NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for health and social care Commissioning outcomes framework programme Briefing paper

Transcription

1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for health and social care Commissioning outcomes framework programme Briefing paper Quality standard topic: Alcohol dependence and harmful alcohol use Potential output: Recommendations for indicator development Date of COF Advisory Committee meeting: 24 September 2012 Contents Introduction... 3 Section 1 Overview... 5 Section 2 Definition, epidemiological summary and clinical management... 8 Section 3 Proposed indicator statements: quality standard on alcohol dependence and harmful alcohol use QS02 Opportunistic screening and brief interventions QS03 Referral to specialist alcohol services QS05 Assessment in specialist alcohol services adults QS06 Assessment in specialist services children and young people QS08 Medically assisted alcohol withdrawal setting QS09 Medically assisted alcohol withdrawal drug regimens NICE quality standard statement QS10 Wernicke s encephalopathy QS11 Psychological interventions and relapse prevention medication for adults QS12 Specialist interventions for children and young people QS13 Outcomes monitoring Section 4 Other outcome indicators identified by the Review Group for alcohol dependence and harmful alcohol use Section 5 Statement from the Chair of the alcohol dependence and harmful alcohol use Review Group Agenda Item 14: Alcohol dependence and harmful alcohol use 1 of 44

2 Section 6 Indicators identified from other sources Section 7 Candidate indicators Agenda Item 14: Alcohol dependence and harmful alcohol use 2 of 44

3 Introduction This briefing paper presents a structured review of draft indicator statements. These indicator statements have been derived either from the NICE quality standard on alcohol dependence and harmful alcohol use or from other sources, for example, relevant indicators in the NHS operating framework. For the purposes of this paper, an indicator statement is defined as a high level statement which, with development and testing, can be used to specify a potential quality indicator for use in the COF. This briefing paper is intended to help inform and guide the selection of indicator statements by the COF Advisory Committee for indicator development. Structure of the briefing paper This briefing paper includes 7 sections. These sections address the requirements of the selection criteria for potential COF indicators as outlined in the COF process guide. Section 1 presents an overview of the NICE quality standard on alcohol dependence and harmful alcohol use and its link to the NHS outcomes framework. Section 2 presents a brief definition and epidemiological summary of alcohol dependence and harmful alcohol use and its clinical management. Section 3 presents the quality statements as presented in the published quality standard alongside the developed indicator statements. This section also includes: an evidence summary for the proposed indicator statement a brief overview of current clinical practice including, where data is available, current baseline and any variation in practice indicator development issues, including a feasibility assessment carried out in collaboration with the NHS Information Centre. Agenda Item 14: Alcohol dependence and harmful alcohol use 3 of 44

4 Section 4 presents outcome indicator statements, and in some cases additional process indicator statements, that the COF indicator alcohol dependence and harmful alcohol use Review Group considered would reflect the provision of high quality care as defined in the Quality Standard as a whole. Section 5 presents a supporting statement by the Chair of the COF indicator alcohol dependence and harmful alcohol use Review Group for consideration by the COF Advisory Committee. Section 6 presents indicators identified from other sources, with an assessment against pre-defined criteria. Section 7 presents an initial technical feasibility assessment of COF the draft indicator statements. Agenda Item 14: Alcohol dependence and harmful alcohol use 4 of 44

5 Section 1 Overview Background The proposed indicator statements presented in this briefing paper have been identified in three ways: from the NICE quality standard for alcohol dependence and harmful alcohol use, published August 2011: NICE quality standard for alcohol dependence and harmful alcohol use. Available from: me.jsp by the COF indicator alcohol dependence and harmful alcohol use Review Group from other sources The quality standard covers the care of children (aged years), young people (aged years) and adults (aged 18 years and over) drinking in a harmful way and those with alcohol dependence in all NHS-funded settings. It also includes opportunistic screening and brief interventions for hazardous and harmful drinkers. The quality standard addresses the prevention and management of Wernicke's encephalopathy but does not cover the separate management of other physical and mental health disorders associated with alcohol use. The proposed indicator statements included in this briefing paper relate to healthcare processes or outcomes that can be influenced, at least in part, by the actions of Clinical Commissioning Groups (for example through decisions on which services to commission, the setting of contracts and the monitoring of the quality of services commissioned and the performance of providers). NHS priorities The quality standard for alcohol dependence and harmful alcohol use, from which some of the proposed indicator statements presented in this report are derived, describes markers of high-quality care that, when delivered collectively, should contribute to improving the effectiveness, safety and Agenda Item 14: Alcohol dependence and harmful alcohol use 5 of 44

6 experience of care for people with alcohol dependence and harmful alcohol use in the following ways [Department of Health, 2010b]: ensuring that people have a positive experience of care treating and caring for people in a safe environment and protecting them from avoidable harm. Relevant overarching indicators 1a Potential Years of Life Lost (PYLL) from causes considered amenable to healthcare 1b Life expectancy at 75 3a Emergency admissions for acute conditions that should not usually require hospital admission 3b Emergency readmissions within 30days of discharge from hospital 4a Patient experience of primary care: i GP services; ii GP Out of Hours services; iii NHS Dental Services 4b Patient experience of hospital care 5a Patient safety incidents reported 5b Patient safety incidents involving severe harm or death Relevant improvement areas Reducing premature mortality from the major causes of death 1.3 Under 75 mortality rate from liver disease* Improving people s experience of outpatient care 4.1 Patient experience of outpatient services Improving hospitals responsiveness to personal needs 4.2 Responsiveness to in-patients personal needs Agenda Item 14: Alcohol dependence and harmful alcohol use 6 of 44

7 Improving people s experience of accident and emergency services 4.3 Patient experience of A&E services Improving access to primary care services 4.4 Access to: i GP services and ii NHS dental services Improving the experience of care for people at the end of their lives 4.6 An indicator to be derived from the survey of bereaved carers Improving experience of healthcare for people with mental illness 4.7 Patient experience of community mental health services Improving children and young people s experience of healthcare 4.8 An indicator to be derived from a Children s Patient Experience Agenda Item 14: Alcohol dependence and harmful alcohol use 7 of 44

8 Section 2 Definition, epidemiological summary and clinical management Definition of alcohol dependence and harmful alcohol use Harmful drinking is defined as a pattern of alcohol consumption causing health problems directly related to alcohol. This could include psychological problems such as depression, alcohol-related accidents or physical illness such as acute pancreatitis. In the longer term, harmful drinkers may go on to develop high blood pressure, cirrhosis, heart disease and some types of cancer, such as mouth, liver, bowel or breast cancer. Alcohol dependence is characterised by craving, tolerance, a preoccupation with alcohol and continued drinking in spite of harmful consequences (for example, liver disease or depression caused by drinking). Alcohol dependence is also associated with increased criminal activity and domestic violence, and an increased rate of significant mental and physical disorders. Although alcohol dependence is defined in ICD-10 and DSM-IV in categorical terms for diagnostic and statistical purposes as being either present or absent, in reality dependence exists on a continuum of severity. However, it is helpful from a clinical perspective to subdivide dependence into categories of mild, moderate and severe. People with mild dependence (those scoring 15 or less on the Severity of Alcohol Dependence Questionnaire; SADQ) usually do not need assisted alcohol withdrawal. People with moderate dependence (with a SADQ score of between 15 and 30) usually need assisted alcohol withdrawal, which can typically be managed in a community setting unless there are other risks. People who are severely alcohol dependent (with a SADQ score of more than 30) will need assisted alcohol withdrawal, typically in an inpatient or residential setting. In this guideline these definitions of severity are used to guide selection of appropriate interventions. Incidence and prevalence Alcohol dependence affects 4% of people aged between 16 and 65 in England (6% of men and 2% of women), and over 24% of the English population (33% of men and 16% of women) consume alcohol in a way that is Agenda Item 14: Alcohol dependence and harmful alcohol use 8 of 44

9 potentially or actually harmful to their health or well-being. Alcohol misuse is also an increasing problem in children and young people, with over 24,000 treated in the NHS for alcohol-related problems in 2008 and Comorbid mental health disorders commonly include depression, anxiety disorders and drug misuse, some of which may remit with abstinence from alcohol but others may persist and need specific treatment. Physical comorbidities are common, including gastrointestinal disorders (in particular liver disease) and neurological and cardiovascular disease. In some people these comorbidities may remit on stopping or reducing alcohol consumption, but many experience long-term consequences of alcohol misuse that may significantly shorten their life. Of the 1 million people aged between 16 and 65 who are alcohol dependent in England, only about 6% per year receive treatment. Reasons for this include the often long period between developing alcohol dependence and seeking help, and the limited availability of specialist alcohol treatment services in some parts of England. Additionally, alcohol misuse is under-identified by health and social care professionals, leading to missed opportunities to provide effective interventions. Management Diagnosis is made on the basis of the symptoms and consequences of alcohol misuse outlined above. Simple biological measures such as liver function tests are poor indicators of the presence of harmful or dependent drinking. Diagnosis and assessment of the severity of alcohol misuse is important because it points to the treatment interventions required. Acute withdrawal from alcohol in the absence of medical management can be hazardous in people with severe alcohol dependence, as it may lead to seizures, delirium tremens and, in some instances, death. Current practice across the country is varied and access to a range of assisted withdrawal and treatment services varies as a consequence. Services for assisted alcohol withdrawal vary considerably in intensity and Agenda Item 14: Alcohol dependence and harmful alcohol use 9 of 44

10 there is a lack of structured intensive community-based assisted withdrawal programmes. Similarly, there is limited access to psychological interventions such as cognitive behavioural therapies specifically focused on alcohol misuse. In addition, when the alcohol misuse has been effectively treated, many people continue to experience problems in accessing services for comorbid mental and physical health problems. Despite the publication of the Models of Care for Alcohol by the Department of Health in 2007 (National Treatment Agency, 2007), alcohol service structures are poorly developed, with care pathways often ill defined. In order to address this last point the three pieces of NICE guidance are integrated into a care pathway. Agenda Item 14: Alcohol dependence and harmful alcohol use 10 of 44

11 Section 3 Proposed indicator statements: quality standard on alcohol dependence and harmful alcohol use A total of 25 indicator statements developed from the NICE quality standard for alcohol dependence and harmful alcohol use (NICE, 2011) have been identified as appropriate by the COF indicator alcohol dependence and harmful alcohol use Review Group for consideration by the COF advisory committee. A further 6 overarching outcome indicators have been identified. These indicator statements have been rated valid by the COF indicator alcohol dependence and harmful alcohol use Review Group. As part of the selection of indicator statements, the Review Group may have rated indicators low where they considered indicators to be low priority or not feasible. These are therefore not presented in this document. It is expected that some of the concepts and timeframes within the indicator may require further clarification as part of the indicator development process. Square brackets have been used to denote concepts within the indicator statement wording where further clarification may be required. For example, [Alcohol-related] readmission to any hospital within [X days/months] after the last previous discharge following an alcohol-related admission. The COF indicator alcohol dependence and harmful alcohol use Review Group has advised that these concepts can be clarified. The clinical and cost effectiveness evidence summaries presented in this section are based on the following sources: The full clinical guideline on Alcohol-use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence. NICE clinical guideline 115 (2011; NICE accredited). The full clinical guideline on Alcohol-use disorders - diagnosis and clinical management of alcohol-related physical complications. NICE clinical guideline 100 (2010; NICE accredited). Agenda Item 14: Alcohol dependence and harmful alcohol use 11 of 44

12 The full public health guidance on Alcohol-use disorders: preventing the development of hazardous and harmful drinking. NICE public health guidance 24 (2010; NICE accredited). Agenda Item 14: Alcohol dependence and harmful alcohol use 12 of 44

13 QS02 Opportunistic screening and brief interventions NICE quality standard statement Health and social care staff opportunistically carry out screening and brief interventions for hazardous and harmful drinking as an integral part of practice. Proposed indicator(s) relevant to the quality statement ALC05 Of people aged 16 years and older in the [defined target population], the proportion who receive [alcohol screening] at least once within [defined time period]. ALC06 Of people aged 16 years and older [screening positive for hazardous or harmful drinking], the proportion who receive [a brief intervention]. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence A combination of systematic reviews, cross-sectional diagnostic evaluations and literature reviews were considered around screening and case identification methods for NICE guideline PH24. The evidence included in the reviews was international in origin and most studies, with the exception of the literature reviews, were assigned a high quality grading. In terms of the brief interventions that were analysed in PH24, extensive heterogeneity was evident, however twenty seven systematic reviews provided a considerable body of evidence supportive of the effectiveness of brief interventions for alcohol misuse. Brief interventions were found to reduce alcohol consumption, alcohol-related mortality, morbidity, injuries, social consequences and the consequent use of healthcare resources and laboratory indicators of alcohol misuse. Sensitivity analysis shows that even fairly long brief interventions (for example, 25 minutes) would appear cost effective versus a do nothing policy. Agenda Item 14: Alcohol dependence and harmful alcohol use 13 of 44

14 Cost effectiveness evidence for screening and brief interventions in the hospital and emergency care setting are scarce. The available evidence does not allow firm conclusions regarding the long-term cost effectiveness of these interventions in a UK setting. However, the evidence does suggest that brief interventions in the emergency care setting may be cost effective in the UK. Current clinical practice including evidence of variation Opportunistic case finding and identification and delivery of brief advice for alcohol is part of the Directed Enhanced Service (DES) specification for the Alcohol related risk reduction scheme, England. GP practices are required to screen newly registered patients aged 16 and over using either one of two shortened versions of the alcohol-use disorders identification test (AUDIT) questionnaire. Patients with a positive score should then be given the full screening test, and offered a brief intervention for a score between 8 and 20, or referral to specialist services for a score greater than 20. It is not known how many practices currently participate in this DES. Indicator development issues Feasibility assessment [3] These indicators will require a new data collection. Other issues As part of Directed Enhanced Service (DES), GP practices are currently rewarded for case finding in newly-registered patients aged 16 and over. Information is submitted from practices to PCT but DES information only represents an estimated 10% of GP registered population; with another 10% visiting GP once a year (ONS/IC information). A collection would need to be developed to have sufficient coverage for use as an indicator. Subject to this development in GP systems and the availability of relevant Read codes, this could be requested for extraction, when General Practice Extraction Service (GPES) is live. Agenda Item 14: Alcohol dependence and harmful alcohol use 14 of 44

15 QS03 Referral to specialist alcohol services NICE quality standard statement People who may benefit from specialist assessment or treatment for alcohol misuse are offered referral to specialist alcohol services and are able to access specialist alcohol treatment. Proposed indicator(s) relevant to the quality statement ALC08 Of people meeting [NICE guidance criteria] for referral to specialist alcohol services, the proportion who are referred to specialist alcohol services.* * Requirement to be linked to indicator 5 on screening ALC09 Of people receiving [screening and scoring X], the proportion who are referred to specialist alcohol services.* * Requirement to be linked to indicator 5 on screening ALC10 Of people accepting referral or self-referring to specialist alcohol services, the proportion who wait more than [X] weeks from referral to [accessing] specialist alcohol services. ALC11 Of people in the [local population] [estimated to be dependent on alcohol], the proportion who [access] specialist alcohol services. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence Screening and brief interventions delivered by a non-specialist practitioner is a cost effective approach for hazardous and harmful drinkers (PH24). However for people with alcohol dependence brief interventions are less effective and referral to a specialist service is likely to be necessary. It is important therefore that health and social care professionals are able to identify and appropriately refer harmful drinkers who do not respond to brief intervention, and those with alcohol dependence, to appropriate specialist services. Agenda Item 14: Alcohol dependence and harmful alcohol use 15 of 44

16 Current clinical practice including evidence of variation The Department of Health (DH) Alcohol Needs Assessment Research Project (ANARP) 1 found extremely low levels of formal identification, treatment and referral of patients with alcohol use disorders by GPs and that GPs tend to under-identify younger patients with alcohol use disorders compared to older patients. A quantitative survey conducted with a random sample of 424 GPs in England, in the same publication, showed a higher level of GP awareness of alcohol use disorders than the General Practice Research Database (GPRD) research. The ANARP study also suggested that, although the majority (71%) of patients with an alcohol use disorder identified by GPs were felt to need specialist treatment, many were not referred. Qualitative research suggests this is because of two main factors: perceived difficulty in access, with waiting lists for specialist treatment being the main reason given; and patient preference not to engage in specialist treatment. In 2008/09, the National Alcohol Treatment Monitoring System (NATMS) 2 recorded self-referrals as the most common source of referral into structured alcohol treatment (38%), with GPs serving as the second most common route into treatment, accounting for 22% of all referrals. The Drug and Alcohol National Occupational Standards (DANOS 3 ) set out the skills required to deliver assessment and interventions under the four-tiered framework. Indicator development issues Feasibility assessment [3] ALC08, 09 and 11 These indicators will require a new data collection. 1 Department of Health, Alcohol needs assessment project (ANARP) (2005) The 2004 national alcohol needs assessment for England. Available from 2 DH and NTA (2010) Statistics from the National Alcohol Treatment Monitoring System (NATMS) 1 st April st March Available from 3 Skills for Health (2002). Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 16 of 44

17 [2] ALC10 This indicator would be available from existing data collections given amendments to the collection (i.e. addition of new data fields). Other issues ALC08 and ALC09 When GPES is live this could be collected providing that the relevant codes are available (these may need to be requested). There are a diverse number of possible referral routes to specialist alcohol services and the NTA do not currently capture the screening, results or referral onwards. Specification of time periods would be beneficial. ALC10 The National Treatment Agency (NTA) monitor via the National Drug Treatment Monitoring Service (NDTMS) the date referred and the date of first appointments to modality. ALC11 Subject to GPs having the information about access and actively recording it, this could be collected via GPES when it is live. There is a need to specify when old records of alcohol dependency would become too out-of-date for this indicator. Regarding the [local population] [estimated to be dependent on alcohol], prevalence is available on Higher, Increasing and Lower Risk drinking (% of drinkers) from However, these data (synthetic estimates) are only available at PCT/LA level. The NTA are currently trying to agree a Prevalence Service User ratio, which would calculate this, but would be based on a combination of prevalence estimates and treatment data. Agenda Item 14: Alcohol dependence and harmful alcohol use 17 of 44

18 QS05 Assessment in specialist alcohol services adults NICE quality standard statement Adults accessing specialist alcohol services for alcohol misuse receive a comprehensive assessment that includes the use of validated measures. Proposed indicator(s) relevant to the quality statement ALC13 Of [eligible] adults [accessing] specialist alcohol services, the proportion who receive a [comprehensive assessment]. ALC14 Of [eligible] adults [accessing] specialist alcohol services, the proportion who are assessed using [appropriate and validated measures] for each applicable assessment domain. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence Development of CG115 guideline recommendations for this quality statement drew from current policy and guidance on the structuring and setting for the delivery of alcohol services and the setting out of aims and components of an assessment for alcohol misuse 4, 5. A narrative synthesis of assessment questionnaires and clinical interviews tools in CG115 identified the four assessment tools listed in recommendation (regarding the use of formal assessment tools to assess the nature and severity of alcohol misuse) as feasible and appropriate to use in an NHS or related healthcare setting. Current clinical practice including evidence of variation No current clinical practice information is presented. 4 Department of Health and National Treatment Agency for Substance Misuse (2006) Models of care for alcohol misusers. Available from 5 Edwards et al (2003) The treatment of drinking problems: A guide for the helping professions. Cambridge University Press. Agenda Item 14: Alcohol dependence and harmful alcohol use 18 of 44

19 Indicator development issues Feasibility assessment [2] ALC13 This indicator would be available from existing data collections given amendments to the collection (i.e. addition of new data fields). [3] ALC14 This would require a new data collection. Other issues ALC13 The National Drug Treatment Monitoring System (NDTMS) monitors Care Plan date and Triage date the COF would need to align to NDTMS terminology. Agenda Item 14: Alcohol dependence and harmful alcohol use 19 of 44

20 QS06 Assessment in specialist services children and young people NICE quality standard statement Children and young people accessing specialist services for alcohol use receive a comprehensive assessment that includes the use of validated measures. Proposed indicator(s) relevant to the quality statement ALC15 Of children and young people [accessing] [specialist services] for alcohol misuse, the proportion who receive a [comprehensive assessment]. ALC16 Of children and young people [accessing] [specialist services] for alcohol use, the proportion who are assessed using [appropriate and validated measures] for each applicable assessment domain. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence The statement is based partly on PH24 and CG115. The recommendation from PH is and is classified as IDE. This is where a recommendation is not directly taken from the evidence statements, but is inferred from the evidence. Current clinical practice including evidence of variation No current clinical practice information is presented. Indicator development issues Feasibility assessment [3] These indicators will require a new data collection. Agenda Item 14: Alcohol dependence and harmful alcohol use 20 of 44

21 QS08 Medically assisted alcohol withdrawal setting NICE quality standard statement People needing medically assisted alcohol withdrawal are offered treatment within the setting most appropriate to their age, the severity of alcohol dependence, their social support and the presence of any physical or psychiatric comorbidities. Proposed indicator(s) relevant to the quality statement ALC23 Of adults meeting [eligibility criteria] for medically assisted alcohol withdrawal [not requiring an inpatient or residential setting], the proportion who [complete] community-based withdrawal treatment. ALC24 Of people meeting [eligibility criteria] for medically assisted alcohol withdrawal and meeting [criteria for inpatient or residential care], the proportion who [complete] withdrawal treatment in an inpatient or residential setting. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence The evidence in CG115 indicated that a community setting for assisted withdrawal is as clinically effective and safe for the majority of patients as an inpatient or residential setting, and it is also likely to be more cost effective. However, some of those with more severe alcohol dependence, often with complex comorbidities, were often excluded from the studies therefore the studies were not representative of those who would typically require inpatient withdrawal management. A number of factors/groups that would indicate that a residential or inpatient setting may be preferred to a community setting were identified, including those with significant psychiatric or physical comorbidity, homelessness, and children and young people. Agenda Item 14: Alcohol dependence and harmful alcohol use 21 of 44

22 CG100 recognised this is a very difficult area as each individual is different and the clinical problem is often compounded by social problems. The GDG agreed, by expert consensus, that individuals may need admission due to the severity or predicted severity of the syndrome, including people presenting following or in a withdrawal seizure or delirium tremens. The GDG agreed by consensus on a lower threshold for admission of the remaining vulnerable groups for example, those who are frail, have learning difficulties or are 16 or 17 years. The GDG discussed a prospective case series reporting that a delay in assessment (greater than 24 hours) was associated with alcohol withdrawal complications. This reflected the group s experience that the late recognition of withdrawal leads to a more severe syndrome. Current clinical practice including evidence of variation The 2008 NAO (National Audit Office) survey 6 found that 30% of GPs had offered medically assisted withdrawal. Provision of hospital-based services was found to be patchy, with certain regions having no inpatient alcohol unit for medically supervised withdrawal. NATMS (National Alcohol Treatment Monitoring System) data shows that 9% of people receiving structured alcohol treatment in 2008/09 accessed inpatient treatment 7. It is not known how many of the remaining 91% needed or underwent assisted withdrawal Indicator development issues Feasibility assessment [2] These indicators are available from existing data collections given amendments to the collection (i.e. addition of new data fields). 6 National Audit Office (2008) Reducing alcohol harm: health services in England for alcohol misuse. Available from 7 DH and NTA (2010) Statistics from the National Alcohol Treatment Monitoring System (NATMS) 1 st April st March Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 22 of 44

23 Other issues These indicators are only partially collected through NDTMS, and would need extension of NDTMS collection into secondary and primary care. The NTA would support this extension, although some consideration may need to be given to the calculation of the numerators. Agenda Item 14: Alcohol dependence and harmful alcohol use 23 of 44

24 QS09 Medically assisted alcohol withdrawal drug regimens NICE quality standard statement People needing medically assisted alcohol withdrawal receive medication using drug regimens appropriate to the setting in which the withdrawal is managed in accordance with NICE guidance. Proposed indicator(s) relevant to the quality statement ALC29 Of people undergoing medically assisted alcohol withdrawal, the proportion who receive medication using drug regimens in [accordance with NICE clinical guidelines 100 and 115]. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence The review of drug regimens for assisted withdrawal in CG115 drew on CG100 for both the initial review of the medication regimens and to ensure that there was a comprehensive and coherent approach to assisted withdrawal across both guidelines. Pharmacotherapy The research studies considered in CG100 did not capture any qualitative aspects of the patient experience (for example, safety, dignity and comfort) and the number of events recorded for each outcome was small. The incidence of reported side-effects of medication was low. No deaths were reported in any of the studies. The GDG noted that the study sizes were small and heterogeneous with respect to inclusion / exclusion criteria and none included young people or older adults in their samples. Therefore, the study populations may not be representative of those presenting to clinical practice. The evidence showed benzodiazepines (tranquillisers that are designed to reduce anxiety and promote calmness, relaxation and sleep) to be more effective than placebo for the prevention of alcohol withdrawal seizures. No Agenda Item 14: Alcohol dependence and harmful alcohol use 24 of 44

25 other significant differences were found within and across the agents considered. The GDG noted that there is wide variation in the choice of agent used in clinical practice, which reflects the lack of evidence supporting a particular agent. In addition, the GDG also considered how some of the complex comorbidities often encountered in specialist alcohol services may be best managed. In the absence of any evidence from the studies reviewed, the GDG reached agreement on this issue by consensus. There is a lack of clinical evidence suggesting the appropriate dose of medication for assisted withdrawal for children and young people as well as older people. However the dose should be lower than that provided for a working-age adult taking into consideration the age, size, and gender of the individual. The cost to the NHS for each of the agents was low and no information was available about how any of the agents affects length of hospital stay or other elements of resource use. The cost-effectiveness is therefore uncertain but given the low cost the therapies would be considered cost-effective. Symptom triggered dosing Overall, symptom triggered dosing is associated with significantly lower doses of benzodiazepines, and with a shorter treatment duration without an increase in the incidence of seizures or delirium tremens. Health economic evidence suggests that symptom-triggered regimen is also cost-effective. The majority of studies were obtained from predominantly male populations admitted to specialist addiction services. There was only one study which reported on the management of withdrawal in a general medical ward setting. Nevertheless, because of the paucity of studies in the acute setting and the apparent benefits of a symptom-triggered regimen in the controlled setting, it was ultimately decided that the recommendation should reflect this apparent Agenda Item 14: Alcohol dependence and harmful alcohol use 25 of 44

26 superiority. It was agreed that a caveat regarding the facilities for assessment and monitoring should be included in the recommendation. The cost-effectiveness analysis comparing symptom-triggered and fixeddosing regimens was assessed. In this analysis, the symptom-triggered option was likely to be cost-saving in a majority of scenario. Current clinical practice including evidence of variation The 2008 NAO survey 8 found that 30% of GPs had offered medically assisted withdrawal. Provision of hospital-based services was found to be patchy, with certain regions having no inpatient alcohol unit for medically supervised withdrawal. NATMS data shows that 9% of people receiving structured alcohol treatment in 2008/09 accessed inpatient treatment 9. It is not known how many of the remaining 91% needed or underwent assisted withdrawal Indicator development issues Feasibility assessment [3] This indicator will require a new data collection. Other issues This indicator is not normally recorded in Primary Care, and it is not possible to fully assess drug regimens in Primary Care data because doses are not coded (they are currently held as free text). 8 National Audit Office (2008) Reducing alcohol harm: health services in England for alcohol misuse. Available from DH and NTA (2010) Statistics from the National Alcohol Treatment Monitoring System (NATMS) 1 st April st March Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 26 of 44

27 QS10 Wernicke s encephalopathy NICE quality standard statement People with suspected, or at high risk of developing, Wernicke s encephalopathy are offered thiamine in accordance with NICE guidance. Proposed indicator(s) relevant to the quality statement ALC33 Of people undergoing medically assisted withdrawal, the proportion who receive thiamine in [accordance with NICE guidance]. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence No studies were found by CG100 that directly identified patients who are at risk of developing Wernicke s encephalopathy and therefore require prophylactic treatment. Two RCTs, one non-randomised trial and two case series were reviewed on the use of thiamine in the prevention and/or treatment of Wernicke s encephalopathy but all recommendations were by consensus. Costs and resource use information associated with vitamin supplementation for the treatment/prevention of Wernicke s encephalopathy was reviewed and accepted that this is likely to be highly cost-effective, especially given the considerable clinical and economic impact related to the development of Wernicke-Korsakoff syndrome. CG115 cross-refers to CG100 but with an additional sentence for a particular group of patients at risk of Wernicke-Korsakoff syndrome. This also is based largely on consensus. Agenda Item 14: Alcohol dependence and harmful alcohol use 27 of 44

28 Current clinical practice including evidence of variation NHS Quality Improvement Scotland (2008) 10 found that, during a 14 day audit period in 15 emergency departments, around a quarter of patients with serious alcohol problems had been prescribed oral thiamine prior to presentation at the emergency department. People presenting with alcoholic hallucinosis and acute alcohol withdrawal syndrome were treated with parenteral B vitamins (PBVs) in more than half of presentations. Among those admitted to hospital, patients presenting with one of the four main alcoholrelated conditions were treated with PBVs in more than half of presentations. Indicator development issues Feasibility assessment [3] This would require a new collection Other issues This information is not normally recorded in primary care. 10 NHS Quality Improvement Scotland (2008) Understanding alcohol misuse in Scotland. Harmful drinking 4: The use of intravenous B vitamins. Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 28 of 44

29 QS11 Psychological interventions and relapse prevention medication for adults NICE quality standard statement Adults who misuse alcohol are offered evidence-based psychological interventions, and those with alcohol dependence that is moderate or severe can in addition access relapse prevention medication in accordance with NICE guidance. Proposed indicator(s) relevant to the quality statement ALC35 Of adults [accessing] specialist alcohol services, the proportion who receive evidence-based psychological interventions in [accordance with NICE clinical guideline 115]. ALC36 Of adults with [moderate or severe alcohol dependence] completing a [successful] withdrawal, the proportion who receive [relapse prevention medication]. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence CG115 reviewed the evidence base around psychological and psychosocial interventions in the treatment and management of alcohol misuse. The overall quality of the evidence was moderate. The strongest evidence for effectiveness in harmful and dependent drinking was for behavioural couple s therapy. The evidence for individual psychological interventions for harmful and mildly dependent drinkers was limited but stronger for CBT, social network and behaviour therapy than other comparator therapies. The costings of the various psychological interventions were considered (indications from the costings was that social network behaviour therapy was less costly than either CBT or behaviour therapy) but, given the uncertainty about the relative cost-effectiveness of the interventions and the need to have Agenda Item 14: Alcohol dependence and harmful alcohol use 29 of 44

30 available a range of interventions to meet the complexity of presenting problems, all three should be recommended as standalone interventions. Current clinical practice including evidence of variation No current clinical practice information is presented. Indicator development issues Feasibility assessment [1] These indicators are available from existing data, no feasibility issues identified at this stage. Other issues ALC36 The National Drug Treatment Monitoring System (NDTMS) currently collects information on community prescribing. Providers report this where pharmacotherapy is offered in order to: - Promote abstinence and prevent relapse - Treat withdrawal symptom during medically assisted withdrawal The dataset is not in a position to categorise relapse prevention until the new core dataset changes, in October. Agenda Item 14: Alcohol dependence and harmful alcohol use 30 of 44

31 QS12 Specialist interventions for children and young people NICE quality standard statement Children and young people accessing specialist services for alcohol use are offered individual cognitive behavioural therapy, or if they have significant comorbidities or limited social support, a multicomponent programme of care including family or systems therapy. Proposed indicator(s) relevant to the quality statement ALC37 Of children and young people with [limited comorbidities and good social support] [accessing] specialist services for alcohol use, the proportion who receive [individual cognitive behavioural therapy]. ALC38 Of children and young people with [significant comorbidities and/or limited social support] [accessing] specialist services for alcohol use, the proportion who receive a [multicomponent treatment programme of care including family or systems therapy]. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence The evidence base is limited for the treatment of alcohol misuse in children and young people. As a consequence, it was required to extrapolate from a number of datasets and sources that did not directly address the treatment of alcohol misuse in children and young people. This included data on adults with alcohol misuse, as well as children and young people with substance misuse, conduct disorder and antisocial personality disorder. This was considered to be a justified approach because there is an urgent need to provide recommendations for the treatment of the increasing problem of alcohol misuse in children and young people. In extrapolating from these datasets, it was recognised that as new evidence emerges the recommendations in this guideline will need revision. Agenda Item 14: Alcohol dependence and harmful alcohol use 31 of 44

32 CG115 used the NICE Antisocial personality disorder (ASPD) guideline (CG77, 2009) for a meta-analysis of eleven trials on family interventions, in the context of conduct disorder, which showed that family interventions are effective for reducing both behavioural problems and offending. Ten trials on multisystemic therapy were also analysed and although there was significant heterogeneity for most outcomes, there was consistent evidence of a medium effect on reduction in offending outcomes including number of arrests and being arrested. A further recent meta-analysis of six trials evaluating multicomponent and family-based interventions (not focussed specifically on alcohol-use) affirmed the findings in the ASPD review and reported that multicomponent family therapies were effective in reducing drinking in adolescents. Only one study has reviewed the evidence of family therapies specifically on alcohol use, reporting that multi-component therapy again showed some benefits over standard group therapy for substance misuse and criminal activity outcomes. Despite limited evidence a reasonably clear picture emerged about the effectiveness of interventions to promote abstinence and prevent relapse in children and young people. There was some evidence for individual interventions such as cognitive behaviour therapy (CBT) and less so for motivational enhancement therapy (MET). There was stronger evidence for the use of multicomponent interventions such as multisystemic therapy, functional family therapy, brief strategic family therapy, and multi-dimensional family therapy, but little evidence to determine whether one of the interventions had any advantage over the others. The guideline therefore concluded that both types of intervention should be made available with CBT reserved for cases where comorbidity is either not present or of little significance; where comorbidity is present, multicomponent interventions should be offered. Agenda Item 14: Alcohol dependence and harmful alcohol use 32 of 44

33 Current clinical practice including evidence of variation NATMS reported that, in 2008/09, around three quarters of interventions with young people had a psychological or psychosocial element 11. This data is not broken down by substance of choice and therefore includes the misuse of drugs as well as alcohol. Less than five under 18s were reported nationally as accessing residential treatment during the year. Indicator development issues Feasibility assessment [3] These indicators will require a new data collection. 11 National Treatment Agency for substance misuse (NTA) (2010) Substance misuse among young people The data for Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 33 of 44

34 QS13 Outcomes monitoring NICE quality standard statement People receiving specialist treatment for alcohol misuse have regular treatment outcome reviews, which are used to plan subsequent care. Proposed indicator(s) relevant to the quality statement ALC40 Of people [accessing] specialist alcohol services, the proportion for whom the AUDIT and APQ are used for outcome monitoring. Assessment against prioritisation criteria Discussion of clinical and cost-effectiveness evidence CG115 found that routine outcome monitoring has been shown to be effective in improving outcomes by a controlled study (N=1020) on feedback provided to psychotherapists. An initial evaluation of two UK demonstration sites for the Improving access to psychological therapy (IAPT) initiative showed that routine session by session measurement provides a more accurate assessment of overall patient outcomes. Characteristics of routine outcome monitoring tools were used as a basis for the consensus-based decision that the AUDIT has the greatest utility as a routine outcome monitoring tool to evaluate drinking-related outcomes. Current clinical practice including evidence of variation NATMS 12 recorded 53,014 clients aged 18 and over who were discharged from treatment during 2008/09. Of these, 26,270 (50%) were discharged successfully. This is defined as completing treatment and not requiring any further structured alcohol intervention. In some cases, there may be evidence of alcohol use but this is not judged by the client s clinician to be problematic or to require treatment. 12 Department of Health and National Treatment Agency (2010) Statistics from the National Alcohol Treatment Monitoring System (NATMS) 1 st April st March Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 34 of 44

35 NATMS 13 recorded 53,014 clients aged 18 and over discharged from treatment during 2008/09. Of these, 12% were discharged alcohol free. 65% of children and young people completed their treatments in the same year 14. Data for under 18s is not broken down by substance of choice and therefore includes the misuse of drugs as well as alcohol, and treatment completers may also include occasional (non-problematic) users, in addition to abstainers. Indicator development issues Feasibility assessment [3] This would require a new data collection. Other issues APQ Alcohol Problems Questionnaire. 13 Department of Health and National Treatment Agency for Substance Misuse (2010) Statistics from the National Alcohol Treatment Monitoring System (NATMS) 1 st April st March Available from 14 National Treatment Agency for substance misuse (NTA) (2010) Substance misuse among young people The data for Available from Agenda Item 14: Alcohol dependence and harmful alcohol use 35 of 44

36 Section 4 Other outcome indicators identified by the Review Group for alcohol dependence and harmful alcohol use As part of the indicator development process, the COF indicator alcohol dependence and harmful alcohol use Review Group considered whether there were any outcome indicator that would reflect the provision of high quality care for people with alcohol dependence and harmful alcohol use as defined in the Quality Standard as a whole or other system wide levers. Indicators that the COF indicator alcohol dependence and harmful alcohol use Review Group considered appropriate are provided below. Other outcome indicators 1. ALC42 Of people [accessing] specialist alcohol services, the proportion who achieve their treatment goals. 2. ALC43 Alcohol-related hospital admissions. 3. ALC44 [Alcohol-related] readmission to any hospital within [X days/months] after the last previous discharge following an alcoholrelated admission. 4. ALC45 [Reduced] quantity and frequency of alcohol consumption in adults [accessing] specialist alcohol services. 5. ALC46 [Reduced] quantity and frequency of alcohol consumption in children and young people [accessing] specialist services for alcohol use. 6. ALC47 [Reduction] in AUDIT score of [screened/intervention] population. Assessment against prioritisation criteria Current clinical practice including evidence of variation 1. See quality statement 13. Agenda Item 14: Alcohol dependence and harmful alcohol use 36 of 44