Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

<p>Abstract</p> <p>Background</p> <p>Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services.</p> <p>Methods</p> <p>A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed.</p> <p>Results</p> <p>We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500.</p> <p>Conclusions</p> <p>The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN82127540">ISRCTN82127540</a></p

CONSORT 2010 statement: extension to randomised pilot and feasibility trials [on behalf of the PAFS consensus group*]

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number. This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites

Toward a “constitution” for behavioral policy-making

Behavioral policy interventions aimed at redirecting individuals’ behavior toward optimal choices are characterized by an important issue which is often overlooked: the lack of an instrument to define what “optimal” means. If agents are subject to behavioral biases leading them to make “wrong” choices, the policy-maker can no longer rely on the revealed preferences approach (e.g., what people choose is what people prefer) for defining a welfare criterion. In this article, we reiterate the argument put forward by some scholars that choosing a suitable welfare criterion once the link between observed choices and individuals’ preferences is broken becomes a problematic task. We review the state of the art in the literature and the possible approaches proposed to overcome the problem, concluding that a solution has not yet been reached. Moreover, we argue that the lack of an established welfare criterion characterizing behavioral policy-making could pave the way to government wanting to restrict individual freedom. In the absence of any legislative constraint for the executive, stating that what individuals choose is not what they prefer in principle justifies any freedom-reducing government intervention, since choices can be arbitrarily labeled “sub-optimal” or “welfare-reducing.” To avoid this risk without turning down the potential of behavioral policy-making, we propose that an independent committee establishes ex ante procedural rules and domains where behavioral policy-making can be implemented. The article suggests some possible examples of normative provisions characterizing this constitution-type document, such as the selective identification of the only sectors where behavioral policies could be effectively applied, the periodic evaluation of policy effects, and the use of sunset clauses

Therapeutics: Electronic cigarettes for smoking cessation

A 42 year old electrician has tried to stop smoking several times, including with the aid of pharmacotherapy and behavioural support. He asks you about using electronic cigarettes (EC). His work partner stopped smoking a year ago and is still using EC now. He has heard that EC are as damaging as the real things and worries that if he ends up addicted to EC he’ll not have gained anything. 60% of current adult smokers in Great Britain have tried EC, and 18% are current EC users. In England, over 40% of people who try to stop smoking do so with the aid of an EC. 52% of current EC users are ex-smokers. Some people who stop smoking with an EC are still using the EC a year later. In this article we look at whether EC help people who smoke cut down and stop smoking, whether there are health risks from EC use, and how these compare with smoking.</p

GPs’ and nurses’ perceptions of electronic cigarettes in England: a qualitative interview study

Background Reports from royal colleges and organisations such as Public Health England suggest that GPs and nurses should advise patients to switch to electronic cigarettes (e-cigarettes) if they do not want to stop smoking using licensed medication. However, there are no data on what practitioners think, feel, or do about e-cigarettes. Aim To explore practitioners’ perceptions and attitudes towards e-cigarettes, and their experiences of discussing e-cigarettes with patients. Design and setting A qualitative interview study was carried out with semi-structured interviews conducted with nurses and GPs across England in 2017. Method Participants were interviewed once either via telephone or face to face. Data were analysed using thematic analysis. Results Interviews were conducted with 23 practitioners (eight nurses and 15 GPs). There were three key themes: ambivalence and uncertainty; pragmatism; and responsibility. Many practitioners had uncertainties about the safety and long-term risks of e-cigarettes. Some had ambivalence about their own knowledge and ability to advise on their use, as well as uncertainty about whether to and what to advise patients. Despite this, many sought to provide honesty in consultations by acknowledging these uncertainties about e-cigarettes with patients and taking a pragmatic approach, believing that e-cigarettes were a ‘step in the right direction’. Practitioners wanted advice from healthcare regulators such as the National Institute for Health and Care Excellence to reassure them about the safety of e-cigarettes, practical tools to support the consultation, and to control their use by providing behavioural support programmes for reduction or cessation. Conclusion Current dissemination strategies for guidelines are not effective in reaching practitioners, who are offering more cautious advice about e-cigarettes than guidelines suggest is reasonable

Therapeutics: Electronic cigarettes for smoking cessation

A 42 year old electrician has tried to stop smoking several times, including with the aid of pharmacotherapy and behavioural support. He asks you about using electronic cigarettes (EC). His work partner stopped smoking a year ago and is still using EC now. He has heard that EC are as damaging as the real things and worries that if he ends up addicted to EC he’ll not have gained anything. 60% of current adult smokers in Great Britain have tried EC, and 18% are current EC users. In England, over 40% of people who try to stop smoking do so with the aid of an EC. 52% of current EC users are ex-smokers. Some people who stop smoking with an EC are still using the EC a year later. In this article we look at whether EC help people who smoke cut down and stop smoking, whether there are health risks from EC use, and how these compare with smoking.</p