Stratified medicine using invasive coronary function testing in angina: A cost-effectiveness analysis of the British Heart Foundation CorMicA trial.

AIM: Coronary angiography is indicated in many patients with known or suspected angina for the investigation of coronary artery disease (CAD). However, up to half of patients with symptoms of ischaemia have no obstructive coronary arteries (INOCA). This large subgroup includes patients with suspected microvascular angina (MVA) and/or vasospastic angina (VSA). Clinical guidelines relating to the management of patients with INOCA are limited. Uncertainty regarding the diagnosis of patients with INOCA presents a health economic challenge, both in terms of healthcare resource utilisation and of quality-of-life impact on patients. METHODS: A cost-effectiveness analysis of the introduction of stratified medicine into the invasive management of INOCA, based on clinical and resource-use data obtained in the CorMicA trial, from a UK NHS perspective. The intervention included an invasive diagnostic procedure (IDP) of coronary vascular function during coronary angiography to define clinical endotypes to target with linked medical therapy. Outcomes of interest were mean total cost and QALY gain between treatment groups, and the incremental cost-effectiveness ratio. We undertook probabilistic sensitivity and scenario analyses. RESULTS: The incremental cost per QALY gained at 12 months was £4500 (£2937, £33264). Compared with a willingness-to-pay (WTP) threshold of £20,000 per QALY, the use of the IDP test is cost-effective. At this WTP threshold there is a 96% probability of the IDP being cost-effective, based on the uncertainty described by bootstrap analysis. CONCLUSIONS: The burden of INOCA, particularly in women, is known to be significant. These findings provided new evidence to inform this unmet clinical need.

Complication rate among people with diabetes at low risk of foot ulceration in Fife, UK: an analysis of routinely collected data.

AIMS: To estimate the rate at which people with diabetes and a low risk of foot ulceration change diabetic foot ulceration risk status over time, and to estimate the rate of ulceration, amputation and death among this population. METHODS: We conducted an observational study of 10 421 people with diabetes attending foot screening in an outpatient setting in NHS Fife, UK, using routinely collected data from a national diabetes register, NHS SCI Diabetes. We estimated the proportion of people who changed risk status and the cumulative incidence of ulceration, amputation and death, respectively, among people with diabetes at low risk of diabetic foot ulceration at 2-year follow-up. RESULTS: At 2-year follow-up, 5.1% (95% CI 4.7, 5.6) of people with diabetes classified as low risk at their first visit had progressed to moderate risk. The cumulative incidence of ulceration, amputation and death was 0.4% (95% CI 0.3, 0.6), 0.1% (95% CI 0.1, 0.2) and 3.4% (95% CI 3.1, 3.8), respectively. CONCLUSIONS: At 2-year follow-up, 5% of people at low risk of diabetic foot ulceration changed clinical risk status and <1% of people experienced foot ulceration or amputation. These findings provide information which will help to inform the current debate regarding optimal foot screening intervals.

Cost-impact study of rotavirus vaccination programme in Scotland.

Aim: In July 2013, the Scottish Government introduced a rotavirus vaccination programme into the childhood immunisation schedule. The aim of this research was to estimate the cost-impact of this programme. Methods: Data for rotavirus-related resource use were identified including laboratory reports, hospitalisations, attendances at accident and emergency departments (A&E), general practice consultations (GP), calls to the National Health Service telephone helpline (NHS24) and prescriptions for common rehydration treatments. We used an interrupted time series analysis approach to assess the impact on resource utilisation in all categories. Appropriate costs were added to the models and predicted pre-and post-vaccination mean annual costs were estimated. The cost of the vaccination programme was estimated using costs from the literature. Results: The vaccination programme was associated with a reduction in utilisation in all measured healthcare resource categories. These reductions were all statistically significant (at the 95% level) with p-values less than 0.001. Reductions ranged from 18% in calls to NHS24 to 73% in positive laboratory reports. The vaccination programme was associated with a reduction in annual healthcare resource costs of 38% (£595,000 per 100,000 infants < 5 years old) in our measured categories (including £495,000 from a reduction in hospital stays). The annual overall cost-impact of the rotavirus vaccination programme (the cost of delivering the programme minus the reduction in resource costs) was estimated at approximately £435,000 per 100,000 infants < 5 years old. Conclusion: The rotavirus vaccination programme was associated with a reduction in all measured categories of rotavirus-related resource use by infants < 5 years old.

A study of differences in surface roughness between sun-exposed and unexposed skin with age.

BACKGROUND: To understand and separate the roles of age and solar ultraviolet exposure (sun damage) on the surface roughness of skin. OBJECTIVES: To determine the effects of age and site (sun exposed vs. unexposed) on skin roughness in normal healthy subjects. SUBJECTS/METHODS: Using a stylus profilometer and silicone skin surface replicas, we have measured skin surface roughness parameters on habitually exposed (back of hand) and habitually unexposed (upper buttock) skin sites from the same individual in a sample of 73 subjects from the normal population. We compared the two sites in order to determine any differences in roughness caused, we postulate, by the effect of solar ultraviolet exposure on the exposed site. RESULTS: We found that the two sites are indistinguishable in roughness until after 30 years of age. For the over 30 years group, the difference between exposed and unexposed skin roughness correlated strongly with age. For all ages, skin roughness showed a positive correlation with age on the unexposed, but not the exposed, site. On the hand site subjects aged 40 years and older had significantly smoother skin than those aged less than 40 years, as measured by one roughness parameter. On the back, the older group had significantly rougher skin than the younger group measured by two roughness parameters. CONCLUSIONS: We propose that on the back of the hands, solar damage reverses or reduces the increase in roughness which would otherwise be caused by intrinsic ageing.

The link between the peel force of adhesive dressings and subjective discomfort in volunteer subjects.

OBJECTIVE: The study compared the level of discomfort experienced by healthy volunteers on the removal of a range of adhesive wounds. METHOD: This was an open, within subject comparative study of six adhesive dressings in 24 volunteers. The test site was the lower back. Allocation of test materials to the test sites was randomised. The peel force of removal was recorded after 24 hours of application using a device that removed the dressing at a constant speed and angle to the skin surface. The discomfort experienced at each removal was assessed by the subjects themselves using an electronic visual analogue scale. RESULTS: Overall, Mepilex Border was given a significantly lower discomfort score (p < or = 0.01) by the subjects than the other dressings. There were no clear differences between the five other products tested. Tielle and Allevyn Adhesive had significantly higher (p < or = 0.05) peel force than the other products. Mepilex Border caused less discomfort on removal than Duoderm Extra Thin, Biatain and Versiva, even though the peel force was similar. Tielle and Allevyn had higher peel force, but the levels of discomfort were not significantly higher for these products. CONCLUSION: It may be that the level of discomfort experienced by subjects on removal of an adhesive dressing is not entirely dependent on the peel force and that other aspects of the interaction of the skin surface and adhesive play a role.

Effects of adhesive dressings on the stratum corneum of the skin.

Two human models were developed to quantify the stratum corneum removed by different adhesive dressings and to measure the peel force of dressing removal and relate this to stratum corneum removal. The first was an open study designed to compare the effects of applying Mepiform Safetac, Tielle and Duoderm Extra Thin to the skin of 12 normal volunteers aged 19-53 years. Treatments were applied once (one 24-hour application) or three times (three x 24-hour applications) to forearm skin which had been prestained with methylene blue. After dressing removal the dye left on the skin was sampled using the skin surface biopsy method and measured spectrophotometrically. The results show that, after one and three applications, the Mepiform Safetac sites had a higher level of dye than those on which the other dressings had been applied (p < 0.05, after three applications). Based on the assumption that the more dye is left on the skin, the less damage is caused, this suggests that Mepiform Safetac is less damaging to the skin surface than the other products tested. In the second study the peel force needed to remove adhesive dressings from prestained skin was measured and related to the amount of stratum corneum removed. Mepilex Border Safetac, Duoderm Extra Thin, Allevyn Adhesive, Biatain Adhesive and Tielle Hydropolymer Dressing were compared in 20 normal volunteers aged 23-64 years. Three consecutive 24-hour applications of each product were made, with measurements of peel force at 24, 48 and 72 hours. The amount of dye remaining on the skin at 72 hours was assessed by the surface biopsy method. Statistically significant differences between products were observed in terms of both peak force and steady state force of removal. Differences in the level of damage to the superficial stratum corneum were also detected. However, low levels of peel force were not always associated with low damage and, therefore, other factors must contribute to stratum corneum removal in this model.