Cost-effectiveness analysis of the geko™ device (an NMES technology) in managing venous leg ulcers in UK healthcare settings.

This study evaluates the cost-effectiveness of the geko device a neuromuscular electro-stimulator technology with standard of care (SoC) versus SoC alone for venous leg ulcer (VLU) treatment, from the UK National Health Service (NHS) perspective over 12 months. Research was conducted across NHS UK facilities, primarily within community services and outpatient leg ulcer clinics, encompassing a total of 51 patients. A partitioned survival model, based on a two-arm randomised controlled trial, assessed wound healing rates using Kaplan-Meier curves and parametric extrapolations over a 12-month time horizon. Costs were derived from UK reference costs the British National Formulary, and the Personal Social Services Research Unit (2021/22). The primary outcome measured was the incremental cost per quality-adjusted life-year gained. The geko device provides additional benefits by stimulating the lateral popliteal nerve, augmenting venous, arterial, and microvascular flow. The addition of the geko device to SoC significantly enhanced outcomes, increasing healing probability by 68% compared to SoC. This integration would result in a cost saving of £774.14 per patient when compared to the SoC alone across the NHS. Economic analyses indicate that integrating the geko device into SoC protocols would reduce the overall NHS expenditure on VLU wound management by as much as 15%. The approach also positively impacted health-related quality of life. The geko™ device when used adjunctively with SoC would be a cost-effective method for managing chronic VLUs within the NHS, improving healing rates and offering economic benefits.

Impact of primary dressings on healing of venous leg ulcers: a French cohort study from the healthcare insurance database.

OBJECTIVE: Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs. METHOD: Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period. RESULTS: In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used. CONCLUSION: This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.

Effectiveness of the Use of the Human Recombinant Epidermal Growth Factor in the Subsidized Regime vs The Contributive Regime in Patients with Venous Ulcers in Bogotá.

Introduction: Vascular ulcers constitute a serious global public health problem, responsible for causing a significant social and economic impact due to their recurrent, disabling nature and the need for prolonged therapies to cure them. Objective: To evaluate the use and efficacy of the rhEGF in the epithelialization of patients with a diagnosis of CEAP stage 6 venous insufficiency, in the two regimes of the health system in Colombia, the contributive (equivalent to a health system where citizens with payment capacity contribute a percentage of their salary) and the subsidized (equivalent to a health system where the state covers the vulnerable population and low socioeconomic level) versus the other treatments used. Methodology: Observational, descriptive, retrospective, multicenter study, in which 105 medical records with 139 ulcers were reviewed, in 2 centers, one belonging to the subsidized system and the other to the contributive system in Colombia. Results: The association with the epithelialization variable of the different treatment groups for ulcers according to the application of the mixed effect model test, for both regimes was for the Biologicals (EC 34.401/p = 0.000), Bioactive Agents (Hydrogels) (EC 24.735/p = 0.005) groups; for the rest of the treatment groups, the results were neither associated nor statistically significant. Conclusion: Intra- and perilesional therapy with rhEGF expands the therapeutic spectrum in patients with venous ulcers, regardless of the type of health system in which it will be applied, shortening the healing time and reaching a possible therapeutic goal, which according to this study there is an association with epithelialization regardless of the regime applied.

The economic impact of infection requiring hospitalization on venous leg ulcers.

OBJECTIVE: To determine the impact of infection (INF) on medical resource utilization (MRU) and cost of care in patients with venous leg ulcers (VLU). METHODS: We performed a retrospective case-control study of 78 patients followed for a minimum of 12 months with C6 VLUs treated by vascular surgeons, at our wound center. To eliminate minor episodes of INF or incorrectly diagnosed episodes, only patients who had an inpatient admission specifically for INF comprised the INF group, whereas all other admissions were excluded for this group. MRU was defined as the number of clinic visits, Visiting Nurse Association (VNA) visits, and inpatient admissions. The actual cost for treatment was determined using financial data provided by both the hospital and physician organization billing units. The total cost over the 1-year follow-up period comprised individual cost centers: inpatient and outpatient facility fees, physician fees, and visiting nurse services. Mean MRU and cost data were compared using the two-sample t-test between INF and NON-INF. RESULTS: Of the 78 patients with C6 VLU, 9 (11.5%) had at least one inpatient admission for INF related to their VLU in the 1-year treatment period, with an additional five recurrent admissions for a total of 14 admissions, whereas 69 NON-INF had three NON-INF-related admissions. There was no difference between INF and NON-INF for usual risk factors, but INF had a greater proportion of congestive heart failure (44%; 13%, P < .02). Regarding MRU, both the number of outpatient wound center visits (INF 16.89 ± 6.41; NON-INF 9.46 ± 7.7, P = .008) and VNA blocks (INF 3.89 ± 2.93; NON-INF 1.94 ± 2.24, P < .02) were greater for INF. Total costs for INF ($27,408 ± $10,859) were threefold higher than those for NON-INF ($11,088 ± $9343, P < .0001) and subsequent VNA costs were doubled for INF ($9956 ± $4657) vs NON-INF ($4657 ± $5486, P = .01). CONCLUSIONS: INFs in patients with VLU led to an overall increase in MRU and cost of care, with the INF cohort requiring more inpatient admissions, outpatient visits, and VNA services than NON-INF. Given the major impact INF has on cost and MRU, better treatment modalities that prevent INF as well as identifying risk factors for INF in patients with VLU are needed.

Human Wound and Its Burden: Updated 2020 Compendium of Estimates.

Significance: Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the United States and the management of wounds has a significant economic impact on health care. Given the aging population, the continued threat of diabetes and obesity worldwide, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial clinical, social, and economic challenge. In 2020, the coronavirus disease (COVID) pandemic dramatically disrupted health care worldwide, including wound care. A chronic nonhealing wound (CNHW) is typically correlated with comorbidities such as diabetes, vascular deficits, hypertension, and chronic kidney disease. These risk factors make persons with CNHW at high risk for severe, sometimes lethal outcomes if infected with severe acute respiratory syndrome coronavirus 2 (pathogen causing COVID-19). The COVID-19 pandemic has impacted several aspects of the wound care continuum, including compliance with wound care visits, prompting alternative approaches (use of telemedicine and creation of videos to help with wound dressing changes among others), and encouraging a do-it-yourself wound dressing protocol and use of homemade remedies/substitutions. Recent Advances: There is a developing interest in understanding how the social determinants of health impact the QoL and outcomes of wound care patients. Furthermore, addressing wound care in the light of the COVID-19 pandemic has highlighted the importance of telemedicine options in the continuum of care. Future Directions: The economic, clinical, and social impact of wounds continues to rise and requires appropriate investment and a structured approach to wound care, education, and related research.

Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial.

Importance: One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective: To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants: Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions: Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures: The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results: The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance: Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration: ClinicalTrials.gov identifier: ISRCTN02335796.

Treatment of venous leg ulcers using bilayered living cellular construct.

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients' physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.

Venous stenting for patients with outflow obstruction and leg ulcers: cost-effectiveness and budget impact analyses.

Aim: To perform cost-effectiveness analysis (CEA) and budget impact analysis (BIA) comparing stenting to standard medical treatment (SMT) for the management of deep venous outflow obstruction and leg ulcers from the Italian Healthcare Service perspective. Materials & methods: A Markov model was developed to project costs and quality-adjusted life-years (QALYs) over 3 years, based on data from literature combined with real-world data. Moreover, a BIA was performed comparing the current scenario (100% SMT) with increasing utilization rates of stenting over SMT from 0.5 to 5%, in the next 5 years. Results: Stenting is a cost-effective (incremental cost-utility ratio €12,388/QALY) or dominant option versus SMT, according to in-patient or day-hospital settings, respectively. Increasing use of stenting over SMT, in the next 5 years, is expected to yield additional costs of 39.5 million Euros (in-patient) or savings of 5.1 million Euros (day-hospital). Conclusion: Stenting is a cost-effective option compared with SMT for patients with deep vein occlusion and ulceration in Italy.

Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial.

BACKGROUND: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial. METHODS: Patients with VLUs measuring 1.5 to 50 cm2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group. RESULTS: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively). CONCLUSIONS: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs.

Cost of managing patients with venous leg ulcers.

The aim of this study was to estimate costs associated with the management of patients with venous leg ulcers (VLUs) from the perspective of the UK National Health Service (NHS). The analysis was undertaken through the Secure Anonymised Information Linkage Databank which brings together and anonymously links a wide range of person-based data from around 75% of general practitioner (GP) practices within Wales (population coverage ~2.5 million). The data covered an 11-year period from 2007 to 2017. All patients linked to the relevant codes were tracked through primary care settings, recording the number of GP practice visits (number of days with an event recorded), and wound treatment utilisation (eg, dressings, bandages, etc.) Resources were valued in monetary terms (£ sterling) and the costs were determined from national published sources of unit costs. This is the first attempt to estimate the costs of managing of VLUs using routine data sources. The direct costs to the Welsh NHS are considerable and represent 1.2% of the annual budget. Nurse visits are the main cost driver with annual estimates of £67.8 million. At a UK level, these costs amount to £1.98 billion. Dressings and compression bandages are also major cost drivers with annual Welsh estimates of £828 790. The direct cost of managing patients with VLUs is £7706 per patient per annum, which translates to an annual cost of over £2 billion, when extrapolated to the UK population. The primary cost driver is the number of district nurse visits. Initiatives to reduce healing times through improving accuracy of initial diagnosis, and improved evidence-based treatment pathways would result in major financial savings.

A Cost-Effectiveness Analysis Comparing Single-use and Traditional Negative Pressure Wound Therapy to Treat Chronic Venous and Diabetic Foot Ulcers.

Lower extremity ulcers such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) have a major clinical and economic impact on patients and providers. PURPOSE: The purpose of this economic evaluation was to determine the cost-effectiveness of single-use negative pressure wound therapy (sNPWT) compared with traditional NPWT (tNPWT) for the treatment of VLUs and DFUs in the United States. METHODS: A Markov decision-analytic model was used to compare the incremental cost and ulcer weeks avoided for a time horizon of 12 and 26 weeks using lower extremity ulcer closure rates from a published randomized controlled trial (N = 161) that compared sNPWT with tNPWT. Treatment costs were extracted from a retrospective cost-minimization study of sNPWT and tNPWT from the payer perspective using US national 2016 Medicare claims data inflated to 2018 costs and multiplied by 7 to estimate the weekly costs of treatment for sNPWT and tNPWT. Two (2) arms of the model, tNPWT and sNPWT, were calculated separately for a combination of both VLU and DFU ulcer types. In this model, a hypothetical cohort of patients began in the open ulcer health state, and at the end of each weekly cycle a proportion of the cohort moved into the closed ulcer health state according to a constant transition probability. The costs over the defined timescale were summed to give a total cost of treatment for each arm of the model, and then the difference between the arms was calculated. Effectiveness was calculated by noting the incidence of healing at 12 and 26 weeks and the total number of open ulcer weeks; the incremental effectiveness was calculated as sNPWT effectiveness minus tNPWT effectiveness. Data were extracted to Excel spreadsheets and subjected to one-way sensitivity, scenario (where patients with unhealed ulcers were changed to standard care at 4 or 12 weeks), probabilistic, and threshold analyses. RESULTS: sNPWT was found to provide an expected cost saving of $7756 per patient and an expected reduction of 1.67 open ulcer weeks per patient over 12 weeks and a cost reduction of $15 749 and 5.31 open ulcer weeks over 26 weeks. Probabilistic analysis at 26 weeks showed 99.8% of the simulations resulted in sNPWT dominating tNPWT. Scenario analyses showed that sNPWT remained dominant over tNPWT (cost reductions over 26 weeks of $2536 and $7976 per patient, respectively). CONCLUSION: Using sNPWT for VLUs and DFUs is likely to be more cost-effective than tNPWT from the US payer perspective and may provide an opportunity for policymakers to reduce the economic burden of lower extremity ulcers.

Clinical and Economic Impact of a Two-layer Compression System for the Treatment of Venous Leg Ulcers: A Systematic Review.

OBJECTIVE: This study evaluates the clinical and cost effectiveness of a 2-layer compression system (2LBA; 3M Coban Two-Layer Compression System; 3M, St Paul, MN) compared with other 2-layer (2LB) and 4-layer (4LB) compression systems in patients with noninfected venous leg ulcers (VLUs). METHODS: The MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation, and EconLit databases were searched from inception up to January 2017. The MEDLINE search was updated on March 31, 2017. Study selection, quality assessment, and data synthesis were undertaken in accordance with recommended standards. Findings were presented narratively. RESULTS: In total, 5 studies (N = 1509 patients) of mixed methodological quality were included. At 6 months, 2LBA achieved better ulcer healing in comparison with 2LBB (odds ratio [OR], 1.57; 95% confidence interval [CI], 1.10-2.24; P = .03) and 4LBA (OR, 1.93, 95% CI, 1.26-2.97; P = .05) in patients with newly diagnosed ulcers only. For a combined population with newly diagnosed and existing VLUs, healing outcomes were OR, 2.87; 95% CI, 1.06-7.77; P = .04, and OR, 16.51; 95% CI, 2.08-131.37; P = .008, for 2LBs and 4LBs, respectively. Results on slippage were inconclusive. Adverse events were infrequent and did not differ significantly between interventions. Lower 6-month NHS costs for the combined population (£2413 vs. £2707 or £2648) and for newly diagnosed patients (£3045 vs. £3842 or £4480) were observed comparing 2LBA with 2LBB or 4LBA. Also, 2LBA was associated with better health-related quality of life (HRQoL) at 6 months. CONCLUSIONS: Based on these findings, 2LBA may result in lower treatment costs and better ulcer healing and HRQoL compared with other multicomponent therapies, especially in patients with newly diagnosed VLUs. However, further high-quality research is needed, especially for outcomes such as slippage and bandage wear time.

Updated leg ulcer pathway: improving healing times and reducing costs.

Regardless of the amount of literature and evidence on leg ulcer management, there are still significant variations in treatment. Implementing a standardised leg ulcer pathway to ensure patients are appropriately and timely assessed could help reduce nursing time and overall costs, while improving healing outcomes and patients' quality of life. Such a pathway was introduced in Lincolnshire and Leicestershire, UK, to treat venous leg ulcers (VLUs). The results showed improved healing times, reduced costs and fewer nurse visits, among other findings.

A Descriptive Revenue Analysis of a Wound-Center IR Collaboration to Treat Lower Extremity Venous Ulcers.

PURPOSE: To describe the revenue from a collaboration between a dedicated wound care center and an interventional radiology (IR) practice for venous leg ulcer (VLU) management at a tertiary care center. MATERIALS AND METHODS: This retrospective study included 36 patients with VLU referred from a wound care center to an IR division during the 10-month active study period (April 2017 to January 2018) with a 6-month surveillance period (January 2018 to June 2018). A total of 15 patients underwent endovascular therapy (intervention group), whereas 21 patients did not (nonintervention group). Work relative value units (wRVUs) and dollar revenue were calculated using the Centers for Medicare and Medicaid Services Physician Fee Schedule. RESULTS: Three sources of revenue were identified: evaluation and management (E&M), diagnostic imaging, and procedures. The pathway generated 518.15 wRVUs, translating to $37,522. Procedures contributed the most revenue (342.27 wRVUs, $18,042), followed by E&M (124.23 wRVUs, $8,881), and diagnostic imaging (51.65 wRVUs, $10,599). Intervention patients accounted for 86.7% of wRVUs (449.48) and 80.0% of the revenue ($30,010). An average of 33 minutes (38.3 hours total) and 2.06 hours (36.8 hours total) were spent on E&M visits and procedures, respectively. CONCLUSIONS: In this collaboration between the wound center and IR undertaken to treat VLU, IR and E&M visits generated revenue and enabled procedural and downstream imaging revenue.

Compression Stockings for the Prevention of Venous Leg Ulcer Recurrence: A Health Technology Assessment.

BACKGROUND: People with chronic venous insufficiency who develop leg ulcers face a difficult condition to treat. Venous leg ulcers may persist for long periods of time and have a negative impact on quality of life. Treatment requires frequent health care provider visits, creating a substantial burden across health care settings.The objective of this health technology assessment was to evaluate the effectiveness, safety, cost-effectiveness, budget impact, and patient experiences of compression stockings for prevention of venous leg ulcer recurrence. METHODS: We conducted a systematic review of the literature to identify randomized trials and observational studies examining the effectiveness of compression stockings in reducing the risk of recurrence of venous leg ulcers after healing and/or reported on the quality of life for patients and any adverse events from the wearing of compression stockings. We performed a literature search to identify studies and evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.We conducted a cost-utility analysis with a 5-year time horizon from the perspective of the Ontario Ministry of Health and Long-Term Care. We compared compression stockings to usual care (no compression stockings) and simulated a hypothetical cohort of 65-year-old patients with healed venous ulcers, using a Markov model. Model input parameters were obtained primarily from the published literature. In addition, we used Ontario costing sources and consultation with clinical experts. We estimated quality-adjusted life years gained and direct medical costs. We conducted sensitivity analyses and a budget impact analysis to estimate the additional costs required to publicly fund compression stockings in Ontario. All costs are presented in 2018 Canadian dollars.We spoke to people who recently began using compression stockings and those who have used them for many years to gain an understanding of their day-to-day experience with the management of chronic venous insufficiency and compression stockings. RESULTS: One randomized controlled trial reported that the recurrence rate was significantly lower at 12 months in people who were assigned to the compression stocking group compared with people assigned to the control group (risk ratio 0.43, 95% CI, 0.27-0.69; P = .001) (GRADE: Moderate). Three randomized controlled trials reported no significant difference in recurrence rates between the levels of pressure. One randomized controlled trial also reported that the risk of recurrence was six times higher in those who did not adhere to compression stockings than in those who did adhere. One single-arm cohort study showed that the recurrence rate was considerably higher in people who did not adhere or had poor adherence (79%) compared with those who adhered to compression stockings (4%).Compared with usual care, compression stockings were associated with higher costs and with increased quality-adjusted life years. We estimated that, on average, the incremental cost-effectiveness ratio of compression stockings was $27,300 per quality-adjusted life year gained compared to no compression stockings. There was some uncertainty in our results, but most simulations (> 70%) showed that the incremental cost-effectiveness ratio remained below $50,000 per quality-adjusted life-year. We estimated that the annual budget impact of funding compression stockings would range between $0.95 million and $3.19 million per year over the next five years.People interviewed commonly reported that chronic venous insufficiency had a substantial impact on their day-to-day lives. There were social impacts from the difficulty or inability to walk and emotional impacts from the loss of independence and fear of ulcer recurrence. There were barriers to the wearing of compression stockings, including replacement cost and the difficulty of putting them on; however, most people interviewed reported that using compression stockings improved their condition and their quality of life. CONCLUSIONS: The available evidence shows that, compared with usual care, compression stockings are effective in preventing venous leg ulcer recurrence and likely to be cost-effective. In people with a healed venous leg ulcer, wearing compression stockings helps to reduce the risk of recurrence by about half. Publicly funding compression stockings for people with venous leg ulcers would result in additional costs to the Ontario health care system over the next 5 years. Despite concerns about cost and the daily chore of wearing compression stockings, most people interviewed felt that compression stockings provided important benefits through reduction of swelling and prevention of recurrence.

Measuring costs and quality of life for venous leg ulcers.

Venous leg ulcers (VLUs) result in substantial economic costs and reduced quality of life (QoL); however, there are few Australian cost estimates, especially using patient-level data. We measured community-setting VLU management costs and the impact on the QoL of affected individuals. VLU patients were recruited from a specialist wound clinic, an outpatient clinic, and two community care clinics in Queensland. Cost data were collected at the baseline visit. QoL (EQ-5D-5L) and wound status data were collected at baseline, 1, 3, and 6 months. Patients were classified into guideline-based/optimal care and usual care groups. Average weekly costs per patient were statistically significantly different between the usual care and optimal care groups-$214.61 and $294.72, respectively (P = 0.04). Baseline average QoL score for an unhealed ulcer was significantly higher in the optimal care group compared with usual care (P = 0.025). Time to healing differed between the usual care group and the optimal care group (P = 0.04), with averages of 3.9 and 2.7 months, respectively. These findings increase the understanding of the costs, QoL, and healing outcomes of VLU care. Higher optimal care costs may be offset by faster time to healing. This study provides data to inform an economic evaluation of guideline-based care for VLUs.

Cost-effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia.

BACKGROUND: Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia. METHODS: A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results. RESULTS: Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings. CONCLUSIONS: This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.

Cost-effectiveness of an electroceutical device in treating non-healing venous leg ulcers: results of an RCT.

OBJECTIVE: To estimate the cost-effectiveness of an externally applied electroceutical (EAE) device, Accel-Heal, in treating non-healing venous leg ulcers (VLUs) in the UK. METHOD: This was a prospective, randomised, double-blind, placebo-controlled, multi-centre study of patients aged ≥18 years with a non-healing VLU. Patients were randomised in the ratio of 1:1 to receive six units of the EAE (consisting of a self-contained, programmed electric microcurrent generator and two skin contact pads) or an identical-looking placebo device over 12 consecutive days. Patients were followed-up for 24 weeks from randomisation, during which time patients received wound care according to the local standard care pathway, completed health-related quality of life (HRQoL) instruments, and health-care resource use was measured. The cost-effectiveness of the EAE device was estimated at 2015/16 prices in those patients who fulfilled the study's inclusion and exclusion criteria (economic analysis population). RESULTS: At 24 weeks after randomisation, 34% and 30% of VLUs in the EAE and placebo groups in the economic analysis population, respectively, had healed. The time-to-healing was a mean of 2.6 and 3.5 months in the EAE and placebo groups, respectively. The area of the wounds that healed in the EAE group was nearly twice that of those in the placebo group (mean: 13.3 versus 7.7cm2 per VLU). Additionally, the pre-randomised duration of the wounds that healed in the EAE group was double that of those in the placebo group (mean: 2.6 versus 1.2 years per VLU). By the end of the study, EAE-treated patients reported less pain, more social functioning and greater overall wellbeing/satisfaction than placebo-treated patients. None of these differences reached statistical significance, but they may be important to patients. There were no significant differences in health-care resource use between the two groups. The incremental cost per quality-adjusted life year (QALY) gained with the EAE device was £4480 at eight weeks, decreasing to £2265 at 16 weeks and -£2388 (dominant) at 24 weeks. The study was confounded by unwarranted variation in patient management between centres and between individual clinicians within each centre. CONCLUSION: Despite the unwarranted variation in the provision of wound care observed in this study, the use of the EAE device resulted in some improved clinical outcomes and patient-reported outcomes, for the same or less cost as standard care, by 24 weeks. Clinicians managing VLUs may wish to consider the findings from this study when making treatment decisions.