Virginia MacNeill

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.

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

BackgroundThe 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 outcomesMethodsTwenty 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.ResultsThe 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.ConclusionThese 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.

G158 Recruiting Ethnic Minority Participants to a Clinical Trial: 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 Parents of children recruited following medical attendance with wheeze were interviewed in their homes. Participants 42 parents, (20 of Bangladeshi origin, 10 white UK, 12 other ethnicities). Results 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 was more effective than study literature, especially for Bangladeshi families, with low parental literacy and high levels of trust in medical professionals contributing 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.