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Open Access Correspondence

Are more observational studies being included in Cochrane Reviews?

Hans Christian Kongsted1* and Merete Konnerup2

Author Affiliations

1 Department of Economics, University of Copenhagen, Øster Farimagsgade 5, DK-1353, Copenhagen K, Denmark

2 The Campbell Collaboration’s steering group and Trygfonden, Lyngby Hovedgade 4, 2. sal, DK-2800, Kongens Lyngby, Denmark

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BMC Research Notes 2012, 5:570  doi:10.1186/1756-0500-5-570

Published: 16 October 2012



Increasing the scope of an evidence based approach to areas outside healthcare has renewed the importance of a long-standing discussion on randomised versus observational study designs in evaluating the effectiveness of interventions. We investigate statistically if an increasing recognition of the role of certain nonrandomised studies to support or generalize the results of randomised controlled trials has had an impact on the actual inclusion criteria applied in Cochrane reviews.


We conduct an on-line search of the Cochrane Database of Systematic Reviews (CDSR) and divide all Cochrane reviews according to their design inclusion criterion: (A) RCTs only or (B) RCTs and (some subset of) observational studies. We test statistically whether a shift in the proportion of category B reviews has occurred by comparing reviews published before 2008 with reviews published during 2008/09.


We find that the proportion of Cochrane reviews choosing a broader inclusion criterion has increased, although by less than two percentage points. The shift is not statistically significant (P = 0.08).


There is currently not sufficient data to support a hypothesis of a significant shift in favour of including observational studies, neither at the aggregate level nor at the level of individual Review Groups within the Cochrane Collaboration.

Systematic reviews; Observational study; Randomized controlled trial