Factors affecting recruitment to an observational multicentre palliative care study
- Patrick C Stone1,
- Bridget Gwilliam1,
- Vaughan Keeley2,
- Chris Todd3,
- Laura C Kelly4 and
- Stephen Barclay5
- 1Division of Population, Health Sciences and Education, St George's University of London, Cranmer Terrace, London, UK
- 2Department of Palliative Medicine, Royal Derby Hospital, Derby, UK
- 3Department of primary care and community health, School of Nursing, Midwifery and Social Work, University Place, The University of Manchester, Manchester, UK
- 4Department of Palliative Medicine, Palliative Care Team, Surrey and Sussex Healthcare NHS Trust, East Surrey Hospital, Redhill, Surrey, UK
- 5Department of Public Health and Primary Care, Primary Care Unit, Institute of Public Health, Cambridge, UK
- Correspondence to Dr Patrick C Stone, Division of Population, Health Sciences and Education, St George's University of London, Cranmer Terrace, London SW17 ORE, UK;
Objectives To identify those factors which adversely affected recruitment to a large multicentre palliative care study.
Methods Patient accrual to a multicentre, observational, palliative care study was monitored at three critical junctures in the research process. (1) Eligibility—did the patient fulfil the study entry criteria? (2) Accessibility—was it possible to access the patient to be able to inform them about the study? (3) Consent—did the patient agree to participate in the study? The reasons why patients were ineligible, inaccessible or refused consent were recorded.
Results 12 412 consecutive referrals to participating clinical services were screened for study inclusion of whom 5394 (43%) were deemed to be ineligible. Of the remaining patients 4617/7018 (66%) were inaccessible to the research team. The most common reasons being precipitous death, ‘gatekeeping’ by clinical staff or rapid discharge. Of the 2410 patients who were visited by the research team and asked to participate in the study 1378 (57%) declined. Overall 8.2% (1018/12 412) of patients screened participated in the study. There were significant differences in recruitment patterns between hospice inpatient units, hospital support and community palliative care teams.
Conclusions Systematic monitoring and analysis of patient flows through the clinical trial accrual process provided valuable insights about the reasons for failure to recruit patients to a clinical trial and may help to improve recruitment in future studies.
- Received 25 October 2012.
- Revision received 25 October 2012.
- Accepted 6 December 2012.
- Published Online First 7 January 2013
- Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode