Strategies to improve recruitment to randomised controlled trials

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

doi:10.1002/14651858.mr000013.pub5

Cited by 289 publications

(249 citation statements)

References 98 publications

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“…13,[15][16][17][18] Our study has a refusal rate similar to those in previously published studies using passive consent 14,16,17 and a response rate similar to those reported in general survey research. 19,20 The opt-out strategy was used in this study to develop a large pool of control subjects from an unbiased sample of participants in anticipation of rapid enrollment during a pandemic and to reduce selection bias over other recruitment strategies.…”

Section: Discussionsupporting

confidence: 82%

Variability in IRBs Regarding Parental Acceptance of Passive Consent

et al. 2014

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OBJECTIVE: Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study. METHODS: We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients. RESULTS: Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs 12.2%; P = .004). The overall refusal rate across both groups was 33.3%. CONCLUSIONS: IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period.

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Section: Discussionsupporting

confidence: 82%

Variability in IRBs Regarding Parental Acceptance of Passive Consent

et al. 2014

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“…Slow and low numbers of recruitment to trials are well reported. [18][19][20][21] Barriers to trial participation include a lack of patient time, issues with their perceived importance of the trial, poor patientclinician relationship, and a lack of compatibility between the trial protocol and usual clinical practice. 19 Strategies to improve recruitment to trials have been advocated and include telephone reminders, participant opt-out versus opt-in options for trial contact, and open designs.…”

Section: Discussionmentioning

confidence: 99%

A Randomised Controlled Trial of Treatment for Post-Stroke Homonymous Hemianopia: Screening and Recruitment

Rowe

Conroy

Barton

et al. 2016

Neuro-Ophthalmology

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“…There A number of reviews have been undertaken on the topic of recruitment to RCTs. 3,19,20 The evidence base drawn on by these reviews primarily originates from secondary care and are medical in nature. Whilst there is a suggestion that some intervention may be effective in improving recruitment (i.e.…”

Section: Discussionmentioning

confidence: 99%

“…2 A review by Treweek and colleagues recognised that achieving recruitment is an issue in medical research, and that knowledge on how to increase recruitment at sites participating in a trial is currently lacking. 3 This challenge was further reinforced by a recent survey of Clinical Trials Units Directors where "research into methods to boost recruitment in trials" was found to be their highest research priority. 4 The FiCTION trial involves the recruitment of children (aged 3 -7 years), which the RECRUIT study found to be even more challenging.…”

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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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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Strategies to improve recruitment to randomised controlled trials

Cited by 289 publications

References 98 publications

Variability in IRBs Regarding Parental Acceptance of Passive Consent

Variability in IRBs Regarding Parental Acceptance of Passive Consent

A Randomised Controlled Trial of Treatment for Post-Stroke Homonymous Hemianopia: Screening and Recruitment

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

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