Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34701
Title: Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.
Austin Authors: Ho, Emma Kwan-Yee;Mobbs, Ralph Jasper;van Gelder, James Montague;Harris, Ian Andrew;Davis, Gavin A ;Stanford, Ralph;Beard, David John;Maher, Christopher Gerard;Prior, Joanna;Knox, Michael;Anderson, David Barrett;Buchbinder, Rachelle;Ferreira, Manuela Loureiro
Affiliation: The University of Sydney, Sydney Musculoskeletal Health, Charles Perkins Centre, Faculty of Medicine and Health, School of Health Sciences, Sydney, NSW, 2050, Australia.;The University of Sydney, Sydney Musculoskeletal Health and the Kolling Institute, Faculty of Medicine and Health, School of Health Sciences, Northern Sydney Local Health District, St Leonards, NSW, 2065, Australia.
NeuroSpine Surgery Reserach Group (NSURG), Sydney, NSW, 2031, Australia.;Prince of Wales Hospital, Barker Street, Randwick, NSW, 2031, Australia.;School of Medicine, University of New South Wales, Sydney, Australia.
Department of Neurosurgery, Concord Repatriation General Hospital, Concord, NSW, 2139, Australia.;Sydney Spine Institute, Burwood, NSW, 2134, Australia.
South West Sydney Clinical Campuses, School of Clinical Medicine, UNSW Medicine & Health, University of New South Wales, Sydney, NSW, 2170, Australia.
Austin Health
Prince of Wales Hospital, Barker Street, Randwick, NSW, 2031, Australia.
The University of Sydney, Sydney Musculoskeletal Health, Charles Perkins Centre, Faculty of Medicine and Health, School of Health Sciences, Sydney, NSW, 2050, Australia.;NHMRC CTC, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
The University of Sydney, Sydney Musculoskeletal Health, Sydney, NSW, 2050, Australia.
The University of Sydney, School of Health Sciences, Faculty of Medicine and Health, Sydney, NSW, 2050, Australia.
The University of Sydney, Sydney Musculoskeletal Health and the Kolling Institute, Faculty of Medicine and Health, School of Health Sciences, Northern Sydney Local Health District, St Leonards, NSW, 2065, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3800, Australia.
Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
The University of Sydney, Sydney Musculoskeletal Health and the Kolling Institute, Faculty of Medicine and Health, School of Health Sciences, Northern Sydney Local Health District, St Leonards, NSW, 2065, Australia.
Issue Date: 6-Dec-2023
Date: 2023
Publication information: Trials 2023-12-06; 24(1)
Abstract: Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.
URI: https://ahro.austin.org.au/austinjspui/handle/1/34701
DOI: 10.1186/s13063-023-07772-5
ORCID: 0000-0002-2479-0081
Journal: Trials
Start page: 794
PubMed URL: 38057932
ISSN: 1745-6215
Type: Journal Article
Subjects: Lumbar Vertebrae/surgery
Appears in Collections:Journal articles

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