Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment

Abstract

BackgroundRecruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation.MethodsRecruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group.Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded.ResultsThere were variations in the time taken to award Research Management approval to run the study at the three sites (45–359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation.ConclusionsPilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial’s recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required.Trial registrationISRCTN63510637; UKCRN id 14092.

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“…A randomized controlled trial (RCT) provides the strongest level of evidence for treatment efficacy, but can be expensive, time-consuming and difficult to implement. Recruitment and retention are among the most significant challenges to conducting an RCT, and present a threat to study feasibility with our target population ( Hubbard et al, 2015 ). Middle-aged and older adults, particularly MWC users, are more likely to decline participation and discontinue treatment due to co-morbidities and complex health conditions ( McMurdo et al, 2011 ; Nary, Froehlich-Grobe & Aaronson, 2011 ).…”

The use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial with embedded feasibility study

“…204 An earlier study that looked explicitly at the impact of pilot work on recruitment did not find a clear link between doing pilot work and successful recruitment. 205 Our feasibility and pilot work suggests variation in sites regarding recruitment parameters (we have written about this in detail elsewhere 141 as well as in this report) and we therefore anticipate that some sites will meet recruitment targets and others will not. Which sites are likely to perform well is difficult to judge in advance.…”

“…We have already published our experiences of recruitment elsewhere. 141 Completion rates are also reported alongside results of analyses of the effect of the intervention on outcomes. These results are presented to inform decisions about conducting a larger multicentre trial to evaluate effectiveness.…”

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“…family and work). These reasons are common in PA intervention studies in people with bowel cancer [41] and cancer trial participation in general [44] and therefore likely to also feature in the future main trial.…”