Sham surgery: justified but practical? A systematic review of sham surgery trials in orthopaedics

Bunzli, Samantha; Dowsey, Michelle M.; Choong, Peter

doi:10.17159/2309-8309/2018/v17n3a1

Cited by 7 publications

(10 citation statements)

References 40 publications

(69 reference statements)

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“…Testing whether a surgical procedure is superior to a placebo, or sham surgery procedure, is necessary for ensuring efficacy, since results may be compromised by a placebo response [ 8 , 9 ]. The placebo effect associated with surgical procedures has been found to be larger than seen in non-invasive interventions, particularly for subjective outcomes such as pain and function [ 10 ], which is the primary purpose of undergoing the surgery.…”

Section: Introductionmentioning

confidence: 99%

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Hinwood

Wall

Lang

et al. 2022

Trials

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Background Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial. Methods A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials. Results Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate. Conclusion Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery.

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Section: Introductionmentioning

confidence: 99%

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Hinwood

Wall

Lang

et al. 2022

Trials

View full text Add to dashboard Cite

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“…The use of sham and placebo surgeries in surgical trials is controversial. Some commentators have argued that surgical placebos are essential, and that surgical interventions should be held to the same rigorous assessment as other medical procedures,6 7 particularly given the expense and risks involved with untested surgical procedures 8 9. However, others have argued it is misguided to consider sham surgery as analogous to sugar pills due to the increased risks and harm to participants without any benefit10–12 and as such consider sham surgery to be unjustified and unethical.…”

Section: Introductionmentioning

confidence: 99%

“…There is evidence to suggest that the number of RCTs in surgery is increasing; however, their use in comparison with other study types remains low 17 18. Furthermore, RCTs for surgery involving a sham procedure are ethically debated and they are also difficult to conduct with most trials not reaching their desired sample size for sufficient power 8…”

Section: Introductionmentioning

confidence: 99%

“…A recent systematic review conducted by the authors on sham surgery trials in orthopaedics found that nine out of ten trials had some risk of bias, and in two trials the benefits of the sham procedure were not considered to outweigh the risks involved 8. Furthermore, it was found that participant recruitment within reasonable timeframes and low threshold for crossover were consistent challenges.…”

Section: Introductionmentioning

confidence: 99%

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Attitudes of patients and surgeons towards sham surgery trials: a protocol for a scoping review of attributes to inform a discrete choice experiment

et al. 2020

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IntroductionIn order to properly evaluate the efficacy of orthopaedic procedures, rigorous, randomised controlled sham surgery trial designs are necessary. However, randomised controlled trials (RCTs) for surgery involving a placebo are ethically debated and difficult to conduct with many failing to reach their desired sample size and power. A review of the literature on barriers and enablers to recruitment, and patient and surgeon attitudes and preferences towards sham surgery trials, will help to determine the characteristics necessary for successful recruitment.Methods and analysisThis review will scope the diverse literature surrounding sham surgery trials with the aim of informing a discrete choice experiment to empirically test patient and surgeon preferences for different sham surgery trial designs. The scoping review will be conducted in accordance with the methodological framework described in Arksey and O’Malley (2005) and reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols extension for Scoping Reviews. The review will be informed by a systematic search of Medline, Embase, PsycInfo, CINAHL and EconLit databases (from database inception to 21 June 2019), a Google Scholar search, and hand searching of reference lists of relevant studies or reviews. Studies or opinion pieces that involve patient, surgeon or trial characteristics, which influence the decision to participate in a trial, will be included. Study selection will be carried out independently by two authors with discrepancies resolved by consensus among three authors. Data will be charted using a standardised form, and results tabulated and narratively summarised with reference to the research questions of the review.Ethics and disseminationThe findings from this review will inform the design of a discrete choice experiment around willingness to participate in surgical trials, the outcomes of which can inform decision and cost-effectiveness models of sham surgery RCTs. The qualitative information from this review will also inform patient-centred outcomes research. The review will be published in a peer-reviewed journal.Trial registration numberCRD42019133296.

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“…However, using RCTs using arthroscopic placebo surgeries is not typical because there are no clear ethical guidelines. We introduce two articles (Bunzli et al and Savulescu et al ) proposing prerequisites for surgical RCTs using placebo surgeries 22 23…”

Section: Introduction: Evidence-based Medicinementioning

confidence: 99%

Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial

2019

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The application of evidence-based medicine helps clinicians avoid unnecessary procedures and decreases unnecessary harm for future patients while sparing economic burdens. Randomised controlled trials (RCTs) most accurately produce best research evidence. In arthroscopic surgery, however, many procedures have been extensively used without supportive evidence verified with RCTs. In this paper, we introduce two procedures (arthroscopic partial menisectomy for degenerative knees and arthroscopic subacromial decompression for subacromial pain syndrome), where over 30 years of procedure usage has continued prior to garnering evidence for the inefficacy of the procedures. The situations are attributed to the fact that clinical trials in arthroscopic surgeries are challenging given the use of placebo controls. A placebo-control RCT can accurately answer research questions about efficacy and safety of surgical procedures; however, the majority of arthroscopic surgeries in practice have not been rigorously tested against placebo surgeries. This is because preparing surgical placebo controls, known as sham surgeries, are ethically controversial. Also considering that high-quality study results often do not change clinical practice due to insufficient knowledge translation, the benefits of such trials may be uncertain to society at large. Additionally, there are a lack of clear guidelines for conducting arthroscopic placebo surgeries in RCTs. We hope that this article helps drive discussion about appropriate use of placebo surgeries in RCTs to produce the best quality evidence in arthroscopic surgery.

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Sham surgery: justified but practical? A systematic review of sham surgery trials in orthopaedics

Cited by 7 publications

References 40 publications

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment

Attitudes of patients and surgeons towards sham surgery trials: a protocol for a scoping review of attributes to inform a discrete choice experiment

Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial

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