Validated assessment scales for the upper face.

BACKGROUND: Age-related upper face changes such as wrinkles, lines, volume loss, and anatomic alterations may affect quality of life and psychological well-being. The development of globally accepted tools to assess these changes objectively is an essential contribution to aesthetic research and routine clinical medicine. OBJECTIVE: To establish the reliability of several upper face scales for clinical research and practice: forehead lines, glabellar lines, crow's feet (at rest and dynamic expression), sex-specific brow positioning, and summary scores of forehead and crow's feet areas and of the entire upper face unit. METHODS AND MATERIALS: Four 5-point photonumerical rating scales were developed to assess glabellar lines and sex-specific brow positioning. Twelve experts rated identical upper face photographs of 50 subjects in two separate rating cycles using all eight scales. Responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for all upper face scales, aesthetic areas, and the upper face score except for the brow positioning scales. Intrarater reliability was high for all scales and resulting scores. CONCLUSION: Except for brow positioning, the upper face rating scales are reliable tools for valid and reproducible assessment of the aging process.

Validated assessment scales for the mid face.

BACKGROUND: The improvement of aesthetic treatment options for age-related mid face changes, such as volume loss, and the increase in patient expectations necessitates the development of more-complex and globally accepted assessment tools. OBJECTIVE: To develop three grading scales for objective assessment of the infraorbital hollow and upper and lower cheek fullness and to establish the reliability of these scales for clinical research and practice. METHODS AND MATERIALS: Three 5-point rating scales were developed to assess infraorbital hollow and upper and lower cheek fullness objectively. Twelve experts rated identical mid face photographs of 50 subjects in two separate rating cycles using the mid face scales. Test responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for the infraorbital hollow, upper cheek fullness, and lower cheek fullness scales. Intrarater reliability was high for all three scales. Both of the cheek fullness scales yielded higher reliabilities when three rather than two views were used to assess the volume changes of the cheek. CONCLUSION: The mid face scales are reliable tools for valid and reproducible assessment of age-related mid face changes.

Validated assessment scales for the lower face.

BACKGROUND: Aging in the lower face leads to lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline. Refined, easy-to-use, validated, objective standards assessing the severity of these changes are required in clinical research and practice. OBJECTIVE: To establish the reliability of eight lower face scales assessing nasolabial folds, marionette lines, upper and lower lip fullness, lip wrinkles (at rest and dynamic), the oral commissure and jawline, aesthetic areas, and the lower face unit. METHODS AND MATERIALS: Four 5-point rating scales were developed to objectively assess upper and lower lip wrinkles, oral commissures, and the jawline. Twelve experts rated identical lower face photographs of 50 subjects in two separate rating cycles using eight 5-point scales. Inter- and intrarater reliability of responses was assessed. RESULTS: Interrater reliability was substantial or almost perfect for all lower face scales, aesthetic areas, and the lower face unit. Intrarater reliability was high for all scales, areas and the lower face unit. CONCLUSION: Our rating scales are reliable tools for valid and reproducible assessment of the aging process in lower face areas.

Validated assessment scale for neck volume.

BACKGROUND: Sagging of the neck aesthetic area is an important indicator of age. The development of complex and globally accepted tools for proper assessment of the change in neck volume is an essential contribution to aesthetic research and the routine clinical setting. OBJECTIVE: To develop a grading scale for the objective assessment of the neck volume and to establish the reliability of this scale for clinical research and practice. MATERIALS AND METHODS: A 5-point rating scale was developed to assess neck volume objectively. Twelve experts rated frontal and lateral neck photographs of 50 subjects in two separate rating cycles using the neck volume scale. Responses of raters were analyzed to assess inter- and intrarater reliability. RESULTS: Interrater reliability for the neck volume scale was almost perfect, with intraclass correlation coefficients for the first and second rating cycles of 0.85 and 0.84, respectively. Intrarater reliability for the neck volume scale was high (0.90) and Pearson correlation coefficients ranged between 0.88 and 0.95 and were statistically significant. CONCLUSION: The neck volume scale demonstrates optimal reliability for clinical research and practice.

Resource utilisation and costs in patients with type 2 diabetes mellitus treated with insulin glargine or conventional basal insulin under real-world conditions in Germany: LIVE-SPP study.

OBJECTIVE: To assess and compare the total costs relevant to diabetes care in patients with type 2 diabetes mellitus (T2D) treated at specialised diabetes practices with either insulin glargine- or conventional basal insulin (neutral protamine Hagedorn [NPH])-based therapies from the German statutory health insurance (SHI) perspective. METHODS: The Long Acting Insulin Glargine Versus NPH Cost Evaluation in Specialised Practices (LIVE-SPP) study is an observational, retrolective, multicentre longitudinal cost comparison in adults with T2D. Costs were evaluated from the German SHI perspective based on official 2005 prices. Average total costs per patient for insulin glargine-versus NPH-based therapies were compared using multivariate general linear modelling. Sensitivity analyses were performed by varying the main cost factors by +/- 25%. RESULTS: Patients (n=1,024, 512 patients per cohort) were on average 62 years of age, with an average 8-year diabetes history at study start. The average unadjusted total annual costs per patient were euro 1,868.41 (95% CI 1,744.27-1,992.56) for insulin glargine-based vs. euro 2,063.72 (95% CI 1,922.91-2,204.54) for NPH-based therapies. Average adjusted total annual costs per patient between insulin glargine- (euro 1,241.13) and NPH-based therapies (euro 1,607.86) were statistically significantly different (p=0.0004). The economic advantage for insulin glargine-based therapies resulted mainly from fewer blood glucose measurements and other diabetes-related materials (e.g. needles). The savings remained stable in one-way sensitivity analyses. CONCLUSIONS: The LIVE-SPP study suggests that insulin glargine-based therapies may offer an economic advantage over NPH-based therapies.

Cost and economic burden of adverse events associated with metastatic melanoma treatments in five countries.

OBJECTIVE: To estimate per-event cost and economic burden associated with managing the most common and/or severe metastatic melanoma (MM) treatment-related adverse events (AEs) in Australia, France, Germany, Italy, and the UK. METHODS: AEs associated with chemotherapy (dacarbazine, paclitaxel, fotemustine), immunotherapy (ipilimumab), and targeted therapy (vemurafenib) were identified by literature review. Medical resource use data associated with managing AEs were collected through two blinded Delphi panel cycles in each of the five countries. Published costs were used to estimate per-event costs and combined with AEs incidence, treatment usage, and MM prevalence to estimate the economic burden for each country. RESULTS: The costliest AEs were grade 3/4 events due to immunotherapy (Australia/France: colitis; UK: diarrhea) and chemotherapy (Germany/Italy: neutropenia/leukopenia). Treatment of AEs specific to chemotherapy (Australia/Germany/Italy/France: neutropenia/leukopenia) and targeted therapy (UK: squamous cell carcinoma) contributed heavily to country-specific economic burden. LIMITATIONS: Economic burden was estimated assuming that each patient experienced an AE only once. In addition, the context of settings was heterogeneous and the number of Delphi panel experts was limited. CONCLUSIONS: Management costs for MM treatment-associated AEs can be substantial. Results could be incorporated in economic models that support reimbursement dossiers. With the availability of newer treatments, establishment of a baseline measure of the economic burden of AEs will be crucial for assessing their impact on patients and regional healthcare systems.

Will vaccination against rotavirus infection with RIX4414 be cost-saving in Germany?

BACKGROUND: Rotavirus gastroenteritis (RVGE) is a frequent disease in young children. The recommended German paediatric immunisation schedule does not currently include rotavirus vaccination. A lack of economic data on the impact of routine vaccination is stated as one of the reasons. As a result, the current coverage rate is low, around 26%. This study investigated whether rotavirus vaccination using the two-dose rotavirus vaccine RIX4414 (Rotarix®, GlaxoSmithKline Vaccines) would be a cost-saving intervention from the perspective of the statutory health insurance (SHI) in Germany. OBJECTIVE: The objective of the study was to analyse health outcomes (number of RVGE cases and hospitalisations prevented) and the associated cost to the SHI when comparing 100% rotavirus vaccination with no vaccination in Germany. METHODS: A Markov cohort model simulated the number of RVGE events and related costs in a German birth cohort over the first 60 months of life with current disease management. The model compared an unvaccinated cohort with a fully vaccinated cohort. Vaccine efficacy data from international clinical trials were combined with German-specific epidemiological and cost data. Results were tested using extensive sensitivity analyses. RESULTS: Full vaccination of a birth cohort against rotavirus disease would be expected to prevent 82% of RVGE cases, reducing RVGE frequency from 28 to 5 events per 100 children in the birth cohort up to age 5 years. The estimated cost reduction with vaccination for that period is predicted to be €9.2 million with 100% coverage (€6.9 million with 75% coverage), mainly due to reductions in SHI reimbursement for productivity losses, hospital stays and visits to office-based physicians due to the vaccine's efficacy against severe disease. CONCLUSIONS: Routine rotavirus vaccination in Germany would reduce the number of hospitalised and outpatient cases. The associated investment could be fully offset by costs avoided in hospital stays, physician visits and SHI reimbursement of productivity losses. Sensitivity analysis indicated that vaccination would be cost-saving in 95% of simulations. Incremental cost was observed only under extreme conditions, especially when the time spent at home due to rotavirus disease was low or when vaccine efficacy against severe disease was heavily decreased.