Publications by authors named "Lee Fleisher"

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs.

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  • Delaying elective noncardiac surgery after an acute myocardial infarction (NSTEMI) leads to better health outcomes, but existing guidelines are outdated and based on old data.
  • A study analyzed Medicare data from surgeries between 2015 and 2020, focusing on patients 67 and older, to determine how the time since an NSTEMI affects postoperative risks.
  • Results showed that surgeries performed within 30 days of an NSTEMI significantly increased the chances of major cardiovascular and cerebrovascular events, with risks leveling off after 30 days for those who had heart procedures, but increasing again after 180 days.
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  • Using artificial intelligence (AI) in healthcare can help doctors make better decisions but has challenges like ensuring it’s safe and fair.
  • The paper suggests making clear rules and methods to develop and test AI systems for patient safety.
  • A big meeting with over 200 experts took place to find solutions on using AI in healthcare, leading to important recommendations for better AI systems.
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  • * Although clinical trial design has evolved, data collection infrastructure still requires heavy investment and labor, limiting the evidence available for understanding how treatments affect different patient groups.
  • * The authors propose a modernized data infrastructure that promotes the integration of diverse data sources and facilitates the reuse of health data, highlighting the importance of multidisciplinary collaboration to track progress in this area.
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Importance: The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated.

Observations: Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation.

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Importance: The Centers for Medicare & Medicaid Services (CMS) Overall Star Rating is widely used by patients and consumers, and there is continued stakeholder curiosity surrounding the inclusion of a peer grouping step, implemented to the 2021 Overall Star Rating methods.

Objective: To calculate hospital star rating scores with and without the peer grouping step, with the former approach stratifying hospitals into 3-, 4-, and 5-measure group peer groups based on the number of measure groups with at least 3 reported measures.

Design, Setting, And Participants: This cross-sectional study used Care Compare website data from January 2023 for 3076 hospitals that received a star rating in 2023.

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  • The study aimed to investigate whether the quality of hospitals before the pandemic influenced the survival rates of Medicare patients hospitalized with COVID-19.
  • Researchers analyzed in-hospital and 30-day mortality rates in relation to pre-pandemic hospital quality, finding that better-rated hospitals had significantly lower mortality rates.
  • Results showed that patients in lower-rated hospitals, specifically those with one star, faced much higher odds of dying either during their hospital stay or within 30 days of discharge compared to those in five-star hospitals.
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Objective: To compare general surgery outcomes at flagship systems, flagship hospitals, and flagship hospital affiliates versus matched controls.

Summary Background Data: It is unknown whether flagship hospitals perform better than flagship hospital affiliates for surgical patients.

Methods: Using Medicare claims for 2018 to 2019, we matched patients undergoing inpatient general surgery in flagship system hospitals to controls who underwent the same procedure at hospitals outside the system but within the same region.

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Importance: In surgical patients, it is well known that higher hospital procedure volume is associated with better outcomes. To our knowledge, this volume-outcome association has not been studied in ambulatory surgery centers (ASCs) in the US.

Objective: To determine if low-volume ASCs have a higher rate of revisits after surgery, particularly among patients with multimorbidity.

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Background: We define a "flagship hospital" as the largest academic hospital within a hospital referral region and a "flagship system" as a system that contains a flagship hospital and its affiliates. It is not known if patients admitted to an affiliate hospital, and not to its main flagship hospital, have better outcomes than those admitted to a hospital outside the flagship system but within the same hospital referral region.

Objective: To compare mortality at flagship hospitals and their affiliates to matched control patients not in the flagship system but within the same hospital referral region.

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The limited number and diversity of resident physicians pursuing careers as physician-scientists in medicine has been a concern for many decades. The Anesthesia Research Council aimed to address the status of the anesthesiology physician-scientist pipeline, benchmarked against other medical specialties, and to develop strategic recommendations to sustain and expand the number and diversity of anesthesiology physician-scientists. The working group analyzed data from the Association of American Medical Colleges and the National Resident Matching Program to characterize the diversity and number of research-oriented residents from US and international allopathic medical schools entering 11 medical specialties from 2009 to 2019.

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