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1.
Am J Nurs ; 121(7): 60-65, 2021 07 01.
Article in English | MEDLINE | ID: mdl-34156388

ABSTRACT

PURPOSE: The purpose of this evidence-based practice project was to reduce the incidence of pressure injuries (PIs) from the use of graduated compression stockings in patients on a gastrointestinal (GI) sarcoma surgery unit. Before this project, the standard of care for preventing deep vein thrombosis (DVT) included the use of graduated compression stockings, anticoagulation therapy, and intermittent pneumatic compression devices. We sought to examine the impact on PI and DVT risk of using only anticoagulation therapy and intermittent pneumatic compression devices. METHODS: The pilot phase of the project began in June 2017 when nurses on the GI sarcoma surgery unit initiated a practice change in which graduated compression stockings were removed during the 7 AM shift change and put back on the patient before bedtime. Data on the incidence of DVTs and PIs were already being collected in our institution's electronic health record and safety intelligence reporting system. The project team monitored the incidence of PIs and DVTs throughout the project. After the pilot project concluded in August 2017, the GI sarcoma surgery unit staff continued the practice of taking off graduated compression stockings during the day, until on June 2018 the use of graduated compression stockings was formally discontinued for all surgical patients, both during the day and night. RESULTS: Data collected during the pilot phase revealed that no PIs or DVTs occurred among the 497 study patients on the GI sarcoma surgery unit. From June to October 2017, the unit cared for a total of 856 patients and PI and DVT rates remained at zero. From the start of the pilot project in June 2017 to October 2018 (five months after the discontinuation of graduated compression stockings on all surgical units) the unit cared for 3,141 patients-an average of 174 patients per month-and had a zero rate of PIs and DVTs. CONCLUSIONS: We found that the use of graduated compression stockings confers more risks than benefits for patients. Our findings prompted the discontinuation of graduated compression stockings use in postoperative patients throughout our institution. In the 17 months after the pilot project was initiated, no PIs occurred among patients in the GI sarcoma surgery unit, which also maintained a zero rate of DVTs.


Subject(s)
Pressure Ulcer/prevention & control , Stockings, Compression/adverse effects , Venous Thrombosis/prevention & control , Evidence-Based Nursing/methods , Female , Humans , Male , Pilot Projects , Postoperative Complications/prevention & control , Stockings, Compression/economics
2.
Cir Esp (Engl Ed) ; 98(9): 516-524, 2020 Nov.
Article in English, Spanish | MEDLINE | ID: mdl-32507499

ABSTRACT

INTRODUCTION: Venous thromboembolism (VTE) represents a serious postoperative complication that can be prevented by adequate thromboprophylaxis. Surveys provide relevant information about clinician's attitudes and preferences regarding VTE prophylaxis. METHODS: Transversal, descriptive study based on a survey sent to general surgeons members of the Spanish Association of Surgeons (AEC), that included 31 questions regarding postoperative VTE and its prevention, as well as three clinical scenarios. RESULTS: 530 surgeons, 21.8% of the 2,429 invited by electronic mail to participate, completed the survey. Most of the answering clinicians work on in big teaching hospitals, and 28.5% are residents. VTE represents a serious problem for 28% of participants. Although 81% consider that their knowledge on the prevention of postoperative VTE is adequate, a similar percentage recognizes the need for further education. The vast majority (98.7%) use low molecular weight heparins, which are considered the most effective and safe modality, followed by mechanical methods. The Caprini risk assessment score is used by 81% of surgeons, who usually start pharmacological prophylaxis preoperatively. However, there are remarkable differences in the dosing of heparins, timing of initiation, and duration, especially in non-oncologic surgical patients. CONCLUSIONS: Most Spanish surgeons are interested in the prevention of postoperative VTE. Overall, the level of knowledge on thromboprophylaxis is adequate. However, our results indicate that there is a need for better education on relevant practical aspects of prophylaxis that could be achieved by incorporating recommendations from recent guidelines to local hospital-based protocols.


Subject(s)
Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Postoperative Complications/prevention & control , Surgeons/statistics & numerical data , Venous Thromboembolism/prevention & control , Aged , Anticoagulants/administration & dosage , Anticoagulants/standards , Attitude of Health Personnel , Cross-Sectional Studies , Female , Heparin, Low-Molecular-Weight/administration & dosage , Heparin, Low-Molecular-Weight/standards , Humans , Intermittent Pneumatic Compression Devices/adverse effects , Intermittent Pneumatic Compression Devices/economics , Knowledge , Male , Middle Aged , Postoperative Complications/epidemiology , Postoperative Complications/pathology , Pulmonary Embolism/mortality , Risk Assessment , Risk Factors , Spain/epidemiology , Stockings, Compression/adverse effects , Stockings, Compression/economics , Surgeons/education , Surveys and Questionnaires/standards , Venous Thromboembolism/complications , Venous Thromboembolism/drug therapy , Venous Thrombosis/complications , Venous Thrombosis/drug therapy , Venous Thrombosis/prevention & control
3.
J Wound Care ; 29(3): 141-151, 2020 Mar 02.
Article in English | MEDLINE | ID: mdl-32160090

ABSTRACT

OBJECTIVE: Approximately between 1.5 and 3.0 per 1000 people are affected by venous leg ulcers (VLUs). The treatment and management of VLUs is costly and recurrence is a major concern. There is evidence that compression stockings can reduce the rate of re-ulceration compared with no compression. We present the first cost-effective analysis of compression stockings in preventing recurrence of VLUs from the perspective of the Ontario healthcare system. METHOD: A cost-utility analysis with a five-year time horizon was conducted. Use of compression stockings was compared with usual care (no compression stockings). We simulated a hypothetical cohort of 65-year-old patients with healed VLUs, using a state-transition model. Model input parameters were obtained mainly from the published literature. We estimated quality-adjusted life years (QALYs) gained and direct medical costs. We conducted various sensitivity analyses. RESULTS: Compared with usual care, compression stockings were associated with higher costs and increased QALYs. Cost-utility analysis showed that the incremental cost-effectiveness ratio of compression stockings was $23,864 per QALY gained compared with no compression stockings. The most influential drivers of cost-effectiveness were the utility value of healed VLUs, cost of stockings, number of stocking replacements, monthly prevention cost and the risk of VLU recurrence. CONCLUSION: Compared with usual care, compression stockings were cost-effective in preventing VLUs, using a willingness-to-pay threshold of $50,000. These observations were consistent even when uncertainty in model inputs and parameters were considered.


Subject(s)
Leg Ulcer/therapy , Stockings, Compression/economics , Cost-Benefit Analysis , Humans , Leg Ulcer/nursing , Ontario , Quality-Adjusted Life Years , Recurrence , Wound Healing
4.
Dtsch Med Wochenschr ; 144(16): e94-e101, 2019 08.
Article in German | MEDLINE | ID: mdl-31416099

ABSTRACT

INTRODUCTION: Patients with leg ulcers often have severe edema of the lower extremities, which should be treated as part of a successful wound treatment. Today in Germany the necessary compression therapies are often performed with very error-prone and time-consuming short-stretch bandages only. Multicomponent systems, adaptive compression bandages and leg ulcer stocking systems are newer, much less error-prone treatment options. In addition to the often lacking knowledge, the fears of high costs are also mentioned as reasons for the lack of prescription of these systems. It was therefore our aim to investigate the costs of different treatment options, differentiated in the outpatient and inpatient sector. METHODS: For the economic calculations, both material and personnel costs were taken into account for different scenarios. RESULTS: Both material and personnel costs were included in the calculation. We were able to demonstrate that the cost for a continuous compression therapy for inpatients accrues between 5.29 Euros to 18.50 Euros per day. For the outpatient setting costs of 2.29 Euros to 34.29 Euros per day were calculated. The different constellations of compression therapy can make sense thus not only for medically but also for economically aspects. CONCLUSION: As a consequence of this data, both the different systems and the economic factors of compression therapy in patients with leg ulcers should be known to the therapists. These treatment options should then be prescribed and performed according to individual factors, taking into account the needs and abilities of the patients.


Subject(s)
Compression Bandages , Leg Ulcer , Stockings, Compression , Compression Bandages/economics , Compression Bandages/statistics & numerical data , Germany , Health Care Costs , Humans , Leg Ulcer/economics , Leg Ulcer/epidemiology , Leg Ulcer/therapy , Stockings, Compression/economics , Stockings, Compression/statistics & numerical data
5.
J Dtsch Dermatol Ges ; 17(8): 775-784, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31305013

ABSTRACT

To date, there have been no studies comparing flat-knit and round-knit compression garments for maintenance therapy of lymphedema of the leg. According to expert opinion, flat-knit fabrics are generally recommended for this purpose. Given the differences in the clinical presentation of lymphedema in terms of disease stage and location as well as patient adherence, and, last but not least, for economic reasons, it seems questionable whether all patients with lymphedema of the leg actually do require flat-knit compression garments. Considering technical aspects, published data and our own clinical experience, it seems reasonable that the choice of compression stockings be based on clinical findings and not on the diagnosis. Typical indications for flat-knit garments include significant differences in leg circumference as well as deep skin folds and edema of the toes/forefoot. However, there are also patients with lymphedema who benefit from round-knit fabrics with a high degree of stiffness. In any case, prior to maintenance therapy, it is essential to adequately decongest the legs using compression bandages and/or adaptive compression systems.


Subject(s)
Clothing/adverse effects , Compression Bandages/adverse effects , Edema/pathology , Lymphedema/therapy , Stockings, Compression/adverse effects , Compression Bandages/economics , Elasticity , Equipment Design , Female , Foot/pathology , Humans , Leg/anatomy & histology , Leg/pathology , Lymphedema/complications , Middle Aged , Patient Compliance , Skinfold Thickness , Stockings, Compression/economics
7.
Ont Health Technol Assess Ser ; 19(2): 1-86, 2019.
Article in English | MEDLINE | ID: mdl-30828407

ABSTRACT

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.


Subject(s)
Leg Ulcer/prevention & control , Secondary Prevention/methods , Stockings, Compression , Varicose Ulcer/prevention & control , Cost-Benefit Analysis , Health Care Costs , Humans , Markov Chains , Patient Satisfaction , Recurrence , Secondary Prevention/economics , Stockings, Compression/economics , Varicose Ulcer/economics
8.
Lancet Haematol ; 5(11): e512-e519, 2018 Nov.
Article in English | MEDLINE | ID: mdl-30314712

ABSTRACT

BACKGROUND: The IDEAL DVT study showed that it was safe to shorten the duration of elastic compression therapy on an individualised basis after deep vein thrombosis for prevention of post-thrombotic syndrome. In this study, we assessed the cost-effectiveness of this strategy. METHODS: IDEAL DVT was a multicentre, randomised, non-inferiority trial that included patients with acute proximal deep vein thrombosis of the leg. After 6 months of elastic compression therapy, patients were randomly assigned (1:1) to the standard 2 years of elastic stocking compression therapy or shortened duration of compression therapy based on the patient's Villalta score. For our cost-effectiveness analysis, we assessed quality-adjusted life-years (QALYs), measured with the three-level version of EQ-5D (EQ-5D-3L; Dutch and UK tariff) and the 36-item Short Form Health Survey (SF-36), and costs in € (health-care and societal perspective) according to the intention-to-treat approach. Data were collected at 3, 6, 12, and 24 months after diagnosis of thrombosis. We calculated incremental net monetary benefit using a QALY threshold of €30 000, and obtained bootstrapped means and 95% CIs. IDEAL DVT is registered with ClinicalTrials.gov, number NCT01429714. FINDINGS: Between March 22, 2011, and July 1, 2015, 865 patients were enrolled in IDEAL DVT. 437 were assigned to individualised duration of elastic compression therapy and 428 to standard duration of elastic compression therapy. Nine patients were eventually excluded because of recurrent venous thromboembolism within 6 months after the first event. From a societal perspective, for every QALY lost measured with the EQ-5D Dutch tariff, cost savings were €305·992 (incremental net monetary benefit €3205, 95% CI 502-5741), and for every QALY lost based on the Short-Form Six-Dimension (SF-6D) utility score (derived from SF-36), cost savings were €6030·941 (€3540, 95% CI 1174-5953). Using the UK tariff for EQ-5D, the individualised strategy was more effective and less costly (€4071, 1452-6647). The probability that the individualised strategy was cost-effective was 99% at a threshold of €30 000 per QALY (EQ-5D Dutch tariff). INTERPRETATION: Individually shortened duration of elastic compression therapy was cost-effective compared with standard duration elastic compression therapy. Use of an individualised approach to elastic stocking compression therapy for the prevention of post-thrombotic syndrome after deep vein thrombosis could lead to substantial costs savings without loss in health-related quality of life. FUNDING: Netherlands Organisation for Health Research and Development.


Subject(s)
Cost-Benefit Analysis , Postthrombotic Syndrome/prevention & control , Stockings, Compression/economics , Humans , Quality of Life , Time Factors
10.
Health Technol Assess ; 19(98): 1-220, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26613365

ABSTRACT

BACKGROUND: Deep-vein thrombosis (DVT) can occur in surgical patients. Routine prophylaxis can be pharmacological and/or mechanical [e.g. graduated compression stockings (GCSs)]. GCSs are available in knee length or thigh length. OBJECTIVE: To establish the expected value of undertaking additional research addressing the relative effectiveness of thigh-length GCSs versus knee-length GCSs, in addition to pharmacoprophylaxis, for prevention of DVT in surgical patients. DESIGN: Systematic review and economic model, including value of information (VOI) analysis. REVIEW METHODS: Randomised controlled trials (RCTs) assessing thigh- or knee-length GCSs in surgical patients were eligible for inclusion. The primary outcome was incidence of DVT. DVT complications and GCSs adverse events were assessed. Random-effects meta-analysis was performed. To draw on a wider evidence base, a random-effects network meta-analysis (NMA) was undertaken for the outcome DVT. A review of trials and observational studies of patient adherence was also conducted. A decision-analytic model was developed to assess the cost-effectiveness of thigh- and knee-length GCSs and the VOI. RESULTS: Twenty-three RCTs were included in the review of effectiveness. There was substantial variation between trials in terms of the patient characteristics, interventions and methods of outcome assessment. Five trials comparing knee-length with thigh-length GCSs with or without pharmacoprophylaxis were pooled; the summary estimate of effect indicated a non-significant trend favouring thigh-length GCSs [odds ratio (OR) 1.48, 95% confidence interval (CI) 0.80 to 2.73]. Thirteen trials were included in the NMA. In the base-case analysis, thigh-length GCSs with pharmacoprophylaxis were more effective than knee-length GCSs with pharmacoprophylaxis (knee vs. thigh OR 1.76, 95% credible interval 0.82 to 3.53). Overall, thigh-length stockings with pharmacoprophylaxis was the most effective treatment, with a 0.73 probability of being the most effective treatment in a new trial of all the treatments. Patient adherence was generally higher with knee-length GCSs, and patients preferred knee-length GCSs. Thigh-length GCSs were found to be cost-effective in all but the subgroup with the lowest baseline risk, although the absolute differences in costs and effects were relatively small. The expected value of perfect information ranged from £0.2M to £178.0M depending on the scenario and subgroup. The relative effect parameters had the highest expected value of partial perfect information and ranged from £2.0M to £39.4M. The value of further research was most evident in the high-risk subgroups. LIMITATIONS: There was substantial variation across the included trials in terms of patient and intervention characteristics. Many of the included trials were old and poorly reported, which reduces the reliability of the results of the review. CONCLUSIONS: Given that the results from both the standard meta-analysis and the NMA lacked precision (CIs were wide) owing to the heterogeneous evidence base, a new definitive trial in high-risk patients may be warranted. However, the efficiency of any further research (i.e. whether this represents value for money) is dependent on several factors, including the acquisition price of GCSs, expected compliance with thigh-length GCSs wear, and whether or not uncertainty can be resolved around possible effect modifiers, as well as the feasibility and actual cost of undertaking the proposed research. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014007202. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Subject(s)
Models, Economic , Stockings, Compression/economics , Venous Thrombosis/prevention & control , Cost-Benefit Analysis , Humans , Patient Compliance/psychology , Postoperative Period , Randomized Controlled Trials as Topic , Stockings, Compression/adverse effects , Treatment Outcome , Venous Thrombosis/drug therapy
11.
Eur J Vasc Endovasc Surg ; 50(6): 794-801, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26433594

ABSTRACT

OBJECTIVE: The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. DESIGN: An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). METHODS: The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). RESULTS: All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. CONCLUSIONS: Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV.


Subject(s)
Ablation Techniques/economics , Health Care Costs , Sclerotherapy/economics , Stockings, Compression/economics , Ultrasonography, Interventional/economics , Varicose Veins/economics , Varicose Veins/therapy , Vascular Surgical Procedures/economics , Ablation Techniques/adverse effects , Cost Savings , Cost-Benefit Analysis , Humans , Markov Chains , Models, Economic , Quality-Adjusted Life Years , Sclerotherapy/adverse effects , State Medicine/economics , Stockings, Compression/adverse effects , Time Factors , Treatment Outcome , Ultrasonography, Interventional/adverse effects , United Kingdom , Varicose Veins/complications , Varicose Veins/diagnosis , Vascular Surgical Procedures/adverse effects
13.
Br J Community Nurs ; Suppl: S30, S32, S34-6, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25950395

ABSTRACT

This article discusses the use of Microfine toe caps (Haddenham, UK) for the treatment of digit swelling. It will discuss the indications and contraindications of the device and offers some case studies where toe caps have been used in clinical practice. The use of the Microfine toe cap offers an alternative to toe bandaging, has many different applications and can be safe and time-saving to apply when used appropriately following a full and holistic assessment.


Subject(s)
Lymphedema/therapy , Stockings, Compression , Toes , Cost Savings , Equipment Design , Humans , Stockings, Compression/economics
15.
Ugeskr Laeger ; 176(32): 1474-7, 2014 Aug 04.
Article in Danish | MEDLINE | ID: mdl-25292468

ABSTRACT

Post-thrombotic syndrome (PTS) is caused by venous insufficiency and is a frequent complication of deep venous thrombosis. Patients with PTS have reduced quality of life and an increased risk of recurrent deep venous thrombosis. Importantly, the risk of PTS is halved by the use of elastic compression stockings. This review outlines important practical aspects related to correct clinical use of these stockings.


Subject(s)
Postthrombotic Syndrome/prevention & control , Stockings, Compression , Venous Thrombosis/prevention & control , Contraindications , Humans , Patient Compliance , Postthrombotic Syndrome/pathology , Postthrombotic Syndrome/therapy , Risk Factors , Stockings, Compression/economics , Venous Thrombosis/therapy
16.
Health Technol Assess ; 18(57): 1-293, v-vi, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25242076

ABSTRACT

BACKGROUND: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB. OBJECTIVES: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers. DESIGN: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model. SETTINGS: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland. PARTICIPANTS: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression. INTERVENTIONS: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB). MAIN OUTCOME MEASURES: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs. RESULTS: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers. CONCLUSIONS: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49373072. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.


Subject(s)
Compression Bandages/statistics & numerical data , Secondary Prevention/methods , Varicose Ulcer/therapy , Wound Healing , Aged , Aged, 80 and over , Compression Bandages/adverse effects , Compression Bandages/economics , Cost-Benefit Analysis , Decision Making , England , Female , Humans , Male , Markov Chains , Middle Aged , Northern Ireland , Outcome and Process Assessment, Health Care/economics , Outcome and Process Assessment, Health Care/statistics & numerical data , Patient Compliance , Quality-Adjusted Life Years , Recurrence , Self Care , Stockings, Compression/adverse effects , Stockings, Compression/economics , Stockings, Compression/statistics & numerical data , Time Factors , Varicose Ulcer/economics
17.
Nurs Times ; 110(15): 19-20, 2014.
Article in English | MEDLINE | ID: mdl-24822382

ABSTRACT

BACKGROUND: Four-layer bandaging is the standard treatment for venous leg ulcers but is bulky and can restrict mobility. Two-layer compression stockings have recently been marketed but their clinical and cost effectiveness were unknown. AIM: To compare the clinical and cost effectiveness of four-layer bandaging with two-layer compression stockings. METHOD: In a pragmatic, open, randomised controlled trial 454 participants were randomly allocated two-layer compression stockings or four-layer bandages and followed for up to 12 months after healing. RESULTS: The median time to ulcer healing was almost identical (stockings group: 99 days, bandaging group: 98 days). More patients allocated stockings changed treatment but ulcer recurrence rates were higher in the bandaging group. Stockings cost 302 sterling pounds less per participant per year and had more than 95% probability of being the most cost-effective treatment. CONCLUSION: Two-layer compression stockings are a viable, cost-effective alternative to four-layer bandaging but may not be suitable for all patients.


Subject(s)
Stockings, Compression/standards , Varicose Ulcer/nursing , Aged , Cost-Benefit Analysis , Humans , Middle Aged , Patient Satisfaction , State Medicine/economics , Stockings, Compression/economics , United Kingdom , Varicose Ulcer/economics , Wound Healing/physiology
18.
Lancet ; 383(9920): 871-9, 2014 Mar 08.
Article in English | MEDLINE | ID: mdl-24315520

ABSTRACT

BACKGROUND: Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS: We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS: We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION: Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING: NIHR Health Technology Assessment programme (07/60/26).


Subject(s)
Compression Bandages , Varicose Ulcer/therapy , Aged , Aged, 80 and over , Compression Bandages/adverse effects , Compression Bandages/economics , Cost-Benefit Analysis , England , Female , Health Care Costs/statistics & numerical data , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Northern Ireland , Quality-Adjusted Life Years , Stockings, Compression/adverse effects , Stockings, Compression/economics , Treatment Outcome , Varicose Ulcer/economics , Wound Healing
19.
Phlebology ; 29(6): 390-6, 2014 Jul.
Article in English | MEDLINE | ID: mdl-23761867

ABSTRACT

OBJECTIVES: Recent French data describing real-life compression stocking use are lacking. This study aimed to describe the actual situation for patients who were prescribed compression stockings by their general practitioner and to assess annual treatment costs from a societal perspective. METHODS: A retrospective analysis using Disease Analyzer database data from 6349 adults with at least one compression stocking prescription between July 2009 and June 2010. RESULTS: Mean patient age was 58 years, and 72.3% of patients were women. Seven out of 10 patients received only a single compression stocking prescription over one year. The estimated mean annual per patient cost was 152.2 ± 100.7 Euros. CONCLUSION: Most patients received only a single compression stocking prescription during one year. General practitioners prescribing compression stockings more often may have a better understanding of venous disease and may manage their patients differently. Although more expensive, this approach may be one which should be accepted more widely.


Subject(s)
Databases, Factual , Primary Health Care/economics , Stockings, Compression/economics , Adult , Aged , Costs and Cost Analysis , Female , Follow-Up Studies , France , Humans , Male , Middle Aged , Primary Health Care/methods , Retrospective Studies
20.
Int J Low Extrem Wounds ; 12(3): 189-98, 2013 Sep.
Article in English | MEDLINE | ID: mdl-24043677

ABSTRACT

Venous leg ulcers affect up to 3% of people aged 65 years and older, present significant pain and suffering, and are associated with long episodes of health care. These chronic wounds recur at rates of up to 69%. A double blind randomized controlled trial was conducted in a home nursing setting in Victoria, Australia to compare the effectiveness of a 23 to 32 mm Hg (moderate) and a 34 to 46 mm Hg (high) compression stocking treatment on venous ulcer recurrence. Participants (n = 100) were monitored for 26 weeks. Study wound recurrence was low (11.8%), and the average time to recurrence was 77.91 days. Adherence to treatment was low (44%) with nonadherence significantly higher in the high-compression stocking group, χ(2)(1) = 8.827, P = .003. Regression modeling found that adherence to treatment significantly predicted study wound recurrence, Wald(1) = 7.917, P = .005. Estimated hazard ratios showed that participants who did not adhere were 9 times more likely to have their wound recur. Risk of recurrence was 3 times greater for those randomized to moderate compression when compared with the high-compression stocking. Implementing strategies that optimize adherence to compression will reduce ulcer recurrence. Once this has been realized, the potential to adhere to high-compression treatment would further reduce the risk of recurrence.


Subject(s)
Stockings, Compression/economics , Varicose Ulcer/therapy , Wound Healing , Aged , Cost-Benefit Analysis , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Prospective Studies , Recurrence , Treatment Outcome , Varicose Ulcer/economics
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