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Placebo Surgery Controlled Trials : Do They Achieve What They Set Out To Do? A Systematic Review

Bunzli, Samantha ; Choong, Emma ; Shadbolt, Cade ; Wall, Laura ; Nelson, Elizabeth ; Schilling, Chris ; Wilding, Helen ; Lohmander, L. Stefan LU orcid ; Balogh, Zsolt J. and Paolucci, Francesco , et al. (2021) In Annals of Surgery 273(6). p.1102-1107
Abstract

OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol... (More)

OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of Surgery
volume
273
issue
6
pages
6 pages
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:33351467
  • scopus:85106541717
ISSN
1528-1140
DOI
10.1097/SLA.0000000000004719
language
English
LU publication?
yes
id
fae53689-8941-4a22-b889-5c2f23b98dd4
date added to LUP
2021-06-11 10:03:56
date last changed
2024-04-20 07:20:04
@article{fae53689-8941-4a22-b889-5c2f23b98dd4,
  abstract     = {{<p>OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).</p>}},
  author       = {{Bunzli, Samantha and Choong, Emma and Shadbolt, Cade and Wall, Laura and Nelson, Elizabeth and Schilling, Chris and Wilding, Helen and Lohmander, L. Stefan and Balogh, Zsolt J. and Paolucci, Francesco and Clarke, Philip and Choong, Peter F.M. and Dowsey, Michelle M.}},
  issn         = {{1528-1140}},
  language     = {{eng}},
  month        = {{06}},
  number       = {{6}},
  pages        = {{1102--1107}},
  publisher    = {{Lippincott Williams & Wilkins}},
  series       = {{Annals of Surgery}},
  title        = {{Placebo Surgery Controlled Trials : Do They Achieve What They Set Out To Do? A Systematic Review}},
  url          = {{http://dx.doi.org/10.1097/SLA.0000000000004719}},
  doi          = {{10.1097/SLA.0000000000004719}},
  volume       = {{273}},
  year         = {{2021}},
}