Efficacy of a 3D Electrospun Synthetic Polymer Matrix on Hard-to-Heal Wounds.

INTRODUCTION: The aim of this study was to evaluate the efficacy of a 3D electrospun synthetic polymer matrix (3DESPM) on hard-to-heal wounds. MATERIALS AND METHODS: This prospective case series took place at four sites. The primary endpoints were the percentage area reduction (PAR) in wound area at four and eight weeks. Secondary endpoints included time to heal (Kaplan-Meier analysis) and the proportion of healed wounds at 12 weeks. After applying 3DESPM, the physician applied sterile saline, as appropriate, to adhere the matrix to the wound bed and facilitate the polymer degradation process. A nonadherent dressing, a secondary dressing, and additional bandages (as needed) were then applied. The physician left the product on the wound until complete degradation was observed, as appropriate, and reapplied, as appropriate. Combination advanced therapies were applied, per physician discretion. RESULTS: Thirty-eight patients (mean age: 64.3 years [SD: 17.6]) with 50 wounds (35 chronic, 70%) participated. The mean number of comorbidities per patient was 4.4 (2.3). All wounds received 3DESPM; 12 wounds (24%) received combination therapies; and 38 wounds (76%) completed the study. The mean (SD) PAR at four and eight weeks was 67.6% (38%) and 80% (35%), respectively. Thirty-three wounds (66%) healed at 12 weeks. The Kaplan-Meier mean time to heal for all wounds was 49.0 days (95% confidence interval: 41.3-56.7). CONCLUSIONS: In a complex patient population with severe comorbidities and heterogeneous wounds, 3DESPM appeared to accelerate the stalled healing process to contribute to wound closure. Further investigation of 3DESPM on a larger patient population and in a controlled setting is pending.

The Impact of Underlying Conditions on Quality-of-Life Measurement Among Patients with Chronic Wounds, as Measured by Utility Values: A Review with an Additional Study.

Significance: Quality of life (QoL) is important to patients with chronic wounds and is rarely formally evaluated. Understanding what comorbidities most affect the individual versus their wounds could be a key metric. Recent Advances: The last 20 years have seen substantial advances in QoL instruments and conversion of patient data to a single value known as the health utilities index (HUI). We review these advances, along with wound-related QoL, and analyze real-world comorbidities challenging wound care. Critical Issues: To understand the impact of underlying comorbidities in a real-world patient population, we examined a convenience sample of 382 patients seen at a hospital-based outpatient wound center. This quality reporting study falls outside the regulations that govern human subject research. Comorbid conditions were used to calculate HUIs using a variety of literature-reported approaches, while Wound-Quality-of-Life (W-QoL) questionnaire data were collected from patients during their first visit. The mean number of conditions per patient was 8; 229 patients (59.9%) had utility values for comorbidities/conditions, which were worse/lower than their wounds' values. Sixty-three (16.5%) patients had depression and/or anxiety, 64 (16.8%) had morbid obesity, and 204 (53.4%) had gait and mobility disorders, all of which could have affected W-QoL scoring. The mean minimum utility value (0.5) was within 0.05 units of an average of 13 studies reporting health utilities from wound care populations using the EuroQol 5 Dimension instrument. Future Directions: The comorbidity associated with the lowest utility value is what might most influence the QoL of patients with chronic wounds. This finding needs further investigation.

The prediction capability of a cataract surgery risk stratification model based on a large electronic medical record dataset.

Purpose: The aim of this study was to develop a risk stratification system that predicts visual outcomes (uncorrected corrected visual acuity at one week and five weeks postoperative) in patients undergoing cataract surgery. Methods: This was a retrospective analysis in a multitier ophthalmology network. Data from all patients who underwent phacoemulsification or manual small-incision cataract surgery between January 2018 and December 2019 were retrieved from an electronic medical record system. There were 122,911 records; 114,172 (92.9%) had complete data included. Logistic regression analyzed unsatisfactory postoperative outcomes using a main effects model only. The final model was cross-checked using forward stepwise selection. The Hosmer-Lemeshow goodness of fit test, the Bayesian information criterion, and Nagelkerke's R2 assessed model fit. Dispersion was calculated from deviance and degrees of freedom and C-stat from receiving operating characteristics analysis. Results: The final phacoemulsification model (n = 48,169) had a dispersion of 1.08 with a Hosmer-Lemeshow goodness of fit of 0.20, a Nagelkerke R2 of 0.19, and a C-stat of 0.72. The final manual small-incision cataract surgery model (n = 66,003) had a dispersion of 1.05 with a Hosmer-Lemeshow goodness of fit of 0.00015, a Nagelkerke R2 of 0.14, and a C-stat of 0.68. Conclusion: The phacoemulsification model had reasonable model fit; the manual small-incision cataract surgery model had poor fit and was likely missing variables. The predictive capability of these models based on a large, real-world cataract surgical dataset was suboptimal to determine which patients could benefit most from sight-restoring surgery. Appropriate patient selection for cataract surgery in developing settings should still rely on clinician thought processes, intuition, and experience, with more complex cases allocated to more experienced surgeons.

Update of a Simple Model to Calculate the Annual Global Productivity Loss Due to Blindness and Moderate and Severe Vision Impairment.

PURPOSE: To develop a simple but more precise model to calculate potential annual productivity losses due to blindness and moderate and severe vision impairment (MSVI) at the national, regional, and global level. METHODS: Productivity loss was defined as the loss of minimum wage/Gross National Income per capita (GNI) incurred by people aged 50-64 years with blindness or MSVI, who were not able to work or worked with reduced earnings in 2020. We developed a global list of minimum wage data from on-line sources. All other model data were sourced from international, standardised, and open-access databases. For blindness, the total productivity loss (not working) incurred by 64%-90% of the affected population was summed up with partial productivity loss, defined as 10%-36% of the affected population earning one-third of that of the sighted population. For MSVI, the total productivity loss for 30%-55% of the affected population was summed with the partial productivity loss, defined as 45%-70% of the affected population having 35% reduced earnings. The costs of blindness and MSVI were summed to obtain the cost of combined vision loss. RESULTS: The global cost of vision loss based on minimum wage was US$160-US$216.32 billion for 2020. The global cost of vision loss using GNI was US$449.36-US$584.66 billion. CONCLUSIONS: A parsimonious model that considers minimum wage and GNI potentially lost due to blindness and MSVI can be used for eye care programming planning and advocacy at the national, regional, and global level.

Meta-analysis of gender inequities in cataract surgical coverage in Latin America.

OBJECTIVE: To perform an updated meta-analysis of cataract surgical coverage (CSC) data in Latin American studies to confirm that gender equity exists in terms of receiving cataract surgery. MATERIALS AND METHODS: A literature search of Rapid Assessment of Avoidable Blindness (RAAB) studies in Latin American published since 2011 was done. Older studies from countries that did not have newer data published were also included. Using summary original study data of CSC rates on an individual basis, a random effects model of meta-analysis was performed to evaluate the differences in CSC between men and women. RESULTS: Nineteen studies from 17 countries were included (Mexico data were pooled). The odds ratios at a visual acuity (VA) of <3/60 and <6/18 were 1.04 [95% confidence interval (CI): 0.82-1.32] and 1.04 (95% CI: 0.90-1.19), respectively, without heterogeneity. There were no significant gender differences for CSC at any VA level. CONCLUSIONS: This updated meta-analysis of CSC data from Latin American countries supports that gender inequity in terms of receiving cataract surgery is not an issue in the region. The results do not provide insight into gender inequity in terms of the quality of cataract surgery and other types of eye care services.

OBJETIVO: Realizar un metaanálisis actualizado de la cobertura de cirugía de catarata en estudios latinoamericanos para confirmar que existe equidad de género en términos del acceso a cirugía de catarata. MATERIAL Y MÉTODOS: Se realizó una búsqueda de la literatura de "Rapid Assessments of Avoidable Blindness (Encuestas Rápida de Ceguera Evitable)" publicados en Latinoamérica desde el 2011. Se incluyeron también estudios anteriores de países que no tenían publicados datos más recientes. Utilizando el compendio de datos de los estudios originales de la cobertura de cirugía de catarata (Cataract Surgery Coverage, CSC por sus siglas en inglés) en base individual, se realizó un modelo de efectos aleatorios de metaanálisis para evaluar las diferencias en la CSC entre hombres y mujeres. RESULTADOS: Se incluyeron 19 estudios de 17 países (los datos de México fueron agrupados). La oportunidad relativa (razón de probabilidades) para una agudeza visual (AV) de <3/60 y <6/18 fueron de 1.04 [95% Intervalo de confianza (IC): 0.82-1.32] y 1.04 (95% IC: 0.90-1.19), respectivamente, sin heterogeneidad. No hubo diferencias significativas para la CSC a ningún nivel de AV. CONCLUSIONES: Este metaanálisis actualizado de la CSC de Latinoamérica, confirma que no existe inequidad de género en términos de acceso a cirugía de catarata en esta región.

The impact of the SARS-CoV-2 pandemic on the management of chronic limb-threatening ischemia and wound care.

In the wake of the coronavirus pandemic, the critical limb ischemia (CLI) Global Society aims to develop improved clinical guidance that will inform better care standards to reduce tissue loss and amputations during and following the new SARS-CoV-2 era. This will include developing standards of practice, improve gaps in care, and design improved research protocols to study new chronic limb-threatening ischemia treatment and diagnostic options. Following a round table discussion that identified hypotheses and suppositions the wound care community had during the SARS-CoV-2 pandemic, the CLI Global Society undertook a critical review of literature using PubMed to confirm or rebut these hypotheses, identify knowledge gaps, and analyse the findings in terms of what in wound care has changed due to the pandemic and what wound care providers need to do differently as a result of these changes. Evidence was graded using the Oxford Centre for Evidence-Based Medicine scheme. The majority of hypotheses and related suppositions were confirmed, but there is noticeable heterogeneity, so the experiences reported herein are not universal for wound care providers and centres. Moreover, the effects of the dynamic pandemic vary over time in geographic areas. Wound care will unlikely return to prepandemic practices. Importantly, Levels 2-5 evidence reveals a paradigm shift in wound care towards a hybrid telemedicine and home healthcare model to keep patients at home to minimize the number of in-person visits at clinics and hospitalizations, with the exception of severe cases such as chronic limb-threatening ischemia. The use of telemedicine and home care will likely continue and improve in the postpandemic era.

Assessing the uncertainty of treatment outcomes in a previous systematic review of venous leg ulcer randomized controlled trials: Additional secondary analysis.

In this secondary analysis of a previous systematic review, we assessed randomized controlled trials evaluating treatments of venous leg ulcers in terms of factors that affect risk of bias at the study level and thus uncertainty of outcomes obtained from the interventions. Articles that assessed the wound bed condition in venous leg ulcers and that were published in English between 1998 and May 22, 2018 were previously searched in PubMed, Embase, CINAHL, CENTRAL, Scopus, Science Direct, and Web of Science. Duplicates and retracted articles were excluded. The following data were extracted to assess the risk of bias: treatment groups; primary and secondary endpoints that were statistically tested between groups, including their results and p values; whether blinding of patients and assessors was done; whether allocation concealment was adequate; whether an intention-to-treat analysis was conducted; whether an appropriate power calculation was correctly done; and whether an appropriate multiplicity adjustment was made, as necessary. Pre- and post-study power calculations were made. The step-up Hochberg procedure adjusted for multiplicity. Results were analysed for all studies, pre-2013 studies, and 2013/post-2013 studies. We included 142 randomized controlled trials that evaluated 14,141 patients. Most studies lacked blinding (72.5-77.5%) and allocation concealment (88.7%). Only 49.3% of trials provided a power calculation, with 27.5% having an appropriate calculation correctly done. Adequate statistical power of the primary endpoint was found in 27.2% of trials. The lack of multiplicity adjustment in 98.6% of studies affected the uncertainty of outcomes in 20% of studies, with the majority of the secondary endpoints (67.7%) in those studies becoming non-significant after multiplicity adjustment. Recent studies tended to weakly demonstrate improved certainty of outcomes. Venous leg ulcer randomized controlled trials have a high degree of uncertainty associated with treatment outcomes. Greater attention to trial design and conduct is needed to improve the evidence base.

Publicly Reported Wound Healing Rates: The Fantasy and the Reality.

Significance: We compare real-world data from the U.S. Wound Registry (USWR) with randomized controlled trials and publicly reported wound outcomes and develop criteria for honest reporting of wound outcomes, a requirement of the new Quality Payment Program (QPP). Recent Advances: Because no method has existed by which wounds could be stratified according to their likelihood of healing among real-world patients, practitioners have reported fantastically high healing rates. The USWR has developed several risk-stratified wound healing quality measures for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) as part of its Qualified Clinical Data Registry (QCDR). This allows practitioners to report DFU and VLU healing rates in comparison to the likelihood of whether the wound would have healed. Critical Issues: Under the new QPP, practitioners must report at least one practice-relevant outcome measure, and it must be risk adjusted so that clinicians caring for the sickest patients do not appear to have worse outcomes than their peers. The Wound Healing Index is a validated risk-stratification method that can predict whether a DFU or VLU will heal, leveling the playing field for outcome reporting and removing the need to artificially inflate healing rates. Wound care practitioners can report the USWR DFU and VLU risk-stratified outcome measure to satisfy the quality reporting requirements of the QPP. Future Directions: Per the requirements of the QPP, the USWR will begin publicly reporting of risk-stratified healing rates once quality measure data have met the reporting standards of the Centers for Medicare and Medicaid Services. Some basic rules for data censoring are proposed for public reporting of healing rates, and others are needed, which should be decided by consensus among the wound care community.

The Hyperbaric Oxygen Therapy Registry: Driving quality and demonstrating compliance.

OBJECTIVE: To provide an update on the status of provider participation in the US Wound Registry (USWR) and its specialty registry the Hyperbaric Oxygen Therapy Registry (HBOTR), which provide much-needed national benchmarking and quality measurement services for hyperbaric medicine. METHODS: Providers can meet many requirements of the Merit-Based Incentive Payment System (MIPS) and simultaneously participate in the HBOTR by transmitting Continuity of Care Documents (CCDs) directly from their certified electronic health record (EHR) or by reporting hyperbaric quality measures, the specifications for which are available free of charge for download from the registry website as electronic clinical quality measures for installation into any certified EHR. Computerized systems parse the structured data transmitted to the USWR. Patients undergoing hyperbaric oxygen (HBO2) therapy are allocated to the HBOTR and stored in that specialty registry database. The data can be queried for benchmarking, quality reporting, public policy, or specialized data projects. RESULTS: Since January 2012, 917,758 clinic visits have captured the data of 199,158 patients in the USWR, 3,697 of whom underwent HBO2 therapy. Among 27,404 patients with 62,843 diabetic foot ulcers (DFUs) captured, 9,908 DFUs (15.7%) were treated with HBO2 therapy. Between January 2016 and September 2018, the benchmark rate for the 1,000 DFUs treated with HBO2 was 7.3%, with an average of 28 treatments per patient. There are 2,100 providers who report data to the USWR by transmitting CCDs from their EHR and 688 who submit quality measure data, 300 (43.6%) of whom transmit HBO2 quality data.

Field Testing Project to Pilot World Health Organization Eye Health Indicators in Latin America.

PURPOSE: To develop and implement mechanisms to collect, report, and assess the World Health Organization (WHO) core eye health indicators in Chile, Honduras, Mexico, Peru, and Uruguay. METHODS: Simple templates for a situational analysis (of data collection and reporting processes), a national data collection strategy, and a national work plan to implement the core eye health indicators were developed. Public and private sector representatives from the ministries of health (MOHs), national vision committees, and national societies of ophthalmology of each country used these tools with 2013 baseline data to improve their data collection processes and collected 2015 data. Final analysis and cross-validation were performed using intraocular lens sales data and last observation carried forward imputation. RESULTS: Study tools were effectively implemented in all five countries and resulted in improved intersectoral stakeholder collaboration and communications, which improved the data collection and reporting processes. More complete and accurate data were reported by 2015 compared to the 2013 baseline. CONCLUSIONS: Multisectoral stakeholders, including national professional societies and national vision committees, should collaborate with MOHs to improve the quality of data that are reported to WHO. This study involved these stakeholders in the data collection processes to better understand the realities of indicator implementation, better manage their expectations, and improve data quality. WHO Member States across the globe can feasibly adapt the study tools and methodologies to strengthen their data collection processes. Overall, the reliability and validity of the indicators is hampered with limitations that prevent fully accurate data from being collected.

Qualified Clinical Data Registries: How Wound Care Practitioners Can Make the Most Out of the Merit-Based Incentive Payment System.

Significance: Wound care practitioners have no professional society to promote participation in a Qualified Clinical Data Registry (QCDR), which is essential to thrive under the Merit-Based Incentive Payment System (MIPS), and until recently have lacked relevant quality measures to report. Practitioners can now participate in the nonprofit U.S. Wound Registry (USWR) QCDR for MIPS credit, which can receive data from any certified electronic health record (EHR) and, in so doing, generate data useful for comparative effectiveness research. Recent Advances: For 2018, the Centers for Medicare and Medicaid Services (CMS) has approved 12 wound care and hyperbaric medicine-relevant quality measures and several clinical practice Improvement Activities, which can be reported for MIPS credit through the USWR. Several QCDR measures have met the CMS 3-year reporting criteria to establish national benchmark rates, likely enabling practitioners to achieve higher quality scores than possible with standard MIPS measures. The structured registry data generated have been harnessed to evaluate adherence to evidence-based clinical practice guidelines, understand real-world patient healing rates, and demonstrate the comparative effectiveness of wound therapies. Critical Issues: Wound care practitioners can participate in a QCDR for MIPS credit, which enables them to optimize their MIPS score, particularly if they transmit data directly from their EHR. Utilizing structured data for comparative effectiveness research may help ensure patient access to advanced therapeutics. Future Directions: By 2019, to overcome technological barriers to participation, USWR quality measures will be available as "apps" for EHRs that support the interface required to achieve the next stage of EHR certification as part of the open Application Programming Initiative.

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records.

The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real-world data. Real-world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor-intensive paradigm. However, real-world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct-from-electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real-world data obtained directly from an electronic health record method. These standards are based on a point-of-care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point-of-care data capture, standardizes usual care linked to quality reporting, and prevents post-hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real-world data needed for comparative effectiveness research.

A new approach to clinical research: Integrating clinical care, quality reporting, and research using a wound care network-based learning healthcare system.

The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.

Systematic review of the current status of programs and general knowledge of diagnosis and management of retinoblastoma / Revisión sistemática del estado actual de los programas y conocimiento general de la diagnosis y manejo de retinoblastoma

Abstract: Background: This systematic review aims to report the current knowledge of retinoblastoma (Rb) and its implications in Mexico. We analyzed clinical and demographic data of patients with Rb at select hospitals with Rb programs or that treat and refer patients with Rb, and identified the gaps in practice. We propose solutions to improve diagnosis, provide adequate treatment, and improve patient uptake. Methods: A general review was conducted on PubMed of peer-reviewed literature on Rb in Mexico. Ophthalmology Department Heads or Directors of Rb programs at seven hospitals in Mexico were contacted for data available on their patients with Rb. Results: Five hospitals provided clinical data on 777 patients with Rb in a period spanning 2000-2015. Of the 122 patients with treatment, 83.4% underwent enucleation. From 33 to 45.3% of Rb tumors in Mexico reach an advanced intraocular stage of development. Knowledge of the disease is limited, despite the fact that the Mexican Retinoblastoma Group has elaborated Rb treatment guidelines and is developing a national Rb registry. Especially in the Southern states, prevalence and outcomes are comparable to African and Asian countries, and only few patients are referred to national treatment centers. Only three institutions have comprehensive Rb programs. Conclusions: There is an immediate need in Mexico to expand primary care providers' knowledge of Rb and to expand and upgrade current Rb programs to meet the needs of the population adequately. Diagnosis and care of Rb patients in Mexico can also be improved by the establishment of a national Rb registry and a national early detection program, and by increased use of the national treatment protocol.

Resumen: Introducción: Esta es una revisión sistemática de los conocimientos actuales del retinoblastoma (Rb) y sus implicaciones en los centros de referencia más importantes del país. Se presenta un análisis situacional de los programas de Rb en México, se identificaron las brechas en la práctica, y se proponen soluciones para mejorar el diagnóstico, tratamiento y referencia oportuna de pacientes. Métodos: Se realizó una revisión general de la literatura publicada sobre Rb en México a través de PubMed. Los datos sociodemográficos de pacientes con Rb fueron obtenidos a través de los directores de programas de retinoblastoma en siete hospitales. Resultados: Casi una tercera parte de los casos Rb se diagnostican en estadios avanzados. A pesar de la existencia del Grupo Mexicano de Retinoblastoma, el conocimiento de esta patología entre los médicos es limitado. Las diferencias en el tratamiento son notorias en el sur del país, donde la prevalencia y los resultados son comparables con África y Asia. Solamente tres instituciones a nivel nacional tienen un programa establecido de Rb. Conclusiones: Existe la necesidad inmediata de consolidar los programas de Rb para cubrir las necesidades reales de la población. Se requiere mejorar la educación del médico de primer contacto, establecer el registro nacional de casos y el programa de detección temprana, establecer los programas de salvamento ocular nacional, y reforzar las instituciones que brindan tratamiento.

Systematic review of the current status of programs and general knowledge of diagnosis and management of retinoblastoma.

BACKGROUND: This systematic review aims to report the current knowledge of retinoblastoma (Rb) and its implications in Mexico. We analyzed clinical and demographic data of patients with Rb at select hospitals with Rb programs or that treat and refer patients with Rb, and identified the gaps in practice. We propose solutions to improve diagnosis, provide adequate treatment, and improve patient uptake. METHODS: A general review was conducted on PubMed of peer-reviewed literature on Rb in Mexico. Ophthalmology Department Heads or Directors of Rb programs at seven hospitals in Mexico were contacted for data available on their patients with Rb. RESULTS: Five hospitals provided clinical data on 777 patients with Rb in a period spanning 2000-2015. Of the 122 patients with treatment, 83.4% underwent enucleation. From 33 to 45.3% of Rb tumors in Mexico reach an advanced intraocular stage of development. Knowledge of the disease is limited, despite the fact that the Mexican Retinoblastoma Group has elaborated Rb treatment guidelines and is developing a national Rb registry. Especially in the Southern states, prevalence and outcomes are comparable to African and Asian countries, and only few patients are referred to national treatment centers. Only three institutions have comprehensive Rb programs. CONCLUSIONS: There is an immediate need in Mexico to expand primary care providers' knowledge of Rb and to expand and upgrade current Rb programs to meet the needs of the population adequately. Diagnosis and care of Rb patients in Mexico can also be improved by the establishment of a national Rb registry and a national early detection program, and by increased use of the national treatment protocol.

Cost-effectiveness of negative pressure wound therapy in patients with many comorbidities and severe wounds of various etiology.

This study analyzed a cross-section of patients with severe chronic wounds and multiple comorbidities at an outpatient wound clinic, with regard to the cost-effectiveness and cost-benefit of negative pressure wound therapy (intervention) vs. no negative pressure wound therapy (control) at 1 and 2 years. Medicare reimbursement charges for wound care were used to calculate costs. Amputation charges were assessed using diagnosis-related groups. Cost-benefit analysis was based on ulcer-free months and cost-effectiveness on quality-adjusted life-years. Undiscounted costs, benefits, quality-adjusted life-years, undiscounted and discounted incremental net health benefits, and incremental cost-effectiveness ratios were calculated for unmatched and matched cohorts. There were 150 subjects in the intervention group and 154 controls before matching and 103 subjects in each of the matched cohorts. Time to heal for the intervention cohort was significantly shorter compared to the controls (270 vs. 635 days, p = 1.0 × 10-7 , matched cohorts). The intervention cohort had higher benefits and quality-adjusted life-year gains compared to the control cohort at years 1 and 2; by year 2, the gains were 68-73% higher. In the unmatched cohorts, the incremental net health benefit was $9,933 per ulcer-free month at year 2 for the intervention; the incremental cost-effectiveness ratio was -825,271 per quality-adjusted life-year gained (undiscounted costs and benefits). For the matched cohorts, the incremental net health benefits was only $1,371 per ulcer-free month for the intervention, but the incremental cost-effectiveness ratio was $366,683 per quality-adjusted life-year gained for year 2 (discounted costs and benefits). In a patient population with severe chronic wounds and serious comorbidities, negative pressure wound therapy resulted in faster healing wounds and was more cost-effective with greater cost-benefits than not using negative pressure wound therapy. Regarding overall cost-effectiveness, the intervention was still expensive, but that is the reality amidst limited treatment options for such serious cases of chronic wounds.