Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric trials in order to optimize the information derived from pediatric participation in clinical trials.

BACKGROUND: Personally controlled health records (PCHRs) are accessible over the Internet and allow individuals to maintain and manage a secure copy of their medical data. These records provide a new opportunity to provide customized health recommendations to individuals based on their record content. Health promotion programs using PCHRs can potentially be used in a variety of settings and target a large range of health issues. OBJECTIVES: The aim was to assess the value of a PCHR in an employee health promotion program for improving knowledge, beliefs, and behavior around influenza prevention. METHODS: We evaluated a PCHR-based employee health promotion program using a randomized controlled trial design. Employees at Hewlett Packard work sites who reported reliable Internet access and email use at least once every 2 days were recruited for participation. PCHRs were provided to all participants for survey administration, and tailored, targeted health messages on influenza illness and prevention were delivered to participants in the intervention group. Participants in the control group received messages addressing cardiovascular health and sun protection. The main outcome measure was improvement in knowledge, beliefs, and behavior around influenza prevention. Secondary outcomes were influenza vaccine rates among household members, the impact of cardiovascular health and sun protection messages on the control group, and the usability and utility of the PCHR-based program for employees. RESULTS: The intervention did not have a statistically significant effect on the influenza knowledge elements we assessed but did impact certain beliefs surrounding influenza. Participants in the intervention group were more likely to believe that the influenza vaccine was effective (OR = 5.6; 95% CI = 1.7-18.5), that there were actions they could take to prevent the flu (OR = 3.2; 95% CI = 1.1-9.2), and that the influenza vaccine was unlikely to cause a severe reaction (OR = 4.4; 95% CI = 1.3-15.3). Immunization rates did not differ between the intervention and control groups. However, participants in the intervention group were more likely to stay home during an infectious respiratory illness compared with participants in the control group (39% [16/41] vs 14% [5/35], respectively; P = .02). The program also succeeded in improving recognition of the signs of heart attack and stroke among participants in the control group. Overall, 78% of participants rated the PCHR as "extremely/very" easy to use, and 73% responded that they would be "extremely/very" likely to participate again in a PCHR-based health promotion system such as this one. CONCLUSIONS: With a small sample size, this study identified a modest impact of a PCHR-based employee health program on influenza prevention and control. Employees found the PCHR acceptable and easy to use, suggesting that it should be explored as a common medium for health promotion in the workplace. TRIAL REGISTRATION: ClinicalTrials.gov NCT00142077.

BACKGROUND: The influence of air travel on influenza spread has been the subject of numerous investigations using simulation, but very little empirical evidence has been provided. Understanding the role of airline travel in large-scale influenza spread is especially important given the mounting threat of an influenza pandemic. Several recent simulation studies have concluded that air travel restrictions may not have a significant impact on the course of a pandemic. Here, we assess, with empirical data, the role of airline volume on the yearly inter-regional spread of influenza in the United States. METHODS AND FINDINGS: We measured rate of inter-regional spread and timing of influenza in the United States for nine seasons, from 1996 to 2005 using weekly influenza and pneumonia mortality from the Centers for Disease Control and Prevention. Seasonality was characterized by band-pass filtering. We found that domestic airline travel volume in November (mostly surrounding the Thanksgiving holiday) predicts the rate of influenza spread (r(2) = 0.60; p = 0.014). We also found that international airline travel influences the timing of influenza mortality (r(2) = 0.59; p = 0.016). The flight ban in the US after the terrorist attack on September 11, 2001, and the subsequent depression of the air travel market, provided a natural experiment for the evaluation of flight restrictions; the decrease in air travel was associated with a delayed and prolonged influenza season. CONCLUSIONS: We provide the first empirical evidence for the role of airline travel in long-range dissemination of influenza. Our results suggest an important influence of international air travel on the timing of influenza introduction, as well as an influence of domestic air travel on the rate of inter-regional influenza spread in the US. Pandemic preparedness strategies should account for a possible benefit of airline travel restrictions on influenza spread.

A critical mass of Internet users will soon enable wide diffusion of electronic communication within medical practice. E-mail between physicians and patients offers important opportunities for better communication. Linking patients and physicians through e-mail may increase the involvement of patients in supervising and documenting their own health care, processes that may activate patients and contribute to improved health. These new linkages may have profound implications for the patient-physician relationship. Although the federal government proposes regulation of telemedicine technologies and medical software, communications technologies are evolving under less scrutiny. Unless these technologies are implemented with substantial forethought, they may disturb delicate balances in the patient-physician relationship, widen social disparities in health outcomes, and create barriers to access to health care. This paper seeks to identify the promise and pitfalls of electronic patient-physician communication before such technology becomes widely distributed. A research agenda is proposed that would provide data that are useful for careful shaping of the communications infrastructure. The paper addresses the need to 1) define appropriate use of the various modes of patient-physician communication, 2) ensure the security and confidentiality of patient information, 3) create user interfaces that guide patients in effective use of the technology, 4) proactively assess medicolegal liability, and 5) ensure access to the technology by a multicultural, multilingual population with varying degrees of literacy.

OBJECTIVES: To determine whether a Web-based educational intervention improves emergency physicians' knowledge about bioterrorism and to survey physicians' knowledge and sources of information on bioterrorism. METHODS: Prospective randomized controlled trial using pre- and postintervention testing in hospitals. Participants were general and pediatric emergency medicine attending physicians, fellows, and fourth-year emergency medicine residents. All participants completed a pretest and attended a lecture on bioterrorism. Participants were then randomized to the Web intervention group that received continuous access to a bioterrorism educational Web site with weekly exposure to case scenarios of diseases due to biological agents, or the control group. Participants were retested after one and six months and surveyed to identify their sources of information and assess their knowledge. RESULTS: Sixty-three physicians completed the pretest. There was no difference in mean +/- standard deviation (SD) pretest scores between Web intervention (45% +/- 10%) and control (44% +/- 10%) groups (mean difference: 1.9%; 95% confidence interval [CI] = -6.7% to 2.9%). There was no significant difference between pre- and posttest scores among groups at one month (Web intervention 48% +/- 10% vs. control 45% +/- 10%; mean difference: 3.3%; 95% CI = -8.5% to 2.0%) and six months (Web intervention 51% +/- 8% vs. control 47% +/- 9%; mean difference: 3.8%; 95% CI = -8.8% to 1.2%). More than 60% of physicians cited media reports as their primary source of information on bioterrorism and believed that their knowledge of bioterrorism was limited after one month. CONCLUSIONS: Providing physicians information on bioterrorism through simulated cases and continuous access to an educational Web site does not increase knowledge of bioterrorism. Physicians are more likely to use media reports for their primary source of information.

OBJECTIVE: The purpose of this study was to evaluate the effects on breastfeeding rates of a private-sector early discharge program and a subsequent government mandate guaranteeing 48 hours of hospital coverage. METHODS: Interrupted time-series analyses were conducted on retrospective data from the automated medical records of a large health maintenance organization in eastern Massachusetts. A population of 20 366 mother-infant pairs with normal vaginal deliveries between October 1990 and March 1998 was identified. This study period spanned the 2 interventions of interest: 1) the introduction of a new health maintenance organization protocol of 1 postpartum overnight hospitalization followed by a nurse home visit for normal vaginal deliveries, then 2) Massachusetts state minimum coverage legislation. Breastfeeding initiation and breastfeeding continuation among initiators (exclusive or with supplements) into the third month of life were determined through a text search of the first 90 days of infants' automated medical records. RESULTS: Both policies had dramatic impacts on length of stay (LOS); postpartum LOS 2 nights rose from 29% of pairs to 65% when the early discharge program was implemented, then fell to 15% after the state mandate. Breastfeeding initiation, however, rose gradually from 71% in the fourth quarter of 1990 to 82% in the first quarter of 1998, with no changes after the interventions. Continuation of breastfeeding among those who initiated remained constant at 73%. Younger maternal age, primiparity, low socioeconomic status, and nonwhite race all were found to be risk factors for lower rates of breastfeeding (either initiation or continuation), but there was no evidence of a decline in breastfeeding associated with shorter LOS among these vulnerable groups. CONCLUSIONS: Early postpartum discharge with outpatient breastfeeding support and a home visitor program has no adverse effects on initiation or continuation of breastfeeding.

BACKGROUND: Starting in the 2006/2007 influenza season, the US Advisory Committee on Immunization Practices expanded its recommendations for seasonal influenza vaccination to include healthy children aged 24-59 months. The parallel Canadian organization, the National Advisory Committee on Immunization, did not at that time issue a similar recommendation, thereby creating a natural experiment to evaluate the effect of the policy in the United States. METHODS: We examined data for 2000/2001 through 2008/2009 and estimated relative changes in visits to the emergency department for influenza-like illness at two pediatric hospitals, one in Boston, Massachusetts, and the other in Montreal, Quebec, following the US policy change. Models were adjusted for virologic factors, seasonal trends and all-cause utilization of the emergency department. RESULTS: Of 1 043 989 visits to the emergency departments of the two hospitals for any reason during the study period, 114 657 visits were related to influenza-like illness. Adjusted models estimated a 34% decline in rates of influenza-like illness among children two to four years old in the US hospital relative to the Canadian hospital (rate ratio 0.66, 95% confidence interval 0.58-0.75) following the 2006 policy change of the Advisory Committee on Immunization Practices. This was accompanied by more modest declines of 11% to 18% for the other age groups studied. INTERPRETATION: The divergence in influenza rates among children in the US and Canadian sample populations after institution of the US policy to vaccinate children two to four years of age is evidence that the recommendation of the US Advisory Committee on Immunization Practices resulted in a reduction in influenza-related morbidity in the target group and may have indirectly affected other pediatric age groups. Provincial adoption of the 2010 recommendation of the National Advisory Committee on Immunization in Canada to vaccinate children two to four years of age might positively affect influenza morbidity in Canada.

Although spatio-temporal patterns of influenza spread often suggest that environmental factors play a role, their effect on the geographical variation in the timing of annual epidemics has not been assessed. We examined the effect of solar radiation, dew point, temperature and geographical position on the city-specific timing of epidemics in the USA. Using paediatric in-patient data from hospitals in 35 cities for each influenza season in the study period 2000-2005, we determined 'epidemic timing' by identifying the week of peak influenza activity. For each city we calculated averages of daily climate measurements for 1 October to 31 December. Bayesian hierarchical models were used to assess the strength of association between each variable and epidemic timing. Of the climate variables only solar radiation was significantly related to epidemic timing (95% CI -0.027 to -0.0032). Future studies may elucidate biological mechanisms intrinsically linked to solar radiation that contribute to epidemic timing in temperate regions.