Appendix B Summary of the methods used to develop this guidance

Introduction

The review 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 Public Health Interventions Advisory Committee (PHIAC) meetings provide further detail about the Committee's interpretation of the evidence and development of the recommendations.

All supporting documents are listed in appendix E and are available on the NICE website.

Guidance development

The stages involved in developing public health intervention guidance are outlined below.

1. Draft scope released for consultation

2. Stakeholder meeting about the draft scope

3. Stakeholder comments used to revise the scope

4. Final scope and responses to comments published on website

5. Evidence reviews and economic modelling undertaken and submitted to PHIAC

6. PHIAC produces draft recommendations

7. Draft guidance (and evidence) released for consultation and for field testing

8. PHIAC amends recommendations

9. Final guidance published on website

10. Responses to comments published on website

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 PHIAC to help develop the recommendations. The overarching questions were:

  • Which interventions, or combination of interventions, are effective and cost effective in helping South Asian people to stop using smokeless tobacco in England?

  • How should interventions be targeted and tailored for the different subcategories of users within the South Asian community (grouped, for example, by gender, age, religion, socioeconomic status or by country of origin)?

  • What opinions, attitudes or cultural practices encourage (or predispose) South Asian people in England to use smokeless tobacco? Do these factors also determine the particular varieties used?

  • Are health professionals aware of the widespread use of smokeless tobacco among South Asian communities and its dangers? Does lack of awareness mean that people are not being referred for, or receiving, support to stop using these products, or that support services are not being commissioned?

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

Reviewing the evidence

Effectiveness and contextual reviews

Two reviews were conducted.

  • Review 1 (effectiveness review) examined the effect of interventions designed to help South Asians stop using smokeless tobacco.

  • Review 2 (contextual review) examined both the contextual factors associated with smokeless tobacco use among South Asians, and health practitioners' views.

The methodology used in both reviews had some elements in common (see below) and the 2 reviews are presented in one report. (The report is entitled 'Systematic review of effectiveness of smokeless tobacco interventions for South Asians and a review of contextual factors relating to smokeless tobacco use among South Asian users and the views of healthcare providers'.)

Identifying the evidence

A number of databases were searched in July and August 2011 for any kind of evidence published from 1990 onwards. (See the report for details of the databases searched.)

In addition, the following searches were carried out:

  • Reference list check of included papers.

  • Cited reference search for papers included in the Web of Science database.

  • Search of 'grey' literature sources in Open Grey and Health Management Information Consortium (HMIC) databases.

Selection criteria

The effectiveness review (review 1) included studies from any country on interventions to help South Asians stop using smokeless tobacco, as follows:

  • Pharmacological interventions for individuals or groups to help them stop using smokeless tobacco.

  • Behavioural support or counselling for individuals or groups to help them stop using smokeless tobacco.

  • Brief interventions (including brief advice) by health and social care professionals, including dental practitioners and GPs or community members and peers.

  • Local, community-based initiatives to raise awareness of the harm caused by smokeless tobacco and to encourage the uptake of cessation services by people who use it.

  • Interventions, including those based in schools and the community, to raise awareness and knowledge among health and social care professionals about smokeless tobacco use.

  • Interventions that were part of: randomised controlled trials (RCT), non-randomised studies, quasi-experimental, controlled before-and-after studies, process evaluations or qualitative studies.

Studies were excluded from review 1 if they:

  • did not cover South Asian populations

  • were non-interventional (that is, no intervention was offered).

Review 2 (contextual review) included studies from Organisation for Economic Cooperation and Development (OECD) countries if they were about South Asian people who were current or past users of smokeless tobacco and covered:

  • Clinicians, support workers, and frontline staff who have worked with South Asian populations on smokeless tobacco use.

  • Views of people who are of South Asian origin who are seeking help to stop using smokeless tobacco.

  • Views of friends and family members who know someone who uses smokeless tobacco.

  • Knowledge, attitudes or views of clinicians, support workers and frontline health staff towards smokeless tobacco and/or smokeless tobacco interventions.

  • Cross-sectional studies that examine smokeless tobacco prevention and use among South Asians.

  • Qualitative studies of the views and use of smokeless tobacco among South Asians.

  • Reports and project briefs on smokeless tobacco.

Studies were excluded from review 2 if they covered:

  • people who were not of South Asian descent

  • providers of smokeless tobacco

  • non-peer reviewed evidence from websites or blogs or anecdotal evidence on smokeless tobacco.

As noted previously (in 3.5 of the considerations section), the distinction between smokeless tobacco prevention and cessation can be blurred for younger people. For this reason, the reviews included the 'Mobilizing youth for tobacco – related initiatives in India' (MYTRI) project. However, programmes solely focused on prevention were not reviewed.

Quality appraisal

Included papers were assessed for methodological rigour and quality using the appropriate NICE methodology checklist, as set out in the NICE technical manual 'Methods for the development of NICE public health guidance' (see appendix E). 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 was summarised in evidence tables (see full reviews).

The findings from the included studies were synthesised and used as the basis for a number of evidence statements relating to each review 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.

Cost effectiveness

There was a review of economic evaluations and an economic modelling exercise.

Review of economic evaluations

Searches for the cost-effectiveness/economics review were undertaken at the same time as the effectiveness searches, using the term 'South Asian smokeless tobacco users'. The searches were carried out in NHS EED (economic evaluation database) via Wiley and Econ Lit via OVID SP. No relevant studies were found.

Economic modelling

An economic model was constructed to incorporate data from the review of effectiveness (review 1).

The model covered four diseases: cardiovascular disease, oral cancer, pancreatic cancer and periodontal disease. Where additional information requirements were identified, targeted searches were undertaken.

The results are reported in 'Costs and effects of strategies to support quitting the use of smokeless tobacco'. It is available on NICE's website.

Fieldwork

Fieldwork was carried out to evaluate how relevant and useful NICE's recommendations are for practitioners and how feasible it would be to put them into practice.

It was conducted with public health managers, commissioners and practitioners who are involved in oral health and tobacco cessation services and those who work with South Asian communities living in England. They included: smoking cessation advisers, dentists, pharmacists and representatives from local authorities, trading standards, the voluntary sector, faith organisations and patients.

The fieldwork comprised:

  • Six focus groups involving a total of 47 participants. The groups met in Birmingham, Bradford, Leicester, London (Tower Hamlets), Luton and Manchester.

  • Telephone interviews with 12 participants.

  • Online survey completed by 14 practitioners.

The locations of the focus groups were selected to ensure a regional spread and to target areas with large South Asian populations. The main issues arising from the fieldwork are set out in Fieldwork findings. See also, 'Helping people of South Asian origin to stop using smokeless tobacco: fieldwork report'.

How PHIAC formulated the recommendations

At its meeting in December 2011, the Public Health Interventions Advisory Committee (PHIAC) 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.

PHIAC 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 an evidence statement(s) (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 February 2012. At its meeting in May 2012, PHIAC amended the guidance in light of comments from stakeholders and experts and the fieldwork. The guidance was signed off by the NICE Guidance Executive in July 2012.

  • National Institute for Health and Care Excellence (NICE)