The selection of an appropriate set of core outcomes is crucial when designing clinical trials in order to compare the effects of interventions across studies. While attempts have been made to define core outcomes in multimorbidity (Smith et al., 2018), there is currently no agreement on outcomes that should be included in trials investigating multimorbidity in low- and middle-income countries (LMICs). Outcomes currently selected and reported in such studies vary, contributing to the heterogeneity of findings in this field and making it difficult to compare and synthesise findings across studies. The lack of representation from LMICs reflects additionally, the lack of global work including and prioritising the perspective of stakeholders from these countries. Current multimorbidity outcome sets do not consider important regional differences such as feasibility of measurement between high income countries and LMICs. This study aims to address this issue through the development of an international consensus on two core outcome sets (COS) for (1) prevention and (2) treatment studies investigating multimorbidity in LMIC settings. In this work, we define multimorbidity as the presence of two or more long-term conditions, including communicable and non-communicable diseases and mental disorders. In line with the approach recommended by the COMET initiative, the development of COS will occur in three stages: (1) the generation of a long list of outcomes, (2) a two-round online Delphi survey and (3) face- to- face consensus meetings to discuss the results of the Delphi survey and agree on the two COS. The process will consider the minimum standards for the design of a COS study (COS-STAD), which includes the careful consideration of the scope, stakeholders and the consensus process. Findings of the study will aim to standardise trials in multimorbidity and will be disseminated through the researchers’ networks and peer-reviewed journals.
ContributorsAishwarya Lakshmi Vidyasagaran 1 , Rubab Ayesha 2 3 , Jan R Boehnke 4 5 , Jamie Kirkham 6 7 , Louise Rose 8 , John R Hurst 9 , Juan Jaime Miranda 10 11 , Rusham Zahra Rana 12 , Rajesh Vedanthan 13 , Mehreen Riaz Faisal 4 , Saima Afaq 14 15 , Gina Agarwal 16 , Carlos Alberto Aguilar-Salinas 17 , Kingsley Akinroye 18 , Rufus Olusola Akinyemi 19 , Syed Rahmat Ali 20 , Rabeea Aman 21 , Cecilia Anza-Ramirez 10 , Koralagamage Kavindu Appuhamy 4 , Se-Sergio Baldew 22 , Corrado Barbui 23 , Sandro Rogerio Rodrigues Batista 24 , María Del Carmen Caamaño 25 , Asiful Haidar Chowdhury 26 , Noemia Teixeira de Siqueira-Filha 4 , Darwin Del Castillo Fernández 10 27 , Laura Downey 28 29 , Oscar Flores-Flores 30 31 , Olga P García 25 , Ana Cristina García-Ulloa 32 , Richard Ig Holt 33 , Rumana Huque 34 35 , Johnblack K Kabukye 36 37 , Sushama Kanan 26 , Humaira Khalid 38 , Kamrun Nahar Koly 39 , Joseph Senyo Kwashie 40 , Naomi S Levitt 41 , Patricio Lopez-Jaramillo 42 43 , Sailesh Mohan 44 45 , Krishna Prasad Muliyala 46 , Qirat Naz 47 , Augustine Nonso Odili 48 , Adewale L Oyeyemi 49 50 , Niels Victor Pacheco-Barrios 10 , Devarsetty Praveen 51 , Marianna Purgato 23 , Dolores Ronquillo 25 , Kamran Siddiqi 4 52 , Rakesh Singh 53 , Phuong Bich Tran 54 , Pervaiz Tufail 55 , Eleonora P Uphoff 56 , Josefien van Olmen 57 , Ruth Verhey 58 , Judy M Wright 59 , Jessica Hanae Zafra-Tanaka 10 , Gerardo A Zavala 4 , Yang William Zhao 28 60 , Najma Siddiqi 4 52 ; COSMOS collaboration
Disease Category: Other
Disease Name: Multimorbidity
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Families
- Governmental agencies
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Semi structured discussion
- Systematic review
We will follow the approach recommended by the COMET initiative, and outlined in the OMERACT handbook. Our research team includes experts in multimorbidity and long-term conditions, including mental health and non-communicable and communicable diseases. We have broad representation from multiple groups with excellent links to community groups that will help secure engagement with relevant stakeholders in LMICs. We will ensure patient, community and public involvement (CPI) throughout the development and delivery of the project and include at least two CPI members in the core research team. Finally, the team includes methods expertise in psychometrics as well as the development of core outcome sets and consensus based processes.
The development of the COS study will involve three stages: (1) the generation of a long list of outcomes (through literature review and interviews), (2) a two-round online Delphi survey and (3) face- to- face consensus meetings to discuss the results of the Delphi survey and agree on the two COS. The process will consider the minimum standards for the design of a COS study (COS- STAD), which includes the careful consideration of the scope, stakeholders and the consensus process.