Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

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

doi:10.1136/bmjopen-2012-002360

Cited by 445 publications

(467 citation statements)

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“…Randomised controlled trials (RCTs) are recognised as the most effective methodology for the evaluation of the effectiveness and safety of healthcare interventions [2], especially when brought together in systematic reviews [3]. However, the lack of high-quality evidence to support clinical decision making means that many fundamental questions in medicine-including in the management of urological patients-remain unanswered.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, effective strategies to improve recruitment include telephone reminders, financial incentives, open-trial designs where participants know which treatment they are receiving in the trial, and use of opt-out rather than opt-in procedures [3]. However, Bower and colleagues [11] highlighted that there was also a need to develop effective interventions aimed at those recruiting to trials.…”

Section: Introductionmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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“…77 If our package of changes had led to an increase in recruitment of 25% (which would be a very large increase), the impact on recruitment targets would have been small. One innovation that might be expected to have a large impact involved CRN staff calling patients, 78 where there is a reasonable evidence base already, including a study testing this approach using employees on a sick list. 79 However, such methods are not available to university research staff because of governance issues.…”

Section: Recruitment Processmentioning

confidence: 99%

Collaborative case management to aid return to work after long-term sickness absence: a pilot randomised controlled trial

et al. 2018

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BackgroundDespite high levels of employment among working-age adults in the UK, there is still a significant minority who are off work with ill health at any one time (so-called ‘sickness absence’). Long-term sickness absence results in significant costs to the individual, to the employer and to wider society.ObjectiveThe overall objective of the intervention was to improve employee well-being with a view to aiding return to work. To meet this aim, a collaborative case management intervention was adapted to the needs of UK employees who were entering or experiencing long-term sickness absence.DesignA pilot randomised controlled trial, using permuted block randomisation. Recruitment of patients with long-term conditions in settings such as primary care was achieved by screening of routine records, followed by mass mailing of invitations to participants. However, the proportion of patients responding to such invitations can be low, raising concerns about external validity. Recruitment in the Case Management to Enhance Occupational Support (CAMEOS) study used this method to test whether or not it would transfer to a population with long-term sickness absence in the context of occupational health (OH).ParticipantsEmployed people on long-term sickness absence (between 4 weeks and 12 months). The pilot was run with two different collaborators: a large organisation that provided OH services for a number of clients and a non-profit community-based organisation.InterventionCollaborative case management was delivered by specially trained case managers from the host organisations. Sessions were delivered by telephone and supported use of a self-help handbook. The comparator was usual care as provided by participants’ general practitioner (GP) or OH provider. This varied for participants according to the services available to them. Neither participants nor the research team were blind to randomisation.Main outcome measuresRecruitment rates, intervention delivery and acceptability to participants were the main outcomes. Well-being, as measured by the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), and return-to-work rates were also recorded.ResultsIn total, over 1000 potentially eligible participants were identified across the sites and invited to participate. However, responses were received from just 61 of those invited (5.5%), of whom 16 (1.5%) were randomised to the trial (seven to treatment, nine to control). Detailed information on recruitment methods, intervention delivery, engagement and acceptability is presented. No harms were reported in either group.ConclusionsThis pilot study faced a number of barriers, particularly in terms of recruitment of employers to host the research. Our ability to respond to these challenges faced several barriers related to the OH context and the study set up. The intervention seemed feasible and acceptable when delivered, although caution is required because of the small number of randomised participants. However, employees’ lack of engagement in the research might imply that they did not see the intervention as valuable.Future workDeveloping effective and acceptable ways of reducing sickness absence remains a high priority. We discuss possible ways of overcoming these challenges in the future, including incentives for employers, alternative study designs and further modifications to recruitment methods.Trial registrationCurrent Controlled Trials ISRCTN33560198.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 6, No. 2. See the NIHR Journals Library website for further project information.

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“…This is consistent with the literature. 40,41 Failure to attend for a routine check-up appointment is a common concern for all 'high-street' NHS dental practices, 42 so retention was always considered to be more of a challenge. Many adult NHS patients on a six-monthly recall strategy for their check-up appointment will fail to respond to reminders and commonly attend between six and 12 months after their previous appointment.…”

Section: Discussionmentioning

confidence: 99%

Assessing the efficacy and social acceptability of using hygienist-therapists as front-line clinicians

2017

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Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

Cited by 445 publications

References 68 publications

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Collaborative case management to aid return to work after long-term sickness absence: a pilot randomised controlled trial

Assessing the efficacy and social acceptability of using hygienist-therapists as front-line clinicians

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