Mapping CushingQOL scores to EQ-5D utility values using data from the European Registry on Cushing's syndrome (ERCUSYN).

PURPOSE: To construct a model to predict preference-adjusted EuroQol 5D (EQ-5D) health utilities for CS using the disease-specific health-related quality of life measure (CushingQOL). METHODS: Data were obtained from the European Registry on CS (ERCUSYN). ERCUSYN is a web-based, multicenter, observational study that enrolled 508 CS patients from 36 centers in 23 European countries. Patients included in the study completed both the EQ-5D and the disease-specific CushingQOL questionnaire. Socio-demographic and clinical data were also collected. The UK tariff values were used to calculate EQ-5D utility scores. Various predictive models were tested, and the final model was selected based on four criteria: explanatory power (adjusted R-squared), consistency of estimated coefficients (sign and parameter estimation), normality of prediction errors (mean error, mean absolute error, root mean squared error), and parsimony. RESULTS: For the mapping analysis, data were available from a total of 129 patients. Mean (SD) age was 43.1 (13) years, and the sample was predominantly female (84.5 %). Patients had a mean (SD) CushingQOL score of 39.7 (17.1) and a mean (SD) 'tariff' value on the EQ-5D of 0.55 (0.3). The model which best met the criteria for selection included the intercept and 3 CushingQOL's questions and had an R(2) of 0.506 and a root mean square error of 0.216. CONCLUSIONS: It was possible to find a mapping function which successfully predicted the EQ-5D UK utilities from disease-specific CushingQOL scores. The function may be useful in calculating EQ-5D scores when EQ-5D data have not been gathered directly in a study.

Prevalence of hiatal hernia by blinded multidetector CT in patients with idiopathic pulmonary fibrosis.

Hiatal hernia (HH) is associated with gastro-oesophageal reflux (GOR) and/or GOR disease and may contribute to idiopathic pulmonary fibrosis (IPF). We hypothesised that HH evaluated by computed tomography is more common in IPF than in asthma or chronic obstructive pulmonary disease (COPD), and correlates with abnormal GOR measured by pH probe testing. Rates of HH were compared in three cohorts, IPF (n=100), COPD (n=60) and asthma (n=24), and evaluated for inter-observer agreement. In IPF, symptoms and anti-reflux medications were correlated with diffusing capacity of the lung for carbon monoxide (D(L,CO)) and composite physiologic index (CPI). HH was correlated with pH probe testing in IPF patients (n=14). HH was higher in IPF (39%) than either COPD (13.3%, p=0.00009) or asthma (16.67%, p=0.0139). The HH inter-observer κ agreement was substantial in IPF (κ=0.78) and asthma (κ=0.86), and moderate in COPD (κ=0.42). In IPF, HH did not correlate with lung function, except in those on anti-reflux therapy, who had a better D(L,CO) (p<0.03) and CPI (p<0.04). HH correlated with GOR as measured by DeMeester scores (p<0.04). HH is more common in IPF than COPD or asthma. In an IPF cohort, HH correlated with higher DeMeester scores, confirming abnormal acid GOR. Presence of HH alone was not associated with decreased lung function.

Predicting beauty: fractal dimension and visual complexity in art.

Visual complexity has been known to be a significant predictor of preference for artistic works for some time. The first study reported here examines the extent to which perceived visual complexity in art can be successfully predicted using automated measures of complexity. Contrary to previous findings the most successful predictor of visual complexity was Gif compression. The second study examined the extent to which fractal dimension could account for judgments of perceived beauty. The fractal dimension measure accounts for more of the variance in judgments of perceived beauty in visual art than measures of visual complexity alone, particularly for abstract and natural images. Results also suggest that when colour is removed from an artistic image observers are unable to make meaningful judgments as to its beauty.

Work productivity loss due to flares in patients with chronic gout refractory to conventional therapy.

OBJECTIVE: Joint pain and swelling during gout flares may lead to considerable morbidity and disability, having an impact on patient work productivity and social participation. The objective of this study was to assess how gout flares affect these activities in patients with chronic gout refractory to conventional therapy. METHODS: A 1-year prospective observational study was conducted among patients with symptomatic disease in the United States in 2001. Inclusion criteria required patients (1) to be age 18 years or older, (2) to have documented, crystal-proven gout, (3) to have symptomatic gout, and (4) to be intolerant or unresponsive to conventional therapy, reflected by SUA ≥ 6.0 mg/dL. Patients were evaluated every 2 months. At each visit, patients completed a gout diary, which included number of flares experienced, duration and severity of each flare, and whether the flare caused: (1) work loss, (2) missed appointments or social events, or (3) impairment of self-care activities. The Short-Form Health Survey (SF-36) was also completed each visit. RESULTS: Analyses were restricted to those who completed the first 6 months of the study (n = 81). Mean number of flares per patient per year was 8.8. Of the patients who were <65 years, 78% reported at least 1 work day lost due to a gout attack during the year. Mean annual work day loss for those <65 years was 25.1 days. A total of 545 of patients reported at least one flare per year that impaired social activities, with a mean of 17.1 social days lost and 52% reported at least one flare per year that compromised normal self-care activities, with a mean of 16.9 days impairment. Correlations between the diary reports and activity-related questions from the SF-36 were significantly positive. LIMITATIONS: The study is limited by small sample size, lack of reference group, and inability to explicitly collect employment information. Age under 65 years was used as a proxy for employment eligibility. CONCLUSION: Flares in patients with chronic gout refractory to conventional therapy significantly affect patient work productivity and social activities.

Alarmingly high prevalence of obesity in haemophilia in the state of Mississippi.

The state of Mississippi has consistently been ranked as the state with most number of obese people in the United States with prevalence rates of >30%. Our aims in this study were to estimate the prevalence of overweight and obesity in children and adults diagnosed with haemophilia in Mississippi, and to assess whether race/ethnicity and the severity of haemophilia are important risk factors. A retrospective chart review was performed for all haemophilic patients seen at the Mississippi Hemophilia Treatment Center. Patients were classified into two major age groups: age 2-19.9 years and > or =20 years. Body mass index (BMI) was calculated from the height and weight in kg m(-2) from the last clinic visit. Out of a total of 132 haemophilic patients, 61% were white and 37% were African American. Overall, 51% of the haemophilic patients were either obese or overweight. The prevalence of obesity in the adult (> or =20 years old) haemophilic patients was 36% and an additional 32% were overweight. A significantly greater proportion of patients >20 years old were overweight or obese as compared with the patients in the 2-19.9 year age range (P < 0.002). However, race/ethnicity and severity of haemophilia were not significant risk factors for overweight and obesity. There is a very high prevalence of obesity in the Mississippi haemophilic population, especially in adults. Particular attention at clinic visits should be paid to the BMI in order to identify patients that are overweight or obese to allow for early and appropriate intervention.

Work hours, sleep patterns and fatigue among merchant marine personnel.

A field study of work and sleep patterns among commercial merchant marine personnel is reported. Data collected over a 10-30-d period from 141 subjects aboard eight ships included information concerning work-rest schedules, sleep timing, alertness on the job and critical fatigue. The data indicate that watchstanders on the 4-on, 8-off schedule show considerable disruption in their sleep. The average sleep duration for all mariners is 6.6 h; watchstanders obtain their sleep in fragmented periods that are frequently less than 5 h in duration. Analysis of critical fatigue shows an incidence of 1-24% across personnel and measures. Of particular concern are the watchstanders on the 04.00-08.00 schedule, who sleep less than 4 h per 24-h period 22% of the time. Potential countermeasures, including changes in scheduling and staffing are proposed.

Perinatal outcomes in the pregnancies of asthmatic women: a prospective controlled analysis.

Prior studies have found an increased incidence of adverse perinatal outcomes of pregnancies in asthmatic mothers, but these studies have been poorly controlled for asthma therapy and other confounding factors. The purpose of this study was to assess perinatal outcomes in actively managed pregnant asthmatic women as compared with matched nonasthmatic controls. Using an inception cohort design, we studied a volunteer sample of 486 pregnant (< 28 wk) women with documented asthma and 486 pregnant nonasthmatic controls with normal pulmonary function. Cases and controls were matched for age, smoking status, parity, and year of delivery. Asthma was managed with step therapy to prevent acute asthmatic episodes and asthma symptoms that interfered with sleep or normal activity. Chronic hypertension was significantly more common (p = 0.007) in asthmatic subjects (3.7%) than in matched controls (1.0%). However, no significant differences in incidences of preeclampsia, perinatal mortality, preterm births, low-birth-weight infants, intrauterine growth retardation, or congenital malformations were observed in the pregnancies of the asthmatic women as compared with the matched controls. Trends were observed toward relationships between more severe asthma requiring emergency therapy or corticosteroids and increased incidences of preeclampsia and low-birth-weight infants, but these associations were not statistically significant. These data suggest that the overall perinatal prognosis for women with actively managed asthma during pregnancy is comparable to that for the nonasthmatic population.

Osteoporosis in corticosteroid-treated asthmatic patients: clinical correlates.

This study sought to identify clinical and laboratory characteristics associated with the development of osteoporosis in 44 corticosteroid (CS)-treated asthmatic patients. Percentage predicted bone density was inversely correlated with both the duration of CS therapy (r = -.39, p = 0.009) and 24-hour urine calcium excretion (chi 2 = 5.2, p = 0.022). Bone density was not related to prednisone equivalent dose, alternate day versus daily therapy or serum cortisol levels. These data suggest that (1) long duration of CS therapy and increased urine calcium may identify patients at increased risk of developing CS-induced osteoporosis, and (2) urinary loss of calcium may be of particular importance in the pathogenesis of this condition.

Increased transient tachypnea of the newborn in infants of asthmatic mothers.

OBJECTIVE: To compare the incidence of transient tachypnea of the newborn (TTN) in infants of asthmatic vs nonasthmatic mothers. RESEARCH DESIGN: Case-control analysis. SETTING: Group model health maintenance organization. PATIENTS: A volunteer sample of 294 pregnant asthmatic women and 294 pregnant nonasthmatic women with normal pulmonary function test results, matched on the basis of age and smoking status. All subjects entered the study before their third trimester of pregnancy. Subjects with multiple gestations and abortions (less than 20 weeks' gestation) were excluded. INTERVENTION: Asthma was treated in the allergy department. Routine obstetric, neonatal, and pediatric care was provided to all patients by staff physicians. MEASUREMENTS/RESULTS: Transient tachypnea occurred in 11 infants (3.7%) of asthmatic women and in one control infant (0.3%). There were no significant differences between asthmatic and matched control subjects in previously defined TTN risk factors, such as the occurrence of longer labors, failure to progress, cesarean sections, premature births, male sex, Apgar scores of less than 7 at 1 minute, or birth weight greater than 4 kg. Although infants of asthmatic mothers were more likely to exhibit wheezing by age 15 months compared with control infants (12.0% vs 3.2%), none of the infants with TTN manifested wheezing by age 15 months. No relationships could be identified in the asthmatic cohort between the occurrence of TTN and asthma severity or medication use (during the pregnancy in general or during labor and delivery in particular). CONCLUSION: Although the mechanism is uncertain, maternal asthma appears to increase the risk of infant TTN.

Issues in the design of drug trials for AIDS.

Although the fundamental principles that drive the design, conduct, and analysis of clinical trials are as applicable to AIDS as to other diseases, there is no question that we have been confronted with unusually difficult challenges in studying therapeutic approaches in this disease area. Treatments are being developed that show great promise, but when investigated further some may be seen to offer no clinical benefit and others may do active harm through toxicity. A group of biostatisticians, meeting in association with the AIDS Clinical Trials Group (ACTG), has discussed and written a report on a number of issues, primarily related to principles of study design, with the goal of stimulating thought on new study designs and the timely implementation of well-designed trials to identify effective treatment strategies for HIV-infected populations. These issues include (1) progression of clinical trials through phases, (2) choices of outcomes, (3) breadth and complexity of clinical trials (eligibility criteria and "low-tech" trials, (4) alternative designs to be used in randomized trials, and (5) the concept of randomized clinical trials as a desirable option, both for patients and for science. The current HIV epidemic makes the requirements of obtaining valid scientific comparisons more important, not less so, but the challenge is to expedite this process.