TY - JOUR
T1 - Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS)
T2 - study protocol
AU - Boehnke, Jan R.
AU - Rana, Rusham Zahra
AU - Kirkham, Jamie J.
AU - Rose, Louise
AU - Agarwal, Gina
AU - Barbui, Corrado
AU - Chase-Vilchez, Alyssa
AU - Churchill, Rachel
AU - Flores-Flores, Oscar
AU - Hurst, John R.
AU - Levitt, Naomi
AU - van Olmen, Josefien
AU - Purgato, Marianna
AU - Siddiqi, Kamran
AU - Uphoff, Eleonora
AU - Vedanthan, Rajesh
AU - Wright, Judy
AU - Wright, Kath
AU - Zavala, Gerardo A.
AU - Siddiqi, Najma
N1 - Funding Information:
Funding This research was funded by the National Institute for Health Research (NIHR) (17/63/130) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK government. The research is also receiving support from Bradford District Care NHS Foundation Trust. Oscar Flores-Flores is supported by the Research Training in Chronic, non-communicable respiratory diseases in Peru, Fogarty International Center, US National Institutes of Health (D43TW011502). The core outcome set development is also supported by the Global Alliance for Chronic Diseases (GACD) Multimorbidity Working Group; the World Psychiatry Association; and by Cochrane Common Mental Disorders which is funded by NIHR (NIHR 129457) and Cochrane Global Mental Health (https://globalmentalhealth.cochrane.org). It is supported by the NCD Alliance by dissemination of participation opportunities to people living with multiple health conditions in its network.
Publisher Copyright:
© Author(s) (or their employer(s)) 2022.
PY - 2022/2/16
Y1 - 2022/2/16
N2 - 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 REGISTATION NUMBER: CRD42020197293.
AB - 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 REGISTATION NUMBER: CRD42020197293.
KW - clinical trials
KW - protocols & guidelines
KW - quality in health care
KW - statistics & research methods
UR - http://www.scopus.com/inward/record.url?scp=85124775595&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-051810
DO - 10.1136/bmjopen-2021-051810
M3 - Article
C2 - 35172996
AN - SCOPUS:85124775595
SN - 2044-6055
VL - 12
SP - e051810
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e051810
ER -