Recruitment issues when primary care population clusters are used in randomised controlled clinical trials: Climbing mountains or pushing boulders uphill?
ABSTRACT Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this paper, we discuss how choosing which population cluster to randomise can impact on the practicalities of recruitment in primary care. We describe strategies developed through our experiences of recruiting primary care organisations to participate in a national randomised controlled trial of a policy to provide community breastfeeding groups for pregnant and breastfeeding mothers, the BIG (Breastfeeding in Groups) trial. We propose an iterative qualitative approach to recruitment; collecting data generated through the recruitment process, identifying themes and using the constant comparative method of analysis. This can assist in developing successful recruitment strategies and contrasts with the standardised approach commonly used when recruiting individuals to participate in randomised controlled trials. Recruiting primary care population clusters to participate in trials is currently an uphill battle in Britain. It is a complex process, which can benefit from applying qualitative methods to inform trial design and recruitment strategy. Recruitment could be facilitated if health service managers were committed to supporting peer reviewed, funded and ethics committee approved research at national level.
SourceAvailable from: Kevin D O'Brien
Dataset: In search of the sample
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ABSTRACT: Our objectives were to evaluate the evidence with regard to the effectiveness and stability of orthodontic treatment interventions for Class II Division 2 malocclusion in children and adolescents. This is a systematic review conducted according to the PRISMA statement. The Cochrane Oral Health Trials Register, the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched to November 2011. Relevant conference abstracts were also screened. No language restrictions were applied. Inclusion criteria were clinical studies with at least 20 subjects with Class II Division 2 malocclusion in which comparisons were made with an untreated Class II Division 2 malocclusion group, another treated Class II Division 2 malocclusion group, or neither. For included studies ranked best on the hierarchy of evidence, assessments of methodologic quality and risk of bias were undertaken. Abstracts and, when appropriate, full articles were examined independently by 2 investigators. Disagreements were resolved through discussion. Treatment changes and stability with or without retainers were measured with the following: skeletal, soft tissue, dental, and occlusal changes; gingival health; temporomandibular joint status and related muscular activity; and quality of life. Of the 322 studies identified in the search, 20 met the final inclusion criteria. All had a high risk of bias. Highly biased evidence exists with regard to management and stability of Class II Division 2 malocclusion. Guidelines are proposed based on current evidence.American journal of orthodontics and dentofacial orthopedics: official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics 08/2012; 142(2):159-169.e9. DOI:10.1016/j.ajodo.2012.03.022 · 1.44 Impact Factor
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ABSTRACT: To describe successful methods of recruitment and identify practice characteristics related to increased recruitment of older people for a randomised controlled trial. General practices in three regions of New Zealand and community-dwelling patients aged 75+ were recruited for the Brief Risk Identification Geriatric Health Tool trial. General practitioners (GPs) were faxed invitations with telephone follow-up. Reply-paid cards with telephone follow-up were used to invite older people. GP and practice characteristics were examined in relationship to recruitment rate. During 2007-2008, 158 of 438 GPs (36%) in 60 of 116 practices approached (52%) were recruited. Regional variation was marked and 3893 of 8308 invited (49%) older people were recruited. The GP's length of time at the practice and training in New Zealand was associated with recruitment success. Despite variability in practice recruitment, a reasonably large and representative sample of older people was recruited through general practices.Australasian Journal on Ageing 07/2013; DOI:10.1111/ajag.12058 · 1.12 Impact Factor