Physician's appraisal vs documented signs and symptoms in the interpretation of food challenge tests: The EuroPrevall birth cohort.

BACKGROUND: Blinded food challenges are considered the current gold standard for the diagnosis of food allergies. We used data from a pan-European multicenter project to assess differences between study centers, aiming to identify the impact of subjective aspects for the interpretation of oral food challenges. METHODS: Nine study centers of the EuroPrevall birth cohort study about food allergy recruited 12 049 newborns and followed them for up to 30 months in regular intervals. Intensive training was conducted and every center visited to ensure similar handling of the protocols. Suspected food allergy was clinically evaluated by double-blind, placebo-controlled food challenges using a nine dose escalation protocol. The primary challenge outcomes based on physician's appraisal were compared to documented signs and symptoms. RESULTS: Of 839 challenges conducted, study centers confirmed food allergy in 15.6% to 53.6% of locally conducted challenges. Centers reported 0 to 16 positive placebo challenges. Worsening of eczema was the most common sign when challenged with placebo. Agreement between documented objective signs and the challenge outcome assigned by the physician was heterogeneous, with Cohen's kappa spanning from 0.42 to 0.84. CONCLUSIONS: These differences suggest that the comparison of food challenge outcomes between centers is difficult despite common protocols and training. We recommend detailed symptom assessment and documentation as well as objective sign-based challenge outcome algorithms to assure accuracy and comparability of blinded food challenges. Training and supervision of staff conducting food challenges is a mandatory component of reliable outcome data.

The costs of care in atrial fibrillation and the effect of treatment modalities in Germany.

OBJECTIVE: Atrial fibrillation (AF) is an increasing burden on health-care systems because of an aging population. This study aimed to estimate health-care resource use and costs of treating AF in Germany. METHOD: A 6-month multicenter prospective observational cohort study with additional 3-month retrospective clinical data collection was performed in physician practices. AF-related resource use was documented by 3-month retrospective and 6-month prospective clinical data from physician charts and prospectively by patient questionnaires at 3 and 6 months. Cost calculation was from the health-care payer perspective. RESULTS: A total of 361 patients (mean age 71 +/- 9 years, 61% male) were recruited from 45 physician practices. Of 311 (86.1%) patients with complete data, 75% had persistent AF; oral anticoagulation and/or aspirin were prescribed in 98%. A rhythm-control strategy was applied in 27%, rate control in 58%, and 15% received neither antiarrhythmic medication nor cardioversion. A higher proportion of rhythm-control patients had paroxysmal AF (P < 0.001). Mean annual AF-related per-patient cost was 827 Euro +/- 1476 (median 386 Euro). 50% of total costs were incurred by 11% of patients, driven by AF-related hospitalizations (44%). Antiarrhythmics and stroke prophylaxis accounted for 20% and 15% of expenditures, respectively. Mean annualized costs were higher for rhythm-control patients than for rate-control patients or those without antiarrhythmic treatment (1572 vs. 780 vs. 544 Euro, P < 0.001). CONCLUSION: This evaluation provides an overview of current treatment modalities and cost of AF management in Germany. Efforts to reduce the economic burden of AF should focus on avoidance of AF hospital admissions and optimization of stroke prevention and rhythm control.

The prevalence of plant food allergies: a systematic review.

BACKGROUND: There is uncertainty regarding the prevalence of allergies to plant food. OBJECTIVE: To assess the prevalence of allergies to plant food according to the different subjective and objective assessment methods. METHODS: Our systematic search of population-based studies (since 1990) in the literature database MEDLINE focused on fruits, vegetables/legumes, tree nuts, wheat, soy, cereals, and seeds. Prevalence estimates were categorized by food item and method used (food challenges, skin prick test, serum IgE, parent/self-reported symptoms), complemented by appropriate meta-analyses. RESULTS: We included 36 studies with data from a total of over 250,000 children and adults. Only 6 studies included food challenge tests with prevalences ranging from 0.1% to 4.3% each for fruits and tree nuts, 0.1% to 1.4% for vegetables, and < 1% each for wheat, soy, and sesame. The prevalence of sensitization against any specific plant food item assessed by skin prick test was usually < 1%, whereas sensitization assessed by IgE against wheat ranged as high as 3.6% and against soy as high as 2.9%. For fruit and vegetables, prevalences based on perception were generally higher than those based on sensitization, but for wheat and soy in adults, sensitization was higher. Meta-analyses showed significant heterogeneity between studies regardless of food item or age group. CONCLUSION: Population-based prevalence estimates for allergies to plant products determined by the diagnostic gold standard are scarce. There was considerable heterogeneity in the prevalence estimates of sensitization or perceived allergic reactions to plant food.

Higher Psoriasis Skin Clearance Is Associated with Lower Annual Indirect Costs in the United States: A Post Hoc Analysis from the CLEAR Study.

BACKGROUND: Psoriasis is associated with a high economic burden to society. New psoriasis systemic treatments offer the potential for improved skin clearance. Whether a higher degree of clearing translates into economic benefit through decreased work impairment has not been fully determined. OBJECTIVE: To assess whether more complete clearing of psoriasis is associated with a reduction in disease-related indirect costs. METHODS: Pooled data from employed patients included in the CLEAR study, a phase 3b study comparing the efficacy and safety of secukinumab (337 subjects) versus ustekinumab (339 subjects), were classified into 4 levels of skin clearance improvement at weeks 16 and 52: Psoriasis Area and Severity Index (PASI) improvement from baseline of < 50% (PASI < 50), 50%-74% (PASI 50-74), 75%-89% (PASI 75-89), and ≥ 90% (PASI ≥ 90). Patients completed the Work Productivity and Activity Impairment questionnaire for psoriasis (WPAI-PSO), which assessed absenteeism, presenteeism, and a composite overall work impairment over the previous 7 days at weeks 16 and 52. U.S. Department of Labor data were used to calculate annual indirect costs due to work productivity loss. RESULTS: In the CLEAR study, 452 (67%) were employed at baseline and included in this analysis. At week 16, mean overall work impairment significantly decreased with higher PASI improvements: 22.8% for PASI < 50, compared with 13.3% for PASI 50-74 (P = 0.001); 6.4% for PASI 75-89 (P < 0.001); and 4.9% for PASI ≥ 90 (P < 0.001), with the majority of work impairment related to presenteeism. Calculated mean work hours lost by overall work impairment decreased with higher PASI improvements: 8.2 hours lost/week (429 hours/year) for patients with PASI 50; 4.6 hours lost/week (251 hours/year) for PASI 50-74; 2.3 hours lost/week (121 hours/year) for PASI 75-89; and 1.8 hours lost/week (93 hours/year) for PASI ≥ 90. Associated mean annual indirect costs due to work productivity loss per worker decreased with higher PASI improvements: $10,318 for PASI < 50, $6,042 for PASI 50-74, $2,901 for PASI 75-89, and $2,233 for PASI ≥ 90. Similar results were observed at week 52. Mean overall work impairment decreased with higher PASI improvements, ranging from 26.3% for PASI < 50 to 6.9% for PASI ≥ 90. A decrease in overall work hours lost (ranging from 9.5 hours lost/week [495 hours/year] for PASI < 50 to 2.5 hours/week [130 hours/year] for PASI ≥ 90), as well as associated annual indirect costs due to work productivity loss (ranging from $11,906 for PASI < 50 to $3,125 for PASI ≥ 90), were also shown with higher PASI improvements at week 52. CONCLUSIONS: Among working patients with moderate to severe psoriasis, higher PASI improvements were associated with lower work productivity loss and reduced annual indirect costs. By improving and sustaining skin clearance, psoriasis treatments may contribute to increased work productivity and decreased societal economic burden. DISCLOSURES: Funding for this study was provided by Novartis Pharmaceuticals. Zhao and Herrera are employed by Novartis. Gilloteau is employed by Novartis Pharma AG. McBride, Graham, and Miles are employed by RTI Health Solutions, which provides consulting and other research services to pharmaceutical, device, governmental, and nongovernmental organizations and received funding from Novartis for manuscript development, analysis development, and general consultation. Feldman reports grants and personal fees from Novartis, Abbvie, Janssen, Lilly, and Celgene, along with personal fees from Amgen and Valeant.

Comparison of Urticaria Activity Score Over 7 Days (UAS7) Values Obtained from Once-Daily and Twice-Daily Versions: Results from the ASSURE-CSU Study.

BACKGROUND: The Urticaria Activity Score summed over 7 days (UAS7) assesses the itch severity and hive count in chronic spontaneous urticaria (CSU) using once- or twice-daily diary-based documentation. OBJECTIVE: The aim of this study was to evaluate the comparability of twice-daily versus once-daily versions of the UAS and the resulting UAS7 values. METHODS: Data came from the ASSURE-CSU study. The twice-daily and once-daily UAS7 was calculated from morning and evening ratings, as well as from exact 24-h evening ratings of hive count and itch severity, respectively. Three UAS7 scores were computed: UAS7 twice daily (UAS7TD), UAS7 once daily for maximum itch (UAS7OD1MAX), and UAS7 once daily for average itch (UAS7OD2AVG). UAS7 values were assigned to five score bands (0, 1-6, 7-15, 16-27, 28-42), reflecting urticaria-free to severe disease activity. The score values and score band ratios of the UAS7TD and UAS7OD versions were compared and assessed for correlation by weighted Cohen's kappa statistics. RESULTS: Data from 614 patients were analyzed. All three versions of the UAS7 yielded very similar results, with a mean (standard deviation) UAS7TD, UAS7OD1MAX, and UAS7OD2AVG of 17.3 (10.49), 17.7 (8.90), and 16.2 (8.68), respectively. Correlation coefficients between UAS7TD and UAS7OD1MAX, UAS7TD and UAS7OD2AVG, and UAS7OD1MAX and UAS7OD2AVG were 0.94, 0.95, and 0.99, respectively, showing very high positive pairwise correlation. The weighted kappa coefficient, κ (95% confidence interval) was 0.78 (0.75-0.82) for UAS7TD versus UAS7OD1MAX, and 0.82 (0.78-0.85) for UAS7TD versus UAS7OD2AVG, demonstrating substantial agreement. CONCLUSIONS: The once- and twice-daily UAS7 scores were highly consistent, supporting the use of either version when evaluating CSU activity.

The burden of chronic spontaneous urticaria: unsatisfactory treatment and healthcare resource utilization in France (the ASSURE-CSU study).

Data on the clinical burden of chronic spontaneous urticaria (CSU) and economic consequences are lacking in France. To characterize the clinical and economic burden of CSU in symptomatic patients despite treatment by analysing data of French patients from the ASSURE-CSU study. ASSURE-CSU was an international observational study that included CSU patients with symptoms that lasted for 12 months or more despite treatment. Disease characteristics and healthcare resource use were obtained from medical records. Data on disease history, health-related quality of life (HR-QoL), and work productivity were collected from a patient survey. A total of 101 patients were analysed (76.2% female; mean age: 48.9 years) with moderate to severe disease (UAS7 score ≥16) in 43.4% and angioedema in 72.3%. The mean (S.D.) total scores of Chronic Urticaria Quality of Life (CU-Q2oL) and Dermatology Life Quality Index (DLQI) were 37.7 (22.3) and 9.7 (6.9), respectively, thus indicating a significant impact of the disease on HR-QoL. Mean absenteeism and presenteeism were 6.4% and 20.8%, respectively, with a mean loss of work productivity estimated at 20.7%. The mean (S.D.) total direct cost of CSU was €2,397 per patient per year and was mainly driven by therapies (€1,435) and inpatient costs (€859). The indirect costs for four weeks were mainly presenteeism (€421) and loss of work productivity (€420). CSU significantly impairs HR-QoL, which increases with the severity of the disease. The direct and indirect costs for the management of symptomatic CSU are an important economic burden.

Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling.

INTRODUCTION: Assessing the consequences of chronic spontaneous/idiopathic urticaria (CSU) requires the evaluation of health-related quality of life (HRQoL) associated with the severity of CSU signs and symptoms. It is important to understand how signs, symptoms, and HRQoL change over time in CSU. Evidence is lacking on how closely changes in signs and symptoms of CSU are related to changes in HRQoL. The objective of this study was to assess the correlation between changes in patient-reported outcome measures (PROMs) of signs and symptoms, dermatologic quality of life (QoL), and urticaria-specific QoL. METHODS: Latent growth models (LGMs) were applied to longitudinal data from three randomized, Phase 3 clinical trials investigating the efficacy and safety of omalizumab in CSU. RESULTS: A near-perfect association between changes in signs and symptoms and changes in dermatologic and urticaria-specific QoLs was identified in each clinical trial when using LGMs (correlation coefficient range 0.88-0.92). CONCLUSION: Evidence showed that changes in signs and symptoms are closely related to changes in HRQoL. However, analyses were performed on clinical trial results of an extremely effective treatment; a less effective treatment with much smaller changes over time may not show such close correlations. Results suggest that any of these PROMs may be used to understand changes in CSU.

EQ-5D Utilities in Chronic Spontaneous/Idiopathic Urticaria.

OBJECTIVES: To obtain utility estimates suitable for use in economic models for chronic spontaneous (idiopathic) urticaria (CSU). METHODS: Patient-level data from three randomized clinical trials-ASTERIA I, ASTERIA II and GLACIAL-were analysed. Health states were derived from the Urticaria Activity Score over 7 days (UAS7); higher scores denote greater activity. The health state score ranges were urticaria free: 0; well-controlled urticaria: 1-6; mild urticaria: 7-15; moderate urticaria: 16-27; and severe urticaria: 28-42. The mean EQ-5D utilities were calculated for each health state. A mixed model was used to predict the EQ-5D according to UAS7 health states in a pooled data set containing all treatment arms and time points from the three trials. Pooled trial data were validated through visual comparisons and interaction terms. Fixed and random effects for trials and patients were included, along with the following covariates: UAS7 health state at baseline (moderate or severe); presence of angioedema at baseline and during follow-up; duration of CSU; number of previous CSU medications; visit; current treatment; and patient age and sex. RESULTS: There was a consistent improvement in EQ-5D utilities as urticaria activity decreased. The mean utilities ranged from 0.710 (severe urticaria) to 0.780 (moderate urticaria), 0.829 (mild urticaria), 0.862 (well-controlled urticaria) and 0.894 (urticaria free). Sensitivity and subgroup analyses confirmed the robustness of the results. CONCLUSION: The results suggest that EQ-5D utility scores increase with decreasing urticaria activity. EQ-5D utility scores enable the health-related quality of life of CSU patients to be compared with that of patients with other diseases.

Cost Utility of Omalizumab Compared with Standard of Care for the Treatment of Chronic Spontaneous Urticaria.

BACKGROUND: Chronic spontaneous urticaria (CSU) negatively impacts patient quality of life and productivity and is associated with considerable indirect costs to society. OBJECTIVE: The aim of this study was to assess the cost utility of add-on omalizumab treatment compared with standard of care (SOC) in moderate or severe CSU patients with inadequate response to SOC, from the UK societal perspective. METHODS: A Markov model was developed, consisting of health states based on Urticaria Activity Score over 7 days (UAS7) and additional states for relapse, spontaneous remission and death. Model cycle length was 4 weeks, and total model time horizon was 20 years in the base case. The model considered early discontinuation of non-responders (response: UAS7 ≤6) and retreatment upon relapse (relapse: UAS7 ≥16) for responders. Clinical and cost inputs were derived from omalizumab trials and published sources, and cost utility was expressed as incremental cost-effectiveness ratios (ICERs). Scenario analyses included no early discontinuation of non-responders and an altered definition of response (UAS7 <16). RESULTS: With a deterministic ICER of £3183 in the base case, omalizumab was associated with increased costs and benefits relative to SOC. Probabilistic sensitivity analysis supported this result. Productivity inputs were key model drivers, and individual scenarios without early discontinuation of non-responders and adjusted response definitions had little impact on results. ICERs were generally robust to changes in key model parameters and inputs. CONCLUSIONS: In this, the first economic evaluation of omalizumab in CSU from a UK societal perspective, omalizumab consistently represented a treatment option with societal benefit for CSU in the UK across a range of scenarios.

Systematic review of treatments for chronic spontaneous urticaria with inadequate response to licensed first-line treatments.

BACKGROUND: Patients with chronic spontaneous urticaria (CSU) are sometimes unresponsive to nonsedating, second-generation, H1 antihistamines; this study summarizes published clinical evidence for patients who remain symptomatic despite treatment. OBJECTIVE: To evaluate, via a systematic literature review, clinical evidence of management strategies for patients with CSU who remain symptomatic despite approved use of nonsedating H1 antihistamines. METHODS: Using a prespecified protocol, we searched MEDLINE, Embase, the Cochrane Library (1 January 1960-20 December 2011), and published conference abstracts (2010-2012). Rigorous criteria identified trials in patients with CSU who had a history of inadequate response to previous treatment or had used combination treatments. Trials evaluating treatment-naïve patients or first-line therapies were excluded. RESULTS: Qualitative data synthesized from 26 randomized, controlled trials, four prospective studies, and one retrospective study showed cyclosporine, desloratadine plus dapsone or dipyridamole, montelukast, and omalizumab reduced urticaria activity scores, weals, and pruritus, versus placebo. Optimal treatment doses and durations were unclear due to varying trial durations, outcome measurement scales, and assessment timings. No safety concerns were reported. CONCLUSIONS: This review confirms that available evidence to guide treatment choice for patients with CSU with inadequate response to H1 antihistamines varies in quality. Further research is warranted due to low-quality trials with methodological and reporting limitations.

ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria.

BACKGROUND: Chronic spontaneous urticaria (CSU) formerly known as chronic idiopathic urticaria (CIU) is a severe and distressing skin condition that remains uncontrolled in approximately one half of patients, despite the use of licensed, recommended doses of modern, second-generation H1-antihistamines. So far, the humanistic, societal and economic burden of CSU/CIU has not been well quantified. Therefore it is important to broaden our understanding of how CSU/CIU impacts patients, society, and healthcare systems, by determining the disease burden of CSU/CIU and the associated unmet need; as well as to further guide the use of new treatments in an efficient and cost-effective manner. METHODS: ASSURE-CSU is an observational, multicenter study being conducted in the UK, Germany, Canada, France, Italy, Spain, and The Netherlands. The study comprises a retrospective medical chart review in conjunction with patient surveys (including validated tools for assessment of disease impact) and an 8-day patient diary. The primary objectives of the study are to describe patient demographics, medical history, treatments, and healthcare resource utilization based on medical-record data and to assess the impact of disease, healthcare resource utilization, work days missed, and productivity loss based on patient-reported data. Approximately 700 patients (aged ≥18 years) will be enrolled who have CSU/CIU despite currently receiving treatment, and have had persistent symptoms for at least 12 months. Data will be collected retrospectively for the 12 months (±1 month) prior to enrolment wherever possible, and prospectively for the week following enrolment. DISCUSSION: ASSURE-CSU will be the first study to examine the economic and humanistic burden of disease in patients diagnosed with CSU/CIU who are symptomatic despite treatment. By combining retrospective evaluation of medical records with prospective patient surveys and 8-day diaries, across seven different countries, the ASSURE-CSU study will contribute to a better understanding and acknowledgement of the burden of disease in patients with symptomatic chronic spontaneous urticaria.

Treatment sequencing after failure of the first biologic in cost-effectiveness models of psoriasis: a systematic review of published models and clinical practice guidelines.

OBJECTIVES: To analyse the treatment sequencing assumptions after failure on a first-line biologic in cost-effectiveness models of treatment of moderate to severe plaque psoriasis, and to compare them with the most recent treatment guidelines. METHODS: A systematic search of MEDLINE, Embase, EconLit and the Cochrane Library databases used free text and Medical Subject Headings terms including psoriasis, biologic therapies indicated for psoriasis, and all types of economic evaluations. Two researchers performed 2-level abstract screening for articles meeting pre-specified inclusion criteria. Assumptions about treatment pathways after first-line biologic failure in the cost-effectiveness models were analysed. A second systematic search was performed for psoriasis clinical practice guidelines. Sequence assumptions were compared with treatment guideline recommendations. RESULTS: Of 25 cost-effectiveness modelling studies identified, ten estimated the incremental cost per responder; time horizons varied (12 weeks-18 months) and treatment sequencing was not considered. In 15 studies where treatment sequencing was considered, with time horizons up to 10 years, five studies included only a switch to nonsystemic therapy or best supportive care after first-line biologic failure. Another five of the 15 treatment-pathway studies were available only as abstracts with no details of the sequence assumptions. In five of the 15 studies, first-line biologic failure was followed by second-line biologic monotherapy, one of the recommendations in current treatment guidelines. In only one of these five studies was the efficacy of the second-line biologic adjusted downwards, compared with first-line treatment. Only one of these studies considered dose titration with a first-line biologic and none combination therapy (biologic plus methotrexate or phototherapy) after first-line biologic failure, as recommended in some treatment guidelines. CONCLUSIONS: Cost-effectiveness models of first-line biologics for moderate to severe plaque psoriasis either do not include subsequent treatment regimens or include only some of the regimens recommended in current treatment guidelines. Results may be sensitive to assumptions about treatment sequencing and the choice and efficacy of subsequent treatment regimens.

[Prevalence of food allergy in Icelandic infants during first year of life]. / Algengi fæduofnæmis hjá íslenskum börnum á fyrsta ári.

OBJECTIVE: This study is a part of EuroPrevall, an EU-funded European food allergy project. The aim was to evaluate the prevalence of food allergy in Icelandic infants during their first year of life. MATERIAL AND METHODS: Infants (n=1,341) were followed prospectively from birth to 12 months of age. Questionnaires were obtained at birth and 12 months. Children with symptoms of possible food allergy were assessed with a skin-prick test (SPT) and specific IgE. Food allergy was confirmed with a double-blind placebo-controlled food challenge (DBPCFC). RESULTS: Out of 170 symptomatic children 44 infants (3.27%) had either positive SPT (n=21; 1.57%) or specific IgE (n=40; 2.98%). Food allergy was confirmed in 25 (1.86%); egg allergy 1.42%, milk 0.52%, fish 0.22%, wheat 0.15%, peanuts 0.15%, and soy 0.07%. Atopic dermatitis was diagnosed in 7.90% (n=106) and according to questionnaires 8.80% had asthma (n=118). Positive family history was the strongest risk factor for asthma (OR=2.12; p<0.001) and atopic dermatitis (OR=1.90; p=0.004). Family history influenced the relationship between predisposing factors and allergy symptoms. CONCLUSION: Our results show lower prevalence of food allergy than previously reported in a study of Icelandic children at two years of age. The prevalence was also lower than reported in some other European countries and could be explained by different genetic and environmental factors.

Anticoagulation treatment for the reduction of stroke in atrial fibrillation: a cohort study to examine the gap between guidelines and routine medical practice.

BACKGROUND: Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 6% of people over 65 years, and carries a 4.5% average annual stroke risk, which can be reduced by appropriate anticoagulation. A multi-centre observational study, Management and Outcomes in the Care of Atrial fibrillation in Germany (MOCA) was conducted to evaluate the current anticoagulation treatment pattern in patients with AF in Germany. METHODS: Patients with AF were recruited from December 2003 to June 2004 in physician practices. Clinical data including International Normalised Ratio (INR) values and anticoagulation strategy were obtained from the physician chart and the patient follow-up, documenting hospitalisations, medications, and complications, was conducted at three and six months. Main outcome measures included anticoagulation methods, practice guidelines adherence and time within recommended anticoagulation range. RESULTS: 361 patients with AF (mean age 71+/-9, 61% male) were recruited in 45 physician practices. 90% of all patients had been treated with Vitamin K-Antagonists (VKA) at some time since AF-diagnosis, 88% were still treated. 10% of patients received aspirin as their anticoagulation therapy. Monitoring occurred at least once a month in over 70% of patients. Monitored INR values were 56% of the time within, 14% below and 30% over the recommended target range. A gap of 40% existed between the guideline recommendations and actual practice. Younger patients (<60 years of age) with no documented risk factors for stroke were over-treated with VKAs and patients older than 75 years without contraindications for anticoagulation were under-treated. CONCLUSIONS: This study presents 'real-life' data in treating patients with AF in Germany and identifies the potential to advance the quality of care with respect to anticoagulation.

Sirolimus-eluting versus bare-metal stents for the reduction of coronary restenosis: 18-month angiographic results from the GERSHWIN Study.

PURPOSE: The GERSHWIN study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term effects of treatment of coronary artery disease (CAD) with sirolimus-eluting stents (SES), as compared to bare-metal stents (BMS). PATIENTS AND METHODS: Within a multicenter, prospective intervention study in 35 hospitals throughout Germany, CAD patients with coronary stenosis and elective percutaneous coronary intervention (PCI) indication were treated either with SES or BMS (sequential control design with a case-to-control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at baseline, 3, 6, 12, and 18 months following PCI to document re-PCI for restenosis, myocardial infarction (MI), coronary bypass surgery (CABG), and death. Angiographic PCI documentation was evaluated by an independent expert. RESULTS: From April 2003 until June 2005, 658 patients were treated with SES (mean age 63 +/- 9 years, 87% male) and 294 patients with BMS (mean age 64 +/- 10 years, 79% male). Significant baseline differences were found by age, gender, household status, three vessel disease, and number of implanted stents. After 18 months, 8% of the SES versus 17% of the BMS group had undergone target vessel revascularization (p adjusted < 0.0001). There were no significant differences between BMS and SES regarding MI, CABG, or death. Re-PCI of target and new non-target vessel lesions was performed at a significantly lower degree of stenosis in SES than in BMS. CONCLUSION: Compared to patients with BMS, patients with implantation of SES experienced considerably fewer target vessel revascularizations. The threshold to perform re-PCI appeared lower in SES than in BMS. An extended evaluation of the effects of SES will be available from the 3-year follow-up of the GERSHWIN study.

The prevalence of food allergy: a meta-analysis.

BACKGROUND: There is uncertainty about the prevalence of food allergy in communities. OBJECTIVE: To assess the prevalence of food allergy by performing a meta-analysis according to the method of assessment used. METHODS: The foods assessed were cow's milk, hen's egg, peanut, fish, shellfish, and an overall estimate of food allergy. We summarized the information in 5 categories: self-reported symptoms, specific IgE positive, specific skin prick test positive, symptoms combined with sensitization, and food challenge studies. We systematically searched MEDLINE and EMBASE for publications since 1990. The meta-analysis included only original studies. They were stratified by age groups: infant/preschool, school children, and adults. RESULTS: A total of 934 articles were identified, but only 51 were considered appropriate for inclusion. The prevalence of self-reported food allergy was very high compared with objective measures. There was marked heterogeneity between studies regardless of type of assessment or food item considered, and in most analyses this persisted after age stratification. Self-reported prevalence of food allergy varied from 1.2% to 17% for milk, 0.2% to 7% for egg, 0% to 2% for peanuts and fish, 0% to 10% for shellfish, and 3% to 35% for any food. CONCLUSION: There is a marked heterogeneity in the prevalence of food allergy that could be a result of differences in study design or methodology, or differences between populations. CLINICAL IMPLICATIONS: We recommend that measurements be made by using standardized methods, if possible food challenge. We need to be cautious in estimates of prevalence based only on self-reported food allergy.