Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Shilling,; Williamson, Paula; Hickey, Helen; Sowden, Emma; Smyth, Rosalind L; Young, Bridget

doi:10.3310/hta15150

Cited by 67 publications

(97 citation statements)

References 168 publications

(232 reference statements)

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“…Initial reports from practices suggest that these gestures are appreciated and useful, primarily in introducing an element of "fun" to the recruitment process, but also helping to keep trial recruitment prominent within the practice. 5 Once participant recruitment to FiCTION is successfully completed we intend to evaluate the impact of the strategies developed from this survey on the overall process of recruitment.…”

Section: Discussionmentioning

confidence: 99%

“…4 The FiCTION trial involves the recruitment of children (aged 3 -7 years), which the RECRUIT study found to be even more challenging. 5 Additionally, these children are being recruited by more than 50 general dental practices across 5 regional centres over the UK. These general dental practices were already busy and few of them had participated in research before.…”

Section: Introductionmentioning

confidence: 99%

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Participant recruitment to FiCTION, a primary dental care trial – survey of facilitators and barriers

et al. 2014

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Participant recruitment to FiCTION, a primary dental care trial -survey of facilitators and barriers Keightley, Alexander; Clarkson, Janet; Maguire, A.; Speed, C.; Innes, Nicola General rightsCopyright and moral rights for the publications made accessible in Discovery Research Portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.• Users may download and print one copy of any publication from Discovery Research Portal for the purpose of private study or research.• You may not further distribute the material or use it for any profit-making activity or commercial gain.• You may freely distribute the URL identifying the publication in the public portal. Take down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Objective: To identify reasons behind a lower than expected participant recruitment rate within the FiCTION trial, a multi-centre paediatric primary dental care randomised controlled trial (RCT). Subjects (materials) and methods:An online survey, based on a previously published tool, consisting of both quantitative and qualitative responses, completed by staff in dental practices recruiting to FiCTION. Ratings from quantitative responses were aggregated to give overall scores for factors related to participant recruitment. Qualitative responses were independently grouped into themes.Results: 39 anonymous responses were received. Main facilitators related to the support received from the central research team and importance of the research question. The main barriers related to low child eligibility rates and the integration of trial processes within routine workloads. Conclusions:These findings have directed strategies for enhancing participant recruitment at existing practices and informed recruitment of further practices. The results help provide a profile of the features required of practices to successfully screen and recruit participants. Future trials in this setting should consider the level of interest in the research question within practices, and ensure trial processes are as streamlined as possible. Research teams should actively support practices with participant recruitment and maintain enthusiasm amongst the entire practice team.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Participant recruitment to FiCTION, a primary dental care trial – survey of facilitators and barriers

et al. 2014

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“…19 Parents were in the same room or an adjacent one when a child's interview was being conducted. Overall, children responded well to questions posed, but sometimes parents added comments to statements made or elaborated when a son or daughter struggled to verbalise his or her thoughts; this is something that others have noted to be helpful when gathering qualitative data from children.…”

Section: Qualitative Interviews With Parents and Children With Cleft mentioning

confidence: 99%

“…33,34 However, the fact that parents decide about participation for a child leads to a bioethical debate about whether or not one can act altruistically on behalf of another. 19 Parents may be concerned about making the 'right decision', seeing the need to protect their child from harm as fundamental. 35 As a consequence, although some studies have found that parents are motivated to consent to a trial for altruistic reasons, 36,37 it can be conditional on reassurances about concerns for a child's safety and well-being.…”

Section: Qualitative Interviews With Parents and Children With Cleft mentioning

confidence: 99%

“…Misunderstanding of randomisation shows that clear information is required when asking mothers and fathers to involve their child in a trial. Shilling et al 19 reported that parents they interviewed liked being able to take away information on which to reflect and to share with family members. Likewise, in our study, parents wanted verbal details about the study to be accompanied by written material which they could discuss with others.…”

Section: Qualitative Interviews With Parents and Children With Cleft mentioning

confidence: 99%

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The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation

Bruce

Harman

Williamson

et al. 2015

Health Technol Assess

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BackgroundCleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate.ObjectivesTo identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies.DesignThe management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP.SettingThe survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients’ homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting.ParticipantsClinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association.ResultsThe clinician survey revealed that care was predominantly delivered via a ‘hub-and-spoke’ model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research.ConclusionsThere exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered.FundingThe National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

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Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

Morain,

Barlevy,

Joffe

et al. 2023

JAMA Netw Open

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ImportanceClassic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.ObjectiveTo explore key stakeholders’ perspectives on dual-role consent in clinical oncology trials.Design, Setting, and ParticipantsThis qualitative study with 43 participants was conducted at a National Cancer Institute–designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study.Main Outcomes and MeasuresInterviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency.ResultsAmong the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants’ understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent.Conclusions and RelevanceThis qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.

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Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study

Cited by 67 publications

References 168 publications

Participant recruitment to FiCTION, a primary dental care trial – survey of facilitators and barriers

Participant recruitment to FiCTION, a primary dental care trial – survey of facilitators and barriers

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

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