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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Methodology

Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2)

Authors: Ralph Möhler, Sascha Köpke, Gabriele Meyer

Published in: Trials | Issue 1/2015

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Abstract

Background

Many 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.

Methods

We 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.

Results

A 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.

Conclusions

CReDECI 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.
Appendix
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Literature
1.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–9.CrossRefPubMed
2.
Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med. 2010;8:24.CrossRefPubMedPubMedCentral
3.
4.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655.CrossRefPubMedPubMedCentral
5.
Michie S, Fixsen D, Grimshaw JM, Eccles MP. Specifying and reporting complex behaviour change interventions: the need for a scientific method. Implement Sci. 2009;4:40.CrossRefPubMedPubMedCentral
6.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–6.CrossRefPubMedPubMedCentral
7.
Möhler R, Bartoszek G, Köpke S, Meyer G. Proposed criteria for reporting the development and evaluation of complex interventions in healthcare (CReDECI): guideline development. Int J Nurs Stud. 2012;49:40–6.CrossRefPubMed
8.
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:e1–37.9.
9.
Campbell MK, Piaggio G, Elbourne DR, Altman DG. CONSORT Group Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.
10.
Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, CONSORT Group. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309.CrossRefPubMed
11.
Zwarenstein M, Treweek S, Gagnier JJ, CONSORT and Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:2390.CrossRef
12.
Mayo-Wilson E, Grant S, Hopewell S, Macdonald G, Moher D, Montgomery P. Developing a reporting guideline for social and psychological intervention trials. Trials. 2013;14:242.CrossRefPubMedPubMedCentral
13.
14.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.CrossRefPubMed
15.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
16.
Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013;14:15.CrossRefPubMedPubMedCentral
17.
Möhler R, Bartoszek G, Meyer G. Quality of reporting of complex healthcare interventions and applicability of the CReDECI list - a survey of publications indexed in PubMed. BMC Med Res Methodol. 2013;13:125.CrossRefPubMedPubMedCentral
18.
19.
20.
Murphy AW, Cupples ME, Smith SM, Byrne M, Byrne MC, Newell J, et al. Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial. BMJ. 2009;339:b4220.CrossRefPubMedPubMedCentral
21.
22.
Köpke S, Mühlhauser I, Gerlach A, Haut A, Haastert B, Möhler R, et al. Effect of a guideline-based multicomponent intervention on use of physical restraints in nursing homes: a randomized controlled trial. JAMA. 2012;307:2177–84.CrossRefPubMed
23.
Haut A, Köpke S, Gerlach A, Mühlhauser I, Haastert B, Meyer G. Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819]. BMC Geriatr. 2009;9:42.CrossRefPubMedPubMedCentral
24.
Redfern J, Rudd AD, Wolfe CD, McKevitt C. Stop stroke: development of an innovative intervention to improve risk factor management after stroke. Patient Educ Couns. 2008;72:201–9.CrossRefPubMed
25.
Spillane V, Byrne MC, Byrne M, Leathem CS, O’Malley M, Cupples ME. Monitoring treatment fidelity in a randomized controlled trial of a complex intervention. J Adv Nurs. 2007;60:343–52.CrossRefPubMed
26.
Smith SM, Paul G, Kelly A, Whitford DL, O’Shea E, O’Dowd T. Peer support for patients with type 2 diabetes: cluster randomised controlled trial. BMJ. 2011;342:d715.CrossRefPubMedPubMedCentral
27.
Linnan L, Steckler A. Process evaluation for public health interventions and research: an overview. In: Steckler A, Linnan L, editors. Process evaluation for public health interventions and research. San Francisco: Jossey-Bass; 2002. p. 1–23.
28.
Reelick MF, Faes MC, Esselink RA, Kessels RP, Olde Rikkert MG: How to perform a preplanned process evaluation for complex interventions in geriatric medicine: exemplified with the process evaluation of a complex falls-prevention program for community-dwelling frail older fallers. J Am Med Dir Assoc. 2011;12:331–36.CrossRefPubMed
29.
Fossey J, Ballard C, Juszczak E, James I, Alder N, Jacoby R, et al. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ. 2006;332:756–61.CrossRefPubMedPubMedCentral
30.
Strong V, Waters R, Hibberd C, Murray G, Wall L, Walker J, et al. Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. Lancet. 2008;372:40–8.CrossRefPubMed
31.
Moher D, Weeks L, Ocampo M, Seely D, Sampson M, Altman DG, et al. Describing reporting guidelines for health research: a systematic review. J Clin Epidemiol. 2011;64:718–42.CrossRefPubMed
32.
Corry M, Clarke M, While AE, Lalor J. Developing complex interventions for nursing: a critical review of key guidelines. J Clin Nurs. 2013;22:2366–86.CrossRefPubMed
33.
Ludvigsen MS, Meyer G, Hall E, Fegran L, Aagaard H, Uhrenfeldt L. Development of clinically meaningful complex interventions - the contribution of qualitative research. Pflege. 2013;26:207–14.CrossRefPubMed
34.
Redfern J, McKevitt C, Wolfe CD. Development of complex interventions in stroke care: a systematic review. Stroke. 2006;37:2410–9.CrossRefPubMed
35.
Möhler R, Richter T, Köpke S, Meyer G. Interventions for preventing and reducing the use of physical restraints in long-term geriatric care - a Cochrane review. J Clin Nurs. 2012;21:3070–81.CrossRefPubMed
36.
Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials. BMJ. 2013;347:f3755.CrossRefPubMedPubMedCentral
37.
Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030.PubMed
38.
Stevens A, Shamseer L, Weinstein E, Yazdi F, Turner L, Thielman J, et al. Relation of completeness of reporting of health research to journals’ endorsement of reporting guidelines: systematic review. BMJ. 2014;348:g3804.CrossRefPubMedPubMedCentral
39.
Guise JM, Chang C, Viswanathan M, Glick S, Treadwell J, Umscheid CA, et al. Agency for Healthcare Research and Quality Evidence-based Practice Center methods for systematically reviewing complex multicomponent health care interventions. J Clin Epidemiol. 2014;67:1181–91.CrossRefPubMed
Metadata
Title
Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2)
Authors
Ralph Möhler
Sascha Köpke
Gabriele Meyer
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0709-y

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