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.

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.

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.

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.

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.

Cohort study evaluating the burden of wounds to the UK's National Health Service in 2017/2018: update from 2012/2013.

OBJECTIVE: To evaluate the prevalence of wounds managed by the UK's National Health Service (NHS) in 2017/2018 and associated health outcomes, resource use and costs. DESIGN: Retrospective cohort analysis of the electronic records of patients from The Health Improvement Network (THIN) database. SETTING: Primary and secondary care sectors in the UK. PARTICIPANTS: Randomly selected cohort of 3000 patients from the THIN database who had a wound in 2017/2018. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients' characteristics, wound-related health outcomes, healthcare resource use and total NHS cost of patient management. RESULTS: There were an estimated 3.8 million patients with a wound managed by the NHS in 2017/2018, of which 70% healed in the study year; 89% and 49% of acute and chronic wounds healed, respectively. An estimated 59% of chronic wounds healed if there was no evidence of infection compared with 45% if there was a definite or suspected infection. Healing rate of acute wounds was unaffected by the presence of infection. Smoking status appeared to only affect the healing rate of chronic wounds. Annual levels of resource use attributable to wound management included 54.4 million district/community nurse visits, 53.6 million healthcare assistant visits and 28.1 million practice nurse visits. The annual NHS cost of wound management was £8.3 billion, of which £2.7 billion and £5.6 billion were associated with managing healed and unhealed wounds, respectively. Eighty-one per cent of the total annual NHS cost was incurred in the community. CONCLUSION: The annual prevalence of wounds increased by 71% between 2012/2013 and 2017/2018. There was a substantial increase in resource use over this period and patient management cost increased by 48% in real terms. There needs to be a structural change within the NHS in order to manage the increasing demand for wound care and improve patient outcomes.

Cohort study evaluating management of burns in the community in clinical practice in the UK: costs and outcomes.

OBJECTIVE: To evaluate health outcomes, resource use and corresponding costs attributable to managing burns in clinical practice, from initial presentation, among a cohort of adults in the UK. DESIGN: Retrospective cohort analysis of the records of a randomly selected cohort of 260 patients from The Health Improvement Network (THIN) database who had 294 evaluable burns. SETTING: Primary and secondary care sectors in the UK. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients' characteristics, wound-related health outcomes, healthcare resource use and total National Health Service (NHS) cost of patient management. RESULTS: Diagnosis was incomplete in 63% of patients' records as the location, depth and size of the burns were missing. Overall, 70% of all the burns healed within 24 months and the time to healing was a mean of 7.8 months per burn. Sixty-six per cent of burns were initially managed in the community and the other 34% were managed at accident and emergency departments. Patients' wounds were subsequently managed predominantly by practice nurses and hospital outpatient clinics. Forty-five per cent of burns had no documented dressings in the patients' records. The mean NHS cost of wound care in clinical practice over 24 months from initial presentation was an estimated £16 924 per burn, ranging from £12 002 to £40 577 for a healed and unhealed wound, respectively. CONCLUSIONS: Due to incomplete documentation in the patients' records, it is difficult to say whether the time to healing was excessive or what other confounding factors may have contributed to the delayed healing. This study indicates the need for education of general practice clinicians on the management and care of burn wounds. Furthermore, it is beholden on the burns community to determine how the poor healing rates can be improved. Strategies are required to improve documentation in patients' records, integration of care between different providers, wound healing rates and reducing infection.

Cost-Effectiveness and Cost-Benefit of Cervical Cancer Screening with Liquid Based Cytology Compared with Conventional Cytology in Germany.

OBJECTIVE: To assess the health economic impact of cervical screening with liquid based cytology (LBC) compared with conventional cytology (CC) in Germany. METHODS: An economic model was constructed depicting the management of a hypothetical cohort of women aged ≥20 years who undergo cervical screening in Germany. The model estimated the cost-effectiveness and cost-benefit of LBC compared with CC at 2017/18 prices over a time-horizon of 70 years. RESULTS: Performing cervical screens with LBC instead of CC is expected to increase the probability of detecting a true positive over a subject's lifetime by 73% (0.038 versus 0.022) and of diagnosing a subject with stage 3 cervical intraepithelial neoplasia (CIN3) (0.019 versus 0.011). Women screened with LBC instead of CC are expected to have a 57% reduction in the probability of having undetected CIN3 (0.006 versus 0.014) and to experience a 44% reduction in the probability of transitioning into disease progression (from 0.018 to 0.010). The mean discounted lifetime cost of healthcare resource use associated with performing cervical screens with LBC and CC was estimated at €4852 and €7523 per subject respectively. For every Euro invested in cervical screening with LBC instead of CC, the German healthcare system could potentially save ~€170 over a subject's lifetime. CONCLUSION: Within the study's limitations, the analysis showed that LBC affords a cost-effective cervical screening test compared with CC in Germany, since it improves detection rates and has the potential to lead to a reduction in disease progression for less cost.

Modelling the annual NHS costs and outcomes attributable to healthcare-associated infections in England.

OBJECTIVES: To estimate the annual health economic impact of healthcare-associated infections (HCAIs) to the National Health Service (NHS) in England. DESIGN: A modelling study based on a combination of published data and clinical practice. SETTING: NHS hospitals in England. PRIMARY AND SECONDARY OUTCOME MEASURES: Annual number of HCAIs, additional NHS cost, number of occupied hospital bed days and number of days front-line healthcare professionals (HCPs) are absent from work. RESULTS: In 2016/2017, there were an estimated 653 000 HCAIs among the 13.8 million adult inpatients in NHS general and teaching hospitals in England, of which 22 800 patients died as a result of their infection. Additionally, there were an estimated 13 900 HCAIs among 810 000 front-line HCPs in the year. These infections were estimated to account for a total of 5.6 million occupied hospital bed days and 62 500 days of absenteeism among front-line HCPs. In 2016/2017, HCAIs were estimated to have cost the NHS an estimated £2.1 billion, of which 99.8% was attributable to patient management and 0.2% was the additional cost of replacing absent front-line HCPs with bank or agency staff for a period of time. When the framework of the model was expanded to include all NHS hospitals in England (by adding specialist hospitals), there were an estimated 834 000 HCAIs in 2016/2017 costing the NHS £2.7 billion, and accounting for 28 500 patient deaths, 7.1 million occupied hospital bed days (equivalent to 21% of the annual number of all bed days across all NHS hospitals in England) and 79 700 days of absenteeism among front-line HCPs. CONCLUSION: This study should provide updated estimates with which to inform policy and budgetary decisions pertaining to preventing and managing these infections. Clinical and economic benefits could accrue from an increased awareness of the impact that HCAIs impose on patients, the NHS and society as a whole.

Modelling the costs and consequences of reducing healthcare-associated infections by improving hand hygiene in an average hospital in England.

OBJECTIVE: To assess the potential clinical and economic impact of introducing an electronic audit and feedback system into current practice to improve hand hygiene compliance in a hypothetical general hospital in England, to reduce the incidence of healthcare-associated infections (HCAIs). METHODS: Decision analysis estimated the impact of introducing an electronic audit and feedback system into current practice to improve hand hygiene compliance among front-line healthcare practitioners (HCPs). RESULTS: The model assumed 4.7% of adult inpatients (ie, ≥18 years of age) and 1.72% of front-line HCPs acquire a HCAI in current practice. The model estimated that if use of the electronic audit and feedback system could lead to a reduction in the incidence of HCAIs of between 5% and 25%, then the annual number of HCAIs avoided could range between 184 and 921 infections per hospital and HCAI-related mortality could range between 6 and 31 deaths per annum per hospital. Additionally, up to 86 days of absence among front-line HCPs could be avoided and up to 7794 hospital bed days could be released for alternative use. Accordingly, the total annual hospital cost attributable to HCAIs could be reduced by between 3% and 23%, depending on the effectiveness of the electronic audit and feedback system. If introduction of the electronic audit and feedback system into current practice could lead to a reduction in the incidence of HCAIs by at least 15%, it would have a ≥0.75 probability of affording the National Health Service (NHS) a cost-effective intervention. CONCLUSION: If the introduction of the electronic audit and feedback system into current practice in a hypothetical general hospital in England can improve hand hygiene compliance among front-line HCPs leading to a reduction in the incidence of HCAIs by ≥15%, it would potentially afford the NHS a cost-effective intervention.

Effectiveness of using an extensively hydrolyzed casein formula supplemented with Lactobacillus rhamnosus GG compared with an extensively hydrolysed whey formula in managing cow's milk protein allergic infants.

Aim: To assess the comparative effectiveness of two hypoallergenic formulae in managing cow's milk allergic infants. Materials & methods: This study retrospectively analyzed the case records of 940 formula-fed cow's milk allergic infants in the UK extracted from The Health Improvement Network database. Results: At 24 months after starting a formula, 77% of infants fed an extensively hydrolyzed casein formula supplemented with Lactobacillus rhamnosus GG (eHCF LGG; n = 470) were estimated to have been successfully managed compared with 63% of matched infants who were fed an extensively hydrolyzed whey formula (eHWF; n = 470; p < 0.001). Additionally, significantly more eHWF-fed infants were estimated to be experiencing gastrointestinal symptoms, eczema and asthma (7.1 vs 3.1%; p < 0.02) at 24 months. Conclusion: First-line management of newly diagnosed cow's milk allergic infants with eHCF LGG may slow down the allergic march seen in cow's milk allergic children.

Cost-effectiveness of using an extensively hydrolyzed casein formula supplemented with Lactobacillus rhamnosus GG in managing IgE-mediated cow's milk protein allergy in the UK.

Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) plus the probiotic Lactobacillus rhamnosus GG (eHCF plus LGG; Nutramigen* LGG®) compared to an eHCF alone as first-line dietary management for Immunoglobulin E (IgE)-mediated cow's milk protein allergy (CMPA) in the UK. Methods: Decision modelling was undertaken to estimate the probability of IgE-mediated cow's milk allergic infants being symptom free (i.e. not experiencing urticaria, eczema, asthma or rhinoconjunctivitis) and developing tolerance to cow's milk by 5 years. The model also estimated the cost (at 2016/2017 prices) of healthcare resource use funded by the UK's National Health Service (NHS) over 5 years after starting a formula, as well as the relative cost-effectiveness of the two dietary formulae. Results: At 5 years after the start of a formula the probability of being symptom free was estimated to be 0.97 and 0.76 among infants who were originally fed eHCF plus LGG and an eHCF alone, respectively. This encompassed the probability of children being asthma free at 5 years after the start of treatment, which was 0.99 and 0.91 in the eHCF plus LGG and eHCF alone groups, respectively. Additionally, the probability of acquiring tolerance to cow's milk was estimated to be 0.94 and 0.66 among infants who were originally fed eHCF plus LGG and an eHCF alone, respectively. The estimated total healthcare cost over 5 years of initially feeding infants with eHCF plus LGG was less than that of feeding infants with an eHCF alone (£4229 versus £5136 per patient). Conclusions: First-line management of newly diagnosed infants with IgE-mediated CMPA with eHCF plus LGG instead of an eHCF alone improves outcome, releases healthcare resources for alternative use, reduces the NHS cost of patient management and thereby affords a cost-effective dietetic strategy to the NHS.

Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study.

OBJECTIVE: To evaluate the patient pathways and associated health outcomes, resource use and corresponding costs attributable to managing unhealed surgical wounds in clinical practice, from initial presentation in the community in the UK. METHODS: This was a retrospective cohort analysis of the records of 707 patients in The Health Improvement Network (THIN) database whose wound failed to heal within 4 weeks of their surgery. Patients' characteristics, wound-related health outcomes and healthcare resource use were quantified, and the total National Health Service (NHS) cost of patient management was estimated at 2015/2016 prices. RESULTS: Inconsistent terminology was used in describing the wounds. 83% of all wounds healed within 12 months from onset of community management, ranging from 86% to 74% of wounds arising from planned and emergency procedures, respectively. Mean time to healing was 4 months per patient. Patients were predominantly managed in the community by nurses and only around a half of all patients who still had a wound at 3 months were recorded as having had a follow-up visit with their surgeon. Up to 68% of all wounds may have been clinically infected at the time of presentation, and 23% of patients subsequently developed a putative wound infection a mean 4 months after initial presentation. Mean NHS cost of wound care over 12 months was £7300 per wound, ranging from £6000 to £13 700 per healed and unhealed wound, respectively. Additionally, the mean NHS cost of managing a wound without any evidence of infection was ~£2000 and the conflated cost of managing a wound with a putative infection ranged from £5000 to £11 200. CONCLUSION: Surgeons are unlikely to be fully aware of the problems surrounding unhealed surgical wounds once patients are discharged into the community, due to inconsistent recording in patients' records coupled with the low rate of follow-up appointments. These findings offer the best evidence available with which to inform policy and budgetary decisions pertaining to managing unhealed surgical wounds in the community.

Cohort study evaluating pressure ulcer management in clinical practice in the UK following initial presentation in the community: costs and outcomes.

OBJECTIVES: The aim of this study was to estimate the patterns of care and annual levels of healthcare resource use attributable to managing pressure ulcers (PUs) in clinical practice in the community by the UK's National Health Service (NHS), and the associated costs of patient management. METHODS: This was a retrospective cohort analysis of the records of 209 patients identified within a randomly selected population of 6000 patients with any type of wound obtained from The Health Improvement Network (THIN) Database, who developed a PU in the community and excluded hospital-acquired PUs. Patients' characteristics, wound-related health outcomes and healthcare resource use were quantified over 12 months from initial presentation, and the corresponding total NHS cost of patient management was estimated at 2015/2016 prices. RESULTS: 50% of all the PUs healed within 12 months from initial presentation, but this varied between 100% for category 1 ulcers and 21% for category 4 ulcers. The mean time to healing ranged from 1.0 month for a category 1 ulcer to 8 months for a category 3/4 ulcer and 10 months for an unstageable ulcer. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 53% of all the ulcers may have been clinically infected at the time of presentation, and 35% of patients subsequently developed a putative wound infection a mean 4.7 months after initial presentation. The mean NHS cost of wound care over 12 months ranged from £1400 for a category 1 ulcer to >£8500 for the other categories of ulcer. Additionally, the cost of managing an unhealed ulcer was 2.4 times more than that of managing a healed ulcer (mean of £5140 vs £12 300 per ulcer). CONCLUSION: This study provides important insights into a number of aspects of PU management in clinical practice in the community 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.

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.

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 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.