Atopic eczema: burden of disease and individual suffering - results from a large EU study in adults.

BACKGROUND: Atopic eczema (AE, atopic dermatitis) is one of the most common non-communicable inflammatory skin diseases affecting 1-5% of the adult population in Europe with marked impairment in quality of life. In spite of great progress in understanding the pathophysiology of disturbed skin barrier and immune deviation, AE still represents a problem in daily clinical practice. Furthermore, the true impact of AE on individual suffering is often not recognized. OBJECTIVES: With a large European study, we wanted to provide insights into the actual suffering and individual burden of disease in adult patients with AE. METHODS: A total of 1189 adult patients (18-87 years, 56% female) with moderate to severe AE were recruited in nine European countries by dermatologists or allergists together with the help of patient organizations. A computer-assisted telephone interview was performed by experienced interviewers between October 2017 and March 2018. The following instruments were used to assess severity or measure quality of life: Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Hospital Anxiety and Depression Scale (HADS-D) and a newly developed Atopic Eczema Score of Emotional Consequences (AESEC). Patients were also asked to self-assess the severity of their disease. RESULTS: Despite current treatment, 45% of participants still had actual moderate to very severe AE in POEM. Due to their skin disease, 57% missed at least 1 day of work in the preceding year. DLQI showed moderate to extremely large impairment in 55%. According to HADS-D, 10% scored on or above the threshold of eight points with signs of depressive symptoms. Assessed with AESEC, 57% were emotionally burdened with feelings such as 'trying to hide the eczema', 'feeling guilty about eczema', having 'problems with intimacy' and more. Of persons actually suffering from severe AE, 88% stated that their AE at least partly compromised their ability to face life. CONCLUSIONS: This real-life study shows that adults with a moderate to severe form of AE are suffering more than what would be deemed acceptable. There is a need for increased awareness of this problem among healthcare professionals, policymakers and the general public to support research in the development of new and more effective treatments and provide access to better and affordable health care for affected patients.

Wrist and scaphoid fractures: a 17-year review of NHSLA litigation data.

Wrist and scaphoid fractures are common injuries seen and treated in everyday orthopaedic practice. The purpose of the study was to assess the trends and reasons for litigation related to wrist and scaphoid fractures within the NHS. Under a freedom of information (FOI) request, data from 1995 to 2012 were provided by the National Health Service Litigation Authority (NHSLA) on all litigation claims made as a result of wrist and scaphoid fractures. A total of 1354 claims relating to the hand and wrist were identified. Wrist and scaphoid fractures accounted for 492 (36.3%) of these claims, and 365 of these claims were settled, representing 74.2% of all wrist and scaphoid fracture claims. Overall, the most common reason for lost claims was due to incorrect, missed or delayed diagnosis (43.5%). Alleged mismanagement (29.5%), poor care (10.1%) and incompetent surgery (8.0%) were other common causes for litigation. This paper augments previous work published in this area and explores litigation trends specific to wrist and scaphoid fractures. We discuss the trends and reasons for litigation in this area, suggesting areas for improvement that may aid health-care professionals who deal with these injuries and potentially help reduce future litigation.

Clinical negligence in foot and ankle surgery: A 17-year review of claims to the NHS Litigation Authority.

We present a review of litigation claims relating to foot and ankle surgery in the NHS in England during the 17-year period between 1995 and 2012. A freedom of information request was made to obtain data from the NHS litigation authority (NHSLA) relating to orthopaedic claims, and the foot and ankle claims were reviewed. During this period of time, a total of 10 273 orthopaedic claims were made, of which 1294 (12.6%) were related to the foot and ankle. 1036 were closed, which comprised of 1104 specific complaints. Analysis was performed using the complaints as the denominator. The cost of settling these claims was more than £36 million. There were 372 complaints (33.7%) involving the ankle, of which 273 (73.4%) were related to trauma. Conditions affecting the first ray accounted for 236 (21.4%), of which 232 (98.3%) concerned elective practice. Overall, claims due to diagnostic errors accounted for 210 (19.0%) complaints, 208 (18.8%) from alleged incompetent surgery and 149 (13.5%) from alleged mismanagement. Our findings show that the incorrect, delayed or missed diagnosis of conditions affecting the foot and ankle is a key area for improvement, especially in trauma practice.

Litigation relating to conditions affecting the shoulder and elbow: an analysis of claims against the National Health Service.

We present a review of claims made to the NHS Litigation Authority (NHSLA) by patients with conditions affecting the shoulder and elbow, and identify areas of dissatisfaction and potential improvement. Between 1995 and 2012, the NHSLA recorded 811 claims related to the shoulder and elbow, 581 of which were settled. This comprised 364 shoulder (64%), and 217 elbow (36%) claims. A total of £18.2 million was paid out in settled claims. Overall diagnosis, mismanagement and intra-operative nerve injury were the most common reasons for litigation. The highest cost paid out resulted from claims dealing with incorrect, missed or delayed diagnosis, with just under £6 million paid out overall. Fractures and dislocations around the shoulder and elbow were common injuries in this category. All 11 claims following wrong-site surgery that were settled led to successful payouts. This study highlights the diagnoses and procedures that need to be treated with particular vigilance. Having an awareness of the areas that lead to litigation in shoulder and elbow surgery will help to reduce inadvertent risks to patients and prevent dissatisfaction and possible litigation.

Patient-Oriented SCORAD (PO-SCORAD): a new self-assessment scale in atopic dermatitis validated in Europe.

BACKGROUND: Patient-oriented medicine is an emerging concept, encouraged by the World Health Organization, to greater involvement of the patient in the management of chronic diseases. The Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) index is a self-assessment score allowing the patient to comprehensively evaluate the actual course of atopic dermatitis (AD), using subjective and objective criteria derived mainly from the SCORAD, a validated AD severity clinical assessment tool. OBJECTIVES: To validate the PO-SCORAD index in a large European population of patients exhibiting all forms of AD severity by assessing its correlation with the SCORAD index. PATIENTS/METHODS: Four hundred and seventy-one patients (185 adults, 286 children) consulting for AD in hospitals from 9 European countries were recruited. The investigators and the patients used the SCORAD and PO-SCORAD scales, respectively, to assess AD severity at inclusion (D0) and 28 ± 7 days later (D28). RESULTS: Patient-Oriented SCORing Atopic Dermatitis and SCORAD scores were significantly correlated at D0 [r = 0.67 (95% CI: 0.62; 0.72), P < 0.0001]. Consistency was confirmed at D28, with a stronger linear correlation between both scales [r = 0.79 (95% CI: 0.75; 0.83), P < 0.0001]. Absolute changes from baseline in SCORAD and PO-SCORAD scores were also significantly correlated [r= 0.71 (95% CI: 0.64; 0.76), P < 0.0001]. Although no specific intervention was investigated, AD improved over the study, with a decrease of PO-SCORAD and SCORAD scores from D0 to D28 by -19.19% and -24.39%, respectively. The consistency of the correlations was similar in the adult and children groups. CONCLUSIONS: This study validated the use of PO-SCORAD to self-assess AD severity and demonstrated its good correlation with SCORAD.

GA2LEN (Global Allergy and Asthma European Network) addresses the allergy and asthma 'epidemic'.

Allergic diseases represent a major health problem in Europe. They are increasing in prevalence, severity and costs. The Global Allergy and Asthma European Network (GA(2)LEN), a Sixth EU Framework Program for Research and Technological Development (FP6) Network of Excellence, was created in 2005 as a vehicle to ensure excellence in research bringing together research and clinical institutions to combat fragmentation in the European research area and to tackle allergy in its globality. The Global Allergy and Asthma European Network has benefited greatly from the voluntary efforts of researchers who are strongly committed to this model of pan-European collaboration. The network was organized in order to increase networking for scientific projects in allergy and asthma around Europe and to make GA(2)LEN the world leader in the field. Besides these activities, research has also been carried out and the first papers are being published. Achievements of the Global Allergy and Asthma European Network can be grouped as follows: (i) those for a durable infrastructure built up during the project phase, (ii) those which are project-related and based on these novel infrastructures, and (iii) the development and implementation of guidelines. The major achievements of GA(2)LEN are reported in this paper.

Adjuvant treatment of atopic eczema: assessment of an emollient containing N-palmitoylethanolamine (ATOPA study).

BACKGROUND: For long-term management of atopic eczema, the use of skin care creams is recommended, but effectiveness of this treatment is not well established. OBJECTIVE: The objective of this study was to yield data on the skin care properties of a cream with a unique lamellar matrix containing N-palmitoylethanolamine (PEA) and to assess quality-of-life variables in patients with mild to moderate atopic eczema. SETTING: In this multinational, multicentre, observational, non-controlled, prospective cohort study, patients between 2 and 70 years of age were enrolled. All patients were supplied with the study product sufficient for treatment over the entire study period. Outcome was followed in periods between 3 and 7 days and 4 and 6 weeks after study start. Data were gathered from doctor reports and patient self-assessments via patient questionnaires. RESULTS: Data from 2456 patients entered the database. The mean examination intervals were 6 days for the 3- to 7-day period and 38 days for the 4- to 6-week period. At study end, intensities of erythema, pruritus, excoriation, scaling, lichenification and dryness were significantly reduced with a combined score reduction of 58.6% in the entire population (57.7% in adults > 12 years and 60.5% in children

[Cost-of-illness study in patients suffering from atopic eczema in Germany]. / Krankheitskostenstudie bei Patienten mit atopischem Ekzem in Deutschland.

BACKGROUND: Atopic eczema is one of the most common skin diseases. In Germany, the economic burden is estimated to be EUR 1.2-3.5 billion yearly. The aim of this study was to show the resource utilization and costs for outpatient care and the out-of-pocket expenses for the patients. PATIENTS AND METHODS: This study was a multi-center, retrospective and prospective cost-of-illness study. Patient characteristics and data on resource utilization were collected with a semi-structured patient questionnaire and by chart abstraction. 193 patients filled in the patient questionnaire; data from 169 patients were obtained by chart abstraction. RESULTS: Average direct medical costs of a disease flare were EUR 123 per patient. Average annual total costs were EUR 1,425 per patient, increasing with severity from EUR 956 (mild) to EUR 2,068 (severe). CONCLUSION: Prolongation of flare-free time and reduction in severity are not only desirable for the patients but also of economic interest.

Improved risk-benefit ratio for topical triamcinolone acetonide in Transfersome in comparison with equipotent cream and ointment: a randomized controlled trial.

BACKGROUND: Transfersome is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. OBJECTIVES: To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome was compared with commercially available TAC-containing cream and ointment. METHODS: Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. RESULTS: A 10-fold lower dose of TAC in Transfersome(R) (2.5 micro g cm-2) was bioequivalent to 25 micro g cm-2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0.01, ointment: P < 0.001). A skin blanching assay revealed different kinetics of the formulations, with a delayed onset of action of the Transfersome and ointment preparations. Ultrasonic measurements revealed a significantly reduced atrophogenic potential. There was a 12.1% reduction in skin thickness given by TAC in Transfersome compared with a 21.1% reduction given by a bioequivalent dose in TAC cream after a 6-week treatment period (P = 0.007). CONCLUSIONS: Transfersome may significantly improve the risk-benefit ratio of topically applied glucocorticosteroids.

Alternative medicine in allergies - prevalence, patterns of use, and costs.

BACKGROUND: There is evidence that the use of alternative medicine (AM) for allergies has increased. However, little is known from population-based studies about what determines its use. The objective of this study was to evaluate the patterns of use of AM for allergies. METHODS: A population-based nested case-control study was conducted in 2000-01 using computer-assisted telephone interviews. Three hundred and fifty-one adults participated (median age 46 years) with allergies including hay fever, asthma, atopic eczema, and food hypersensitivity. Information was obtained on demographics, prevalence, motivation, information, type of AM, provider, costs, willingness to pay, and subjective assessment of AM. RESULTS: 26.5% of participants used AM because of their allergies. Compared to nonusers, this group of users was significantly younger (median age 43 vs 47; p=0.004) and better educated (school education > 8 year vs

[German instrument for the assessment of quality of life in skin diseases (DIELH). Internal consistency, reliability, convergent and discriminant validity and responsiveness]. / Deutsches Instrument zur Erfassung der Lebensqualität bei Hauterkrankungen (DIELH). Interne Konsistenz, Reliabilität, konvergente und diskriminante Validität und Veränderungssensitivität.

BACKGROUND AND OBJECTIVE: Performance and psychometric testing of the German Instrument for the Assessment of Quality of Life in Skin Diseases (DIELH). PATIENTS/METHODS: The instrument consisting of 36 questions (maximum skore 180, 7 domains) was used in 836 outpatients and quality assessments (validity, reliability, responsiveness) were performed. RESULTS: The total skore had a mean of 54 pts. (STD 31, range 0-157) and was normally distributed. Women reported a higher impact on quality of life (median 56 vs. 49, p < 0.001). In terms of discriminant validity significant differences between diagnostic groups were observed with high scorings for patients with eczema, psoriasis, urticaria, and acne (p < 0.001). Tests for internal consistency (Cronbach's alpha 0.71-0.92) and reliability (r = 0.73-0.86) revealed valid results. The DIELH correlated well with the DLQI (r = 0.78, p < 0.001) and moderately with 3 domains of the SF 36 (r = 0.25-0.30, p < 0.01). Changes in the quality of life after 4 weeks were consistent with the corresponding changes of the skin condition and partially significant. CONCLUSIONS: In the use within a large patient sample the DIELH proved to be feasible, valid, reliable, and responsive.

[Intralesional methotrexate injection: an effective time and cost saving therapy alternative in keratoacanthomas that are difficult to treat surgically]. / Intraläsionale Methotrexat-Injektion. Eine wirkungsvolle, zeit- und kostensparende Therapiealternative bei operativ schwierig zu behandelnden Keratoakanthomen.

A 53 year old female patient developed a keratoacanthoma, present on the left side of her nose for two months. After repeated unsuccessful trials with cryotherapy, she was treated with intralesional injection of methotrexate performed twice with a weekly internal. This led to complete resolution within 5 weeks. Although controlled studies on the effect of methotrexate in keratoacanthoma are not available, the rapid regression and the good cosmetic result suggest that this therapy may play a beneficial role in treating these lesions especially in problem locations.

The Dyshidrotic Eczema Area and Severity Index - A score developed for the assessment of dyshidrotic eczema.

BACKGROUND: Dyshidrotic eczema of the palms and soles is a common condition, which can be rather resistant to treatment. Therapy studies and their comparability are of clinical importance. OBJECTIVE: As standardized assessment methods for the severity of this particular form of eczema are lacking, we developed a severity index for dyshidrotic eczema. METHODS: The Dyshidrotic Eczema Area and Severity Index (DASI) is based on the severity grade of single items - number of vesicles per square centimetre (V), erythema (E), desquamation (S) and itch (I) - and the extension of the affected area (A) and is calculated with defined score points (p) as: DASI = (pv + pE = pS + pI) x pA. RESULTS: In two treatment studies on dyshidrotic hand eczema, the DASI was found to be a simple and useful tool to assess the severity of dyshidrotic eczema and the effect of therapy. CONCLUSION: The DASI needs to be further validated in larger cohorts.

Patent ductus arteriosus ligation: are we doing better?

Limitation on health care resource use is stimulating critical evaluation of previous preoperative standards. We retrospectively reviewed the clinical and hospital financial records of all children admitted for patent ductus arteriosus ligation from July 1984 to April 1994 for age, perioperative length of stay, readmissions for postoperative surgical problem, and hospital charges adjusted to 1994 dollars. Patients with an isolated patent ductus arteriosus, greater than 3 months of age, without preoperative or postoperative complications were included in this study and stratified into two groups based on date of operation. Group I had operation before January 1, 1991, and group II had operation on or after January 1, 1991. Comparison of these two groups revealed a significant difference in perioperative length of stay (group I, 3.9 +/- 1.2 days [mean +/- standard deviation]; group II, 2.7 +/- 0.9 days; p < 0.0001) and in hospital charges (group I, $8,700 +/- $2,100; group II, $6,600 +/- $1,000; p < 0.0001). These data support the premise that children older than 3 months undergoing elective ligation of a patent ductus arteriosus have been treated with improved efficiency and less charge without an increase in postdischarge morbidity. Health care policy decisions have forced us to evaluate the standards of perioperative care more critically.

Comparison of methods for the macroscopic assessment of epicutaneous allergic contact reactions in guinea pigs.

40 guinea pigs were sensitised with a 50% solution of 2,4-dinitro-1-chlorobenzene (DNCB) and challenged 14 days later with DNCB 0.05%. Four parameters were determined to evaluate the challenge reaction after 24, 48, 72 and 96 h: (a) intensity of erythema, (b) reaction area (product of the largest diameters of the reaction in vertical alignment), (c) increase in skinfold thickness and (d) reaction volume (product of the reaction area and the increase in skinfold thickness). The test reactions were read blind by 2 independent observers, yielding small but significant differences in all methods except determination of the reaction area. Further statistical analysis revealed a linear correlation between the intensity of erythema and the other 3 parameters determined, as well as between the reaction area and the reaction volume. In contrast, the increase in skinfold thickness did not correlate linearly either with the reaction area or the reaction volume. When the results of the 24- and 48-h readings were compared, the characteristic crescendo reaction of contact allergy was demonstrable by all methods except the determination of the reaction area. After the 48-h reading, a continuous decrease of reactions was found with all methods. It is concluded that the determination of the reaction area and consequently of the reaction volume are not suitable for exact measurement of epicutaneous allergic contact reactions in guinea pigs. The most precise results will be obtained by measuring the increase in skinfold thickness, whereas the determination of the intensity of erythema, which is easier to perform, may be sufficient for many purposes.(ABSTRACT TRUNCATED AT 250 WORDS)