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The clinical judgment of a physician is one of the most important aspects of medical quality, yet it is rarely captured with quality measures in use today. We propose a novel approach using individualized physician benchmarking that measures the appropriateness of care that a physician delivers by looking at their practice pattern in a specific clinical situation. A prime application of our novel approach to appropriateness measures is the surgical management of peripheral artery disease and claudication. We discuss 4 potential consensus metrics for the treatment of claudication that explore appropriateness of care of claudication management and are meaningful, actionable, and quantifiable. Given the multitude of medical specialties involved in the care of patients with peripheral artery disease and the consequences of both preemptive and delayed care, it is in all of our interests to promote data transparency with confidential communications to outlier physicians while advocating for evidence-based management., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: There is persistent controversy surrounding the merit of surgical volume benchmarks being used solely as a sufficient proxy for assessing the quality of open abdominal aortic aneurysm (AAA) repair. Importantly, operative volume quotas may fail to reflect a more nuanced and comprehensive depiction of surgical outcomes most relevant to patients. Accordingly, we herein propose a patient-centered textbook outcome (TO) for AAA repair that is analogous to other large magnitude extirpative operations performed in other surgical specialties, and test its feasibility to discriminate hospital performance using Society for Vascular Surgery (SVS) volume guidelines., Methods: All elective open infrarenal AAA repairs (OAR) in the SVS-Vascular Quality Initiative were examined (2009-2022). The primary end point was a TO, defined as a composite of no in-hospital complication or reintervention/reoperation, length of stay of ≤10 days, home discharge, and 1-year survival rates. The discriminatory ability of the TO measure was assessed by comparing centers that did or did not meet the SVS annual OAR volume threshold recommendation (high volume ≥10 OARs/year; low volume <10 OARs/year). Logistic regression and multivariable models adjusted for patient and procedure-related differences., Results: A total of 9657 OARs across 198 centers were analyzed (mean age, 69.5 ± 8.4 years; female, 26%; non-White, 12%). A TO was identified in 44% (n = 4293) of the overall cohort. The incidence of individual TO components included no in-hospital complication (61%), no in-hospital reintervention or reoperation (92%), length of stay of ≤10 days (78%), home discharge (76%), and 1-year survival (91%). Median annual center volume was 6 (interquartile range, 3-10) and a majority of centers did not meet the SVS volume suggested threshold (<10 OARs/year, n = 148 [74%]). However, most patients (6265 of 9657 [65%]) underwent OAR in high-volume hospitals. When comparing high- and low-volume centers, a TO was more likely to occur in high-volume institutions: ≥10 OARs/year (46%) vs <10 OARs/year (42%; P = .0006). The association of a protective effect for higher center volume remained after risk adjustment (odds ratio, 1.1; 95% confidence interval, 1.05-1.26; P = .003)., Conclusions: TOs for elective OAR reflect a more nuanced and comprehensive patient centered proxy to measure care delivery, consistent with other surgical specialties. Surprisingly, a TO was achieved in <50% of elective AAA cases nationally. Although the likelihood of a TO seems to correlate with SVS center volume recommendations, it more importantly reflects elements which may be prioritized by patients and thus offers insights into further improving real-world AAA care., Competing Interests: Disclosures None., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the "2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures." The new performance measures are taken from the "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis.

Against the background of the discussion about a comprehensive regional mental health care service, the essay discusses the possibility of a comprehensive, transparent and meaningful evaluation. Proposals for how structures, processes, and outcomes may be assessed are presented. We argue for collecting data that are transparent and actionable on all levels of care organisations. The suggested evaluation would be innovative, meaningful for individual patients, services, health care organisations and whole regions, and thus a way for a data-driven ongoing quality improvement., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Objective: To examine the relationship between stroke care infrastructure and stroke quality-of-care outcomes at 29 spoke hospitals participating in the Medical University of South Carolina (MUSC) hub-and-spoke telestroke network., Materials and Methods: Encounter-level data from MUSC's telestroke patient registry were filtered to include encounters during 2015-2022 for patients aged 18 and above with a clinical diagnosis of acute ischemic stroke, and who received intravenous tissue plasminogen activator. Unadjusted and adjusted generalized estimating equations assessed associations between time-related stroke quality-of-care metrics captured during the encounter and the existence of the two components of stroke care infrastructure-stroke coordinators and stroke center certifications-across all hospitals and within hospital subgroups defined by size and rurality., Results: Telestroke encounters at spoke hospitals with stroke coordinators and stroke center certifications were associated with shorter door-to-needle (DTN) times (60.9 min for hospitals with both components and 57.3 min for hospitals with one, vs. 81.2 min for hospitals with neither component, p <.001). Similar patterns were observed for the percentage of encounters with DTN time of ≤60 min (63.8% and 68.9% vs. 32.0%, p <.001) and ≤45 min (34.0% and 38.4% vs. 8.42%, p <.001). Associations were similar for other metrics (e.g., door-to-registration time), and were stronger for smaller (vs. larger) hospitals and rural (vs. urban) hospitals., Conclusions: Stroke coordinators or stroke center certifications may be important for stroke quality of care, especially at spoke hospitals with limited resources or in rural areas., Competing Interests: Declaration of competing interest We declare no competing interests., (Copyright © 2024. Published by Elsevier Inc.)

Aim: To identify minimum reporting standards for assessing the processes and outcomes of Australian primary care dietetics practice., Methods: A sequential, mixed-method, exploratory process with peer-nominated Australian 'thought leaders'. A literature review was undertaken to identify possible standards, followed by semi-structured qualitative interviews with thought leaders. Content analysis was used to identify a comprehensive group of items that could inform evidence-based reporting standards. Two rounds of a modified Delphi survey were conducted with the same thought leaders to seek consensus on the most relevant items. Individual items were analysed for content validity, and those with a rating of excellent item-content validity (index >0.78) were included as evidenced-based standards for primary care practice., Results: Twenty-six thought leaders (response rate: 87%) from all mainland Australian states completed a qualitative interview and two rounds of modified-Delphi consensus surveys. Items were identified and categorised into three domains: business, clinical, and implementation. Content analysis identified 216 items published or used in practice by the thought leaders. After two rounds of consensus review, 97 items (45 business, 33 clinical, and 19 implementation) achieved excellent consensus ratings. Combining these items into a standardised tool, the scale-content validity index average was >0.90, which is considered excellent content validity., Conclusions: This study has identified minimum reporting standards for evidence-based process and outcome assessments in primary care dietetics practice in Australia. Incorporating such standards into a standardised tool could enable benchmarking across the dietetics workforce and contribute to a broader understanding of the dietetic impact on public health., (© 2022 The Authors. Nutrition & Dietetics published by John Wiley & Sons Australia, Ltd on behalf of Dietitians Australia.)

Importance: The Medicare Merit-based Incentive Payment System (MIPS) influences reimbursement for hundreds of thousands of US physicians, but little is known about whether program performance accurately captures the quality of care they provide., Objective: To examine whether primary care physicians' MIPS scores are associated with performance on process and outcome measures., Design, Setting, and Participants: Cross-sectional study of 80 246 US primary care physicians participating in the MIPS program in 2019., Exposures: MIPS score., Main Outcomes and Measures: The association between physician MIPS scores and performance on 5 unadjusted process measures, 6 adjusted outcome measures, and a composite outcome measure., Results: The study population included 3.4 million patients attributed to 80 246 primary care physicians, including 4773 physicians with low MIPS scores (≤30), 6151 physicians with medium MIPS scores (>30-75), and 69 322 physicians with high MIPS scores (>75). Compared with physicians with high MIPS scores, physicians with low MIPS scores had significantly worse mean performance on 3 of 5 process measures: diabetic eye examinations (56.1% vs 63.2%; difference, -7.1 percentage points [95% CI, -8.0 to -6.2]; P < .001), diabetic HbA1c screening (84.6% vs 89.4%; difference, -4.8 percentage points [95% CI, -5.4 to -4.2]; P < .001), and mammography screening (58.2% vs 70.4%; difference, -12.2 percentage points [95% CI, -13.1 to -11.4]; P < .001) but significantly better mean performance on rates of influenza vaccination (78.0% vs 76.8%; difference, 1.2 percentage points [95% CI, 0.0 to 2.5]; P = .045] and tobacco screening (95.0% vs 94.1%; difference, 0.9 percentage points [95% CI, 0.3 to 1.5]; P = .001). MIPS scores were inconsistently associated with risk-adjusted patient outcomes: compared with physicians with high MIPS scores, physicians with low MIPS scores had significantly better mean performance on 1 outcome (307.6 vs 316.4 emergency department visits per 1000 patients; difference, -8.9 [95% CI, -13.7 to -4.1]; P < .001), worse performance on 1 outcome (255.4 vs 225.2 all-cause hospitalizations per 1000 patients; difference, 30.2 [95% CI, 24.8 to 35.7]; P < .001), and did not have significantly different performance on 4 ambulatory care-sensitive admission outcomes. Nineteen percent of physicians with low MIPS scores had composite outcomes performance in the top quintile, while 21% of physicians with high MIPS scores had outcomes in the bottom quintile. Physicians with low MIPS scores but superior outcomes cared for more medically complex and socially vulnerable patients, compared with physicians with low MIPS scores and poor outcomes., Conclusions and Relevance: Among US primary care physicians in 2019, MIPS scores were inconsistently associated with performance on process and outcome measures. These findings suggest that the MIPS program may be ineffective at measuring and incentivizing quality improvement among US physicians.

Organizations are often challenged to demonstrate the evidence of empirical outcomes required for Magnet® application and designation. Theoretically, the application of evidence-based guidelines to the clinical setting leads to empirical outcomes. However, successful integration of guidelines into practice remains problematic. This article explains how organizations can leverage implementation science to promote the effective uptake of best practice standards to achieve the outcomes necessary to improve care and demonstrate Magnet standards., Competing Interests: The author declares no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Robust quality indicators (QIs) are essential for monitoring and improving the quality of care and learning from good practice. We aimed to identify and assess QIs for the care of older people and people with dementia who are nearing the end of life and recommend QIs for use with routinely collected electronic data across care settings., Methods: A systematic review was conducted, including five databases and reference chaining. Studies describing the development of QIs for care of older people and those with dementia nearing the end of life were included. QIs were categorized as relating to processes or outcomes, and mapped against six care domains. The psychometric properties (acceptability, evidence base, definition, feasibility, reliability, and validity) of each QI were assessed; QIs were categorized as robust, moderate, or poor., Results: From 12,980 titles and abstracts screened, 37 papers and 976 QIs were included. Process and outcome QIs accounted for 780 (79.7%) and 196 (20.3%) of all QIs, respectively. Many of the QIs concerned physical aspects of care (n = 492, 50.4%), and very few concerned spiritual and cultural aspects of care (n = 19, 1.9%). Three hundred and fifteen (32.3%) QIs were robust and of those 220 were measurable using routinely collected electronic data. The final shortlist of 71 QIs came from seven studies., Conclusions: Of the numerous QIs developed for care of older adults and those with dementia nearing the end of life, most had poor or moderate psychometric properties or were not designed for use with routinely collected electronic datasets. Infrastructure for data availability, combined with use of robust QIs, is important for enhancing understanding of care provided to this population, identifying unmet needs, and improving service provision., (© 2021 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society.)

Purpose: Competency-based assessment, using entrustable professional activities (EPAs), is rapidly being implemented worldwide without sufficient agreement on the essential elements of EPA-based assessment. The rapidity of implementation has left little time to understand what works in what circumstances and why or why not. The result is the attempted execution of a complex service intervention without a shared mental model for features needed to remain true to implementing an EPA assessment framework as intended. The purpose of this study was to identify the essential core components necessary to maintain integrity in the implementation of this intended intervention., Method: A formal consensus-building technique, the Delphi process, was used to identify core components for implementing an EPA-based assessment framework. Twelve EPA experts from the United States, Canada, and the Netherlands participated in this process in February and March 2020. In each Delphi round, participants rated possible core components on a scale from 1 to 6, with 1 reflecting the worst fit and 6 the best fit for EPA-based assessment implementation. Predetermined automatic inclusion and exclusion criteria for candidate core components were set at ≥ 80% of participants assigning a value of 5 or 6 and ≥ 80% assigning a value of 1 or 2, respectively., Results: After 3 rounds, participants prioritized 10 of 19 candidate core components for inclusion: performance prediction, shared local mental model, workplace assessment, high-stakes entrustment decisions, outcomes based, value of the collective, informed clinical competency committee members, construct alignment, qualitative data, and entrustment decision consequences. The study closed after 3 rounds on the basis of the rankings and comments., Conclusions: Using the core components identified in this study advances efforts to implement an EPA assessment framework intervention as intended, which mitigates the likelihood of making an incorrect judgment that the intervention demonstrates negative results., (Copyright © 2021 by the Association of American Medical Colleges.)

Objective: To explore the safety and efficacy of artificial coma induction to treat status epilepticus (SE) immediately after first-line antiseizure treatment instead of following the recommended approach of first using second-line drugs., Methods: Clinical and electrophysiologic data of all adult patients treated for SE from 2017 to 2018 in the Swiss academic medical care centers from Basel and Geneva were retrospectively assessed. Primary outcomes were return to premorbid neurologic function and in-hospital death. Secondary outcomes were the emergence of complications during SE, duration of SE, and intensive care unit (ICU) and hospital stays., Results: Of 230 patients, 205 received treatment escalation after first-line medication. Of those, 27.3% were directly treated with artificial coma and 72.7% with second-line nonanesthetic antiseizure drugs. Of the latter, 16.6% were subsequently put on artificial coma after failure of second-line treatment. Multivariable analyses revealed increasing odds for coma induction after first-line treatment with younger age, the presence of convulsions, and an increased SE severity as quantified by the Status Epilepticus Severity Score (STESS). While outcomes and complications did not differ compared to patients with treatment escalation according to the guidelines, coma induction after first-line treatment was associated with shorter SE duration and ICU and hospital stays., Conclusions: Early induction of artificial coma is performed in more than every fourth patient and especially in younger patients presenting with convulsions and more severe SE. Our data demonstrate that this aggressive treatment escalation was not associated with an increase in complications but with shorter duration of SE and ICU and hospital stays., Classification of Evidence: This study provides Class III evidence that early induction of artificial coma after unsuccessful first-line treatment for SE is associated with shorter duration of SE and ICU and hospital stays compared to the use of a second-line nonanesthetic antiseizure drug instead of or before anesthetics, without an associated increase in complications., (© 2021 American Academy of Neurology.)

Cannulation is essential for haemodialysis with arteriovenous access, but also damages the arteriovenous access making it prone to failure, is associated with complications and affects patients' experiences of haemodialysis. Managing Access by Generating Improvements in Cannulation is a national UK quality improvement project, designed to improve cannulation practice in the United Kingdom, ensuring it reflects current needling recommendations. It uses a simple quality improvement method, the Model for Improvement, to structure improvement to cannulation practice. It assists units in the practical implementation of the British Renal Society and Vascular Access Society of Britain and Ireland needling recommendations, ensuring actual cannulation practice reflects what is defined as best practice in cannulation. An eLearning package and awareness materials have been developed, to assist units in changing their cannulation practice. The Kidney Quality Improvement Partnership provides a structure for Managing Access by Generating Improvements in Cannulation that promotes development and dissemination. It is hoped that Managing Access by Generating Improvements in Cannulation will raise an understanding about the cannulation of arteriovenous access and change behaviours and beliefs around correct cannulation practice, to ensure longevity of this lifeline.

Patient-reported outcomes (PROs) are elicited directly from patients so they can describe their overall health status, including their symptoms, function, and quality of life. While commonly used as end points in clinical trials, PROs can play an important role in routine clinical care, population health management, and as a means for quantifying the quality of patient care. In this review, we propose that PROs be used to improve patient-centered care in the treatment of cardiovascular diseases given their importance to patients and society and their ability to improve doctor- provider communication. Furthermore, given the current variability in patients' health status across different clinics and the fact that PROs can be improved by titrating therapy, we contend that PROs have a key opportunity to serve as measures of healthcare quality., Competing Interests: Dr. Garcia is supported by the National Heart, Lung and Blood Institutes of Health Under Aware Number 5T32H110837. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH). Dr. Spertus discloses grant funding from NIH and Abbott Vascular. He serves on a scientific advisory board for United Healthcare and Blue Cross Blue Shield of Kansas City and is a consultant for Novartis, Bayer, AstraZeneca, Janssen, Merck, Myokardia, and Amgen. He has intellectual property rights for the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire and an equity interest in Health Outcomes Sciences.

Objective: Based on the concept of total quality management, the practice of managing needle-stick and sharps injuries was analyzed to improve nursing quality., Methods: Using total quality management, an improvement plan was completed. Standard operating procedures for infusion therapy and monitoring of the circulatory system were made to reduce the utilization of winged metal needles and the frequency of needle-stick injuries. From 2015 to 2018, four cross-sectional surveys were conducted on the use of winged metal needles, peripheral intravenous catheters, central venous catheters, peripherally inserted central catheters, and implantable venous access ports and the status of needle-stick and sharps injuries in our hospital during the 4 years., Results: Four cross-sectional surveys showed that the percentage of winged metal needle utilization decreased significantly from 13% to 0.5%, and that of peripheral intravenous catheters increased from 77% to 87%. Zero tolerance of winged metal needles increased from 33 to 60 nursing units, an improvement rate of 81.82%. The number of needle-stick injuries decreased from 71 to 21, a decrease of 70.42%. Needle-stick injuries occurred mainly during waste disposal (34.71%) and needle withdrawal (18.18%) and when recapping needles (9.92%)., Conclusion: Based on total quality management, the implementation of zero tolerance of winged metal needles is much better. The use of winged metal needles and the incidence of needle-stick injuries are reduced. Total quality management is of great clinical value in preventing needle-stick injuries.

Background: The aim of the present study is to develop relevant quality indicators (QI) to monitor and improve quality of care in vascular surgery., Methods: The Delphi method was used to incorporate expert opinion to reach consensus on a set of QI. A national expert panel consisting of 52 vascular surgeons was installed on a voluntary basis and endorsed by the Belgian Society of Vascular Surgery and the Flemish Hospital Network KU Leuven. A task force team consisting of 12 surgeons was created to serve as a delegation of the expert panel to discuss and filter the obtained data from the different Delphi rounds., Results: A total of 3 Delphi rounds were needed to reach consensus on a set of 20 QI. Each QI had a content validity index (using a 7-point Likert scale), a feasibility index, and a target level. Twelve outcome indicators and 8 process indicators on several vascular topics were selected: overall for all vascular treatments (n = 1), arterial occlusive disease in general (n = 3), arterial occlusive disease of the lower limbs (n = 4), arterial occlusive disease of the carotid arteries (n = 5), arterial aneurysm disease in general (n = 2), arterial aneurysm disease with endovascular treatment (n = 1), and venous disease (n = 4)., Conclusions: This resulted in the successful identification of 20 validated and relevant vascular QI, focusing on arterial occlusive disease, arterial aneurysm disease, and venous disease. The next step in this project will be the performance of an implementation study., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The situation of coronavirus disease 2019 (COVID-19) pandemic in the Indian subcontinent is worsening. In Bangladesh, rate of new infection has been on the rise despite limited testing facility. Constraint of resources in the health care sector makes the fight against COVID-19 more challenging for a developing country like Bangladesh. Vascular surgeons find themselves in a precarious situation while delivering professional services during this crisis. With the limited number of dedicated vascular surgeons in Bangladesh, it is important to safeguard these professionals without compromising emergency vascular care services in the long term. To this end, we at the National Institute of Cardiovascular Diseases and Hospital, Dhaka, have developed a working guideline for our vascular surgeons to follow during the COVID-19 pandemic. The guideline takes into account high vascular work volume against limited resources in the country., Methods: A total of 307 emergency vascular patients were dealt with in the first 4 COVID-19 months (March through June 2020) according to the working guideline, and the results were compared with the 4 pre-COVID-19 months. Vascular trauma, dialysis access complications, and chronic limb-threatening ischemia formed the main bulk of the patient population. Vascular health care workers were regularly screened for COVID-19 infection., Results: There was a 38% decrease in the number of patients in the COVID-19 period. Treatment outcome in COVID-19 months were comparable with that in the pre-COVID-19 months except that limb loss in the chronic limb-threatening ischemia patients was higher. COVID-19 infection among the vascular health care professionals was low., Conclusions: Vascular surgery practice guidelines customized for the high work volume and limited resources of the National Institute of Cardiovascular Diseases and Hospital, Dhaka were effective in delivering emergency care during COVID-19 pandemic, ensuring safety of the caregivers. Despite the fact that similar guidelines exist in different parts of the world, we believe that the present one is still relevant on the premises of a deepening COVID-19 crisis in a developing country like Bangladesh., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Study Question: Can a core outcome set to standardize outcome selection, collection, and reporting across future infertility research be developed?, Summary Answer: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCT) and systematic reviews evaluating potential treatments for infertility., What Is Known Already: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions, and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret., Study Design, Size, Duration: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries)., Participants/materials, Setting, Methods: Healthcare professionals, researchers, and people with fertility problems were brought together in an open and transparent process using formal consensus science methods., Main Results and the Role of Chance: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin, and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable., Limitations, Reasons for Caution: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition, and an arbitrary consensus threshold., Wider Implications of the Findings: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection, and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Ferility and Sterility, and Human Reproduction, have committed to implementing this core outcome set., Study Funding/competing Interest(s): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund, and Maurice and Phyllis Paykel Trust. Siladitya Bhattacharya reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. Hans Evers reports being the Editor Emeritus of Human Reproduction. José Knijnenburg reports research sponsorship from Ferring and Theramex. Richard Legro reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. Ben Mol reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. Craig Niederberger reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. Annika Strandell reports consultancy fees from Guerbet. Ernest Ng reports research sponsorship from Merck. Lan Vuong reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form., Trial Registration Number: Core Outcome Measures in Effectiveness Trials Initiative: 1023., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The Society for Vascular Surgery (SVS) created Objective Performance Goals (OPGs) for critical limb ischemia (CLI) in 2009. It was previously shown that endovascular therapy for CLI was not meeting these benchmarks. The OPG for all peripheral interventions is <8% for major adverse cardiac events (MACE), <8% for major adverse limb events (MALE), and <3% for major amputation. The goal of this study is to evaluate if outcomes have improved for CLI in recent years, specifically 2015-2018., Methods: The Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) was queried to identify patients who underwent endovascular intervention for critical limb ischemia from 2011-2018. Cohorts were divided into 2011-2014 and 2015-2018. Primary 30-day outcomes were MACE, MALE, and major amputation. Univariate analyses were performed using the Fisher's exact test and the Wilcoxon rank-sum test. Multivariate analysis comparing groups was performed using inverse probability weights and trend over time analysis was performed using logistic regression with year of intervention as a continuous variable., Results: From 2011 to 2018, 7,168 patients underwent an endovascular intervention for CLI. 28% were classified as "OPG high anatomic risk," and 17% were classified as "OPG high clinical risk." The 2015-2018 cohort vs. the 2011-14 cohort experienced MACE in 3.3% vs. 2.7% (p = .23), MALE in 9.1% vs. 8.9% (p = 0.83), and amputation in 4.0% vs. 4.2% (p = 0.71). When only high anatomic risk patients were considered (n = 1988), MACE was experienced in 2.4% vs. 2.2% (p = 0.87), MALE by 9.5% vs. 10.6% (p = 0.47) and amputation by 5.1% vs. 6.0% (p = 0.40). When only high clinical risk patients were considered (n = 1224), MACE was experienced in 5.2% vs. 3.9% (p = 0.33), MALE by 8.0% vs. 7.4% (p = 0.74) and amputation by 3.9% vs. 3.7% (p = 0.88). Comparing 2015-2018 to the reference 2011-2014, MALE adjusted odds ratio (AOR) = 0.99, 95% CI [0.83-1.18], MACE AOR = 1.19 95% CI [0.88-1.60], and major amputation AOR = 0.91 95% CI [0.70-1.17]. There were no decreases in the trend over time for MALE (AOR per year 0.97, CI [.94-1.02], major amputation (AOR per year: 0.97, CI [0.91-1.03], nor for MACE (AOR per year: 1.05, CI [.98-1.13])., Conclusion: Outcomes following endovascular interventions for CLI continue to underperform when compared to OPG benchmarks for MALE and amputations. There is no decrease over time for these target outcomes. Target MACE events remain acceptable despite the increasing clinical complexity of patients being treated.

Mandatory measurement and disclosure of outcome measures are commonly used policy tools in healthcare. The effectiveness of such disclosures relies on the extent to which the new information produced by the mandatory system is internalized by the healthcare organization and influences its operations and decision-making processes. We use panel data from the Japanese National Hospital Organization to analyze performance improvements following regulation mandating standardized measurement and peer disclosure of patient satisfaction performance. Drawing on value of information theory, we document the absolute value and the benchmarking value of new information for future performance. Controlling for ceiling effects in the opportunities for improvement, we find that the new patient satisfaction measurement system introduced positive, significant, and persistent mean shifts in performance (absolute value of information) with larger improvements for poorly performing hospitals (benchmarking value of information). Our setting allows us to explore these effects in the absence of confounding factors such as incentive compensation or demand pressures. The largest positive effects occur in the initial period, and improvements diminish over time, especially for hospitals with poorer baseline performance. Our study provides empirical evidence that disclosure of patient satisfaction performance information has value to hospital decision makers.

Background: Little is known about adherence to American Heart Association/American Stroke Association (AHA/ASA) stroke performance measures in developing countries like Peru., Aims: We assessed adherence and determined factors associated with adherence to the AHA/ASA stroke performance measures at a reference center for neurological diseases in Lima, Peru., Methods: We conducted a retrospective chart review of 150 stroke patients admitted to the Neurological Institute of Neurological Science from 2014 to 2016 to ascertain adherence to 15 different AHA/ASA stroke performance measures. Adherence was measured as a simple proportion, with both single and composite measures. Associations were analyzed with nonparametric statistics and multivariate logistic regression., Results: Mean adherence to AHA/ASA stroke performance measures was 47%. We observed a statistically significant relationship between adherence to ischemic stroke performance measures and being married (OR = 3.78, 95% CI: 1.05-13.55), as well as an inverse relationship with an onset of symptoms of greater than 4.5 h prior to arrival at the hospital compared to those with ≤ 4.5 h (OR = 0.14, 95% CI: 0.02-0.97). Compared to patients with a lower National Institutes of Health Stroke Scale (NIHSS) score (<13), those with a score of ≥13 were less likely to have good adherence (OR = 0.11, 95% CI: 0.04-0.31)., Conclusions: The mean composite measure of adherence to internationally recognized standards of stroke management in our Peruvian institution was below the level needed for an achievement award by AHA/ASA. An intervention targeted toward stroke prevention and training could lead to improved outcomes of stroke patients in Peru., Competing Interests: Declaration of Interest None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Identifying actionable resuscitation practices that vary across hospitals could improve adherence to process measures or outcomes after in-hospital cardiac arrest (IHCA). We sought to examine whether hospital debriefing frequency after IHCA varies across hospitals and whether hospitals which routinely perform debriefing have higher rates of process-of-care compliance or survival. Methods We conducted a nationwide survey of hospital resuscitation practices in April of 2018, which were then linked to data from the Get With The Guidelines-Resuscitation national registry for IHCA. Hospitals were categorized according to their reported frequency of debriefing immediately after IHCA; rarely (0%-20% of all IHCA cases), occasionally (21%-80%), and frequently (81%-100%). Hospital-level rates of timely defibrillation (≤2 minutes), epinephrine administration (≤5 minutes), survival to discharge, return of spontaneous circulation, and neurologically intact survival were comparted for patients with IHCA from 2015 to 2017. Results Overall, there were 193 hospitals comprising 44 477 IHCA events. Mean patient age was 65±16, 41% were females, and 68% were of White race. Across hospitals, 84 (43.5%) rarely performed debriefings immediately after an IHCA, 82 (42.5%) performed debriefing sessions occasionally, and 27 (14.0%) performed debriefing frequently. There was no association between higher reported debriefing frequency and hospital rates of timely defibrillation and epinephrine administration. Mean hospital rates of risk-standardized survival to discharge were similar across debriefing frequency groups (rarely 25.6%; occasionally 26.0%; frequently 25.2%, P =0.72), as were hospital rates of risk-adjusted return of spontaneous circulation (rarely 72.2%; occasionally 73.0%; frequently 70.0%, P =0.06) and neurologically intact survival (rarely 21.9%, occasionally 22.2%, frequently 21.1%, P =0.75). Conclusions In a large contemporary nationwide quality improvement registry, hospitals varied widely in how often they conducted debriefings immediately after IHCA. However, hospital debriefing frequency was not associated with better adherence to timely delivery of epinephrine or defibrillation or higher rates of IHCA survival.

Background: Target lesion percutaneous coronary intervention (TLPCI) within 1 year of PCI has been proposed by critics of public reporting of short-term mortality as an alternative measure for PCI reporting., Methods: New York's PCI registry was used to identify 1-year repeat TLPCI and 1-year repeat TLPCI/mortality for patients discharged between December 1, 2013 and November 30, 2014. Significant independent predictors of the outcomes were identified. Hospital and cardiologist risk-adjusted outcomes were calculated, and outlier status and correlations of risk-adjusted rates were examined for the three outcomes., Results: The adverse outcome rates were 1.30, 4.21, and 8.97% for in-hospital/30-day mortality, 1-year repeat TLPCI, and 1-year repeat TLPCI/mortality. There were many commonalities but also many differences in significant predictors of the outcomes. Hospital and cardiologist risk-adjusted 1-year repeat TLPCI rates and repeat TLPCI/mortality rates were poorly correlated with risk-adjusted in-hospital/30-day mortality rates (eg, Spearman R = -.16 [p = .23] and .27 [p = .04], respectively, for hospital 1-year repeat TLPCI vs. in-hospital/30-day mortality). Many more providers were found to have significantly higher and lower rates for repeat TLPCI than for short-term mortality., Conclusions: Hospital and cardiologist quality assessments are very different for TLPCI and repeat TLPCI/mortality than they are for short-term mortality. Repeat TLPCI/mortality rates are highly correlated with repeat TLPCI rates, but outlier providers differ. More study of repeat TLPCI and all the patient, cardiologist, and hospital factors associated with it may be required before using it as a supplement to, or in lieu of, short-term mortality in public reporting of PCI outcomes., (© 2019 Wiley Periodicals, Inc.)

Objective: Composite measures may better objectify hospital performance than individual outcome measures (IOM). Textbook outcome (TO) is an outcome measure achieved for an individual patient when all undesirable outcomes are absent. The aim of this study was to assess TO as an additional outcome measure to evaluate quality of care in symptomatic patients treated by carotid endarterectomy (CEA)., Methods: All symptomatic patients treated by CEA in 2018, registered in the Dutch Audit for Carotid Interventions, were included. TO was defined as a composite of the absence of 30 day mortality, neurological events (any stroke or transient ischaemic attack [TIA]), cranial nerve deficit, haemorrhage, 30 day readmission, prolonged length of stay (LOS; > 5 days) and any other surgical complication. Multivariable logistic regression was used to identify covariables associated with achieving TO, which were used for casemix adjustment for hospital comparison. For each hospital, an observed vs. expected number of events ratio (O/E ratio) was calculated and plotted in a funnel plot with 95% control limits., Results: In total, 70.7% of patients had a desired outcome within 30 days after CEA and therefore achieved TO. Prolonged LOS was the most common parameter (85%) and mortality the least common (1.1%) for not achieving TO. Covariates associated with achieving TO were younger age, the absence of pulmonary comorbidity, higher haemoglobin levels, and TIA as index event. In the case mix adjusted funnel plot, the O/E ratios between hospitals ranged between 0.63 and 1.27, with two hospitals revealing a statistically significantly lower rate of TO (with O/E ratios of 0.63 and 0.66)., Conclusion: In the Netherlands, most patients treated by CEA achieve TO. Variation between hospitals in achieving TO might imply differences in performance. TO may be used as an additive to the pre-existing IOM, especially in surgical care with low baseline risk such as CEA., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Importance: Hospital safety culture remains a critical consideration when seeking to reduce medical errors and improve quality of care. Little is known regarding whether participation in a comprehensive, multicomponent, statewide quality collaborative is associated with changes in hospital safety culture., Objective: To examine whether implementation of a comprehensive, multicomponent, statewide surgical quality improvement collaborative is associated with changes in hospital safety culture., Design, Setting, and Participants: In this survey study, the Safety Attitudes Questionnaire, a 56-item validated survey covering 6 culture domains (teamwork, safety, operating room safety, working conditions, perceptions of management, and employee engagement), was administered to a random sample of physicians, nurses, operating room staff, administrators, and leaders across Illinois hospitals to assess hospital safety culture prior to launching a new statewide quality collaborative in 2015 and then again in 2017. The final analysis included 1024 respondents from 36 diverse hospitals, including major academic, community, and rural centers, enrolled in ISQIC (Illinois Surgical Quality Improvement Collaborative)., Exposures: Participation in a comprehensive, multicomponent statewide surgical quality improvement collaborative. Key components included enrollment in a common standardized data registry, formal quality and process improvement training, participation in collaborative-wide quality improvement projects, funding support for local projects, and guidance provided by surgeon mentors and process improvement coaches., Main Outcomes and Measures: Perception of hospital safety culture., Results: The overall survey response rate was 43.0% (580 of 1350 surveys) in 2015 and 39.0% (444 of 1138 surveys) in 2017 from 36 hospitals. Improvement occurred in all the overall domains, with significant improvement in teamwork climate (change, 3.9%; P = .03) and safety climate (change, 3.2%; P = .02). The largest improvements occurred in individual measures within domains, including physician-nurse collaboration (change, 7.2%; P = .004), reporting of concerns (change, 4.7%; P = .009), and reduction in communication breakdowns (change, 8.4%; P = .005). Hospitals with the lowest baseline safety culture experienced the largest improvements following collaborative implementation (change range, 11.1%-14.9% per domain; P < .05 for all). Although several hospitals experienced improvement in safety culture in 1 domain, most hospitals experienced improvement across several domains., Conclusions and Relevance: This survey study found that hospital enrollment in a statewide quality improvement collaborative was associated with overall improvement in safety culture after implementing multiple learning collaborative strategies. Hospitals with the poorest baseline culture reported the greatest improvement following implementation of the collaborative.

Introduction: Subthalamic nucleus deep brain stimulation (STN DBS) for Parkinson disease (PD) normalizes neuronal hypersynchrony in the beta frequency range (13-30 Hz). The spatial correspondence of maximal beta power to the site of optimal stimulation along the DBS lead trajectory has been debated., Methods: We determined the trajectory locations of the active contact, maximal beta power, and the dorsal border of the STN (DB-STN) in DBS patients. Beta power profiles were measured during intraoperative microelectrode recording (MER). Active contact locations were assigned during blinded, postoperative DBS programming. The DB-STN was identified both electrophysiologically during MER and anatomically on MRI. After grouping DBS trajectories into quadrants relative to the anatomic STN midpoint, we examined regional variations in the relative trajectory locations of the three entities., Results: STN DBS significantly improved motor performance for all 13 DBS patients, with active contacts at the DB-STN. Along trajectories passing posterior-medial to the STN midpoint, maximal beta power co-localized with active contacts at the DB-STN (difference Δ = 0.4 ± 1.6 mm, p = 0.57). By contrast, in posterior-lateral trajectories, maximal beta arose within the STN, ventral to active contacts (Δ = 1.9 ± 1.3 mm, p = 0.002). For trajectories anterior to the STN midpoint, maximal beta power co-localized with the DB-STN, while active contacts were ventral to peak beta power (p = 0.05)., Conclusion: Our findings indicate that co-localization of optimal stimulation and beta power varies by anatomical region in STN DBS for Parkinson disease., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Located on the Borneo Island, Sarawak is the largest state of Malaysia and has a population distinctive from Peninsular Malaysia. The ischaemic stroke data in Sarawak had not been reported despite the growing number of patients annually. We aimed to investigate patient characteristics, management, and outcomes of ischaemic stroke in Sarawak and benchmark the results with national and international published data., Methods: We included ischaemic stroke cases admitted to Sarawak General Hospital between June 2013 and August 2018 from Malaysia National Stroke Registry. We performed descriptive analyses on patient demographics, cardiovascular risk factors, prior medications, smoking status, arrival time, thrombolysis rate, Get With The Guidelines (GWTG)-Stroke measures, and outcomes at discharge. We also numerically compared the results from Sarawak with the published data from selected national and international cohorts., Results: We analysed 1435 ischaemic stroke cases. The mean age was 60.1±13.2 years old; 64.9% were male; median baseline National Institute of Health Stroke Scale was seven points. Hypertension was the most prevalent risk factor of ischaemic stroke; 12.7% had recurrent stroke; 13.7% were active smokers. The intravenous thrombolysis rate was 18.8%. We achieved 80-90% in three GWTG-Stroke performance measures and 90-98% in four additional quality measures in our ischaemic stroke management. At discharge, 57% had modified Rankin Scale of 0-2; 6.7% died during hospitalisation. When compared with selected national and international data, patients in Sarawak were the youngest; Sarawak had more male and more first-ever stroke. Thrombolysis rate in Sarawak was higher compared with most studies in the comparison. Functional outcome at discharge in Sarawak was better than national cohort but still lagging behind when compared with the developed countries. In-hospital mortality rate in Sarawak was slightly lower than the national data but higher when compared with other countries., Conclusion: Our study described characteristics, management, and outcomes of ischaemic stroke in Sarawak. We achieved high compliance with most of GTWG-Stroke performance and quality indicators. Sarawak had better outcomes than the national results on ischaemic stroke. However, there is still room for improvement when compared with other countries. Actions are needed to reduce the cardiovascular burdens for stroke prevention, enhance healthcare resources for stroke care, and improve intravenous thrombolysis treatment in Sarawak., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Professional societies publish clinical practice guidelines to provide evidence-based recommendations to improve care and to reduce practice variation. However, the degree of compliance with the guidelines and its impact on outcomes have not been well defined. This study used the Vascular Quality Initiative (VQI) abdominal aortic aneurysm (AAA) registries to determine current compliance with and impact of recent Society for Vascular Surgery (SVS) AAA guidelines., Methods: Recommendations from the SVS AAA guidelines were reviewed and assessed as to whether they could be evaluated with current VQI data sets. The degree of compliance with these individual recommendations was calculated by center and correlated with clinical outcomes. Data were analyzed by univariate analysis and mixed effects multivariable logistic regression. Statistical significance was measured at P < .05., Results: Of the 111 SVS recommendations, 10 could be evaluated using VQI registries. The mean center-specific compliance rate ranged from 40% (smoking cessation 2 weeks before open AAA [OAAA] repair) to 99% (preservation of flow to one internal iliac artery during endovascular aneurysm repair [EVAR]). Some recommendations were associated with improved outcomes (eg, cell salvage for OAAA repair and antibiotic prophylaxis), whereas others were not (eg, EVAR at a center with >10 cases per year or door-to-intervention time <90 minutes for ruptured AAA). With multivariable analysis, compliance with preservation of flow to the internal iliac artery decreased major adverse cardiac events in EVAR and marginally decreased in-hospital and 1-year mortality in OAAA repair. Antibiotic administration decreased surgical site infection, major adverse cardiac events, and in-hospital mortality and marginally decreased respiratory complications and 1-year mortality in EVAR. Cell salvage for OAAA repair decreased 1-year mortality. Tobacco cessation before EVAR or OAAA repair decreased respiratory complications and 1-year mortality., Conclusions: The VQI registry is a valuable tool that can be used to measure compliance with SVS AAA guidelines. Compliance with recommendations was associated with improved outcomes and should be encouraged for providers. Participation in the VQI registry provides an objective assessment of performance and compliance with guidelines. VQI provider and center reports may be used as a focus for quality improvement efforts., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Gestational diabetes mellitus is a rising global public health problem that can have short- and long-term sequelae for both mother and offspring. However, there are limited evidences on the effect of gestational diabetes mellitus on adverse neonatal outcomes using the updated international diagnostic criteria on adverse effects on neonatal outcomes. Therefore, this study was aimed to examine the effects of gestational diabetes mellitus on the risk of adverse neonatal outcomes in Ethiopia., Methods: A prospective cohort study was conducted among pregnant women recruited from antenatal clinics and followed through pregnancy to delivery. Gestational diabetes mellitus was diagnosed using a two-hour 75g oral glucose tolerance test strategy with recent criteria. Multivariable log-binomial model was used to identify the effects of gestational diabetes mellitus on the risk of adverse neonatal outcomes which includes macrosomia, low birth weight, large for gestational age, small for gestational age, preterm birth, low Apgar score at the first minute, low Apgar score at fifth minute, and composite adverse neonatal outcome., Results: Among pregnant women (n=1027) included in the follow up data on neonatal outcomes were available for 684 (118 newborns of mothers with gestational diabetes mellitus and 566 newborns of women without gestational diabetes mellitus). There was a statistical baseline difference between the two groups by maternal age, dietary diversity status, level of physical activity, and antenatal depression. The incidence of composite adverse neonatal outcome was significantly higher (P<0.001) among newborns from mothers with gestational diabetes mellitus (51.7%) than among newborns from mothers without gestational diabetes mellitus (25.8%). Significantly higher risk of developing adverse neonatal outcomes among newborns from gestational diabetes mellitus mothers was observed for composite adverse neonatal outcome (Adjust Relative Risk (ARR)=1.72; 95% CI: 1.35, 2.19), macrosomia (ARR= 3.81; 95% CI: 1.95, 7.45), large for gestational age (ARR= 2.38; 95% CI: 1.41, 4.03), preterm birth (ARR= 2.03; 95% CI: 1.17, 3.53), low Apgar score at the first minute (ARR= 1.71; 95% CI: 1.02, 2.86), and fifth minute (ARR= 2.14; 95% CI: 1.05, 4.36). However, no significant differences in the risk of low birth weight and small for gestational age by gestational diabetes mellitus status., Conclusions: Gestational diabetes mellitus increases the risk of adverse neonatal outcomes particularly macrosomia, large for gestational age, preterm birth, and poor Apgar score. Hence, the role of preventing gestational diabetes mellitus is quite crucial to improve neonatal outcomes., Competing Interests: Declaration of Competing Interest None declared, (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Health care quality metrics are crucial to medical institutions, payers, and patients. Obtaining current and reliable quality data is challenging, as publicly reported databases lag by several years. Vizient Clinical Data Base (previously University Health Consortium) is utilized by over 5,000 academic and community medical centers to benchmark health care metrics with results based on predetermined Vizient service lines. We sought to assess the accuracy and reliability of vascular surgery service line metrics, as determined by Vizient., Methods: Vizient utilizes encounter data submitted by participating medical centers and generates a diverse array of health care metrics ranging from mortality to costs. All inpatient cases captured by Vizient under the vascular surgery service line were identified at the University of Massachusetts Medical Center (fiscal year 2016). Each case within the service line was reviewed and categorized as "vascular" or "nonvascular" based on care provided by UMass vascular surgery faculty: vascular = vascular surgery was integral part of care, nonvascular = vascular surgery had minimal or no involvement. Statistical analysis comparing length of stay (LOS), cost, readmission, mortality, and complication rates between vascular and nonvascular cohorts was performed. All inpatient cases discharged by a vascular surgeon National Provider Identifier number were also reviewed and categorized according to Vizient service lines., Results: Vizient's vascular surgery service line identified 696 cases, of which 556 (80%) were vascular and 140 (20%) were nonvascular. When comparing these 2 cohorts, vascular cases had a significantly lower LOS (3.4 vs. 8.7 days; P < 0.0001), cost ($8,535 vs. $16,498; P < 0.0001), and complication rate (6.5% vs. 18%; P < 0.0001) than nonvascular. Mortality was also lower (1.6% vs. 5.7%; P < 0.01), but after risk-adjustment, this difference was not significant. When discharging vascular surgeon National Provider Identifier was used to identify vascular surgery cases, only 69% of these cases were placed within the vascular surgery service line., Conclusions: Health care quality metrics play an important role for all stakeholders but obtaining accurate and reliable data to implement improvements is challenging. In this single institution experience, inpatient cases that were not under the direction or care of a vascular surgeon resulted in significantly negative impacts on LOS, cost, complication rate, and mortality to the vascular surgery service line, as defined by a national clinical database. Therefore, clinicians must understand the data abstracting and reporting process before implementing effective strategic plans., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Separation from extracorporeal life support (ECLS) is often based on individual decisions rather than evaluated standard operating procedures (SOPs). Therefore, we strived to evaluate a SOP, summarizing specific treatment paths for this group of patients., Methods: A total of 107 cardiovascular patients were supported with ECLS within a 4-year period. Fifty-three patients were treated before the SOP was introduced (group A) and 54 patients were treated afterward (group B). Patient characteristics and outcomes were analyzed and compared between the two time periods regarding baseline characteristics, compliance with SOP criteria, and the end points successful weaning and 30-day survival., Results: Successful weaning rose significantly from 56.6 to 74.1% ( p  = 0.045) and 30-day survival rate increased from 34.0 to 50.0% ( p  = 0.069) after implementation of the SOP. Successful weaning was significantly associated with daily echocardiography ( p  = 0.012) and circulatory support with dobutamine ( p  = 0.026). The investigated other criteria used in the weaning process did not show a significant correlation with better outcome., Conclusion: The SOP for ECLS weaning showed higher weaning rates compared with a weaning based on individual decisions. Although only parts of the SOP were associated with higher weaning and survival rates, the SOP was experienced as a useful guideline for standardized ECLS management., Competing Interests: Dr. Trummer reports personal fees from Resuscitec GmbH, outside the submitted work. All other authors have no conflict of interest., (Georg Thieme Verlag KG Stuttgart · New York.)

Cardiovascular registries play an integral role in providing real-world data on a number of cardiovascular conditions and allowing measurement of quality metrics across a large cohort of patients. Over the past 35 years, the number of cardiovascular registries has skyrocketed, and their use will only continue to grow as data on novel procedures and devices will need to be collected and analyzed. The American College of Cardiology and Society of Thoracic Surgeons Transcatheter Valve Therapy Registry is just one example of a modern registry that plays a crucial role in collecting data on patients undergoing transcatheter valvular procedures. Through public reporting registries, data can be shared on a hospital and provider level for many quality performance measures. There remains much work to be done on allowing automated data extraction from the electronic medical record directly into registries. No matter how sophisticated and complete a registry is, it can never overcome the problem of treatment selection bias that is inherent in observational data. This review discusses the growth, benefits, and limitations of national registries and their role in developing evidence for best clinical practice, measuring outcomes, providing feedback to clinicians, and improving quality of care., Competing Interests: Conflict of Interest Disclosure: The author has completed and submitted the Methodist DeBakey Cardiovascular Journal Conflict of Interest Statement and none were reported., (© 2020 Houston Methodist Hospital Houston, Texas.)

Over the past two decades, Medicare and other payers have been looking at ways to base payment for cardiovascular care on the quality and outcomes of care delivered. Public reporting of hospital performance on a series of quality measures began in 2004 with basic processes of care such as aspirin use and influenza vaccination, and it expanded in later years to include outcomes such as mortality and readmission rates. Following the passage of the Affordable Care Act in March 2010, Medicare and other payers moved forward with pay-for-performance programs, more commonly referred to as value-based purchasing (VBP) programs. These programs are largely based on an underlying fee-for-service payment infrastructure and give hospitals and clinicians bonuses or penalties based on their performance. Another new payment mechanism, called alternative payment models (APMs), aims to move towards episode-based or global payments to improve quality and efficiency. The two most relevant APMs for cardiovascular care include Accountable Care Organizations and bundled payments. Both VBP programs and APMs have challenges related to program efficacy, accuracy, and equity. In fact, despite over a decade of progress in measuring and incentivizing high-quality care delivery within cardiology, major limitations remain. Many of the programs have had little benefit in terms of clinical outcomes yet have led to marked administrative burden for participants. However, there are several encouraging prospects to aid the successful implementation of value-based high-quality cardiovascular care, such as more sophisticated data science to improve risk adjustment and flexible electronic health records to decrease administrative burden. Furthermore, payment models designed specifically for cardiovascular care could incentivize innovative care delivery models that could improve quality and outcomes for patients. This review provides an overview of current efforts, largely at the federal level, to pay for high-quality cardiovascular care and discusses the challenges and prospects related to doing so., Competing Interests: Conflict of Interest Disclosure: Dr. Joynt Maddox does contract work for the United States Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. There are no other financial conflicts of interest to report., (© 2020 Houston Methodist Hospital Houston, Texas.)

The American health care system has many great successes, but there continue to be opportunities for improving quality, access, and cost. The fee-for-service health care paradigm is shifting toward value-based care and will require accountability around quality assurance and cost reduction. As a result, many health care entities are rallying health care providers, administrators, regulators, and patients around a national imperative to create a culture of safety and develop systems of care to improve health care quality. However, the culture of patient safety and quality requires rigorous assessment of outcomes, and while numerous data collection and decision support tools are available to assist in quality assessment and performance improvement, the public reporting of this data can be confusing to patients and physicians alike and result in unintended negative consequences. This review explores the aims of health care reform, the national efforts to create a culture of quality and safety, the principles of quality improvement, and how these principles can be applied to patient care and medical practice., Competing Interests: Conflict of Interest Disclosure: The author has completed and submitted the Methodist DeBakey Cardiovascular Journal Conflict of Interest Statement and none were reported., (© 2020 Houston Methodist Hospital Houston, Texas.)

Background: In Thailand, hospital accreditation (HA) is widely recognized as one of the system tools to promote effective operation of universal health coverage. This nationwide study aims to examine the relationship between accredited statuses of the provincial hospitals and their mortality outcomes., Method: A 5-year retrospective analysis of the Universal Coverage Scheme's claim dataset was conducted, using 1 297 869 inpatient discharges from 76 provincial hospital networks under the Ministry of Public Health. Mortality outcomes of 3 major acute care conditions, including acute myocardial infarction, acute stroke, and sepsis, were selected., Results: Using generalized estimating equations to adjust for area-based control variables, hospital networks with HA-accredited provincial hospitals showed significant associations with lower standardized mortality ratios of acute stroke and sepsis., Conclusion: Our findings added supportive evidence that HA, as an organizational and health system management tool, could help promote hospital quality and safety in a developing country, leading to better outcomes.

Background: Central line-associated bloodstream infections are serious life-threatening infections in the intensive care unit setting., Methods: To analyze the impact of the International Nosocomial Infection Control Consortium (INICC) Multidimensional Approach (IMA) and INICC Surveillance Online System (ISOS) on central line-associated bloodstream infection rates in Bahrain from January 2013 to December 2016, we conducted a prospective, before-after surveillance, cohort, observational study in one intensive care unit in Bahrain. During baseline, we performed outcome and process surveillance of central line-associated bloodstream infection on 2320 intensive care unit patients, applying Centers for Disease Control and Prevention's National Healthcare Safety Network definitions. During intervention, we implemented IMA through ISOS, including (1) a bundle of infection prevention interventions, (2) education, (3) outcome surveillance, (4) process surveillance, (5) feedback on central line-associated bloodstream infection rates and consequences, and (6) performance feedback of process surveillance. Bivariate and multivariate regression analyses were performed using a logistic regression model to estimate the effect of the intervention on the central line-associated bloodstream infection rate., Results: During baseline, 672 central line days and 7 central line-associated bloodstream infections were recorded, accounting for 10.4 central line-associated bloodstream infections per 1000 central line days. During intervention, 13,020 central line days and 48 central line-associated bloodstream infections were recorded. After the second year, there was a sustained 89% cumulative central line-associated bloodstream infection rate reduction to 1.2 central line-associated bloodstream infections per 1000 central line days (incidence density rate, 0.11; 95% confidence interval 0.1-0.3; p, 0.001). The average extra length of stay of patients with central line-associated bloodstream infection was 23.3 days, and due to the reduction of central line-associated bloodstream infections, 367 days of hospitalization were saved, amounting to a reduction in hospitalization costs of US$1,100,553., Conclusion: Implementing IMA was associated with a significant reduction in the central line-associated bloodstream infection rate in Bahrain.

Cardiac rehabilitation is a comprehensive model of secondary prevention proven to reduce mortality and morbidity. The World Health Organization is developing a Package of Rehabilitation Interventions for implementation by ministries of health as part of universal healthcare across the continuum. Through a systematic review, we sought to identify the best-quality cardiac rehabilitation guidelines, and extract their recommendations for implementation by member states. A systematic search was undertaken of academic databases and guideline repositories, among other sources, through to April 2019, for English-language cardiac rehabilitation guidelines from the last 10 years, free from conflicts, and with strength of recommendations. Two authors independently considered all citations. Potentially eligible guidelines were rated for quality using the Appraisal of Guidelines for Research and Evaluation tool, and for other characteristics such as being multi-professional, comprehensive and international in perspective; the latter criteria were used to inform selection of 3-5 guidelines meeting inclusion criteria. Equity considerations were also extracted. Altogether, 2076 unique citations were identified. Thirteen passed title and abstract screening, with six guidelines potentially eligible for inclusion in the Package of Rehabilitation Interventions and rated for quality; for two guidelines the Appraisal of Guidelines for Research and Evaluation tool ratings did not meet World Health Organization minimums. Of the four eligible guidelines, three were selected: the International Council of Cardiovascular Prevention and Rehabilitation (2016), National Institute for Health and Care Excellence (#172; 2013) and Scottish Intercollegiate Guideline Network (#150; 2017). Extracted recommendations were comprehensive, but psychosocial recommendations were contradictory and diet recommendations were inconsistent. A development group of the World Health Organization will review and refine the recommendations which will then undergo peer review, before open source dissemination for implementation.

Background: Access to specialty palliative care delivery in the intensive care unit is inconsistent across institutions. The intensive care unit at the study institution uses a screening tool to identify patients likely to benefit from specialty palliative care, yet little is known about outcomes associated with the use of screening tools., Objective: To identify outcomes associated with specialty palliative care referral among patients with critical illness., Methods: Records of 112 patients with positive results on palliative care screening were retrospectively reviewed to compare outcomes between patients who received a specialty palliative care consult and those who did not. Primary outcome measures were length of stay, discharge disposition, and escalation of care., Results: Sixty-five patients (58%) did not receive a palliative care consult. No significant differences were found in length of hospital or intensive care unit stay. Most patients who experienced mechanical ventilation did not receive a palliative care consultation (χ2 = 5.14, P = .02). Patients who were discharged to home were also less likely to receive a consult (χ2 = 4.1, P = .04), whereas patients who were discharged to hospice were more likely to receive a consult (χ2 = 19.39, P < .001)., Conclusions: Unmet needs exist for specialty palliative care. Understanding the methods of identifying patients for specialty palliative care and providing them with such care is critically important. Future research is needed to elucidate the factors providers use in their decisions to order or defer specialty palliative care consultation., (©2020 American Association of Critical-Care Nurses.)

This article examines approaches for improving the efficiency and effectiveness of quality metrics currently in use in neonatal care. Desirable characteristics of quality metrics are discussed, the criteria and process for their development are presented, and the uses and limitations of current neonatal outcome and process metrics are explored together with approaches for improving metric performance. Discussion includes enhancing quality metrics through optimizing improvement readiness, sustaining improvements once achieved, and use of improvement science methods to improve metric validity., Competing Interests: Declaration of Competing Interest The authors have no conflicts to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: We compared screening methods for asymptomatic venous thromboembolism (VTE) in patients with acute spine and spinal cord injuries (SCI). Patients were screened by D-dimer monitoring alone (DS group) or by D-dimer monitoring combined with ultrasonography (DUS group). Design: Prospective cohort study. Setting: One department of a university hospital in Japan. Participants: 114 patients treated for acute SCI between 2011 and 2017. Interventions: N/A. Outcome Measures: D-dimers were measured upon admission and 1, 3, 5, 7, and 14 days thereafter. DUS-group patients also underwent an ultrasound 7 days after admission. If ultrasonography indicated deep venous thrombosis (DVT), or if D-dimer levels increased to ≥ 10 µg/mL, the patient was assessed for VTE, including DVT or pulmonary embolism (PE), by contrast venography. We analyzed the incidence of VTE detected in the DS and DUS groups. Results: In the DS group, D-dimers were elevated (≥ 10 µg/mL) in 15 of 70 patients (21.4%), and 9 of the 15 had asymptomatic VTE (12.9%, DVT 11.4%, PE 5.7%). In the DUS group, one patient developed VTE on day 4, and D-dimers were elevated in 13 of 43 patients (30.2%), ultrasonography indicated DVT in 12 patients (27.9%), and asymptomatic VTE was diagnosed in 12 patients (27.9%, DVT 27.9%, PE 4.7%). The DUS group had a higher incidence of DVT (P = 0.002) and VTE (P = 0.042) than the DS group. Conclusions: Combined D-dimer and ultrasound screening in patients with acute SCI improved the detection of VTE, including PE, compared with D-dimer screening alone.

Objective: to construct conceptual and operational definitions of Nursing Outcomes "Breastfeeding establishment: infant (1000)" and "Breastfeeding establishment: maternal (1001)"., Method: integrative literature review in the following databases: PUBMED (United States National Library of Medicine); LILACS (Latin American and Caribbean Health Sciences Literature); CINAHL (Cumulative Index to Nursing and Allied Health Literature); SciVerse SCOPUS; Web of Science; BDENF (Brazilian Nursing Database) and EMBASE (Excerpta Medica Database). The gray literature was explored to elucidate topics not covered by the articles. Of 3242 articles, 96 were selected to be read in full, and 43 were used for constructing the definitions. Five theses, three dissertations, three books and two manuals were selected., Results: all the results were reviewed. The definitions facilitated the improvement of the content proposed by the Nursing Outcomes Classification, favoring its application in clinical practice and supporting the development of research and teaching., Conclusion: it was proposed to change the definition of the two outcomes, as well as to change the title of one of them to "Breastfeeding establishment: newborn & infant" (1000), modifying seven of its indicators and excluding one. For the outcome related to the mother, it was proposed to modify two indicators and exclude one.

Background Sustained return of spontaneous circulation (ROSC) is the most proximal and direct assessment of acute resuscitation quality in hospitals. However, validated tools to benchmark hospital rates for ROSC after in-hospital cardiac arrest currently do not exist. Methods and Results Within the national Get With The Guidelines-Resuscitation registry, we identified 83 206 patients admitted from 335 hospitals from 2014 to 2017 with in-hospital cardiac arrest. Using hierarchical logistic regression, we derived and validated a model for ROSC, defined as spontaneous and sustained ROSC for ≥20 consecutive minutes, from 24 pre-arrest variables and calculated rates of risk-standardized ROSC for in-hospital cardiac arrest for each hospital. Overall, rates of ROSC were 72.0% and 72.7% for the derivation and validation cohorts, respectively. The model in the derivation cohort had moderate discrimination (C-statistic 0.643) and excellent calibration ( R 2 of 0.996). Seventeen variables were associated with ROSC, and a parsimonious model retained 10 variables. Before risk-adjustment, the median hospital ROSC rate was 70.5% (interquartile range: 64.7-76.9%; range: 33.3-89.6%). After adjustment, the distribution of risk-standardized ROSC rates was narrower: median of 71.9% (interquartile range: 68.2-76.4%; range: 42.2-84.6%). Overall, 56 (16.7%) of 335 hospitals had at least a 10% absolute change in percentile rank after risk standardization: 27 (8.0%) with a ≥10% negative percentile change and 29 (8.7%) with a ≥10% positive percentile change. Conclusions We have derived and validated a model to risk-standardize hospital rates of ROSC for in-hospital cardiac arrest. Use of this model can support efforts to compare acute resuscitation survival across hospitals to facilitate quality improvement.

Background: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR., Methods and Results: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0-88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4-8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, P <0.001; 6.5% [5.6-8.6] in the worst-case scenario, P <0.001)., Conclusions: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000020423.

Background: Medicare patients with coronary artery disease (CAD) have been a significant focus of value-based payment programs for outpatient practices. Physicians and policymakers, however, have voiced concern that value-based payment programs may penalize practices that serve vulnerable populations. This study evaluated whether outpatient practices that serve socioeconomically disadvantaged populations have worse CAD outcomes, and if this reflects the delivery of lower-quality care or rather, patient and community factors beyond the care provided by physician practices., Methods and Results: Retrospective cohort study of Medicare fee-for-service patients ≥65 years with CAD at outpatient practices participating in the the Practice Innovation and Clinical Excellence registry from January 1, 2010 to January 1, 2015. Outpatient practices were stratified into quintiles by the proportion of most disadvantaged patients-defined by an area deprivation score in the highest 20% nationally-served at each practice site. Prescription of guideline recommended therapies for CAD as well as clinical outcomes (emergency department presentation for chest pain, hospital admission for unstable angina or acute myocardial infarction [AMI], 30-day readmission after AMI, and 30-day mortality after AMI) were evaluated by practice-level socioeconomic disadvantage with hierarchical logistic regression models, using practices serving the fewest socioeconomically disadvantaged patients as a reference. The study included 453 783 Medicare fee-for-service patients ≥65 years of age with CAD (mean [SD] age, 75.3 [7.7] years; 39.7% female) cared for at 271 outpatient practices. At practices serving the highest proportion of socioeconomically disadvantaged patients (group 5), compared with practices serving the lowest proportion (group 1), there was no significant difference in the likelihood of prescription of antiplatelet therapy (odds ratio [OR], 0.94 [95% CI, 0.69-1.27]), β-blocker therapy if prior myocardial infarction or left ventricular ejection fraction <40% (OR, 0.97 [95% CI, 0.69-1.35]), ACE (angiotensin-converting enzyme) inhibitor or angiotensin receptor blocker if left ventricular ejection fraction <40% and/or diabetes mellitus (OR, 0.93 [95% CI, 0.74-1.19]), statin therapy (OR, 0.88 [95% CI, 0.68-1.14]), or cardiac rehabilitation (OR, 0.45 [95% CI, 0.20-1.00]). Patients cared for at the most disadvantaged-serving practices (group 5) were more likely to be admitted for unstable angina (adjusted OR, 1.46 [95% CI, 1.04-2.05]). There was no significant difference in the likelihood of emergency department presentation for chest pain or hospital admission for AMI between practices. Thirty day mortality rates after AMI were higher among patients at the most disadvantaged-serving practices (aOR, 1.31 [95% CI, 1.02-1.68]), but 30-day readmission rates did not differ. All associations were attenuated after additional adjustment for patient-level area deprivation index., Conclusions: Physician outpatient practices that serve the most socioeconomically disadvantaged patients with CAD perform worse on some clinical outcomes, despite providing similar guideline-recommended care as other practices, and consequently could fare poorly under value-based payment programs. Social factors beyond care provided by outpatient practices may partly explain worse outcomes. Policymakers should consider accounting for socioeconomic disadvantage in value-based payment programs initiatives that target outpatient practices.

Background: Palliative care is highly relevant for patients with heart failure (HF), and there is a need for quantitative information on quality of care. Accordingly, this study aimed to develop a set of quality indicators (QIs) for palliative care of HF patients, and to conduct a practical pilot measurement of the proposed QIs in clinical practice., Methods and results: We used a modified Delphi technique, a consensus method that involves a comprehensive literature review, face-to-face multidisciplinary panel meeting, and anonymous rating in 2 rounds. A 15-member multidisciplinary expert panel individually rated each potential indicator on a scale of 1 (lowest) to 9 (highest) for appropriateness. All indicators receiving a median score ≥7 without significant disagreement were included in the final set of QIs. Through the consensus-building process, 35 QIs were proposed for palliative care in HF patients. Practical measurement in HF patients (n=131) from 3 teaching hospitals revealed that all of the proposed QIs could be obtained retrospectively from medical records, and the following QIs had low performance (<10%): "Intervention by multidisciplinary team", "Opioid therapy for patients with refractory dyspnea", and "Screening for psychological symptoms"., Conclusions: The first set of QIs for palliative care of HF patients was developed and could clarify quantitative information and might improve the quality of care.

Background: Facilitation and collaboration differentiates person-centred practice (PcP) from biomedical practice. In PcP, a person-centred consultation requires clinicians to juggle three processes: facilitation, clinical reasoning and collaboration. How best to measure PcP in these processes remains a challenge., Aim: To assess the measurement of facilitation and collaboration in selected reviews of PcP instruments., Methods: Ovid Medline and Google Scholar were searched for review articles evaluating measurement instruments of patient-centredness or person-centredness in the medical consultation., Results: Six of the nine review articles were selected for analysis. Those articles considered the psychometric properties and rigour of evaluation of reviewed instruments. Mostly, the articles did not find instruments with good evidence of reliability and validity. Evaluations in South Africa rendered poor psychometric properties. Tools were often not transferable to other socio-cultural-linguistic contexts, both with and without adaptation., Conclusion: The multiplicity of measurement tools is a product of many dimensions of person-centredness, which can be approached from many perspectives and in many service scenarios inside and outside the medical consultation. Extensive research into the myriad instruments found no single valid and reliable measurement tool that can be recommended for general use. The best hope for developing one is to focus on a specific scenario, conduct a systematic literature review, combine the best items from existing tools, involve multiple disciplines and test the tool in real-life situations.

Quality assessment in vascular access procedures for hemodialysis is not clearly defined. The aim of this article is to compare various guidelines regarding recommendation on quality control in angioaccess surgery. The overall population of end-stage renal disease patients and patients in need for hemodialysis treatment is growing every year. Chronic intermittent hemodialysis is still the main therapy. The formation of a functional angioaccess is the cornerstone in the management of those patients. Native (autologous) arteriovenous fistula is the best vascular access available. A relatively high percentage of primary failure and fistula abandonment increases the need for quality control in this field of surgery. There are very few recommendations of quality assessment on creation of a vascular access for hemodialysis in the searched guidelines. Some guidelines recommend the proportion of native arteriovenous fistula in incident and prevalent patients as well as the maximum tolerable percentage of central venous catheters and complications. According to some guidelines, surgeon's experience and expertise have a considerable influence on outcomes. There are no specific recommendations regarding surgeon's specialty, grade, level of skills, and experience. In conclusion, there is a weak recommendation in the guidelines on quality control in vascular access surgery. Quality assessment criteria should be defined in this field of surgery. According to these criteria, patients and nephrologists could choose the best vascular access center or surgeon. Centers with best results should be referral centers, and centers with poorer results should implement quality improvement programs.