Rescuing human fetal tissue research in the United States: A call for additional regulatory reform.
Ontology highlight
ABSTRACT:
SUBMITTER: MacDuffie KE
PROVIDER: S-EPMC8693650 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:: Colorectal cancer has the second highest cancer-related mortality rate, with an estimated 881,000 deaths worldwide in 2018. The urgent need to reduce the incidence and mortality rate requires innovative strategies to improve prevention, early diagnosis, prognostic biomarkers, and treatment effectiveness. Caloric restriction (CR) is known as the most robust nutritional intervention that extends lifespan and delays the progression of age-related diseases, with remarkable results for cancer protection. Other forms of energy restriction, such as periodic fasting, intermittent fasting, or fasting-mimicking diets, with or without reduction of total calorie intake, recapitulate the effects of chronic CR and confer a wide range of beneficial effects towards health and survival, including anti-cancer properties. In this review, the known molecular, cellular, and organismal effects of energy restriction in oncology will be discussed. Energy-restriction-based strategies implemented in colorectal models and clinical trials will be also revised. While energy restriction constitutes a promising intervention for the prevention and treatment of several malignant neoplasms, further investigations are essential to dissect the interplay between fundamental aspects of energy intake, such as feeding patterns, fasting length, or diet composition, with all of them influencing health and disease or cancer effects. Currently, effectiveness, safety, and practicability of different forms of fasting to fight cancer, particularly colorectal cancer, should still be contemplated with caution.
| S-EPMC7019819 | biostudies-literature
Project description:Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and "more than minimally manipulated" human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as "minimally manipulated tissue" and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
| S-EPMC8016716 | biostudies-literature
Project description:Interprofessional education (IPE) and collaborative practice (CP) have been prolific areas of inquiry exploring research questions mostly concerned with local program and project assessment. The actual sphere of influence of this research has been limited. Often discussed separately, this article places IPE and CP in the same conceptual space. The interface of these form a nexus where new knowledge creation may be facilitated. Rigorous research on IPE in relation to CP that is relevant to and framed by health system reform in the U.S. is the ultimate research goal of the National Center for Interprofessional Practice and Education at the University of Minnesota. This paper describes the direction and scope for a focused and purposive IPECP research agenda linked to improvement in health outcomes, contextualized by health care reform in the U.S. that has provided a revitalizing energy for this area of inquiry. A research agenda articulates a focus, meaningful and robust questions, and a theory of change within which intervention outcomes are examined. Further, a research agenda identifies the practices the area of inquiry is interested in informing, and the types of study designs and analytic approaches amenable to carrying out the proposed work.
| S-EPMC4776700 | biostudies-other
Project description:Background and objectives: Peritoneal dialysis (PD) for ESKD is associated with similar mortality, higher quality of life, and lower costs compared with hemodialysis (HD), but has historically been underused. We assessed the effect of the 2011 Medicare prospective payment system (PPS) for dialysis on PD initiation, modality switches, and stable PD use.Design, setting, participants, & measurements: Using US Renal Data System and Medicare data, we identified all United States patients with ESKD initiating dialysis before (2006-2010) and after (2011-2013) PPS implementation, and observed their modality for up to 2 years after dialysis initiation. Using logistic regression models, we examined the associations between PPS and early PD experience (any PD 1-90 days after initiation), late PD use (any PD 91-730 days after initiation), and modality switches (PD-to-HD or HD-to-PD 91-730 days after initiation). We adjusted for patient, dialysis facility, and regional characteristics.Results: Overall, 619,126 patients with incident ESKD received dialysis at Medicare-certified facilities, 2006-2013. Observed early PD experience increased from 9.4% before PPS to 12.6% after PPS. Observed late PD use increased from 12.1% to 16.1%. In adjusted analyses, PPS was associated with increased early PD experience (odds ratio [OR], 1.51; 95% confidence interval [95% CI], 1.47 to 1.55; P<0.001) and late PD use (OR, 1.47; 95% CI, 1.45 to 1.50; P<0.001). In subgroup analyses, late PD use increased in part due to an increase in HD-to-PD switches among those without early PD experience (OR, 1.59; 95% CI, 1.52 to 1.66; P<0.001) and a decrease in PD-to-HD switches among those with early PD experience (OR, 0.92; 95% CI, 0.87 to 0.98; P=0.004).Conclusions: More patients started, stayed on, and switched to PD after dialysis payment reform. This occurred without a substantial increase in transfers to HD.
| S-EPMC6895485 | biostudies-literature
Project description:IntroductionReduction in health inequalities and providing universal access to health care have been identified as two important global milestones by the World Health Organization for countries to achieve by 2030. Therefore, recognizing the magnitude of oral health inequalities in India has become a pressing priority to improve access to dental care within the country. This scoping review was conducted with the aim of reviewing, collating and analysing the current knowledge base on oral health inequalities in India.MethodologyThe scoping review followed Arksey and O'Malley's approach, and reporting was performed in accordance with the PRISMA-ScR guidelines. A systematic search was conducted on Scopus, PubMed, Web of Science, and EMBASE to identify literature addressing one or more dimensions of oral health inequalities in India, published in English between January 2002 and April 2022. The data were charted, and qualitative analysis was performed to derive themes, highlighting the key concepts emerging from this review.ResultsIn accordance with the eligibility criteria, a total of 71 articles retrieved through database search and backward citation search were included in this scoping review. The major themes ranged from individual to diverse sociodemographic factors acting as barriers to and facilitators of access to dental care. Deficiencies in human resources for oral health, along with a wide diversity in dental service provision and dental education were other major themes contributing to inequality. Subsequently, this has resulted in recommendations on restructuring the dental workforce and their development and modifications in oral health care policies and practices. The qualitative synthesis demonstrates the intertwined nature of the multiple factors that influence the goal of achieving an affordable, accessible, extensive and inclusive oral healthcare system in India.ConclusionsThis comprehensive review provides a broad perspective on oral health inequalities in India, providing valuable insights for both researchers and policymakers in this area and guiding their efforts towards achieving universal oral health coverage in the Indian context.
| S-EPMC10664303 | biostudies-literature
Project description:Background and objectivesSarcomas represent a heterogeneous group of tumors, and there is lack of data describing contemporary changes in patterns of care. We evaluated the epidemiology of sarcomas over 12 recent years.MethodsThe Surveillance, Epidemiology and End Results (SEER) database was queried for sarcoma cases from 2002-2014. Patient, tumor and treatment factors, and trends over time were studied overall and by subtype. Univariable and multivariable logistic regression models and 5-year survival and cause-specific mortality (CSM) were summarized.ResultsThere were 78,527 cases of sarcomas with an overall incidence of 7.1 cases per 100,000 people, increasing from 6.8 in 2002 to 7.7 in 2014. Sarcoma NOS(14.8%) and soft tissue(43.4%) were the most common histology and primary site, respectively. A majority of tumors were high-grade(33.6%) and >5 cm(51.3%). CSM was 28.6% and 5-year survival was 71.4%. Many patients had unknown-grade(42.2%), which associated with 2.6 times increased odds of no surgical intervention.ConclusionsThis comprehensive national study highlights important trends including increasing incidence, changing histologic types, and underestimation of true incidence. A large proportion of sarcomas are inadequately staged (unknown-grade 42.2%) with lack of appropriate surgical treatment. Our study highlights need for standardization of care for sarcomas.
| S-EPMC6497437 | biostudies-literature
Project description:Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10-6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.
| S-EPMC6140579 | biostudies-literature
Project description: Not available
| S-EPMC6467299 | biostudies-literature
Project description: Not available
| S-EPMC10840109 | biostudies-literature
Project description:Tea is a steeped beverage made from the leaves of Camellia sinensis. Globally, this healthy, caffeine-containing drink is one of the most widely consumed beverages. At least 50 countries produce tea and most of the production information and tea research is derived from international sources. Here, we discuss information related to tea production, genetics, and chemistry as well as production issues that affect or are likely to affect emerging tea production and research in the United States. With this review, we relay current knowledge on tea production, threats to tea production, and solutions to production problems to inform this emerging market in the United States.
| S-EPMC9538180 | biostudies-literature