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General Services Administration

governmentWashington, United States

Research output, citation impact, and the most-cited recent papers from General Services Administration (United States). Aggregated across the NobleBlocks index of 300M+ scholarly works.

Total works
569
Citations
17.8K
h-index
72
i10-index
223
Also known as
Administración de Servicios GeneralesAdministration des services générauxGeneral Services Administration

Top-cited papers from General Services Administration

Tracking Cardiac Rehabilitation Participation and Completion Among Medicare Beneficiaries to Inform the Efforts of a National Initiative
Matthew D. Ritchey, Sha Maresh, Jessica McNeely, Thomas Shaffer +4 more
2020· Circulation Cardiovascular Quality and Outcomes360doi:10.1161/circoutcomes.119.005902

BACKGROUND: Despite cardiac rehabilitation (CR) being shown to improve health outcomes among patients with heart disease, its use has been suboptimal. In response, the Million Hearts Cardiac Rehabilitation Collaborative developed a road map to improve CR use, including increasing participation rates to ≥70% by 2022. This observational study provides current estimates to measure progress and identifies the populations and regions most at risk for CR service underutilization. METHODS AND RESULTS: We identified Medicare fee-for-service beneficiaries who were CR eligible in 2016, and assessed CR participation (≥1 CR session attended), timely initiation (participation within 21 days of event), and completion (≥36 sessions attended) through 2017. Measures were assessed overall, by beneficiary characteristics and geography, and by primary CR-qualifying event type (acute myocardial infarction hospitalization; coronary artery bypass surgery; heart valve repair/replacement; percutaneous coronary intervention; or heart/heart-lung transplant). Among 366 103 CR-eligible beneficiaries, 89 327 (24.4%) participated in CR, of whom 24.3% initiated within 21 days and 26.9% completed CR. Eligibility was highest in the East South Central Census Division (14.8 per 1000). Participation decreased with increasing age, was lower among women (18.9%) compared with men (28.6%; adjusted prevalence ratio: 0.91 [95% CI, 0.90-0.93]) was lower among Hispanics (13.2%) and non-Hispanic blacks (13.6%) compared with non-Hispanic whites (25.8%; adjusted prevalence ratio: 0.63 [0.61-0.66] and 0.70 [0.67-0.72], respectively), and varied by hospital referral region and Census Division (range: 18.6% [East South Central] to 39.1% [West North Central]) and by qualifying event type (range: 7.1% [acute myocardial infarction without procedure] to 55.3% [coronary artery bypass surgery only]). Timely initiation varied by geography and qualifying event type; completion varied by geography. CONCLUSIONS: Only 1 in 4 CR-eligible Medicare beneficiaries participated in CR and marked disparities were observed. Reinforcement of current effective strategies and development of new strategies will be critical to address the noted disparities and achieve the 70% participation goal.

Bioenergy and Wildlife: Threats and Opportunities for Grassland Conservation
Joseph Fargione, Thomas R. Cooper, David J. Flaspohler, Jason Hill +4 more
2009· BioScience255doi:10.1525/bio.2009.59.9.8

Demand for land to grow corn for ethanol increased in the United States by 4.9 million hectares between 2005 and 2008, with wide-ranging effects on wildlife, including habitat loss. Depending on how biofuels are made, additional production could have similar impacts. We present a framework for assessing the impacts of biofuels on wildlife, and we use this framework to evaluate the impacts of existing and emerging biofuels feedstocks on grassland wildlife. Meeting the growing demand for biofuels while avoiding negative impacts on wildlife will require either biomass sources that do not require additional land (e.g., wastes, residues, cover crops, algae) or crop production practices that are compatible with wildlife. Diverse native prairie offers a potential approach to bioenergy production (including fuel, electricity, and heat) that is compatible with wildlife. Additional research is required to assess the compatibility of wildlife with different composition, inputs, and harvest management approaches, and...

The Role of Male Ornaments and Courtship Behavior in Female Mate Choice of Red Jungle Fowl
Marlene Zuk, Randy Thornhill, J. David Ligon, Kristine Johnson +4 more
1990· The American Naturalist243doi:10.1086/285107

Mate-choice experiments allowing a female red jungle fowl (Gallus gallus) to choose between two roosters showed female preferences for several male secondary sex characters. In 1987, male comb length was most strongly related to mating success, with eye color and the color of some ornamental feathers also being important in choice. In 1988, males with darker, redder eyes were again chosen more frequently, but comb color explained a significant portion of mating-success variation, whereas comb length was unimportant. Females did not choose older males over younger ones, but, in our sample, older and younger roosters did not differ on the basis of traits used in making choices. Male courtship behavior was generally not significantly different between chosen and unchosen males, and behavior was not correlated with morphological characters. Comb characteristics are facultative and are probably good indicators of individual condition, suggesting that females using these traits to distinguish among males could be obtaining good genes for their offspring.

Treatment of Bacterial Prostatitis
Benjamin A. Lipsky, Ivor Byren, Christopher T. Hoey
2010· Clinical Infectious Diseases243doi:10.1086/652861

Prostatitis is characterized by voiding symptoms and genitourinary pain and is sometimes associated with sexual dysfunction. Up to 25% of men receive a diagnosis of prostatitis in their lifetime, but <10% have a proven bacterial infection. The causes and treatment of nonbacterial prostatitis are largely unknown, but bacterial prostatitis is caused by infection with uropathogens, especially gram-negative bacilli, although infection is sometimes due to gram-positive and atypical microorganisms. Acute bacterial prostatitis is easily diagnosed (by abrupt urogential and often systemic symptoms, along with bacteriuria) and treated (by systemic antibiotic therapy). Chronic bacterial prostatitis is characterized by prolonged or recurrent symptoms and relapsing bacteriuria; diagnosis traditionally requires comparing urinary specimens obtained before with specimens obtained after prostatic massage. Treating chronic bacterial prostatitis requires prolonged therapy with an antibiotic that penetrates the prostate (ie, one with high lipid solubility, a low degree of ionization, high dissociation constant, low protein binding, and small molecular size). We review recent pharmacological and clinical data on treating bacterial prostatitis.

Collaborative knowledge work environments
Judith Heerwagen, Kevin Kampschroer, Kevin Powell, Vivian Loftness
2004· Building Research & Information239doi:10.1080/09613210412331313025

How can the physical design of the workplace enhance collaborations without compromising an individual's productivity? The body of research on the links between physical space and collaboration in knowledge work settings is reviewed. Collaboration is viewed as a system of behaviours that includes both social and solitary work. The social aspects of collaboration are discussed in terms of three dimensions: awareness, brief interaction and collaboration (working together). Current knowledge on the links between space and the social as well as individual aspects of collaborative work is reviewed. The central conflict of collaboration is considered: how to design effectively to provide a balance between the need to interact and the need to work effectively by oneself. The body of literature shows that features and attributes of space can be manipulated to increase awareness, interaction and collaboration. However, doing so frequently has negative impacts on individual work as a result of increases in noise distractions and interruptions to on-going work. The effects are most harmful for individual tasks requiring complex and focused mental work. The negative effects are compounded by a workplace that increasingly suffers from cognitive overload brought on by time stress, increased workload and multitasking.

NUMERICAL COMPUTATIONS OF STORM SURGES WITHOUT BOTTOM STRESS
Chester P. Jelesnianski
1966· Monthly Weather Review197doi:10.1175/1520-0493(1966)094<0379:ncossw>2.3.co;2

A numerical storm surge model, using the linearized form of the transport equations, is used to compute surges in a rectangular basin of variable depth and with three open water boundaries. The computed surges are sensitive to the initial placements of model tropical storms that are stationary, very slow moving, or moving parallel to the coast at any speed. These storms generate shelf seiches and a type of resurgent edge wave of significant amplitude. On the other hand, the computed surges are almost insensitive to initial placement of moderate and fast-moving storms. The numerical model is used to construct a prototype prediction system in the form of polar graphs which give coastal surge magnitude and dispersion against storm strength and speed and direction of motion.

Acoustic methods for the remote probing of the lower atmosphere
C. G. Little
1969· Proceedings of the IEEE184doi:10.1109/proc.1969.7010

The potential usefulness of acoustic methods for the remote probing of the lower atmosphere is reviewed. Starting with a comparison of the effects of temperature, wind, and humidity fluctuations upon the refractive index of air to electromagnetic and acoustic waves, it is shown that the fluctuations in acoustic refractive index may be expected to be about 1000 times stronger than in the radio case. The opportunities for passive and for line-of-sight remote acoustical sensing of the troposphere offered by this relatively strong interaction are briefly identified. Since the scattered power is proportional to the square of the refractive index fluctuations, the scatter of acoustic waves may be expected to be roughly one million times stronger than for radio waves. Based on the theoretical work of Kallistratova (but including the effects of atmospheric absorption), the system parameters required for effective acoustic echo-sounding of the lower atmosphere are deduced. It is concluded that the acoustic sounding technique could be developed to monitor, to heights of at least 1500 meters, 1) the vertical profile of wind speed and direction, 2) the vertical profile of humidity, 3) the location and intensity of temperature inversions, 4) the three-dimensional spectrum of mechanical turbulence, and 5) the three-dimensional spectrum of temperature inhomogeneity (i.e., of optical refractive index fluctuation). Typical time and height resolutions for the proposed acoustic echo-sounders could be of the order 10 seconds and 10 meters; the spatial wave number explored could range from about 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-2</sup> m <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-1</sup> to about 400 m <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-1</sup> .

A Case Study of Successful Partnering Implementation
Lisa M. Ellram, Owen R.V. Edis
1996· International Journal of Purchasing and Materials Management172doi:10.1111/j.1745-493x.1996.tb00227.x

This article provides a detailed case study of successful buyer‐supplier partnership development and maintenance at the Eastman Kodak Company. Kodak followed a methodical approach, adapting a managerial guideline for “partnering” originally developed by one of the authors in 1991. The term “partnering” is used here in the sense of cooperative buyer‐supplier relationships, rather than in the legal sense. This article provides a summary of the key issues Kodak faced, along with the benefits it has experienced in developing and maintaining successful partnering relationships.

Summer Institute to Improve University Science Teaching
Christine Pfund, Sarah Miller, Kerry Brenner, Peter J. Bruns +4 more
2009· Science155doi:10.1126/science.1170015

The goal of the National Academies Summer Institute is to change teaching practices in introductory, undergraduate biology courses.

Organizational Culture and Climate Correlates of Job Satisfaction
Jocelyn J. Johnson, Cherita L. McIntye
1998· Psychological Reports136doi:10.2466/pr0.1998.82.3.843

Data were collected from 8,126 employees in a large government service agency using an anonymous survey measuring 19 different aspects of organizational culture and climate. Correlation indicated positive and significant associations for the measure of Job Satisfaction on the survey with all remaining measures. The measures of culture most strongly related to scores on Job Satisfaction were Empowerment and Involvement, and Recognition. Measures of climate most strongly associated with scores on Job Satisfaction were Communication, followed by Goals, Creativity and Innovation, and Decision-making. Results are discussed in terms of their practical and meaningful relevance to organizational effectiveness.

MauG, a Novel Diheme Protein Required for Tryptophan Tryptophylquinone Biogenesis
Yongting Wang, M. Elizabeth Graichen, Aimin Liu, Arwen R. Pearson +2 more
2003· Biochemistry132doi:10.1021/bi034243q

The biosynthesis of methylamine dehydrogenase (MADH) from Paracoccus denitrificans requires four genes in addition to those that encode the two structural protein subunits. None of these gene products have been previously isolated. One of these, mauG, exhibits sequence similarity to diheme cytochrome c peroxidases and is required for the synthesis of the tryptophan tryptophylquinone (TTQ) prosthetic group of MADH. A system was developed for the homologous expression of MauG in P. denitrificans. Its signal sequence was correctly processed, and it was purified from the periplasmic cell fraction. The protein contains two covalent c-type hemes, as predicted from the deduced sequence. EPR spectroscopy reveals that the protein as isolated possesses about equal amounts of one high-spin heme with axial symmetry and one low-spin heme with rhombic symmetry. The low-spin heme contains a major and minor component suggesting a small degree of heme heterogeneity. The high-spin heme and the major low-spin heme component each exhibit resonances that are atypical of c-type hemes and dissimilar to those reported for diheme cytochrome c peroxidases. MauG exhibited only very weak peroxidase activity when assayed with either c-type cytochromes or o-dianisidine as an electron donor. Fully reduced MauG was shown to bind carbon monoxide and could be reoxidized by oxygen. The relevance of these unusual properties of MauG is discussed in the context of its role in TTQ biogenesis.

A REGRESSION METHOD FOR OBTAINING REAL-TIME TEMPERATURE AND GEOPOTENTIAL HEIGHT PROFILES FROM SATELLITE SPECTROMETER MEASUREMENTS AND ITS APPLICATION TO NIMBUS 3 “SIRS” OBSERVATIONS
William L. Smith, H. M. Woolf, Warren J. Jacob
1970· Monthly Weather Review124doi:10.1175/1520-0493(1970)098<0582:armfor>2.3.co;2

A least squares regression method is formulated for obtaining global temperature and geopotential height profiles from satellite radiation measurements, particularly those obtained by the Sate1lite Infra-Red Spectrometer (SIRS) aboard the Nimbus 3 satellite launched Apr. 14, 1969. Regression equations relating temperature and geopotential height to spectral radiance observations are derived. A method accounting for the influence of clouds, mountains, and hot terrain on the solutions is described. Results obtained from Nimbus 3 radiance data are presented. The procedure described herein has been successfully applied to Nimbus 3 SIRS observations on a real-time basis. The temperature and geopotential heights obtained are being used operationally by the National Meteorological Center in their objective constant pressure analyses. Numerous meteorological results are given to demonstrate the usefulness of this new sounding tool.

Circadian-effective light and its impact on alertness in office workers
MG Figueiro, Michael J. Kalsher, BC Steverson, Judith Heerwagen +2 more
2018· Lighting Research & Technology124doi:10.1177/1477153517750006

A field study was conducted at two U.S. federal government office sites and two U.S. embassies to demonstrate whether circadian-effective lighting (providing circadian stimulus (CS) values of CS ≥ 0.3) could be installed in office buildings, and to determine whether this lighting intervention would reduce sleepiness and increase alertness, vitality and energy in office workers while at work. Desktop and/or overhead luminaires provided circadian-effective lighting at participants’ eyes during a two-day intervention. A pendant-mounted Daysimeter device was used to measure participant-specific CS values during the baseline and the intervention days. Participants also completed questionnaires inquiring about sleep habits, stress and subjective feelings of vitality and energy. The Daysimeter data showed that participants were exposed to significantly higher amounts of circadian-effective light while at work during the two intervention days compared to the baseline day. Self-reported sleepiness scores were significantly reduced during the intervention days compared to the baseline day. As hypothesised, participants also reported feeling significantly more vital, energetic and alert on the intervention days compared to the baseline day. The present results from four independent office environments demonstrate that lighting systems delivering a CS ≥ 0.3 can reduce sleepiness and increase vitality and alertness in office workers.

Crystal structure of the precursor of galactose oxidase: An unusual self-processing enzyme
S.J. Firbank, Melanie S. Rogers, Carrie M. Wilmot, David M. Dooley +4 more
2001· Proceedings of the National Academy of Sciences123doi:10.1073/pnas.231463798

Galactose oxidase (EC 1.1.3.9 ) is a monomeric enzyme that contains a single copper ion and catalyses the stereospecific oxidation of primary alcohols to their corresponding aldehydes. The protein contains an unusual covalent thioether bond between a tyrosine, which acts as a radical center during the two-electron reaction, and a cysteine. The enzyme is produced in a precursor form lacking the thioether bond and also possessing an additional 17-aa pro-sequence at the N terminus. Previous work has shown that the aerobic addition of Cu 2+ to the precursor is sufficient to generate fully processed mature enzyme. The structure of the precursor protein has been determined to 1.4 Å, revealing the location of the pro-sequence and identifying structural differences between the precursor and the mature protein. Structural alignment of the precursor and mature forms of galactose oxidase shows that five regions of main chain and some key residues of the active site differ significantly between the two forms. The precursor structure provides a starting point for modeling the chemistry of thioether bond formation and pro-sequence cleavage.

Spatial Layout and Face-to-Face Interaction in Offices—A Study of the Mechanisms of Spatial Effects on Face-to-Face Interaction
Mahbub Rashid, Kevin Kampschroer, Jean Wineman, Craig Zimring
2006· Environment and Planning B Planning and Design118doi:10.1068/b31123

In this paper we report a study that uses space-syntax theories and techniques to develop a model explaining how spatial layouts, through their effects on movement and visible copresence, may affect face-to-face interaction in offices. Though several previous space-syntax studies have shown that spatial layouts have significant effects on movement and face-to-face interaction in offices, none has investigated the relations among movement, visible copresence, and face-to-face interaction in offices with significantly different layouts. On the basis of statistical analyses of the spatial and behavioral data collected at four moderately large offices, this study shows that spatial layouts have consistent effects on movement, but inconsistent effects on visible copresence and face-to-face interaction; that visible copresence, not movement, is an important predictor of face-to-face interaction; that movement has negligible effects on the relationship between visible copresence and face-to-face interaction; and that functional programs have little or no effect on the culture of face-to-face interaction in these offices. Limitations of the research design for workplace study and implications of the research findings for workplace design and management are discussed.

Development and evaluation of fully automated demand response in large facilities
Mary Ann Piette, Osman Sezgen, David Watson, Naoya Motegi +2 more
2004116doi:10.2172/840331

This report describes the results of a research project to develop and evaluate the performance of new Automated Demand Response (Auto-DR) hardware and software technology in large facilities. Demand Response (DR) is a set of activities to reduce or shift electricity use to improve electric grid reliability, manage electricity costs, and ensure that customers receive signals that encourage load reduction during times when the electric grid is near its capacity. The two main drivers for widespread demand responsiveness are the prevention of future electricity crises and the reduction of electricity prices. Additional goals for price responsiveness include equity through cost of service pricing, and customer control of electricity usage and bills. The technology developed and evaluated in this report could be used to support numerous forms of DR programs and tariffs. For the purpose of this report, we have defined three levels of Demand Response automation. Manual Demand Response involves manually turning off lights or equipment; this can be a labor-intensive approach. Semi-Automated Response involves the use of building energy management control systems for load shedding, where a preprogrammed load shedding strategy is initiated by facilities staff. Fully-Automated Demand Response is initiated at a building or facility through receipt of an external communications signal--facility staff set up a pre-programmed load shedding strategy which is automatically initiated by the system without the need for human intervention. We have defined this approach to be Auto-DR. An important concept in Auto-DR is that a facility manager is able to ''opt out'' or ''override'' an individual DR event if it occurs at a time when the reduction in end-use services is not desirable. This project sought to improve the feasibility and nature of Auto-DR strategies in large facilities. The research focused on technology development, testing, characterization, and evaluation relating to Auto-DR. This evaluation also included the related decisionmaking perspectives of the facility owners and managers. Another goal of this project was to develop and test a real-time signal for automated demand response that provided a common communication infrastructure for diverse facilities. The six facilities recruited for this project were selected from the facilities that received CEC funds for new DR technology during California's 2000-2001 electricity crises (AB970 and SB-5X).

US Government Linked Open Data: Semantic.data.gov
James Hendler, Jeanne Holm, Chris Musialek, G. E. Thomas
2012· IEEE Intelligent Systems114doi:10.1109/mis.2012.27

This article discusses Data.gov, the world's largest open government, data-sharing website, and the use of linked data in some of the site's community pages.

Effects of the physical work environment on physiological measures of stress
Julian F. Thayer, Bart Verkuil, Jos F. Brosschotj, Kampschroer Kevin +4 more
2010· European Journal of Cardiovascular Prevention & Rehabilitation113doi:10.1097/hjr.0b013e328336923a

AIMS: In this study we investigated the effects of the physical work environment on two physiological measures of the stress response. METHODS AND RESULTS: Circadian variations in vagally mediated heart rate variability (HRV) and the morning rise in cortisol were evaluated in 60 participants working in a government building either in a traditional (individual offices and old cubicles; n=40) or a modern workspace (individualized cubicles with improved views and lighting; n=20). Results revealed significant linear (B=-1.03; confidence interval: -1.05 to -1.01, P<0.05) and quadratic (B=1.001; confidence interval: 1.0004-1.002, P<0.05) trends by office type interactions for indices of vagally mediated HRV. Individuals in the old office space had flatter slopes and thus less circadian variation including less HRV at night, and a larger rise in cortisol upon awakening compared with those in the new office space. CONCLUSION: These results indicate that physical features of the work environment may affect two aspects of the physiological stress response: circadian variations in HRV and the morning rise in cortisol. These findings have important social, economic, and public health implications for work environment risk factors on health.

Relationship Between Workplace Spatial Settings and Occupant-Perceived Support for Collaboration
Ying Hua, Vivian Loftness, Judith Heerwagen, Kevin Powell
2010· Environment and Behavior108doi:10.1177/0013916510364465

The increasingly collaborative nature of knowledge-based work requires workplaces to support both dynamic interactions and concentrated work, both of which are critical for collaboration performance. Given the prevalence of open-plan settings, this requirement has created new challenges for workplace design. Therefore, an understanding of the relationship between the spatial characteristics of workplace settings and the support for collaboration that is perceived by office workers is valuable and timely. Based on a study of 308 office workers in 27 office spaces, this article examines the relationship between a series of workplace spatial characteristics and the support that is perceived by the occupants for collaborations. The spatial characteristics that were examined included individual workstation characteristics that were derived from the literature and a new set of floor-plan layout variables that highlighted shared spaces that are critical for a variety of formal and informal collaboration activities at work. The key characteristics of workplace spatial settings that were associated with the support that the occupants perceived for collaboration were the distance from workstation to meeting space, the distance from workstation to shared service area, the distance from workstation to kitchen/coffee area, and the percentage of floor space that was dedicated to shared services and amenities.

Effect of Peer Comparison Letters for High-Volume Primary Care Prescribers of Quetiapine in Older and Disabled Adults
Adam Sacarny, Michael L. Barnett, Jackson Le, Frank Tetkoski +2 more
2018· JAMA Psychiatry104doi:10.1001/jamapsychiatry.2018.1867

Importance: Antipsychotic agents, such as quetiapine fumarate, are frequently overprescribed for indications not supported by clinical evidence, potentially causing harm. Objective: To investigate if peer comparison letters targeting high-volume primary care prescribers of quetiapine meaningfully reduce their prescribing. Design, Setting, and Participants: Randomized clinical trial (intent to treat) conducted from 2015 to 2017 of prescribers and their patients nationwide in the Medicare program. The trial targeted the 5055 highest-volume primary care prescribers of quetiapine in 2013 and 2014 (approximately 5% of all primary care prescribers of quetiapine). Interventions: Prescribers were randomized (1:1 ratio) to receive a placebo letter or 3 peer comparison letters stating that their quetiapine prescribing was high relative to their peers and was under review by Medicare. Main Outcomes and Measures: The primary outcome was the total quetiapine days supplied by prescribers from the intervention start to 9 months. Secondary outcomes included quetiapine receipt from all prescribers by baseline patients, quetiapine receipt by patients with low-value or guideline-concordant indications for therapy, mortality, and hospital use. In exploratory analyses, the study followed outcomes to 2 years. Results: Of the 5055 prescribers, 231 (4.6%) were general practitioners, 2428 (48.0%) were in family medicine, and 2396 (47.4%) were in internal medicine; 4155 (82.2%) were male. All were included in the analyses. Over 9 months, the treatment arm supplied 11.1% fewer quetiapine days per prescriber vs the control arm (2456 vs 2864 days; percentage difference, 11.1% fewer days; 95% CI, -13.1% to -9.2% days; P < .001; adjusted difference, -319 days; 95% CI, -374 to -263 days; P < .001), which persisted through 2 years (15.6% fewer days; 95% CI, -18.1% to -13.0%; P < .001). At the patient level, individuals in the treatment arm received 3.9% (95% CI, -5.0% to -2.9%; P < .001) fewer days of quetiapine from all prescribers over 9 months, with a larger decrease among patients with low-value vs guideline-concordant indications (-5.9% [95% CI, -8.0% to -3.9%] vs -2.4% [95% CI, -4.0% to -0.9%], P = .01 for test that effects were equal for both patient groups). There was no evidence of substitution to other antipsychotics, and 9-month mortality and hospital use were similar between the treatment vs control arms. Conclusions and Relevance: Peer comparison letters caused substantial and durable reductions in quetiapine prescribing, with no evidence of negative effects on patients. Trial Registration: ClinicalTrials.gov identifier: NCT02467933.