Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review

Sian Cousins; Natalie S. Blencowe; Carmen Tsang; Ava Lorenc; Katy Chalmers; Andrew J. Carr; Marion K. Campbell; Jonathan A. Cook; David J. Beard; Jane M. Blazeby

doi:10.1016/j.jclinepi.2019.11.016

Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review

Sian Cousins^*, Natalie S. Blencowe, Carmen Tsang, Ava Lorenc, Katy Chalmers, Andrew J. Carr, Marion K. Campbell, Jonathan A. Cook, David J. Beard, Jane M. Blazeby

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

12 Citations (Scopus)

Abstract

Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.

Original language	English
Pages (from-to)	109-116
Number of pages	8
Journal	Journal of Clinical Epidemiology
Volume	119
DOIs	https://doi.org/10.1016/j.jclinepi.2019.11.016
Publication status	Published - Mar 2020

Funding

Funding: This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1) (www.bristol.ac.uk/population-health-sciences/centres/conduct2), an NIHR senior investigator award (NF-SI-0514-10114) and the Bristol Royal College of Surgeons Trials Centre. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. Funders played no role in any aspect of study design, analysis or publication decisions.

Keywords

Invasive procedures
Methodology
Placebo surgery
Surgery
Systematic review

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@article{cd18ec9a712f43568adb447592341125,

title = "Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review",

abstract = "Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.",

keywords = "Invasive procedures, Methodology, Placebo surgery, Surgery, Systematic review",

author = "Sian Cousins and Blencowe, {Natalie S.} and Carmen Tsang and Ava Lorenc and Katy Chalmers and Carr, {Andrew J.} and Campbell, {Marion K.} and Cook, {Jonathan A.} and Beard, {David J.} and Blazeby, {Jane M.}",

year = "2020",

month = mar,

doi = "10.1016/j.jclinepi.2019.11.016",

language = "English",

volume = "119",

pages = "109--116",

journal = "Journal of Clinical Epidemiology",

issn = "0895-4356",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement

T2 - a systematic review

AU - Cousins, Sian

AU - Blencowe, Natalie S.

AU - Tsang, Carmen

AU - Lorenc, Ava

AU - Chalmers, Katy

AU - Carr, Andrew J.

AU - Campbell, Marion K.

AU - Cook, Jonathan A.

AU - Beard, David J.

AU - Blazeby, Jane M.

PY - 2020/3

Y1 - 2020/3

N2 - Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.

AB - Objectives: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. Study Design and Setting: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. Results: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. Conclusion: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.

KW - Invasive procedures

KW - Methodology

KW - Placebo surgery

KW - Surgery

KW - Systematic review

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DO - 10.1016/j.jclinepi.2019.11.016

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AN - SCOPUS:85077472590

SN - 0895-4356

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EP - 116

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review

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