Universität zu Köln

Mueller, Dirk, Sauerland, Stefan ORCID: 0000-0003-1048-796X, Neugebauer, Edmund A. M. and Immenroth, Marc (2010). Reported effects in randomized controlled trials were compared with those of nonrandomized trials in cholecystectomy. J. Clin. Epidemiol., 63 (10). S. 1082 - 1091. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1878-5921

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Abstract

Objectives: Because external validity of randomized controlled trials (RCTs) may be insufficient, the performance of nonrandomized controlled trials (nRCTs) is increasingly debated. RCTs and nRCTs were compared using the example of laparoscopic vs. open cholecystectomy (LC vs. OC). Study Design and Setting: RCTs and nRCTs comparing LC and OC were identified by searching PubMed. To assess internal and external validity of the studies, patient characteristics, relative risks, and mean differences of RCTs and nRCTs were compared by meta-analytic techniques. Results: In total, 162 studies were analyzed (136 nRCTs and 26 RCTs). Significant discrepancies between RCT- and nRCT-based results were revealed for 3 of 15 variables: overall complications (P < 0.021), wound infections (P < 0.014), and length of hospital stay (P < 0.005). In RCTs and in nRCTs, length of hospital stay and return to work were significantly reduced when using LC compared with OC. The results of nRCTs were more often heterogeneous among themselves (11 of 15) as compared with RCTs (4 of 15). Conclusion: The results of RCTs and nRCTs differ significantly in at least 20% of the variables. External validities of RCTs and nRCTs in LC vs. OC appear to be similar. Between-study heterogeneity was larger in nRCTs than in RCTs of cholecystectomy. (C) 2010 Elsevier Inc. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mueller, Dirk UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauerland, Stefan UNSPECIFIED orcid.org/0000-0003-1048-796X UNSPECIFIED Neugebauer, Edmund A. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Immenroth, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-495705
DOI:	10.1016/j.jclinepi.2009.12.009
Journal or Publication Title:	J. Clin. Epidemiol.
Volume:	63
Number:	10
Page Range:	S. 1082 - 1091
Date:	2010
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1878-5921
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SMALL-INCISION CHOLECYSTECTOMY; DESIGN AFFECTS OUTCOMES; BILE-DUCT INJURY; LAPAROSCOPIC CHOLECYSTECTOMY; SINGLE-BLIND; QUALITY; SURGERY; INTERVENTION; METAANALYSES; THERAPY Multiple languages Health Care Sciences & Services; Public, Environmental & Occupational Health Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/49570