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Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol
  1. Jan R. Boehnke1,2,
  2. Rusham Zahra Rana3,
  3. Jamie J. Kirkham4,
  4. Louise Rose5,
  5. Gina Agarwal6,
  6. Corrado Barbui7,8,
  7. Alyssa Chase-Vilchez9,
  8. Rachel Churchill10,
  9. Oscar Flores-Flores11,12,
  10. John R. Hurst13,
  11. Naomi Levitt14,
  12. Josefien van Olmen15,
  13. Marianna Purgato7,8,
  14. Kamran Siddiqi2,16,
  15. Eleonora Uphoff10,
  16. Rajesh Vedanthan17,
  17. Judy Wright18,
  18. Kath Wright19,
  19. Gerardo A. Zavala2,
  20. Najma Siddiqi2,16
  1. 1School of Health Sciences, University of Dundee, Dundee, UK
  2. 2Department of Health Sciences, University of York, York, UK
  3. 3Institute of Psychiatry, Rawalpindi Medical University, Rawalpindi, Pakistan
  4. 4Centre for Biostatistics, The University of Manchester, Manchester, UK
  5. 5Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK
  6. 6Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada
  7. 7WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy
  8. 8Cochrane Global Mental Health, University of Verona, Verona, Italy
  9. 9Global Alliance for Chronic Diseases, London, UK
  10. 10Centre for Reviews and Dissemination and Cochrane Common Mental Disorders, University of York, York, UK
  11. 11Facultad de Medicina Humana, Centro de Investigación del Envejecimiento (CIEN), Universidad San Martin de Porres, Lima, Peru
  12. 12Asociación Benéfica PRISMA, Lima, Peru
  13. 13UCL Respiratory, University College London, London, UK
  14. 14Chronic Disease Initiative for Africa and Division of Endocrinology, Department of Medicine, University of Cape Town, Cape Town, South Africa
  15. 15Department of Family Medicine and Population Health, University of Antwerp, Antwerpen, Belgium
  16. 16Hull York Medical School, York, UK
  17. 17Department of Population Health, NYU Grossman School of Medicine, New York University, New York, New York, USA
  18. 18Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
  19. 19Centre for Reviews and Dissemination, University of York, York, UK
  1. Correspondence to Dr Jan R. Boehnke; j.r.boehnke{at}dundee.ac.uk

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 registation number CRD42020197293.

  • statistics & research methods
  • protocols & guidelines
  • quality in health care
  • clinical trials
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2021-051810

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    Footnotes

    • Twitter @jrboehnke, @rvedanthan, @jmwleeds

    • Contributors NS and JRB conceived the study. JRB, JJK, RZR, LR and NS led the design of the research. JRB, NS and RZR drafted the manuscript. JRB, RZR, JJK, LR, GA, CB, AC, RC, OF-F, JRH, NL, JvO, MP, KS, EPU, RV, JMW, KW, GAZ, NS made substantial contributions to the conception or design of the work. JRB, RZR, JJK, LR, GA, CB, AC, RC, OF-F, JRH, NL, JvO, MP, KS, EPU, RV, JMW, KW, GAZ, NS revised it critically for important intellectual content. JRB, RZR, JJK, LR, GA, CB, AC, RC, OF-F, JRH, NL, JvO, MP, KS, EPU, RV, JMW, KW, GAZ, NS gave their final approval of the version to be published. JRB, RZR, JJK, LR, GA, CB, AC, RC, OF-F, JRH, NL, JvO, MP, KS, EPU, RV, JMW, KW, GAZ, NS agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • 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.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.