Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis

Houghton, Catherine; Dowling, Maura; Meskell, Pauline; Hunter, Andrew; Gardner, Heidi; Conway, Aislinn; Treweek, Shaun; Sutcliffe, Katy; Noyes, Jane; Devane, Declan; Nicholas, Jane R; Biesty, Linda

doi:10.1002/14651858.mr000045

Cited by 60 publications

(28 citation statements)

References 41 publications

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“…Given the significant amount of evidence that already exists around these themes [1,[10][11][12][13][14][15], we present our findings using summary tables to highlight the key issues that were identified during ACTIVE and PRESTO. We then provide a descriptive account of 'eligibility criteria' and 'patient pathways', two themes that were identified as influencing recruitment and retention during ACTIVE and PRESTO which are not featured in Phelps et al's review [1].…”

Section: Resultsmentioning

confidence: 99%

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Scantlebury

McDaid

Brealey

et al. 2021

Trials

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Background Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. Participants Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registration ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,

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Section: Resultsmentioning

confidence: 99%

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Scantlebury

McDaid

Brealey

et al. 2021

Trials

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“…10,22,31 This is supported by previous research which suggests that rather than the professional role or level of seniority of the person seeking consent, it is whether the person delivering the trial information is approachable, trustworthy, participant-centred and knowledgeable. 41…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

2021

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Background: Critical care trials are limited by problems with participant recruitment, and little is known about the most effective ways to enhance trial participation. Despite clinical research improving in the past decades within intensive care, participant recruitment remains a challenge. Not all eligible patients are identified, and opportunities for enrolment into clinical trials are often missed. Interventions to facilitate recruitment need to be identified to improve trial conduct in the critical care environment. Therefore, we aimed to establish the effectiveness of recruitment strategies in critical care trials in order to inform future research practice. Methods: Databases including MEDLINE, Embase, CINAHL and PsycINFO were searched for English language papers from inception to February 2020. The objectives were to: (1) establish the effectiveness of recruitment strategies and (2) recommend how effective recruitment strategies can inform research practice. Two reviewers independently assessed papers for inclusion and critically appraised the quality of the studies. Discrepancies were discussed within the research team. Relevant data were extracted and thematically coded into five overarching themes using a narrative synthesis approach. The review was prospectively registered on PROSPERO (CRD42019160519). Results: The search resulted in 2509 initially identified articles, with 15 that met the inclusion criteria. Articles reported a combination of quantitative, mixed methods and qualitative studies and a range of low-, moderate- and high-quality studies. Although, in-keeping with narrative synthesis approaches, none were excluded based on methodological quality. Five themes were identified relating to: patient eligibility identification, who provides information and seeks consent, resource limitations, research culture or environment and the consent model used. The relative success of recruitment strategies was dependent upon the experience and availability of the staff involved in the approach, trial design, the application of the strategy to the specific intensive care environment, the acceptability of the recruitment and consent models used, and the efficiency of the recruitment procedures. Opportunities for consent were missed in a proportion of eligible patients in most studies, suggesting that clinicians may avoid recruiting more complex patients or in more complex situations and that further development of strategies is needed. Conclusion: More effective recruitment strategies are required to enhance recruitment and the representativeness of the patient sample obtained in critical care trials, in order to expand the evidence base for treatments in this field. Greater focus is needed on assessing the performance of different recruitment strategies within different types of studies and critical care research environments. Future research should explore key stakeholders’ experiences of, and attitudes towards, recruitment and establish the most important and feasible modifiable barriers to recruitment.

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“…Exploration of recruitment and retention issues in trials is extensive. Factors highlighted as important during the design and implementation phases of RCTs include: trial design, incentives, patient characteristics, support for recruiters, and patient and recruiter preferences for treatment [1,2,4,[14], [15], [16], [17], [18]]. …”

Section: Introductionmentioning

confidence: 99%

Treatment preference and recruitment to pediatric RCTs: A systematic review

Beasant

Brigden

Parslow

et al. 2019

Contemporary Clinical Trials Communications

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BackgroundRecruitment to pediatric randomised controlled trials (RCTs) can be a challenge, with ethical issues surrounding assent and consent. Pediatric RCTs frequently recruit from a smaller pool of patients making adequate recruitment difficult. One factor which influences recruitment and retention in pediatric trials is patient and parent preferences for treatment.PurposeTo systematically review pediatric RCTs reporting treatment preference.MethodsDatabase searches included: MEDLINE, CINAHL, EMBASE, and COCHRANE.Qualitative or quantitative papers were eligible if they reported: pediatric population, (0–17 years) recruited to an RCT and reported treatment preference for all or some of the participants/parents in any clinical area. Data extraction included: Number of eligible participants consenting to randomisation arms, number of eligible patients not randomised because of treatment preference, and any further information reported on preferences (e.g., if parent preference was different from child).ResultsFifty-two studies were included. The number of eligible families declining participation in an RCT because of preference for treatment varied widely (between 2 and 70%) in feasibility, conventional and preference trial designs. Some families consented to trial involvement despite having preferences for a specific treatment. Data relating to ‘participant flow and recruitment’ was not always reported consistently, therefore numbers who were lost to follow-up or withdrew due to preference could not be extracted.ConclusionsFamilies often have treatment preferences which may affect trial recruitment. Whilst children appear to hold treatment preferences, this is rarely reported. Further investigation is needed to understand the reasons for preference and the impact preference has on RCT recruitment, retention and outcome.

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Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis

Cited by 60 publications

References 41 publications

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Effectiveness of participant recruitment strategies for critical care trials: A systematic review and narrative synthesis

Treatment preference and recruitment to pediatric RCTs: A systematic review

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