Cost-effectiveness of continuous subcutaneous insulin infusion in people with type 2 diabetes in the Netherlands.

AIMS: Up to 30% of insulin-treated type 2 diabetes patients are unable to achieve HbA1c targets despite optimization of insulin multiple daily injections (MDI). For these patients the use of continuous subcutaneous insulin infusion (CSII) represents a useful but under-utilized alternative. The aim of the present analysis was to examine the cost-effectiveness of initiating CSII in type 2 diabetes patients failing to achieve good glycemic control on MDI in the Netherlands. METHODS: Long-term projections were made using the IMS CORE Diabetes Model. Clinical input data were sourced from the OpT2mise trial. The analysis was performed over a lifetime time horizon. The discount rates applied to future costs and clinical outcomes were 4% and 1.5% per annum, respectively. RESULTS: CSII was associated with improved quality-adjusted life expectancy compared with MDI (9.38 quality-adjusted life years [QALYs] vs 8.95 QALYs, respectively). The breakdown of costs indicated that ∼50% of costs were attributable to diabetes-related complications. Higher acquisition costs of CSII vs MDI were partially offset by the reduction in complications. The ICER was estimated at EUR 62,895 per QALY gained and EUR 60,474 per QALY gained when indirect costs were included. CONCLUSIONS: In the Netherlands, CSII represents a cost-effective option in patients with type 2 diabetes who continue to have poorly-controlled HbA1c despite optimization of MDI. Since the ICER falls below the willingness-to-pay threshold of EUR 80,000 per QALY gained, CSII is likely to represent good-value for money in the treatment of poorly-controlled T2D patients compared with MDI.

Measuring the nursing work environment: translation and psychometric evaluation of the Essentials of Magnetism.

AIM: Translate the Essentials of Magnetism II© (EOMII; Dutch Nurses' Association, Utrecht, The Netherlands) and assess its psychometric properties in a culture different from its origin. BACKGROUND: The EOMII, developed in the USA, measures the extent to which organizations/units provide healthy, productive and satisfying work environments. As many healthcare organizations are facing difficulties in attracting and retaining staff nurses, the EOMII provides the opportunity to assess the health and effectiveness of work environments. METHODS: A three-phased (respectively N = 13, N = 74 and N = 2542) combined descriptive and correlational design was undertaken for translation and evaluation validity and psychometric qualities of the EOMII for Dutch hospitals (December 2009-January 2010). We performed forward-backward translation, face and content validation via cross-sectional survey research, and semi-structured interviews on relevance, clarity, and recognizability of instruments' items. Psychometric testing included principal component analysis using varimax rotation, item-total statistics, and reliability in terms of internal consistency (Cronbach's α) for the total scale and its subscales. RESULTS: Face validity was confirmed. Items were recognizable, relevant and clear. Confirmatory factor analysis indicated that five of eight subscales formed clear factors. Three original subscales contained two factors. Item-total correlations ranged from 0.43 to 0.83. One item correlated weakly (0.24) with its subscale. Cronbach's α for the entire scale was 0.92 and ranged from 0.58 to 0.92 for eight subscales. CONCLUSIONS: Dutch-translated EOMII (D-EOMII) demonstrated acceptable reliability and validity for assessing hospital staff nurses' work environment. IMPLICATIONS FOR NURSING AND HEALTH POLICY: The D-EOMII can be useful and effective in identifying areas in which change is needed for a hospital to pursue an excellent work environment that attracts and retains well-qualified nurses.

A controlled study of the effects of RU58841, a non-steroidal antiandrogen, on human hair production by balding scalp grafts maintained on testosterone-conditioned nude mice.

Human hair growth can be monitored for several months after the transplantation of scalp samples from men with androgen-dependent alopecia on to female nude mice. Hair production from balding sites has been shown to be inhibited in testosterone-conditioned nude mice. We used this recently reported model to study the effect of a new non-steroidal antiandrogen-RU58841-on human hair growth. Twenty productive scalp grafts from balding men were maintained for 8 months after grafting on to nude mice, and hair production was monitored monthly for 6 months. All mice were conditioned by the topical application of testosterone (testosterone propionate, 300 micrograms in 10 microL; 5 days/week) on the non-grafted flank. The scalp samples were divided equally according to the estimated hair production potential, which was based on the amount of hair present on the scalp samples before grafting. Each of the two equal groups of grafts was further allocated at random to be treated topically (5 days/week) with blinded solutions of either RU58841 1% in ethanol, or ethanol as a control. Twenty-eight active follicles appeared on the 10 control grafts. Among them only two follicles (7%) initiated a second hair cycle. However, the 10 RU58841-treated grafts bore a total of 29 active follicles, and eight of them (28%) showed a second cycle. The values for the linear hair growth rates (LHGR) were significantly (P < 0.04) higher in the RU58841-treated group. Recycling and increased LHGR indicate a positive action for RU58841 on human hair growth from balding samples grafted on to testosterone-conditioned nude mice, and encourage a clinical trial to evaluate its potential in the treatment of androgen-dependent alopecia.

Human hair production by scalp samples grafted onto nude mice. Biochemical data on normal human hair and the genetic defect trichothiodystrophy.

The authors report on a laboratory model for continuous production of human hair during long periods of time. This study shows that the amino acid composition of hairs collected in situ from human scalp was similar to that of terminal hairs produced by the donors' scalp follicles grafted and maintained onto nude mice. A similar experiment was performed with scalp samples from a foetus with trichothiodystrophy (TTD). The amino acid analysis of TTD lanugo hairs and of the TTD shafts produced by grafted scalp specimens was consistent with findings published in the literature: severe decrease of cys (< 50% of control values) and moderate decrease of thr and pro (80% of control values or less) with an increase of ala-asp-ile-leu-lys-met-phe (120% of control values or more). These changes indicate a decrease of high sulphur proteins (HSP) and consequently a relative increase of keratins. Furthermore, when foetal scalp samples were grafted, the lanugo hairs transformed into terminal hairs along with normal initiation of melanisation. Hence, keratin and HSP gene expression and regulation of melanogenesis in the normal and genetically defective TTD human hair follicle grafts appear to be independent of systemic host-related factors, at least during a 6 months follow-up period after grafting. The present experimental evidence further supports conclusions gained from previous assays with normal and TTD variant scalp grafts, i.e. that the nude mouse bearing human scalp specimens may serve as a clinically relevant laboratory model for evaluating regulation of normal and abnormal gene expression in the hair follicle under well controlled experimental conditions.

The phototrichogram: analysis of some technical factors of variation.

Photographic methods for hair evaluation are frequently proposed as an alternative to more invasive methods (trichogram or biopsy). The reliability in terms of quantitative follow-up of hair growth has not been evaluated properly. We report results of comparative studies of scalp hair evaluation with various photographic methods. Statistically significant findings were a better detection of scalp hairs using the original enlargement x 3 as compared to x 2 (212 vs. 167 hair follicles/cm2) and a more acceptable estimate of linear hair growth rate with 'scalp immersion proxigraphy' (SIP) (0.317 mm/day) as compared with classical phototrichogram pictures where this variable was underestimated by 30% on average (0.27 mm/day). SIP-generated linear hair growth rates were very close to the micrometric method (0.37 mm/day). Therefore SIP x 3 images appear preferable for hair growth monitoring during clinical trials.

Morphological and biochemical characteristics of trichothiodystrophy-variant hair are maintained after grafting of scalp specimens on to nude mice.

Trichothiodystrophy (TTD) is a hair defect associated with abnormal composition of the high-sulphur proteins (HSP). HSP can be modified quantitatively (reduced amount of qualitatively normal HSP: TTD-variant) and qualitatively (TTD). In this study we show that the amino acid composition of hairs collected from the scalp of a patient with TTD-variant (donor) was preserved in hairs produced by donor scalp follicles maintained up to 6 months as grafts on to nude mice. It is the first time that an exceptionally rare, clinically and biochemically well-characterized hair dysplasia has been maintained under laboratory conditions for a long period of time. The linear growth rate of TTD-variant hairs was similar to that of control hairs grown under comparable conditions. The persistence of disease-specific abnormalities in the hair shaft indicates that the TTD-variant mutation is expressed without significant quantitative modifications, and appears independent of systemic host-related factors. This model may serve as a clinically relevant working platform for evaluating regulation of abnormal gene expression in the hair follicle under well-controlled experimental conditions.

Comparative evaluation of scalp hair by phototrichogram and unit area trichogram analysis within the same subjects.

Quantitative evaluation of scalp hair requires techniques that are reproducible. The unit area trichogram is such a method but is unsuitable for large-scale clinical trials. An alternative may be the phototrichogram--a non-plucking, non-invasive method. Hair variables were evaluated in 12 Caucasian subjects employing both methods. The mean value for total hair density was significantly underestimated by the phototrichogram (181 versus 237 hairs/cm2); however, no significant difference was found between this phototrichogram value and the number of non-vellus hairs/cm2. Estimates for the percentage of anagen hairs were similar with both methods. Hair diameters from the phototrichogram were too unreliable to be of any practical use. Analysis of the individual hair data revealed that light hair was much more difficult to evaluate than dark hair. Consequently, Caucasian subjects with light hair or dark skin subjects with dark hair should be excluded from studies employing phototrichograms.

Monitoring of skin response to sodium lauryl sulphate: clinical scores versus bioengineering methods.

The present trial was designed to evaluate clinical scores (single observer) of sodium lauryl sulphate (SLS)-induced skin irritation in a group of subjects (n = 10) over a 10-day period along with various skin function parameters. In order to avoid significant variations due to secondary phenomena, the following parameters were recorded with non-invasive instruments in this order: skin capacitance (C1; arbitrary units; CM420 Corneometer), transepidermal water loss (TEWL; g/m2.h; Evaporimeter) and laser Doppler flowmetry (CBFV: cutaneous blood flow values; Periflux). All examinations were performed during winter on reclined relaxed subjects present for at least 10 min in a test room with controlled temperature and relative humidity (t degrees: 19.5-20.7 degrees C and RH: 47.3-60.3%). The analysis of differential data (delta = value at tx-value before test; 2-way ANOVA) was made on single parameters as a function of site (volar forearm versus neck) and time (from 24 h after 48-h occlusion with 5% SLS up to 10 days later). The profile of erythema scores over time differed between neck and forearm, but the delta CBFV readings with the laser Doppler instrument did not detect significant site-time interactions. Roughness (blind evaluation with palpating finger) and capacitance readings (delta C1) showed significant differences between sites, but the profile over time was similar in both locations. delta TEWL did not differ according to anatomical location. The reason for different erythema scores on neck and forearm might be related to inherent regional variation of optical properties of the skin or to a substantial contribution of SLS-induced roughness to the readings of erythema.(ABSTRACT TRUNCATED AT 250 WORDS)