Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study
Authors: Vidyasagaran Aishwarya Lakshmi , Ayesha Rubab , Boehnke Jan R , Kirkham Jamie , Rose Louise , Hurst John R , Miranda Juan Jaime , Rana Rusham Zahra , Vedanthan Rajesh , Faisal Mehreen Riaz , Afaq Saima , Agarwal Gina , Aguilar-Salinas Carlos Alberto , Akinroye Kingsley , Akinyemi Rufus Olusola , Ali Syed Rahmat , Aman Rabeea , Anza-Ramirez Cecilia , Appuhamy Koralagamage Kavindu , Baldew Se-Sergio , Barbui Corrado , Batista Sandro Rogerio Rodrigues , Caamaño María del Carmen , Chowdhury Asiful Haidar , de Siqueira-Filha Noemia Teixeira , Del Castillo Fernández Darwin , Downey Laura , Flores-Flores Oscar , García Olga P , García-Ulloa Ana Cristina , Holt Richard IG , Huque Rumana , Kabukye Johnblack K , Kanan Sushama , Khalid Humaira , Koly Kamrun Nahar , Kwashie Joseph Senyo , Levitt Naomi S , Lopez-Jaramillo Patricio , Mohan Sailesh , Muliyala Krishna Prasad , Naz Qirat , Odili Augustine Nonso , Oyeyemi Adewale L , Pacheco-Barrios Niels Victor , Praveen Devarsetty , Purgato Marianna , Ronquillo Dolores , Siddiqi Kamran , Singh Rakesh , Tran Phuong Bich , Tufail Pervaiz , Uphoff Eleonora P , van Olmen Josefien , Verhey Ruth , Wright Judy M , Zafra-Tanaka Jessica Hanae , Zavala Gerardo A , Zhao Yang William , Siddiqi Najma 
Published: August 2024

IntroductionThe 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.MethodsTo 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.ResultsThe 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.ConclusionFollowing 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 numberCRD42020197293.