Background: Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for\ntrialists to make recruitment performance publicly available. This article presents our experience of recruiting to a\npilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation.\nMethods: Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated\nnumber of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and\niii) recruitment rates in previous studies. The following recruitment procedure was used:\n1. Nurse assessed patients for eligibility.\n2. Patients signed a screening form indicating interest in and agreement to be approached by a researcher\nabout the study.\n3. An appointment was made at which the patient signed a consent form and was randomised to the\nintervention or control group.\nInformation about all patients considered for the study and subsequently included or excluded at each stage of\nthe recruitment process and reasons given were recorded.\nResults: There were variations in the time taken to award Research Management approval to run the study at the\nthree sites (45ââ?¬â??359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for\nunder-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing\nall patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a\nscreening form being lost to the study before consenting and randomisation.\nConclusions: Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely\nto influence recruitment performance in a future trial and inform the development of that trialââ?¬â?¢s recruitment strategies.\nPilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small\nnumber of sites, and contextual differences between sites are likely to impact recruitment performance in any future\ntrial. This means that ongoing monitoring and evaluation in trials are likely to be required.
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