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

OBJECTIVES: The general anesthetic sevoflurane is being repurposed as a topical analgesic for painful chronic wounds. We conducted a Bayesian cost-effectiveness analysis (CEA) comparing the addition of domiciliary topical sevoflurane to conventional analgesics (SEVOFLURANE, n = 38) versus conventional analgesics alone (CONVENTIONAL, n = 26) for the treatment of nonrevascularizable painful leg ulcers in an outpatient Pain Clinic of a Spanish tertiary hospital. METHODS: We used real-world data collected from charts to conduct this CEA from a public healthcare perspective and with a one-year time horizon. Costs of analgesics, visits and admissions were considered, expressed in €2016. Analgesic effectiveness was measured with SPID (Sum of Pain Intensity Difference). A Bayesian regression model was constructed, including "treatment" and baseline characteristics for patients ("arterial hypertension") and ulcers ("duration", "number", "depth", "pain") as covariates. The findings were summarized as a cost-effectiveness plane and a cost-effectiveness acceptability curve. One-way sensitivity analyses, a re-analysis excluding those patients who died or suffered from leg amputation, and an extreme scenario analysis were conducted to reduce uncertainty. RESULTS: Compared to CONVENTIONAL, SEVOFLURANE was associated with a 46% reduction in costs, and the mean incremental effectiveness (28.15±3.70 effectiveness units) was favorable to SEVOFLURANE. The estimated probability for SEVOFLURANE being dominant was 99%. The regression model showed that costs were barely influenced by any covariate, whereas effectiveness was noticeably influenced by "treatment". All sensitivity analyses showed the robustness of the model, even in the extreme scenario analysis against SEVOFLURANE. CONCLUSIONS: SEVOFLURANE was dominant over CONVENTIONAL as it was less expensive and much more effective.

[Quality of life and burden of disease in peripheral arterial disease: a study among Hungarian patients]. / Magyarországi perifériás veroérbetegek életminoség és betegségteher vizsgálatának eredményei.

INTRODUCTION: Peripheral arterial disease may occur in about of 14% of patients with high blood pressure, of which 1-3% suffer from chronic critical limb ischemia. Literature data on the quality of life according to the Fontaine stages are very limited. AIM: The aim of this study was to assess the quality of life of Hungarian patients with peripheral arterial disease regarding Fontaine stages II, III and IV. METHODS: The study was based on a cross-sectional survey, which was carried out in four angiologic centres. One hundred and two respondents with peripheral arterial disease (43% woman) were evaluated. The average age of the patients was 70 years (SD-10). RESULTS: Based on the EQ-5D index, the results of the quality of life assessment with respect to Fontaine stages II, III and IV were 0.66, 0.35 and 0.18, respectively. In each stage the EQ-5D values were lower than the values of the age-matched average population. The results of the Pain Visual Analogue Scale (0-100 mm) were 38, 65 and 71 mm in Fontaine stages II, III and IV, respectively, and this showed a strong correlation with the EQ-5D (R = -0.68). In stage Fontaine IV the quality of life of the patients was significantly lower among those who had pain at rest and ALSO ulcer on the leg. CONCLUSIONS: Peripheral disease with clinical symptoms causes significant reduction in quality of life which can be measured with EQ-5D. It becomes worse as we move along the Fontaine stages. While measuring the health gain in stage Fontaine IV, the health gain from the reduction of pain in rest and partial recovery from ulcer should be taken into account.

VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers.

OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of low-dose ultrasound delivered in conjunction with standard care against standard care alone in the treatment of hard-to-heal venous ulcers. DESIGN: A multicentre, pragmatic, two-armed randomised controlled trial with an economic evaluation. SETTING: Community nurse services; community leg ulcer clinics; hospital outpatient leg ulcer clinics, among both urban and rural settings in England, Scotland, Northern Ireland and Ireland. PARTICIPANTS: Patients with a venous leg ulcer of > 6 months' duration or > 5 cm2 and an ankle-brachial pressure index of ≥ 0.8. In total, 337 patients were recruited to the study. INTERVENTIONS: Participants in the intervention group received low-dose ultrasound (0.5 W/cm2) delivered at 1 MHz, pulsed pattern of 1 : 4, applied to periulcer skin (via a water-based contact gel) weekly for up to 12 weeks alongside standard care. Standard care consisted of low-adherent dressings and compression therapy, renewed as recommended by the patient's nurse and modified if required to reflect changes in ulcer and skin condition. The output of the ultrasound machines was checked every 3 months to confirm intervention fidelity. MAIN OUTCOME MEASURES: The primary end point was time to healing of the largest eligible ulcer (reference ulcer). Secondary outcomes were time to healing of all ulcers, proportion of patients healed, percentage and absolute change in ulcer size, proportion of time patients were ulcer free, cost of treatments, health-related quality of life (HRQoL), adverse events, withdrawal and loss to follow-up. RESULTS: There was a small, and statistically not significant, difference in the median time to complete ulcer healing of all ulcers in favour of standard care [median 328 days, 95% confidence interval (CI) 235 days, inestimable] compared with ultrasound (median 365 days, 95% CI 224 days, inestimable). There was no difference between groups in the proportion of patients with ulcers healed at 12 months (72/168 in ultrasound vs 78/169 standard care), nor in the change in ulcer size at 4 weeks. There was no evidence of a difference in recurrence of healed ulcers. There was no difference in HRQoL [measured using the Short Form questionnaire-12 items (SF-12)] between the two groups. There were more adverse events with ultrasound than with standard care. Ultrasound therapy as an adjuvant to standard care was found not to be a cost-effective treatment when compared with standard care. The mean cost of ultrasound was £197.88 (bias-corrected 95% CI -£35.19 to £420.32) higher than standard care per participant per year. There was a significant relationship between ulcer healing and area and duration at baseline. In addition, those centres with high recruitment rates had the highest healing rates. CONCLUSIONS: Low-dose ultrasound, delivered weekly during dressing changes, added to the package of current best practice (dressings, compression therapy) did not increase ulcer healing rates, affect quality of life (QoL) or reduce recurrence. It was associated with higher costs and more adverse events. There is no evidence that adding low-dose ultrasound to standard care for 'hard-to-heal' ulcers aids healing, improves QoL or reduces recurrence. It increases costs and adverse events. The relationship between ulcer healing rates and patient recruitment is worthy of further study. TRIAL REGISTRATION: Current Controlled Trials ISRCTN21175670. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 13. See the HTA programme website for further project information.

Quality of nursing care from the perspective of patients with leg ulcers.

OBJECTIVE: To investigate and analyse the quality of nursing care in a primary care setting from the perspective of patients with leg ulcers and determine the subjective importance that patients attach to various aspects of quality of care. METHOD: All of the patients with leg ulcers at 15 primary care centres in the south east of Sweden were invited to participate. They were given the short version of the Quality from the Patient's Perspective questionnaire (QPP) to fill in. This included a number of closed and open questions relating to their perceptions of the quality of their nursing care and the importance of this care to them. RESULTS: Overall, the patients in this study perceived that the quality of nursing care was high. However, important areas for improvement were revealed, including the need for an increase in patient-focused care, continuity of care and better pain relief. CONCLUSION: To address the weak points highlighted by the study, we recommend that nurses explore patient perceptions of pain in greater detail and invite patients take a more active role in the management of their leg ulcers.

Novel noninvasive identification of biomarkers by analytical profiling of chronic wounds using volatile organic compounds.

A complex profile of volatile organic compounds ("VOC"s) emanates from human skin, which is altered by changes in the body's metabolic or hormonal state, the external environment, and the bacterial species colonizing the skin surface. The aim of this study was to compare VOC profiles sampled from chronic leg wounds with those from asymptomatic skin. Five participants with chronic arterial leg ulcers were selected. VOC samples were obtained using polydimethylsilicone membranes ("skin-patch method") and analyzed by gas chromatography-ion trap mass spectrometry. Resultant data were analyzed using multivariate analysis and mass spectral matches were compared against the National Institute of Standards and Technology database. Principal component analysis showed differences in profiles obtained from healthy skin and boundary areas and between profiles from healthy skin and lesion samples (p<0.05). Partial least squares for discriminant analysis gave an average prediction accuracy of 73.3% (p<0.05). Mass spectral matching (verified against microbial swab results) identified unique VOCs associated with each sample area, wound bacterial colonization, and ingested medications. This study showcases a reproducible, robust, noninvasive methodology that is applicable in a clinical setting and may offer a new, hitherto unexplored, class of biochemical markers underpinning the metabolism of chronic wounds.

How can community nurses improve quality of life for patients with leg ulcers?

Researchers have explored how leg ulceration affects patients' quality of life but little has been written about the role of community nurses in the assessment and management of life quality in these patients. This article describes how leg ulcers affect quality of life and the challenges nurses face in understanding patients' subjective experience. Practical recommendations are made for improving this aspect of care.

Leg ulceration in Portugal: quality of life.

This study was undertaken to examine the impact of chronic leg ulceration on patients' health-related quality of life in an audit of practice in Lisbon, Portugal, and to observe the changes following 12 weeks of treatment. A questionnaire was administered at entry into an observational study and following 12 weeks of treatment. Patients entering the study were asked to complete the Nottingham Health Profile (NHP), Euroqol and visual analogue (VA) pain questionnaires at entry and after 12 weeks. Principal analysis compared final scores with those found at baseline and compared results with Portuguese normative data. In total, 98 patients entered the study and completed the initial questionnaire, with 68 (69.3%) patients completing the follow-up questionnaire. There were significantly (P < 0.001) higher scores for the patients compared with normative data for all domains of the NHP (all P < 0.001). Improvements were noted for all NHP scores after 12 weeks, although only bodily pain showed a significant improvement [mean difference (d) = 10.5, P = 0.003], with significant improvement also in Euroqol (d = 0.10, P = 0.027). Energy and social isolation improved substantially in the eight (11.8%) patients whose ulcers healed, but did not achieve statistical significance, although VA pain score did (d = 4.85, P < 0.001). Patients suffering from leg ulceration show modest improvements in perceived health following 12 weeks of usual care in Portugal. Improvements in practice may enhance the magnitude of these improvements.

Ulcer-related problems and health care needs in patients with venous leg ulceration: a descriptive, cross-sectional study.

BACKGROUND: Patients with leg ulceration often have long lasting and recurrent wounds. The treatment exists mainly of wound-care and compression therapy. International literature shows several indications of problems in relation to leg ulceration, but no studies were performed to give a comprehensive overview of all problems identified and care received related to these problems. OBJECTIVES: The aim of the study was to describe leg ulcer-related problems in patients with leg ulcers based on venous insufficiency or a mixed aetiology. Furthermore, an inventory of current care and care deficits in the care for leg ulcer patients was made. METHODS: The study had a descriptive, cross-sectional design. A sample of 141 patients was taken from the population of outpatient clinics of seven hospitals in the Netherlands. Data were collected through patient interviews, questionnaires and wound-observations. Medical information was provided by the dermatologist or derived from the patients' medical file. RESULTS: The study identified a number of serious problems. Main problems were pain (85%), outdoor mobility (47%) and problems in finding appropriate footwear (60%). Statistical analysis showed no differences between patients with ulcers based on a venous aetiology and ulcers based on mixed aetiology. Fifty to seventy percent of the patients did not receive any care in relation to these problems. Only a rather small proportion of the patients, however, regarded the help as insufficient. CONCLUSION: Care at outpatient clinics is mainly focused on wound care and compression therapy. Pain treatment and care related to problems encountered by patients appears to be insufficient. This is not only affecting the patient's quality of life, but is likely to affect also the healing process and prevention of leg ulcers. Nurses and dermatologist should take their responsibilities in this matter.

Non-medical prescribing in nurse-led community leg ulcer clinics.

Over the past decade, nurse prescribing in the community has improved clinical care, providing timely access to many products required for patients to receive appropriate treatment. Until recently, nurses who have qualified as nurse prescribers have only been able to prescribe from a limited list of products. Within the leg ulcer clinic environment, the majority of prescriptions written have been related to wound care. This article describes the introduction of extended independent prescribing (now known as non-medical prescribing) and how this type of prescribing has scope for revolutionizing clinical practice in all healthcare settings. There are, however, many contentious issues for clinicians prescribing in this new role, including systems for communication, clinical governance, and attitudes of other professionals.

Chronic leg ulcers, part 2: Do they affect a patient's social life?

This article describes a qualitative study into how chronic venous leg ulceration impacts on the social dimension of a patient's life and is presented in two parts. Part one discussed the background to the study, gave an overview of the literature and described the methodology. This second part will discuss the findings in relation to the literature together with implications for practice.

The views of patients living with healed venous leg ulcers.

AIM: To examine the views of patients with a diagnosis of venous insufficiency who had experienced at least one episode of venous ulceration that had been treated and healed. METHOD: Ten participants (five female, five male) were recruited from a community-based healed leg ulcer clinic. In-depth semi-structured interviews were conducted with participants. The interview data were then transcribed and analysed for themes and patterns. FINDINGS: Three themes emerged: symptoms, treatment and coping mechanisms, each with sub-themes. Long-term pain, changes in body image, limitations to lifestyle and difficulties with treatment were described by participants. Level of knowledge was found to be related to the coping measures demonstrated by participants, which included non-acceptance and normalisation. CONCLUSION: Future developments and reviews of existing services in the overall management of patients with venous ulceration need to include a shift of emphasis to encompass the chronic nature of the underlying disease, with socially acceptable interventions aimed at controlling or limiting the consequences to the patient.

Diagnosis, assessment and management of mixed aetiology ulcers using reduced compression.

Accurate diagnosis of mixed aetiology leg ulcers depends on detailed assessment by a trained practitioner. This paper, the fourth in a six-part series on leg ulcers, describes how reduced compression bandaging can achieve successful outcomes.

Quality of life and leg ulceration from the patient's perspective.

Chronic leg ulceration can have a profound impact on a patient's quality of life. Studies have shown that pain, and general interference with normal activities of living, are the major themes emerging which are often not dealt with in a consistent manner by healthcare professionals. A literature review of this subject shows that although a number of studies have been carried out on quality of life related to chronic leg ulceration, there is little evidence that these findings are being addressed in daily management of these often complex leg ulcer patients. The aim of this article is to examine the research relating to quality of life and leg ulceration, and to attempt to determine what the most important issues are from the patient's perspective, in an effort to improve the way nurses manage their care.

Pain in chronic leg ulcers.

OBJECTIVES: Describe the characteristics of pain in patients with chronic leg ulcers, correlate these descriptions with the characteristics of the ulcers and with patients' sociodemographic data, and determine the measures used for pain management. DESIGN: Descriptive and cross-sectional study with quantitative approach. SETTING AND SUBJECTS: The convenience sample was composed of 90 patients with chronic leg ulcers drawn from 4 outpatient departments in Sao Paulo and Curitiba. INSTRUMENTS: Intensity and quality of patients' pain were determined using a 0-10 numeric pain intensity rating scale and a short version of the McGill Pain Questionnaire. METHODS: After gaining ethics committee approval, patients were selected during their ambulatory visits and interviewed by researchers. Data obtained were analyzed using the Kolmogorov-Smirnov Normality test, Mann-Whitney test, Chi-Square test, and Spearman's Correlation coefficient. RESULTS: Seventy-three (81.11%) patients had venous ulcers. The mean pain intensity reported was 3.10 (SD = 3.15), the mean intensity of the "worst pain of the week" was 7.56 (SD = 2.96), and the mean intensity of the "best pain of the week" was 2.05 (SD = 2.37). The McGill Questionnaire showed that sensitive descriptors were most frequently used to describe the pain. Statistically significant correlations (P < .05) were observed. The most intense pain was reported in subjects from the lowest income bracket studied and female gender and was correlated with alterations in sleep, movement, walking, and mood. Nonsteroidal antiinflammatory drugs were most commonly used (70%) for pain management. CONCLUSIONS: This study indicates the need for more attention and understanding on the part of healthcare workers regarding leg ulcer pain and its characteristics and the need for specific and effective procedures designed to contribute to the improvement in quality of life of these individuals.

[Nutritional status assessment of patients with leg ulcers]. / Evaluation du statut nutritionnel des malades atteints d'ulcères de jambe.

INTRODUCTION: Nutritional deficiencies may delay the wound healing process. The aim of this study was to evaluate the prevalence of protein malnutrition in patients presenting with a leg ulcers and to determine which clinical data can predict malnutrition on population. PATIENTS AND METHODS: This prospective survey included community patients, hospitalized in rehabilitation care unit for treatment of a leg ulcer unhealed for at least 3 months. Clinical, anthropometric and biological data were collected on admission. RESULTS: Sixty-six patients, mean age 72.9 +/- 16.3 years, were included. Fifty-three p. 100 presented wound surfaces over 30 cm(2); 59 p. 100 of the ulcers had lasted for more than one year; 62 p. 100 of the ulcers were venous. 48.5 p. 100 of the patients exhibited protein malnutrition defined by biological criteria, associated with an inflammatory syndrome in 66 p. 100. Anemia and an inflammatory syndrome were present in respectively 59 and 58 p. 100 of the patients. Neither anthropometric measurements nor nutritional intake or wound characteristics significantly differenced between patients with malnutrition or not. Hypoalbuminemia was significantly more frequent and severe in patients aged over 70. DISCUSSION: Protein malnutrition prevalence is very high in patients with leg ulcers, particularly in the elderly. Since nutritional interview or clinical data failed to predict protein malnutrition, systematic biological assessment is justified in all patients with leg ulcers.

Older women's experience of living with chronic leg ulceration.

In this study the authors sought to gain insight into the lives of older women, to focus on the experience of living with leg ulcers and to explore women's views by talking to them about their experiences. Twelve English-speaking women aged over 70 years who had experienced leg ulceration for 3 years or more were interviewed. Analysis of the interview text revealed two overarching themes: (i) gaining and maintaining control over vulnerable limb(s); and (ii) lifestyle consequences of chronic leg ulceration and impaired mobility. These themes contained several subthemes including: (i) nagging pain; (ii) self-expertise and infection; (iii) leakage, smell and embarrassment; (iv) fighting for skin and limb integrity; (v) wearing non-preferred apparel; (vi) loneliness; and (vii) coping, determination and hope. The findings of this research show that elderly women who live with leg ulcers experience multiple consequences. While the everyday problems of living with an unhealed would are addressed by the community nurse, other more subtle consequences may be overlooked. Recognition of the complex and sometimes hidden concerns of these women could help to avert the sense of helplessness which currently exists.

[Assessment of the efficacy of venous support by elastic bandages using transcutaneous measurement of oxygen pressure (TcPO2)]. / Appréciation par la mesure de la pression d'oxygène transcutanée (Tc PO2) de l'effet d'une contention veineuse par bandes élastiques.

Venous contention with elastic bandages is widely used in the treatment of Venous Insufficiency. We have attempted to number the clinical improvement by measuring TcPO2. Our study includes 16 cases; divided as follows: 6 healthy subjects (reference), 5 patients with severe varicose veins of the lower extremities, without ulcer, and 5 patients with varicose veins with ulcer of the leg. Measurements were carried out before and after 10 hours of venous contention. For each patient we have used a light bandage (x) with stretching to 30 and 50% of its length, and a heavy bandage (x) with stretching of 20 and 40%. Our results show, after contention, a decreased TcPO2 in the reference group, but an improvement of this TcPO2 in patients with varicose veins, with or without ulcer. This improvement is more marked with the use of light bandages.