Dataset Information

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

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.

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 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.

Prospero registration number

CRD42020197293.

SUBMITTER: Vidyasagaran AL

PROVIDER: S-EPMC11340216 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Vidyasagaran Aishwarya Lakshmi AL Ayesha Rubab R Boehnke Jan R JR Kirkham Jamie J Rose Louise L Hurst John R JR Miranda Juan Jaime JJ Rana Rusham Zahra RZ Vedanthan Rajesh R Faisal Mehreen Riaz MR Afaq Saima S Agarwal Gina G Aguilar-Salinas Carlos Alberto CA Akinroye Kingsley K Akinyemi Rufus Olusola RO Ali Syed Rahmat SR Aman Rabeea R Anza-Ramirez Cecilia C Appuhamy Koralagamage Kavindu KK Baldew Se-Sergio SS Barbui Corrado C Batista Sandro Rogerio Rodrigues SRR Caamaño María Del Carmen MDC Chowdhury Asiful Haidar AH de Siqueira-Filha Noemia Teixeira NT Del Castillo Fernández Darwin D Downey Laura L Flores-Flores Oscar O García Olga P OP García-Ulloa Ana Cristina AC Holt Richard Ig RI Huque Rumana R Kabukye Johnblack K JK Kanan Sushama S Khalid Humaira H Koly Kamrun Nahar KN Kwashie Joseph Senyo JS Levitt Naomi S NS Lopez-Jaramillo Patricio P Mohan Sailesh S Muliyala Krishna Prasad KP Naz Qirat Q Odili Augustine Nonso AN Oyeyemi Adewale L AL Pacheco-Barrios Niels Victor NV Praveen Devarsetty D Purgato Marianna M Ronquillo Dolores D Siddiqi Kamran K Singh Rakesh R Tran Phuong Bich PB Tufail Pervaiz P Uphoff Eleonora P EP van Olmen Josefien J Verhey Ruth R Wright Judy M JM Zafra-Tanaka Jessica Hanae JH Zavala Gerardo A GA Zhao Yang William YW Siddiqi Najma N

BMJ global health 20240819 8

<h4>Introduction</h4>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 trial ...[more]

PMID: 39160083

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Project description:IntroductionThe 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.MethodsTo 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.ResultsThe 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.ConclusionFollowing 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.

Project description: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 analysisFollowing 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 disseminationThe 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 numberCRD42020197293.

Project description:IntroductionDelirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults.Methods and analysisWe will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0-1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement.Ethics and disseminationWe are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users.

Project description:AimsTo identify and categorise core components of effective stigma reduction interventions in the field of mental health in low- and middle-income countries (LMICs) and compare these components across cultural contexts and between intervention characteristics.MethodsSeven databases were searched with a strategy including four categories of terms ('stigma', 'mental health', 'intervention' and 'low- and middle-income countries'). Additional methods included citation chaining of all papers identified for inclusion, consultation with experts and hand searching reference lists from other related reviews. Studies on interventions in LMICs aiming to reduce stigma related to mental health with a stigma-related outcome measure were included. All relevant intervention characteristics and components were extracted and a quality assessment was undertaken. A 'best fit' framework synthesis was used to organise data, followed by a narrative synthesis.ResultsFifty-six studies were included in this review, of which four were ineffective and analysed separately. A framework was developed which presents a new categorisation of stigma intervention components based on the included studies. Most interventions utilised multiple methods and of the 52 effective studies educational methods were used most frequently (n = 83), and both social contact (n = 8) and therapeutic methods (n = 3) were used infrequently. Most interventions (n = 42) based their intervention on medical knowledge, but a variety of other themes were addressed. All regions with LMICs were represented, but every region was dominated by studies from one country. Components varied between regions for most categories indicating variation between cultures, but only a minority of studies were developed in the local setting or culturally adapted.ConclusionsOur study suggests effective mental health stigma reduction interventions in LMICs have increased in quantity and quality over the past five years, and a wide variety of components have been utilised successfully - from creative methods to emphasis on recovery and strength of people with mental illness. Yet there is minimal mention of social contact, despite existing strong evidence for it. There is also a lack of robust research designs, a high number of short-term interventions and follow-up, nominal use of local expertise and the research is limited to a small number of LMICs. More research is needed to address these issues. Some congruity exists in components between cultures, but generally they vary widely. The review gives an in-depth overview of mental health stigma reduction core components, providing researchers in varied resource-poor settings additional knowledge to help with planning mental health stigma reduction interventions.

Project description:ObjectivesCo-occurrence of tuberculosis (TB) with other chronic conditions (TB multimorbidity) increases complexity of management and adversely affects health outcomes. We aimed to map the prevalence of the co-occurrence of one or more chronic conditions in people with TB and associated health risks by systematically reviewing previously published systematic reviews.DesignSystematic review of systematic reviews (meta-review).SettingLow-income and middle-income countries (LMICs).PapersWe searched in Medline, Embase, PsycINFO, Social Sciences Citation Index, Science Citation Index, Emerging Sources Citation Index and Conference Proceedings Citation Index, and the WHO Global Index Medicus from inception to 23 October 2020, contacted authors and reviewed reference lists. Pairs of independent reviewers screened titles, abstracts and full texts, extracted data and assessed the included reviews' quality (AMSTAR2). We included systematic reviews reporting data for people in LMICs with TB multimorbidity and synthesised them narratively. We excluded reviews focused on children or specific subgroups (eg, incarcerated people).Primary and secondary outcome measuresPrevalence or risk of TB multimorbidity (primary); any measure of burden of disease (secondary).ResultsFrom the 7557 search results, 54 were included, representing >6 296 000 people with TB. We found that the most prevalent conditions in people with TB were depression (45.19%, 95% CI: 38.04% to 52.55%, 25 studies, 4903 participants, I2=96.28%, high quality), HIV (31.81%, 95% CI: 27.83% to 36.07%, 68 studies, 62 696 participants, I2=98%, high quality) and diabetes mellitus (17.7%, 95% CI: 15.1% to 20.0.5%, 48 studies, 48,036 participants, I2=98.3%, critically low quality).ConclusionsWe identified several chronic conditions that co-occur in a significant proportion of people with TB. Although limited by varying quality and gaps in the literature, this first meta-review of TB multimorbidity highlights the magnitude of additional ill health burden due to chronic conditions on people with TB.Prospero registration numberCRD42020209012.

Project description:BackgroundClinically suspected and laboratory-confirmed bloodstream infections are frequent causes of morbidity and mortality during neonatal care. The most effective infection prevention and control interventions for neonates in low- and middle-income countries (LMIC) are unknown.AimTo identify effective interventions in the prevention of hospital-acquired bloodstream infections in LMIC neonatal units.MethodsMedline, PUBMED, the Cochrane Database of Systematic Reviews, EMBASE and PsychInfo (January 2003 to October 2020) were searched to identify studies reporting single or bundled interventions for prevention of bloodstream infections in LMIC neonatal units.ResultsOur initial search identified 5206 articles; following application of filters, 27 publications met the inclusion and Integrated Quality Criteria for the Review of Multiple Study Designs assessment criteria and were summarized in the final analysis. No studies were carried out in low-income countries, only 1 in Sub-Saharan Africa and just 2 in multiple countries. Of the 18 single-intervention studies, most targeted skin (n = 4) and gastrointestinal mucosal integrity (n = 5). Whereas emollient therapy and lactoferrin achieved significant reductions in proven neonatal infection, glutamine and mixed probiotics showed no benefit. Chlorhexidine gluconate for cord care and kangaroo mother care reduced infection in individual single-center studies. Of the 9 studies evaluating bundles, most focused on prevention of device-associated infections and achieved significant reductions in catheter- and ventilator-associated infections.ConclusionsThere is a limited evidence base for the effectiveness of infection prevention and control interventions in LMIC neonatal units; bundled interventions targeting device-associated infections were most effective. More multisite studies with robust study designs are needed to inform infection prevention and control intervention strategies in low-resource neonatal units.

Dataset Information

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

Introduction

Methods

Registration

Results

Conclusion

Prospero registration number

Publications

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

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