eprintid: 20502
rev_number: 10
eprint_status: archive
userid: 1589
dir: disk0/00/02/05/02
datestamp: 2016-04-14 10:59:11
lastmod: 2016-06-20 12:45:22
status_changed: 2016-04-14 10:59:11
type: article
metadata_visibility: show
creators_name: Probst, Pascal
creators_name: Grummich, Kathrin
creators_name: Heger, Patrick
creators_name: Zaschke, Steffen
creators_name: Knebel, Phillip
creators_name: Ulrich, Alexis
creators_name: Büchler, Markus W.
creators_name: Diener, Markus K.
title: Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study
subjects: 610
divisions: 910200
abstract: Background: Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT.   Methods/design: A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration’s tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %.   Discussion: Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT.   Systematic review registration: PROSPERO 2015: CRD42015026837  .
date: 2016
publisher: BioMed Central
id_scheme: DOI
id_number: http://dx.doi.org/10.1186/s13643-016-0226-4
ppn_swb: 1657244202
own_urn: urn:nbn:de:bsz:16-heidok-205027
language: eng
bibsort: PROBSTPASCBLINDINGIN2016
full_text_status: public
publication: Systematic Reviews
volume: 5
number: 48
place_of_pub: London
pagerange: 1-6
issn: 2046-4053
citation:   Probst, Pascal ; Grummich, Kathrin ; Heger, Patrick ; Zaschke, Steffen ; Knebel, Phillip ; Ulrich, Alexis ; Büchler, Markus W. ; Diener, Markus K.  (2016) Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.  Systematic Reviews, 5 (48).  pp. 1-6.  ISSN 2046-4053     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/20502/1/13643_2016_Article_226.pdf