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
{"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.","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Registration: </strong>https://www.comet-initiative.org/Studies/Details/1580.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Prospero registration number: </strong>CRD42020197293.</p>","PeriodicalId":9137,"journal":{"name":"BMJ Global Health","volume":"9 8","pages":""},"PeriodicalIF":7.1000,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11340216/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Global Health","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1136/bmjgh-2024-015120","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
引用次数: 0
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.
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.
期刊介绍：
BMJ Global Health is an online Open Access journal from BMJ that focuses on publishing high-quality peer-reviewed content pertinent to individuals engaged in global health, including policy makers, funders, researchers, clinicians, and frontline healthcare workers. The journal encompasses all facets of global health, with a special emphasis on submissions addressing underfunded areas such as non-communicable diseases (NCDs). It welcomes research across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialized studies. The journal also encourages opinionated discussions on controversial topics.
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