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[Preprint]. 2024 Jan 30:2024.01.29.24301589.
doi: 10.1101/2024.01.29.24301589.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in low- and middle-income countries: the COSMOS study

Aishwarya Lakshmi Vidyasagaran  1 , Rubab Ayesha  2 , Jan Boehnke  3 , Jamie Kirkham  4 , Louise Rose  5 , John Hurst  6 , J Jaime Miranda  7 , Rusham Zahra Rana  8 , Rajesh Vedanthan  9 , Mehreen Faisal  1 , Najma Siddiqi  10 ; COSMOS Collaboration
Affiliations

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in low- and middle-income countries: the COSMOS study

Aishwarya Lakshmi Vidyasagaran et al. medRxiv. .

Update in

  • Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.
    Vidyasagaran AL, Ayesha R, Boehnke JR, Kirkham J, Rose L, Hurst JR, Miranda JJ, Rana RZ, Vedanthan R, Faisal MR, Afaq S, Agarwal G, Aguilar-Salinas CA, Akinroye K, Akinyemi RO, Ali SR, Aman R, Anza-Ramirez C, Appuhamy KK, Baldew SS, Barbui C, Batista SRR, Caamaño MDC, Chowdhury AH, de Siqueira-Filha NT, Del Castillo Fernández D, Downey L, Flores-Flores O, García OP, García-Ulloa AC, Holt RI, Huque R, Kabukye JK, Kanan S, Khalid H, Koly KN, Kwashie JS, Levitt NS, Lopez-Jaramillo P, Mohan S, Muliyala KP, Naz Q, Odili AN, Oyeyemi AL, Pacheco-Barrios NV, Praveen D, Purgato M, Ronquillo D, Siddiqi K, Singh R, Tran PB, Tufail P, Uphoff EP, van Olmen J, Verhey R, Wright JM, Zafra-Tanaka JH, Zavala GA, Zhao YW, Siddiqi N; COSMOS collaboration. Vidyasagaran AL, et al. BMJ Glob Health. 2024 Aug 19;9(8):e015120. doi: 10.1136/bmjgh-2024-015120. BMJ Glob Health. 2024. PMID: 39160083 Free PMC article.

Abstract

Introduction: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. A core outcome set (COS) appropriate for the study of multimorbidity in LMIC contexts does not presently exist. This is required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at the prevention and treatment of multimorbidity in LMICs.

Methods: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups with representation from 33 countries (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals, and policy makers). Consensus meetings were used to reach agreement on the two final COS. Registration: https://www.comet-initiative.org/Studies/Details/1580.

Results: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention, and six treatment outcomes were added from Delphi round one. Delphi round two surveys were completed by 95 of 132 round one participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) Adverse events, (2) Development of new comorbidity, (3) Health risk behaviour, and (4) Quality of life; and four for the treatment COS: (1) Adherence to treatment, (2) Adverse events, (3) Out-of-pocket expenditure, and (4) Quality of life.

Conclusion: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.

Keywords: Core outcome sets; LMICs; Multimorbidity; Prevention; Treatment.

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Conflict of interest statement

COMPETING INTERESTS None declared.

Figures

Figure 1a.
Figure 1a.
Development of COS for trials of interventions to prevent multimorbidity in LMICs.
Figure 1b.
Figure 1b.
Development of COS for trials of interventions to treat multimorbidity in LMICs.
See this image and copyright information in PMC

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