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An exploration of patients’ experiences of participation in a randomised controlled trial of the Manchester Acute Coronary Syndromes (MACS) decision rule
  1. Patricia van den Berg1,
  2. Sarah Kendal2,
  3. Helen V Alderson3,
  4. Richard Body4,5
  1. 1 Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands
  2. 2 School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK
  3. 3 Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK
  4. 4 Emergency Department, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK
  5. 5 University of Manchester, Manchester, UK
  1. Correspondence to Professor Richard Body, Emergency Department, Manchester Royal Infirmary, Oxford Road, Manchester, M13 9WL, UK; richard.body{at}manchester.ac.uk

Abstract

Background As an important part of a pilot study to determine the feasibility of a large randomised controlled trial (RCT) comparing use of the Manchester Acute Coronary Syndromes (MACS) decision rule with standard care, we aimed to explore patient attitudes and potential barriers to participation in a trial of this nature.

Methods We conducted a qualitative study nested within a pilot RCT comparing use of the MACS rule (which could enable some patients with chest pain to be discharged earlier) with standard care. Semi-structured interviews with consenting participants were conducted with reference to a bespoke topic guide. Interviews were audio recorded, transcribed verbatim and analysed using the Framework method with an inductive approach.

Results The 10 interviewees expressed that participation in the trial was generally acceptable. All but one recommended participation to others. Participants who were in pain or anxious at the time of arrival reported that the initial invitation to participate in the trial was sometimes made too early. The approach was welcome, providing they had been given time to settle. Interviewees welcomed the opportunity that trial participation offered for them to play a more active role in their healthcare and to reduce unnecessary waiting time. Participants appeared to like the fact that participation in the trial might mean they could return home sooner and welcomed the provision of follow-up. Although several participants described being generally sceptical of medical research, they were amenable to participation in this trial. This appears to be because they agreed with the need for research in this field and perceived the intervention as non-invasive.

Conclusions Patients were positive about their participation in this RCT comparing the MACS rule with standard care. A number of areas for improving trial design were identified and should be considered in the planning of future large trials.

Trial registration ISRCTN 86818215

Research ethics committee reference 13/NW/0081

UKCRN registration ID 14334

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Footnotes

  • Contributors RB designed the trial and contributed with HA to data acquisition. PB, RB and SK contributed substantially to the data analysis.

    PB drafted the manuscript and RB, SK and HA revised it critically for important intellectual content.

    All four authors provided final approval of the version to be published and agree to be accountable for all aspects of the work.

  • Funding This trial was funded by the UK National Institute for Health Research via a postdoctoral fellowship grant (reference PDF-2012-05-193) awarded to RB. The trial was sponsored by Central Manchester University Hospitals NHS Foundation Trust. Except for the sponsors providing the required monitoring and governance checks, the sponsors and funders of this work played no role in the design and conduct of the study; data collection; analysis; decision to publish; or preparation of the manuscript.

  • Competing interests RB has previously undertaken research involving donation of reagents without charge by Roche, Abbott, Alere, Siemens and Randox. He has accepted the provision of economy class travel and accommodation to present findings unrelated to this work at two Roche-sponsored conferences and at a scientific session sponsored by Randox.

  • Ethics approval Greater Manchester Central Research Ethics Committee, reference 13/NW/0081.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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