Article

Recruitment issues when primary care population clusters are used in randomised controlled trials: Climbing mountains or pushing boulders uphill?

Centre For Rural Health, University of Aberdeen, The Green House, Beechwood Business Park North, Inverness IV2 3BL, Scotland, UK.
Contemporary Clinical Trials (Impact Factor: 1.94). 06/2007; 28(3):232-41. DOI: 10.1016/j.cct.2006.08.004
Source: PubMed

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.

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    • "Many examples in the literature demonstrate that recruitment is a problem affecting medical research but no reports appear to exist for dentistry/ orthodontics. Studies in all of the following have experienced problems: primary care [10]; HIV clinical trials [11]; asthma [12]; psychiatric studies [13] and oncology [14]. Lovato et al. [11] discussed many issues hindering recruitment, including barriers to recruitment of diverse populations due to language and cultural factors, beliefs about medical research, and the appropriateness of available protocols. "

    Full-text · Dataset · Oct 2013
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    • "Many examples in the literature demonstrate that recruitment is a problem affecting medical research but no reports appear to exist for dentistry/ orthodontics. Studies in all of the following have experienced problems: primary care [10]; HIV clinical trials [11]; asthma [12]; psychiatric studies [13] and oncology [14]. Lovato et al. [11] discussed many issues hindering recruitment, including barriers to recruitment of diverse populations due to language and cultural factors, beliefs about medical research, and the appropriateness of available protocols. "
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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.
    Full-text · Article · Aug 2012 · American journal of orthodontics and dentofacial orthopedics: official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics
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    • "This is particularly the case for cluster randomised trials (CRTs), where intact social groups (for example, primary care clinics or schools), rather than individuals, are the unit of randomisation [4,5]. Lower level evidence in the form of case studies describing recruitment successes and failures experienced in individual patient RTs [6-10] and CRTs which recruit patients to receive an intervention [11-13] exists. Results of these studies suggest that barriers such as time constraints, forgetting to recruit, and too few eligible patients influence recruitment rates [9,14,15]. "
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    ABSTRACT: Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain. General practitioners enrolled in the study were posted a questionnaire, consisting of quantitative items and an open-ended question, to assess possible reasons for poor patient recruitment. Descriptive statistics were used to summarise quantitative items and responses to the open-ended question were coded into categories. Seventy-nine general practitioners completed at least one item (79/94 = 84%), representing 68 practices (85% practice response rate), and 44 provided a response to the open-ended question. General practitioners recalled inviting a median of two patients with acute low-back pain to participate in the trial over a seven-month period; they reported that they intended to recruit patients, but forgot to approach patients to participate; and they did not perceive that patients had a strong interest or disinterest in participating. Additional open-ended comments were generally consistent with the quantitative data. A number of barriers to the recruitment of patients with acute low-back pain by general practitioners in a professional-cluster trial were identified. These barriers were similar to those that have been identified in the literature surrounding the recruitment of patients in individual patient randomised trials. To advance the evidence base for patient recruitment strategies in primary care settings, trialists undertaking professional-cluster trials need to develop and evaluate patient recruitment strategies that minimise the efforts required by practice staff to recruit patients, while also meeting privacy and ethical responsibilities and minimising the risk of selection bias.
    Full-text · Article · Mar 2011 · BMC Medical Research Methodology
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