Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale.

INTRODUCTION: Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial. MATERIALS/METHODS: Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. RESULTS: Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing. CONCLUSIONS: This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

Screening for eating disorders: false negatives and eating disorders not otherwise specified

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Objective: To study the problem of false negatives in the screening for eating disorders. Subjects and Methods: We administered the Eating Attitudes Test (EAT40) and the Eating Disorder Inventory (EDI) to 186 Italian female students (age 17.68 ± 0.9; BMI 20.84 ± 2.69). Then we submitted not only high-scorers but also all the subjects to a semi-structured diagnostic interview (Eating Disorder Examination - EDE 12.0D). The diagnosis of eating disorders not otherwise specified (EDNOS) was applied to cases which met all the DSM-IV criteria for AN and/or BN with one exception. Results: 17 girls (9.1 percents) fulfilled diagnostic criteria for eating disorders: 1 bulimia nervosa full-syndrome and 16 EDNOS. Of the 17 girls 11 were EAT low-scorers (< 30) and 8 were EDI low-scorers (< 50); 5 subjects scored below the cutoff on both instruments. We calculated sensitivity (35.3 percents), specificity (88.8 percents), positive predictive value (PPV, 24.0 percents) and negative predictive value (NPV, 93.2 percents) of the EAT40; the respective values for the EDI were 52.9 percents (sensitivity), 85.2 percents (specificity), 26.4 percents (PPV) and 94.7 percents (NPV). Discussion and Conclusion: Our data show that the introduction of the EDNOS diagnoses increases the PPV of the two questionnaires but lowers their sensitivity. We conclude that using a two stage screening approach leads to a very high rate of false negatives with a significant underestimation of the prevalence of eating disorders, particularly of EDNOS (AU)

Predictors of professional and personal satisfaction with a career in psychiatry.

BACKGROUND: Many factors, including personal experience and personality traits, contribute to the emotional difficulties that psychiatrists experience in their professional work. The nature of the work itself also plays a significant role. OBJECTIVE: To determine those personal and professional characteristics that predict satisfaction with the practice of psychiatry. METHOD: We mailed a questionnaire that included items pertaining to aspects of personal and professional life to the entire population of psychiatrists in Ontario (N = 1574). RESULTS: Of the 1574, 52% (n = 802) responded. We conducted a series of regression analyses to determine factors related to career satisfaction or regret. A belief in the intrinsic value of psychiatry, a low perceived degree of emotional burden from patients, financial success, and satisfaction with psychotherapeutic work emerged consistently as significant predictors. A subsequent discriminant function analysis indicated that all 4 of these variables accurately predicted those psychiatrists with extreme satisfaction or dissatisfaction with work. CONCLUSIONS: These results reveal several variables associated with career satisfaction in the practice of psychiatry that might be useful to discuss with residents who are beginning their careers.

Relationship between bipolar illness and binge-eating disorders.

In this study we describe the frequency of eating disorders (EDs) in a group of bipolar (BP) patients. We evaluated a sample of 51 outpatients, diagnosed as having BP I disorder on the basis of the Structured Clinical Interview for DSM-IV (SCID). Each of these subjects was administered the Binge Eating Disorder Clinical Interview (BEDCI) to determine the presence of binge eating disorder (BED) or bulimia nervosa (BN). Of the 51 BP patients, 14 (9 BED, 5 BN) met criteria for an ED. Most patients developed binge eating coincident with the first episode of BP disorder or after the onset of it. This was true for those who developed BED as well as BN, and involved both manic and depressive phases. All BN patients were women (5/5), and family history of binge eating was present in 80% of BN subjects, but only in 22.2% of BED and 29.7% of non-ED BP patients. We found a high frequency of concordance between BP illness and binge eating problems in our sample of BP patients. Given the temporal sequence of the mood disorder, which generally preceded the ED, we suggest a model in which the ED evolves due to modulation of emotions with food, as well as use of medications to treat BP disorder that disrupt hunger and satiety mechanisms. Given differences in gender distribution and family history, cultural and familial influences may also be significant in the minority of BP binge-eating patients who develop BN.

Gender differences in the practice characteristics and career satisfaction of psychiatrists in Ontario.

OBJECTIVE: The authors explored practice characteristics, activities, and career satisfaction of male and female psychiatrists. METHOD: A questionnaire was mailed to all practicing psychiatrists in Ontario, Canada, to which 52% responded. RESULTS: More women specialized in child, women's mental health and geriatrics than did men, while men specialized more in forensics and psychosomatics. Women saw fewer patients for pharmacotherapy than did men. Women spent more time in session with their patients than did the men. Women were less involved in research, less likely to hold pharmaceutical funding, and less likely to have published within the last 5 years than men. Women described their careers as less successful than men but felt less regret in choosing psychiatry as a career. CONCLUSIONS: Men and women practicing psychiatry in Canada show similar differences to that reported in the U.S., although women report more satisfaction with their careers than men in Canada, a finding not reported in the U.S.

Characteristics of eating disorder patients without a drive for thinness.

OBJECTIVE: The aim of this study was to investigate two samples of patients affected by anorexia nervosa (AN) or bulimia nervosa (BN), respectively, with and without the diagnostic feature of drive for thinness (DT). METHOD: The samples comprised 70 consecutive eating disorder (ED) outpatients at the Department of Psychiatry (University of Pisa) and 106 AN patients admitted to a day hospital in Toronto, Canada. Subjects were assessed on clinical and psychometric parameters. RESULTS: In both countries, 17% of the subjects had low DT as measured by the Eating Disorder Inventory (EDI). They comprised the atypical group and appeared to have less severe psychopathology. DISCUSSION: Weight phobia should not be viewed as critical to the diagnosis of ED and DT could be a culture-bound dimension. Considering the differences between the two groups, the characterization of patients as typical and atypical may be clinically useful.