Shedding light on research participation effects in behaviour change trials: a qualitative study examining research participant experiences.

BACKGROUND: The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes METHODS: Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach. RESULTS: The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes. CONCLUSION: These participants described no dramatic impacts attributable to taking part in this study. This study demonstrates the likely value of well conducted qualitative studies of subtle research participation effects, which may be particularly important to explore for alcohol. Separating unintended influences in trial participation from the effects of behaviour change interventions being evaluated therein is necessary for valid estimates of intervention effects.

Determining counselling communication strategies associated with successful quits in the National Health Service community pharmacy Stop Smoking programme in East London: a focused ethnography using recorded consultations.

OBJECTIVES: To determine communication strategies associated with smoking cessation in the National Health Service community pharmacy Stop Smoking programme. SETTING: 11 community pharmacies in three inner east London boroughs. PARTICIPANTS: 9 stop smoking advisers and 16 pairs of smokers who either quit or did not quit at 4 weeks, matched on gender, ethnicity, age and smoking intensity. METHOD: 1-3 audio-recorded consultations between an adviser and each pair member over 5-6 weeks were analysed using a mixed-method approach. First a content analysis was based on deductive coding drawn from a theme-oriented discourse analysis approach and the Roter Interaction Analysis System. Core themes were identified through this quantification to explore in detail the qualitative differences and similarities between quitters and non-quitters. RESULTS: Quantitative analysis revealed advisers used a core set of counselling strategies that privileged the 'voice of medicine' and often omitted explicit motivational interviewing. Smokers tended to quit when these core strategies were augmented by supportive talk, clear permission for smokers to seek additional support from the adviser between consultations, encouragement for smokers to use willpower. The thematic analysis highlighted the choices made by advisers as to which strategies to adopt and the impacts on smokers. The first theme 'Negotiating the smoker-adviser relationship' referred to adviser judgements about the likelihood the smoker would quit. The second theme, 'Roles of the adviser and smoker in the quit attempt', focused on advisers' counselling strategies, while the third theme, 'Smoker and adviser misalignment on reasons for smoking, relapsing and quitting', concerned inconsistencies in the implementation of National Centre for Smoking Cessation and Training recommendations. DISCUSSION: Advisers in community pharmacies should use the advantages of their familiarity with smokers to ensure appropriate delivery of patient-centred counselling strategies and reflect on the impact on their counselling of early judgements of smoker success.

Understanding recruitment and retention in the NHS community pharmacy stop smoking service: perceptions of smoking cessation advisers.

OBJECTIVES: To understand views of pharmacy advisers about smoker recruitment and retention in the National Health Service community pharmacy stop smoking programme. DESIGN: Thematic framework analysis of semistructured, in-depth interviews applying the Theoretical Domains Framework and COM-B behaviour change model. We aimed to identify aspects of adviser behaviour that might be modified to increase numbers joining and completing the programme. PARTICIPANTS: 25 stop smoking advisers (13 pharmacists and 12 support staff). SETTING: 29 community pharmacies in 3 inner east London boroughs. RESULTS: Advisers had preconceived ideas about smokers likely to join or drop out and made judgements about smokers' readiness to quit. Actively recruiting smokers was accorded low priority due in part to perceived insufficient remuneration to the pharmacy and anticipated challenging interactions with smokers. Suggestions to improve smoker recruitment and retention included developing a more holistic and supportive approach using patient-centred communication. Training counter assistants were seen to be important as was flexibility to extend the programme duration to fit better with smokers' needs. CONCLUSIONS: Cessation advisers feel they lack the interpersonal skills necessary to engage well with smokers and help them to quit. Addressing advisers' behaviours about active engagement and follow-up of clients, together with regular skills training including staff not formally trained as cessation advisers, could potentially boost numbers recruited and retained in the stop smoking programme. Adjustments to the pharmacy remuneration structure to incentivise recruitment and to allow personalisation of the programme for individual smokers should also be considered.

Experiences of front-line health professionals in the delivery of telehealth: a qualitative study.

BACKGROUND: Telehealth is an emerging field of clinical practice but current UK health policy has not taken account of the perceptions of front-line healthcare professionals expected to implement it. AIM: To investigate telehealth care for people with long-term conditions from the perspective of the front-line health professional. DESIGN AND SETTING: A qualitative study in three sites within the UK (Kent, Cornwall, and the London Borough of Newham) and embedded in the Whole Systems Demonstrator evaluation, a large cluster randomised controlled trial of telehealth and telecare for patients with long-term and complex conditions. METHOD: Semi-structured qualitative interviews with 32 front-line health professionals (13 community matrons, 10 telehealth monitoring nurses and 9 GPs) involved in the delivery of telehealth. Data were analysed using a modified grounded theory approach. RESULTS: Mixed views were expressed by front-line professionals, which seem to reflect their levels of engagement. It was broadly welcomed by nursing staff as long as it supplemented rather than substituted their role in traditional patient care. GPs held mixed views; some gave a cautious welcome but most saw telehealth as increasing their work burden and potentially undermining their professional autonomy. CONCLUSION: Health care professionals will need to develop a shared understanding of patient self-management through telehealth. This may require a renegotiation of their roles and responsibilities.

Recruiting ethnic minority participants to a clinical trial: a qualitative study.

OBJECTIVES: To compare the motives and experiences of different ethnic groups participating in a randomised double blind placebo-controlled trial of montelukast in preschool wheeze, and to assess parents' or guardians' understanding of trial procedures and their implications, including the collection of genetic material. DESIGN: Qualitative interviews with parents or guardians. SETTING: Interviews occurred in the homes of London children recruited to a national multicentre clinical trial following primary and secondary care attendance with wheeze. PARTICIPANTS: 42 parents (20 of Bangladeshi origin, 10 white UK, 12 other ethnicities) of preschool children enrolled in a clinical trial. RESULTS: Bangladeshi families were relatively reluctant to participate in the qualitative study, despite strong engagement with the parent study. Anxiety related to wheezing was a common primary motive for trial enrolment. Parents viewed the trial as a route to improved treatment. Verbal delivery of trial information appeared more effective than study literature, especially for Bangladeshi families, with low parental literacy and high levels of trust in medical professionals potential contributors to this effect. All ethnic groups expressed a low understanding and/or retention of essential study concepts such as randomisation and genetic testing. CONCLUSIONS: Bangladeshi families are particularly motivated to participate in clinical trials despite variable comprehension of study concepts. This motivation is more strongly contingent on strong researcher-subject rapport than on the quality of study literature. Trial teams seeking to recruit from South Asian populations should emphasise face-to-face verbal explanation of trial concepts and procedures and consider modified trial literature.

Forming partnerships with parents from a community development perspective: lessons learnt from Sure Start.

The aim of this study is to explore some of the issues of service user participation in the planning and delivery of public services from a community development perspective. It draws on an action research evaluation study of a local Sure Start programme, which was introduced into an area without a tradition of community involvement in decisions about local services. The study describes and analyses the challenges of parent participation in the organisation and delivery of the Sure Start programme at an operational and strategic level, using findings from semi-structured interviews, observations and critical conversations with Sure Start parents, staff and members of the Sure Start management board. The main substantive findings are that there was a lack of shared understanding of the nature of parent participation in all its facets and this undermined the efforts of parents and staff in the development of the programme. These findings also raise broader issues about participation, the place of parental partnerships with professionals and ways in which collaboration between the two may be interpreted and evolve.