title: 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: BACKGROUND
  Recruitment 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.
  
  
  METHODS
  Recruitment 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.
  
  
  RESULTS
  There 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.
  
  
  CONCLUSIONS
  Pilot 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.
  
  
  BACKGROUND
  ISRCTN63510637; UKCRN id 14092.
authors.affiliation: Cancer Care Research Centre, School of Health Sciences, University of Stirling, Highland Campus, Old Perth Road, Inverness, IV2 3JH UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Hubbard
authors.affiliation: Faculty of Life Science, Sport and Social Sciences, Edinburgh Napier University, Sighthill Campus, Edinburgh, EH11 4BN UK.
authors.forename: Anna
authors.initials: A
authors.lastname: Campbell
authors.affiliation: Cancer Trials Unit, Tower Block 2, Room 20, UHW, Heath Park, Cardiff, CF14 4XW UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Davies
authors.affiliation: Cancer Care Research Centre, School of Health Sciences, University of Stirling, Highland Campus, Old Perth Road, Inverness, IV2 3JH UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Munro
authors.affiliation: Cancer Care Research Centre, School of Health Sciences, University of Stirling, Stirling, FK9 4LA UK.
authors.forename: Aileen V
authors.initials: AV
authors.lastname: Ireland
authors.affiliation: Cardiac Unit, Raigmore Hospital, Old Perth Road, Inverness, IV2 3UJ UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Leslie
authors.affiliation: NHS Highland, Inverness, IV2 3BW UK ; Colorectal Surgery, Raigmore Hospital, Old Perth Road, Inverness, IV2 3UJ UK.
authors.forename: Angus Jm
authors.initials: AJ
authors.lastname: Watson
authors.affiliation: Health Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD UK.
authors.forename: Shaun
authors.initials: S
authors.lastname: Treweek
keywords: Cancer survivorship; Colorectal cancer; Complex intervention; Pilot trial; Pragmatic intervention; Recruitment