Guidance

Appendix B Summary of the methods used to develop this guidance

Appendix B Summary of the methods used to develop this guidance

Introduction

The reviews and economic modelling report include full details of the methods used to select the evidence (including search strategies), assess its quality and summarise it.

The minutes of the Programme Development Group (PDG) meetings provide further detail about the Group's interpretation of the evidence and development of the recommendations.

All supporting documents are listed in appendix E.

Key questions

The key questions were established as part of the scope. They formed the starting point for the reviews of evidence and were used by the PDG to help develop the recommendations. The overarching questions were:

  • Which interventions are effective and cost effective in encouraging people from high-risk groups to use services that currently (or potentially could) offer hepatitis B or C testing?

  • What prevents people in high-risk groups from seeking and accepting a hepatitis B or hepatitis C test? How do these factors differ for each group – and what factors increase the likelihood that they will seek and accept a test?

  • Which interventions are effective and cost effective at overcoming the barriers to hepatitis B or C testing faced by high-risk groups and professionals?

  • What type of services and activities need to be commissioned to encourage people who have tested positive to continue to seek support?

These questions were made more specific for each review (see reviews for further details).

Reviewing the evidence

Qualitative review

One qualitative review was conducted (review 1).

Identifying the evidence

A number of databases were searched in March/April 2011 for qualitative studies exploring the views on, and experiences of, hepatitis B and C testing and treatment among people at greatest risk. Five journals with the highest yield of references were selected as follows:

  • Australian Health Review

  • Gastroenterology Nursing

  • International Journal of Drug Policy

  • Journal of Community Health

  • Journal of Viral Hepatitis.

All journal issues (113) and supplements published between 2008 and 2011 were hand-searched. A number of websites were also searched. For details, see the review.

Selection criteria

Studies were included in review 1 if they considered:

  • Groups at an increased risk of hepatitis B and C infection, their close contacts and practitioners who treat them or are involved in preventive activities.

  • Mixed 'low'- and 'high'-risk populations where it was possible to attribute the findings to particular high-risk populations.

  • The views and experiences of groups at increased risk in relation to case-finding, testing, communication of test results or subsequent treatment.

  • Patient and practitioner perspectives on the barriers to, and opportunities for, changing behaviour in relation to hepatitis B and C testing and subsequent care and treatment.

Studies were excluded if they:

  • Focused solely on general population groups or groups at low risk of hepatitis B or C.

  • Used structured questionnaires as the sole method of data collection.

  • Only reported quantitative data not elicited from the patients or providers themselves.

Effectiveness review

One review of effectiveness was conducted (review 2).

Identifying the evidence

A number of databases were searched in July 2011 for studies from 1990 onwards.

Selection criteria

Studies were included in the effectiveness review if they:

  • Targeted groups at increased risk of hepatitis B and C infection.

  • Targeted healthcare professionals involved in hepatitis B and C testing and treatment.

  • Aimed to raise awareness of hepatitis B and C testing services among people from high-risk groups.

  • Encouraged people from high-risk groups and their close contacts to use hepatitis B and C testing services.

  • Improved access to testing services.

Studies were excluded if they focused on changing the behaviour of people who inject drugs (in relation to injecting or sharing practices but without reference to case-finding or testing).

See each review for details of the inclusion and exclusion criteria.

Quality appraisal

Included papers were assessed for methodological rigour and quality using the NICE methodology checklist, as set out in the NICE technical manual Methods for the development of NICE public health guidance. Each study was graded (++, +, –) to reflect the risk of potential bias arising from its design and execution.

Study quality

++ All or most of the checklist criteria have been fulfilled. Where they have not been fulfilled, the conclusions are very unlikely to alter.

+ Some of the checklist criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are unlikely to alter the conclusions.

– Few or no checklist criteria have been fulfilled. The conclusions of the study are likely or very likely to alter.

The evidence was also assessed for its applicability to the areas (populations, settings, interventions) covered by the scope of the guidance. Each evidence statement concludes with a statement of applicability (directly applicable, partially applicable, not applicable).

Summarising the evidence and making evidence statements

The review data were summarised in evidence tables (see full reviews).

The findings from the reviews were synthesised and used as the basis for a number of evidence statements relating to each key question. The evidence statements were prepared by the external contractors (see appendix A). The statements reflect their judgement of the strength (quality, quantity and consistency) of evidence and its applicability to the populations and settings in the scope.

Mapping review

The mapping review comprised a survey of awareness-raising and other activities to encourage groups at increased risk of hepatitis B and C to seek support.

Identifying the evidence

Telephone interviews and an online questionnaire were used with healthcare professionals and representatives of voluntary and community sector organisations who work with people at increased risk of hepatitis B and C infection. See the review for details.

Cost effectiveness

There was a review of economic evaluations and two economic modelling exercises.

Review of economic evaluations

There was a review of economic evaluations as part of the effectiveness review (review 2). Studies were included if they reported both costs (regardless of how estimated) and outcomes (regardless of how specified).

Economic modelling

Three economic models were constructed to incorporate data from the reviews of effectiveness and cost effectiveness.

A dynamic model was developed to estimate the cost effectiveness of interventions to promote hepatitis testing among people who inject drugs. The model had to be dynamic to account for the ongoing transmission of hepatitis C between people who inject drugs.

Two static models were developed to evaluate interventions aimed at migrant groups. (Hepatitis B and C case finding and treatment in the UK will have an effect on morbidity among people tested, but little impact on the incidence of chronic infection, because most new cases have not been caused by infection within the UK.)

The results are reported in: 'An economic evaluation of finding cases of hepatitis B and C infection in UK migrant populations'; and 'Assessing the cost-effectiveness of interventions aimed at promoting and offering hepatitis C testing to injecting drug users: An economic modelling report'.

How the PDG formulated the recommendations

At its meetings in May, July, September, November and December 2011 and February, March and April 2012, the Programme Development Group (PDG) considered the evidence and cost effectiveness to determine:

  • whether there was sufficient evidence (in terms of strength and applicability) to form a judgement

  • where relevant, whether (on balance) the evidence demonstrates that the intervention or programme/activity can be effective or is inconclusive

  • where relevant, the typical size of effect (where there is one)

  • whether the evidence is applicable to the target groups and context covered by the guidance.

The PDG developed draft recommendations through informal consensus, based on the following criteria:

  • Strength (type, quality, quantity and consistency) of the evidence.

  • The applicability of the evidence to the populations/settings referred to in the scope.

  • Effect size and potential impact on the target population's health.

  • Impact on inequalities in health between different groups of the population.

  • Equality and diversity legislation.

  • Ethical issues and social value judgements.

  • Cost effectiveness (for the NHS and other public sector organisations).

  • Balance of harms and benefits.

  • Ease of implementation and any anticipated changes in practice.

Where possible, recommendations were linked to evidence statements (see appendix C for details). Where a recommendation was inferred from the evidence, this was indicated by the reference 'IDE' (inference derived from the evidence).

The draft guidance, including the recommendations, was released for consultation in June 2012. At its meeting in September 2012, the PDG amended the guidance in light of comments from stakeholders and experts. The guidance was signed off by the NICE Guidance Executive in November 2012.