Obesogenic Environmental Influences on Young Adults: Evidence From Randomized Dormitory Assignment

This study utilizes a natural experiment—conditionally random dormitory assignments of first-year US college students—to investigate the influence of obesogenic environmental factors in explaining changes in weight and exercise behavior during the 2009–2010 academic year. The design addresses potential selection biases resulting from the likelihood that individuals sort into built environments that match their preferences for exercise and healthy eating. We find some evidence that the food environment, specifically access to campus dining, significantly affected the weight of female students in our study. Females assigned to dormitories where the nearest campus dining hall was closed on the weekends gained about 1 lb less over the course of the year than females assigned to dormitories near dining halls that were open 7 days a week. We also find some evidence that female who lived in close proximity to a grocery store gained less weight over the course of the year. Finally, females who lived closer to campus gym reported more frequent exercise over the course of the year. We do not find significant effects of the built environment on weight changes of males in our sample, but we are cautious to draw strong conclusions from this because the male weight change in our sample was quite small

Draft crystal structure of the vault shell at 9-A resolution.

Vaults are the largest known cytoplasmic ribonucleoprotein structures and may function in innate immunity. The vault shell self-assembles from 96 copies of major vault protein and encapsulates two other proteins and a small RNA. We crystallized rat liver vaults and several recombinant vaults, all among the largest non-icosahedral particles to have been crystallized. The best crystals thus far were formed from empty vaults built from a cysteine-tag construct of major vault protein (termed cpMVP vaults), diffracting to about 9-A resolution. The asymmetric unit contains a half vault of molecular mass 4.65 MDa. X-ray phasing was initiated by molecular replacement, using density from cryo-electron microscopy (cryo-EM). Phases were improved by density modification, including concentric 24- and 48-fold rotational symmetry averaging. From this, the continuous cryo-EM electron density separated into domain-like blocks. A draft atomic model of cpMVP was fit to this improved density from 15 domain models. Three domains were adapted from a nuclear magnetic resonance substructure. Nine domain models originated in ab initio tertiary structure prediction. Three C-terminal domains were built by fitting poly-alanine to the electron density. Locations of loops in this model provide sites to test vault functions and to exploit vaults as nanocapsules

Patent Punting: How FDA and Antitrust Courts Undermine the Hatch-Waxman Act to Avoid Dealing with Patents

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing than FDA to address the merits of the underlying patent infringement actions, preferring to rely on misleading proxies such as the existence of a “reverse payment” in the settlement agreement. Antitrust litigation is, at best, a belated and awkward mechanism for correcting the effects of improperly delayed generic entry. But FDA is well-positioned to make timely determinations of which patents meet the statutory criteria for deferring generic entry. With proper staffing and resources, FDA could use its expertise in drug regulation to make rough assessments of the relationship between particular patents and the scope of FDA approval in NDAs and ANDAs quickly and cheaply, while leaving patent infringement remedies intact. Only those patents that FDA decides could reasonably be asserted against an unauthorized generic would lead FDA to stay approval of the generic pending litigation of the infringement action. The result would be a reduction in incentives to pursue dubious patent infringement claims, with a corresponding reduction in opportunities for anti-competitive settlements

Patent Punting: How FDA and Antitrust Courts Undermine the Hatch-Waxman Act to Avoid Dealing with Patents

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing than FDA to address the merits of the underlying patent infringement actions, preferring to rely on misleading proxies such as the existence of a “reverse payment” in the settlement agreement. Antitrust litigation is, at best, a belated and awkward mechanism for correcting the effects of improperly delayed generic entry. But FDA is well-positioned to make timely determinations of which patents meet the statutory criteria for deferring generic entry. With proper staffing and resources, FDA could use its expertise in drug regulation to make rough assessments of the relationship between particular patents and the scope of FDA approval in NDAs and ANDAs quickly and cheaply, while leaving patent infringement remedies intact. Only those patents that FDA decides could reasonably be asserted against an unauthorized generic would lead FDA to stay approval of the generic pending litigation of the infringement action. The result would be a reduction in incentives to pursue dubious patent infringement claims, with a corresponding reduction in opportunities for anti-competitive settlements

Stability of a Giant Connected Component in a Complex Network

We analyze the stability of the network's giant connected component under impact of adverse events, which we model through the link percolation. Specifically, we quantify the extent to which the largest connected component of a network consists of the same nodes, regardless of the specific set of deactivated links. Our results are intuitive in the case of single-layered systems: the presence of large degree nodes in a single-layered network ensures both its robustness and stability. In contrast, we find that interdependent networks that are robust to adverse events have unstable connected components. Our results bring novel insights to the design of resilient network topologies and the reinforcement of existing networked systems

INTERDEPENDENT INFRASTRUCTURE RESILIENCE IN THE U.S. VIRGIN ISLANDS: PRELIMINARY ASSESSMENT

Prepared for: Federal Emergency Management AgencyThe U.S. Virgin Islands (USVI) is a territory comprised of three main islands—Saint Croix, Saint John, and Saint Thomas—and a number of smaller surrounding islands, located in the Leeward Islands of the Lesser Antilles approximately 40 miles east of Puerto Rico and over 1,100 miles from Miami, Florida. In September 2017, two Category-5 hurricanes made landfall within a two-week period and collectively devastated the homes, businesses, and infrastructure throughout the Territory.This technical report (1) explains the structure, function, and tensions associated with energy, water, transportation, and communication infrastructure that were chronic problems prior to the hurricanes; (2) documents hurricane response, recovery, and mitigation activities for these infrastructure systems after the hurricanes; and (3) provides concrete approaches to overcome potential barriers to resilience (where they exist) and open questions for research (where they do not yet exist).Federal Emergency Management AgencyFederal Emergency Management AgencyApproved for public release; distribution is unlimited

A Survey of Training and Practice Patterns of Massage Therapists in Two US States

Background: Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics. Methods: As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits). Results: Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians. Conclusion: This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy

Finding shortest and nearly shortest path nodes in large substantially incomplete networks

Dynamic processes on networks, be it information transfer in the Internet, contagious spreading in a social network, or neural signaling, take place along shortest or nearly shortest paths. Unfortunately, our maps of most large networks are substantially incomplete due to either the highly dynamic nature of networks, or high cost of network measurements, or both, rendering traditional path finding methods inefficient. We find that shortest paths in large real networks, such as the network of protein-protein interactions (PPI) and the Internet at the autonomous system (AS) level, are not random but are organized according to latent-geometric rules. If nodes of these networks are mapped to points in latent hyperbolic spaces, shortest paths in them align along geodesic curves connecting endpoint nodes. We find that this alignment is sufficiently strong to allow for the identification of shortest path nodes even in the case of substantially incomplete networks. We demonstrate the utility of latent-geometric path-finding in problems of cellular pathway reconstruction and communication security

Adaptive School-based Implementation of CBT (ASIC): clustered-SMART for building an optimized adaptive implementation intervention to improve uptake of mental health interventions in schools

Abstract Background Depressive and anxiety disorders affect 20–30% of school-age youth, most of whom do not receive adequate services, contributing to poor developmental and academic outcomes. Evidence-based practices (EBPs) such as cognitive behavioral therapy (CBT) can improve outcomes, but numerous barriers limit access among affected youth. Many youth try to access mental health services in schools, but school professionals (SPs: counselors, psychologists, social workers) are rarely trained adequately in CBT methods. Further, SPs face organizational barriers to providing CBT, such as lack of administrative support. Three promising implementation strategies to address barriers to school-based CBT delivery include (1) Replicating Effective Programs (REP), which deploys customized CBT packaging, didactic training in CBT, and technical assistance; (2) coaching, which extends training via live supervision to improve SP competence in CBT delivery; and (3) facilitation, which employs an organizational expert who mentors SPs in strategic thinking to promote self-efficacy in garnering administrative support. REP is a relatively low-intensity/low-cost strategy, whereas coaching and facilitation require additional resources. However, not all schools will require all three strategies. The primary aim of this study is to compare the effectiveness of a school-level adaptive implementation intervention involving REP, coaching, and facilitation versus REP alone on the frequency of CBT delivered to students by SPs and student mental health outcomes. Secondary and exploratory aims examine cost-effectiveness, moderators, and mechanisms of implementation strategies. Methods Using a clustered, sequential multiple-assignment, randomized trial (SMART) design, ≥ 200 SPs from 100 schools across Michigan will be randomized initially to receive REP vs. REP+coaching. After 8 weeks, schools that do not meet a pre-specified implementation benchmark are re-randomized to continue with the initial strategy or to augment with facilitation. Discussion EBPs need to be implemented successfully and efficiently in settings where individuals are most likely to seek care in order to gain large-scale impact on public health. Adaptive implementation interventions hold the promise of providing cost-effective implementation support. This is the first study to test an adaptive implementation of CBT for school-age youth, at a statewide level, delivered by school staff, taking an EBP to large populations with limited mental health care access. Trial registration NCT03541317 —Registered on 29 May 2018 on ClinicalTrials.gov PRShttps://deepblue.lib.umich.edu/bitstream/2027.42/145606/1/13012_2018_Article_808.pd