Development of a CONSORT extension for interventions in public health and related disciplines

Sean Grant, Paul Montgomery, Evan Mayo Wilson

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)


Many interventions in public health and related specialties are complex and challenging to assess. These interventions can have interacting components at several levels, with multiple and variable outcomes that require sophisticated assessments and analyses. Understanding randomised studies of these complex UPSCaLE (pUblic health, Psychology, Social work, CriminoLogy, and Education) interventions requires detailed reports of the interventions tested and methods used to assess them; however, reports of these trials often omit important information. Poor reporting hinders proper critical appraisal and synthesis of trials in systematic reviews, thereby impeding the effective transfer of research evidence to policy and practice decision-making. The CONSORT statement is a guideline for reporting randomised trials that has versions for reporting cluster, pragmatic, and non-pharmacological intervention trials. Despite improvements in reporting of these trials in medical disciplines, several studies have shown persistent deficiencies in the reporting quality of randomised studies of UPSCaLE interventions. Several researchers have suggested developing a new CONSORT extension for UPSCaLE interventions because of their unique and complex features, which is the objective of this multiphased project.

This project has five phases. The first phase, which has been completed, included scientific literature reviews to assess reporting guidelines for and the current reporting quality of publications of UPSCaLE intervention trials. The second phase will be a Delphi exercise to generate a prioritised list of possible items to include in the CONSORT extension. The third phase will be a formal consensus meeting to select reporting items to add to or modify for the CONSORT extension. The fourth phase is writing the guideline documents, including an explanation and elaboration document that provides detailed advice and examples of good reporting for each reporting standard. The final phase will consist of simultaneous publication of the guideline in many journals, guideline endorsement by journals and funding organisations, presentations at conferences and organisational meetings, and a dedicated website allowing feedback about the guideline.

We identified 14 reporting guidelines and five reporting quality assessment methods, yielding a total of 147 relevant reporting standards. Official CONSORT guidelines had better practices for development and dissemination of reporting guidelines, yet other reporting guidelines for empirical intervention research yielded 89 modified standards for UPSCaLE interventions not identified in CONSORT guidance. A systematic review of UPSCaLE intervention trials (n=239) showed that many key aspects of UPSCaLE intervention trials were often poorly reported. The Delphi exercise is set to begin in January, 2013.

A new CONSORT extension for UPSCaLE interventions could improve reporting of these trials. This extension could improve the critical appraisal of research and its use in evidence-based decision-making. We aim to enlist stakeholders in UPSCaLE intervention research in the development and dissemination of the guideline to reach the best-informed consensus on guideline content and to improve empirical intervention methods in public health science.

SG holds a linked University of Oxford Clarendon Fund-Green Templeton College Annual Fund Scholarship. The UK Economic and Social Research Council has indicated that it will fund the project's future phases. No other funding sources were provided for the research to date.

All authors contributed equally to literature search, figures, study design, data interpretation, and writing. SG did data collection and data analysis. The University of Oxford, Green Templeton College, and the Economic and Social Research Council had no role in the study design, collection, analysis, or interpretation of data; writing of the report; or the decision to submit for publication. SG had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Conflicts of interest
SG, PM, and EM-W are members of the project executive for the development of this CONSORT extension.
Original languageEnglish
Pages (from-to)14
Number of pages1
JournalThe Lancet
Issue numberSpecial 14
Publication statusPublished - 23 Nov 2012


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