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Background: Variation in outcomes after percutaneous coronary interventions (PCI) may reflect differences in quality of care. To date, however, we lack a methodology to monitor and improve national hospital 30-day mortality rates among patients undergoing PCI.Methods and Results: We developed hierarchical logistic regression models to calculate hospital risk-standardized 30-day all-cause PCI mortality rates. Due to differences in risk, patients were divided into 2 cohorts: those with ST-segment elevation myocardial infarction or cardiogenic shock, and those with no ST-segment elevation myocardial infarction and no cardiogenic shock. The models were derived using 2006 data from the CathPCI Registry linked with administrative claims data, and validated using comparable 2005 data. In the derivation cohort of the ST-segment elevation myocardial infarction or shock model (n=15 123), the unadjusted 30-day mortality rate was 9.2%. The final model included 13 variables with the observed mortality rates ranging from 1.4% to 40.3% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate were 8.5% and 9.7%, with 5th and 95th percentiles of 7.6% and 11.0%. In the derivation cohort of the no ST-segment elevation myocardial infarction and no shock model (n=110 529), the unadjusted 30-day mortality rate was 1.4%. The final model included 16 variables with the observed predicted mortality rates ranging from 0.1% to 7.0% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate across 612 hospitals were 1.3% and 1.6%, with 5th and 95th percentiles of 1.0% and 2.0%.Conclusions: These National Quality Forum endorsed registry-based models produce estimates of hospital risk-standardized mortality rates for patients undergoing PCI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine the proportion of first time driving while alcohol impaired (DWI) offenders who drive while their driver's license is suspended. DESIGN: Systematic, unobtrusive observations were conducted by surveillance professionals from Pinkerton Investigative Services, Inc, of first time offenders in the City of Milwaukee, Wisconsin, and Bergen County, New Jersey. Observations included two four hour periods during suspension (one weekday morning, one Friday/Saturday evening) and two four hour periods after license reinstatement (matched by day of week and time of day). Focus groups of first time offenders were conducted in each site. SETTING: New Jersey laws pertaining to license suspension for DWI and driving while suspended are stronger than Wisconsin laws. SUBJECTS: 93 recently convicted first time DWI offenders (57 in Milwaukee and 36 in Bergen County). MAIN OUTCOME MEASURES: Proportion of subjects observed driving during suspension and after license reinstatement, with reference to all subjects and subjects observed traveling by any means. RESULTS: Of subjects observed traveling while suspended, 88% of Milwaukee subjects compared with 36% of Bergen County subjects drove. Five percent of Milwaukee subjects and 78% of Bergen County subjects reinstated their driver's license. Bergen County subjects were significantly more likely to drive after reinstatement (54%) than during suspension (25%). CONCLUSION: Prevalence of driving while suspended among first time offenders is high and can vary substantially between jurisdictions. However, the license suspension can have a positive impact on the driving patterns of offenders during suspension, relative to after license reinstatement. Lower prevalence of driving while suspended in New Jersey may partly be attributable to that state's tougher laws. [ABSTRACT FROM AUTHOR]

Objective: To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures., Design: Mixed qualitative-quantitative approach., Setting: Convened seven meetings with stakeholders to obtain input and feedback on the tool., Participants: Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country., Interventions: With stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals., Outcomes: Abstraction tool to evaluate the quality of informed consent documents., Results: We identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%., Conclusions: We identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent., Competing Interests: Competing interests: The authors of this manuscript receive support to develop quality measures for the Centers for Medicare and Medicaid Services for public reporting. The informed consent measure is not currently implemented but was made publicly available so that hospitals could use the measure as a self-evaluation tool. The authors report working under contract with the Centers for Medicare and Medicaid Services to support quality measurement programmes, including developing a measure of informed consent document quality. The measure is not currently part of any quality reporting programmes, although the Centers for Medicare and Medicaid Services has made publicly available for use by hospitals to support quality improvement efforts. ES also reports receiving support from the Food and Drug Administration to support projects within the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI); from the National Institute on Minority Health and Health Disparities (U54MD010711-01) to study precision-based approaches to diagnosing and preventing hypertension; and from the National Institute of Biomedical Imaging and Bioengineering (R01 EB028106-01) to study a cuff-less blood pressure device. HMK also reports being a recipient of a research grant, through Yale, from Medtronic and the US Food and Drug Administration to develop methods for postmarket surveillance of medical devices; was a recipient of a research grant with Medtronic and is the recipient of a research grant from Johnson & Johnson, through Yale University, to support clinical trial data sharing; was a recipient of a research agreement, through Yale University, from the Shenzhen Center for Health Information for work to advance intelligent disease prevention and health promotion; collaborates with the National Center for Cardiovascular Diseases in Beijing; receives payment from the Arnold & Porter Law Firm for work related to the Sanofi clopidogrel litigation, from the Ben C Martin Law Firm for work related to the Cook Celect IVC filter litigation, and from the Siegfried and Jensen Law Firm for work related to Vioxx litigation; chairs a Cardiac Scientific Advisory Board for UnitedHealth; was a participant/participant representative of the IBM Watson Health Life Sciences Board; is a member of the Advisory Board for Element Science, the Advisory Board for Facebook and the Physician Advisory Board for Aetna; and is the cofounder of Hugo Health, a personal health information platform, and cofounder of Refactor Health, an enterprise healthcare AI-augmented data management company., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: In appropriately selected patients with severe carotid stenosis, carotid revascularization reduces ischemic stroke. Prior clinical research has focused on the efficacy and safety of carotid revascularization, but few investigators have considered readmission as a clinically important outcome., Objectives: The aims of this study were to examine frequency, timing, and diagnoses of 30-day readmission following carotid revascularization; to assess differences in 30-day readmission between patients undergoing carotid endarterectomy (CEA) and carotid artery stenting (CAS); to describe hospital variation in risk-standardized readmission rates (RSRR); and to examine whether hospital variation in the choice of procedure (CEA vs. CAS) is associated with differences in RSRRs., Methods: We used Medicare fee-for-service administrative claims data to identify acute care hospitalizations for CEA and CAS from 2009 to 2011. We calculated crude 30-day all-cause hospital readmissions following carotid revascularization. To assess differences in readmission after CAS compared with CEA, we used Kaplan-Meier survival curves and fitted mixed-effects logistic regression. We estimated hospital RSRRs using hierarchical generalized logistic regression. We stratified hospitals into 5 groups by their proportional CAS use and compared hospital group median RSRRs., Results: Of 180,059 revascularizations from 2,287 hospitals, CEA and CAS were performed in 81.5% and 18.5% of cases, respectively. The unadjusted 30-day readmission rate following carotid revascularization was 9.6%. Readmission risk after CAS was greater than that after CEA. There was modest hospital-level variation in 30-day RSRRs (median: 9.5%; range 7.5% to 12.5%). Variation in proportional use of CAS was not associated with differences in hospital RSRR (range of median RSRR across hospital groups 9.49% to 9.55%; p = 0.771)., Conclusions: Almost 10% of Medicare patients undergoing carotid revascularization were readmitted within 30 days of discharge. Compared with CEA, CAS was associated with a greater readmission risk. However, hospitals' RSRR did not differ by their proportional CAS use., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the effects of Washington, D.C. law prohibiting drivers' use of hand-held cell phones on such use., Methods: Daytime observations of drivers were conducted at signalized intersections in D.C. in March 2004, several months before the law took effect on July 1, 2004, and again in October 2004. As a comparison, observations also were conducted in areas of Virginia and Maryland located close to the D.C. border. Maryland and Virginia placed no limitations on drivers' phone use. Use was observed for 36,091 vehicles in D.C., 25,151 vehicles in Maryland, and 28,483 vehicles in Virginia., Results: The rate of talking on hand-held cell phones among drivers in D.C. declined significantly from 6.1% before the law to 3.5% after. Phone use declined slightly in Maryland and increased significantly in Virginia so that, relative to the patterns of hand-held phone use in the two states, phone use in D.C. declined 50%. Hand-held phone use in D.C. declined comparably among drivers of vehicles registered in all three jurisdictions. D.C. police issued 2,556 citations and 1,232 warnings for cell phone violations during July-November 2004. There were spates of media coverage when the law was passed and when it took effect., Conclusions: D.C.'s law prohibiting drivers' hand-held phone use had a strong effect on such use among drivers in D.C. Without ongoing publicized enforcement of the law, long-term compliance may be difficult to achieve.

Objective: Teenagers have very high motor vehicle crash rates, and their use of seat belts is generally lower than that of adults. A potential school-based strategy to increase teenagers' belt use is a policy making parking privileges contingent on belt use by student drivers and their passengers. This study evaluated the effects of implementing a school belt policy., Methods: The effects of a belt policy were evaluated during the 2003-2004 school year at high schools in two states: Connecticut, a state with a primary enforcement belt law and high belt use rates, and Mississippi, a state with a secondary enforcement law and generally low use rates. Both schools enforced the policy, and violations resulted in a graduated set of penalties leading to the potential loss of parking privileges. Baseline and post-policy belt use rates were obtained from observation surveys of student drivers and their teenage passengers coming to and from school. Changes in belt use were examined relative to belt use trends at comparison schools without a belt policy. Implementation of the policies also was monitored., Results: In Mississippi, among students arriving at school in the morning, driver belt use increased from 42% before the policy to 67% about 6 months after; passenger belt use increased from 16% to 61%, although sample sizes were small. These increases were significantly larger than expected, based on belt use trends at the comparison school in Mississippi. In Connecticut, where 86% of drivers and 79% of their passengers already were belted prior to the policy, there was no significant change. Both schools publicized and monitored the belt policy, and most enforcement occurred in the morning as students arrived at school., Conclusions: Based on a small-scale application of a belt policy at two schools in different states, a school belt policy may have stronger effects in states where belt use is low. Strong penalties and enforcement are essential elements of an effective policy. Adequate resources and commitment are needed for schools to implement and monitor the type of strong policy needed to sustain high belt use rates. Replication of this study in additional schools appears warranted.

Introduction: Selective Traffic Enforcement Programs (sTEPs) are a proven method to change motorists' behavior. Since 1997, the Connecticut DOT's Division of Highway Safety has organized a statewide seat belt enforcement program, with sTEP waves every three or four months. To date, 28 waves have been implemented., Method: Pre-wave and post-wave seat belt observation surveys are conducted by both state and municipal police across the state. Survey results, as well as a summary of all enforcement activity during the wave, are submitted for evaluation., Results: Connecticut seat belt use has continued to rise from one wave to the next in a predictable "saw blade" pattern., Conclusions: The data clearly demonstrate that agencies that have participated in a greater number of waves have experienced the greatest increase in belt use. Belt use has not yet plateaued and additional sTEP enforcement seems indicated. However, evidence from other states suggests that a plateau may occur somewhere in the mid 80% range., Impact on Industry: Should this occur, Connecticut will work toward strengthening the round the clock model, emphasizing the importance of aggressive primary enforcement.

Objective: To determine whether substantial short term declines in drivers' use of handheld cell phones, after a state ban, were sustained one year later., Design: Drivers' daytime handheld cell phone use was observed in four New York communities and two Connecticut communities. Observations were conducted one month before the ban, shortly after, and 16 months after. Driver gender, estimated age, and vehicle type were recorded for phone users and a sample of motorists., Intervention: Effective 1 November 2001, New York became the only state in the United States to ban drivers' handheld cell phone use. Connecticut is an adjacent state without such a law., Sample: 50,033 drivers in New York, 28,307 drivers in Connecticut., Outcome Measures: Drivers' handheld cell phone use rates in New York and Connecticut and rates by driver characteristics., Results: Overall use rates in Connecticut did not change. Overall use in New York declined from 2.3% pre-law to 1.1% shortly after (p<0.05). One year later, use was 2.1%, higher than immediately post-law (p<0.05) and not significantly different from pre-law. Initial declines in use followed by longer term increases were observed for males and females, drivers younger than 60, and car and van drivers; use patterns varied among the four communities. Publicity declined after the law's implementation. No targeted enforcement efforts were evident. Cell phone citations issued during the first 15 months represented 2% of all traffic citations., Conclusions: Vigorous enforcement campaigns accompanied by publicity appear necessary to achieve longer term compliance with bans on drivers' cell phone use.

Background: In response to public concern about driver distraction from cellular telephones, New York became the first state to ban handheld cell phone use while driving. The law, accompanied by considerable publicity, included a warning phase (November 2001), after which violators could be fined. Until March 2002, fines could be waived if motorists provided proof of purchase of hands-free accessories., Methods: Daytime cell phone use among passenger vehicle drivers was observed at controlled intersections 1 month before the law's implementation, after fines could be issued (December 2001), and after waivers were not allowed (March 2002). Use was observed for 37,462 vehicles in four New York communities and 21,315 vehicles in two central Connecticut communities. Driver gender, estimated age, and vehicle type were recorded for cell phone users and a sample of passing motorists., Results: The use rate in New York declined significantly from 2.3% before the law to 1.1% after the law (P < 0.05). Use rates in Connecticut, an adjacent state without a law, did not change. In both states, use was higher among drivers of sport utility vehicles (P < 0.05) and minimal among drivers ages 60 or older. In New York, observed use declined among drivers younger than 60, male and female drivers, and all vehicle types., Conclusions: A well-publicized law restricting drivers' use of handheld cell phones had a strong effect on behavior. Whether compliance will remain high is unknown.