Abstract
BackgroundThe development and evaluation of complex interventions in healthcare has obtained increased awareness. The Medical Research Council’s (MRC) framework for the development and evaluation of complex interventions and its update offers guidance for researchers covering the phases development, feasibility/piloting, and evaluation. Comprehensive reporting of complex interventions enhances transparency and is essential for researchers and policy-makers. Recently, a set of 16 criteria for reporting complex interventions in healthcare (CReDECI) was published. The aim of this study is to evaluate the reporting quality in publications of complex interventions adhering to either the first or the updated MRC framework, and to evaluate the applicability of CReDECI.MethodsA systematic PubMed search was conducted. Two reviewers independently checked titles and abstracts for inclusion. Trials on complex interventions adhering to the MRC framework and including an evaluation study in English and German were included. For all included trials and for all publications which reported on phases prior to the evaluation study, related publications were identified via forward citation tracking. The quality of reporting was assessed independently by two reviewers using CReDECI. Inter-rater agreement and time needed to complete the assessment were determined.ResultsTwenty-six publications on eight trials were included. The number of publications per trial ranged from 1 to 6 (mean 3.25). The trials demonstrate a good reporting quality for the criteria referring to the development and feasibility/piloting. For the criteria addressing the introduction of the intervention and the evaluation, quality of reporting varied widely. Two trials fulfilled 7 and 8 items respectively, five trials fulfilled one to five items and one trial offered no information on any item. The mean number of items with differing ratings per trial was two. The time needed to rate a trial ranged from 30 to 90 minutes, depending on the number of publications.ConclusionsAdherence to the MRC framework seems to have a positive impact on the reporting quality on the development and piloting of complex interventions. Reporting on the evaluation could be improved. CReDECI is a practical instrument to check the reporting quality of complex interventions and could be used alongside design-specific reporting guidelines.
Highlights
The development and evaluation of complex interventions in healthcare has obtained increased awareness
Main reasons for exclusion were that the interventions were not labelled as complex or the studies did not adhere to the Medical Research Council (MRC) framework
We identified a small number of trials whose authors explicitly stated having adhered to the MRC framework for developing and evaluating complex interventions [2]
Summary
The development and evaluation of complex interventions in healthcare has obtained increased awareness. The Medical Research Council’s (MRC) framework for the development and evaluation of complex interventions and its update offers guidance for researchers covering the phases development, feasibility/piloting, and evaluation. While the first framework [1] implied a linear approach comprising one preclinical and four clinical phases, the updated framework [2,3] builds on a circular model which gives a better reflection of the flexibility or even nonlinearity of the research process. Both versions cover the same methodological steps of development, piloting and evaluation of a complex intervention, and the long-term implementation after the complex intervention has demonstrated its effectiveness. The development and evaluation of complex interventions requires several studies using different methods and study designs [1,2,3,4]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
