IntroductionProgress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).Materials and methodsUsing a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.ResultsFindings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized.ConclusionsThe consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments.
IntroductionLack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients’ quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments.Methods and analysisThis international qualitative study uses interviews with patients to explore their experiences with CL to (1) elicit outcomes and eligibility criteria for clinical trials important to them and (2) to better understand their needs and views about the disease and their requirements and expectations from treatment. Here, we describe the set-up of this collaborative study and the protocol. Data collection is ongoing.The protocol includes study design, preparation, conduct and analysis of individual interviews with approximately 80 patients in seven countries (Burkina Faso, Brazil, two sites in Colombia, Iran, Morocco, Peru and Tunisia) where CL is prevalent. Principal investigators and sites were selected through an open call, and two workshops were organised for protocol development and training in conduct and analysis of qualitative health research. Patient recruitment aims at covering a maximum variation of experiences. Transcripts will be analysed to identify outcomes and eligibility criteria as well as further topics that are expected to emerge from the interviews, such as direct and indirect costs related to CL, its psychological impact, preferred modes of drug administration and traditional treatments.Ethics and disseminationThe study received ethical approval by the responsible committees of each of the participating institutions. Findings will be disseminated through publication in peer-reviewed journals, scientific meetings and to participants and their communities.
Objective: The treatment of cutaneous leishmaniasis is toxic, has contraindications, and a high cost. The objective of this study was to estimate the cost-effectiveness of thermotherapy versus pentavalent antimonials for the treatment of cutaneous leishmaniasis. Methods: Effectiveness was the proportion of healing and safety with the adverse effects; these parameters were estimated from a controlled clinical trial and a meta-analysis. A standard costing was conducted. Average and incremental cost-effectiveness ratios were estimated. The uncertainty regarding effectiveness, safety, and costs was determined through sensitivity analyses.
IntroducciónAunque resulte paradójico este editorial aborda la situación actual de una especialidad, la Reumatología Pediátrica (RP), que oficialmente no existe en España. Esto es así porque en el año 2014 las especialidades pediátricas continúan sin ser reconocidas oficialmente en nuestro país. El hecho de que no exista reconocimiento legal implica que ni existen unos requisitos mínimos para ejercer adecuadamente la especialidad ni se dispone de un plan formativo oficial. Por tanto, cualquier profesional proveniente tanto del campo de la Pediatría como de la Reumatología, independientemente de su formación específica en RP, puede atender en España a niños con enfermedades reumáticas. Esta situación, sin duda legal, puede repercutir y repercute en la calidad de la atención prestada.A pesar de ello no hay que perder de vista el largo camino recorrido por nuestra especialidad que ha llevado a su pleno desarrollo y reconocimiento en muchos países de la Unión Europea. La Reumatología Pediátrica como especialidad diferenciadaLa Reumatología Pediátrica inició su andadura como especialidad en los años cincuenta del siglo pasado tanto en EE.UU. (creación de los Special Treatment Centers for Rheumatic disorders) como en Europa (Taplow, Reino Unido). En aquellos años los niños eran considerados como "adultos pequeños" [1] y la Pediatría valorada por muchos internistas como una especialidad de segundo orden, por lo que los niños con enfermedades reumáticas eran atendidos por especialistas de adultos. Los primeros pediatras que empezaron a atender a niños con estas enfermedades carecían lógicamente de la formación ne-
Background: Cutaneous leishmaniasis causes a high disease burden in Colombia, and available treatments present systemic toxicity, low patient compliance, contraindications, and high costs. The purpose of this study was to estimate the cost-effectiveness of thermotherapy versus Glucantime in patients with cutaneous leishmaniasis in Colombia. Methods: Cost-effectiveness study from an institutional perspective in 8133 incident cases. Data on therapeutic efficacy and safety were included, calculating standard costs; the outcomes were disability adjusted life years (DALYs) and the number of patients cured. The information sources were the Colombian Public Health Surveillance System, disease burden studies, and one meta-analysis of controlled clinical trials. Incremental cost-effectiveness was determined, and uncertainty was evaluated with tornado diagrams and Monte Carlo simulations.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.