Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

Donovan, Jenny; Rooshenas, Leila; Jepson, Marcus; Elliott, Daisy; Wade, Julia; Avery, Kerry; Mills, Nicola; Wilson, Caroline; Paramasivan, Sangeetha; Blazeby, Jane M

doi:10.1186/s13063-016-1391-4

Cited by 196 publications

(287 citation statements)

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“…Many studies (23/35) explored recruitment issues within the context of a single RCT [13,[23][24][25][30][31][32][33][36][37][38][39][40]42,44,[46][47][48][51][52][53][54]56], whilst eight provided a synthesis of results from multiple RCTs [26][27][28]41,45,49,50,55]. Four studies sampled healthcare professionals who recruited to RCTs generally, rather than a specific trial [29,34,35,43].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32][33][34][35][36][37][38][39][40][41][43][44][45][46][47][48][49][50][51][52][53][54][55][56].…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Studies consisted mostly of interviews or focus groups with those involved in recruitment to RCTs [13,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]39,[42][43][44][46][47][48][49][50][51][52][53][54][55][56], sometimes alongside interviews with patients who had been offered the opportunity to join the trial [23][24][25][26]33,37]. Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,50,52,55]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Several studies alluded to the complexities of combining research with clinical roles [23,[26][27][28][29][30]36,39,42,43,48,[50][51][52]55]. Findings from interviews with recruiting staff from six RCTs showed that whilst they expressed strong commitment to the RCT and research in general, clinicians and nurses experienced emotional and intellectual challenges related to their roles as scientists and clinicians [27,28].…”

Section: Emotional Challenges Of Dual Rolesmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Context: The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective: This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand-and subsequently improverecruitment and informed consent within a range of clinical trials. Evidence acquisition: A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis: The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions: Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary: Qualitative research is a term used to describe a range of methods that can be implemented to understand participants' perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand-and improve-recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.

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Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Summary Of Included Papersmentioning

confidence: 99%

“…Several studies audio recorded consultations where recruiters discussed the RCT with eligible patients [13,[24][25][26]31,32,38,40,41,44,45,49,50,52,55]…”

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Emotional Challenges Of Dual Rolesmentioning

confidence: 99%

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Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

et al. 2017

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Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice

Rogers

Reeves

Byrne

et al. 2017

British Journal of Surgery

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BackgroundRecruitment into surgical RCTs can be threatened if new interventions available outside the trial compete with those being evaluated. Adapting the trial to include the new intervention may overcome this issue, yet this is not often done in surgery. This paper describes the challenges, rationale and methods for adapting an RCT to include a new intervention.MethodsThe By‐Band study was designed in the UK in 2009–2010 to compare the effectiveness of laparoscopic adjustable gastric band and Roux‐en‐ gastric bypass for severe obesity. It contained a pilot phase to establish whether recruitment was possible, and the grant proposal specified that an adaptation to include sleeve gastrectomy would be considered if practice changed and recruitment was successful. Information on changing obesity surgery practice, updated evidence and expert opinion about trial design were used to inform the adaptation.ResultsThe pilot phase recruited over 13 months in 2013–2014 and randomized 80 patients (79 anticipated). During this time, major changes in obesity practice in the UK were observed, with gastric band reducing from 32·6 to 15·8 per cent and sleeve gastrectomy increasing from 9·0 to 28·1 per cent. The evidence base had not changed markedly. The British Obesity and Metabolic Surgery Society and study oversight committees supported an adaptation to include sleeve gastrectomy, and a proposal to do so was approved by the funder.ConclusionAdaptation of a two‐group surgical RCT can allow evaluation of a third procedure and maintain relevance of the RCT to practice. It also optimizes the use of existing trial infrastructure to answer an additional important research question. Registration number: ISRCTN00786323 (http://www.isrctn.com/).

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Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial

Andrews¹,

Bessent²,

Blazeby³

et al. 2023

Obesity

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Objective This paper reports the study design, participant characteristics, and recruitment results of By‐Band‐Sleeve, which investigated the clinical and cost‐effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK. Methods A pragmatic open adaptive noninferiority trial with 3‐year follow‐up was conducted. Participants were randomly assigned to bypass or band initially and to sleeve after the adaptation. Co‐primary end points are weight loss and health‐related quality of life assessed using the EQ‐5D utility index. Results Between December 2012 and August 2015, the study recruited into two groups and, after the adaptation, into three groups until September 2019. The study screened 6960 patients; 4732 (68%) were eligible and 1351 (29%) were randomized; 5 subsequently withdrew consent to use data, leaving 462, 464, and 420 assigned to bypass, band, and sleeve, respectively. Baseline data showed high levels of obesity (mean BMI = 46.4 kg/m2; SD: 6.9) and comorbidities (e.g., 31% diabetes), low scores for health‐related quality of life, and high levels of anxiety and depression (e.g., 25% abnormal scores). Nutritional parameters were poor, and the average equivalized household income was low (£16,667). Conclusions By‐Band‐Sleeve fully recruited. Participant characteristics are consistent with contemporary patients having bariatric surgery, and therefore the results will be generalizable.

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Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

Cited by 196 publications

References 37 publications

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Understanding and Improving Recruitment to Randomised Controlled Trials: Qualitative Research Approaches

Adaptation of the By-Band randomized clinical trial to By-Band-Sleeve to include a new intervention and maintain relevance of the study to practice

Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial

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