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Open Access 01-12-2014 | Protocol

Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study

Authors: Pascal Probst, Kathrin Grummich, Alexis Ulrich, Markus W Büchler, Phillip Knebel, Markus K Diener

Published in: Systematic Reviews | Issue 1/2014

Abstract

Background

Industry sponsorship has been identified as a factor correlating with positive research findings in several fields of medical science. To date, the influence of industry sponsorship in general and abdominal surgery has not been fully studied. This protocol describes the rationale and planned conduct of a systematic review to determine the association between industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery.

Methods/design

A literature search in the Cochrane Library, MEDLINE and EMBASE and additional hand searches in relevant citations will be conducted. In order to cover all relevant areas of general and abdominal surgery, a new literature search strategy called multi-PICO search strategy (MPSS) has been developed. No language restriction will be applied. The search will be limited to publications between January 1985 and July 2014. Information on funding source, outcome, study characteristics and methodological quality will be extracted.

The association between industry sponsorship and positive outcome will be tested by a chi-squared test. A multivariate logistic regression analysis will be performed to control for possible confounders, such as number of study centres, multinational trials, methodological quality, journal impact factor and sample size.

Discussion

This study was designed to clarify whether industry-sponsored trials report more positive outcomes than non-industry trials. It will be the first study to evaluate this topic in general and abdominal surgery. The findings of this study will enable surgical societies, in particular, to give advice about cooperation with the industry and disclosure of funding source based on empirical evidence.

Systematic review registration

PROSPERO CRD42014010802

Available only for authorised users

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Title: Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study
Authors: Pascal Probst
Kathrin Grummich
Alexis Ulrich
Markus W Büchler
Phillip Knebel
Markus K Diener
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Systematic Reviews / Issue 1/2014
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/2046-4053-3-138

At a glance: The STEP trials

Springer Medicine

Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study

Abstract

Background

Methods/design

Discussion

Systematic review registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Systematic review registration

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