摘要：Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines ( http://tinyurl.com/consort-study ). SOCIAL AND PSYCHOLOGICAL interventions aim to improve physical health, mental health, and associated social outcomes. They are often complex and typically involve multiple, interacting intervention components (e.g., several behavior change techniques) that may act and target outcomes on several levels (e.g., individual, family, community). 1 Moreover, these interventions may be contextually dependent upon the hard-to-control environments in which they are delivered, (e.g., health care settings, correctional facilities). 2,3 The functions and processes of these interventions may be designed to accommodate particular individuals or contexts, taking on different forms while still aiming to achieve the same objective. 4,5 Complex interventions are common in public health, psychology, education, social work, criminology, and related disciplines. For example, multisystemic therapy is an intensive intervention for juvenile offenders. Based on social-ecological and family systems theories, multisystemic therapy providers target a variety of individual, family, school, peer, neighborhood, and community influences on psychosocial and behavioral problems. 6 Treatment teams of professional therapists and caseworkers work with individuals, their families, and their peer groups to provide tailored services. 7 These services may be delivered in homes, social care, and community settings. Other examples of social and psychological interventions may be found in reviews by the Cochrane Collaboration (e.g., the Developmental, Psychosocial, and Learning Problems Group, the Cochrane Public Health Group) and the Campbell Collaboration. 8,9 To understand their effects and to keep services up to date, academics, policymakers, journalists, clinicians, and consumers rely on research reports of intervention studies in scientific journals. Such reports should explain the methods, including the design, delivery, uptake, and context of interventions, as well as subsequent results. Accurate, complete, and transparent reporting is essential for readers to make best use of new evidence, to achieve returns on research investment, to meet ethical obligations to research participants and consumers of interventions, and to minimize waste in research. However, randomized controlled trials are often poorly reported within and across disciplines including criminology, 10 social work, 11 education, 12 psychology, 13,14 and public health. 15 Biomedical researchers have developed guidelines to improve the reporting of randomized controlled trials of health-related interventions. 16 However, many social and behavioral scientists have not fully adopted these guidelines, which may not be wholly adequate for social and psychological interventions in their current form. 10,13,17,18 Because of the unique features of these interventions, updated reporting guidance is needed. We describe the development of a reporting guideline that aims to improve the quality of reports of randomized controlled trials of social and psychological interventions. We explain how reporting guidelines have improved the quality of reports in medicine, and why guidelines have not yet improved the quality of reports in other disciplines. We introduce a plan to develop a new reporting guideline for randomized controlled trials—an extension of Consolidated Standards of Reporting Trials (CONSORT) for social and psychological interventions—which will be written by using recommended techniques for guideline development and dissemination. 19 Wide stakeholder involvement and consensus are needed to create a useful, acceptable, and evidence-based guideline, so we hope to recruit stakeholders from multiple disciplines and professions. Randomized trials are not the only rigorous method for evaluating interventions; many alternatives exist when randomized controlled trials are not possible or appropriate because of scientific, practical, and ethical concerns. 20 Nonetheless, randomized controlled trials are important to policymakers, practitioners, scientists, and service users, as they are generally considered the most valid and reliable research method for estimating the effectiveness of interventions. 21 Moreover, many of the issues faced in reporting randomized controlled trials also relate to other evaluation designs. As a result, this project will focus on standards for randomized controlled trials that could then also inform the development of future guidelines for other evaluation designs. Reporting guidelines list (in the form of a checklist) the minimum information required to understand the methods and results of studies. They do not prescribe research conduct, but facilitate the writing of transparent reports by authors and appraisal of reports by research consumers. For example, the CONSORT Statement 2010 is an evidence-based guideline; to identify items, the developers reviewed evidence of trial design and conduct that could contribute to bias. With consensus methods, they developed a checklist of 25 items and a flow diagram. 16 CONSORT has improved the reporting of thousands of medical experiments. 22 It has been endorsed by more than 600 journals, 23 and it is supported by the Institute of Educational Sciences. 12 CONSORT is the only guideline for reporting randomized controlled trials that has been developed with such rigor, and it has remained more prominent than any other guideline for more than 15 years; for greatest impact, then, any further reporting guidelines related to randomized controlled trials should be developed in collaboration with the CONSORT Group.
