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; Corrado Barbui; Alyssa Chase-Vilchez; 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

BMJ Open. 2022 Feb 16;12(2):e051810. doi: 10.1136/bmjopen-2021-051810.

Authors

Jan R Boehnke^{1

2}, Rusham Zahra Rana³, Jamie J Kirkham⁴, Louise Rose⁵, Gina Agarwal⁶, Corrado Barbui^{7

8}, Alyssa Chase-Vilchez⁹, Rachel Churchill¹⁰, Oscar Flores-Flores^{11

12}, John R Hurst¹³, Naomi Levitt¹⁴, Josefien van Olmen¹⁵, Marianna Purgato^{7

8}, Kamran Siddiqi^{2

16}, Eleonora Uphoff¹⁰, Rajesh Vedanthan¹⁷, Judy Wright¹⁸, Kath Wright¹⁹, Gerardo A Zavala², Najma Siddiqi^{2

16}

Affiliations

¹ School of Health Sciences, University of Dundee, Dundee, UK [email protected].
² Department of Health Sciences, University of York, York, UK.
³ Institute of Psychiatry, Rawalpindi Medical University, Rawalpindi, Pakistan.
⁴ Centre for Biostatistics, The University of Manchester, Manchester, UK.
⁵ Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
⁶ Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ WHO 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 Cochrane Global Mental Health, University of Verona, Verona, Italy.
⁹ Global Alliance for Chronic Diseases, London, UK.
¹⁰ Centre for Reviews and Dissemination and Cochrane Common Mental Disorders, University of York, York, UK.
¹¹ Facultad de Medicina Humana, Centro de Investigación del Envejecimiento (CIEN), Universidad San Martin de Porres, Lima, Peru.
¹² Asociación Benéfica PRISMA, Lima, Peru.
¹³ UCL Respiratory, University College London, London, UK.
¹⁴ Chronic Disease Initiative for Africa and Division of Endocrinology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
¹⁵ Department of Family Medicine and Population Health, University of Antwerp, Antwerpen, Belgium.
¹⁶ Hull York Medical School, York, UK.
¹⁷ Department of Population Health, NYU Grossman School of Medicine, New York University, New York, New York, USA.
¹⁸ Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
¹⁹ Centre for Reviews and Dissemination, University of York, York, 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.

Keywords: clinical trials; protocols & guidelines; quality in health care; statistics & research methods.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Delphi Technique
Developing Countries*
Humans
Multimorbidity*
Outcome Assessment, Health Care
Research Design
Systematic Reviews as Topic
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding