TY - JOUR
T1 - Development of a core outcome set for multimorbidity trials in low- and middle-income countries (COSMOS): Study Protocol
AU - Boehnke, Jan
AU - Rana, Rusham
AU - Kirkham, Jamie
AU - Rose, Louise
AU - Agarwal, Gina
AU - Barbui, Carrarado
AU - Chase, Alyssa
AU - Churchill, Rachel
AU - Flores-Flores, Oscar
AU - Hurst, John
AU - Levitt, Naomi
AU - van Olmen, Josefien
AU - Purgato, Marianna
AU - Siddiqi, Kamaran
AU - Uphoff, Eleonora
AU - Vedanthan, Rajesh
AU - Wright, Judy
AU - Wright, Kath
AU - Zaval, Gerardo
AU - Siddiqi, Najma
PY - 2021/3/30
Y1 - 2021/3/30
N2 - Introduction‘Multimorbidity’ describes the presence of two or more long-term conditions, which can includecommunicable and non-communicable diseases, and mental disorders. The rising global burdenfrom multimorbidity is well-documented, but trial evidence for effective interventions in low- andmiddle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental totrial design to ensure cross-study comparability, but there is currently no agreement on a coreoutcome set (COS) to include in trials investigating multimorbidity specifically in LMIC. Ouraim is to develop international consensus on two COS for trials of interventions to prevent andtreat multimorbidity in LMIC settings.Methods and AnalysisFollowing methods recommended by the Core Outcome Measures in Effectiveness Trials(COMET initiative), the development of these two COS will occur in three stages: (1) generationof 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 systematicreview of multimorbidity intervention and prevention trials and interviews with people livingwith multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcometaxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomesfrom people living with multimorbidity, caregivers, healthcare professionals, policy makers, andresearchers in LMICs. Finally, consensus meetings will be held to discuss the Delphi surveyresults and agree outcomes for inclusion in the two COS.Ethics and disseminationThe study has been approved by the Research Governance Committee of the Department ofHealth Sciences, University of York, UK [HSRGC/2020/409/D:COSMOS]. Each participatingcountry/research group will obtain local ethics board approval. Informed consent will be obtainedfrom all participants. We will disseminate findings through peer-reviewed open accesspublications, and presentations at global conferences selected to reach a wide range of LMICstakeholders.
AB - Introduction‘Multimorbidity’ describes the presence of two or more long-term conditions, which can includecommunicable and non-communicable diseases, and mental disorders. The rising global burdenfrom multimorbidity is well-documented, but trial evidence for effective interventions in low- andmiddle-income countries (LMICs) is limited. Selection of appropriate outcomes is fundamental totrial design to ensure cross-study comparability, but there is currently no agreement on a coreoutcome set (COS) to include in trials investigating multimorbidity specifically in LMIC. Ouraim is to develop international consensus on two COS for trials of interventions to prevent andtreat multimorbidity in LMIC settings.Methods and AnalysisFollowing methods recommended by the Core Outcome Measures in Effectiveness Trials(COMET initiative), the development of these two COS will occur in three stages: (1) generationof 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 systematicreview of multimorbidity intervention and prevention trials and interviews with people livingwith multimorbidity and their caregivers in LMICs. Outcomes will be classified using an outcometaxonomy. Two-round Delphi surveys will be used to elicit importance scores for these outcomesfrom people living with multimorbidity, caregivers, healthcare professionals, policy makers, andresearchers in LMICs. Finally, consensus meetings will be held to discuss the Delphi surveyresults and agree outcomes for inclusion in the two COS.Ethics and disseminationThe study has been approved by the Research Governance Committee of the Department ofHealth Sciences, University of York, UK [HSRGC/2020/409/D:COSMOS]. Each participatingcountry/research group will obtain local ethics board approval. Informed consent will be obtainedfrom all participants. We will disseminate findings through peer-reviewed open accesspublications, and presentations at global conferences selected to reach a wide range of LMICstakeholders.
U2 - doi.org/10.1101/2021.03.23.21253685
DO - doi.org/10.1101/2021.03.23.21253685
M3 - Article
JO - medRxiv
JF - medRxiv
ER -