Evidence map›Paper›PMID 27012940›Full record

ArticleSystematic reviews2016

Blinding in randomized controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

Pascal Probst, Kathrin Grummich, Patrick Heger, Steffen Zaschke, Phillip Knebel, Alexis Ulrich, Markus W Büchler, Markus K Diener

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Systematic reviews, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03823456 (Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients), which is not on this map. Cited by 48 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03823456 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Self-acupressure for Cancer-related Symptom Cluster of Insomnia, Depression, and Anxiety in Cancer Patients: a Feasibility Randomized Controlled Trial

TypeinterventionalSponsorThe Hong Kong Polytechnic UniversityRan2018 to 2019Enrolled114ConditionsInsomnia, Anxiety, DepressionArmsSelf-acupressure, Sham Self-acupressure
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  11. A Systematic Review and Meta-analysis of Physical Exercise Prehabilitation in Major Abdominal Surgery (PROSPERO 2017 CRD42017080366).Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
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  19. Minimally Invasive Versus Open Pancreatoduodenectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Pascal ProbstDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.ORCID http://orcid.org/0000-0002-0895-4015
Kathrin GrummichThe Study Center of the German Surgical Society (SDGC), University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Patrick HegerDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Steffen ZaschkeDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Phillip KnebelDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Alexis UlrichDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Markus W BüchlerDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Markus K DienerDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. markus.diener@med.uni-heidelberg.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlinding 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/

designA 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.

Indexed as

Double-Blind MethodSingle-Blind MethodAbdomenBiasHumansRandomized Controlled Trials as TopicSystematic Reviews as TopicBiasBlindingDetection biasGeneral and abdominal surgeryPerformance biasRandomized controlled trialRisk of biasSystematic review

Identifiers

PMID27012940
PMCPMC4806514

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.