Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol

Boehnke, Jan R.; Rana, Rusham Zahra; Kirkham, Jamie J; Rose, Louise; Agarwal, Gina; Barbui, Corrado; Chase-Vilchez, Alyssa; Churchill, Rachel; Flores-Flores, Oscar; Hurst, John R.; Levitt, Naomi; Olmen, Josefien Van; Purgato, Marianna; Siddiqi, Kamran; Uphoff, Eleonora; Vedanthan, Rajesh; Wright, Judy; Wright, Kath; Zavala, Gerardo; Siddiqi, Najma

doi:10.1136/bmjopen-2021-051810

Cited by 7 publications

(10 citation statements)

References 40 publications

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“…The other 17 core outcomes were grouped across the following domains: patient-reported effects and behaviours; physical activity and function; consultation-related; and health systems (Box 5). Another outcome set has been developed for measuring quality of care in multimorbidity using data from EHRs 255 , and recent 256 and ongoing work 257 aims to identify core outcomes in trials of prevention and treatment of multimorbidity in LMICs.…”

Section: Outcomes Of Carementioning

confidence: 99%

Multimorbidity

Skou

Mair

Fortin

et al. 2022

Nat Rev Dis Primers

380

283

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Interest in multimorbidity -commonly defined as the co-occurrence of at least two chronic conditions in the same individual 1 -has increased in the past few years owing to its substantial effect on the individual and the individual's family, as well as on health systems and on society, particularly in resource-poor settings 2-4 . Multimorbidity is distinct from the related concept of comorbidity, which refers to the combined effects of additional conditions in relation to the index condition in an individual [5][6][7][8] . By contrast, care for multimorbidity is patient-centred and does not routinely give priority to any single condition, although in clinical care, patients and clinicians will usually focus on the most pressing problems that the patient is experiencing.People with multimorbidity are more likely to die prematurely, be admitted to hospital and have an increased length of stay than people with a single chronic condition 9,10 . Multimorbidity is also associated with poorer function and health-related quality of life (HRQOL), depression and intake of multiple drugs (polypharmacy) and greater socioeconomic costs [11][12][13][14][15][16][17][18] . Most health care is designed to treat individual conditions rather than providing comprehensive, person-centred care 2,19,20 , which often leads to fragmented and sometimes contradictory care for people with multimorbidity and increases their treatment burden 21 Moreover, treating one condition at a time is inefficient and unsatisfactory for both people with multimorbidity and their health-care providers [22][23][24] .Multimorbidity is increasingly common owing to changes in lifestyle risk factors, notably physical inactivity and obesity, and population ageing that in part reflects improvements in survival from acute and chronic conditions 2,19,25,26 . Multimorbidity is associated with socioeconomic status and age 3,19,25,27 . However, although age is the strongest driver of multimorbidity, in absolute numbers, more people <65 years of age have multimorbidity than people ≥65 years of age, partly because more people in the general population are in that age group. Moreover, this emphasizes that multimorbidity is not just a feature of ageing 19,26 .Multimorbidity is further complicated in low-income and middle-income countries (LMICs) by the overlap of compounding factors, including adverse environmental and early life stressors linked to poverty, limited social infrastructure and poorer family coping mechanisms, that translate into chronic diseases occurring at earlier ages [28][29][30][31] . LMICs also have a higher prevalence of multimorbidity-related financial burden 32,33 and have weaknesses in health systems including a greater focus Treatment burdenThe workload associated with managing treatments and health-care recommendations and the impact of this on an individual and their supporters.

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Section: Outcomes Of Carementioning

confidence: 99%

Multimorbidity

Skou

Mair

Fortin

et al. 2022

Nat Rev Dis Primers

380

283

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“…The overall study was guided by an expert group, which included global health multimorbidity researchers, clinicians, experts in COS development methods, as well as people from LMICs with lived experience of multimorbidity and carer representatives. The main steps of the different stages are described below, and the published protocol provides further details (26).…”

Section: Methodsmentioning

confidence: 99%

“…Data on study characteristics, outcomes, and outcome measures were extracted from included studies by one researcher, with 10% of extractions cross- verified by a senior researcher. The objective of the review was to compile a list of previously studied outcomes rather than to summarise intervention effect; therefore study quality was not assessed (26).…”

Section: Methodsmentioning

confidence: 99%

“…The main topics included participants’ experience of living with [or caring for someone living with] multimorbidity and their view on what matters as the result of interventions to prevent or treat and/or care for their conditions. The interview schedule was published as part of the protocol (26). Interviews were conducted in-person by qualified interviewers in local languages and either audio- recorded or if not possible (because of technology limitations or the participant withholding consent), recorded in detailed interviewer notes.…”

Section: Methodsmentioning

confidence: 99%

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

Vidyasagaran,

Ayesha,

Boehnke

et al. 2024

Preprint

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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. A core outcome set (COS) appropriate for the study of multimorbidity in LMIC contexts does not presently exist. This is 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 the prevention and treatment of multimorbidity 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 with representation from 33 countries (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals, and policy makers). 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 six treatment outcomes were added from Delphi round one. Delphi round two surveys were completed by 95 of 132 round one 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 LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs.

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“…Basic demographic information was gathered from participants (age, gender, marital status, highest level of education, socioeconomic status, occupation, and disability). A semi-structured interview guide was prepared, which was then translated into the participants’ home languages by the local research teams and backward translated to ensure consistency 30. All interviews were audio recorded—and where not possible, contemporaneous notes were taken.…”

Section: Methodsmentioning

confidence: 99%

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

Tran,

Ali,

Ayesha

et al. 2024

BMJ Glob Health

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People living with multimorbidity (PLWMM) have multiple needs and require long-term personalised care, which necessitates an integrated people-centred approach to healthcare. However, people-centred care may risk being a buzzword in global health and cannot be achieved unless we consider and prioritise the lived experience of the people themselves. This study captures the lived experiences of PLWMM in low- and middle-income countries (LMICs) by exploring their perspectives, experiences, and aspirations.We analysed 50 semi-structured interview responses from 10 LMICs across three regions—South Asia, Latin America, and Western Africa—using an interpretative phenomenological analysis approach.The bodily, social, and system experiences of illness by respondents were multidirectional and interactive, and largely captured the complexity of living with multimorbidity. Despite expensive treatments, many experienced little improvements in their conditions and felt that healthcare was not tailored to their needs. Disease management involved multiple and fragmented healthcare providers with lack of guidance, resulting in repetitive procedures, loss of time, confusion, and frustration. Financial burden was exacerbated by lost productivity and extreme finance coping strategies, creating a vicious cycle. Against the backdrop of uncertainty and disruption due to illness, many demonstrated an ability to cope with their conditions and navigate the healthcare system. Respondents’ priorities were reflective of their desire to return to a pre-illness way of life—resuming work, caring for family, and maintaining a sense of independence and normalcy despite illness. Respondents had a wide range of needs that required financial, health education, integrated care, and mental health support.In discussion with respondents on outcomes, it appeared that many have complementary views about what is important and relevant, which may differ from the outcomes established by clinicians and researchers. This knowledge needs to complement and be incorporated into existing research and treatment models to ensure healthcare remains focused on the human and our evolving needs.

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Development of a core outcome set for multimorbidity trials in low/middle-income countries (COSMOS): study protocol

Cited by 7 publications

References 40 publications

Multimorbidity

Multimorbidity

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

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

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