Inclusion of alternative study designs for evaluating clinical interventions that require implementation of services in Cochrane Reviews

Article type
Authors
Stojanova J1, Stojanova JB2
1CIESAL (Interdisciplinary Centre for Health Studies), Universidad de Valparaíso
2x
Abstract
Background: clinical interventions that are complex and involve implementation of a service may be difficult to evaluate by randomized clinical trials (RCTs).

Objectives: the present work aims to evaluate, among Cochrane Reviews, what types of interventions are evaluated by alternative study designs, namely controlled before-after (CBA) and interrupted time series (ITS) analysis, and also elucidate how many Cochrane Reviews of clinical interventions that might be considered complex, or require service implementation, did not include alternative designs, where it might have been appropriate to do so.

Methods: the present work is a descriptive study. The Cochrane Library was searched using 'controlled before-after' and 'interrupted time series', as well as related related terms, for reviews published between January 2011 and January 2019. The types of interventions involved were characterized by a pre-established scheme. In parallel, we retrieved all reviews published in 2018 and characterized the interventions similarly.

Results: among reviews that included CBA and ITS studies (176), seven (4%) concerned clinical service-level interventions. The majority were published by the Effective Practice and Organisation of Care (EPOC) Review Group; two of the seven interventions classified as clinical service-level interventions were EPOC reviews. Among the 611 reviews evaluating interventions that were published in 2018, 589 did not include these quasi-experimental designs. A substantial proportion of these could be classified as clinical interventions requiring implementation of a service, hence might benefit from including alternative designs to RCTs. Detailed results will be presented at the 2019 Cochrane Colloquium.

Conclusions: there is scope for more reviews to include alternative study designs, particularly those concerning clinical interventions involving implementation of a service.

Patient or healthcare consumer involvement: none