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.

Compression for Primary Prevention, Treatment, and Prevention of Recurrence of Venous Leg Ulcers: An Evidence-and Consensus-Based Algorithm for Care Across the Continuum.

Chronic venous insufficiency is a prevalent disease that frequently leads to development of venous leg ulcers. While a number of evidence-based clinical practice guidelines have been developed that provide guidance for clinicians when caring for patients with chronic venous insufficiency, they lack adequate detail concerning selection and application of compression for prevention and management of venous leg ulcers. In order to address this need, the WOCN Society appointed a task force to develop an algorithm for compression for primary prevention, treatment, and prevention of recurrent venous leg ulcers in persons with chronic venous insufficiency. The task force used findings from a scoping literature review to identify current best evidence needed to support decision points and pathways within the algorithm. In addition, the task force convened a panel of 20 clinicians and researchers with expertise in lower extremity venous disorders in order to establish consensus around pathways and decision points within the algorithm lacking robust evidence. Following initial construction of the algorithm, a second interdisciplinary group of expert clinicians established content validity and provided additional qualitative feedback used to complete final revisions of the algorithm. This article reviews the process used to create this landmark algorithm, including generation of the evidence- and consensus-based statements used in its construction, the various pathways, and rich supplemental materials embedded within the algorithm, and the process used to establish content validity.

Subjective and objective assessment of patients' compression therapy skills as a predicator of ulcer recurrence.

AIMS AND OBJECTIVES: To verify whether the subjectively and objectively assessed patient's skills in applying compression therapy constitute a predicting factor of venous ulcer recurrence. BACKGROUND: Systematic implementation of compression therapy by the patient is a core of prophylaxis for recurrent ulcers. Therefore, patient education constitutes a significant element of care. However, controversies remain if all individuals benefit equally from education. DESIGN: A retrospective analysis. METHODS: The study included medical records of patients with venous ulcers (n = 351) treated between 2001 and 2011 at the Clinic for Chronic Wounds at Bydgoszcz Clinical Hospital. We compared two groups of patients, (1) with at least one episode of recurrent ulcer during the five-year observation period, and (2) without recurrences throughout the analysed period in terms of their theoretical skills and knowledge on compression therapy recorded at baseline and after one month. RESULTS: Very good self-assessment of a patient's compression therapy skills and weak assessment of these skills by a nurse proved significant risk factors for recurrence of the ulcers on univariate analysis. The significance of these variables as independent risk factors for recurrent ulcers has been also confirmed on multivariate analysis, which also took into account other clinical parameters. CONCLUSIONS: Building up proper compression therapy skills among the patients should be the key element of a properly construed nurse-based prophylactic program, as it is the most significant modifiable risk factor for recurrent ulcers. Although the development of compression skills is undeniably important, also other factors should be considered, e.g. surgical correction of superficial reflux. RELEVANCE TO CLINICAL PRACTICE: Instruction on compression therapy should be conducted by properly trained nursing personnel - the nurses should have received both content and psychological training. The compression therapy training should contain practical instruction with guided exercises and in-depth objective assessment of the effects of the training.

[Prevention of leg ulcer]. / Prevencija potkoljenicnog vrijeda.

Lower leg ulcers is the most common form of ulceration of the lower extremities. The prevalence of leg ulcer varies among studies from 0.1% to 0.6%. In the majority of studies, 1% of the population develop leg ulcer at least once in lifetime. The prevalence is higher in elderly people. There are several hypotheses used to explain the pathophysiological steps leading from the popliteal venous hypertension in value. Currently, the treatment of leg ulcer relies on due knowledge of ulcer pathophysiology and making an accurate diagnosis. Venous disease has a significant impact on quality of life and work productivity. In addition, costs associated with the prevention and treatment of lower leg ulcers are significant.

Endovenous thermal ablation for healing venous ulcers and preventing recurrence.

BACKGROUND: Venous leg ulcers represent the worst extreme within the spectrum of chronic venous disease. Affecting up to 3% of the adult population, this typically chronic, recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The current mainstay of treatment for venous leg ulcers is compression therapy, which has been shown to enhance ulcer healing rates. Open surgery on the veins in the leg has been shown to reduce ulcer recurrence rates, but it is an unpopular option and many patients are unsuitable. The efficacy of the newer, minimally-invasive endovenous thermal techniques has been established in uncomplicated superficial venous disease, and these techniques are now beginning to be used in the management of venous ulceration, though the evidence for this treatment is currently unclear. It is hypothesised that, when used with compression, ablation may further reduce pressures in the leg veins, resulting in improved rates of healing. Furthermore, since long-term patient concordance with compression is relatively poor, it may prove more popular, effective and cost-effective to provide a single intervention to reduce recurrence, rather than life-long treatment with compression. OBJECTIVES: To determine the effects of superficial endovenous thermal ablation on the healing, recurrence and quality of life of people with active or healed venous ulcers. SEARCH METHODS: In August 2013 we searched Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions on the language of publication but there was a date restriction based on the fact that superficial endovenous thermal ablation is a comparatively new medical technology. SELECTION CRITERIA: Randomised clinical trials comparing endovenous thermal ablative techniques with compression therapy alone for venous leg ulcers were eligible for inclusion. Trials had to report on at least one objective measure of ulcer healing (primary outcome) such as proportion of ulcers healed at a given time point, time to complete healing, change in ulcer size, proportion of ulcers recurring over a given time period, or at a specific point, and ulcer-free days. Secondary outcomes sought included patient-reported quality of life, economic data and adverse events. DATA COLLECTION AND ANALYSIS: Details of potentially eligible studies were extracted and summarised using a data extraction table. Data extraction and validity assessment were performed independently by two review authors, and any disagreements resolved by consensus or by arbitration of a third review author. MAIN RESULTS: No eligible randomised controlled trials were identified. There is an absence of evidence regarding the effects of superficial endovenous thermal ablation on ulcer healing, recurrence or quality of life of people with venous leg ulcer disease. AUTHORS' CONCLUSIONS: The review identified no randomised controlled trials on the effects on ulcer healing, recurrence or quality of life, of superficial endovenous thermal ablation in people with active or healed venous leg ulcers. Adequately-powered, high quality randomised controlled trials comparing endovenous thermal ablative interventions with compression therapy are urgently required to explore this new treatment strategy. These should measure and report outcomes that include time to ulcer healing, ulcer recurrence, quality of life and cost-effectiveness.

Cuidados às pessoas com úlcera venosa: percepção dos enfermeiros da estratégia de saúde da família / Care for people with venous ulcers: the perception of nurses in the family health strategy / Atención a personas con úlceras varicosas: percepción de los enfermeros de la estrategia salud de la familia

Trata-se de um estudo descritivo com abordagem qualitativa, cujos objetivos foram identificar o conhecimento dos enfermeiros das Equipesde Saúde da Família (ESF) do distrito sanitário III de Uberaba-MG sobre os cuidados necessários às pessoas portadoras de úlcera venosa edescrever suas percepções. Após a aprovação no Comitê de Ética, os dados foram coletados com 16 enfermeiros, por meio de entrevistasemiestruturada. Utilizou-se a técnica de análise por Bardin. Na análise dos dados, surgiram três categorias: conhecimento adequado,conhecimento insuficiente e desconhecimento, relacionados ao conhecimento sobre úlcera venosa, seus cuidados, orientações e abordagemintegral do portador. O conhecimento específico do profissional, sua capacitação, as melhores condições de trabalho, a utilização daintegralidade e a adoção de um protocolo são essenciais para o aprimoramento dos cuidados da pessoa com úlcera venosa, diminuindo,assim, o tempo de cicatrização e os índices de recidiva.

This is a descriptive study with a qualitative approach, aimed at identifying the knowledge of nurses in the Family Health Teams (FHT) from theThird Health District of Uberaba, Minas Gerais, with regard to the necessary care given to people that suffer from venous ulcers and describingtheir perceptions. After receiving approval by the Ethics Committee, the data were collected from sixteen nurses through semi-structuredinterviews. The Bardin analysis technique was used. Three categories were set up for data analysis – sufficient knowledge, insufficient knowledge,and lack of knowledge – all concerning knowledge about venous ulcers, how to care for them, guidance, and comprehensive approaches to thepatient. The nurses’ specific knowledge, their training, best working conditions, the use of integral health care, and the adoption of a protocolare essential to improved care for patients with venous ulcers, thus reducing the healing time and recurrence rates.

Se trata de un estudio descriptivo con enfoque cualitativo cuyo objetivo fue identificar el conocimiento de enfermeras de los Equipos de Salud de la Familia(ESF) del distrito sanitario III de Uberaba-MG acerca de los cuidados necesarios a personas con úlceras venosas y describir sus percepciones. Después de laaprobación de la investigación por parte del Comité de Ética, los datos fueron recogidos con 16 enfermeras, a través de entrevistas semiestructuradas. Se utilizóla técnica de análisis de Bardin. Al analizar los datos se consideraron tres categorías: conocimiento adecuado, conocimiento suficiente y desconocimiento,relacionados con el conocimiento sobre úlcera venosa, sus cuidados atención, orientación y enfoque global del paciente. El conocimiento específico delprofesional, su capacitación y la adopción de un protocolo son esenciales para mejorar la atención de estos pacientes con miras a disminuir el tiempo decicatrización y los índices de reincidencia.

Why insurers should reimburse for compression stockings in patients with chronic venous stasis.

BACKGROUND: Chronic venous stasis ulcers produce substantial morbidity rates and result in a significant expense to society. Fortunately, compression stockings (CS) have been found to reduce the rate of recurrence in patients with previous ulceration. Surprisingly, Medicare and other insurers do not reimburse the expense associated with CS or with patient education (Ed), which is essential to ensure compliance. METHODS: A Markov decision analysis model was used for analysis of the cost-effectiveness of a strategy of reimbursement for CS and Ed (prophylaxis) versus one that does not supply these resources in a 55-year-old patient with prior venous stasis ulceration. The mean time to ulcer recurrence (53 months with CS+Ed; 18.7 months without prophylaxis), the mean time for ulcer healing (4.6 months), the probabilities of hospitalization (12%) and amputation (0.4%) after the development of an ulcer, and quality-adjustment factors (0.80 during ulcer treatment) were derived from the literature. The cost of CS ($300/year) and Ed ($93 for initial evaluation; $58/year; $40/recurrence) and the medical cost of ulcer treatment (average cost, $1621/recurrence) were calculated from our hospital cost accounting system. RESULTS: A strategy of CS and Ed was cost saving, with 0.37 quality-adjusted life years and $5904 saved, compared with a strategy that does not provide these resources. The inclusion of loss of revenue related to absence from work in the analysis increased cost savings to $17,080 during the patient's lifetime. With sensitivity analysis, CS and Ed remained cost-effective (lifetime cost per quality-adjusted life year saved, <$60,000) if amputations and the cost of ulcer treatment were eliminated or if the cost of prophylaxis was increased to 600% of the base-case. The mean time to recurrence in patients with CS and Ed needed to be reduced from 53 months to 21.1 months before this strategy was no longer cost-effective. CONCLUSION: Prophylactic CS and Ed in patients with prior venous stasis ulceration are cost saving, even with the most conservative of assumptions. Insurers should routinely reimburse for these interventions.

Stockings and the prevention of recurrent venous ulcers.

BACKGROUND: Cost-effective therapy that heals ulcers rapidly and prevents recurrence would significantly impact patient care and the health system. OBJECTIVE: To evaluate compression stockings for treatment of venous ulcerations and prevention of recurrent ulceration; to analyze patient compliance; and to evaluate cost of compression stocking therapy. METHODS: Stocking therapy healed venous ulcers in 53 patients. The effect of continued stocking use on ulcer recurrence rate and treatment costs was evaluated. RESULTS: Twenty-five patients had good stocking usage; one developed recurrence (4%). Twenty-eight patients had bad or none usage; 22 had at least one recurrence (79%). Bad/none usage was associated with 31 of 32 (97%) recurrent ulcerations; good usage was associated with 52 of 58 (90%) nonrecurrent ulcers. Cost was a major reason for noncompliance. CONCLUSIONS: Continued stocking use after ulcer healing will prevent most recurrences and will provide a significant cost saving to the nation's health care budget.