Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development

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Abstract

Methods of research on complex interventions have received increasing awareness in nursing and health care science. The British Medical Research Council's (MRC) framework on the development and evaluation of complex interventions has been widely applied. It does, however, not specifically support authors to comprehensively and transparently report their complex study to ensure interpretation of study results and replicability of the intervention. So far, no reporting criteria for the development and evaluation of complex interventions have been published.

Based on the updated MRC framework and corresponding methodological literature, a set of criteria on the reporting and evaluation of complex interventions has been developed and reviewed by experts in the field. As a result, a criteria list comprising 16 items has been created covering the first three stages of the MRC framework: (1) development; (2) feasibility and piloting; and (3) introduction of the intervention and evaluation. The list provides a minimum standard of criteria necessary to ensure high quality reporting of studies on the development and evaluation of complex interventions. In a final step, the reporting criteria on complex interventions have to pass a formal consensus process according to the methods recommended by the EQUATOR network.

Section snippets

Background

The majority of interventions in the field of nursing as well as medicine comprise more than a single component and is of complex nature including a number of components, acting either independently or inter-dependently (Craig et al., 2008b). Complex interventions have gathered increasing awareness in nursing science. Several articles explicitly outlining their intervention as complex have been published recently (e.g. Faes et al., 2011). Methodological papers on the development and evaluation

Frameworks for the development and evaluation of complex interventions

In 2000, the British Medical Research Council (MRC) firstly published a framework for the development and evaluation of complex interventions, aiming to provide guidance for researchers in recognising methodological challenges (Campbell et al., 2000). The MRC framework has been highly influential. It has, however, been criticized for linearity of increasing evidence, lack of methodological guidance, and neglect of social, political and geographical contexts in which complex interventions are

Reporting of the development and evaluation of complex interventions in healthcare

The updated version of the MRC framework (Craig et al., 2008a) emphasises high quality reporting as an important element at each stage of the research process. In a recently published systematic review, we evaluated the effects of interventions aimed to reduce and prevent the use of physical restraints in geriatric long-term care (Möhler et al., 2011). All interventions included were of complex nature, offering educational programmes and additional components. Reporting of the development and

The need for a reporting statement

The MRC framework recommends the adherence to reporting statements like CONSORT for randomised-controlled trials as a prerequisite of transparent reporting of complex interventions (Craig et al., 2008a). Available reporting statements are, however, not specifically addressing all relevant criteria for reporting on complex interventions’ development and evaluation (Armstrong et al., 2008, Mayo-Wilson, 2007). A statement by the Workgroup for Intervention Development and Evaluation Research (

Development of the criteria list

Based on a systematic literature search (PubMed, June 2010), we identified publications on complex interventions’ methodology. For the development of the criteria list, the MRC framework was used as main source of information (Craig et al., 2008a, Craig et al., 2008b) since it contains the most relevant methodological aspects discussed for the development and evaluation of complex interventions. From these publications, all information on relevant aspects for reporting the development and

The criteria list

First stageDevelopment

  • Item 1:

    Description of the intervention's underlying theoretical considerations (Craig et al., 2008a, Michie et al., 2009, van Meijel et al., 2004).

    Explanation: The theoretical basis of the intervention should be clearly stated. This includes the theory on which the intervention is founded as well as, if available, empirical evidence from studies in different settings or countries.

    Example:

    • The educational programme was developed based on the Social Learning Theory (Ref).

    • The

Discussion

The proposed criteria list represents a literature-based and expert reviewed suggestion, defining indispensable elements for high quality reporting of the development and evaluation of complex interventions. This could be the basis for the development of a reporting statement.

In contrast to other reporting statements, we have not arranged items in categories referring to sections of a publication (title, abstract, etc.), but in stages of the development and evaluation process of complex

Conclusion

An increasing number of publications on methodological issues of the development and evaluation of complex interventions as well as studies referring to the MRC framework document the relevance of this topic in nursing and health care science. Our criteria list comprises a minimum standard for transparent and comprehensive reporting of complex interventions, which is considered highly relevant for both authors and editors. We invite the scientific community to critically appraise the criteria

Acknowledgements

We acknowledge the contributions of Ingrid Mühlhauser, Jan Hamers, and Matthias Lenz by reviewing the criteria list.
Conflicts of interest

None declared.
Funding

The paper was part of a project which has been funded by the Ministry of Education and Research, Germany (preparation of a systematic review on physical restraint reduction approaches). The sponsor was not involved in the planning, performance or publication of this work.
Ethical approval

None.

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