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

COSMOS collaboration; 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; Patricio Lopez-Jaramillo; 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

doi:10.1136/bmjgh-2024-015120

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

COSMOS collaboration
, Aishwarya Lakshmi Vidyasagaran (Lead / Corresponding author)
, 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, Patricio Lopez-Jaramillo, 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

Health Sciences

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

7 Citations (Scopus)

119 Downloads (Pure)

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.

Original language	English
Article number	e015120
Number of pages	13
Journal	BMJ Global Health
Volume	9
Issue number	8
DOIs	https://doi.org/10.1136/bmjgh-2024-015120
Publication status	Published - 19 Aug 2024

UN SDGs

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

SDG 3 Good Health and Well-being
SDG 10 Reduced Inequalities

Keywords

Humans
Multimorbidity
Developing Countries
Delphi Technique
Adult
Outcome Assessment, Health Care
Qualitative Research
Female
Treatment
Other study design
Prevention strategies

ASJC Scopus subject areas

Health(social science)
Health Policy
General Medicine
General Nursing
General Health Professions
Public Health, Environmental and Occupational Health

Access to Document

10.1136/bmjgh-2024-015120Licence: CC BY

Final Published VersionFinal published version, 2.34 MBLicence: CC BY

Cite this

COSMOS collaboration, Vidyasagaran, A. L., Ayesha, R., Boehnke, J. R., Kirkham, J., Rose, L., Hurst, J. R., Miranda, J. J., Rana, R. Z., Vedanthan, R., Faisal, M. R., Afaq, S., Agarwal, G., Aguilar-Salinas, C. A., Akinroye, K., Akinyemi, R. O., Ali, S. R., Aman, R., Anza-Ramirez, C., ... Siddiqi, N. (2024). Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study. BMJ Global Health, 9(8), Article e015120. https://doi.org/10.1136/bmjgh-2024-015120

@article{ab7c0b67341340b78854951342eaf2b6,

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

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.",

keywords = "Humans, Multimorbidity, Developing Countries, Delphi Technique, Adult, Outcome Assessment, Health Care, Qualitative Research, Female, Treatment, Other study design, Prevention strategies",

author = "\{COSMOS collaboration\} and Vidyasagaran, \{Aishwarya Lakshmi\} and Rubab Ayesha and Boehnke, \{Jan R\} and Jamie Kirkham and Louise Rose and Hurst, \{John R\} and Miranda, \{Juan Jaime\} and Rana, \{Rusham Zahra\} and Rajesh Vedanthan and Faisal, \{Mehreen Riaz\} and Saima Afaq and Gina Agarwal and Aguilar-Salinas, \{Carlos Alberto\} and Kingsley Akinroye and Akinyemi, \{Rufus Olusola\} and Ali, \{Syed Rahmat\} and Rabeea Aman and Cecilia Anza-Ramirez and Appuhamy, \{Koralagamage Kavindu\} and Se-Sergio Baldew and Corrado Barbui and Batista, \{Sandro Rogerio Rodrigues\} and Caama{\~n}o, \{Mar{\'i}a Del Carmen\} and Chowdhury, \{Asiful Haidar\} and \{de Siqueira-Filha\}, \{Noemia Teixeira\} and \{Del Castillo Fern{\'a}ndez\}, Darwin and Laura Downey and Oscar Flores-Flores and Garc{\'i}a, \{Olga P\} and Garc{\'i}a-Ulloa, \{Ana Cristina\} and Holt, \{Richard IG\} and Rumana Huque and Kabukye, \{Johnblack K\} and Sushama Kanan and Humaira Khalid and Koly, \{Kamrun Nahar\} and Kwashie, \{Joseph Senyo\} and Levitt, \{Naomi S\} and Patricio Lopez-Jaramillo and Sailesh Mohan and Muliyala, \{Krishna Prasad\} and Qirat Naz and Odili, \{Augustine Nonso\} and Oyeyemi, \{Adewale L\} and Pacheco-Barrios, \{Niels Victor\} and Devarsetty Praveen and Marianna Purgato and Dolores Ronquillo and Kamran Siddiqi and Rakesh Singh and Tran, \{Phuong Bich\} and Pervaiz Tufail and Uphoff, \{Eleonora P\} and \{van Olmen\}, Josefien and Ruth Verhey and Wright, \{Judy M\} and Zafra-Tanaka, \{Jessica Hanae\} and Zavala, \{Gerardo A.\} and Zhao, \{Yang William\} and Najma Siddiqi",

note = "{\textcopyright} Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. ",

year = "2024",

month = aug,

day = "19",

doi = "10.1136/bmjgh-2024-015120",

language = "English",

volume = "9",

journal = "BMJ Global Health",

issn = "2059-7908",

publisher = "BMJ Publishing Group",

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COSMOS collaboration, Vidyasagaran, AL, Ayesha, R, Boehnke, JR, Kirkham, J, Rose, L, Hurst, JR, Miranda, JJ, Rana, RZ, Vedanthan, R, Faisal, MR, Afaq, S, Agarwal, G, Aguilar-Salinas, CA, Akinroye, K, Akinyemi, RO, Ali, SR, Aman, R, Anza-Ramirez, C, Appuhamy, KK, Baldew, S-S, Barbui, C, Batista, SRR, Caamaño, MDC, Chowdhury, AH, de Siqueira-Filha, NT, Del Castillo Fernández, D, Downey, L, Flores-Flores, O, García, OP, García-Ulloa, AC, Holt, RIG, Huque, R, Kabukye, JK, Kanan, S, Khalid, H, Koly, KN, Kwashie, JS, Levitt, NS, Lopez-Jaramillo, P, Mohan, S, Muliyala, KP, Naz, Q, Odili, AN, Oyeyemi, AL, Pacheco-Barrios, NV, Praveen, D, Purgato, M, Ronquillo, D, Siddiqi, K, Singh, R, Tran, PB, Tufail, P, Uphoff, EP, van Olmen, J, Verhey, R, Wright, JM, Zafra-Tanaka, JH, Zavala, GA, Zhao, YW & Siddiqi, N 2024, 'Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study', BMJ Global Health, vol. 9, no. 8, e015120. https://doi.org/10.1136/bmjgh-2024-015120

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study. / COSMOS collaboration; Vidyasagaran, Aishwarya Lakshmi (Lead / Corresponding author); Ayesha, Rubab et al.
In: BMJ Global Health, Vol. 9, No. 8, e015120, 19.08.2024.

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

TY - JOUR

T1 - Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries

T2 - the COSMOS study

AU - COSMOS collaboration

AU - Vidyasagaran, Aishwarya Lakshmi

AU - Ayesha, Rubab

AU - Boehnke, Jan R

AU - Kirkham, Jamie

AU - Rose, Louise

AU - Hurst, John R

AU - Miranda, Juan Jaime

AU - Rana, Rusham Zahra

AU - Vedanthan, Rajesh

AU - Faisal, Mehreen Riaz

AU - Afaq, Saima

AU - Agarwal, Gina

AU - Aguilar-Salinas, Carlos Alberto

AU - Akinroye, Kingsley

AU - Akinyemi, Rufus Olusola

AU - Ali, Syed Rahmat

AU - Aman, Rabeea

AU - Anza-Ramirez, Cecilia

AU - Appuhamy, Koralagamage Kavindu

AU - Baldew, Se-Sergio

AU - Barbui, Corrado

AU - Batista, Sandro Rogerio Rodrigues

AU - Caamaño, María Del Carmen

AU - Chowdhury, Asiful Haidar

AU - de Siqueira-Filha, Noemia Teixeira

AU - Del Castillo Fernández, Darwin

AU - Downey, Laura

AU - Flores-Flores, Oscar

AU - García, Olga P

AU - García-Ulloa, Ana Cristina

AU - Holt, Richard IG

AU - Huque, Rumana

AU - Kabukye, Johnblack K

AU - Kanan, Sushama

AU - Khalid, Humaira

AU - Koly, Kamrun Nahar

AU - Kwashie, Joseph Senyo

AU - Levitt, Naomi S

AU - Lopez-Jaramillo, Patricio

AU - Mohan, Sailesh

AU - Muliyala, Krishna Prasad

AU - Naz, Qirat

AU - Odili, Augustine Nonso

AU - Oyeyemi, Adewale L

AU - Pacheco-Barrios, Niels Victor

AU - Praveen, Devarsetty

AU - Purgato, Marianna

AU - Ronquillo, Dolores

AU - Siddiqi, Kamran

AU - Singh, Rakesh

AU - Tran, Phuong Bich

AU - Tufail, Pervaiz

AU - Uphoff, Eleonora P

AU - van Olmen, Josefien

AU - Verhey, Ruth

AU - Wright, Judy M

AU - Zafra-Tanaka, Jessica Hanae

AU - Zavala, Gerardo A.

AU - Zhao, Yang William

AU - Siddiqi, Najma

PY - 2024/8/19

Y1 - 2024/8/19

N2 - 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.

AB - 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.

KW - Humans

KW - Multimorbidity

KW - Developing Countries

KW - Delphi Technique

KW - Adult

KW - Outcome Assessment, Health Care

KW - Qualitative Research

KW - Female

KW - Treatment

KW - Other study design

KW - Prevention strategies

UR - https://www.scopus.com/pages/publications/85206291937

U2 - 10.1136/bmjgh-2024-015120

DO - 10.1136/bmjgh-2024-015120

M3 - Article

C2 - 39160083

SN - 2059-7908

VL - 9

JO - BMJ Global Health

JF - BMJ Global Health

IS - 8

M1 - e015120

ER -

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

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

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)

Quality of life dimensions in people living with mental disorders: moving beyond global scores

Time is now to consider how we evaluate person-centred care—the role of patient-reported outcomes

An interpretative phenomenological analysis of the lived experience of people with multimorbidity in low- and middle-income countries

Panel: Measuring what matters: How do we know that we do?

Quality assurance, quantitative, and qualitative evaluation methods for psychotherapeutic interventions including assessment instruments (annually)

Severe mental illness and multimorbidity

Cite this

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

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

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

Quality of life dimensions in people living with mental disorders: moving beyond global scores

Time is now to consider how we evaluate person-centred care—the role of patient-reported outcomes

An interpretative phenomenological analysis of the lived experience of people with multimorbidity in low- and middle-income countries

Activities

Panel: Measuring what matters: How do we know that we do?

Quality assurance, quantitative, and qualitative evaluation methods for psychotherapeutic interventions including assessment instruments (annually)

Severe mental illness and multimorbidity

Cite this