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. 2017 Sep;34(9):593-598.
doi: 10.1136/emermed-2016-206073. Epub 2017 May 12.

An exploration of patients' experiences of participation in a randomised controlled trial of the Manchester Acute Coronary Syndromes (MACS) decision rule

Patricia van den Berg  1 , Sarah Kendal  2 , Helen V Alderson  3 , Richard Body  4   5
Affiliations
Free article

An exploration of patients' experiences of participation in a randomised controlled trial of the Manchester Acute Coronary Syndromes (MACS) decision rule

Patricia van den Berg et al. Emerg Med J. 2017 Sep.
Free article

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.

Keywords: acute coronary syndrome; clinical; emergency department utilisation; qualitative research; research; risk management.

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Conflict of interest statement

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.

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