The quality of the evidence base for clinical pathway effectiveness: room for improvement in the design of evaluation trials.
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.
Office of the Dean, School for Public Health and Primary Care, Medicine & Life Sciences, Maastricht University, Maastricht, The Netherlands. thomas.rotter@maastrichtuniversity.nl
Thomas
T
Rotter
Leigh
L
Kinsman
Erica
E
James
Andreas
A
Machotta
Ewout W
EW
Steyerberg
D015982:Bias; D002986:Clinical Trials as Topic; D019091:Critical Pathways / Q000592:standards*; D019317:Evidence-Based Medicine; D017408:Guidelines as Topic; D006801:Humans; D007902:Length of Stay; D015201:Meta-Analysis as Topic; D010043:Outcome and Process Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment; D015983:Selection Bias