The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study
To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinic...
Main Authors: | , , , , , , , , , , , , |
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Format: | Journal article |
Language: | English |
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Oxford University Press
2016
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author | Griffin, DR Dickenson, EJ Wall, PDH Realpe, A Adams, A Parsons, N Hobson, R Achten, J Costa, ML Foster, NE Hutchinson, CE Petrou, S Donovan, JL |
author_facet | Griffin, DR Dickenson, EJ Wall, PDH Realpe, A Adams, A Parsons, N Hobson, R Achten, J Costa, ML Foster, NE Hutchinson, CE Petrou, S Donovan, JL |
author_sort | Griffin, DR |
collection | OXFORD |
description | To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT. |
first_indexed | 2024-03-06T18:58:18Z |
format | Journal article |
id | oxford-uuid:12a306f5-7d78-47e9-910f-d3201ea05c6e |
institution | University of Oxford |
language | English |
last_indexed | 2024-03-06T18:58:18Z |
publishDate | 2016 |
publisher | Oxford University Press |
record_format | dspace |
spelling | oxford-uuid:12a306f5-7d78-47e9-910f-d3201ea05c6e2022-03-26T10:09:01ZThe feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility studyJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:12a306f5-7d78-47e9-910f-d3201ea05c6eEnglishSymplectic Elements at OxfordOxford University Press2016Griffin, DRDickenson, EJWall, PDHRealpe, AAdams, AParsons, NHobson, RAchten, JCosta, MLFoster, NEHutchinson, CEPetrou, SDonovan, JLTo determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT. |
spellingShingle | Griffin, DR Dickenson, EJ Wall, PDH Realpe, A Adams, A Parsons, N Hobson, R Achten, J Costa, ML Foster, NE Hutchinson, CE Petrou, S Donovan, JL The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title | The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title_full | The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title_fullStr | The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title_full_unstemmed | The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title_short | The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study |
title_sort | feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome the fashion feasibility study |
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