Strategies to improve recruitment to randomised controlled trials

Treweek, Shaun; Mitchell, Elizabeth; Pitkethly, Marie; Cook, Jonathan; Kjeldstrøm, Monica; Taskila, Taina; Johansen, Marit; Sullivan, Frank; Wilson, Sue; Jackson, Catherine; Jones, Ritu

doi:10.1002/14651858.mr000013.pub4

Cited by 169 publications

(186 citation statements)

References 51 publications

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“…It is worth noting that there is no good-quality evidence for the superiority of direct face-to-face recruitment compared with mail-outs in this population. 109 Even had there been it is unlikely that we would have had the reach or the resources required to reach full accrual using face-to-face accrual. We attempted to recruit through a range of other stakeholders, including GPs, health trainers and health champions, but this was not successful (see Chapter 3, Recruitmant of trial participants).…”

Section: Recruitment and Retentionmentioning

confidence: 99%

A randomised controlled trial and cost-effectiveness evaluation of ‘booster’ interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

Goyder

Hind

Breckon

et al. 2014

Health Technology Assessment

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Section: Recruitment and Retentionmentioning

confidence: 99%

A randomised controlled trial and cost-effectiveness evaluation of ‘booster’ interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

Goyder

Hind

Breckon

et al. 2014

Health Technology Assessment

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“…However, available evidence to support recruitment strategies is sparse. 396 the overall response rate tends to be low. Although it might be possible to adopt this strategy for older people, who do tend to register in primary care, our knowledge of the barriers to recruitment identified in earlier stages of the AMP project made such an approach problematic.…”

Section: Discussionmentioning

confidence: 97%

Increasing equity of access to high-quality mental health services in primary care: a mixed-methods study

Dowrick

Chew‐Graham

Lovell

et al. 2013

Programme Grants for Applied Research

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BackgroundEvidence-based interventions exist for common mental health problems. However, many people are unable to access effective care because it is not available to them or because interactions with caregivers do not address their needs. Current policy initiatives focus on supply-side factors, with less consideration of demand.Aim and objectivesOur aim was to increase equity of access to high-quality primary mental health care for underserved groups. Our objectives were to clarify the mental health needs of people from underserved groups; identify relevant evidence-based services and barriers to, and facilitators of, access to such services; develop and evaluate interventions that are acceptable to underserved groups; establish effective dissemination strategies; and begin to integrate effective and acceptable interventions into primary care.Methods and resultsExamination of evidence from seven sources brought forward a better understanding of dimensions of access, including how people from underserved groups formulate (mental) health problems and the factors limiting access to existing psychosocial interventions. This informed a multifaceted model with three elements to improve access: community engagement, primary care quality and tailored psychosocial interventions. Using a quasi-experimental design with a no-intervention comparator for each element, we tested the model in four disadvantaged localities, focusing on older people and minority ethnic populations. Community engagement involved information gathering, community champions and focus groups, and a community working group. There was strong engagement with third-sector organisations and variable engagement with health practitioners and commissioners. Outputs included innovative ways to improve health literacy. With regard to primary care, we offered an interactive training package to 8 of 16 practices, including knowledge transfer, systems review and active linking, and seven agreed to participate. Ethnographic observation identified complexity in the role of receptionists in negotiating access. Engagement was facilitated by prior knowledge, the presence of a practice champion and a sense of coproduction of the training. We developed a culturally sensitive well-being intervention with individual, group and signposting elements and tested its feasibility and acceptability for ethnic minority and older people in an exploratory randomised trial. We recruited 57 patients (57% of target) with high levels of unmet need, mainly through general practitioners (GPs). Although recruitment was problematic, qualitative data suggested that patients found the content and delivery of the intervention acceptable. Quantitative analysis suggested that patients in groups receiving the well-being intervention improved compared with the group receiving usual care. The combined effects of the model included enhanced awareness of the psychosocial intervention among community organisations and increased referral by GPs. Primary care practitioners valued community information gathering and access to the Improving Access to Mental Health in Primary Care (AMP) psychosocial intervention. We consequently initiated educational, policy and service developments, including a dedicated website.ConclusionsFurther research is needed to test the generalisability of our model. Mental health expertise exists in communities but needs to be nurtured. Primary care is one point of access to high-quality mental health care. Psychosocial interventions can be adapted to meet the needs of underserved groups. A multilevel intervention to increase access to high-quality mental health care in primary care can be greater than the sum of its parts.Study registrationCurrent Controlled Trials ISRCTN68572159.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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“…Watson et al 66 and Treweek et al 67 reviewed the published literature around improving recruitment to trials. Watson et al…”

Section: Recruitmentmentioning

confidence: 99%

Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

Raftery

Young

Stanton

et al. 2015

Health Technology Assessment

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BackgroundBy 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot ‘metadata’ on clinical trials funded by the HTA programme.ObjectivesThe aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility.Data sourcesPublished monographs and internal HTA documents.Review methodsA database was developed, ‘populated’ using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped.ResultsOne hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term ‘randomised trial’ in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data.LimitationsThe study was limited by being confined to 125 randomised trials by one funder.ConclusionsMetadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here.FundingThe National Institute for Health Research HTA programme.

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Strategies to improve recruitment to randomised controlled trials

Cited by 169 publications

References 51 publications

A randomised controlled trial and cost-effectiveness evaluation of ‘booster’ interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

A randomised controlled trial and cost-effectiveness evaluation of ‘booster’ interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods

Increasing equity of access to high-quality mental health services in primary care: a mixed-methods study

Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the National Institute for Health Research Health Technology Assessment programme

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