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      Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment

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          Abstract

          Background

          A randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment.

          Aim

          To describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and to enable others to learn from this experience.

          Design & setting

          A pragmatic RCT was designed to compare two pain medication prescription strategies for treatment of (sub)acute sciatica in general practice. After 1 year of patient recruitment, the trial was prematurely terminated.

          Method

          To analyse the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed to the participating GPs for their views on the recruitment process.

          Results

          A total of 116 GPs from 37 general practices collaborated in the trial. Only eight of 234 patients were included after 12 months. The 22 GPs who offered their opinion on the main reasons for unsuccessful recruitment considered that these were the low incidence rate and strict eligibility criteria, a strong patient and/or GP preference, and time constraints.

          Conclusion

          For this RCT, multiple factors were related to recruitment problems but it remains unknown which determinants prevailed. As the research question is unanswered but remains relevant, it is recommended that GPs’ daily practice is taken into account when designing an RCT, a pilot study should be performed for feasibility of recruitment, and GP assistants should be involved at an early stage.

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          Most cited references34

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          Barriers to participation in randomised controlled trials: a systematic review.

          A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.
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            Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

            This review is an abridged version of a Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2010, Issue 4, Art. No.: MR000013 DOI: 10.1002/14651858.MR000013.pub5 (see www.thecochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and Cochrane Database of Systematic Reviews should be consulted for the most recent version of the review. Objective To identify interventions designed to improve recruitment to randomised controlled trials, and to quantify their effect on trial participation. Design Systematic review. Data sources The Cochrane Methodology Review Group Specialised Register in the Cochrane Library, MEDLINE, EMBASE, ERIC, Science Citation Index, Social Sciences Citation Index, C2-SPECTR, the National Research Register and PubMed. Most searches were undertaken up to 2010; no language restrictions were applied. Study selection Randomised and quasi-randomised controlled trials, including those recruiting to hypothetical studies. Studies on retention strategies, examining ways to increase questionnaire response or evaluating the use of incentives for clinicians were excluded. The study population included any potential trial participant (eg, patient, clinician and member of the public), or individual or group of individuals responsible for trial recruitment (eg, clinicians, researchers and recruitment sites). Two authors independently screened identified studies for eligibility. Results 45 trials with over 43 000 participants were included. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (risk ratio (RR) 1.66, 95% CI 1.03 to 2.46; two studies, 1058 participants), use of opt-out rather than opt-in procedures for contacting potential participants (RR 1.39, 95% CI 1.06 to 1.84; one study, 152 participants) and open designs where participants know which treatment they are receiving in the trial (RR 1.22, 95% CI 1.09 to 1.36; two studies, 4833 participants). However, the effect of many other strategies is less clear, including the use of video to provide trial information and interventions aimed at recruiters. Conclusions There are promising strategies for increasing recruitment to trials, but some methods, such as open-trial designs and opt-out strategies, must be considered carefully as their use may also present methodological or ethical challenges. Questions remain as to the applicability of results originating from hypothetical trials, including those relating to the use of monetary incentives, and there is a clear knowledge gap with regard to effective strategies aimed at recruiters.
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              A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies

              Background Randomised controlled trials (RCTs) are the gold standard assessment for health technologies. A key aspect of the design of any clinical trial is the target sample size. However, many publicly-funded trials fail to reach their target sample size. This study seeks to assess the current state of recruitment success and grant extensions in trials funded by the Health Technology Assessment (HTA) program and the UK Medical Research Council (MRC). Methods Data were gathered from two sources: the National Institute for Health Research (NIHR) HTA Journal Archive and the MRC subset of the International Standard Randomised Controlled Trial Number (ISRCTN) register. A total of 440 trials recruiting between 2002 and 2008 were assessed for eligibility, of which 73 met the inclusion criteria. Where data were unavailable from the reports, members of the trial team were contacted to ensure completeness. Results Over half (55%) of trials recruited their originally specified target sample size, with over three-quarters (78%) recruiting 80% of their target. There was no evidence of this improving over the time of the assessment. Nearly half (45%) of trials received an extension of some kind. Those that did were no more likely to successfully recruit. Trials with 80% power were less likely to successfully recruit compared to studies with 90% power. Conclusions While recruitment appears to have improved since 1994 to 2002, publicly-funded trials in the UK still struggle to recruit to their target sample size, and both time and financial extensions are often requested. Strategies to cope with such problems should be more widely applied. It is recommended that where possible studies are planned with 90% power.
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                Author and article information

                Journal
                BJGP Open
                BJGP Open
                bjgpoa
                bjgpoa
                BJGP Open
                Royal College of General Practitioners
                2398-3795
                04 October 2017
                October 2017
                : 1
                : 3
                : bjgpopen17X101085
                Affiliations
                [1 ]deptGP trainee and PhD student, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [2 ]deptGP trainee and PhD student, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [3 ]deptProfessor of General Practice, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [4 ]deptGP, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [5 ]deptGP, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [6 ]deptProfessor of Neurosurgery, Department of Neurosurgery , Leiden University Medical Center , Leiden, The Netherlands
                [7 ]deptPatient and Board Member of 'De Wervelkolom' , Dutch Association for Back Pain Patients , Lichtenvoorde, The Netherlands
                [8 ]deptAssociate Professor, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [9 ]deptProfessor of Osteoarthritis and Related Disorders, Departments of General Practice and Orthopedics , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                [10 ]deptAssistant Professor, Department of General Practice , Erasmus MC, University Medical Center , Rotterdam, The Netherlands
                Author notes
                *For correspondence:  w.vandergaag@ 123456erasmusmc.nl
                Article
                bjgpopen17X101085
                10.3399/bjgpopen17X101085
                6169930
                30564680
                d161e130-e537-4902-ad83-21e69f592e84
                Copyright © The Authors, 2017

                This article is Open Access: CC BY-NC 4.0 license ( https://creativecommons.org/licenses/by-nc/4.0/)

                History
                : 23 December 2016
                : 27 March 2017
                Categories
                Research

                primary health care,general practice,randomized controlled trial,patient recruitment,early termination of clinical trials,study design

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