Development of a CONSORT extension for social and psychological interventions

<b>Background:</b> Defined by their mechanisms, social and psychological interventions are those interventions that work through mental processes and social phenomena. They are often complex and challenging to evaluate, so understanding randomised controlled trials (RCTs) of these interventions requires detailed reports of the interventions tested and the methods used to assess them. However, reports of these RCTs often omit important information. Poor reporting hinders critical appraisal and synthesis of RCTs in systematic reviews, thereby impeding the effective transfer of research evidence to policy and practice. The Consolidated Standards for Reporting Trials (CONSORT) Statement is a reporting guideline that has contributed to improvements in the quality of RCT manuscripts in journals publishing medical research. However, studies have shown persistent deficiencies in the reporting quality of social and psychological intervention trials. A new CONSORT extension for these interventions may be needed given their distinct and complex features. This DPhil thesis reports on a project to develop and disseminate an official CONSORT Extension for Social and Psychological Interventions: CONSORT-SPI. <b>Structure:</b> Following a preface, this DPhil thesis includes eight chapters. Chapter 1 provides an overview of the conceptual rationale that prompted the CONSORT-SPI project. Chapter 2 details the project protocol, which consists of a five-phase methodology that follows current best practices for reporting guideline development and dissemination. Chapter 3 discusses systematic literature reviews to assess reporting guidelines for and the reporting quality of publications of social and psychological intervention RCTs. Chapter 4 discusses an online, international Delphi process to generate a prioritised list of possible items to include in the CONSORT-SPI extension. Chapter 5 discusses a formal consensus meeting to select reporting items to add to or modify for the CONSORT-SPI Extension checklist. Chapter 6 involves drafts of the CONSORT-SPI checklist as well as a template for the Explanation and Elaboration (E&amp;E) document providing detailed advice and examples of good reporting for each checklist item. These drafts have not yet been circulated to co-authors or other members of the project team; their purpose in this thesis is to give an indication of how previous project phases have led into initial prototypes of the checklist and E&amp;E;, which will undergo further development and revision by the project team before publication. Chapter 7 proposes a coordinated dissemination and implementation strategy informed by theoretical frameworks and tools used to guide the implementation of clinical guidelines and empirically-supported interventions. The final chapter summarises the information gained from the CONSORT-SPI project to date, assesses strengths and limitations of the project methodology, and discusses implications for future research. <b>Conclusion:</b> A CONSORT-SPI Extension could improve the reporting quality of social and psychological intervention RCTs. This extension could also facilitate better critical appraisal of this body of research and its use in evidence-based decision-making. With successful dissemination and implementation, the guideline will hopefully contribute to the improvement of intervention evaluations—as well as the methodology underpinning these studies—within the social and behavioural sciences.

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