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.pub2

Cited by 113 publications

(148 citation statements)

References 180 publications

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“…6,32,[35][36][37][38] The timeliest approach was deferred consent, however the use of this differed between studies and researchers report discomfort in using this model. 26,[39][40][41] Whether the approach was by a researcher or clinician had no significant difference on consent rates, but characteristics of the approach such as rapport was found to affect participation. 10,23,32 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 the delivering the trial information is approachable, trustworth , parti ipa t-e tred a d k owledgea le.…”

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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Section: Discussionmentioning

confidence: 99%

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

2021

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“…These findings resonate with Houghton et al's conceptual model which indicates that prospective randomised controlled trial participants will consider what they stand to gain or lose, altruistic motives, social influences and the burden of participation. 10 However, unique to the early phase cancer trial context is that patients often express therapeutic misconception (believing the intent of the trial is to benefit them) 31 50 and unrealistic optimism (believing they will experience better outcomes than others), 18 19 posing ethical challenges for trialists. 51 Consistent with existing guidance on developing decision aids for clinical trials, 48 it will, thus, be important to present CAR-T cell therapy safety and efficacy findings with an emphasis on how safety and efficacy data compare to usual care and other available options.…”

Section: Accessible Informationmentioning

confidence: 99%

“…Global themes, key domains, subthemes and example belief statements and quotes No to be frank with you I don't really know very much [laugh] about that.' -Participant #12 I would like to know more about treatment efficacy (10). 'I guess I would want them to sort of have a fairly good sense as to whether or not overall it was gonna be beneficial for me long-term or, you know, especially in comparison with what other treatment modalities are available to me.'…”

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confidence: 99%

“…Or I know there's no guarantee about anything but just if there was a plan implemented to mitigate most or whatever could be done to reverse the side effects or treat the side effects appropriately and to know all the risks of doing the trial.' -Participant #7 I would like to know more about the logistics of participating in a CAR-T trial (10). 'I think that would depend on like what would be the logistics?…”

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confidence: 99%

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Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

et al. 2021

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ObjectivesBench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial.DesignWe used qualitative semistructured interviews to identify potential barriers and enablers to patients’ hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs.ParticipantsCanadian adult patients diagnosed with haematological malignancies.ResultsIn total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources).ConclusionUsing the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration:NCT03765177; Pre-results.

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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 113 publications

References 180 publications

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

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

Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial

Treatment preference and recruitment to pediatric RCTs: A systematic review

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