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BMC Med Res Methodol. 2012; 12: 80.
Published online Jun 18, 2012. doi:  10.1186/1471-2288-12-80
PMCID: PMC3424110
The quality of the evidence base for clinical pathway effectiveness: Room for improvement in the design of evaluation trials
Thomas Rotter,corresponding author#1 Leigh Kinsman,#2 Erica James,#3 Andreas Machotta,#4 and Ewout W Steyerberg#5
1Office of the Dean, School for Public Health and Primary Care (CAPHRI), Faculty of Health, Medicine & Life Sciences, Maastricht University, Maastricht, The Netherlands
2School of Rural Health, Monash University, Bendigo, Australia
3School of Medicine and Public Health, Priority Research Centre in Health Behaviour, Priority Research Centre for Physical Activity and Nutrition, Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia
4Department of Anesthesiology, Sophia Childrens Hospital, Erasmus University Rotterdam, Rotterdam, The Netherlands
5Center for Medical Decision Making, Department of Public Health, Erasmus MC – University Medical Center Rotterdam, Rotterdam, The Netherlands
corresponding authorCorresponding author.
#Contributed equally.
Thomas Rotter: thomas.rotter/at/maastrichtuniversity.nl; Leigh Kinsman: leigh.kinsman/at/monash.edu; Erica James: erica.james/at/newcastle.edu.au; Andreas Machotta: a.machotta/at/erasmusmc.nl; Ewout W Steyerberg: e.steyerberg/at/erasmusmc.nl
Received July 20, 2011; Accepted May 16, 2012.
Abstract
Background
The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs.
Methods
An integral component of the review process was a rigorous appraisal of the methodological quality of published CPW evaluations. This allowed the identification of strengths and limitations of the evidence base for CPW effectiveness. We followed the validated Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria for randomized and non-randomized clinical pathway evaluations. In addition, we tested the hypotheses that simple pre-post studies tend to overestimate CPW effects reported.
Results
Out of the 260 primary studies meeting CPW content criteria, only 27 studies met the EPOC study design criteria, with the majority of CPW studies (more than 70 %) excluded from the review on the basis that they were simple pre-post evaluations, mostly comparing two or more annual patient cohorts. Methodologically poor study designs are often used to evaluate CPWs and this compromises the quality of the existing evidence base.
Conclusions
Cochrane EPOC methodological criteria, including the selection of rigorous study designs along with detailed descriptions of CPW development and implementation processes, are recommended for quantitative evaluations to improve the evidence base for the use of CPWs in hospitals.
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