Complexity Co ple ty a and d evidence ev de ce synthesis: a complex l methodological h d l i l challenge! Jane Noyes Bangor University Lead Convenor Cochrane Qualitative and Implementation l Methods h d Group Methodological g Investigation g of Cochrane Reviews of Complex Interventions (MICCI) Acknowledge fellow methodologists who met at Montebello January 2012 Key y methodological g issues What do we mean by a systematic review of complex interventions? • Simple questions can be asked of complex interventions • C Complex l questions ti can b be asked k d off non-complex l interventions i t ti • Complex questions can be asked of complex interventions • Purpose of the ‘complex’ review must be to explore ‘complexity’ rather than just ‘effect’ • Question development: PICO is too restricting when the purpose of the review is to explore complexity Slum upgrading strategies involving physical environment and infrastructure interventions and their effects on health and sociosocio economic outcomes. Turley R, Saith R, Bhan N, Rehfuess E, Carter B. What do we mean byy complexity? p y • Complex intervention (synthesis of all published definitions) • Intervention complexity (i.e. situation in which we expect the effect of an intervention to be modified by variant properties or characteristics of the intervention itself); • Implementation complexity (i.e. situation in which we expect the effects of an intervention to be modified by variant characteristics of the i l implementation t ti process)) • Context complexity (i.e. situation in which we expect the effects of an intervention to be modified by variant properties or characteristics of the setting or context in which an intervention is implemented); and • Complexity in participant responses (i.e. (i e situation in which we expect the effects of an intervention to be modified by variant characteristic of participants receiving the intervention). Acknowledgement Ian Shemilt, Laurie Anderson, Susan Michie and co-authors What type of evidence is likely to be useful in answering complex systematic review questions? A range of evidence – RCTs, Non randomised studies, process evaluations, qualitative evidence Cochrane methodology is adapting to accommodate different types of evidence – g development p of a new Chapter p in Laurie and Mark leading Cochrane handbook. J ki Ch Jackie Chandler dl – One O off the h Cochrane C h H Handbook db k Edi Editors What methods are appropriate for answering complex systematic review questions? Synthesis Options for Complex Intervention Reviews Qualitative synthesis to Quantitative synthesis to determine effects and explore context, heterogeneity etc. Meta-analysis, meta regression or narrative summary configure/ summarise / integrate qualitative data to address specific questions on complexity in relation to a Cochrane intervention review Thematic analysis without theory generation E.g. Framework synthesis Qualitative synthesis to develop explanatory theory or models to explore/explain complexity Meta ethnography Meta-ethnography Thematic analysis with theory generation Grounded theory Mixed-method synthesis to integrate and interpret quantitative, mixed-method and qualitative evidence within a single approach or integrated model to develop explanatory theory and explore/explain complexity Realist review Qualitative Case Analysis EPPI approach Narrative synthesis (Popay et al) Bayesian synthesis Critical interpretive synthesis Product Pooled effect size and/or description of individual studies Product Aggregated/configured narrative findings from source papers Product Explanatory theory, analytical or conceptual framework or interpretative framework/ mechanism Product Integrated synthesis of quantitative and qualitative evidence to explore/explain complexity Adapted from Noyes and Lewin 2011 Product Integrated synthesis of quantitative effects evidence and qualitative evidence to explore/explain l / l i complexity l it Key issue is that the question and d issue i off complexity should drive the choice of design/methods Reviews teams stick with familiar methods rather than the most appropriate pp p method What conceptual frameworks and tools are available to help make sense of complexity? MICCI project – developing a toolkit that may help Cochrane authors. Examples include: The BeHEMoTh Procedure Booth et al Guidance on identifying theory to inform design, conduct and analysis of systematic reviews of behaviour change interventions. Glasziou Gl i et all Taking T ki h healthcare lh interventions from trial into practice. Guidance G id on d detailed il d d description i i off an intervention and how it is implemented Michie S et al The behaviour change wheel. A framework for describing the components of behaviour change interventions Perera et al. Graphical method for depicting randomised trials of complex i t interventions. ti A graphical method for depicting randomised trials of complex interventions What new tools are in development? MICCI project: iCAT_SR: Intervention Complexity Assessment Tool for Systematic Reviews Aid to disaggregating intervention ‘components’ and their delivery, and rating interventions across a set of 10 ‘dimensions’ that have b been identified id tifi d as pertinent ti t iin assessing their complexity Acknowledge Simon Lewin, Andy Oxman, Jackie Chandler and all the people who have supported iCAT_SR development Use of logic models Anderson et al. 2011 Using logic models to capture complexity in systematic review Turley et al 2013 Slum upgrading review: methodological challenges that arise in systematic reviews of complex interventions Future Research and Development agenda Final paper in the JCE Montebello series outlines a R&D agenda: High level overview. Need to: • Address how complexity is conceptualised, framed, analysed and interpreted in systematic reviews that ask complex questions of interventions with varying g of complexity. p y degrees • Test and evaluate how the range of existing synthesis methods and tools is useful for addressing questions about complexity, and to determine where further methodological development is needed to fill important gaps. AND • Dimensions of complexity need to be explicitly described in primary study/ systematic review reports – an intervention complexity extension to the CONSORT and d PRISMA statements t t t would ld help h l with ith standardised t d di d reporting. ti Jane Noyes [email protected] Bangor University Acknowledgements: Cochrane MIF Fund. Fund CIHR CIHR. All colleagues who have contributed to the debate and methodological work Thank you!
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