Guidance

Research recommendations

Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

1 Is contingency management effective in reducing alcohol consumption in people who misuse alcohol compared with standard care?

This question should be answered using a randomised controlled design that reports short-and medium-term outcomes (including cost-effectiveness outcomes) of at least 18 months' duration. Particular attention should be paid to the reproducibility of the treatment model and training and supervision of those providing the intervention to ensure that the results are robust and generalisable. The outcomes chosen should reflect both observer and service user-rated assessments of improvement and the acceptability of the intervention. The study needs to be large enough to determine the presence or absence of clinically important effects, and mediators and moderators of response should be investigated.

Why this is important

Psychological interventions are an important therapeutic option for people with alcohol-related problems. However, even with the most effective current treatment (for example, cognitive behavioural therapies and social network and environment-based therapies), the effects are modest at best and the treatments are not effective for everyone. Contingency management has a considerable and compelling evidence base in the treatment of substance misuse (for example, opioid misuse) but there is only a limited, if promising, evidence base for contingency management in the treatment of alcohol-related problems. The results of this research will have important implications for the provision of psychological treatment for alcohol misuse in the NHS.

2 What methods are most effective for assessing and diagnosing the presence and severity of alcohol misuse in children and young people?

This question should be answered in a programme of research that uses a cross-sectional cohort design testing:

  • the sensitivity and specificity of a purpose-designed suite of screening and case identification measures of alcohol misuse against a diagnostic gold standard (DSM-IV or ICD-10)

  • the reliability and validity of a purpose-designed suite in characterising the nature and the severity of the alcohol misuse in children and young people and their predictive validity in identifying the most effective treatment when compared with current best practice.

    Particular attention should be paid to the feasibility of the measures in routine care and the training required to obtain satisfactory levels of accuracy and predictive validity. The programme needs to be large enough to encompass the age range (10 to 17 years) and the comorbidity that often accompanies alcohol misuse in children and young people.

Why this is important

Alcohol misuse is an increasingly common problem in children and young people. However, diagnostic instruments are poorly developed or not available for children and young people. In adults there is a range of diagnostic and assessment tools (with reasonable sensitivity and specificity, and reliability and validity) that are recommended for routine use in the NHS to both assess the severity of the alcohol misuse and to guide treatment decisions. No similar well-developed measures exist for children and young people, with the result that problems are missed and/or inappropriate treatment is offered. The results of this study will have important implications for the identification and the provision of effective treatment in the NHS for children and young people with alcohol-related problems.

3 Is acupuncture effective in reducing alcohol consumption compared with standard care?

This question should be answered using a randomised controlled design that reports short-and medium-term outcomes (including cost-effectiveness outcomes) of at least 12 months' duration. Particular attention should be paid to the reproducibility of the treatment model and training and supervision of those providing the intervention to ensure that the results are robust and generalisable. The outcomes chosen should reflect both observer and service user-rated assessments of improvement and the acceptability of the treatment. The study needs to be large enough to determine the presence or absence of clinically important effects, and mediators and moderators of response should be investigated.

Why this is important

Non-pharmacological treatments are an important therapeutic option for people with alcohol-related problems. There is an evidence base for acupuncture in reducing craving but not alcohol consumption in a number of small trials. The evidence for pharmacological treatments (for example, acamprosate or naltrexone) and psychological treatments (for example, cognitive behavioural therapies and social network and environment-based therapies) is modest at best and the treatments are not effective for everyone. Anecdotal evidence suggests that acupuncture, like psychological treatment, is valued by service users both in alcohol misuse and substance misuse services (although the evidence base for effectiveness is weak). The results of this study will have important implications for increased treatment choice in the NHS for people who misuse alcohol.

4 For which service users who are moderately and severely dependent on alcohol is an assertive community treatment model a clinically and cost-effective intervention compared with standard care?

This question should be answered using a randomised controlled design in which participants are stratified for severity and complexity of presenting problems. It should report short- and medium-term outcomes (including cost-effectiveness outcomes) of at least 18 months' duration. Particular attention should be paid to the reproducibility of the treatment model and training and supervision of those providing the intervention to ensure that the results are robust and generalisable. The outcomes chosen should reflect both observer and service user-rated assessments of improvement (including personal and social functioning) and the acceptability of the intervention. The study needs to be large enough to determine the presence or absence of clinically important effects, and mediators and moderators of response should be investigated.

Why this is important

Many people, in particular those with severe problems and complex comorbidities, do not benefit from treatment and/or lose contact with services. This leads to poor outcomes and wastes resources. Assertive community treatment models have been shown to be effective in retaining people in treatment in those with serious mental illness and who misuse alcohol and drugs but the evidence for an impact on outcomes is not proven. A number of small pilot studies suggest that an assertive community approach can bring benefit in both service retention and clinical outcomes in alcohol misuse. Given the high morbidity and mortality associated with chronic severe alcohol dependence the results of this study will have important implications for the structure and provision of alcohol services in the NHS.

5 For people with moderate and severe alcohol dependence who have significant comorbid problems, is an intensive residential rehabilitation programme clinically and cost effective when compared with intensive community-based care?

This question should be answered using a prospective cohort study of all people who have moderate and severe alcohol dependence entering residential and intensive community rehabilitation programmes in a purposive sample of alcohol treatment services in the UK. It should report short- and medium-term outcomes (including cost-effectiveness outcomes) of at least 18 months' duration. Particular attention should be paid to the characterisation of the treatment environment and the nature of the interventions provided to inform the analysis of moderators and mediators of treatment effect. The outcomes chosen should reflect both observer and service user-rated assessments of improvement (including personal and social functioning) and the acceptability of the intervention. The study needs to be large enough to determine the presence or absence of clinically important effects, and mediators and moderators of response should be investigated. A cohort study has been chosen as the most appropriate design as previous studies in this area that have attempted to randomise participants to residential or community care have been unable to recruit clinically representative populations.

Why this is important

Many people, in particular those with severe problems and complex comorbidities, do not benefit from treatment and/or lose contact with services. One common approach is to offer intensive residential rehabilitation and current policy favours this. However, the research on the effectiveness of residential rehabilitation is uncertain with a suggestion that intensive community services may be as effective. The interpretation of this research is limited by the fact that many of the more severely ill people are not entered into the clinical trials because some clinicians are unsure of the safety of the community setting. However, clinical opinion is divided on the benefits of residential rehabilitation, with some suggesting that those who benefit are a motivated and self-selected group who may do just as well with intensive community treatment, which is currently limited in availability. Given the costs associated with residential treatment and the uncertainty about outcomes, the results of this study will have important implications for the cost effectiveness and provision of alcohol services in the NHS.

6 For people with alcohol dependence, which medication is most likely to improve adherence and thereby promote abstinence and prevent relapse?

This question should be answered by: a) an initial development phase in which a series of qualitative and quantitative reasons for non-adherence/discontinuing drugs used in the treatment of alcohol are explored; b) a series of pilot trials of novel interventions developed to address the problems identified in (a) undertaken to support the design of a series of definitive trials; c) a (series of) definitive trial(s) of the interventions that were successfully piloted in (b) using a randomised controlled design that reports short-term (for example, 3 months) and longer-term (for example, 18 months) outcomes. The outcomes chosen should reflect both observer and service user-rated assessments of improvement and the acceptability of the intervention. Each individual study needs to be large enough to determine the presence or absence of clinically important effects, and mediators and moderators of response should be investigated.

Why this is important

Rates of attrition in trials of drugs to promote abstinence and prevent relapse in alcohol dependence are high (often over 65%), yet despite this the interventions are still clinically and cost effective. Retaining more service users in treatment could further significantly improve outcomes for people who misuse alcohol and ensure increased effectiveness in the use of health service resources. The outcome of these studies may also help improve clinical confidence in the use of effective medications (such as acamprosate and naltrexone), which despite their cost effectiveness are currently offered to only a minority of eligible NHS service users. Overall, the results of these studies will have important implications for the provision of pharmacological treatment in the NHS for alcohol misuse.