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

Mohler, R. Albert; Köpke, Sascha; Meyer, Gabriele

doi:10.1186/s13063-015-0709-y

Cited by 253 publications

(229 citation statements)

References 38 publications

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“…Complex interventions may not be described in sufficient detail to allow dismantling of key ingredients. Recent reporting guideline initiatives, such as CReDICI 2 (Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline)38 and CONSORT-SPI (Social and Psychological Interventions)39 seek to address this. The MRC’s recent guidance on process evaluations may also help identification of components, and assessment of delivery and fidelity of complex interventions 40.…”

Section: Discussionmentioning

confidence: 99%

Approaches for synthesising complex mental health interventions in meta-analysis

Caldwell¹,

Welton

2016

Evid Based Mental Health

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Clinical and statistical heterogeneity are commonplace in meta-analysis of mental health interventions. One possible source of this heterogeneity is the complexity of the intervention being evaluated. Complexity may relate to the intervention, or to the way in which it is implemented; however, the most common interpretation of a complex intervention is one which has multiple, potentially interacting components. In this article we outline different analytical strategies suggested for incorporating intervention complexity in a meta-analysis. INTRODUCTIONAccording to the Centre for Evidence-Based Medicine's hierarchies of evidence, systematic reviews of homogenous well-conducted randomised controlled trials (RCTs) provide the best evidence for evaluating intervention effectiveness.1 Homogeneity implies that each study included in a meta-analysis is estimating a single, true underlying relative intervention effect, so that any differences in estimates between studies are due to sampling error alone.2 If homogeneity does not hold, a single, fixed treatment effect meta-analysis model should not be assumed and a random effects model may be more appropriate.2 3 In systematic reviews of interventions for mental health, it could be argued that the homogeneity assumption is unlikely to hold in general. This is because the clinical variation observed across patient populations, therapist fidelity, intervention and comparator conditions, and outcomes (both patient and clinician reported) can give rise to statistical heterogeneity in meta-analysis. Indeed, heterogeneity might be considered inevitable.

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Section: Discussionmentioning

confidence: 99%

Approaches for synthesising complex mental health interventions in meta-analysis

Caldwell¹,

Welton

2016

Evid Based Mental Health

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“…We report the development of the intervention in line with the Criteria for Reporting the Development and Evaluation of Complex Interventions (CReDECI 2) [56] and its evaluation in line with the ‘guidelines for reporting embedded recruitment trials’ [17]. …”

Section: Methodsmentioning

confidence: 99%

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Hughes-Morley

Hann

Fraser

et al. 2016

Trials

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BackgroundPatient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants.MethodsThis is a cluster trial, embedded within a host trial (‘EQUIP’) recruiting service users diagnosed with severe mental illness. The intervention was informed by a systematic review, a qualitative study, social comparison theory and a stakeholder workshop including service users and carers. Adopting Participatory Design approaches, we co-designed the recruitment intervention with PPIR partners using a leaflet to advertise the PPIR in EQUIP and sent potential participants invitations with the leaflet (intervention group) or not (control group). Primary outcome was the proportion of patients enrolled in EQUIP. Secondary outcomes included the proportions of patients who positively responded to the trial invitation.ResultsThirty-four community mental health teams were randomised and 8182 service users invited. For the primary outcome, 4% of patients in the PPIR group were enrolled versus 5.3% of the control group. The intervention was not effective for improving recruitment rates (adjusted OR = 0.75, 95% CI = 0.53 to 1.07, p = 0.113). For the secondary outcome of positive response, the intervention was not effective, with 7.3% of potential participants in the intervention group responding positively versus 7.9% of the control group (adjusted OR = 0.74, 95% CI = 0.53 to 1.04, p = 0.082). We did not find a positive impact of directly advertising PPIR on any other outcomes.ConclusionTo our knowledge, this is the largest ever embedded trial to evaluate a recruitment or PPIR intervention. Advertising PPIR did not improve enrolment rates or any other outcome. It is possible that rather than advertising PPIR being the means to improve recruitment, PPIR may have an alternative impact on trials by making them more attractive, acceptable and patient-centred. We discuss potential reasons for our findings and implications for recruitment practice and research.Trial registration numbersISRCTN, ISRCTN16488358. Registered on 14 May 2014.Study Within A Trial, SWAT-26. Registered on 21 January 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1718-1) contains supplementary material, which is available to authorized users.

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“…With a limited number of guidelines to help address the potential greyness, we have examined two reporting guidelines for potential use with hybrid clinical and implementation interventions: the Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare (CReDECI2) andcbv the Template for Intervention Description and Replication (TIDieR). The CReDECI2 allows for a broad range of study designs and captures elements important to the contextual aspects of implementation [55]. Likewise, TIDieR does not map onto a particular study design but focuses on healthcare interventions, requiring an explanation of theory, context, intermediaries, and outcomes [56].…”

Section: Main Textmentioning

confidence: 99%

Clinical interventions, implementation interventions, and the potential greyness in between -a discussion paper

Eldh

Almost

DeCorby-Watson

et al. 2017

BMC Health Serv Res

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BackgroundThere is increasing awareness that regardless of the proven value of clinical interventions, the use of effective strategies to implement such interventions into clinical practice is necessary to ensure that patients receive the benefits. However, there is often confusion between what is the clinical intervention and what is the implementation intervention. This may be caused by a lack of conceptual clarity between ‘intervention’ and ‘implementation’, yet at other times by ambiguity in application. We suggest that both the scientific and the clinical communities would benefit from greater clarity; therefore, in this paper, we address the concepts of intervention and implementation, primarily as in clinical interventions and implementation interventions, and explore the grey area in between.DiscussionTo begin, we consider the similarities, differences and potential greyness between clinical interventions and implementation interventions through an overview of concepts. This is illustrated with reference to two examples of clinical interventions and implementation intervention studies, including the potential ambiguity in between. We then discuss strategies to explore the hybridity of clinical-implementation intervention studies, including the role of theories, frameworks, models, and reporting guidelines that can be applied to help clarify the clinical and implementation intervention, respectively.ConclusionSemantics provide opportunities for improved precision in depicting what is ‘intervention’ and what is ‘implementation’ in health care research. Further, attention to study design, the use of theory, and adoption of reporting guidelines can assist in distinguishing between the clinical intervention and the implementation intervention. However, certain aspects may remain unclear in analyses of hybrid studies of clinical and implementation interventions. Recognizing this potential greyness can inform further discourse.

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

Cited by 253 publications

References 38 publications

Approaches for synthesising complex mental health interventions in meta-analysis

Approaches for synthesising complex mental health interventions in meta-analysis

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Clinical interventions, implementation interventions, and the potential greyness in between -a discussion paper

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