Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol

Jan R. Boehnke; Rusham Zahra Rana; Jamie J.  Kirkham; Louise Rose; Gina  Agarwal; Corrardo Barbui; Alyssa Chase; Rachel Churchill; Oscar Flores-Flores; John . R. Hurst; Naomi Levitt; Josefien van Olmen; Marianna Purgato; Kamran  Siddiqi; Eleonora Uphoff; Rajesh Vedanthan; Judy Wright; Kath Wright; Gerardo A. Zavala; Najma Siddiqi

doi:10.1136/bmjopen-2021-051810

Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol

Jan R. Boehnke (Lead / Corresponding author), Rusham Zahra Rana, Jamie J. Kirkham, Louise Rose, Gina Agarwal, Corrardo Barbui, Alyssa Chase, Rachel Churchill, Oscar Flores-Flores, John . R. Hurst, Naomi Levitt, Josefien van Olmen, Marianna Purgato, Kamran Siddiqi, Eleonora Uphoff, Rajesh Vedanthan, Judy Wright, Kath Wright, Gerardo A. Zavala, Najma Siddiqi

Health Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

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 Registration Number: CRD42020197293.

Original language	English
Article number	e051810
Pages (from-to)	1-8
Number of pages	8
Journal	BMJ Open
Volume	12
Issue number	2
Early online date	16 Feb 2022
DOIs	https://doi.org/10.1136/bmjopen-2021-051810
Publication status	Published - Feb 2022

Keywords

Core Outcome Set
Comorbidity
Multimorbidity
Low- and Middle-Income Countries
Delphi
Consensus
protocols & guidelines
clinical trials
statistics & research methods
quality in health care

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1136/bmjopen-2021-051810Licence: CC BY

Final Published VersionFinal published version, 631 KBLicence: CC BY

Cite this

Boehnke, J. R., Rana, R. Z., Kirkham, J. J., Rose, L., Agarwal, G., Barbui, C., Chase, A., Churchill, R., Flores-Flores, O., Hurst, J. . R., Levitt, N., van Olmen, J., Purgato, M., Siddiqi, K., Uphoff, E., Vedanthan, R., Wright, J., Wright, K., Zavala, G. A., & Siddiqi, N. (2022). Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol. BMJ Open, 12(2), 1-8. Article e051810. https://doi.org/10.1136/bmjopen-2021-051810

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title = "Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol",

abstract = "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 Registration Number: CRD42020197293.",

keywords = "Core Outcome Set, Comorbidity, Multimorbidity, Low- and Middle-Income Countries, Delphi, Consensus, protocols & guidelines, clinical trials, statistics & research methods, quality in health care",

author = "Boehnke, {Jan R.} and Rana, {Rusham Zahra} and Kirkham, {Jamie J.} and Louise Rose and Gina Agarwal and Corrardo Barbui and Alyssa Chase and Rachel Churchill and Oscar Flores-Flores and Hurst, {John . R.} and Naomi Levitt and {van Olmen}, Josefien and Marianna Purgato and Kamran Siddiqi and Eleonora Uphoff and Rajesh Vedanthan and Judy Wright and Kath Wright and Zavala, {Gerardo A.} and Najma Siddiqi",

note = "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.",

year = "2022",

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doi = "10.1136/bmjopen-2021-051810",

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Boehnke, JR, Rana, RZ, Kirkham, JJ, Rose, L, Agarwal, G, Barbui, C, Chase, A, Churchill, R, Flores-Flores, O, Hurst, JR, Levitt, N, van Olmen, J, Purgato, M, Siddiqi, K, Uphoff, E, Vedanthan, R, Wright, J, Wright, K, Zavala, GA & Siddiqi, N 2022, 'Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol', BMJ Open, vol. 12, no. 2, e051810, pp. 1-8. https://doi.org/10.1136/bmjopen-2021-051810

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AU - Boehnke, Jan R.

AU - Rana, Rusham Zahra

AU - Kirkham, Jamie J.

AU - Rose, Louise

AU - Agarwal, Gina

AU - Barbui, Corrardo

AU - Chase, 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 - 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.

PY - 2022/2

Y1 - 2022/2

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 Registration 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 Registration Number: CRD42020197293.

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KW - Multimorbidity

KW - Low- and Middle-Income Countries

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KW - Consensus

KW - protocols & guidelines

KW - clinical trials

KW - statistics & research methods

KW - quality in health care

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DO - 10.1136/bmjopen-2021-051810

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Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Improving Outcomes in Mental and Physical Comorbidity and Developing Research Capacity (IMPACT) in South Asia (joint with University of York)

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

Severe mental illness and multimorbidity

Minimum and optimum measures for multimorbidity projects

Does what matter to you matter to me? Are we measuring the right things?

Cite this

Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): Study Protocol

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Projects

Improving Outcomes in Mental and Physical Comorbidity and Developing Research Capacity (IMPACT) in South Asia (joint with University of York)

Research output

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

Activities

Severe mental illness and multimorbidity

Minimum and optimum measures for multimorbidity projects

Does what matter to you matter to me? Are we measuring the right things?

Cite this