Patients frequently present to multiple hospitals for acute care visits, resulting in incomplete medical records at any given site, and placing patients at risk for poor quality of care. Our objective was to determine the number of patients presenting for their acute care needs across multiple hospitals in Massachusetts over a three year period. There were 665,481 adult patients who presented to a median of 2 different hospitals (range 2-55) in the course of the study period. Integration of medical information across sites, such as through personally controlled health records, could improve the availability of medical information across sites of care.

BACKGROUND: The development of health information technologies should be informed by iterative experiments in which qualitative and quantitative methodologies provide a deeper understanding of the abilities, needs, and goals of the target audience for a personal health application. OBJECTIVE: Our objective was to create an interface for parents of children with attention-deficit hyperactivity/disorder (ADHD) to enter disease-specific information to facilitate data entry with minimal task burden. METHODS: We developed an ADHD-specific personal health application to support data entry into a personally controlled health record (PCHR) using a three-step, iterative process: (1) a needs analysis by conducting focus groups with parents of children with ADHD and an heuristic evaluation of a prerelease version of a PCHR, (2) usability testing of an initial prototype personal health application following a "think aloud" protocol, (3) performance testing of a revised prototype, and (4) finalizing the design and functionality of the ADHD personal health application. Study populations for the three studies (focus groups and two usability testing studies) were recruited from organizations in the greater Boston area. Study eligibility included being an English- or Spanish-speaking parent who was the primary caretaker of a school-age child with ADHD. We determined subjects' health literacy using the Test of Functional Health Literacy in Adults (TOFHLA). We assessed subjects' task burden using the National Aeronautics and Space Administration (NASA) Task Load Index. To assess the impact of factors associated with the time spent entering data, we calculated Pearson correlation coefficients (r) between time on task and both task burden and subject characteristics. We conducted t tests to determine if time on task was associated with successful task completion. RESULTS: The focus groups included three cohorts: 4 Spanish-speaking parents with diverse health literacy, 4 English-speaking parents with lower health literacy, and 7 English-speaking parents with higher health literacy. Both the initial usability testing cohort (n = 10) and the performance-testing cohort (n = 7) included parents of diverse health literacy and ethnicity. In performance testing, the prototype PCHRs captured patient-specific data with a mean time on task of 11.9 minutes (SD 6.5). Task burden experienced during data entry was not associated with successful task completion (P = .92). Subjects' past computer experience was highly correlated with time on task (r = .86, P = .01), but not with task burden (r = .18, P = .69). The ADHD personal health application was finalized in response to these results by (1) simplifying the visual environment, (2) including items to support users limited by health literacy or technology experience, and (3) populating the application's welcome screen with pictures of culturally diverse families to establish a personal family-oriented look and feel. CONCLUSIONS: Our patient-centered design process produced a usable ADHD-specific personal health application that minimizes the burden of data entry.

IMPORTANCE: Surveillance systems for elucidating the burden of hypoglycemia are limited. OBJECTIVE: To quantify experiences of hypoglycemia and related harms, members of an international online diabetes social network with insulin-dependent diabetes mellitus were polled through a software application ("app"). Aggregate results were returned to participants through network channels. DESIGN: The study period was from March 2011 through April 2012, during which time retrospective reports about experiences with hypoglycemia and related harms were collected from participants using the app. SETTING: The study was undertaken within the TuDiabetes.org international online diabetes social network. PARTICIPANTS: Eligibility criteria included TuDiabetes membership, age 13 years or older, a self-reported diagnosis of diabetes mellitus, ability to read and write English, and Internet access. Of 2827 app users, 687 (response rate, 24.3%) opted in to the volunteer sample. MAIN OUTCOME MEASURES: Primary outcomes included the following: frequency of "going low" (having a low glucose value in the past 2 weeks) and episodes of severe hypoglycemia (in the past 12 months), and, for respondents reporting recent and/or severe hypoglycemia, lifetime experience of vehicle crashes or severe medical injury, daily debilitating worry, and withdrawal from driving, exercise, sex, and going outside of the home to avoid hypoglycemia and consequences. Secondary outcomes included measures of research engagement. RESULTS: Of 613 respondents (24.3% of app users), 49.1% reported more than 4 episodes of "going low" in the past 2 weeks and 29.2% reported 1 or more severe low in the past year; 16.6% reported both more than 4 recent low episodes and 1 or more severe event in the past year. Harms were common, including daily debilitating worry (45.8%), vehicle crash or injury (15.0%), and withdrawal from exercise, driving, leaving home, and having sex (54.0%, 37.4%, 24.8%, and 22.7%, respectively). Of all respondents, 54.2% reported multiple harms, the risks for which were highest (73.7%) among respondents with a past-year severe event (odds ratio, 2.39; 95% CI, 1.60-3.58; P .001 controlling for frequent recent low episodes and demographic and disease factors). Engagement was high, with 96.6% of the sample permitting recontact for research and 31.7% posting personal study data on their app profile page; 40.5% of 2825 unique page views of research-related materials published on the community site involved views of returned research results. CONCLUSIONS AND RELEVANCE: Participatory surveillance of hypoglycemia in an online diabetes social network enables characterization of patient-centered harms in a community sample and bidirectional communication with affected persons, augmenting traditional surveillance.

BACKGROUND AND OBJECTIVE: Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events. METHODS: Participatory surveillance of members of a non-profit online social network, TuDiabetes.org, from October 2011 to September 2012. Subjects were volunteers from a group within TuDiabetes, actively engaged online in participatory surveillance. They used the free TuAnalyze app, a privacy-preserving method to report detailed clinical information, available through the network. Network members were polled about finger-stick blood glucose monitors, continuous glucose monitors, and insulin delivery devices, including insulin pumps and insulin pens. RESULTS: Of 549 participants, 75 reported device-related adverse events, nearly half (48.0%) requiring intervention from another person to manage the event. Only three (4.0%) of these were reported by participants to the FDA. All TuAnalyze reports contained outcome information compared with 22% of reports to the FDA. Hypoglycemia and hyperglycemia were experienced by 48.0% and 49.3% of participants, respectively. DISCUSSION: Members of an online community readily engaged in participatory surveillance. While polling distributed online populations does not yield generalizable, denominator-based rates, this approach can characterize risk within online communities using a bidirectional communication channel that enables reach-back and intervention. CONCLUSIONS: Engagement of distributed communities in social networks is a viable complementary approach to traditional public health surveillance for adverse events related to medical devices.

STUDY OBJECTIVES: We assessed the validity and completeness of data in the past medical history (PMH) obtained electronically from parents and examined effects of the human-computer interface and sociodemographic variables on electronic parental report. METHODS: We compared parents' electronic report of PMH data with a criterion standard, structured face-to-face interview by a pediatrician blinded to the electronic data. The electronic medical record interface enabled parents to provide 5 elements of the PMH: birth status, allergies, current medications, immunization status, and previous hospitalizations. The setting was the emergency department waiting room in an academic, urban children's hospital; parents of infants up to 12 months old participated. Outcome measures were validity of the PMH data obtained using the electronic medical record interface and odds of having an invalid or incomplete response using the electronic medical record interface. RESULTS: One hundred parents were enrolled (69.4% of eligible subjects). Study subjects did not differ from nonenrollees on demographic variables and visit characteristics. The validity of the electronic medical record interface data was high across the PMH elements (94% to 99%). Two demographic features predicted invalid response: parental primary language other than English or Spanish (odds ratio [OR] 11.4, 95% confidence interval CI 1.7 to 76.3), and Asian ethnicity (OR 14. 6, 95% CI 1.2 to 182.4). Incomplete responses were predicted by limited previous experience with computers; computer-naive subjects had an eightfold increased odds of skipping a question (OR 7.9, 95% CI 1.8 to 34.6). CONCLUSION: Parents are accurate independent reporters of their infants' general PMH using the electronic medical record interface. Their participation in care may be enhanced by allowing them to contribute medical information directly to the electronic medical record.

BACKGROUND: A quasi-experimental intervention study composed of control and intervention periods was conducted to determine if a parent-driven health information technology influenced completeness of documentation and adherence to evidence-based emergency care for children. METHODS: Structured chart abstraction was used to assess documentation and correctness of clinical actions at test ordering, medication prescribed for disease, and medication ordered for pain in a tertiary care pediatric emergency department and a suburban general emergency department. During the intervention periods, parents of children who presented with complaints related to otitis media, urinary tract infection, head trauma, or asthma entered data into a health information technology (ParentLink), which produced treatment plans in the context of evidence-based guidelines. RESULTS: Of 1,410 subjects analyzed, 1,072 (76%) were assigned to one of four disease categories: urinary tract infection (22%), otitis media (20%), asthma (11%) and head trauma (47%). During ParentLink use, documentation of pain significantly improved (28% incomplete [control] versus 15% [intervention], p = .003). Incorrect actions for pain treatment decreased, but not significantly (33% [control] versus 24% [intervention], p = .13). ParentLink did not influence actions for test ordering or prescribing for disease. DISCUSSION: Parent-driven health information technology intended to translate parents' knowledge into clinical practice and to support evidence-based care suggested a trend toward modest impact on pain management but did not demonstrate broad effects across diseases or care processes. The emergence and proliferation of personally controlled health records (PCHRs) presents opportunities for patients and parents to control their medical profiles. Although ParentLink is not a comprehensive PCHR, it represents a step in incorporating parent-derived information into medical decision making.

Patient controlled health records(PCHRs) provide widespread and flexible access to integrated medical information. Unique legal challenges arise where the patient is a minor. Variations in laws and statutes concerning minor's rights to privacy and confidentiality, and institutions' local interpretations of them, need to be integrated in the principles governing PCHRs. We propose a legal framework to guide the development of access policies for PCHRs to ensure appropriate privacy and confidentiality protection surrounding minors.

BACKGROUND: Recent withdrawals of major drugs have highlighted the critical importance of drug safety surveillance in the postmarketing phase. Limitations of spontaneous report data have led drug safety professionals to pursue alternative postmarketing surveillance approaches based on healthcare administrative claims data. These data are typically analysed by comparing the adverse event rates associated with a drug of interest to those of a single comparable reference drug. OBJECTIVE: The aim of this study was to determine whether adverse event detection can be improved by incorporating information from multiple reference drugs. We developed a pharmacological network model that implemented this approach and evaluated its performance. METHODS: We studied whether adverse event detection can be improved by incorporating information from multiple reference drugs, and describe two approaches for doing so. The first, reported previously, combines a set of related drugs into a single reference cohort. The second is a novel pharmacoepidemiological network model, which integrates multiple pair-wise comparisons across an entire set of related drugs into a unified consensus safety score for each drug. We also implemented a single reference drug approach for comparison with both multi-drug approaches. All approaches were applied within a sequential analysis framework, incorporating new information as it became available and addressing the issue of multiple testing over time. We evaluated all these approaches using statin (HMG-CoA reductase inhibitors) safety data from a large healthcare insurer in the US covering April 2000 through March 2005. RESULTS: We found that both multiple reference drug approaches offer earlier detection (6-13 months) than the single reference drug approach, without triggering additional false positives. CONCLUSIONS: Such combined approaches have the potential to be used with existing healthcare databases to improve the surveillance of therapeutics in the postmarketing phase over single-comparator methods. The proposed network approach also provides an integrated visualization framework enabling decision makers to understand the key high-level safety relationships amongst a group of related drugs.

BACKGROUND: Clinical trial registries are in widespread use to promote transparency around trials and their results. OBJECTIVE: To describe characteristics of drug trials listed in ClinicalTrials.gov and examine whether the funding source of these trials is associated with favorable published outcomes. DESIGN: An observational study of safety and efficacy trials for anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006. SETTING: ClinicalTrials.gov, a Web-based registry of clinical trials launched in 1999. MEASUREMENTS: Publications resulting from the trials for the 5 drug categories of interest were identified, and data were abstracted on the trial record and publication, including timing of registration, elements of the study design, funding source, publication date, and study outcomes. Assessments were based on the primary funding categories of industry, government agencies, and nonprofit or nonfederal organizations. RESULTS: Among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations. Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; P 0.001 across groups), to use an active comparator in controlled trials (36.8%; P = 0.010 across groups), to be multicenter (89.0%; P 0.001 across groups), and to enroll more participants (median sample size, 306 participants; P 0.001 across groups). Overall, 362 (66.3%) trials had published results. Industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organization-funded trials (P 0.001). Trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%; P = 0.013). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials to 56.2% among nonprofit or nonfederal organization-funded trials without industry contributions (P = 0.005 across groups). LIMITATIONS: The publication status of a trial could not always be confirmed, which could result in misclassification. Additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting. CONCLUSION: In this sample of registered drug trials, those funded by industry were less likely to be published within 2 years of study completion and were more likely to report positive outcomes than were trials funded by other sources. PRIMARY FUNDING SOURCE: National Library of Medicine and National Institute of Child Health and Human Development, National Institutes of Health.