Development of a core outcome set for multimorbidity trials in low- and middle-income countries (COSMOS): Study Protocol
Notice bibliographique
Résumé
Abstract Introduction ‘Multimorbidity’ describes the presence of two or more long-term conditions, which can include communicable and non-communicable diseases, and mental disorders. The rising global burden from multimorbidity is well-documented, but trial evidence for effective interventions in low- and 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 LMIC. Our aim is to develop international consensus on two COS 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 (COMET initiative), the development of these two COS will occur 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 will be held to discuss the Delphi survey results and agree outcomes for inclusion in the two COS. 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. Trial registration PROSPERO ID CRD42020197293 COMET https://www.comet-initiative.org/Studies/Details/1580 Strengths and limitations of this study The development process follows guidelines and best practice recommendations for developing core outcome sets and integrates four sources of information. Interviews with people living with multimorbidity and caregivers are conducted in several LMICs (in South Asia, Africa and Latin America), by local teams, and in local languages to identify outcomes relevant to them. The Delphi survey and consensus meetings are conducted in English which limits the breadth of participation in these stages of the process. Despite involvement of a wide range of LMIC stakeholders in the process, there may be some limitations to the generalisability of the final core outcome sets due to the heterogeneity of target conditions and the diversity of countries, cultures and experiences.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,162 | 0,145 |
| Méta-épidémiologie (sens strict) | 0,005 | 0,005 |
| Méta-épidémiologie (sens large) | 0,009 | 0,009 |
| Bibliométrie | 0,006 | 0,007 |
| Études des sciences et des technologies | 0,005 | 0,004 |
| Communication savante | 0,007 | 0,006 |
| Science ouverte | 0,004 | 0,006 |
| Intégrité de la recherche | 0,008 | 0,010 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,076 | 0,021 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».