TRIPLE C reporting principles for case study evaluations of the role of context in complex interventions

Background: Guidance and reporting principles such as CONSORT (for randomised trials) and PRISMA (for systematic reviews) have greatly improved the reporting, discoverability, transparency and consistency of published research. We sought to develop similar guidance for case study evaluations undertaken to explore the influence of context on the processes and outcomes of complex interventions. Methods: A range of experts were recruited to an online Delphi panel, sampling for maximum diversity in disciplines (e.g. public health, health services research, organisational studies), settings (e.g. country), and sectors (e.g. academic, policy, third sector). To inform panel deliberations, we prepared background materials based on: [a] a systematic meta-narrative review of empirical and methodological literatures on case study, context and complex interventions; [b] the collective experience of a network of health systems and public health researchers; and [c] the established RAMESES II standards (which cover one kind of case study). We developed a list of topics and issues based on these sources and encouraged panel members to provide free text comments. Their feedback informed development of a set of items in the form of questions for potential inclusion in the reporting principles. We circulated these by email, asking panel members to rank each potential item twice (for relevance and validity) on a 7-point Likert scale. This sequence was repeated twice. Results: We recruited 51 panel members from 50 organisations across 12 countries, who brought experience of a range of case study research methods and applications. 26 completed all three Delphi rounds, reaching over 80% consensus on 16 items covering title, abstract, definitions of terms, philosophical assumptions, research question(s), rationale, how context and complexity relates to the intervention, ethical approval, empirical methods, findings, use of theory, generalisability and transferability, researcher perspective and influence, conclusions and recommendations, and funding and conflicts of interest. Conclusion: The ‘Triple C’ (Case study, Context, Complex interventions) reporting principles recognise that case studies are undertaken in different ways for different purposes and based on different philosophical assumptions. They are designed to be enabling rather than prescriptive, and to make case study evaluation reporting on context and complex health interventions more comprehensive, accessible and useable.