Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study
Journal
BMJ Global Health
ISSN
2059-7908
Date Issued
2024-08
Author(s)
Aishwarya Lakshmi Vidyasagaran
Rubab Ayesha
Jan R Boehnke
Jamie Kirkham
Louise Rose
John R Hurst
Juan Jaime Miranda
Rusham Zahra Rana
Rajesh Vedanthan
Mehreen Riaz Faisal
Saima Afaq
Gina Agarwal
Carlos Alberto Aguilar-Salinas
Kingsley Akinroye
Rufus Olusola Akinyemi
Syed Rahmat Ali
Rabeea Aman
Cecilia Anza-Ramirez
Koralagamage Kavindu Appuhamy
Se-Sergio Baldew
Corrado Barbui
Sandro Rogerio Rodrigues Batista
María del Carmen Caamaño
Asiful Haidar Chowdhury
Noemia Teixeira de Siqueira-Filha
Darwin Del Castillo Fernández
Laura Downey
Oscar Flores-Flores
Olga P García
Ana Cristina García-Ulloa
Richard IG Holt
Rumana Huque
Johnblack K Kabukye
Sushama Kanan
Humaira Khalid
Kamrun Nahar Koly
Joseph Senyo Kwashie
Naomi S Levitt
Sailesh Mohan
Krishna Prasad Muliyala
Qirat Naz
Augustine Nonso Odili
Adewale L Oyeyemi
Niels Victor Pacheco-Barrios
Devarsetty Praveen
Marianna Purgato
Dolores Ronquillo
Kamran Siddiqi
Rakesh Singh
Phuong Bich Tran
Pervaiz Tufail
Eleonora P Uphoff
Josefien van Olmen
Ruth Verhey
Judy M Wright
Jessica Hanae Zafra-Tanaka
Gerardo A Zavala
Yang William Zhao
Najma Siddiqi
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. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist.
These are 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 preventing and treating multimorbidity in adults 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 (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries.
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 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 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 adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO registration number CRD42020197293.
These are 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 preventing and treating multimorbidity in adults 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 (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries.
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 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 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 adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO registration number CRD42020197293.