Variability in IRBs regarding parental acceptance of passive consent.

OBJECTIVE: Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study. METHODS: We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients. RESULTS: Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%. CONCLUSIONS: IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period.

Subjective social status predicts wintertime febrile acute respiratory illness among women healthcare personnel.

OBJECTIVE: We ask whether subjective social status (SSS) predicts rates of wintertime febrile acute respiratory illness (ARI). METHODS: 1,373 women and 346 men were enrolled from September 1 through November 30, 2010 as part of a prospective cohort study of health care personnel (HCP) at two medical centers. A questionnaire was completed at enrollment followed by 20 weeks of surveillance. ARI was an illness with fever and cough self-reported via weekly telephone or Internet-based surveillance. RESULTS: For both sexes, lower SSS was associated with younger age, less education, lower neighborhood household income, being unmarried, lower occupational status, working in outpatient settings, and poorer self-rated health status. Demographic and occupational covariates explained 23% and 42% of the variance (R²) in SSS among women and men, respectively. Smoking, exercise frequency, and sleep quality were also associated with SSS, but these factors explained little additional variance (3-4%). Among women HCP, lower SSS at enrollment was associated with higher rates of subsequent ARI (unadjusted ß = -.21 [±.05], p < .001 for ordinal data). Adjusting for all covariates reduced the effect size of the SSS minimally (adjusted ß = -.19 [±.06], p < .001). Among men HCP, there was no univariate SSS-ARI association and after adjusting for all covariates the effect was opposite of our hypothesis (adjusted ß = .33 [±.17], p < .05). CONCLUSIONS: Women (but not men) with lower SSS were more likely to report an ARI during surveillance, and the SSS-ARI association was independent of demographics, occupational status, health, and health behaviors.

Outcomes that matter: a qualitative study with persons with schizophrenia and their primary caregivers in India.

BACKGROUND: Involving persons with schizophrenia and their families in designing, implementing and evaluating mental health services is increasingly emphasised. However, there is little information on desired outcomes from the perspectives of these stakeholders from low and middle income countries (LMIC). AIMS: To explore and define outcomes desired by persons with schizophrenia and their primary caregivers from their perspectives. METHOD: In-depth interviews were held with 32 persons with schizophrenia and 38 primary caregivers presenting for care at one rural and one semi-urban site in India. Participants were asked what changes they desired in the lives of persons affected by the illness and benefits they expected from treatment. Data was analysed using thematic and content analysis. RESULTS: Eleven outcomes were desired by both groups: symptom control; employment/education; social functioning; activity; fulfilment of duties and responsibilities; independent functioning; cognitive ability; management without medication; reduced side-effects; self-care; and self-determination. Social functioning, employment/education and activity were the most important outcomes for both groups; symptom control and cognitive ability were more important to persons with schizophrenia while independent functioning and fulfilment of duties were more important to caregivers. CONCLUSIONS: Interventions for schizophrenia in India should target both clinical and functional outcomes, addressing the priorities of both affected persons and their caregivers. Their effectiveness needs to be evaluated independently from both perspectives.

The expected emotional benefits of influenza vaccination strongly affect pre-season intentions and subsequent vaccination among healthcare personnel.

BACKGROUND: The relative importance of different attitudes in predicting vaccination among healthcare personnel (HCP) is unclear. We hypothesized that HCP who feel at risk without vaccination or say they would regret not getting vaccinated would be more likely to get vaccinated than HCP who do not expect these emotional benefits. METHODS: A prospective cohort of 1544 HCP with direct patient care was enrolled from September 18 to December 18, 2010 at Scott & White Healthcare in Texas and Kaiser Permanente Northwest in Oregon and Washington. An Internet-based questionnaire assessed pre-season intention to be vaccinated and included 12 questions on attitudes about vaccination: single-item measures of perceived susceptibility and vaccine effectiveness, 5 items that were summed to form a concerns about vaccine scale, and 5 items summed to form an emotional benefits of vaccination scale. Influenza vaccination status for the 2010-2011 season and for 5 prior seasons was confirmed by medical record extraction. RESULTS: There were significant differences between vaccinated and unvaccinated HCP on all attitude items; 72% of vaccinated HCP agreed that they "worry less about getting the flu" if vaccinated, compared to only 26% of the unvaccinated (odds ratio=7.4, 95% confidence interval=5.8-9.5). In a multivariate model, the emotional benefits scale was the strongest predictor of 2010-2011 seasonal influenza vaccination, after adjusting for other attitude measures, prior vaccination history, and pre-season intention to be vaccinated. The predictive value of the emotional benefits scale was strongest for HCP with low pre-season intention to be vaccinated, where HCP vaccine receipt was 15% versus 83% for those with low versus high scores on the emotional benefits scale. CONCLUSIONS: The expected emotional benefits of vaccination strongly affect seasonal influenza vaccination among HCP, even after taking into account other attitudes, pre-season intentions, and prior vaccination history. These attitudes are promising targets for future vaccination campaigns.

Immunizations, neonatal hyperbilirubinemia and animal-induced injuries.

PURPOSE OF REVIEW: To report recent research findings and new recommendations on immunizations, neonatal hyperbilirubinemia, and animal-induced injuries. RECENT FINDINGS: Vaccines against rotavirus and human papilloma virus have entered clinical use. Varicella outbreaks among previously vaccinated children have prompted the recommendation for a two-dose varicella vaccine series. Broader coverage for influenza vaccination is now recommended in the US and Canada. Diagnosis and treatment of neonatal hyperbilirubinemia uses population and hour-based norms for total serum bilirubin and assessment of risk factors. Delayed cord clamping is not apparently a risk factor for jaundice but warrants more study. Universal predischarge screening shows promise but is not yet officially recommended. New treatments for hyperbilirubinemia are being evaluated. Dogs are the chief cause of animal bites in children and the largest reservoir for rabies worldwide. In North America and Europe, cats and wild animals cause most human rabies. Postexposure prophylaxis should follow region-appropriate guidelines. SUMMARY: New vaccines are available against rotavirus and human papilloma virus. Changes have been made to official immunization recommendations. Appropriate vaccine use can reduce the pediatric disease burden further. Hyperbilirubinemia is the subject of ongoing study, which may lead to improved diagnosis and treatment protocols and reduce the incidence of acute bilirubin encephalopathy. The best tool for rabies prevention after an animal bite is prompt postexposure prophylaxis.