Cost-effectiveness of ChloraSolv in treating hard-to-heal venous leg ulcers.

OBJECTIVE: To estimate whether the topical, amino acid-buffered hypochlorite debriding gel ChloraSolv (RLS Global AB, Sweden) could potentially afford the UK's health services a cost-effective intervention for hard-to-heal venous leg ulcers (VLUs). METHOD: A Markov model representing the management of hard-to-heal VLUs with ChloraSolv plus standard care (SC) or SC alone was populated with inputs from an indirect comparison of two propensity score-matched cohorts. The model estimated the relative cost-effectiveness of ChloraSolv in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2021/2022 prices. RESULTS: Addition of ChloraSolv to an SC protocol was found to increase the probability of healing by 36% (from 0.14 to 0.19) after 12 weeks, and by 79% (from 0.24 to 0.43) after 24 weeks. This led to a marginal increase in health-related quality of life. Treatment with ChloraSolv plus SC instead of SC alone reduced the total cost of wound management by 8% (£189 per VLU) at 12 weeks and by 18% (£796 per VLU) at 24 weeks. Use of ChloraSolv was estimated to improve health outcomes at reduced cost. Sensitivity analysis showed that use of ChloraSolv plus SC remained a cost-effective treatment with plausible variations in costs and effectiveness. CONCLUSION: Within the limitations of the study, the addition of ChloraSolv to an SC protocol potentially affords a cost-effective treatment to the UK's health services for managing hard-to-heal VLUs.

Cost-effectiveness of two reduced pressure compression systems in treating newly diagnosed venous leg ulcers.

OBJECTIVE: To assess the clinical outcomes and cost-effectiveness of using two different reduced pressure compression systems in treating newly diagnosed venous leg ulcers (VLUs) in clinical practice, from the perspective of the UK's National Health Service (NHS). METHODS: This was a modelling study based on a retrospective cohort analysis of the case records of patients with a newly diagnosed VLU, randomly extracted from The Health Improvement Network (THIN) database, who were initially treated with a two-layer cohesive compression bandage (TLCCB Lite; Coban 2 Lite, 3M, US) or a two-layer compression system (TLCS Reduced; Ktwo Reduced, Urgo, France). No significant differences were detected between the groups. Nevertheless, analysis of covariance (ANCOVA) was performed to enable differences in patients' outcomes between the groups to be adjusted for any heterogeneity in baseline covariates. Clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over 12 months after starting treatment. RESULTS: Time from wound onset to starting compression was a mean of two months. The probability of healing at 12 months was 0.59 in the TLCCB Lite group and 0.53 in the TLCS Reduced group. Patients in the TLCCB Lite group experienced a marginally better health-related quality of life (HRQoL) of 0.02 quality-adjusted life years (QALYs) per patient compared to those in the TLCS Reduced group. The 12-month NHS wound management cost was £3883 per patient treated with TLCCB Lite and £4235 per patient treated with TLCS Reduced. When the analysis was repeated without ANCOVA, the findings from the base case analysis remained unchanged (i.e., use of TLCCB Lite improved outcomes at lower cost). CONCLUSION: Within the study's limitations, treating newly diagnosed VLUs with TLCCB Lite instead of TLCS Reduced potentially affords a cost-effective use of NHS-funded resources in clinical practice, since it is expected to result in an increased healing rate, better HRQoL and a lower NHS wound management cost.

Relative cost-effectiveness of three compression bandages in treating newly diagnosed venous leg ulcers in the UK.

OBJECTIVE: To assess the clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2, 3M, US) compared with a two-layer compression system (TLCS; KTwo, Urgo, France) and a cohesive inelastic bandage system (CIBR; Actico, L&R, Germany) in treating newly diagnosed venous leg ulcers (VLUs) in clinical practice, from the perspective of the UK's National Health Service (NHS). METHOD: This was a modelling study based on a retrospective cohort analysis of the case records of patients with a newly diagnosed VLU randomly extracted from the The Health Improvement Network (THIN) database who were treated with TLCCB, TLCS or CIBR. No significant differences were detected between the groups. Nevertheless, analysis of covariance was performed to enable differences in patients' outcomes between the groups to be adjusted for any heterogeneity in baseline covariates. Clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over 12 months after starting treatment. RESULTS: There were 250 patients in each group. Time from wound onset to starting compression was a mean of two months. The healing distribution of the TLCCB-treated patients was significantly different from that of the other two cohorts (p=0.003); the probability of healing at 12 months was 0.62, 0.51 and 0.49 in the TLCCB, TLCS and CIBR groups, respectively. Patients treated with TLCCB experienced better health-related quality of life (HRQoL) over 12 months (0.86 quality-adjusted life years (QALYs) per patient), compared with those treated with TLCS and CIBR (0.83 and 0.82 QALYs per patient, respectively). The 12-month NHS wound management cost was £3693, £4451 and £4399 per patient in the TLCCB, TLCS and CIBR groups, respectively. CONCLUSION: Within the model's limitations, treating newly diagnosed VLUs with TLCCB instead of the other two compression systems appears to afford a more cost-effective use of NHS-funded resources in clinical practice, since it is expected to result in increased healing, better HRQoL and a lower wound management cost for the NHS.

Cost-effectiveness of Debrichem in managing hard-to-heal venous leg ulcers in the UK.

OBJECTIVE: To estimate whether the topical debriding agent, Debrichem, could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of hard-to-heal venous leg ulcers (VLUs). METHOD: A Markov model was constructed depicting the management of hard-to-heal VLUs with Debrichem plus standard care (SC) or SC alone over a period of 12 months. The model was populated with inputs from an indirect comparison of two propensity score-matched cohorts. The model estimated the cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2019/20 prices. RESULTS: Addition of Debrichem to a SC protocol to treat hard-to-heal VLUs was found to increase the probability of healing by 75% (from 0.35 to 0.61) by 12 months, and to increase health-related quality of life over 12 months from 0.74 to 0.84 QALYs per patient. The 12-month cost of treatment with Debrichem plus SC (£3128 per patient) instead of SC alone (£7195 per patient) has the potential to reduce the total NHS cost of wound management by up to 57%. Hence, Debrichem was estimated to improve health outcomes for less cost. Sensitivity analysis showed that Debrichem plus SC remained a cost-effective (dominant) treatment with plausible variations in costs and effectiveness. CONCLUSION: Within the limitations of the study, the addition of Debrichem to a SC protocol potentially affords a cost-effective treatment to the NHS for managing hard-to-heal VLUs.

Cost-effectiveness of using intermittent pneumatic compression to manage hard-to-heal venous leg ulcers in the UK.

OBJECTIVE: To estimate whether thigh-administered intermittent pneumatic compression (IPC) could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of hard-to-heal venous leg ulcers (VLUs). METHOD: A Markov model was constructed depicting the management of hard-to-heal VLUs with IPC plus standard care or standard care alone over a period of 24 weeks. The model estimated the cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2019/20 prices. RESULTS: Treatment of hard-to-heal VLUs with IPC plus standard care instead of standard care alone is expected to increase the probability of healing by 58% (from 0.24 to 0.38) at 24 weeks and increase health-related quality of life over 24 weeks from 0.32 to 0.34 QALYs per patient. Additionally, the cost of treating with IPC plus standard care (£3,020 per patient) instead of standard care alone (£3,037 per patient) has the potential to be cost-neutral if use of this device is stopped after 6 weeks in non-improving wounds. Sensitivity analysis showed that the relative cost-effectiveness of IPC plus standard care remains <£20,000 per QALY with plausible variations in costs and effectiveness. CONCLUSION: Within the limitations of this study, the addition of IPC to standard care potentially affords a cost-effective treatment to the NHS for managing hard-to-heal VLUs. However, a controlled study is required to validate the outcomes of this analysis.

Potential cost-effectiveness of using adjunctive dehydrated human amnion/chorion membrane allograft in the management of non-healing diabetic foot ulcers in the United Kingdom.

The aim of this study was to estimate the cost-effectiveness of using dehydrated human amnion/chorion membrane (dHACM) allografts (Epifix) as an adjunct to standard care, compared with standard care alone, to manage non-healing diabetic foot ulcers (DFUs) in secondary care in the United Kingdom, from the perspective of the National Health Service (NHS). A Markov model was constructed to simulate the management of diabetic lower extremity ulcers over a period of 1 year. The model was used to estimate the cost-effectiveness of using adjunctive dHACM, compared with standard care alone, to treat non-healing DFUs in the United Kingdom, in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2019/2020 prices. The study estimated that at 12 months after the start of treatment, use of adjunctive dHACM instead of standard care alone is expected to lead to a 90% increase in the probability of healing, a 34% reduction in the probability of wound infection, a 57% reduction in the probability of wound recurrence, a 6% increase in the probability of avoiding an amputation, and 8% improvement in the number of QALYs. Additionally, if £4062 is spent on dHACM allografts per ulcer, then adjunctive use of dHACM instead of standard care alone is expected to lead to an incremental cost per QALY gain of £20 000. However, if the amount spent on dHACM allografts was ≤£3250 per ulcer, the 12-month cost of managing an ulcer treated with adjunctive dHACM would break-even with that of DFUs treated with standard care, and it would have a 0.95 probability of being cost-effective at the £20 000 per QALY threshold. In conclusion, within the study's limitations, and within a certain price range, adjunctive dHACM allografts afford the NHS a cost-effective intervention for the treatment of non-healing DFUs within secondary care among adult patients with type 1 or 2 diabetes mellitus in the United Kingdom.

Potential cost-effectiveness of using a collagen-containing dressing in managing diabetic foot ulcers in the UK.

OBJECTIVE: To estimate whether a collagen-containing dressing could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of diabetic foot ulcers (DFUs). METHOD: A decision model depicting the management of a DFU was constructed and populated with a combination of published clinical outcomes, resource use estimates and utilities for DFUs. The model estimated the incremental cost-effectiveness of a collagen-containing dressing plus standard care compared with standard care alone over a period of four months in terms of the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Treatment of DFUs of >6 months duration with a collagen-containing dressing plus standard care instead of standard care alone is expected to increase the probability of healing from 0.08 to 0.53 by four months and increase health-related quality of life at four months from 0.156 to 0.163 QALYs per patient. Additionally, treatment with a collagen-containing dressing has the potential to reduce management costs by 22% over four months when compared with standard care alone (from £2897 to £2255 per patient). Treatment of new DFUs with a collagen-containing dressing plus standard care instead of standard care alone was also found to improve outcomes for less cost. CONCLUSION: Within the study's limitations, use of a collagen-containing dressing plus standard care instead of standard care alone potentially affords the NHS a cost-effective (dominant) treatment for both non-healing and new DFUs, since it improves outcomes for less cost. Hence, protocols should be established which enable clinicians to effectively introduce collagen-containing dressings into care pathways and monitor response to treatment.

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.

Cost-effectiveness of using a collagen-containing dressing plus compression therapy in non-healing venous leg ulcers.

OBJECTIVE: To estimate whether collagen-containing dressings could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of non-healing venous leg ulcers (VLUs). METHOD: This was a modelling study performed from the perspective of the UK's NHS. A combination of published clinical outcomes, resource utilisation estimates and utilities for VLUs enabled the construction of a decision model, depicting the management of a chronic VLU with standard care or with a collagen-containing dressing plus compression therapy followed by standard care, over a period of 6 months. The model estimated the incremental cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2015/16 prices. RESULTS: The treatment of VLUs of >6 months' duration with a collagen-containing dressing plus compression therapy followed by standard care, instead of standard care, is expected to increase the probability of healing from 0.11 to 0.49 by 6 months and increase health-related quality of life at 6 months from 0.331 to 0.373 QALYs per patient. Additionally, treatment with a collagen-containing dressing plus compression therapy followed by standard care has the potential to reduce management costs by 40% over 6 months when compared with standard care (from £6328 to £3789 per patient). CONCLUSION: Within the study's limitations, including a collagen-containing dressing into a standard care protocol compared with standard care potentially affords the NHS a cost-effective (dominant) treatment since it improves outcomes for less cost.

Venous leg ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.

Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing diabetic foot ulcers (DFUs) in clinical practice by the UK's National Health Service (NHS), and the associated costs of patient management. This was a retrospective cohort analysis of the records of 130 patients with a newly diagnosed DFU in The Health Improvement Network (THIN) database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015-2016 prices. Patients were predominantly managed in the community by nurses, with minimal clinical involvement of specialist physicians. 5% of patients saw a podiatrist, and 5% received a pressure-offloading device. Additionally, 17% of patients had at least one amputation within the first 12 months from initial presentation of their DFU. 14% of DFUs were documented as being clinically infected at initial presentation, although an additional 31% of patients were prescribed an antimicrobial dressing at the time of presentation. Of all the DFUs, 35% healed within 12 months, and the mean time to healing was 4·4 months. Over the study period, 48% of all patients received at least one prescription for a compression system, but significantly more patients healed if they never received compression (67% versus 16%; P < 0·001). The mean NHS cost of wound care over 12 months was an estimated £7800 per DFU (of which 13% was attributable to amputations), ranging from £2140 to £8800 per healed and unhealed DFU, respectively, and £16 900 per amputated wound. Consolidated medical records from a primary care held database provided 'real-world evidence' highlighting the consequences of inefficient and inadequate management of DFUs in clinical practice in the UK. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (i) wound prevention, (ii) improving wound-healing rates and (iii) reducing infection and amputation rates.

Health economic burden that different wound types impose on the UK's National Health Service.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to the management of different wound types by the UK's National Health Service (NHS) in 2012/2013 and the annual costs incurred by the NHS in managing them. This was a retrospective cohort analysis of the records of 2000 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and all health care resource use were quantified, and the total NHS cost of patient management was estimated at 2013/2014 prices. The NHS managed an estimated 2·2 million patients with a wound during 2012/2013. Patients were predominantly managed in the community by general practitioners (GPs) and nurses. The annual NHS cost varied between £1·94 billion for managing 731 000 leg ulcers and £89·6 million for managing 87 000 burns, and associated comorbidities. Sixty-one percent of all wounds were shown to heal in an average year. Resource use associated with managing the unhealed wounds was substantially greater than that of managing the healed wounds (e.g. 20% more practice nurse visits, 104% more community nurse visits). Consequently, the annual cost of managing wounds that healed in the study period was estimated to be £2·1 billion compared with £3·2 billion for the 39% of wounds that did not heal within the study year. Within the study period, the cost per healed wound ranged from £698 to £3998 per patient and that of an unhealed wound ranged from £1719 to £5976 per patient. Hence, the patient care cost of an unhealed wound was a mean 135% more than that of a healed wound. Real-world evidence highlights the substantial burden that wounds impose on the NHS in an average year. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (a) wound prevention, (b) accurate diagnosis and (c) improving wound-healing rates.

Healthcare costs and outcomes of managing ß-thalassemia major over 50 years in the United Kingdom.

BACKGROUND: The objective was to estimate the incidence-based costs of treating ß-thalassemia major (BTM) to the United Kingdom's National Health Service (NHS) over the first 50 years of a patient's life in terms of healthcare resource use and corresponding costs and the associated health outcomes. STUDY DESIGN AND METHODS: This was a modeling study based on information obtained from a systematic review of published literature and clinicians involved in managing BTM in the United Kingdom. A state transition model was constructed depicting the management of BTM over a period of 50 years. The model was used to estimate the incidence-based health economic impact that BTM imposes on the NHS and patients' health status in terms of the number of quality-adjusted life-years (QALYs) over 50 years. RESULTS: The expected probability of survival at 50 years is 0.63. Of patients who survive, 33% are expected to be without any complication and the other 67% are expected to experience at least one complication. Patients' health status over this period was estimated to be a mean of 11.5 discounted QALYs per patient. Total healthcare expenditure attributable to managing BTM was estimated to be £483,454 ($720,201) at 2013/14 prices over 50 years. The cost of managing BTM could be potentially reduced by up to 37% if one in two patients had a bone marrow transplant, with an ensuing improvement in health-related quality of life. CONCLUSION: This analysis provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions pertaining to this rare disease.

NHS generic project: response from the wound care community.

This series of letters outlines the response from MA Healthcare, key opinion leaders, and industry to the news that the Government is planning to introduce a generic project for wound dressings, limiting products to three main suppliers.

Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension.

BACKGROUND: A post-hoc analysis was performed on the data from a 54 weeks phase III study (ClinicalTrials.gov identifier: NCT00923091) to measure changes in the health-related quality of life (HRQoL) of 2,690 patients aged ≥18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ), using the MINICHAL and EQ-5D instruments. METHODS: Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period. Analysis of covariance (ANCOVA) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores. RESULTS: Patients' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6. Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33%. Patients' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively, increasing by 6% and 12% over the study period. Patients' QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs. The ANCOVA showed that changes in patients' HRQoL was likely to have been influenced by patients' achievement of blood pressure control, the amount of concomitant medication and patients' last used dosage strength of antihypertensive. Linear regression showed that blood pressure improvement may have been associated with improved HRQoL. CONCLUSIONS: This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients' HRQoL. Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients' HRQoL.

Cost-effectiveness of using Polyheal compared with surgery in the management of chronic wounds with exposed bones and/or tendons due to trauma in France, Germany and the UK.

The objective of this study was to assess the cost-effectiveness of Polyheal compared with surgery in treating chronic wounds with exposed bones and/or tendons (EB&T) due to trauma in France, Germany and the UK, from the perspective of the payers. Decision models were constructed depicting the management of chronic wounds with EB&T and spanned the period up to healing or up to 1 year. The models considered the decision by a plastic surgeon to treat these wounds with Polyheal or surgery and was used to estimate the relative cost-effectiveness of Polyheal at 2010/2011 prices. Using Polyheal instead of surgery is expected to increase the probability of healing from 0·93 to 0·98 and lead to a total health-care cost of €7984, €7517 and €8860 per patient in France, Germany and the UK, respectively. Management with surgery is expected to lead to a total health-care cost of €12 300, €18 137 and €11 330 per patient in France, Germany and the UK, respectively. Hence, initial treatment with Polyheal instead of surgery is expected to lead to a 5% improvement in the probability of healing and a substantial decrease in health-care costs of 35%, 59% and 22% in France, Germany and the UK, respectively. Within the models' limitations, Polyheal potentially affords the public health-care system in France, Germany and the UK a cost-effective treatment for chronic wounds with EB&T due to trauma, when compared with surgery. However, this will be dependent on Polyheal's healing rate in clinical practice when it becomes routinely available.

NHS generic project: response from the wound care community.

This series of letters outlines the response from MA Healthcare, key opinion leaders and industry to the news that the Government is planning to introduce a generic project for wound dressings.

Utility values for specific hepatic encephalopathy health states elicited from the general public in the United Kingdom.

BACKGROUND AND AIMS: To elicit utility values for five health states corresponding to increasing severity of hepatic encephalopathy, from members of the general public in the UK. The health states studied were Conn grades 0, 1, 2, 3 and 4. METHODS: Interviewer-administered time trade-off (TTO) and standard gamble (SG) utilities were elicited for the five health states from a random sample of 200 members of the general public in the UK, using health state descriptions validated by clinicians and members of the general public. RESULTS: Respondents' mean age was 49.5 years and 49% were female. Mean utilities were 0.962 (TTO) and 0.915 (SG) for Conn grade 0; 0.912 (TTO) and 0.837 (SG) for Conn grade 1; 0.828 (TTO) and 0.683 (SG) for Conn grade 2; 0.691 (TTO) and 0.489 (SG) for Conn grade 3; and 0.429 (TTO) and 0.215 (SG) for Conn grade 4. The TTO and SG values between the five Conn grades were significantly different (p < 0.001). Additionally, the TTO value was significantly higher than the SG value for the corresponding state (p <0.0001). CONCLUSION: These findings quantify how different Conn grades and level of response to treatment may impact on the health-related quality of life of patients with hepatic encephalopathy. There were greater preference values for lower levels of disease, with the highest value associated with Conn grade 0. These health state preference values can be used to estimate the outcomes of different interventions for hepatic encephalopathy in terms of quality-adjusted life years.

Cohort study assessing the impact of COVID-19 on venous leg ulcer management and associated clinical outcomes in clinical practice in the UK.

OBJECTIVE: To assess the impact of the COVID-19 pandemic on venous leg ulcer (VLU) management by the UK's health services and associated outcomes. DESIGN: Retrospective cohort analysis of the electronic records of patients from The Health Improvement Network database. SETTING: Clinical practice in primary and secondary care. PARTICIPANTS: A cohort of 1946 patients of whom 1263, 1153 and 733 had a VLU in 2019, 2020 and 2021, respectively. PRIMARY AND SECONDARY OUTCOME MEASURES: Clinical outcomes and wound-related healthcare resource use. RESULTS: VLU healing rate in 2020 and 2021 decreased by 16% and 42%, respectively, compared with 2019 and time to heal increased by >85%. An estimated 3% of patients in 2020 and 2021 had a COVID-19 infection. Also, 1% of patients in both years had VLU-related sepsis, 0.1%-0.2% developed gangrene and 0.3% and 0.6% underwent an amputation on part of the foot or lower limb in 2020 and 2021 (of whom 57% had diabetes), respectively. The number of community-based face-to-face clinician visits decreased by >50% in both years and >35% fewer patients were referred to a hospital specialist. In 2020 and 2021, up to 20% of patients were prescribed dressings without compression compared with 5% in 2019. The total number of wound care products prescribed in 2020 and 2021 was >50% less than that prescribed in 2019, possibly due to the decreased frequency of dressing change from a mean of once every 11 days in 2019 to once every 21 days in 2020 and 2021. CONCLUSIONS: There was a significant trend towards decreasing care during 2020 and 2021, which was outside the boundaries considered to be good care. This led to poorer outcomes including lower VLU healing rates and increased risk of amputation. Hence, the COVID-19 pandemic appears to have had a deleterious impact on the health of patients with a VLU.

Cohort study to characterise surgical site infections after open surgery in the UK's National Health Service.

OBJECTIVE: To characterise surgical site infections (SSIs) after open surgery in the UK's National Health Service. DESIGN: Retrospective cohort analysis of electronic records of patients from Clinical Practice Research Datalink, linked with Hospital Episode Statistics' secondary care datasets. SETTING: Clinical practice in the community and secondary care. PARTICIPANTS: Cohort of 50 000 adult patients who underwent open surgery between 2017 and 2022. OUTCOME MEASURES: Incidence of SSI, clinical outcomes, patterns of care and costs of wound management. RESULTS: 11% (5281/50 000) of patients developed an SSI a mean of 18.4±14.7 days after their surgical procedure, of which 15% (806/5281) were inpatients and 85% (4475/5281) were in the community after hospital discharge. The incidence of SSI varied according to anatomical site of surgery. The incidence also varied according to a patient's risk and whether they underwent an emergency procedure. SSI onset reduced the 6 months healing rate by a mean of 3 percentage points and increased time to wound healing by a mean of 15 days per wound. SSIs were predominantly managed in the community by practice and district nurses and 16% (850/5281) of all patients were readmitted into hospital. The total health service cost of surgical wound management following SSI onset was a mean of £3537 per wound ranging from £2542 for a low-risk patient who underwent an elective procedure to £4855 for a high-risk patient who underwent an emergency procedure. CONCLUSIONS: This study provides important insights into several aspects of SSI management in clinical practice in the UK that have been difficult to ascertain from surveillance data. Surgeons are unlikely to be fully aware of the true incidence of SSI and how they are managed once patients are discharged from hospital. Current SSI surveillance services appear to be under-reporting the actual incidence.