Development of a core outcome set for multimorbidity trials in low- and middle-income countries (COSMOS): Study Protocol

Jan Boehnke, Rusham Rana, Jamie Kirkham, Louise Rose, Gina Agarwal, Carrarado Barbui, Alyssa Chase, Rachel Churchill, Oscar Flores-Flores, John Hurst, Naomi Levitt, Josefien van Olmen, Marianna Purgato, Kamaran Siddiqi, Eleonora Uphoff, Rajesh Vedanthan, Judy Wright, Kath Wright, Gerardo Zaval, Najma Siddiqi

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Abstract

Introduction
‘Multimorbidity’ describes the presence of two or more long-term conditions, which can include
communicable and non-communicable diseases, and mental disorders. The rising global burden
from multimorbidity is well-documented, but trial evidence for effective interventions in low- and
middle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental to
trial design to ensure cross-study comparability, but there is currently no agreement on a core
outcome set (COS) to include in trials investigating multimorbidity specifically in LMIC. Our
aim is to develop international consensus on two COS for trials of interventions to prevent and
treat multimorbidity in LMIC settings.

Methods and Analysis
Following methods recommended by the Core Outcome Measures in Effectiveness Trials
(COMET initiative), the development of these two COS will occur in three stages: (1) generation
of a long list of potential outcomes for inclusion; (2) two-round online Delphi surveys; and (3)
consensus meetings. First, to generate an initial list of outcomes, we will conduct a systematic
review of multimorbidity intervention and prevention trials and interviews with people living
with multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcome
taxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomes
from people living with multimorbidity, caregivers, healthcare professionals, policy makers, and
researchers in LMICs. Finally, consensus meetings will be held to discuss the Delphi survey
results and agree outcomes for inclusion in the two COS.

Ethics and dissemination
The study has been approved by the Research Governance Committee of the Department of
Health Sciences, University of York, UK [HSRGC/2020/409/D:COSMOS]. Each participating
country/research group will obtain local ethics board approval. Informed consent will be obtained
from all participants. We will disseminate findings through peer-reviewed open access
publications, and presentations at global conferences selected to reach a wide range of LMIC
stakeholders.
Original languageEnglish
Number of pages21
JournalmedRxiv
DOIs
Publication statusPublished - 30 Mar 2021

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