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Stephanie F Armstrong,1 Julian F Guest1,2 1Catalyst Consultants, Rickmansworth, UK; 2Faculty of Life Sciences and Medicine, King’s College, London, UKCorrespondence: Julian F GuestCatalyst Consultants, 7 Gilham Court, Ebury Road, Rickmansworth, Hertfordshire WD3 1FZ, UKTel +44 1923 450045Fax +44 1923 450046Email julian.guest@catalyst-health.comObjective: 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.Keywords: cancer, cervical screening, conventional cytology, cost-effectiveness, liquid based cytology, Germany, Papanicolaou

Julian F Guest,1,2 Fernando Moya,3 Paula M Sisk,4 Mark L Hudak,5 Devon Kuehn6 1Catalyst Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Coastal Carolina Neonatology, Wilmington, NC, USA; 4Novant Health Forsyth Medical Center, Winston Salem, NC, USA; 5Department of Pediatrics, University of Florida College of Medicine, Jacksonville, FL, USA; 6Department of Pediatrics, East Carolina University, Greenville, NC, USA Objective: To estimate the cost-effectiveness of using a liquid human milk fortifier (LHMF) compared to a powdered human milk fortifier (PHMF) in preterm infants in the US from the perspective of third-party payers and parents.Methods: This was a decision modelling study using patient data obtained from a randomized controlled trial comparing a LHMF with a PHMF in preterm infants, supplemented with additional data obtained by performing a chart review among 79% of the trial patients. The model estimated the cost-effectiveness of LHMF versus PHMF in US$ at 2014/2015 prices.Results: More infants in the LHMF group were discharged home (92% versus 89%) and more infants in the PHMF group were transferred to another unit (9% versus 5%). Gestational age was an independent predictor for being discharged home (odds ratio of 2.18; p=0.006 for each week of gestational age). Mean length of neonatal intensive care unit (NICU) stay was 1 day less in the LHMF than the PHMF group (62.3 versus 63.4 days), but mean length of NICU stay among infants who developed NEC or sepsis was 79.3 days and 61.2 days in the PHMF and LHMF groups, respectively. Total management cost up to discharge was $10,497 per infant less in the LHMF group than the PHMF group ($240,928 versus $251,425).Conclusion: Using LHMF instead of PHMF in preterm infants enabled resources to be freed-up for alternative use within the system. There is no health economic reason why LHMF should not be used in preference to PHMF in the NICU. Keywords: cost-effectiveness, milk fortifiers, neonatal intensive care, preterm infants, US

Julian F Guest,1,2 Ariana C Yang,3 Jane Oba,4 Maraci Rodrigues,5 Rosane Caetano,6 Lilian Polster7 1Catalyst Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Universidade de São Paulo, São Paulo & Universidade Estadual de Campinas, São Paulo, Brazil; 4Hospital Israelita Albert Einstein, São Paulo, Brazil & Hospital Municipal Menino Jesus, São Paulo, Brazil; 5Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, Brazil; 6General Pediatrician, Rio de Janeiro, Brazil; 7General Pediatrician, São Paulo, Brazil Objective: To estimate the cost-effectiveness of three alternative dietetic strategies for cow’s milk allergy in Brazil: 1) using an extensively hydrolyzed casein formula (eHCF; ­Nutramigen) as a first-line formula, but switching to an amino acid formula (AAF) if infants remain symptomatic; 2) using an AAF as a first-line formula and then switching to an eHCF after 4 weeks once infants are symptom-free, but switching back to an AAF if infants become symptomatic; and 3) using an AAF as a first-line formula and keeping all infants on that formula. The analysis was conducted from the perspective of the Brazilian public health care system, Sistema Único de Saude.Methods: Decision modeling was used to estimate the probability of immunoglobulin E (IgE)-mediated and non-IgE-mediated allergic infants developing tolerance to cow’s milk by 12 months from starting a formula. The models also estimated the Sistema Único de Saude cost (at 2013/2014 prices) of managing infants over 12 months after starting a formula, as well as the relative cost-effectiveness of each of the dietetic strategies.Results: The probability of developing tolerance to cow’s milk by 12 months from starting a formula was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were initially fed with an eHCF, compared with those who were initially fed with an AAF. The total health care cost of initially feeding an eHCF to cow’s milk allergic infants was less than that of initially feeding both IgE-mediated and non-IgE-mediated infants with an AAF.Conclusion: Within the study’s limitations, using an eHCF instead of an AAF for the first-line management of newly-diagnosed infants with cow’s milk allergy affords a cost-effective use of publicly funded resources, since it improves the outcome for less cost. Keywords: amino acid formula, Brazil, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula

Julian F Guest,1,2 Diana Weidlich,1 Maciej Kaczmarski,3 Elzbieta Jarocka-Cyrta,4 Natalia Kobelska-Dubiel,5 Agnieszka Krauze,6 Iwona Sakowska-Maliszewska,7 Anna Zawadzka-Krajewska8 1Catalyst Health Economics Consultants, Northwood, Middlesex, 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Department of Pediatrics, Gastroenterology, and Allergology, Medical University of Bialystok, Białystok, 4Uniwersytet Warmińsko‑Mazurski, Wydział Nauk Medycznych, Katedra Pediatrii Klinicznej, Olsztyn, 5Department of Pediatric Gastroenterology and Metabolic Diseases, Poznań University of Medical Sciences, Poznań, 6Klinika Pneumonologii i Alergologii Wieku Dziecięcego, Warsaw, 7Poradnia Gastroenterologiczna Centrum Pediatrii, Sosnowiec, 8Department of Pediatric Pneumonology and Allergology, Medical University of Warsaw, Warsaw, Poland Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) containing the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) as an initial treatment for cow’s milk allergy compared with eHCF alone and amino acid formulas (AAF) in Poland from the perspective of the Polish National Health Fund (Narodowy Fundusz Zdrowia [NFZ]) and parents. Methods: Decision modeling was used to estimate the probability of cow’s milk allergic infants developing tolerance to cow’s milk by 18 months. The model also estimated the cost to the NFZ and parents (Polish Zloty [PLN] at 2013–2014 prices) for managing infants over 18 months after starting one of the formulas as well as the relative cost-effectiveness of each of the formulas. Results: The probability of developing tolerance to cow’s milk by 18 months was higher among infants who were fed eHCF + LGG (0.82) compared with those fed eHCF alone (0.53) or an AAF (0.22). An infant who is initially managed with eHCF + LGG is expected to consume fewer health care resources than infants managed with the other formulas. Hence, the estimated total health care cost incurred by the NFZ for initially feeding infants with eHCF + LGG (PLN 5,693) was less than that of feeding infants with eHCF alone (PLN 7,749) or an AAF (PLN 24,333). However, the total cost incurred by parents for initially feeding infants with an AAF (PLN 815) was marginally less than that of feeding with eHCF + LGG (PLN 993), which was less than that of feeding with eHCF alone (PLN 1,226). Conclusion: Using eHCF + LGG instead of eHCF alone or an AAF for first-line management of newly diagnosed infants with cow’s milk allergy affords a cost-effective use of NFZ-funded resources, since it improves outcome for less cost. Whether eHCF + LGG would be viewed as being cost-effective by parents is dependent on their willingness to pay an additional cost for additional tolerance acquisition to cow’s milk. Keywords: amino acid formula, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula, Lactobacillus Rhamnosus GG, Poland

Julian F Guest,1,2 Diana Weidlich,1 J Ignacio Mascuñan Díaz,3 Juan J Díaz,4 Pedro Manuel Ojeda,5 J Pablo Ferrer-González,6 David Gil,7 Isabel Onrubia Vaquero,8 Pedro Rincón Victor9 1Catalyst Health Economics Consultants, Northwood, Middlesex, 2Faculty of Life Sciences and Medicine, King’s College, London, UK; 3Centro de Salud de Paterna, Valencia, Spain; 4Hospital Universitario Central de Asturias, Oviedo, 5Clínica de Asma y Alergia Doctores Ojeda, 6Hospital General de Requena, Valencia, 7Hospital Universitario Virgen de la Arrixaca, Murcia, 8Centro de Salud Valle de la Oliva, Majadahonda, 9Centro de Salud la Chopera, Alcobendas, Spain Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) as a first-line management for cow’s milk allergy compared with eHCF alone, and amino acid formulae in Spain, from the perspective of the Spanish National Health Service (SNS).Methods: Decision modeling was used to estimate the probability of immunoglobulin E (IgE)-mediated and non–IgE-mediated allergic infants developing tolerance to cow’s milk by 18 months. The models also estimated the SNS cost (at 2012/2013 prices) of managing infants over 18 months after starting a formula as well as the relative cost-effectiveness of each of the formulae.Results: The probability of developing tolerance to cow’s milk by 18 months was higher among infants with either IgE-mediated or non–IgE-mediated allergy who were fed eHCF + LGG compared with those fed one of the other formulae. The total health care cost of initially feeding infants with eHCF + LGG was less than that of feeding infants with one of the other formulae. Hence, eHCF + LGG affords the greatest value for money to the SNS for managing both IgE-mediated and non–IgE-mediated cow’s milk allergy.Conclusion: Using eHCF + LGG instead of eHCF alone or amino acid formulae for first-line management of newly-diagnosed infants with cow’s milk allergy affords a cost-effective use of publicly funded resources because it improves outcome for less cost. A randomized controlled study showing faster tolerance development in children receiving a probiotic-containing formula is required before this conclusion can be confirmed.Keywords: amino acid formula, cost-effectiveness, cow’s milk allergy, extensively hydrolyzed formula, Spain, Lactobacillus rhamnosus GG

Julian F Guest,1,2 Monica Panca,1 Olga Ovcinnikova,1 Rita Nocerino3 1CATALYST Health Economics Consultants, Northwood, Middlesex, UK; 2Faculty of Life Sciences and Medicine, King's College, London, UK; 3Department of Translational Medical Science, Pediatric Section, University of Naples 'Federico II', Naples, Italy Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) containing the probiotic Lactobacillus rhamnosus GG, (eHCF + LGG; Nutramigen LGG) as first-line management for cow's milk allergy (CMA) compared with eHCF alone, soy-based formulae (SBF), hydrolyzed rice formulae (HRF), and amino acid formulae (AAF) in Italy, from the perspective of the Italian National Health Service (INHS) and parents. Methods: Decision modeling was used to estimate the probability of infants developing tolerance to cow's milk by 18 months, based on an observational study dataset. The model also estimated the cost (at 2012/2013 prices) of health care resource use funded by the INHS and formulae paid for by parents over 18 months after starting a formula, as well as the relative cost-effectiveness of each of the formulae. Results: The probability of developing tolerance to cow's milk by 18 months was higher among infants with either IgE-mediated or non-IgE-mediated allergy who were fed eHCF + LGG compared to those fed one of the other formulae. The total health care cost of initially feeding infants with eHCF + LGG was less than that of feeding infants with one of the other formulae. Hence, eHCF + LGG affords the greatest value for money to both the INHS and parents of infants with either IgE-mediated or non-IgE-mediated CMA. Conclusion: Using eHCF + LGG instead of eHCF, SBF, HRF, or an AAF for first-line management of newly diagnosed infants with CMA in Italy affords a cost-effective use of publicly funded resources, and is cost-effective from the parents' perspective, since it improves outcome for less cost. A randomized controlled study showing faster tolerance development in children receiving a probiotic-containing formula is required before this conclusion can be confirmed. Keywords: amino acid formula, extensively hydrolyzed formula, soy-based formulae, hydrolyzed rice formulae

Olga Ovcinnikova,1 Monica Panca,1 Julian F Guest1,2 1CATALYST Health Economics Consultants, Northwood, London, 2Faculty of Life Sciences and Medicine, King’s College, London, UK Objectives: The aim was to estimate the cost-effectiveness of using an extensively hydrolyzed casein formula (eHCF) plus the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) compared to an eHCF alone (Nutramigen) and an amino acid formula (AAF; Neocate) as first-line dietary management for cow’s milk allergy (CMA) in the US. Methods: Using a cohort study design, the analysis was based on the case records of 136 eHCF-fed, 59 eHCF + LGG-fed, and 217 matched AAF-fed infants extracted from the Truven Health MarketScan® Commercial Claims Database (a nationally representative database of the commercially insured population of the US). Clinical outcomes and health care resource use (with corresponding costs at 2012 prices), following first-line dietary management with each formula, were estimated over 12 months from the start of feeding. Differences in infants’ outcomes and resource use between groups were adjusted for any differences in baseline covariates. Results: Infants were

Objective: This article assesses the cost-effectiveness of pentostatin compared with cladribine in the management of hairy cell leukemia (HCL) in the United Kingdom. Methods: A systematic literature search for papers on HCL was performed using MEDLINE, EMBASE, Current Contents, NHS Economic Evaluation Database, and the Cochrane computerized database. Search terms were HCL plus 1 of the following: incidence, prevalence, epidemiology, cladribine, interferon, pentostatin, rituximab, splenectomy, utility, quality of life, cost-effectiveness, cost-utility, resource utilization, economic, or cost. Published clinical outcomes and estimates of health care resource use obtained from 10 consultant hematologists across the United Kingdom were used to construct a 5-year Markov model depicting the current management of HCL in the United Kingdom. Utilities for health states in the model were obtained from the general public using standard gamble, time tradeoff, and visual analog scale techniques. The model was used to consider the decision by a clinician to initially treat an HCL patient with either pentostatin or cladribine and to estimate the relative cost-effectiveness of pentostatin over 5 years (at 2007/2008 prices) from the perspective of the UK's National Health Service (NHS). Results: According to the model, 64% of all pentostatin-treated patients are expected to be in relapse-free remission at 5 years compared with 49% of cladribine-treated patients (P = 0.04). Repeat treatment of initial partial responders, nonresponders, and those who relapse during the 5 years is expected to result in complete remission in 92% of pentostatintreated patients and 90% of cladribine-treated patients at 5 years. Using pentostatin instead of cladribine is expected to lead to a minimal cost increase (from £21,325 to £21,609) and an improvement in health status (from 3.64 to 3.77 quality-adjusted life-years [QALYs]) over 5 years. Hence, the cost per QALY gained from using pentostatin is expected to be £5000. Moreover, pentostatin has a 0.90 probability of being cost-effective for a threshold of £20,000 per QALY. Accordingly, using pentostatin as a first-line treatment for patients with HCL is an effective use of NHS resources. Conclusion: Based on current practice, this model predicts that pentostatin is a cost-effective treatment compared with cladribine in the management of HCL from the perspective of the UK's NHS. [ABSTRACT FROM AUTHOR]

Objective: To estimate the clinical and economic impact of using macrogol 3350 plus electrolytes (macrogol 3350; Movicol; Movicol Paediatric Plain) in an outpatient setting compared to enemas and suppositories and manual evacuation to treat paediatric faecal impaction.Methods: A chart review was undertaken to extract clinical outcomes and resource use from the case notes of a cohort of children aged 2-11 years with faecal impaction who initially received either macrogol 3350 (in an outpatient setting) or enemas and suppositories or manual evacuation for initial disimpaction. Five centres across England and Wales participated in the study. These data were used to inform a decision model which depicted the management of children during the disimpaction phase and for a period of 12 weeks following initial disimpaction. Unit resource costs at 2005/2006 prices were applied to the resource utilisation estimates within the model, enabling the incremental costs and consequences of using macrogol 3350 in an outpatient setting, compared to the other treatments, to be estimated.Results: 112 patients treated with macrogol 3350, 101 who received enemas and suppositories and 11 who underwent a manual evacuation were eligible for analysis. Ninety-seven per cent of children treated with macrogol 3350 were successfully disimpacted within 5 days, compared to 73% of those who received enemas and suppositories and 89% of those who underwent a manual evacuation (p < 0.001). There were no significant differences in reported adverse events between the different treatments for disimpaction, with the exception of vomiting which was significantly higher among those who underwent a manual evacuation (18% versus 2% with the other treatments; p < 0.01). There were no significant differences in the number of clinician outpatient visits between treatments. However, macrogol 3350-treated patients had significantly fewer hospital admissions than those who received the other interventions (0.1 versus 1.4 and 1.0 for enemas and suppositories and manual evacuation respectively; p < 0.05) and occupied fewer bed days. The total NHS cost of disimpaction and subsequent maintenance of children initially treated with macrogol 3350 was estimated to be 694 pounds sterling (95% CI: 496 pounds sterling; 892 pounds sterling). This compared with 2759 pounds sterling (95% CI: 1266 pounds sterling; 4252 pounds sterling) and 2333 pounds sterling (95% CI: 1609 pounds sterling; 3058 pounds sterling) for those who initially received enemas and suppositories or underwent a manual evacuation, respectively. Hence, using macrogol 3350 instead of enemas and suppositories and manual evacuation to disimpact the whole annual cohort of faecally impacted children aged 2-11 years in England could potentially reduce annual NHS expenditure on this condition by 59% (5 million pounds sterling) and reduce the annual number of paediatric hospital admissions for this condition by 92% (4330).Conclusion: Within the limitations of our model, macrogol 3350 affords the NHS a clinically effective and cost-effective treatment for the disimpaction of children suffering from faecal impaction compared to enemas and suppositories or a manual evacuation, and has the potential to release healthcare resources for alternative use within the system. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-utility of levonorgestrel intrauterine system (LNG-IUS; Mirena) compared to second generation endometrial ablative techniques [i.e. microwave endometrial ablation (MEA) and thermal balloon endometrial ablation (TBEA)) and hysterectomy in the UK.Methods: Clinical and utility data from a 5-year randomised controlled trial comparing LNG-IUS with hysterectomy were combined with further data from published studies to construct a state-transition (Markov) model. The model depicted the movement of patients between health states over 5 years following treatment for menorrhagia. The model was used to estimate the cost-utility of LNG-IUS followed by ablation (L-A); LNG-IUS followed by hysterectomy (L-H); immediate ablation (MEA or TBEA) and immediate hysterectomy in the UK at 2004/2005 prices, from the perspective of the UK's National Health Service (NHS).Main Outcome Measures and Results: The expected 5-yearly cost of treating menorrhagia with L-A, L-H, TBEA, MEA and hysterectomy was estimated to be 828 pounds sterling, 1355 pounds sterling, 1679 pounds sterling, 1812 pounds sterling and 2983 pounds sterling per patient respectively and the expected level of health gain to be 4.14, 4.12, 4.13, 4.13 and 4.01 QALYs per patient respectively. LNG-IUS followed by ablation dominated all the alternative treatments. Hysterectomy was dominated by the alternative treatments. Sensitivity analysis found the model to be sensitive to the quality of life data used.Conclusion: Within the model's limitations, LNGIUS followed by ablation appears to offer the NHS a cost-effective treatment for menorrhagia, when compared to immediate surgery, affording the NHS a less expensive treatment modality without detrimental effects on resulting health gain. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-utility of bio-electric stimulation therapy (Posifect) compared to standard care in elderly patients with chronic, non-healing wounds of > 6 months duration, from the perspective of the National Health Service (NHS) in the UK.Methods: Clinical and resource use data from a 16 week clinical evaluation of bio-electric stimulation therapy among patients who had recalcitrant wounds were combined with utility data obtained from a standard gamble analysis to construct a 16 week Markov model. The model considers the decision by a clinician to continue with a patient's previous care plan or treat with bio-electric stimulation therapy. Unit resource costs at 2005/2006 prices were applied to the resource utilisation estimates within the model, enabling the cost-utility of bio-electric stimulation therapy compared to standard care to be estimated. The acquisition cost of Posifect had not been decided at the time of performing this study. Hence, the base case analysis used a cost of 50 pounds per dressing.Results: 33% of all wounds are expected to heal within 16 weeks after the start of bio-electric stimulation therapy. Consequently, using bio-electric stimulation therapy is expected to lead to a 51% decrease in the number of domiciliary clinician visits, from 4.7 to 2.3 per week. The model also showed that using bio-electric stimulation therapy instead of patients' standard care is expected to reduce the NHS cost of managing them by 16% from 2287 pounds (95% CI: 1838 pounds; 2735 pounds) to 1921 pounds (95% CI: 1609 pounds; 2233 pounds) and result in a health gain of 0.023 QALYs over 16 weeks. Hence, bio-electric stimulation therapy was found to be a dominant treatment. Sensitivity analyses demonstrated that the cost-utility of using bio-electric stimulation therapy relative to standard care is very sensitive to the acquisition cost of the therapy, the acquisition cost of patients' drugs and the number of clinician visits and less sensitive to utility values and the acquisition cost of other dressings.Conclusion: Within the limitations of the model, bio-electric stimulation therapy is expected to afford the NHS a cost-effective dressing compared to standard care in the management of chronic non-healing wounds of > 6 months duration. Bio-electric stimulation therapy's acquisition cost is expected to be offset by a reduction in the requirement for domiciliary clinician visits, leading to a release of NHS resources for use elsewhere in the system, thereby generating an increase in NHS efficiency. [ABSTRACT FROM AUTHOR]

Background and Aims: Organic chloramines have been developed as a topical wound bed preparation gel. This study aimed to estimate whether the addition of chloramine gel (Chlorasolv, RLS Global AB, Sweden) to standard care compared with standard care alone would afford a cost‑effective technology to the UK's health services for treating infected, non-healing diabetic foot ulcers (DFUs)., Methods: A Markov model was developed to simulate the management of infected, non-healing DFUs. The model utilised data from a randomised controlled trial and was used to estimate the cost-effectiveness of chloramine plus standard care compared with standard care alone over a period of 24 weeks, expressed as the incremental cost per quality-adjusted life year (QALY) gained at 2021/22 prices., Results: Using adjunctive chloramine to treat infected, non-healing DFUs was found to shorten the time to healing by 36% (from a mean of 17.1 weeks per ulcer to a mean of 11.0 weeks per ulcer). This translated into a 6% improvement in the probability of being healed by 24 weeks and a corresponding 3% improvement in health-related quality of life (HRQoL). Also, use of adjunctive chloramine was found to reduce the total cost of ulcer management by 13%. Sensitivity analysis found that adjunctive chloramine remained a cost-effective treatment, even when the value of the model inputs was varied by ±20%., Conclusion: Within the limitations of the study, treatment with adjunctive chloramine instead of standard care alone could potentially afford the UK's health services a cost-effective debridement strategy for infected, non-healing DFUs, due to its ability to accelerate the time to healing., Competing Interests: The authors declare no conflicts of interest., (© 2024 The Authors. Health Science Reports published by Wiley Periodicals LLC.)

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.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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., (© 2021 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

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.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

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.

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to estimate the cost-effectiveness of Coblation compared with cold steel tonsillectomy in adult and paediatric patients in the UK., Method: Decision analysis was undertaken by combining published clinical outcomes with resource utilisation estimates derived from a panel of clinicians., Results: Using a cold steel procedure instead of Coblation is expected to generate an incremental cost of more than £2000 for each additional avoided haemorrhage, and the probability of cold steel being cost-effective was approximately 0.50. Therefore, the cost-effectiveness of the two techniques was comparable. When the published clinical outcomes were replaced with clinicians' estimates of current practice, Coblation was found to improve outcome for less cost, and the probability of Coblation being cost-effective was at least 0.70., Conclusion: A best-case scenario suggests Coblation affords the National Health Service a cost-effective intervention for tonsillectomy in adult and paediatric patients compared with cold steel procedures. A worst-case scenario suggests Coblation affords the National Health Service an equivalent cost-effective intervention for adult and paediatric patients.

Objective: To estimate the cost-effectiveness of using an extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG (eHCF + LGG; Nutramigen LGG) compared with an eHCF alone and an amino acid formula (AAF) in treating cow's milk allergy (CMA) in the US, from the perspective of third-party insurers and from parents., Methods: A decision model was used to estimate the probability of cow's milk allergic infants developing tolerance to cow's milk by 18 months. The model also estimated the cost to insurers and parents (US dollars at 2016 prices) of managing infants over 18 months after starting one of the formulae, as well as the relative cost-effectiveness of each of the formulae., Results: The probability of developing tolerance to cow's milk was higher among infants who were fed eHCF + LGG compared with those fed an eHCF alone or an AAF. Infants who are initially fed with eHCF + LGG are expected to utilize fewer healthcare resources than those fed with one of the other formulae. Hence, the estimated total healthcare cost incurred by third-party insurers and parents of initially feeding infants with eHCF + LGG was less than that of feeding infants with an eHCF alone or an AAF., Conclusion: Initial management of newly-diagnosed cow's milk allergic infants with eHCF + LGG was found to afford a cost-effective strategy to both third-party insurers and parents when compared to an eHCF alone or an AAF.

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., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

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 7.7cm 2 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.

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.

Objective: To estimate clinical progression and resource utilisation together with the associated costs of managing children and adults with LAL Deficiency, at a tertiary referral centre in the UK., Methods: A retrospective chart review was undertaken of patients in the UK with a confirmed diagnosis of LAL Deficiency who were managed at a LAL Deficiency tertiary referral treatment centre. Patients' pathways, treatment patterns, health outcomes and resource use were quantified over differing lengths of time for each patient enabling the NHS cost of patient management in tertiary care to be estimated., Results: The study population comprised 19 patients of whom 58% were male. Mean age at the time of initial presentation was 15.5 years and the mean age at diagnosis was 18.0 years. 63%, 53% and 42% of patients had hepatomegaly, abnormal lipid storage and splenomegaly at a mean age of presentation of 17.8, 17.1 and 20.9 years, respectively. Over a period of 50 years there were a mean of 48.5 clinician visits and 3.4 hospital admissions per patient. The mean NHS cost of patient management at a LAL Deficiency tertiary referral treatment centre, spanning a period of over 50 years was £61,454 per patient., Conclusion: This study provides important insights into a number of aspects of the disease that are difficult to ascertain from published case reports. Additionally, it provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions pertaining to managing this ultra-orphan disease.

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.

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., (© 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

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., (© 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI., Methods: Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality., Results: Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline., Conclusion: Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings. Notwithstanding, any introduction of an effective treatment with a differential mode of administration into healthcare systems must be followed by a change in clinical practice and patient management in order to fully achieve desirable economic outcomes.

Objective: Our aim was to estimate the prevalence-based cost of illness imposed by nocturia (≥2 nocturnal voids per night) in Germany, Sweden, and the UK in an average year., Methods: Information obtained from a systematic review of published literature and clinicians was used to construct an algorithm depicting the management of nocturia in these three countries. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use, and (3) annual societal cost arising from presenteeism and absenteeism attributable to nocturia in each country., Results: In an average year, there are an estimated 12.5, 1.2, and 8.6 million patients ≥20 years of age with nocturia in Germany, Sweden, and the UK, respectively. In an average year in each country, respectively, these patients were estimated to have 13.8, 1.4, and 10.0 million visits to a family practitioner or specialist, ~91,000, 9000, and 63,000 hospital admissions attributable to nocturia and 216,000, 19,000, and 130,000 subjects were estimated to incur a fracture resulting from nocturia. The annual direct cost of healthcare resource use attributable to managing nocturia was estimated to be approximately €2.32 billion in Germany, 5.11 billion kr (€0.54 billion) in Sweden, and £1.35 billion (€1.77 billion) in the UK. The annual indirect societal cost arising from both presenteeism and absenteeism was estimated to be approximately €20.76 billion in Germany and 19.65 billion kr (€2.10 billion) in Sweden. In addition, in the UK, the annual indirect cost due to absenteeism was an estimated £4.32 billion (€5.64 billion)., Conclusions: Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on patients, health services, and society as a whole.