How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review
Introduction Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e071094.full |
| _version_ | 1797429723012268032 |
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| author | Jane M Blazeby David J Beard Natalie S Blencowe Sian Cousins Katy Chalmers Marion K Campbell Alexander Gormley |
| author_facet | Jane M Blazeby David J Beard Natalie S Blencowe Sian Cousins Katy Chalmers Marion K Campbell Alexander Gormley |
| author_sort | Jane M Blazeby |
| collection | DOAJ |
| description | Introduction Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.Method A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.Results From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9–49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.Conclusion Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.PROSPERO registration number CRD42021287371. |
| first_indexed | 2024-03-09T09:17:16Z |
| format | Article |
| id | doaj.art-e0ff07b5da1a4a34a39fad9bebfd3c13 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:17:16Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-e0ff07b5da1a4a34a39fad9bebfd3c132023-12-02T07:05:08ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2022-071094How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic reviewJane M Blazeby0David J Beard1Natalie S Blencowe2Sian Cousins3Katy Chalmers4Marion K Campbell5Alexander Gormley6Surgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences; RCSEng Surgical Intervention Trials Unit; NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UKSurgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKSurgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKSurgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UKRoyal College of Surgeons of England, Aberdeen Surgical Trials Centre; Health Services Research Unit, University of Aberdeen, Aberdeen, UKBristol Dental School, University of Bristol, Bristol, UKIntroduction Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.Method A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.Results From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9–49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.Conclusion Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.PROSPERO registration number CRD42021287371.https://bmjopen.bmj.com/content/13/11/e071094.full |
| spellingShingle | Jane M Blazeby David J Beard Natalie S Blencowe Sian Cousins Katy Chalmers Marion K Campbell Alexander Gormley How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review BMJ Open |
| title | How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review |
| title_full | How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review |
| title_fullStr | How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review |
| title_full_unstemmed | How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review |
| title_short | How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review |
| title_sort | how do pilot and feasibility studies inform randomised placebo controlled trials in surgery a systematic review |
| url | https://bmjopen.bmj.com/content/13/11/e071094.full |
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