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

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Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement : a systematic review. / Cousins, Sian; Blencowe, Natalie S; Tsang, Carmen; Lorenc, Ava; Chalmers, Katy; Carr, Andrew J; Campbell, Marion K; Cook, Jonathan A; Beard, David J; Blazeby, Jane M.

In: Journal of Clinical Epidemiology, Vol. 119, 01.03.2020, p. 109-116.

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Cousins, Sian ; Blencowe, Natalie S ; Tsang, Carmen ; Lorenc, Ava ; Chalmers, Katy ; Carr, Andrew J ; Campbell, Marion K ; Cook, Jonathan A ; Beard, David J ; Blazeby, Jane M. / Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement : a systematic review. In: Journal of Clinical Epidemiology. 2020 ; Vol. 119. pp. 109-116.

Bibtex

@article{0a6be86761064a24b30535ab8b2c1d61,
title = "Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review",
abstract = "ObjectivesTo examine key methodological considerations for using a placebo intervention in randomised controlled trials (RCTs) evaluating invasive procedures, including surgery.Study design and settingRCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to 31st December 2017 were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, hand searching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centres) and - i) rationale for using placebos; ii) minimisation of risk; iii) information provision; iv) offering the treatment intervention to patients randomised to placebo; v) delivery of co-interventions; vi) intervention standardisation and fidelity were extracted and summarised descriptively.ResultsIdentified were 113 articles reporting 96 RCTs. Most were conducted in gastrointestinal surgery (n=40, 42{\%}) and evaluated minimally invasive procedures (n=44, 46{\%}). Over two thirds randomised fewer than 100 patients (n=65, 68{\%}) and a third were single centre (n=31, 32{\%}). A third (n=33, 34{\%}) did not report a rationale for using a placebo. Most common strategies to minimise 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 randomised to placebo in 43 trials (45{\%}). Co-interventions were inconsistently reported, but 64 trials (67{\%}) stated that anaesthesia was matched between groups. Attempts to standardise interventions and monitor their delivery were reported in n=7, (7{\%}) and n=4, (4{\%}) trials, respectively. ConclusionMost 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 optimise the transparency of trial reporting in this area.",
keywords = "Surgery, placebo surgery, invasive procedures, systematic review, methodology",
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 = "2019",
month = "11",
day = "28",
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.",

}

RIS - suitable for import to EndNote

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 - 2019/11/28

Y1 - 2019/11/28

N2 - ObjectivesTo examine key methodological considerations for using a placebo intervention in randomised controlled trials (RCTs) evaluating invasive procedures, including surgery.Study design and settingRCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to 31st December 2017 were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, hand searching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centres) and - i) rationale for using placebos; ii) minimisation of risk; iii) information provision; iv) offering the treatment intervention to patients randomised to placebo; v) delivery of co-interventions; vi) intervention standardisation and fidelity were extracted and summarised descriptively.ResultsIdentified were 113 articles reporting 96 RCTs. Most were conducted in gastrointestinal surgery (n=40, 42%) and evaluated minimally invasive procedures (n=44, 46%). Over two thirds randomised fewer than 100 patients (n=65, 68%) and a third were single centre (n=31, 32%). A third (n=33, 34%) did not report a rationale for using a placebo. Most common strategies to minimise 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 randomised to placebo in 43 trials (45%). Co-interventions were inconsistently reported, but 64 trials (67%) stated that anaesthesia was matched between groups. Attempts to standardise interventions and monitor their delivery were reported in n=7, (7%) and n=4, (4%) trials, respectively. ConclusionMost 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 optimise the transparency of trial reporting in this area.

AB - ObjectivesTo examine key methodological considerations for using a placebo intervention in randomised controlled trials (RCTs) evaluating invasive procedures, including surgery.Study design and settingRCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to 31st December 2017 were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, hand searching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centres) and - i) rationale for using placebos; ii) minimisation of risk; iii) information provision; iv) offering the treatment intervention to patients randomised to placebo; v) delivery of co-interventions; vi) intervention standardisation and fidelity were extracted and summarised descriptively.ResultsIdentified were 113 articles reporting 96 RCTs. Most were conducted in gastrointestinal surgery (n=40, 42%) and evaluated minimally invasive procedures (n=44, 46%). Over two thirds randomised fewer than 100 patients (n=65, 68%) and a third were single centre (n=31, 32%). A third (n=33, 34%) did not report a rationale for using a placebo. Most common strategies to minimise 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 randomised to placebo in 43 trials (45%). Co-interventions were inconsistently reported, but 64 trials (67%) stated that anaesthesia was matched between groups. Attempts to standardise interventions and monitor their delivery were reported in n=7, (7%) and n=4, (4%) trials, respectively. ConclusionMost 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 optimise the transparency of trial reporting in this area.

KW - Surgery

KW - placebo surgery

KW - invasive procedures

KW - systematic review

KW - methodology

UR - http://www.scopus.com/inward/record.url?scp=85077472590&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2019.11.016

DO - 10.1016/j.jclinepi.2019.11.016

M3 - Article

C2 - 31786153

AN - SCOPUS:85077472590

VL - 119

SP - 109

EP - 116

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -