{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T07:21:17Z","timestamp":1782199277013,"version":"3.54.5"},"update-to":[{"DOI":"10.1371\/journal.pntd.0012393","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,9,17]],"date-time":"2024-09-17T00:00:00Z","timestamp":1726531200000}}],"reference-count":35,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T00:00:00Z","timestamp":1724889600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100022370","name":"Global Challenges Research Fund","doi-asserted-by":"publisher","award":["MR\/P024661\/1"],"award-info":[{"award-number":["MR\/P024661\/1"]}],"id":[{"id":"10.13039\/501100022370","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosntds.org"],"crossmark-restriction":false},"short-container-title":["PLoS Negl Trop Dis"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methodology &amp; principal findings<\/jats:title>\n                    <jats:p>\n                      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\u2019 meeting adopting the Nominal Group Technique. A final consensual agreement on outcome domains and items required to measure these domains was established. \u201cClinical Cure\u201d was defined as the ideal overall \"General Concept\". The five Core Outcome Domains included\n                      <jats:bold>Signs<\/jats:bold>\n                      capturing clinical morphology, diameter, and induration of an index lesion with the aid of a palpability score,\n                      <jats:bold>Treatment Efficac<\/jats:bold>\n                      y assessing percentage change in size of the lesion and re-epithelialization compared to baseline,\n                      <jats:bold>Treatment Impact<\/jats:bold>\n                      which included an investigator and patient visual analogue score, and\n                      <jats:bold>Clinical Sequelae<\/jats:bold>\n                      rating pigment change, atrophic and hypertrophic\/keloid scars. It was agreed that two open-ended questions should be included to capture some aspects of\n                      <jats:bold>Health-Related Quality of Life<\/jats:bold>\n                      as a means of capturing a patient-focused approach.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pntd.0012393","type":"journal-article","created":{"date-parts":[[2024,8,29]],"date-time":"2024-08-29T16:04:36Z","timestamp":1724947476000},"page":"e0012393","update-policy":"https:\/\/doi.org\/10.1371\/journal.pntd.corrections_policy","source":"Crossref","is-referenced-by-count":4,"title":["Development of a Core Outcome Measure Instrument; \"LeishCOM_LCL\u201d, for Localised Cutaneous Leishmaniasis"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8173-334X","authenticated-orcid":true,"given":"Shalindra","family":"Ranasinghe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sujai","family":"Senarathne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vijani","family":"Somaratne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles J. 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Leishmaniasis [cited 2023 June 27]. 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