Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis.
<h4>Background</h4>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...
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| Format: | Article |
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Public Library of Science (PLoS)
2024-08-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0012393 |
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| author | Shalindra Ranasinghe Sujai Senarathne Vijani Somaratne Charles J N Lacey Surangi Jayakody Amila Wickramasinghe Indira Kahawita Hiro Goto Mitali Chatterjee José A L Lindoso Vivak Parkash Surya J Chaudhuri Renu Wickremasinghe Nilay K Das Paul M Kaye Alison M Layton |
| author_facet | Shalindra Ranasinghe Sujai Senarathne Vijani Somaratne Charles J N Lacey Surangi Jayakody Amila Wickramasinghe Indira Kahawita Hiro Goto Mitali Chatterjee José A L Lindoso Vivak Parkash Surya J Chaudhuri Renu Wickremasinghe Nilay K Das Paul M Kaye Alison M Layton |
| author_sort | Shalindra Ranasinghe |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methodology & principal findings</h4>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.<h4>Conclusion</h4>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. |
| format | Article |
| id | doaj-art-99e2cc4468e64c2781188f74d29b6bff |
| institution | Kabale University |
| issn | 1935-2727 1935-2735 |
| language | English |
| publishDate | 2024-08-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj-art-99e2cc4468e64c2781188f74d29b6bff2025-08-20T03:25:46ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352024-08-01188e001239310.1371/journal.pntd.0012393Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis.Shalindra RanasingheSujai SenarathneVijani SomaratneCharles J N LaceySurangi JayakodyAmila WickramasingheIndira KahawitaHiro GotoMitali ChatterjeeJosé A L LindosoVivak ParkashSurya J ChaudhuriRenu WickremasingheNilay K DasPaul M KayeAlison M Layton<h4>Background</h4>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.<h4>Methodology & principal findings</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pntd.0012393 |
| spellingShingle | Shalindra Ranasinghe Sujai Senarathne Vijani Somaratne Charles J N Lacey Surangi Jayakody Amila Wickramasinghe Indira Kahawita Hiro Goto Mitali Chatterjee José A L Lindoso Vivak Parkash Surya J Chaudhuri Renu Wickremasinghe Nilay K Das Paul M Kaye Alison M Layton Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. PLoS Neglected Tropical Diseases |
| title | Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. |
| title_full | Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. |
| title_fullStr | Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. |
| title_full_unstemmed | Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. |
| title_short | Development of a Core Outcome Measure Instrument; "LeishCOM_LCL", for Localised Cutaneous Leishmaniasis. |
| title_sort | development of a core outcome measure instrument leishcom lcl for localised cutaneous leishmaniasis |
| url | https://doi.org/10.1371/journal.pntd.0012393 |
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