Abstract
BackgroundMany healthcare interventions are of complex nature, consisting of several interacting components. Complex interventions are often described inadequately. A reporting guideline for complex interventions was published in 2012 (Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare, CReDECI) and was recently checked for its practicability. The reporting guideline was developed following the recommendations of the EQUATOR network but excluding a formal consensus process. Therefore, a consensus process was initiated, to revise the reporting guideline.MethodsWe used a three-phase consensus process consisting of (1) a web-based feedback survey on the published reporting guideline, (2) a face-to-face consensus conference, and (3) a final online review and feedback round to create the revised CReDECI. The consensus process was organized and conducted via the REFLECTION network.ResultsA total of 45 attendees from 16 European countries took part in the face-to-face consensus conference. The revised reporting guideline (CReDECI 2) comprises 13 items on three stages: development, feasibility and piloting, and evaluation of a complex intervention. Each item is illustrated by an explanation and an example. In contrast with most of the available reporting guidelines, CReDECI 2 does not focus on a specific study design, to reflect the use of different qualitative and quantitative designs and methods in the development and evaluation of complex interventions.ConclusionsCReDECI 2 is a formally consented reporting guideline aiming to improve the reporting quality of the development and evaluation stages of complex interventions in healthcare. Since the guideline does not focus on a specific study design, design-specific reporting guidelines may additionally be used.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0709-y) contains supplementary material, which is available to authorized users.
Highlights
Many healthcare interventions are of complex nature, consisting of several interacting components
Design and participants The original CReDECI guideline was revised in three steps: (1) feedback on the first CReDECI guideline was collected via online questionnaires, (2) a face-to-face consensus conference was held to develop a draft revised guideline, and (3) the revised guideline was sent to all consensus conference attendees to reach a final consensus
The reporting guideline has been revised based on a formal consensus process, following the recommendations of the EQUATOR network [18]
Summary
Many healthcare interventions are of complex nature, consisting of several interacting components. A reporting guideline for complex interventions was published in 2012 (Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare, CReDECI) and was recently checked for its practicability. The reporting guideline was developed following the recommendations of the EQUATOR network but excluding a formal consensus process. In 1996, the first CONSORT statement was published to improve the reporting quality of randomized controlled trials (RCTs) [1]. In the following years, reporting guidelines for various study designs or specific types of study design, such as cluster RCTs or pragmatic trials, have been published. In 2006, the EQUATOR network was established, which aimed at Another topic that has been discussed intensively in recent years reflects the challenges of developing and evaluating complex healthcare interventions.
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