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

Jan R. Boehnke (Lead / Corresponding author), Rusham Zahra Rana, Jamie J. Kirkham, Louise Rose, Gina Agarwal, Corrardo Barbui, Alyssa Chase, Rachel Churchill, Oscar Flores-Flores, John . R. Hurst, Naomi Levitt, Josefien van Olmen, Marianna Purgato, Kamran Siddiqi, Eleonora Uphoff, Rajesh Vedanthan, Judy Wright, Kath Wright, Gerardo A. Zavala, Najma Siddiqi

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)
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Abstract

Introduction: 'Multimorbidity' describes the presence of two or more long-term conditions, which can include communicable, non-communicable diseases, and mental disorders. The rising global burden from multimorbidity is well documented, but trial evidence for effective interventions in low-/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 LMICs. Our aim is to develop international consensus on two COSs 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 initiative, the development of these two COSs will occur in parallel 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 including all of these stakeholders will be held to agree outcomes for inclusion in the two COSs.

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.

Prospero Registration Number: CRD42020197293.

Original languageEnglish
Article numbere051810
Pages (from-to)1-8
Number of pages8
JournalBMJ Open
Volume12
Issue number2
Early online date16 Feb 2022
DOIs
Publication statusPublished - Feb 2022

Keywords

  • Core Outcome Set
  • Comorbidity
  • Multimorbidity
  • Low- and Middle-Income Countries
  • Delphi
  • Consensus
  • protocols & guidelines
  • clinical trials
  • statistics & research methods
  • quality in health care

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