CONSORT-SPI: A CONSORT extension for social and psychological interventions

This project aims to create an evidence-based guideline for reporting randomized controlled trials (RCTs) of social and psychological interventions.

Principal Investigator: Professor Paul Montgomery

Co-Investigators: Dr Evan Mayo-Wilson, Assistant Scientist, Johns Hopkins University Bloomberg School of Public Health, Dr Sean Grant, Associate Behavioral & Social Scientist, RAND Corporation, Dr Sally Hopewell, Senior Research Fellow, Centre for Statistics in Medicine, (University of Oxford), Professor Geraldine Macdonald, Professor of Social Work, Institute of Child Care Research, (Queen’s University Belfast), Professor Susan Michie, Professor of Health Psychology and Deputy Director of the Centre for Outcomes Research and Effectiveness, (University College London), Prof David Moher, Research Chair in Systematic Reviews, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Centre for Practice-Changing Research (CPCR), (The Ottawa Hospital - General Campus)

This CONSORT Extension is a collaboration of 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.

This project is funded by a research grant from the UK Economic and Social Research Council (ESRC).

About the project

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 in criminology, education, psychology, public health, social work, and related disciplines often omit, or inadequately report, this information. The magnitude of these deficiencies is particularly striking when comparing RCT reporting quality in social and behavioural science journals to health care and medical journals. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers.

The CONSORT Statement is a guideline widely used in medicine to help authors report RCTs. The original statement and later extensions have improved the quality of medical trial reporting, but there has been limited uptake in social and behavioural sciences, as the greater complexity of interventions in these disciplines gives rise to new issues that are not adequately addressed in existing guidelines.  

Scientists who develop and evaluate social and psychological interventions need a reporting guideline that is appropriate for the trials that they conduct. To address this need, we are developing a CONSORT extension for social and psychological interventions: CONSORT-SPI. This guideline will incorporate lessons from previous extensions and other reporting guidelines, and it will include a revised checklist tailored to the unique needs of these complex interventions. To promote widespread uptake and impact, we will follow best practices for guideline development. Improved reporting will ultimately increase the usefulness of interventions by ensuring the usability of trial reports.

Outputs

Publications

Montgomery, P., Grant, S., Hopewell, S., Macdonald, G., Moher, D., Michie, S., & Mayo-Wilson, E. (2013). Protocol for CONSORT-SPI: An Extension for Social and Psychological Interventions. Implementation Science, 8, 99. doi:10.1186/1748- 5908-8-99 

Grant, S., Mayo-Wilson, E., Melendez-Torres, G.J., & Montgomery, P. (2013). The reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications. PLoS One, 8(5), e65442. doi:10.1371/journal.pone.0065442

Mayo-Wilson, E., Grant, S. Hopewell, S., Macdonald, G., Moher, D., & Montgomery, P., (2013). Developing a reporting guideline for social and psychological intervention trials. Versions available in:

• American Journal of Public Health
• British Journal of Psychiatry
• British Journal of Social Work
• Journal of Experimental Criminology
• Research on Social Work Practice
• Trials

Grant, S., Montgomery, P., Hopewell, S., Macdonald, G., Moher, D, & Mayo-Wilson, E. (2013). Letter to the Editor: New guidelines are needed to improve the reporting of trials in addiction sciences. Addiction, 108, 1687-1688.

Gardner, F., Mayo-Wilson, E., Montgomery, P., Hopewell, S., Macdonald, G., Moher, D, & Grant, S. (2013). Editorial Perspective: New guidelines are needed to improve the reporting of trials in child and adolescent mental health. Journal of Child Psychology and Psychiatry, 54(7), 810-812.

Grant, S., Montgomery, P., & Mayo-Wilson, E. (2012). Development of a CONSORT extension for interventions in public health and related disciplines. The Lancet, 380(Supp. 3). S14.

Spreckelsen, T., Grant, S. P., & Montgomery, P. (2012). Letters: Additional requirements for complex interventions. BMJ, 345, e8003.

Presentations

Montgomery, P., Grant, S., & Mayo-Wilson, E. (2013, January). Reporting quality of complex social intervention trials: A CONSORT extension for complex social interventions. Oral presentation at 17th annual Society for Social Work and Research (SSWR) Conference, San Diego, USA.

Grant, S., Montgomery, P., & Mayo-Wilson, E. (2012, November). Development of a CONSORT extension for interventions in public health and related disciplines. Oral presentation at the Royal Society of Medicine’s Public Health Science: A National Conference Dedicated to New Research in Public Health, London, UK.

Grant, S. P., & Montgomery, P. (2012, October). Development of a CONSORT Extension for Complex Social Interventions. Meeting held at the 20th annual Cochrane Colloquium, Auckland, New Zealand.

Montgomery, P., & Grant, S. P. (2011, October). Development of a CONSORT extension for randomised controlled trials evaluating complex behavioural change and psychological interventions. Workshop at the 19th annual Cochrane Colloquium, Madrid, Spain.

Montgomery, P., Mayo-Wilson, E., & Grant, S. P. (2011, August). Will you CONSORT with me? Improving reporting quality to improve outcomes for people and organizations. Poster presented at the 1st annual Global Implementation Conference, Washington, D.C., USA.

Montgomery, P., & Grant, S. P. (2011, August). Will you CONSORT with me? Presentation given at the Centre for Evidence-Based Crime Policy and Campbell Collaboration Joint Symposium on Evidence-Based Policy, Washington, D.C., USA.