Systematic Review Protocol. What is the comparative effectiveness of nurse led cardiac clinics in adult patients with a diagnosis of CHD.

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1 Systematic Review Protocol What is the comparative effectiveness of nurse led cardiac clinics in adult patients with a diagnosis of CHD. Contact Reviewer: Ms Tammy Page Research Officer Reviews The Joanna Briggs Institute Royal Adelaide Hospital North Terrace Adelaide SA 5000 Ph: tamara.page@adelaide.edu.au Secondary Contact: Mr Craig Lockwood Co-ordinator of Systematic Reviews Ph: craig.lockwood@adelaide.edu.au

2 Background This review protocol was developed to guide the completion of a systematic review on nurse-led cardiac clinics. The literature suggests that nurse-led clinics can be distinguished by certain characteristics or features related to structure and/or function. The focus is on health rather than illness, and emphasising life management rather than diagnosis and interventions.1 For the purpose of this review nurse-led clinics are defined as providing a service for the consumer, which is managed and staffed solely by nurses, with the ability to assess or treat and consult or refer the consumer to other health disciplines as required. A wide range of health care issues have been managed via nurse-led clinics, including chronic disorders such as, asthma, hypertension, and diabetes. The management of chronic disorders by nurse-led clinics rather than acute care is one way of decreasing the escalating costs of health care. Customer satisfaction levels as high as 97% are reported in some clinics. 1 For this review nurse-led will incorporate nurse-led clinics in any setting. On the basis of the initial literature reviewed, and the volume of information on nurse-led clinics, this protocol was focused to summarise current best evidence addressing nurse-led cardiac clinics. Background of cardiac clinics Coronary heart disease (CHD) is the major cause of illness and death in Western countries and this is likely to increase as the average age of the population rises. 2 Heart failure is documented as being the leading cause of hospitalisation in cardiovascular patients and is quite often associated with frequent readmission rates. 3 Consumers with established CHD are at the highest risk of experiencing further coronary events. Lifestyle measures can contribute significantly to a reduction in cardiovascular mortality in established CHD. 4 Preventing disease progression in patients with established CHD is termed secondary prevention. 4 Optimisation of management of CHD to curtail costs without impairing patient's quality of life is a prime consideration in the current economic climate. 3 There is a need for alternative strategies and there is evidence that trained practice nurses in a variety of settings can successfully identify cardiovascular risk factors; providing education and referrals as required, as well as manage risk factors in patients with established CHD.

3 Objectives The objective of this review is to present the best available evidence related to nurse-led cardiac clinics. The specific review question to be addressed is: What is the comparative effectiveness of nurse led cardiac clinics in adult patients with a diagnosis of CHD. Criteria for considering studies for this review Types of studies This review will consider any randomised controlled trials (RCT) that evaluate cardiac centred nurse-led clinics. In the absence of randomised controlled trials (RCTs), other research designs such as non-randomised controlled trials and before and after studies will be considered for inclusion in a narrative summary to enable the identification of current approaches and possible future strategies related to nurse-led clinics. Types of participants Adults (18+) presenting with a diagnosis of coronary heart disease to a nurse-led clinic. Types of interventions The interventions of interest are those related to: Education Assessment Consultation Referral Administrative structures or models Types of outcome measures Outcome measures including: Readmissions Admission rates Cost effectiveness Consumer satisfaction Clinic utilization rate Referrals Search strategy for identification of studies The search will seek to find both published and unpublished studies in the English language. A three-step search strategy will be used. An initial limited search of MEDLINE and CINAHL databases will be undertaken to identify key words contained in the title or abstract, and index terms used to describe relevant articles. A second extensive search will be undertaken using all identified key words and index terms. The third step will be a search of the reference lists and bibliographies of all relevant articles.

4 Initial search terms will be: Nurse?led Health promotion The databases to be searched will include: CINAHL MEDLINE Current Contents Cochrane Library Database of Abstracts of Reviews of Effectiveness Expanded Academic Index Electronic Collections Online Turning Research Into Practice (TRIP) Database Rural The search for unpublished studies will include: Dissertation Abstracts International Proceedings First All studies identified during the database search will be assessed for relevance to the review based on the information provided in the title, abstract and descriptor/mesh terms, and a full report will be retrieved for all studies that meet the inclusion criteria. Studies identified from reference list searches will be assessed for relevance based on the study title. When the full report has been retrieved, two independent reviewers will compare studies to the inclusion criteria to determine their relevance to this systematic review. Methods of the review Critical Appraisal All identified studies that meet the inclusion criteria will be assessed by two independent reviewers for methodological validity prior to inclusion in the review (see Appendix I). If consensus cannot be achieved assessment by a third reviewer would be undertaken. Critical appraisal of studies will focus on: Selection bias Performance bias Attrition bias Detection bias Data Collection Two independent reviewers will perform data extraction. To minimise the risk of error during the transcription of data, a data collection tool was developed (see Appendix II).

5 The data to be collected will include: Demographic information about the study population Description of the intervention Description of the outcome measures The study method Results data Data Synthesis When two or more comparable RCTs are identified the results will be pooled in a metaanalysis to determine the effectiveness of the intervention. Comparability of studies will be in terms of the specific study population, intervention and outcome measures. Review Manager, version 4.04 will be used to perform the meta-analysis. Heterogeneity between comparable studies will be assessed using Chi Square and visual inspection of the graphic presentation of results. Significant heterogeneity will be considered present when the p- value is less than Double data entry will be utilised to minimise the risk of error during the data entry phase of the analysis. The type of data collected will determine the approach used during the meta-analysis. For dichotomous data, odds ratio will be used as the summary measure of effect. For continuous data that uses the same scale, the weighted mean difference will be used as the summary measure of effect. For continuous data that uses different scales, the standardised mean difference will be used as the most appropriate summary of effect. The 95% confidence interval will be calculated for each study. Where statistical pooling is not appropriate or possible, the findings will be summarised in narrative form.

6 References 1 Robinson KR. Nurse-managed primary care delivery clinics. Nursing Clinics of North America 2000; 35(2): McAlister FA, Lawson F, Teo KK,AArmstrong PW. Randomised trials of secondary prevention programmes in coronary heart disease: systematic review. BMJ 2001; 323(7319): Cline CM, Israelsson BY, Willenheimer RB, Broms K,Erhardt LR. Cost effective management programme for heart failure reduces hospitalisation. Heart 1998; 80): Flanagan M. Secondary prevention of chronic heart disease in primary care - a healthy heart initiative. Quarterly journal of medicine 1999; 92(

7 Appendix I FORM 4.1 The Joanna Briggs Institute Experimental Critical Appraisal Form Experimental studies Yes No (if no, use observational form 4.2) Author Year Record Number Questions 1 to 4 must be answered yes for study to be included in the meta-analysis. 1) Were the participants randomised to study groups? 2) Other than the research intervention, were participants in each groups treated the same? 3) Were the outcomes measured in the same manner for all participants? 4) Were groups comparable at entry? Studies that answer no to questions 5-10 will only be included in the systematic review if no other higher quality studies are identified available, however this must be noted in the report. 5) Was randomisation of participants blinded? 6) Were those assessing outcome blinded to treatment allocation (if outcome not objective such as survival or length of hospitalisation)? 7) Was allocation to treatment groups concealed from the allocator? yes no not clear

8 8) Was an appropriate statistical analysis used? yes no not clear 9) Were outcomes measured in a reliable way? yes no not clear 10) Was there adequate follow-up of participants? yes no not clear (less than 80% followed up) SUMMARY TOTAL YES NO? DECISION USE NARRATIVE SUMMARY ONLY REJECT FURTHER INFORMATION NEEDED COMMENTS

9 FORM 4.2 The Joanna Briggs Institute Observational Critical Appraisal Form Observational studies Yes No (if no use experimental form 4.1) Author Year Record Number 1) Is the study based on a random or pseudo-random sample? 2) Are the criteria for inclusion in the sample clearly defined? 3) Were the outcomes assessed using objective criteria? 4) If comparisons are being made, was there sufficient description of the groups? 5) Was an appropriate statistical analysis used? SUMMARY TOTAL YES NO? N/A DECISION USE REJECT FURTHER INFORMATION NEEDED COMMENTS

10 Appendix II The Joanna Briggs Institute Data Extraction Form FORM 5 Author Record Number Journal Year Reviewer Method Setting Participants Number of Participants Group A Group B Group C Control Intervention 1 Intervention 2 Interventions Group A Group B Control Intervention 1 Group C Intervention 2

11 Outcome Measures Definition Other Outcomes Measures Outcome Description Scale / Measure

12 Results Dichotomous Data Outcome Control Group number / total number Treatment Group number / total number Continuous Data Outcome Control Group mean & SD (number) Treatment Group mean & SD (number) Authors Conclusions Comments