Skip to main content
Top
Published in:

Open Access 01-12-2023 | Commentary

Further considerations for placebo controls in surgical trials

Authors: Marion K. Campbell, David J. Beard, Jane M. Blazeby, Sian Cousins, the ASPIRE group

Published in: Trials | Issue 1/2023

Login to get access

Abstract

The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive placebo control. Based on a more recent international expert workshop in June 2022, we now provide further insights into this topic. These include the purpose and design of invasive placebo controls, patient information provision and how findings from these trials may be used to inform decision-making.
Literature
1.
go back to reference Beard DJ, Campbell MK, Blazeby JM, Carr AJ, Weijer C, Cuthbertson BH, et al. Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet. 2020;395(10226):828–38.CrossRefPubMed Beard DJ, Campbell MK, Blazeby JM, Carr AJ, Weijer C, Cuthbertson BH, et al. Considerations and methods for placebo controls in surgical trials (ASPIRE guidelines). Lancet. 2020;395(10226):828–38.CrossRefPubMed
2.
go back to reference Beard DJ, Campbell MK, Blazeby JM, Carr AJ, Weijer C, Cuthbertson BH, et al. Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop. Health Technol Assess. 2021;25(53):1–52.CrossRefPubMedPubMedCentral Beard DJ, Campbell MK, Blazeby JM, Carr AJ, Weijer C, Cuthbertson BH, et al. Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop. Health Technol Assess. 2021;25(53):1–52.CrossRefPubMedPubMedCentral
3.
go back to reference Cousins S, Blencowe NS, Tsang C, Lorenc A, Chalmers K, Carr AJ, et al. Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review. J Clin Epidemiol. 2020;119:109–16.CrossRefPubMedPubMedCentral Cousins S, Blencowe NS, Tsang C, Lorenc A, Chalmers K, Carr AJ, et al. Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review. J Clin Epidemiol. 2020;119:109–16.CrossRefPubMedPubMedCentral
4.
go back to reference Cousins S, Blencowe NS, Tsang C, Chalmers K, Mardanpour A, Carr AJ, et al. Optimizing the design of invasive placebo interventions in randomized controlled trials. Br J Surg. 2020;107(9):1114–22.CrossRefPubMedPubMedCentral Cousins S, Blencowe NS, Tsang C, Chalmers K, Mardanpour A, Carr AJ, et al. Optimizing the design of invasive placebo interventions in randomized controlled trials. Br J Surg. 2020;107(9):1114–22.CrossRefPubMedPubMedCentral
5.
go back to reference Kroslak M, Murrell GAC. Surgical treatment of lateral epicondylitis: a prospective, randomized, double-blinded, placebo-controlled clinical trial. Am J Sports Med. 2018;46(5):1106–13.CrossRefPubMed Kroslak M, Murrell GAC. Surgical treatment of lateral epicondylitis: a prospective, randomized, double-blinded, placebo-controlled clinical trial. Am J Sports Med. 2018;46(5):1106–13.CrossRefPubMed
6.
go back to reference Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31–40.CrossRefPubMed Al-Lamee R, Thompson D, Dehbi HM, Sen S, Tang K, Davies J, et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391(10115):31–40.CrossRefPubMed
7.
go back to reference Paavola M, Malmivaara A, Taimela S, Kanto K, Inkinen J, Kalske J, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018;362: k2860.CrossRefPubMedPubMedCentral Paavola M, Malmivaara A, Taimela S, Kanto K, Inkinen J, Kalske J, et al. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ. 2018;362: k2860.CrossRefPubMedPubMedCentral
8.
go back to reference Anderson DB, Ferreira ML, Harris IA, Davis GA, Stanford R, Beard D, et al. SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial. BMJ Open. 2019;9(2): e024944.CrossRefPubMedPubMedCentral Anderson DB, Ferreira ML, Harris IA, Davis GA, Stanford R, Beard D, et al. SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial. BMJ Open. 2019;9(2): e024944.CrossRefPubMedPubMedCentral
9.
go back to reference Anderson DB, Mobbs RJ, Eyles J, Meyer SE, Machado GC, Davis GA, et al. Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis. Heliyon. 2019;5(5): e01683.CrossRefPubMedPubMedCentral Anderson DB, Mobbs RJ, Eyles J, Meyer SE, Machado GC, Davis GA, et al. Barriers to participation in a placebo-surgical trial for lumbar spinal stenosis. Heliyon. 2019;5(5): e01683.CrossRefPubMedPubMedCentral
10.
go back to reference Anderson DB, Beard DJ, Sabet T, Eyles JP, Harris IA, Adie S, et al. Evaluation of placebo fidelity and trial design methodology in placebo-controlled surgical trials of musculoskeletal conditions: a systematic review. Pain. 2022;163(4):637–51.CrossRefPubMed Anderson DB, Beard DJ, Sabet T, Eyles JP, Harris IA, Adie S, et al. Evaluation of placebo fidelity and trial design methodology in placebo-controlled surgical trials of musculoskeletal conditions: a systematic review. Pain. 2022;163(4):637–51.CrossRefPubMed
11.
go back to reference Bishop FL, Coghlan B, Geraghty AW, Everitt H, Little P, Holmes MM, et al. What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy. BMJ Open. 2017;7(6): e015516.CrossRefPubMedPubMedCentral Bishop FL, Coghlan B, Geraghty AW, Everitt H, Little P, Holmes MM, et al. What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy. BMJ Open. 2017;7(6): e015516.CrossRefPubMedPubMedCentral
12.
go back to reference Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ. 2013;346: f2820.CrossRefPubMedPubMedCentral Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ. 2013;346: f2820.CrossRefPubMedPubMedCentral
13.
go back to reference Leigh JP, Sypes EE, Straus SE, Demiantschuk D, Ma H, Brundin-Mather R, et al. Determinants of the de-implementation of low-value care: a multi-method study. BMC Health Serv Res. 2022;22(1):450.CrossRefPubMedPubMedCentral Leigh JP, Sypes EE, Straus SE, Demiantschuk D, Ma H, Brundin-Mather R, et al. Determinants of the de-implementation of low-value care: a multi-method study. BMC Health Serv Res. 2022;22(1):450.CrossRefPubMedPubMedCentral
14.
go back to reference Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348: g3253.CrossRefPubMedPubMedCentral Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348: g3253.CrossRefPubMedPubMedCentral
15.
go back to reference Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, et al. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391(10118):329–38.CrossRefPubMedPubMedCentral Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, et al. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018;391(10118):329–38.CrossRefPubMedPubMedCentral
16.
go back to reference Blencowe NS, Mills N, Cook JA, Donovan JL, Rogers CA, Whiting P, et al. Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials. Br J Surg. 2016;103(10):1377–84.CrossRefPubMedPubMedCentral Blencowe NS, Mills N, Cook JA, Donovan JL, Rogers CA, Whiting P, et al. Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials. Br J Surg. 2016;103(10):1377–84.CrossRefPubMedPubMedCentral
17.
go back to reference Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.CrossRefPubMedPubMedCentral Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.CrossRefPubMedPubMedCentral
Metadata
Title
Further considerations for placebo controls in surgical trials
Authors
Marion K. Campbell
David J. Beard
Jane M. Blazeby
Sian Cousins
the ASPIRE group
Publication date
01-12-2023
Publisher
BioMed Central
Published in
Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07417-7

Other articles of this Issue 1/2023

Trials 1/2023 Go to the issue