The selection of an appropriate set of core outcomes is crucial when designing clinical trials in order to compare the effects of interventions across studies. While attempts have been made to define core outcomes in multimorbidity (Smith et al., 2018), there is currently no agreement on outcomes that should be included in trials investigating multimorbidity in low- and middle-income countries (LMICs). Outcomes currently selected and reported in such studies vary, contributing to the heterogeneity of findings in this field and making it difficult to compare and synthesise findings across studies. The lack of representation from LMICs reflects additionally, the lack of global work including and prioritising the perspective of stakeholders from these countries. Current multimorbidity outcome sets do not consider important regional differences such as feasibility of measurement between high income countries and LMICs. This study aims to address this issue through the development of an international consensus on two core outcome sets (COS) for (1) prevention and (2) treatment studies investigating multimorbidity in LMIC settings. In this work, we define multimorbidity as the presence of two or more long-term conditions, including communicable and non-communicable diseases and mental disorders. In line with the approach recommended by the COMET initiative, the development of COS will occur in three stages: (1) the generation of a long list of outcomes, (2) a two-round online Delphi survey and (3) face- to- face consensus meetings to discuss the results of the Delphi survey and agree on the two COS. The process will consider the minimum standards for the design of a COS study (COS-STAD), which includes the careful consideration of the scope, stakeholders and the consensus process. Findings of the study will aim to standardise trials in multimorbidity and will be disseminated through the researchers’ networks and peer-reviewed journals.Contributors
Principal Investigator: Dr. Najma Siddiqi
Affiliation: Department of Health Sciences, University of York and Hull York Medical School. NIHR Global Health Research Group IMPACT in South Asia https://www.york.ac.uk/healthsciences/research/mental-health/projects/impact/
Collaborators and affiliations:
Dr. Gina Agarwal, McMaster University, Canada. Zunayed Al Azdi, ARK Foundation, Bangladesh. Dr. Jan R. Boehnke, School of Health Sciences, University of Dundee, UK. Dr. Job van Boven, University Medical Center Groningen, New Zealand. Dr. Rachel Churchill, Cochrane Common Mental Disorders and Centre for Reviews and Dissemination, University of York, UK. Dr. Meena Daivadanam, Department of Food Studies, Nutrition and Dietetics, Uppsala University, Sweden. Dr. Oscar Flores-Flores, Centro de Investigación del Envejecimiento, Universidad de San Martin de Porres, Peru. Professor. John Hurst, UCL Respiratory, University College London, UK. Professor Jamie Kirkham, Centre for Biostatistics, University of Manchester, UK. Dr. Naomi Levitt, Division of Diabetic Medicine and Endocrinology, Groote Schuur Hospital and University of Cape Town, South Africa. Dr. Josefien van Olmen, University of Antwerp, Belgium. Gary Parker, Global Alliance for Chronic Diseases, UK. Rusham Zahra Rana, IMPACT, Institute of Psychiatry, Pakistan. Dr. Kamran Siddiqi, Department of Health Sciences, University of York and Hull York Medical School, York, UK. Dr. Eleonora Uphoff, Cochrane Common Mental Disorders, Centre for Reviews and Dissemination, University of York, UK. Judy Wright, University of Leeds, UK. Kath Wright, Centre for Reviews and Dissemination, University of York, UK. Dr. Gerardo Zavala, Department of Health Sciences, University of York, UK.
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Semi structured discussion
- Systematic review
We will follow the approach recommended by the COMET initiative, and outlined in the OMERACT handbook. Our research team includes experts in multimorbidity and long-term conditions, including mental health and non-communicable and communicable diseases. We have broad representation from multiple groups with excellent links to community groups that will help secure engagement with relevant stakeholders in LMICs. We will ensure patient, community and public involvement (CPI) throughout the development and delivery of the project and include at least two CPI members in the core research team. Finally, the team includes methods expertise in psychometrics as well as the development of core outcome sets and consensus based processes.
The development of the COS study will involve three stages: (1) the generation of a long list of outcomes (through literature review and interviews), (2) a two-round online Delphi survey and (3) face- to- face consensus meetings to discuss the results of the Delphi survey and agree on the two COS. The process will consider the minimum standards for the design of a COS study (COS- STAD), which includes the careful consideration of the scope, stakeholders and the consensus process.