A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials
A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials
Rationale: randomised controlled trials (RCTs) of surgical interventions are increasing. Such trials encounter challenges that are not present in RCTs of non-surgical interventions because of the nature of the intervention. Several studies have explored patients' experiences of surgical trials to improve recruitment or identify barriers and facilitators to research in this setting. Synthesizing these studies may reveal further insights or confirm whether saturation of relevant themes has been achieved.
Objective: this review aimed to understand the experiences of adults who are invited to participate in surgical RCTs.
Method: MEDLINE, Web of Science, and CINAHL were searched to identify articles meeting the inclusion criteria. Assessment of quality was conducted with studies given an overall quality rating of good, fair, or poor. A segregated approach was used to synthesize the data. This method included a thematic synthesis of the qualitative data and a narrative review of the quantitative data. The findings of both syntheses were then integrated.
Results: thirty-four articles reporting 28 trials were included. This review found that the decision to participate in a surgical trial is influenced by multiple factors including patients' individual circumstances and attitudes, and the characteristics of the trial itself. The study identified three themes which encompass both qualitative and quantitative findings. These themes reveal it was important for patients to i) make sense of the trial and trial processes, ii) weigh up the risks and benefits of their different treatment options and participation, and iii) trust the trial and staff.
Conclusions: a patient-centred approach to trial recruitment may help staff build trusting relationships with patients and address their individual concerns about the trial and the risks and benefits of participation.
Mixed-methods systematic review, Patient experience, Qualitative, Randomised controlled trial, Recruitment, Surgery, Thematic synthesis
Phelps, E.
aeb9306e-cb34-44e3-bb08-87e9b6acffec
Tutton, Elizabeth
0348edbd-fc1a-4955-b7e9-0740124c32b1
Griffin, Xavier L.
95c2a79c-af80-47c8-9475-338eb506aa7a
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
May 2020
Phelps, E.
aeb9306e-cb34-44e3-bb08-87e9b6acffec
Tutton, Elizabeth
0348edbd-fc1a-4955-b7e9-0740124c32b1
Griffin, Xavier L.
95c2a79c-af80-47c8-9475-338eb506aa7a
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
Phelps, E., Tutton, Elizabeth, Griffin, Xavier L. and Baird, Janis
(2020)
A mixed-methods systematic review of patients' experience of being invited to participate in surgical randomised controlled trials.
Social Science & Medicine, 253, [112961].
(doi:10.1016/j.socscimed.2020.112961).
Abstract
Rationale: randomised controlled trials (RCTs) of surgical interventions are increasing. Such trials encounter challenges that are not present in RCTs of non-surgical interventions because of the nature of the intervention. Several studies have explored patients' experiences of surgical trials to improve recruitment or identify barriers and facilitators to research in this setting. Synthesizing these studies may reveal further insights or confirm whether saturation of relevant themes has been achieved.
Objective: this review aimed to understand the experiences of adults who are invited to participate in surgical RCTs.
Method: MEDLINE, Web of Science, and CINAHL were searched to identify articles meeting the inclusion criteria. Assessment of quality was conducted with studies given an overall quality rating of good, fair, or poor. A segregated approach was used to synthesize the data. This method included a thematic synthesis of the qualitative data and a narrative review of the quantitative data. The findings of both syntheses were then integrated.
Results: thirty-four articles reporting 28 trials were included. This review found that the decision to participate in a surgical trial is influenced by multiple factors including patients' individual circumstances and attitudes, and the characteristics of the trial itself. The study identified three themes which encompass both qualitative and quantitative findings. These themes reveal it was important for patients to i) make sense of the trial and trial processes, ii) weigh up the risks and benefits of their different treatment options and participation, and iii) trust the trial and staff.
Conclusions: a patient-centred approach to trial recruitment may help staff build trusting relationships with patients and address their individual concerns about the trial and the risks and benefits of participation.
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A mixed-methods systematic review of patients' experience
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More information
Accepted/In Press date: 22 March 2020
e-pub ahead of print date: 27 March 2020
Published date: May 2020
Additional Information:
Funding Information:
The lead author is funded by a NIHR HTA grant - National Institue for Health Research, Health Technology Assessment - United Kingdom and the Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford , United Kingdom
Publisher Copyright:
© 2020
Keywords:
Mixed-methods systematic review, Patient experience, Qualitative, Randomised controlled trial, Recruitment, Surgery, Thematic synthesis
Identifiers
Local EPrints ID: 441654
URI: http://eprints.soton.ac.uk/id/eprint/441654
ISSN: 0277-9536
PURE UUID: 650f1e5d-dc93-448b-bfe7-0d964a4389b5
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Date deposited: 23 Jun 2020 16:30
Last modified: 17 Mar 2024 02:56
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Contributors
Author:
E. Phelps
Author:
Elizabeth Tutton
Author:
Xavier L. Griffin
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