Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Ovine Iliac Vein Model for Endovascular Thrombectomy of Acute Deep Venous Thrombosis

An ovine iliac vein thrombosis model was devised to test a wall-contacting rotational thrombectomy device. Thrombosis was successfully induced in 9 sheep with an average clot length of 31 mm ± 12 and >60% vessel occlusion on angiography. The thrombus was subsequently removed, maintaining normal intraoperative pulmonary arterial pressure (5.9 mm Hg ± 3.6) and complete distal reperfusion after thrombectomy. Additionally, the sheep were without signs of vascular trauma or embolic complications on gross necropsy and histopathologic analysis. The findings from this study support the use of an ovine iliac deep vein thrombosis model for testing of a lower extremity thrombectomy device.     

Evaluating a Food Pantry–Based Intervention to Improve Food Security,Dietary Intake,and Quality in Midwestern Food Pantries

BackgroundVoices for Food was a longitudinal community, food pantry–based intervention informed by the social ecological model, and designed to improve food security, dietary intake, and quality among clients, which was carried out in 24 rural food pantries across 6 Midwestern states.ObjectiveOur objective was to evaluate changes in adult food security, dietary intake, and quality from baseline (2014) to follow-up (2016), and to assess the role of adult food security on dietary outcomes.DesignA multistate, longitudinal, quasi-experimental intervention with matched treatment and comparison design was used to evaluate treatment vs comparison group changes over time and changes in both groups over time.Participants/settingAdult food pantry clients (n = 617) completed a demographic food security survey, and up to three 24-hour dietary recalls at baseline (n = 590) and follow-up (n = 160).InterventionCommunity coaching served as the experimental component, which only “treatment” communities received, and a food council guide and food pantry toolkit were provided to both “treatment” and matched “comparison” communities.Main outcome measuresChange in adult food security status, mean usual intakes of nutrients and food groups, and Healthy Eating Index-2010 scores were the main outcome measures.Statistical analyses performedLinear mixed models estimated changes in outcomes by intervention group and by adult food security status over time.ResultsImprovements in adult food security score (–0.7 ± 0.3; P = .01), Healthy Eating Index-2010 total score (4.2 ± 1.1; P < .0001), and empty calories component score (3.4 ± 0.5; P <.0001) from baseline to follow-up were observed in treatment and comparison groups, but no statistically significant changes were found for adult food security status, dietary quality, and usual intakes of nutrients and food groups between the 2 groups over time. The intervention effect on dietary quality and usual intake changes over time by adult food security status were also not observed.ConclusionsFood pantry clients in treatment and comparison groups had higher food security and dietary quality at the follow-up evaluation of the Voices for Food intervention trial compared with baseline, despite the lack of difference among the groups as a result of the experimental coaching component.     

Biomolecular alterations in the early life stages of four food fish following acute exposure of Triclosan

We investigated the effect of acute concentrations of triclosan (TCS; 96 h exposure and 10d post exposure) on the free amino acid, primary (SDS-PAGE) and secondary (FT-IR) structure of proteins in the embryos/larvae of Cyprinus carpio, Ctenopharyngodon idella, Labeo rohita and Cirrhinus mrigala. A concentration dependent increase in free amino acids, upregulation of polypeptides (100 and 70 kDa in C. carpio, C. idella and L. rohita, 55, 45, 36 kda in C. idella and L. rohita and 22 kDa in all the fish) and a decline in percent area of all the selected peaks of the FT-IR spectra was observed after exposure and recovery period. The decline in percent area was greatest for L. rohita at peak 1080 – 1088 cm⁻¹ (−75.99%) after exposure and at peak 2854 – 2855 cm⁻¹ (−53.59%) after recovery. Curve fitting analysis revealed a decrease in α-helices and increase in β-sheets in all fish after exposure and recovery period. The results suggest that TCS elicits alterations in biomolecules of fish embryos.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported.MethodsPatients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.ConclusionsThis study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.     

FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。