Content Uniformity of Over-the-Counter Melatonin

Dietary supplements are loosely regulated in comparison to over-the-counter and prescription drugs. Numerous tests for safety and efficacy are required before drugs can be marketed. However, the Food and Drug Administration does not require thorough examination of supplements before they are sold. Dietary supplements generally adhere to the phrase, “safe, until proven unsafe,” with safety determined solely through post-market adverse event reports. Substandard regulation of supplement manufacturing leads to warranted doubt about the safety and efficacy of dietary supplements. Within the dietary supplement market there are regulatory bodies, such as the United States Pharmacopeia (USP), that provide optional verification services to manufacturers. If utilized, these regulatory bodies ensure that manufacturers meet specific standards in regard to Current Good Manufacturing Practices (cGMP), purity of ingredients, and overall integrity of their product. Numerous studies have revealed a history of inaccuracies in supplement product labeling. Researchers conducting these studies consistently conclude that there is a need for stricter regulation and finer application of cGMP within supplement manufacturing companies. One of the most popular dietary supplements on the market, melatonin, has been the focus in a number of studies evaluating supplement product content integrity. Melatonin is commonly used to treat insomnia and to cure symptoms of jet lag. According to past research, these melatonin products often contain an amount of active ingredient that significantly differs from respective product labeling. Most research regarding melatonin product integrity has occurred outside of the past ten years, leaving the need for newer research. Melatonin 3 mg will be purchased from six different manufacturers with three manufacturers possessing USP verification. Within each manufacturer, melatonin 3 mg from five separate lot numbers will be purchased. Ten tablets from each bottle (totaling 300 tablets) will be analyzed using a high-pressure liquid chromatography machine in order to determine actual melatonin content in each tablet. Data will be recorded and compared to determine accuracy of product labeling and batch-to-batch content uniformity. Data from USP-verified melatonin will be compared with non-verified products in order to determine if regulatory body verification is effective at improving content uniformity

Clinician Burnout and Satisfaction with Resources in Caring for Complex Patients

Objective: To describe primary care clinicians\u27 self-reported satisfaction, burnout and barriers for treating complex patients. Methods: We conducted a survey of 1554 primary care clinicians in 172 primary care clinics in 18 health care systems across 8 states prior to the implementation of a collaborative model of care for patients with depression and diabetes and/or cardiovascular disease. Results: Of the clinicians who responded to the survey (n=709; 46%), we found that a substantial minority (31%) were experiencing burnout that was associated with lower career satisfaction (P\u3c.0001) and lower satisfaction with resources to treat complex patients (P\u3c.0001). Less than 50% of clinicians rated their ability to treat complex patients as very good to excellent with 21% rating their ability as fair to poor. The majority of clinicians (72%) thought that a collaborative model of care would be very helpful for treating complex patients. Conclusions: Burnout remains a problem for primary care clinicians and is associated with low job satisfaction and low satisfaction with resources to treat complex patients. A collaborative care model for patients with mental and physical health problems may provide the resources needed to improve the quality of care for these patients

Predicting suicide attempts and suicide deaths among adolescents following outpatient visits

BACKGROUND: Few studies report on machine learning models for suicide risk prediction in adolescents and their utility in identifying those in need of further evaluation. This study examined whether a model trained and validated using data from all age groups works as well for adolescents or whether it could be improved. METHODS: We used healthcare data for 1.4 million specialty mental health and primary care outpatient visits among 256,823 adolescents across 7 health systems. The prediction target was 90-day risk of suicide attempt following a visit. We used logistic regression with least absolute shrinkage and selection operator (LASSO) and generalized estimating equations (GEE) to predict risk. We compared performance of three models: an existing model, a recalibrated version of that model, and a newly-learned model. Models were compared using area under the receiver operating curve (AUC), sensitivity, specificity, positive predictive value and negative predictive value. RESULTS: The AUC produced by the existing model for specialty mental health visits estimated in adolescents alone (0.796; [0.789, 0.802]) was not significantly different than the AUC of the recalibrated existing model (0.794; [0.787, 0.80]) or the newly-learned model (0.795; [0.789, 0.801]). Predicted risk following primary care visits was also similar: existing (0.855; [0.844, 0.866]), recalibrated (0.85 [0.839, 0.862]), newly-learned (0.842, [0.829, 0.854]). LIMITATIONS: The models did not incorporate non-healthcare risk factors. The models relied on ICD9-CM codes for diagnoses and outcome measurement. CONCLUSIONS: Prediction models already in operational use by health systems can be reliably employed for identifying adolescents in need of further evaluation

Pandemic Strain of Foot-and-Mouth Disease Virus Serotype O

The PanAsia strain is spreading explosively in Asia and extending to parts of Africa and Europe

Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study

<p>Abstract</p> <p>Background</p> <p>Data protection is important for all information systems that deal with human-subjects data. Grid-based systems – such as the cancer Biomedical Informatics Grid (caBIG) – seek to develop new mechanisms to facilitate real-time federation of cancer-relevant data sources, including sources protected under a variety of regulatory laws, such as HIPAA and 21CFR11. These systems embody new models for data sharing, and hence pose new challenges to the regulatory community, and to those who would develop or adopt them. These challenges must be understood by both systems developers and system adopters. In this paper, we describe our work collecting policy statements, expectations, and requirements from regulatory decision makers at academic cancer centers in the United States. We use these statements to examine fundamental assumptions regarding data sharing using data federations and grid computing.</p> <p>Methods</p> <p>An interview-based study of key stakeholders from a sample of US cancer centers. Interviews were structured, and used an instrument that was developed for the purpose of this study. The instrument included a set of problem scenarios – difficult policy situations that were derived during a full-day discussion of potentially problematic issues by a set of project participants with diverse expertise. Each problem scenario included a set of open-ended questions that were designed to elucidate stakeholder opinions and concerns. Interviews were transcribed verbatim and used for both qualitative and quantitative analysis. For quantitative analysis, data was aggregated at the individual or institutional unit of analysis, depending on the specific interview question.</p> <p>Results</p> <p>Thirty-one (31) individuals at six cancer centers were contacted to participate. Twenty-four out of thirty-one (24/31) individuals responded to our request- yielding a total response rate of 77%. Respondents included IRB directors and policy-makers, privacy and security officers, directors of offices of research, information security officers and university legal counsel. Nineteen total interviews were conducted over a period of 16 weeks. Respondents provided answers for all four scenarios (a total of 87 questions). Results were grouped by broad themes, including among others: governance, legal and financial issues, partnership agreements, de-identification, institutional technical infrastructure for security and privacy protection, training, risk management, auditing, IRB issues, and patient/subject consent.</p> <p>Conclusion</p> <p>The findings suggest that with additional work, large scale federated sharing of data within a regulated environment is possible. A key challenge is developing suitable models for authentication and authorization practices within a federated environment. Authentication – the recognition and validation of a person's identity – is in fact a global property of such systems, while authorization – the permission to access data or resources – mimics data sharing agreements in being best served at a local level. Nine specific recommendations result from the work and are discussed in detail. These include: (1) the necessity to construct separate legal or corporate entities for governance of federated sharing initiatives on this scale; (2) consensus on the treatment of foreign and commercial partnerships; (3) the development of risk models and risk management processes; (4) development of technical infrastructure to support the credentialing process associated with research including human subjects; (5) exploring the feasibility of developing large-scale, federated honest broker approaches; (6) the development of suitable, federated identity provisioning processes to support federated authentication and authorization; (7) community development of requisite HIPAA and research ethics training modules by federation members; (8) the recognition of the need for central auditing requirements and authority, and; (9) use of two-protocol data exchange models where possible in the federation.</p

Housing Affordability, Tenure and Mental Health in Australia and the United Kingdom: A Comparative Panel Analysis

The paper contributes insights into the role of tenure in modifying the relationship between housing affordability and health, using a cross-national comparison of similar post-industrial nations ? Australia and the United Kingdom ? with different tenure structures. The paper utilises longitudinal data from the Household, Income and Labour Dynamics in Australia Survey (HILDA) and British Household Panel Survey (BHPS) to examine change in the mental health of individuals associated with housing becoming unaffordable and considers modification by tenure. We present evidence that the role of tenure in the relationship between housing and health is context dependent and should not be unthinkingly generalised across nations. These findings suggest that the UK housing context offers a greater level of protection to tenants living in unaffordable housing when compared with Australia, and this finds expression in the mental health of the two populations. We conclude that Australian governments could improve the mental health of their economically vulnerable populations through more supportive housing policies

Combined tumor plus nontumor interim FDG‐PET parameters are prognostic for response to chemoradiation in squamous cell esophageal cancer

We have investigated the prognostic value of two novel interim F-18-fluorodeoxyglucose positron emission tomography (FDG-PET) parameters in patients undergoing chemoradiation (CRT) for esophageal squamous cell carcinoma (ESCC): one tumor parameter (maximal standardized uptake ratio rSUR) and one normal tissue parameter (change of FDG uptake within irradiated nontumor-affected esophagus increment SUVNTO). PET data of 134 European and Chinese patients were analyzed. Parameter establishment was based on 36 patients undergoing preoperative CRT plus surgery, validation was performed in 98 patients receiving definitive CRT. Patients received PET imaging prior and during fourth week of CRT. Clinical parameters, baseline PET parameters, and interim PET parameters (rSUR and increment SUVNTO) were analyzed and compared to event-free survival (EFS), overall survival (OS), loco-regional control (LRC) and freedom from distant metastases (FFDM). Combining rSUR and increment SUVNTO revealed a strong prognostic impact on EFS, OS, LRC and FFDM in patients undergoing preoperative CRT. In the definitive CRT cohort, univariate analysis with respect to EFS revealed several staging plus both previously established interim PET parameters as significant prognostic factors. Multivariate analyses revealed only rSUR and increment SUVNTO as independent prognostic factors (p = 0.003, p = 0.008). Combination of these parameters with the cutoff established in preoperative CRT revealed excellent discrimination of patients with a long or short EFS (73% vs. 17% at 2 years, respectively) and significantly discriminated all other endpoints (OS, p < 0.001; LRC, p < 0.001; FFDM, p = 0.02), even in subgroups. Combined use of interim FDG-PET derived parameters increment SUVNTO and rSUR seems to have predictive potential, allowing to select responders for definitive CRT and omission of surgery