The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials

Abstract

ObjectiveThe aim of the study was to investigate how doctors considered and experienced the concept of equipoise while recruiting patients to randomized controlled trials (RCTs).Study Design and SettingIn-depth interviews with 32 doctors in six publicly funded pragmatic RCTs explored their perceptions of equipoise as they undertook RCT recruitment. The RCTs varied in size, duration, type of complex intervention, and clinical specialties. Interview data were analyzed using qualitative content and thematic analytical methods derived from grounded theory and synthesized across six RCTs.ResultsAll six RCTs suffered from poor recruitment. Doctors wanted to gather robust evidence but experienced considerable discomfort and emotion in relation to their clinical instincts and concerns about patient eligibility and safety. Although they relied on a sense of community equipoise to justify participation, most acknowledged having “hunches” about particular treatments and patients, some of which undermined recruitment. Surgeons experienced these issues most intensely. Training and support promoted greater confidence in equipoise and improved engagement and recruitment.ConclusionRecruitment to RCTs is a fragile process and difficult for doctors intellectually and emotionally. Training and support can enable most doctors to become comfortable with key RCT concepts including equipoise, uncertainty, patient eligibility, and randomization, promoting a more resilient recruitment process in partnership with patients.

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

“…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].…”

“…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]…”

“…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].…”

“…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,…”

“…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.…”