Developing a Reporting Guideline for Social and Psychological Intervention Trials

Abstract

Social and psychological interventions are often complex. Understanding randomised controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT 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. In this paper, we explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for RCTs: CONSORT-SPI (an Extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/ CONSORT-study).

A systematic review and meta-analysis of the effectiveness of food safety education interventions for consumers in developed countries

“…The blinding criteria noted above are important to prevent against differential treatment and assessment of outcomes in participants based on possible knowledge of their group assignment, particularly for subjective outcomes such as attitudes and self-reported behaviours [ 26 ]. However, we recognize that blinding is challenging and often not feasible to implement in the context of educational interventions [ 53 ], and we did not downgrade the overall risk-of-bias rating for study outcomes based solely on unclear ratings for these criteria. For some criteria high risk-of-bias ratings were noted for RCTs and NRTs mostly due to incomplete outcome data and selective reporting resulting from a large and imbalanced proportion of drop-outs in one of the intervention groups [ 54 , 55 ], exclusion of some results from analysis [ 56 , 57 ], omission of quantitative results for some non-significant findings [ 40 , 54 , 57 ], and in one case because the similarity of baseline characteristics between intervention groups could not be determined [ 58 ].…”

“…Future experimental research investigating the effectiveness of food safety education interventions should aim to conduct and report methods and findings in accordance with appropriate guidelines for RCTs (CONSORT) and NRTs (TREND) [ 59 , 60 ]. An extension to the CONSORT guidelines is also planned for social and psychological interventions [ 53 ].…”

Setting-up a clinical trial: Some methodological recommendations

“…To increase the transparency and value of publications, different guidelines have been developed; the CONSORT statement, for instance, has considerably improved report quality (Lucy Turner et al, 2011). Moreover, guidelines are essential for readers to evaluate and make best use of new evidence (Montgomery et al, 2013).…”

“…For instance, explicit guidelines related to external validity and process evaluations are still missing (Armstrong et al, 2008;Prescott et al, 1999). For these reasons, more specific guidelines have been created: An attempt in this direction are JARS (Journal Article Reporting Standards), developed by the American Psychological Association (APA) (Publications & Communications Board Working Group on Journal Article Reporting, 2008), or the CONsolidated Standard Of Reporting Trials ---Social and Psychological Interventions (CONSORT-SPI), which is being developed by the Centre for Evidence Based Intervention at the University of Oxford, the Centre for Outcomes Research and Effectiveness at University College London, and the Institute of Child Care Research at Queen's University Belfast, in association with the CONSORT Group (Montgomery et al, 2013).…”

Randomised Controlled Trials in WOHP Interventions: A Review and Guidelines for Use

“…Indeed, there are now over 400 academic journals globally that explicitly support the CONSORT statement. This is not confined to medical journals; it is also supported by psychology journals, and with a revised CONSORT for psychology and sociology currently being developed (CONSORT‐SPI; Grant et al, ; Montgomery et al, ), these reporting standards will be increasingly common in psychology. Moreover, other disciplines, including occupational therapy and planning and development, are actively pursuing similar guidelines (Dahl Rasmussen, Malchow‐Møller, & Barnebeck Andersen, ), suggesting that the CONSORT is seen as a way of moving the science of interventions forward.…”