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Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review

OBJECTIVES: To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding. DESIGN: Systematic...

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Autores principales: Wartolowska, Karolina, Collins, Gary S, Hopewell, Sally, Judge, Andrew, Dean, Benjamin J F, Rombach, Ines, Beard, David J, Carr, Andrew J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800115/
https://www.ncbi.nlm.nih.gov/pubmed/27008687
http://dx.doi.org/10.1136/bmjopen-2015-010194
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author Wartolowska, Karolina
Collins, Gary S
Hopewell, Sally
Judge, Andrew
Dean, Benjamin J F
Rombach, Ines
Beard, David J
Carr, Andrew J
author_facet Wartolowska, Karolina
Collins, Gary S
Hopewell, Sally
Judge, Andrew
Dean, Benjamin J F
Rombach, Ines
Beard, David J
Carr, Andrew J
author_sort Wartolowska, Karolina
collection PubMed
description OBJECTIVES: To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding. DESIGN: Systematic review. DATA SOURCES AND STUDY SELECTION: The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014. RESULTS: 63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50–100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups. CONCLUSIONS: This review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials.
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spelling pubmed-48001152016-03-29 Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review Wartolowska, Karolina Collins, Gary S Hopewell, Sally Judge, Andrew Dean, Benjamin J F Rombach, Ines Beard, David J Carr, Andrew J BMJ Open Surgery OBJECTIVES: To find evidence, either corroborating or refuting, for many persisting beliefs regarding the feasibility of carrying out surgical randomised controlled trials with a placebo arm, with emphasis on the challenges related to recruitment, funding, anaesthesia or blinding. DESIGN: Systematic review. DATA SOURCES AND STUDY SELECTION: The analysis involved studies published between 1959 and 2014 that were identified during an earlier systematic review of benefits and harms of placebo-controlled surgical trials published in 2014. RESULTS: 63 trials were included in the review. The main problem reported in many trials was a very slow recruitment rate, mainly due to the difficulty in finding eligible patients. Existing placebo trials were funded equally often from commercial and non-commercial sources. General anaesthesia or sedation was used in 41% of studies. Among the reviewed trials, 81% were double-blinded, and 19% were single-blinded. Across the reviewed trials, 96% (range 50–100%) of randomised patients completed the study. The withdrawal rate during the study was similar in the surgical and in the placebo groups. CONCLUSIONS: This review demonstrated that placebo-controlled surgical trials are feasible, at least for procedures with a lower level of invasiveness, but also that recruitment is difficult. Many of the presumed challenges to undertaking such trials, for example, funding, anaesthesia or blinding of patients and assessors, were not reported as obstacles to completion in any of the reviewed trials. BMJ Publishing Group 2016-03-15 /pmc/articles/PMC4800115/ /pubmed/27008687 http://dx.doi.org/10.1136/bmjopen-2015-010194 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
spellingShingle Surgery
Wartolowska, Karolina
Collins, Gary S
Hopewell, Sally
Judge, Andrew
Dean, Benjamin J F
Rombach, Ines
Beard, David J
Carr, Andrew J
Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title_full Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title_fullStr Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title_full_unstemmed Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title_short Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
title_sort feasibility of surgical randomised controlled trials with a placebo arm: a systematic review
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800115/
https://www.ncbi.nlm.nih.gov/pubmed/27008687
http://dx.doi.org/10.1136/bmjopen-2015-010194
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