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

Gill Hubbard, Anna Campbell, Zoe Davies, Julie Munro, Aileen V Ireland, Stephen Leslie, Angus JM Watson, Shaun Treweek

Research output: Contribution to journalArticle

6 Citations (Scopus)
5 Downloads (Pure)

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:
1.
1.
Nurse assessed patients for eligibility.



2.
2.
Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.



3.
3.
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.

Trial registration

ISRCTN63510637; UKCRN id 14092.
Original languageEnglish
Article number15
Number of pages12
JournalPilot & Feasibility Studies
Volume1
Early online date14 Apr 2015
DOIs
Publication statusPublished - 14 Apr 2015

Fingerprint

Colonic Neoplasms
Randomized Controlled Trials
Patient Admission
Consent Forms
Cardiac Rehabilitation
Random Allocation
Appointments and Schedules
Nurses
Research Personnel
Control Groups
Research

Keywords

  • pilot trial
  • recruitment
  • complex intervention
  • pragmatic intervention
  • cancer survivorship
  • colorectal cancer

Cite this

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. / Hubbard, Gill; Campbell, Anna; Davies, Zoe; Munro, Julie; Ireland, Aileen V; Leslie, Stephen; Watson, Angus JM; Treweek, Shaun.

In: Pilot & Feasibility Studies, Vol. 1, 15, 14.04.2015.

Research output: Contribution to journalArticle

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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 = "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:1. 1.Nurse assessed patients for eligibility. 2. 2.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study. 3. 3.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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author = "Gill Hubbard and Anna Campbell and Zoe Davies and Julie Munro and Ireland, {Aileen V} and Stephen Leslie and Watson, {Angus JM} and Shaun Treweek",
note = "Acknowledgements We are grateful to the nurses who were involved in the recruitment and study participants in each site. We are also grateful to our patient advisor, Gillian Sweetman, for helping to draft information sheets and consent forms. The Health Services Research Unit, University of Aberdeen, is core funded by the Chief Scientist Office of the Scottish Government Health Directorates.",
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T1 - Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation

T2 - lessons learned to improve recruitment

AU - Hubbard, Gill

AU - Campbell, Anna

AU - Davies, Zoe

AU - Munro, Julie

AU - Ireland, Aileen V

AU - Leslie, Stephen

AU - Watson, Angus JM

AU - Treweek, Shaun

N1 - Acknowledgements We are grateful to the nurses who were involved in the recruitment and study participants in each site. We are also grateful to our patient advisor, Gillian Sweetman, for helping to draft information sheets and consent forms. The Health Services Research Unit, University of Aberdeen, is core funded by the Chief Scientist Office of the Scottish Government Health Directorates.

PY - 2015/4/14

Y1 - 2015/4/14

N2 - 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:1. 1.Nurse assessed patients for eligibility. 2. 2.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study. 3. 3.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.

AB - 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:1. 1.Nurse assessed patients for eligibility. 2. 2.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study. 3. 3.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.

KW - pilot trial

KW - recruitment

KW - complex intervention

KW - pragmatic intervention

KW - cancer survivorship

KW - colorectal cancer

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DO - 10.1186/s40814-015-0009-z

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VL - 1

JO - Pilot & Feasibility Studies

JF - Pilot & Feasibility Studies

SN - 2055-5784

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