The great divide: A qualitative investigation of factors influencing researcher access to potential randomised controlled trial participants in mental health settings

Patterson, Sue; Kramo, Kofi; Soteriou, Tony; Crawford, Mike

doi:10.3109/09638237.2010.520367

Cited by 51 publications

(66 citation statements)

References 11 publications

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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%

“…Recruiters were from urological cancer trials [13,23,25,27,28,40,41,44,55], other cancer trials [24,27,28,32,35,40,44,49,50,52,54,55], mental health [27,28,39,46,50,55], orthopaedics [31,33,38,49,56], diabetes [36,47], vascular surgery [40,49], peripartum trials [37,53], HIV [30], smoking cessation [42], and pressure area care [51]. The majority of studies (32/35) focused on RCTs that were conducted in the UK [13,[24][25][26][27][28][29][31][32]…”

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%

“…Lawton et al (2016) [37] Peripartum pilot RCT comparing drug with placebo in the UK Interviews with clinicians/nurses (n = 27) and patients (n = 22) Mann et al (2014) [38] Pilot study comparing intraoperative local anaesthetic wound infiltration or usual care for joint pain in the UK [43] Clinicians and nurses involved in research (including RCTs) in the UK Interviews with clinicians and nurses (n = 11) Paramasivan et al (2011) [44] Feasibility study comparing surgery with radiotherapy for bladder cancer in the UK Interviews with clinicians/nurses (n = 9) and TMG (n = 2) RCT consultations recorded (n = 4) Paramasivan et al (2015) [45] Two anonymised UK RCTs differed in clinical contexts and complexity of the recruitment process However, some studies suggested that even when logistical and organisational issues were addressed, recruitment continued to be challenging [27,28,46]. Indeed, several recent studies have highlighted that there may be more deep-rooted reasons as to why recruitment can be difficult.…”

Section: Exploring Facilitators and Barriers To Recruitmentmentioning

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%

Section: Summary Of Included Papersmentioning

confidence: 99%

Section: Exploring Facilitators and Barriers To Recruitmentmentioning

confidence: 99%

See 3 more Smart Citations

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

et al. 2017

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Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine

Kwakye

Garner

Baldwin

et al. 2016

Hum. Psychopharmacol Clin Exp

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ObjectiveThe objective of this study was to develop an in‐depth understanding of healthy volunteers' experiences of mental health trials.MethodsA qualitative study was nested within a healthy volunteer placebo‐controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis.ResultsInterviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self‐monitored their bodies' reactions, and guessed which treatment they received. On being un‐blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed.ConclusionsSmall changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; “active” placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un‐blinding participants to treatment allocation. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd.

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Researcher practitioner engagement in health research: The development of a new concept

Daniels

Gillen

Casson

2021

Research in Nursing & Health

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The engagement of frontline practitioners in the production of research-derived knowledge is often advocated. Doing so can address perceived gaps between what is known from research and what happens in clinical practice. Engagement practices span a continuum, from co-production approaches underpinned by principles of equality and power sharing to those which can minimalize practitioners' contributions to the knowledge production process. We observed a conceptual gap in published healthcare literature that labels or defines practitioners' meaningful contribution to the research process.We, therefore, aimed to develop the concept of "Researcher Practitioner Engagement" in the context of academically initiated healthcare research in the professions of nursing, midwifery, occupational therapy, physiotherapy, and speech and language therapy. Guided by Schwartz-Barcott et al.'s hybrid model of concept development, published examples were analyzed to establish the attributes, antecedents, and consequences of this type of engagement. Academic researchers (n = 17) and frontline practitioners (n = 8)with relevant experience took part in online focus groups to confirm, eliminate, or elaborate on these proposed concept components. Combined analysis of theoretical and focus group data showed that the essence of this form of engagement is that practitioners' clinical knowledge is valued from a study's formative stages. The practitioner's clinical perspectives inform problem-solving and decision-making in study activities and enhance the professional and practice relevance of a study. The conceptual model produced from the study findings forms a basis to guide engagement practices, future concept testing, and empirical evaluation of engagement practices.

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The great divide: A qualitative investigation of factors influencing researcher access to potential randomised controlled trial participants in mental health settings

Cited by 51 publications

References 11 publications

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

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

Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine

Researcher practitioner engagement in health research: The development of a new concept

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