.7 4/ Food stamps 87.4 5/ Protective services 31.0 Siegel 1980 Health care behaviours 1/ Acceptance score: 4 months 0.217 12 months 0.084 2/ Interaction/ stimulation score: 4 months 0.198 12 months 0.190 3/ Consoling score: 4 months 0.102 4/ Positive/ negative score: 12 months 0.046 % drug use: 1/ Cocaine/heroin 45.6 2/ Marijuana 25.4 3/ Alcohol 64.8 1/ Maternal responsiveness score 3.6 2/ Infant warmth score 2.5 % use of services: 1/ AFDC 89.3 2/ medical assistance 91.7 3/ WIC 95.2 4/ Food stamps 91.7 5/ Protective services 11.9 Intervention 1: home visit and extended contact 1/ Acceptance score: 4 months 0.258 12 months 0.091 2/ interaction/ stimulation score: 4 months 0.209 12 months 0.203 3/ Consoling score: 4 months 0.136 4/ Positive/negative score: 12 months 0.078 Intervention 2: extended contact only 1/ Acceptance score: 4 months 0.245 12 months 0.085 2/ Interaction/stimulation score: 4 months 0.203 12 months 0.201 3/ Consoling score: 4 months 0.135 4/ 1/ Mean difference 0.40 (-1.94-2.74) 2/ Mean difference 0.07 (-2.39-2.53) 3/ Mean difference 0.23 (-3.58-4.03) 1/ Mean difference 0.11 (-0.17-0.39) 5/ p<0.01 1/ 4 months p<0.0001 12 months p= NS 2/ 4 months p<0.0002 12 months p<0.004 3/ p<0.02 4/ p=ns

Table 10. LHWs to promote mother-child interaction compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. Positive/negative score: 12 months 0.078 Intervention 3: home visit only 1/ Acceptance score: 4 months 0.221 12 months 0.085 2/ Interaction/stimulation score: 4 months 0.198 12 months 0.193 3/ Consoling score: 4 months 0.110 4/ Positive/negative score: 12 months 0.046 Health status and well being 1/ Child abuse/neglect = 3/52 Intervention 1: home visit and extended contact 1/ Child abuse/neglect = 4/47 Intervention 2: extended contact only 1/ Child abuse/neglect = 3/50 Intervention 3: home visit only 1/ Child abuse/neglect = 7/53 Other Health care utilization by infants 1/ Hospitalizations = 3 2/ ER visits = 13 3/ Prev. care visits = 4.1 4/ Immunizations = 4.5 Intervention 1: home visit and extended contact 1/ Hospitalizations = 4 2/ ER visits = 9 3/ Prev. care visits = 3.8 4/ Immunizations = 4.7 Intervention 2: extended contact only 1/ Hospitalizations = 1 2/ ER visits = 13 3/ Prev. care visits = 3.8 4/ Immunizations = 4.4 Intervention 3: home visit only 1/ Hospitalizations = 4 2/ ER visits = 11 3/ Prev. care visits = 4.1 4/ Immunizations = 5.1 82

Table 11. LHWs providing support for alcoholics compared with office support / usual care Study Outcome type Control group Intervention group Statistical sig. Lapham 1995 Helath care behaviours 1/ Alcohol use (days) 5.3 (1.1) 2/ Stable housing (days) 13.9 (1.7) 3/ Employed (days) 8.5 (1.1) Leigh 1999 Health care behaviours 1/ no. drinking days pre= 18.2 (9.0) week 1/12=9.9 (10.2) 2-6/12=9.2 (8.6) 7-12/12=9.5 (9.1) 2/ Mean quantity/day pre= 12.7 (8.9) 1/12=3.7 (5.3) 2-6/12=3.0 (2.7) 7-12/12= 3.9 (4.4) 3/ Median no. weeks attended 15.3 weeks Health status and well being Social development 1/ Physical health 2/ Emotional function 1/ Employment 2/ Social stability 3/ Income 4/ Use of leisure Intervention group 1: case management; substance abuse counselling services; 4 months of transitional housing 1/ Alcohol use (days) 7.4 (1.1) 2/ Stable housing (days) 11.0 (1.7) 3/ Employed (days) 7.8 (1.1) Intervention group 2: 4 months of transitional housing 1/ Alcohol use (days) 7.1 (1.3) 2/ Stable housing (days) 13.3 (2.0) 3/ Employed (days) 7.0 (1.3) Intervention group 3: 4 months of housing 1/ Alcohol use (days) 3.8 (1.9) 2/ Stable housing (days) 14.4 (2.9) 3/ Employed (days) 8.8 (1.9) 1/ no. drinking days pre= 17.1 (10.0) week 1/12= 9.6 (10.1) 2-6/12=10.0 (8.3) 7-12/12=11.0(10.2) 2/ Mean quantity/day pre= 14.0 (6.4) 1/12=3.8 (4.2) 2-6/12=4.4 (3.7) 7-12/12= 4.5 (4.6) 3/ Median no. weeks attended 14.7 weeks 1/ Physical health 2/ Emotional function 1/ Employment 2/ Social stability 3/ Income 4/ Use of leisure 1/ p=ns 2/ p=ns 3/ p=ns No main effects for treatment for treatment condition or gender but effect for time [F(6, 66)= 15.16, p<0.001] 1/ p<0.05 in favour of OB group 2/ p<0.01 in favour of OB group 1/, 2/, 3/, 4/ all NS 83

84 Table 12. LHWs providing support for mothers of sick children compared with usual care Study Outcome type Control group Intervention group Statistical sig. Ireys 1996 Health status and well being 1/ PSI scale a) Total: baseline = 20.7; 15 months = 20.3; change = -0.4 b) Depression: baseline = 18.2; 15 months = 17.2; change = -1.0 c) Anxiety: baseline = 15.3; 15 months = 15.6; change = 0.3 d) Anger: baseline = 31.1; 15 months = 35.5; change = 4.4 e) Cognitive disturbance: baseline = 31.1; 15 months = 25.4; change = -5.7 2/ Perceived availability of social support 2.1 Index of overall availability of social support. Baseline score = 3.9; 15 month score = 4.3 2.2 Proportion indicating that no one understands my burden : Baseline = 15.8%; 15 months = 15.8%. 2.3 Proportion indicating support some/none of the time. Baseline = 26.3%; 15 months = 31.6%. 2.4 Number of sources of support: Baseline = 5.1; 15 months = 6.5 Ireys 2001 Health status and well being 1/ maternal physical health 2/ maternal anxiety: (i) baseline for all conditions = 19.2 (SD 13.2); 12 months = 21.5 (16.4). (ii) Mean anxiety scores for the highly anxious control group mothers increased from 31.9 at baseline to 31.6 at 12 months. (iii) Mean anxiety scores for the low anxiety experimental group increased from 9.9 at baseline to 14.1 at 12 months post baseline. 3/ maternal depression: figures not given 4/ stressful life events: figures not given 5/ Child psychosocial adjustment: (a) baseline total mean score = 89.27 (SD = 10.0); follow-up mean score = 86.98 (SD = 11.23) (i) Hostility: baseline total mean score = 22.47 (SD = 3.95); follow up 1/ PSI scale a) Total: baseline = 24.0; 15 months = 18.9; change = -5.1 b) Depression: baseline = 23.9; 15 months = 17.8; change = -6.1 c) Anxiety: baseline = 16.9; 15 months = 11.6; change = -5.3 d) Anger: baseline = 35.1; 15 months = 31.1; change = 4.0 e) Cognitive disturbance: baseline = 33.0; 15 months = 29.3; change = -3.7 2/ Perceived availability of social support 2.1 Index of overall availability of social support. Baseline score = 3.5; 15 month score = 4.3 2.2 Proportion indicating that no one understands my burden : Baseline = 30.4%; 15 months = 4.4%. 2.3 Proportion indicating support some/none of the time. Baseline = 39.1%; 15 months = 21.7%. 2.4 Number of sources of support: Baseline = 4.3; 15 months = 7.0 1/ maternal physical health 2/ maternal anxiety: (i) baseline for all conditions = 18.9 (SD 14.2); 12 months = 16.8 (14.9). (ii) Mean anxiety scores for the highly anxious experimental group decreased from 33.3 at baseline to 26.4 at 12 months post baseline. (iii) Mean anxiety scores for the low anxiety experimental group increased from 10.5 at baseline to 11.1 at 12 months post baseline. 3/ maternal depression: figures not given 4/ stressful life events: figures not given 5/ Child psychosocial adjustment: (a) baseline total mean score = 88.35 (SD = 9.91); follow-up mean score = 90.21 (SD = 9.27) (i) Hostility: baseline total mean score = 22.22 (SD = 3.63); follow 1/ Difference in change in mean PSI score from baseline to 15 months was NS. Changes in the subscale scores were also NS. 2.1 NS 2.2NS 2.3 NS for between group differences and change scores 2.4 NS for between group differences and change scores 1/ 2/ 2.i) p = 0.03. Multivariate analysis also suggested that the intervention was successful in reducing anxiety in the experimental group (p<0.05). Mothers who reported good, fair or poor health benefited particularly from the intervention (p<0.01) compared to those who reported very good or excellent health. 3/ no effect. 4/ no effect 5/ (a) p = <.01 using analysis of variance controlling for preintervention scores. Multiple regression analysis controlling for baseline scores showed that the intervention had significant effects on the hostility (t=-2.56, p=.01) and anxiety / depression (t = -3.28; p=.001) subscales. (b) not stated. (c) Multiple regression of

Table 12. LHWs providing support for mothers of sick children compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. mean score = 22.00 (SD = 4.45) (ii) Peer: baseline total mean score = 12.21 (SD = 2.66); follow up total mean score = 11.53 (SD = 2.92) (iii) Dependency: baseline total mean score = 11.86 (SD = 2.14); follow up total mean score = 12.05 (SD = 2.00) (iv) Withdrawal: baseline total mean score = 14.76 (SD = 1.43); follow up total mean score = 14.80 (SD = 1.47) (v) Anxiety/ depression: baseline total mean score = 16.52 (SD = 2.26); follow up total mean score = 16.05 (SD = 2.48) (vi) Productivity: baseline total mean score = 11.24 (SD = 2.70); follow up total mean score = 10.33 (SD = 2.80) (b) proportion of children falling below cut off score of total group mean at baseline minus 1 SD: baseline = 15%; follow-up = 21% 6/ Child s self-esteem (a) overall - no data provided. (b) effect on children with low physical self-esteem at baseline: - baseline physical self- esteem = 86.67 - follow-up physical self-esteem = 81.24 up mean score = 23.23 (SD = 3.41) (ii) Peer: baseline total mean score = 12.00 (SD = 3.10); follow up total mean score = 12.22 (SD = 2.59) (iii) Dependency: baseline total mean score = 11.45 (SD = 2.56); follow up total mean score = 11.81 (SD = 2.59) (iv) Withdrawal: baseline total mean score = 15.01 (1.31); follow up total mean score = 14.95 (SD = 1.50) (v) Anxiety/ depression: baseline total mean score = 16.29 (SD = 2.52); follow up total mean score = 17.08 (SD = 2.14) (vi) Productivity: baseline total mean score = 11.03 (SD = 2.74); follow up total mean score = 10.78 (2.72) (b) proportion of children falling below cut off score of total group mean at baseline minus 1 SD: baseline = 19%; follow-up = 10% 6/ Child s self-esteem (a) overall - no data provided. (b) effect on children with low physical self-esteem at baseline - baseline physical self- esteem = 85.45 - follow-up physical self-esteem = 88.07 follow-up adjustment scores, controlling for baseline adjustment scores: p<.01; and adding baseline physical self-esteem scores: p<.001. 6/ Child depression - not signficant 7/ Child report of general anxiety - not signficant 8/ Child s selfesteem (a) not significant on overall measure (b) effect on children with low physical self-esteem at baseline - effect of intervention more pronounced as compared with children with moderate to high self-esteem (bivariate analysis) Silver 1997 Health status and well being 1/ Children s illness related functional impairment: no data provided 2/ 2.1 Stressful life events = 3.0 2.2 Among mothers with greater life stress (5 or more SLE): post-intervention Anxiety score = 29.1 (n=41) 1/ Children s illness related functional impairment: no data provided 2/ 2.1 Stressful life events = 3.4 2.2 Among mothers with greater life stress (5 or more SLE): post-intervention Anxiety score = 23.1 (n=56) 1/ NS at baseline. Not measured postintervention. 2/ 2.1 NS. 2.2 F (1.94) = 4.61 (p<.05). 85 Other 1/ Maternal capacity to provide care: Psychiatric Symptom Index (PSI) - Total score: baseline = 20.3 (SD=14.3); postintervention = 20.1 (SD=14.7); adjusted = 21.4 - depression: baseline = 20.8 (SD=16.6); postintervention 1/ Maternal capacity to provide care: Psychiatric Symptom Index (PSI) - Total score: baseline = 24.1 (SD=15.5); postintervention = 22.1 (SD=15.4); adjusted = 20.9 - depression: baseline = 23.8 (SD=17.5); postintervention 1/ All NS. Also, there was no pattern of post-intervention differences in PSI scores based on level of mother s participation in the intervention.

Table 12. LHWs providing support for mothers of sick children compared with usual care (Continued) Study Outcome type Control group Intervention group Statistical sig. = 19.6 (SD=16.9); adjusted = 20.5 - anxiety: baseline = 17.6 (SD=17.4); postintervention = 17.3 (SD=18.0); adjusted = 18.5 - anger: baseline = 23.9 (SD=16.5); postintervention = 25.8 (SD=19.0); adjusted = 27.3 - cognitive disturbance: baseline = 22.7 (SD=18.7); postintervention = 23.2 (SD=18.3); adjusted = 24.5 = 22.1 (SD=17.5); adjusted = 21.3 - anxiety: baseline = 21.4 (SD=18.0); postintervention = 19.4 (SD=17.5); adjusted = 18.2 - anger: baseline = 29.0 (SD=19.8); postintervention = 26.7 (SD=19.2); adjusted = 25.3 - cognitive disturbance: baseline = 27.1 (SD=19.7); postintervention = 25.0 (SD=19.5); adjusted = 23.8 86

87 Table 13. LHWs providing home aide services for the elderly compared with day care / usual Study Outcome type Control group Intervention group Statistical sig. McNeil 1995 Health status and well being 1/ Subjective health score: baseline = 1.8 (SD = 0.9); 6 weeks = 1.9 (SD = 0.7) 2/ Memorial University of Newfoundland Scale of Happiness (MUNSH): baseline = 29.2 (SD = 7.4); 6 weeks = 27.7 (SD = 8.9) 3/ Beck Depression Inventory (BDI total): baseline = 15.2 (SD = 2.4); 6 weeks = 14.7 (SD = 3.7) 4/ Psychological symptoms: baseline = 8.4 (SD = 2.1); 6 weeks = 8.0 (SD = 2.1) 5/ Somatic symptoms: baseline = 6.8 (SD = 1.7); 6 weeks = 6.4 (SD =1.8) 6/ Aerobic capacity: baseline = 610.5 (SD = 188.1); 6 weeks = 578.1 (SD = 168.8) Nielsen 1972 Consumer satisfaction 1/ self assessed contentment score (mean change) = -0.06 2/ Observer ratings (mean change) = 0.23 Health care behaviours 1/ Days in long stay institution = 53.12 2/ Days in hospital BRH before discharge = 15.96 3/ Rehospitalisation after discharge = 11.44 4/ Admitted long stay institutions = 14 Intervention 1: Walking 1/ Subjective health score: baseline = 1.7 (SD = 0.5); 6 weeks = 3.2 (SD = 0.9) 2/ MUNSH: baseline = 16.1 (SD = 7.4); 6 weeks = 26.6 (SD = 9.6) 3/ Depression (BDI total): baseline = 16.6 (SD = 3.1); 6 weeks = 11.1 (SD = 3.0) 4/ Psychological symptoms: baseline = 8.9 (SD = 3.5); 6 weeks = 5.8 (SD = 2.4) 5/ Somatic symptoms: baseline = 7.7 (SD = 2.5); 6 weeks = 5.3 (SD =1.6) 6/ Aerobic capacity: baseline = 649.0 (SD = 170.9); 6 weeks = 819.5 (SD = 225.1) Intervention 2: Conversation 1/ Subjective health: baseline = 1.7 (SD = 1.0); 6 weeks = 1.9 (SD = 1.0) 2/ MUNSH baseline = 22.7 (SD = 9.4); 6 weeks = 29.8 (SD = 8.6) 3/ Depression (BDI total): baseline = 16.0 (SD = 3.6); 6 weeks = 11.8 (SD = 4.0) 4/ Psychological symptoms: Baseline = 9.1 (SD = 3.8); 6 weeks = 5.8 (SD = 4.2) 5/ Somatic symptoms: baseline = 6.9 (SD = 1.8); 6 weeks = 6.0 (SD = 1.2) 6/ Aerobic capacity: baseline = 575.6 (SD = 261.1); 6 weeks = 611.4 (SD = 185.6) 1/ self assessed contentment score (mean change) = 0.50 2/ Observer ratings (mean change) = 1.25 1/ Days in long stay institution = 8.34 2/ Days in hospital BRH before discharge = 21.58 3/ Rehospitalisation after discharge 6.84 4/ Admitted long stay institutions = 4 Health status and well being 1/ Deaths = 4 1/ Deaths = 6 1/ p=ns 1/ Walking: pre to post test comparison p<0.1 Walking: post test score higher than conversation or control p<0.005 2/ Pretest MUNSH lower for walking compared to control p<0.5 Walking: pre to post test comparison p<0.01 Conversation: pre to post test comparison p<0.01 3/ Control: post test scores higher than exercise or conversation p<0.05 Walking: pre to post test comparison p<0.05 Conversation: pre to post test comparison p<0.05 4/ Control: post test scores higher than exercise or conversation p<0.05 Walking: pre to post test comparison p<0.05 Conversation: pre to post test comparison p<0.05 5/ Walking: pre to post test comparison p<0.05 6/ Walking: pre to post test comparison p<0.05 Walking: post test scores higher than conversation or control p<0.05 1/ p<0.10 2/ p<0.02 1/ p<0.01 2/ NS 3/ NS 4/ p<0.025

Wan 1980 Health status and well being Control values are included in intervention column Intervention 1: homemaker services Proportion of patients experiencing positive outcomes: 1/ Mortality Intervention 12.9% Control 20.5% Difference -7.6% 2/ Activities of Daily Living (ADI) Physical functioning Intervention 67.5% (n=194) Control 54.7% (190) Difference 12.8% 3/ Contentment level Intervention 70.5% (190) Control 63.5 (189) Difference 7.0% 4/ Mental functioning Intervention 73.4% (188) Control 67.4% (189) Difference 6% 5/ Activity level Intervention 74.7% (194) Control 65.8% (190) Difference 8.9% Intervention 2: daycare services Proportion of patients experiencing positive outcomes: 1/ Mortality Intervention 26.4% Control 36.3% Difference -8.9% 2/ ADL physical functioning Intervention 62.2% (307) Control 55.7% (323) Difference 6.5% 3/ Contentment level Intervention 62.8% (304) Control 51.7% (319) Difference 11.1% 4/ Mental functioning Intervention 61.4% (298) Control 57.0 (314) Difference 4.4% 5/ Activity level Intervention 57.3% (298) Control 57.0%(314) Difference 0.3% Intervention 3: homemaker and daycare services 1/ Mortality Intervention 10.2% Control 28.8% Difference -18.6% 2/ ADL physical functioning Intervention 69.5% (59) Control 56.3% (80) Difference 13.2% 3/ Contentment level Intervention 83.1 % (59) Control 53.8 % (80) Difference 29.3% 4/ Mental functioning Intervention 75.9% (58) Homemaker services 1/ p<0.01 2/ p<0.01 3/ p=ns 4/ p=ns 5/ p=ns Daycare services 1/ p<0.01 2/ p=ns 3/ p<0.05 4/ p=ns 5/ p=ns Homemaker and daycare services 1/ p<0.001 2/ p<0.05 3/ p<0.01 4/ p<0.05 5/ p<0.05 88

Table 13. LHWs providing home aide services for the elderly compared with day care / usual (Continued) Study Outcome type Control group Intervention group Statistical sig. Williams 1992 Health status and well being 1/ Physical status: mean change in score = 0.9 2/ Disability level: mean change in score = 2.6 3/ Mental status: mean change in score = 0.7 Control 58.2% (74) Difference 17.7% 5/ Activity level Intervention 67.8% (59) Control 50.0% (80) Difference 17.8% 1/ Physical status: mean change in score = 0.9 2/ Disability level: mean change in score = 2.1 3/ Mental status: mean change in score = 0.6 1-3/ Not significant but 2 subgroups (women 75-79 yrs living alone and men over 80 yrs) showed significant differences between intervention and control for physical status and Townsend score respectively 89

90 Table 14. LHW interventions not grouped by intention Study Outcome type Control group Intervention group Statistical sig. Carpenter 1990 Health care behaviours 1/ Total number of days spent in institutions = 16088 (16103) 2/ Number of people admitted for >6 months = 20 (21) 3/ No admissions (individuals) = 252(107) 4/ mean length of stay = 63.8 5/ Pattern of admissions to institutions 6/ Rate of referral for domiciliary visits from geriatric or psychogeriatric services - data not provided 7/ Rate of referral to the psychogeriatric day hospital - data not provided 8/ Rate of referral to the community psychiatric nursing service - data not provided 9/ Number of referral to the geriatric day hospital = 14 10/ Number of referrals for meals on wheels = 12 11/ Number of referrals for home helps = 23 12/ Number of referrals for aids to daily living = 118 13/ Pattern of referral for community support services - data not provided 14/ Primary health care team contacts - data not provided Health status and well being 1/ Change in activities of daily living score (primary outcome) = mean(sd) disability score rose from 20.2 (5.6) to 23.1 (7.9) 2/ Mortality = 54 3/ Number of falls - from 17 to 36 1/ Total number of days spent in institutions = 12079 (12064) 2/ Number of people admitted for >6 months = 8 3/ No admissions (individuals) = 335(121) 4/ mean length of stay = 36.1 5/ Pattern of admissions to institutions 6/ Rate of referral for domiciliary visits from geriatric or psychogeriatric services - data not provided 7/ Rate of referral to the psychogeriatric day hospital - data not provided 8/ Rate of referral to the community psychiatric nursing service - data not provided 9/ Number of referrals to the geriatric day hospital = 29 10/ Number of referrals for meals on wheels = 23 11/ Number of referrals for home helps = 29 12/ number of referrals for aids to daily living = 144 13/ data not provided 14/ data not provided 1/ Change in activities of daily living score (primary outcome) = mean(sd) disability score rose from 19.7 (4.7) to 22.3 (6.9) 2/ Mortality = 66 3/ Number of falls remained at 12 1/ not reported 2/ p=0.03 3/ not reported 4/ data not provided 5/ p<.001 6/ data not provided 7/ data not provided 8/ data not provided 9/ p<.05 10/ p=.06 11/ not reported 12/ not reported 13/ data not provided 14/ no significant difference between 1/ not significant 2/ data not provided 3/ p<.05

Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Graham 1992 Health care behaviours Frequency of clinic attendance: 0.93 (n=48) Health status and well being Proportion of LBW babies born to high risk mothers: 7.5% (n=53) Heller 1995 Health care behaviours 10% still smoking 44% changed diet Health status and well being Quality of life factor scores 1/ Emotional 6 weeks=4.98 (0.11) 6 weeks change from baseline= - 0.33 (0.10) 6 months= 5.22 (0.11) 6 months change= - 0.12 (0.11) 2/ Physical 6 weeks=4.97 (0.10) 6 months=5.29 (0.11) 3/ Social 6 weeks=5.31 (0.09) 6 months 5.65 (0.10) Frequency of clinic attendance: 4 home visits: 1.17 (n=49) Some home visits: 1.12 (n=49) Proportion of LBW babies born to high risk mothers: 4 home visits: 7.7% (n=52) Some home visits: 12.9% (n=62) 6% still smoking 54% changed diet Quality of life factor scores 1/ Emotional 6 weeks=5.07 (0.11) 6 weeks change from baseline= - 0.13 (0.09) 6 months= 5.32 (0.12) 6 months change= - 0.02 (0.11) 2/ Physical 6 weeks=5.02 (0.10) 6 months=5.35 (0.11) 3/ Social 6 weeks=5.45 (0.09) 6 months=5.72 (0.10) 4 visits: p=0.007 some visits: p=0.029 4 visits: p=0.98 some visits: p=0.51 P not reported p=0.03 1/ Emotional; 6 weeks: p=0.54 6 weeks change: p=0.14 6 months=0.55 6 months change=0.54 6 weeks=0.72 6 months=0.67 6 weeks=0.28 6 months=0.62 91 Black 1995 Health status and well being (Black 1995) Control children aged 1-12 months at recruitment 1/ Growth Weight for age score - 1.1 (SD = 1.0) Weight for height score -0.8 (SD = 1.1) Height for age score Intervention children aged 1-12 months at recruitment 1/ Growth Weight for age score -1.3 (SD = 1.1) Weight for height score -1.0 (SD = 1.4) Height for age score - 0.8 (SD = 1.1) p=ns

92 Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. - 1.0 (SD = 1.0) 2/ Cognitive development score 86.1 (SD = 18.7) 3/ Motor development score 91.5 (SD = 18.7) 4/ Language development scores Receptive 88.0 (SD = 15.9) Expressive 86.1 (SD = 18.2) 5/ Parent-child interaction scores Child interactive competence 3.31 (SD = 0.48) Parent nurturance 2.21 (SD = 0.71) Negative control 3.89 (SD = 0.61) 6/ Home Observation for Measurement of the Environment (HOME) score 29.3 (SD = 4.2) Control children aged 12.1-24.9 months at recruitment 1/ Growth Weight for age score - 1.7 (SD = 0.7) Weight for height score -1.3 (SD = 0.6) Height for age score - 0.9 (SD = 1.0) 2/ Cognitive development score 80.8 (SD = 15.2) 3/ Motor development score 91.6 (SD = 14.2) 4/ Language development scores Receptive 82.7 (SD = 17.2) Expressive 83.3 (SD = 19.0) 2/ Cognitive development score 89.3 (SD = 17.4) 3/ Motor development score 92.0 (SD = 14.6) 4/ Language development scores Receptive 88.5 (SD = 14.0) Expressive 86.1 (SD = 16.9) 5/ Parent-child interaction scores Child interactive competence 3.33 (SD = 0.66) Parent nurturance 2.24 (SD = 0.65) Negative control 3.78 (SD = 0.69) 6/ HOME score 31.6 (SD = 3.6) Intervention children aged 12.1-24.9 months at recruitment 1/ Growth Weight for age score - 1.8 (SD = 0.6) Weight for height score -1.5 (SD = 0.5) Height for age score - 0.7 (SD = 1.1) 2/ Cognitive development score 81.9 (SD = 12.5) 3/ Motor development score 92.0 (SD = 12.2) 4/ Language development scores Receptive 83.2 (SD = 10.2) Expressive 83.4 (SD = 11.7) 5/ Parent-child interaction scores Child interactive competence 3.66 (SD = 0.51) Parent nurturance 2.46 (SD = 0.85)

93 Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Helath status and well being (Hutcheson 1997) 5/ Parent-child interaction scores Child interactive competence 3.64 (SD = 0.69) Parent nurturance 2.42 (SD = 0.78) Negative control 3.77 (SD = 0.72) 6/ HOME score 30.3 (SD = 5.7) Cognitive development (Batelle Developmental Inventory): 1/ Children of mothers with high levels of negative affectivity: mean = 77.8, SD = 12.2 2/ Children of mothers with low levels of negative affectivity: mean = 71.6, SD = 17.9 Motor development (Batelle Developmental Inventory): 1/ Children of mothers with high levels of negative affectivity: mean =89.0, SD = 20.5 2/ Children of mothers with low levels of negative affectivity: mean = 75.7, SD = 19.2 Task engagement during play: 1/ Children of mothers with high levels of negative affectivity: mean = 3.2, SD = 0.4 2/ Children of mothers with low levels of negative affectivity: mean = 3.7, SD = 0.3 Negative affect during play: 1/ Children of mothers with high levels of negative affectivity: mean = 3.6, SD = 0.3 2/ Children of mothers with low Negative control 3.66 (SD = 0.59) 6/ HOME score 32.4 (SD = 5.1) Cognitive development (Batelle Developmental Inventory): 1/ Children of mothers with high levels of negative affectivity: mean = 77.4, SD = 18.3 2/ Children of mothers with low levels of negative affectivity: mean = 84.9, SD = 13.2 Motor development (Batelle Developmental Inventory): 1/ Children of mothers with high levels of negative affectivity: mean =85.0, SD = 21.0 2/ Children of mothers with low levels of negative affectivity: mean = 95.6, SD = 13.3 Task engagement during play: 1/ Children of mothers with high levels of negative affectivity: mean = 2.9, SD = 0.6 2/ Children of mothers with low levels of negative affectivity: mean = 3.2, SD = 0.5 Negative affect during play: 1/ Children of mothers with high levels of negative affectivity: mean = 3.5, SD = 0.5 2/ Children of mothers with low Cognitive development: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity Motor development: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity Task engagement: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity Negative affect: Significant in favour of home-based (LHW) intervention, particularly for children of mothers with low levels of negative affectivity

94 Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. levels of negative affectivity: mean = 3.4, SD = 0.6 Warmth during play: 1/ Children of mothers with high levels of negative affectivity: mean = 2.9, SD = 0.5 2/ Children of mothers with low levels of negative affectivity: mean = 2.5, SD = 0.5 Ramadas 2003 Health status and well being 1/ Number incident oral cancers: Early=16 Interim=106 2/ Mortality: Early=9/16 (56.3%) Interim= 62/106 (58.5%) Tudiver 1992 Health care behaviours Questionnaire (%) 1/ i. practicing unsafe anal sex: -13.7% ii. practicing safer anal sex: +3.9% iii. practicing no anal sex: +4.2% 2/ Number of sexual partners: no significant changes 3/ Anal intercourse knowledge: no significant changes 4/ Knowledge of AIDS risk: 3% increase, no significant difference between groups 5/ Condom efficacy: no change levels of negative affectivity: mean = 3.7, SD = 0.2 Warmth during play: 1/ Children of mothers with high levels of negative affectivity: mean = 2.8, SD = 0.5 2/ Children of mothers with low levels of negative affectivity: mean = 2.9, SD = 0.5 1/ Number incident oral cancers: Early=47 Interim=149 2/ Mortality: Early=7/47 (14.9%) Interim= 65/149 (43.6%) Intervention 1: LHWs Questionnaire response (%) 1/ i. practicing unsafe anal sex: - 40% ii. practicing safer anal sex: +13.3% iii. practicing no anal sex: +13.3% 2/ Number of sexual partners: no significant changes 3/ Anal intercourse knowledge: no significant changes 4/ Knowledge of AIDS risk: 7% increase, no significant difference between groups 5/ Condom efficacy: 4% increase Intervention 2: Professionals Questionnaire response (%) 1/ i. practicing unsafe anal sex: -14.1% Sensitivity: Early=76.6% Interim= 81.5% Specificity: Early=76.2% Interim=84.8% Positive Predictive Value: Early=1.0% Interim=39.6% 1/ not stated 4/ Knowledge of AIDS risk: adjusted final scores were 0.32% higher for combined treatment groups than the controls = effect size of 0.20 standard deviation units [not sure if this is relevant to the review, given that the treatment groups have been combined] 5/ not reported. Mean final score for combined treatment groups was 0.33% higher than for adjusted means of controls = 0.17 std deviation units

Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Voorhees 1996 Health care behaviours 1/ Quit rate among smokers [primary outcome]: - self reported quit = 21.5% (20/93) - biochemically validated quit = 15.05% (14/93) 2/ Shifts in stages of change among smokers [primary outcome] - proportions in the no change, and regression outcome groups = 66% ii. practicing safer anal sex: +14.8% iii. practicing no anal sex: - 2.5% 2/ Number of sexual partners: no significant changes 3/ Anal intercourse knowledge: no significant changes 4/ Knowledge of AIDS risk: 10% increase, no significant difference between groups 5/ Condom efficacy: 5% increase 1/ Quit rate among smokers [primary outcome]: - self reported quit = 27.13% (54/199) - biochemically validated quit = 19.59% (39/199) 2/ Shifts in stages of change among smokers [primary outcome] - proportions in the no change, and regression outcome groups = 54% 1/ - self report: chi squared = 1.06, p =.48 - biochemical: chi squared = 0.88; p =.35 2/ Shifts in stages of change among smokers [primary outcome] - proportions in the positive progress, no change, and regression outcome groups: chi squared = 3.78; p =.05 - crude OR comparing intervention groups and progress status (positive vs no change and regression) = 1.73 (p =.037) 95 Von Korff 1998 Health status and well being 1/ Pain intensity: - baseline: 5.66 (SD=2.06) - 3 months: 4.02 (2.13) - 6 months: 4.07 (0.85) - 12 months: 3.79 (2.35) 2/ Roland Disability Questionnaire 1/ Pain intensity: - baseline: 5.36 (1.99) - 3 months: 3.87 (SD = 2.21) - 6 months: 3.37 (0.82) - 12 months: 3.22 (2.03) 2/ Roland Disability Questionnaire 1/ Pain intensity: - 3 months: p =.748-6 months: p =.064-12 months: p =.19 2/ Roland Disability Questionnaire

96 Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Other score - baseline: 9.42 (6.45) - 3 months: 7.4 (SD = 6.33) - 6 months: 7.23 (6.51) - 12 months: 6.75 (6.39) 3/ Short-Form 36 Mental Health Inventory - baseline: 68.6 (19.7) - 3 months: 72.7 (SD = 19.7) - 6 months: 76.1 (18.4) - 12 months: 75.8 (16.3) 4/ Interference rating: - baseline: 5.19 (2.43) - 3 months: 3.55 (SD = 2.49) - 6 months: 3.35 (2.59) - 12 months: 3.1 (2.66) 1/ Attitudes towards back pain selfcare - baseline: 2.70 (0.70) - 3 months: 3.0 (SD = 0.74) - 6 months: 2.96 (0.85) - 12 months: 3.04 (0.82) 2/ Back pain worries - baseline: 6.44 (2.81) - 3 months: 4.62 (SD = 3.17) - 6 months: 4.28 (3.15) - 12 months: 3.83 (3.08) 3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP - baseline: 46.8% - 3 months: 62% - 6 months: 66.1% - 12 months: 60% score - baseline: 9.50 (6.11) - 3 months: 6.56 (SD = 5.61) - 6 months: 5.83 (5.89) - 12 months: 5.75 (6.31) 3/ Short-Form 36 Mental Health Inventory - baseline: 70.3 (18.2) - 3 months: 74.8 (SD = 16.4) - 6 months: 75.9 (15.6) - 12 months: 77.8 (16.1) 4/ Interference rating: - baseline: 5.07 (2.44) - 3 months: 3.24 (SD = 2.4) - 6 months: 2.77 (2.45) - 12 months: 2.78 (2.38) 1/ Attitudes towards back pain selfcare - baseline: 2.70 (0.71) - 3 months: 3.15 (SD = 0.8) - 6 months: 3.22 (0.82) - 12 months: 3.24 (0.81) 2/ Back pain worries - baseline: 5.80 (2.55) - 3 months: 4.0 (SD = 2.82) - 6 months: 2.97 (2.65) - 12 months: 2.63 (2.58) 3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP - baseline 50.4% - 3 months: 69.1% - 6 months: 78.6% - 12 months: 76.8% Weinberger 1989 Utilization of LHW Mean number of contacts between Intervention 1: Telephone p<0.0001 score - 3 months: p =.088-6 months: p =.007-12 months: p =.092 3/ Short-Form 36 Mental Health Inventory - 3 months: p =.631-6 months: p =.990-12 months: p =.828 4/ Interference rating: - 3 months: p =.737-6 months: p =.204-12 months: p =.76 1/ Attitudes towards back pain selfcare - 3 months: p =.047-6 months: p =.032-12 months: p =.10 2/ Back pain worries - 3 months: p =.612-6 months: p =.013-12 months: p =.013 3/ The next time I have back or leg pain, I will try to manage problem without seeing a HCP - 3 months: p =.242-6 months: p =.034-12 months: p =.008

Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Consumer satisfaction Health care behaviours patients and LHWs = 0 Rand Corporation satisfaction with health care scale = 13.5 % non-compliant with medications over the preceding week = 30.4 Mean number of contacts between patients and LHWs = 2.95 Intervention 2: Clinic Mean number of contacts between patients and LHWs = 9.52 Intervention 3: Both Mean number of contacts between patients and LHWs = 8.53 Intervention 1: Telephone Rand Corporation satisfaction with health care scale = 13.5 Intervention 2: Clinic Rand Corporation satisfaction with health care scale = 13.9 Intervention 3: Both Rand Corporation satisfaction with health care scale = 13.9 Intervention 1: Telephone % non-compliant with medications over the preceding week = 26.6 Intervention 2: Clinic % non-compliant with medications over the preceding week = 34.4 Intervention 3: Both % non-compliant with medications over the preceding week = 24.5 p = NS p =NS 97 Health status and well being 1/ Arthritis Impact Measurement Scales (AIMS) (a) psychological health = 3.04 (b) physical health = 2.65 (c) pain = 6.58 2/ Philedelphia Geriatric Center Morale Scale = 7.9 3/ AIMS on subgroup of patients Intervention 1: Telephone 1/ Arthritis Impact Measurement Scales (AIMS) (a) psychological health = 2.94 (b) physical health = 2.47 (c) pain = 5.76 2/ Philedelphia Geriatric Center Morale Scale = 7.3 1/ (a) psychological health = NS (b) physical health = NS (c) pain = NS 2/ NS 3/ - pain: p=<.01 - physical: p=0.16 Between group effect size

98 Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Other whose records showed (a) radiographic confirmed OA of the knee and (b)no change in OA medication or referral for physical therapy during the study (Rene et al 1992 (c) were in control(n=15) or telephone only (n=22) groups - pain = 6.53 (SD 2.99) - physical function = 2.8 (SD 1.78) Interpersonal support Evaluation List (ISEL) = 28.9 Wertz 1986 Health status and well being Porch Index of Communication Ability (PICA), mean change between entry and week 12 1/ gestural score = 12.96 2/ verbal score = 9.85 3/ graphic score = 10.20 4/ overall score = 12.23 3/ - pain 4.59 (SD2.43) - physical 1.86 (SD1.35) Intervention 2: Clinic 1/ Arthritis Impact Measurement Scales (AIMS) (a) psychological health = 3.27 (b) physical health = 2.97 (c) pain = 6.24 2/ Philedelphia Geriatric Center Morale Scale = 8.1 Intervention 3: Both 1/ Arthritis Impact Measurement Scales (AIMS) (a) psychological health = 2.88 (b) physical health = 2.67 (c) pain = 6.04 2/ Philedelphia Geriatric Center Morale Scale = 8.2 Intervention 1: Telephone ISEL = 28.9 Intervention 2: Clinic ISEL = 28.0 Intervention 3: Both ISEL = 28.9 Intervention 1: Home PICA mean change between entry and week 12: 1/ gestural score = 13.99 2/ verbal score = 13.10 3/ graphic score = 16.11 4/ overall score = 16.86 Intervention 2: Clinic PICA mean change between entry and week 12: Pain=0.65 Physical =0.53 p = NS Only significant result is overeall difference between groups 1 and 3 (+5.93) p<0.05 based on pairwise multiple comparisons

Table 14. LHW interventions not grouped by intention (Continued) Study Outcome type Control group Intervention group Statistical sig. Zwarenstein 2000 Health status and well being Clinic DOT 1/ Successful TB treatment completion, including patients cured and those who completed treatment = 33 (57%) 2/ Successful TB treatment in new patients = 24 (67%) 3/ Successful TB treatment in retreatment patients = 9 (41%) 4/ Successful TB treatment in women patients = 26 (67) 5/ Successful TB treatment in male patients = 7 (37%) 1/ gestural score = 17.50 2/ verbal score = 13.85 3/ graphic score = 17.03 4/ overall score = 18.16 Intervention 1: LHW observed 1/ Successful TB treatment completion, including patients cured and those who completed treatment = 40 (74%) 2/ Successful TB treatment in new patients = 30 (91%) 3/ Successful TB treatment in retreatment patients = 10 (48%) 4/ Successful TB treatment in women patients = 17 (63%) 5/ Successful TB treatment in male patients = 23 (85%) Intervention 2: Self observed 1/ Successful TB treatment completion, including patients cured and those who completed treatment = 26 (59%) 2/ Successful TB treatment in new patients = 14 (52%) 3/ Successful TB treatment in retreatment patients = 12 (71%) 4/ Successful TB treatment in women patients = 16 (64%) 5/ Successful TB treatment in male patients = 10 (52%) 1/ p= 0.136 2/ LHW vs clinic difference = 24.2% (6-42.5%); LHW vs self difference = 39.1 % (17.8-60.3) 3/ LHW vs clinic 6.7% (-22.9-36.3); LHW vs self difference = -23% (-53.4-7.5) 4/ LHW vs clinic difference = 48.3% (22.8-73.8); LHW vs self difference = 32.6% (6.4-58.7) 5/ LHW vs clininc difference = -3.7% (-27.2-19.8); LHW vs self = -1% (-27.2-25.2) 99

A N A L Y S E S Comparison 01. LHW interventions to promote breast cancer screening uptake compared with usual care Outcome title No. of No. of studies participants Statistical method Effect size 01 Breast cancer screening uptake 5 Adjusted RR (Random) 95% CI 1.05 [0.99, 1.12] Comparison 02. LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care Outcome title 01 Breastfeeding up to 2 weeks postpartum No. of No. of studies participants Statistical method Effect size 4 Adjusted RR (Random) 95% CI 1.69 [0.91, 3.12] Comparison 03. LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care Outcome title 01 Breastfeeding between 2 weeks and 6 months postpartum No. of No. of studies participants Statistical method Effect size 4 Adjusted RR (Random) 95% CI 2.93 [0.88, 9.71] Comparison 04. LHW interventions to promote immunization uptake compared with usual care Outcome title No. of No. of studies participants Statistical method Effect size 01 Immunization uptake 3 Adjusted RR (Random) 95% CI 1.30 [1.14, 1.48] Comparison 05. LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care Outcome title No. of No. of studies participants Statistical method Effect size 01 Morbidity and mortality 3 Adjusted RR (Random) 95% CI 0.74 [0.58, 0.93] I N D E X T E R M S Medical Subject Headings (MeSH) Allied Health Personnel; Community Health Aides; Community Health Services; Health Promotion; Home Health Aides; Primary Health Care; Randomized Controlled Trials MeSH check words Humans Title Authors Contribution of author(s) C O V E R S H E E T Lay health workers in primary and community health care Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, van Wyk B, Bosch-Capblanch X, Patrick M SL, JD and MZ wrote the protocol, with contributions from GA and BvW. All authors assessed studies for inclusion; participated in data extraction; and contributed to data analysis. SL and PP undertook the meta-analysis with assistance from the other authors. PP and SL drafted the study report and all authors commented on this. 100

Issue protocol first published 2003/1 Review first published 2005/1 Date of most recent amendment 20 July 2005 Date of most recent SUBSTANTIVE amendment 08 November 2004 What s New Information not supplied by author Date new studies sought but none found Information not supplied by author Date new studies found but not yet included/excluded Information not supplied by author Date new studies found and included/excluded Information not supplied by author Date authors conclusions section amended Information not supplied by author Contact address Dr Simon Lewin Senior Scientist Environmental Epidemiology Unit London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT UK E-mail: simon.lewin@lshtm.ac.uk Tel: +44 20 7927 2102 Fax: +44 20 7580 4524 DOI 10.1002/14651858.CD004015.pub2 Cochrane Library number CD004015 Editorial group Cochrane Effective Practice and Organisation of Care Group Editorial group code HM-EPOC 101

Analysis 01.01. G R A P H S A N D O T H E R T A B L E S Comparison 01 LHW interventions to promote breast cancer screening uptake compared with usual care, Outcome 01 Breast cancer screening uptake Review: Lay health workers in primary and community health care Comparison: 01 LHW interventions to promote breast cancer screening uptake compared with usual care Outcome: 01 Breast cancer screening uptake Study log [Adjusted RR] Adjusted RR (Random) Weight Adjusted RR (Random) (SE) 95% CI (%) 95% CI 01 General promotion Andersen 2000 0.04 (0.04) 78.0 1.04 [ 0.97, 1.12 ] Hoare 1994 0.04 (0.13) 6.3 1.04 [ 0.81, 1.34 ] Sung 1997 0.24 (0.18) 3.2 1.27 [ 0.89, 1.82 ] Subtotal (95% CI) 87.5 1.05 [ 0.98, 1.13 ] Test for heterogeneity chi-square=1.17 df=2 p=0.56 I² =0.0% Test for overall effect z=1.46 p=0.1 02 Promotion among non-users Duan 2000 0.04 (0.16) 4.2 1.04 [ 0.76, 1.42 ] Subtotal (95% CI) 4.2 1.04 [ 0.76, 1.42 ] Test for heterogeneity: not applicable Test for overall effect z=0.24 p=0.8 03 Promotion among users Duan 2000 0.09 (0.11) 8.3 1.09 [ 0.88, 1.36 ] Subtotal (95% CI) 8.3 1.09 [ 0.88, 1.36 ] Test for heterogeneity: not applicable Test for overall effect z=0.79 p=0.4 Total (95% CI) 100.0 1.05 [ 0.99, 1.12 ] Test for heterogeneity chi-square=1.28 df=4 p=0.86 I² =0.0% Test for overall effect z=1.64 p=0.1 0.1 0.2 0.5 1 2 5 10 Favours control Favours treatment 102

Analysis 02.01. Review: Comparison: Outcome: Comparison 02 LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care, Outcome 01 Breastfeeding up to 2 weeks postpartum Lay health workers in primary and community health care 02 LHWs to promote breastfeeding up to 2 weeks postpartum compared with usual care 01 Breastfeeding up to 2 weeks postpartum Study log [Adjusted RR] Adjusted RR (Random) Weight Adjusted RR (Random) (SE) 95% CI (%) 95% CI Caulfield 1998 0.70 (0.41) 20.4 2.01 [ 0.91, 4.45 ] Dennis 2002 0.10 (0.13) 29.2 1.10 [ 0.85, 1.43 ] Haider 2000 1.04 (0.12) 29.6 2.82 [ 2.24, 3.55 ] Morrow 1999 0.22 (0.39) 20.8 1.24 [ 0.58, 2.68 ] Total (95% CI) 100.0 1.69 [ 0.91, 3.12 ] Test for heterogeneity chi-square=28.98 df=3 p=<0.0001 I² =89.6% Test for overall effect z=1.66 p=0.1 0.01 0.1 1 10 100 Favours control Favours treatment Analysis 03.01. Comparison 03 LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care, Outcome 01 Breastfeeding between 2 weeks and 6 months postpartum Review: Lay health workers in primary and community health care Comparison: 03 LHWs to promote breastfeeding (2 weeks and 6 months postpartum) compared with usual care Outcome: 01 Breastfeeding between 2 weeks and 6 months postpartum Study log [Adjusted RR] Adjusted RR (Random) Weight Adjusted RR (Random) (SE) 95% CI (%) 95% CI Dennis 2002 0.19 (0.15) 26.4 1.21 [ 0.91, 1.61 ] Haider 2000 2.45 (0.25) 25.7 11.64 [ 7.09, 19.09 ] Morrell 2000 0.05 (0.26) 25.6 1.06 [ 0.64, 1.75 ] Morrow 1999 1.70 (0.53) 22.3 5.50 [ 1.93, 15.68 ] Total (95% CI) 100.0 2.93 [ 0.88, 9.71 ] Test for heterogeneity chi-square=70.11 df=3 p=<0.0001 I² =95.7% Test for overall effect z=1.76 p=0.08 0.01 0.1 1 10 100 Favours control Favours treatment 103

Analysis 04.01. Review: Comparison: Outcome: Comparison 04 LHW interventions to promote immunization uptake compared with usual care, Outcome 01 Immunization uptake Lay health workers in primary and community health care 04 LHW interventions to promote immunization uptake compared with usual care 01 Immunization uptake Study log [Adjusted RR] Adjusted RR (Random) Weight Adjusted RR (Random) (SE) 95% CI (%) 95% CI 01 Children Barnes 1999 0.19 (0.22) 9.5 1.21 [ 0.79, 1.86 ] Johnson 1993 0.27 (0.15) 19.1 1.31 [ 0.97, 1.78 ] Subtotal (95% CI) 28.6 1.28 [ 1.00, 1.64 ] Test for heterogeneity chi-square=0.09 df=1 p=0.77 I² =0.0% Test for overall effect z=1.94 p=0.05 02 Adults Krieger 2000 0.27 (0.08) 71.4 1.31 [ 1.12, 1.53 ] Subtotal (95% CI) 71.4 1.31 [ 1.12, 1.53 ] Test for heterogeneity: not applicable Test for overall effect z=3.35 p=0.0008 Total (95% CI) 100.0 1.30 [ 1.14, 1.48 ] Test for heterogeneity chi-square=0.11 df=2 p=0.95 I² =0.0% Test for overall effect z=3.87 p=0.0001 0.1 0.2 0.5 1 2 5 10 Favours control Favours treatment 104

Analysis 05.01. Review: Comparison: Outcome: 01 Mortality Comparison 05 LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care, Outcome 01 Morbidity and mortality Lay health workers in primary and community health care 05 LHWs to reduce morbidity and mortality from ARI and malaria compared with usual care 01 Morbidity and mortality Study log [Adjusted RR] Adjusted RR (Random) Weight Adjusted RR (Random) (SE) 95% CI (%) 95% CI Kidane 2000-0.52 (0.09) 35.3 0.59 [ 0.50, 0.71 ] Mtango 1986-0.21 (0.10) 33.7 0.81 [ 0.67, 0.98 ] Subtotal (95% CI) 68.9 0.69 [ 0.51, 0.94 ] Test for heterogeneity chi-square=5.37 df=1 p=0.02 I² =81.4% Test for overall effect z=2.39 02 Morbidity p=0.02 Chongsuvivat 1996-0.16 (0.12) 31.1 0.86 [ 0.68, 1.07 ] Subtotal (95% CI) 31.1 0.86 [ 0.68, 1.07 ] Test for heterogeneity: not applicable Test for overall effect z=1.35 p=0.2 Total (95% CI) 100.0 0.74 [ 0.58, 0.93 ] Test for heterogeneity chi-square=8.28 df=2 p=0.02 I² =75.8% Test for overall effect z=2.56 p=0.01 0.1 0.2 0.5 1 2 5 10 Favours treatment Favours control 105