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      Cost-effectiveness analysis of domiciliary topical sevoflurane for painful leg ulcers

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          Abstract

          Objectives

          The general anesthetic sevoflurane is being repurposed as a topical analgesic for painful chronic wounds. We conducted a Bayesian cost-effectiveness analysis (CEA) comparing the addition of domiciliary topical sevoflurane to conventional analgesics (SEVOFLURANE, n = 38) versus conventional analgesics alone (CONVENTIONAL, n = 26) for the treatment of nonrevascularizable painful leg ulcers in an outpatient Pain Clinic of a Spanish tertiary hospital.

          Methods

          We used real-world data collected from charts to conduct this CEA from a public healthcare perspective and with a one-year time horizon. Costs of analgesics, visits and admissions were considered, expressed in €2016. Analgesic effectiveness was measured with SPID (Sum of Pain Intensity Difference). A Bayesian regression model was constructed, including “treatment” and baseline characteristics for patients (“arterial hypertension”) and ulcers (“duration”, “number”, “depth”, “pain”) as covariates. The findings were summarized as a cost-effectiveness plane and a cost-effectiveness acceptability curve. One-way sensitivity analyses, a re-analysis excluding those patients who died or suffered from leg amputation, and an extreme scenario analysis were conducted to reduce uncertainty.

          Results

          Compared to CONVENTIONAL, SEVOFLURANE was associated with a 46% reduction in costs, and the mean incremental effectiveness (28.15±3.70 effectiveness units) was favorable to SEVOFLURANE. The estimated probability for SEVOFLURANE being dominant was 99%. The regression model showed that costs were barely influenced by any covariate, whereas effectiveness was noticeably influenced by “treatment”. All sensitivity analyses showed the robustness of the model, even in the extreme scenario analysis against SEVOFLURANE.

          Conclusions

          SEVOFLURANE was dominant over CONVENTIONAL as it was less expensive and much more effective.

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          Most cited references53

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          The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

          Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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            Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force.

            Economic evaluations of health interventions pose a particular challenge for reporting because substantial information must be conveyed to allow scrutiny of study findings. Despite a growth in published reports, existing reporting guidelines are not widely adopted. There is also a need to consolidate and update existing guidelines and promote their use in a user-friendly manner. A checklist is one way to help authors, editors, and peer reviewers use guidelines to improve reporting. The task force's overall goal was to provide recommendations to optimize the reporting of health economic evaluations. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement is an attempt to consolidate and update previous health economic evaluation guidelines into one current, useful reporting guidance. The CHEERS Elaboration and Explanation Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force facilitates the use of the CHEERS statement by providing examples and explanations for each recommendation. The primary audiences for the CHEERS statement are researchers reporting economic evaluations and the editors and peer reviewers assessing them for publication. The need for new reporting guidance was identified by a survey of medical editors. Previously published checklists or guidance documents related to reporting economic evaluations were identified from a systematic review and subsequent survey of task force members. A list of possible items from these efforts was created. A two-round, modified Delphi Panel with representatives from academia, clinical practice, industry, and government, as well as the editorial community, was used to identify a minimum set of items important for reporting from the larger list. Out of 44 candidate items, 24 items and accompanying recommendations were developed, with some specific recommendations for single study-based and model-based economic evaluations. The final recommendations are subdivided into six main categories: 1) title and abstract, 2) introduction, 3) methods, 4) results, 5) discussion, and 6) other. The recommendations are contained in the CHEERS statement, a user-friendly 24-item checklist. The task force report provides explanation and elaboration, as well as an example for each recommendation. The ISPOR CHEERS statement is available online via Value in Health or the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices - CHEERS Task Force webpage (http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp). We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting, and ultimately, better health decisions. To facilitate wider dissemination and uptake of this guidance, we are copublishing the CHEERS statement across 10 health economics and medical journals. We encourage other journals and groups to consider endorsing the CHEERS statement. The author team plans to review the checklist for an update in 5 years. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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              Decision Modelling for Health Economic Evaluation

              In financially constrained health systems across the world, increasing emphasis is being placed on the ability to demonstrate that health care interventions are not only effective, but also cost-effective. This book deals with decision modelling techniques that can be used to estimate the value for money of various interventions including medical devices, surgical procedures, diagnostic technologies, and pharmaceuticals. Particular emphasis is placed on the importance of the appropriate representation of uncertainty in the evaluative process and the implication this uncertainty has for decision making and the need for future research. This highly practical guide takes the reader through the key principles and approaches of modelling techniques. It begins with the basics of constructing different forms of the model, the population of the model with input parameter estimates, analysis of the results, and progression to the holistic view of models as a valuable tool for informing future research exercises. Case studies and exercises are supported with online templates and solutions. This book will help analysts understand the contribution of decision-analytic modelling to the evaluation of health care programmes. [Ed.]
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: SupervisionRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                20 September 2021
                2021
                : 16
                : 9
                : e0257494
                Affiliations
                [1 ] Department of Applied Economics, Faculty of Economics, University of Castilla La Mancha, Albacete, Spain
                [2 ] Department of Hospital Pharmacy, Torrecárdenas Hospital Complex, Almería, Spain
                [3 ] Unit of Pain—Department of Anesthesiology, Torrecárdenas Hospital Complex, Almería, Spain
                [4 ] Department of Anesthesiology, Complejo Hospitalario Universitario, Albacete, Spain
                Universidad Nacional Autonoma de Nicaragua Leon, NICARAGUA
                Author notes

                Competing Interests: Dr. Selva-Sevilla and Dr. Cortiñas-Sáenz have nothing to disclose. Dr. Fernández-Ginés has a patent “Analgetic microspheres comprising a volatile halogenated anaesthetic” issued to Dámaso Fernández-Ginés. Dr. Gerónimo-Pardo owned stock options from Vapogenix Inc, and he had a personal interest in the issue since he started the repurposing process for the inhalation general anesthetic sevoflurane to be used as a topical analgesic. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                [¤a]

                Current address: Department of Hospital Pharmacy, Hospital La Inmaculada, Huércal Overa, Almería, Spain

                [¤b]

                Current address: Department of Anesthesiology, Hospital Universitario Virgen de las Nieves, Granada, Spain

                Author information
                https://orcid.org/0000-0001-9911-7572
                Article
                PONE-D-21-09306
                10.1371/journal.pone.0257494
                8452083
                4ec4910c-efc8-49c3-b78a-ae7e9a7f41d5
                © 2021 Selva-Sevilla et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 21 March 2021
                : 2 September 2021
                Page count
                Figures: 2, Tables: 5, Pages: 18
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Pain
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Ulcers
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Analgesics
                Medicine and Health Sciences
                Pain Management
                Analgesics
                Social Sciences
                Economics
                Economic Analysis
                Cost-Effectiveness Analysis
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pain Management
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Opioids
                Social Sciences
                Economics
                Health Economics
                Medicine and Health Sciences
                Health Care
                Health Economics
                Medicine and Health Sciences
                Health Care
                Health Care Facilities
                Hospitals
                Biology and Life Sciences
                Physiology
                Physiological Processes
                Tissue Repair
                Wound Healing
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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