Development of a Core Outcome Measure Instrument; "LeishCOM_LCL”, for Localised Cutaneous Leishmaniasis
Rattachement africain : lk, gb, br, in. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: Localized cutaneous leishmaniasis (LCL) is a chronic ulcerating disease. A literature review identified inconsistencies in clinical trials. The aims of this study were to reach a consensus on the most important domains to measure when assessing LCL, agree on parameters to measure the domains, and develop a tool representing a Core Outcome Set (COS), for use in clinical assessment of LCL. METHODOLOGY & PRINCIPAL FINDINGS: A literature review was conducted to identify any existing COS for LCL embracing agreed Outcome Domains, i.e. what to measure and any Outcome Measurement Instruments (OMIs). As no COS was available, potential outcome domains for assessment of LCL were identified through an international collaborative approach using e-consultations and virtual discussions with expert stakeholders (n = 20) from geographically different LCL endemic countries. Subsequent judgmental validation process included a face-to-face multidisciplinary stakeholders' meeting adopting the Nominal Group Technique. A final consensual agreement on outcome domains and items required to measure these domains was established. "Clinical Cure" was defined as the ideal overall "General Concept". The five Core Outcome Domains included Signs capturing clinical morphology, diameter, and induration of an index lesion with the aid of a palpability score, Treatment Efficacy assessing percentage change in size of the lesion and re-epithelialization compared to baseline, Treatment Impact which included an investigator and patient visual analogue score, and Clinical Sequelae rating pigment change, atrophic and hypertrophic/keloid scars. It was agreed that two open-ended questions should be included to capture some aspects of Health-Related Quality of Life as a means of capturing a patient-focused approach. CONCLUSION: LeishCOM_LCL was generated to reflect a COS for LCL. This captured demographic details, agreed outcome domains and measures to assess these domains. Validation of LeishCOM_LCL will be reported in a separate paper. Development of a Patient Reported Outcome Measure will be considered in the future.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Development of a Core Outcome Measure Instrument; "LeishCOM_LCL”, for Localised Cutaneous Leishmaniasis
- Date Crossref
- 29/08/2024
- Éditeur
- Public Library of Science (PLoS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Sri Jayewardenepura Department of Parasitology pays non établi dans la noticeUniversité ou école supérieure
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University of York York Biomedical Research Institute pays non établi dans la noticeUniversité ou école supérieure
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Hull York Medical School pays non établi dans la noticeUniversité ou école supérieure
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University of Warwick Warwick Medical School pays non établi dans la noticeUniversité ou école supérieure
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Harrogate and District NHS Foundation Trust pays non établi dans la noticeÉtablissement de santé
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National Hospital of Sri Lanka pays non établi dans la noticeÉtablissement de santé
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Universidade de São Paulo Department of Preventive Medicine pays non établi dans la noticeUniversité ou école supérieure
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Institute of Post Graduate Medical Education and Research pays non établi dans la noticeUniversité ou école supérieure
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Instituto de Infectologia Emílio Ribas pays non établi dans la noticeÉtablissement de santé
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College of Medicine & Sagore Dutta Hospital pays non établi dans la noticeÉtablissement de santé
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District General Hospital Dermatology Unit pays non établi dans la noticeÉtablissement de santé
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Harrogate and NHS District Foundation Trust pays non établi dans la noticeOrganisation à but non lucratif
Department of Parasitology — University of Sri Jayewardenepura, York Biomedical Research Institute — University of York et Hull York Medical School, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.