Adverse events related to unapproved stem cell products and other regenerative interventions: recommendations for more robust regulation of the direct-to-consumer marketplace

Tweetable abstract Adverse events continue to occur in the direct-to-consumer market for unapproved regenerative interventions and US FDA alone cannot adequately address the problem. Other public health strategies are needed to provide better patient protection.

Genetic testing—whether to allow complete freedom? Direct to consumer tests versus genetic tests for medical purposes

Direct-to-consumer tests opened the opportunity of genetic testing without medical supervision, e.g., without medical referral and medical interpretation of the results. Thus, these approaches allow for free access to information concerning individual genetic profile increasing the area of personal freedom, but also posing the risk of false (positive and negative) or misinterpreted results along with health and psychological negative consequences. The paper discusses medical and non-medical applications of DTC, exploring also the legal framework implemented by European states and organizations. These legal acts strive to control the developing DTC market through such basic principles as patient protection, informed consent, medical information confidentiality, and the rights to know and to refuse knowledge about one’s genetic predispositions.

General radiographic patient dose monitoring using conformity test data

Currently, the Nuclear Energy Supervisory Agency (BAPETEN) is actively guiding users or license holders related to patient protection against radiation hazards or often referred to as radiation protection and safety on medical exposure. Protection against medical exposure became a big issue when the mandatory compliance test on X-ray equipment for diagnostic and interventional radiology was introduced. In addition, license holders through their medical practitioners are also required to use the level of medical exposure guidelines. While PERKA BAPETEN No. 9, 2011 concerning the Suitability Test of Diagnostic and Interventional Radiology X-Ray device, states that one of the test parameters that directly affect the patient's radiation dose and determine the feasibility of operating the X-Ray device to the patient is information on the dose or rate of radiation dose received by the patient. Monitoring doses with Entrance Surface Air Kerma (ESAK) or what is often referred to as ESD (entrance surface dose) using suitability conformity test data starting from 50,60,70,80,90 and 100 kVp with 20 mAs at SID 100 meters. The results of the research on the value of ESAK was 0.049 mGy, an ESAK value that still met the national I-DRL value from BAPETEN Regulation No. 1211/K/V/2021.

Unmet Healthcare Need Due to Cost Concerns among U.S. Transgender and Gender-Expansive Adults: Results from a National Survey

This study examines past-year unmet healthcare need due to cost experienced by transgender and gender-expansive (TGE) adults in the United States in the context of the Patient Protection and Affordable Care Act (ACA). It also aims to estimate the importance of having health insurance among TGE Americans (transgender men, transgender women, nonbinary/genderqueer people, and cross-dressers). Data were from the 2015 U.S. Transgender Survey (N = 19,157 adults, aged 25 to 64 years). Multivariable logistic regression models were used to determine the adjusted odds ratios (AOR) and 95 percent confidence intervals (CI) of TGE individuals’ past-year unmet healthcare need due to cost. Although the majority (86.8 percent) reported seeing a doctor or healthcare provider in the past year, 32.1 percent reported past-year unmet healthcare need due to cost. One in six respondents (17.1 percent) was uninsured and almost one-third (29.8 percent) were at/near poverty. The prevalence of unmet healthcare need was greater among the uninsured (65.1 percent) than among the insured (25.2 percent). Compared with transgender women, nonbinary/genderqueer people (AOR = 1.31, 95% CI [1.18, 1.46]) and transgender men (AOR = 1.30, 95% CI [1.18, 1.42]) had greater odds of unmet healthcare need due to cost. Social workers can lobby to fully enact the ACA by underscoring affordability and availability as important dimensions of healthcare access for TGE populations.

In the Pursuit of Privacy: The Promises and Predicaments of Federated Learning in Healthcare

Artificial Intelligence and its subdomain, Machine Learning (ML), have shown the potential to make an unprecedented impact in healthcare. Federated Learning (FL) has been introduced to alleviate some of the limitations of ML, particularly the capability to train on larger datasets for improved performance, which is usually cumbersome for an inter-institutional collaboration due to existing patient protection laws and regulations. Moreover, FL may also play a crucial role in circumventing ML’s exigent bias problem by accessing underrepresented groups’ data spanning geographically distributed locations. In this paper, we have discussed three FL challenges, namely: privacy of the model exchange, ethical perspectives, and legal considerations. Lastly, we have proposed a model that could aide in assessing data contributions of a FL implementation. In light of the expediency and adaptability of using the Sørensen–Dice Coefficient over the more limited (e.g., horizontal FL) and computationally expensive Shapley Values, we sought to demonstrate a new paradigm that we hope, will become invaluable for sharing any profit and responsibilities that may accompany a FL endeavor.

Venom Immunotherapy: From Proteins to Product to Patient Protection

In this review, we outline and reflect on the important differences between allergen-specific immunotherapy for inhalant allergies (i.e., aeroallergens) and venom-specific immunotherapy (VIT), with a special focus on Venomil® Bee and Wasp. Venomil® is provided as a freeze-dried extract and a diluent to prepare a solution for injection for the treatment of patients with IgE-mediated allergies to bee and/or wasp venom and for evaluating the degree of sensitivity in a skin test. While the materials that make up the product have not changed, the suppliers of raw materials have changed over the years. Here, we consolidate relevant historical safety and efficacy studies that used products from shared manufacture supply profiles, i.e., products from Bayer or Hollister–Stier. We also consider the characterization and standardization of venom marker allergens, providing insights into manufacturing controls that have produced stable and consistent quality profiles over many years. Quality differences between products and their impacts on treatment outcomes have been a current topic of discussion and further research. Finally, we review the considerations surrounding the choice of depot adjuvant most suitable to augmenting VIT.

Analysis of Average Glandular Dose (AGD) and Associated Parameters for Conventional and Digital X-Ray Mammography

In this study, we determined the average glandular dose (AGD) from the craniocaudal (CC) and mediolateral oblique (MLO) views of 496 breasts (247 women) at eight clinics in Sudan. The incident air kerma from the X-ray tube output values and typical patient-specific breast exposure factors were measured. AGD values were inferred from the measured incident air kerma and breast-specific dose conversion coefficients. The AGD per CC and MLO projection and per woman ranged from 0.34–5.3 mGy (average: 2.46), 0.29–3.39 mGy (average: 1.50), and 0.6–7.4 mGy (average: 3.95). The proposed national diagnostic reference levels (mGy) are 3.48, 2.03, and 6.44 mGy for CC, MLO, and per woman, respectively. Establishing the proposed diagnostic reference levels is an essential step in ensuring patient protection from radiation and will help promote dose optimization for X-ray mammography at the national levels and beyond. The results provide important baseline data that can be used to formulate the national diagnostic reference levels.

Behavior of Children during Dental Care with Rubber Dam Isolation: A Randomized Controlled Study

Background: The establishment of the dental dam improves dentist working conditions and patient protection. The purpose of this study was to analyze the behavior of the child during dental care with or without a dam. Methods: In this interventional randomized study, 51 patients are divided into two groups, one with a rubber dam and the other with cotton roll isolation. Their behavior was observed during the treatment of temporary molars. The duration of the treatment, the patient’s feeling with a visual analogue scale (VAS), the behavior (B) of the child measured with a hetero-evaluation scale (modified Venham scale) and the cardiac frequency (CF) were measured. Results: The group treated with a rubber dam has a significant decrease in the various stress parameters that have been identified (B, p value = 0.034; CF, p value = 0.015). Subgroups of patients with and without nitrous oxide sedation were compared and similar results were obtained. Conclusions: Isolation with a rubber dam reduces child’s stress during dental care. Although it is slightly more time-consuming and training is necessary for a quick and effective placement, it allows dentists to perform dental care in the best possible conditions, while reducing dental anxiety in young patients.