161. Standards and Ethics Issues in the Determination of Death: A Position Paper From the American College of Physicians.
The determination of a patient's death is of considerable medical and ethical significance. Death is a biological concept with social implications. Acting with honesty, transparency, respect, and integrity is critical to trust in the patient-physician relationship, and the profession, in life and in death. Over time, cases about the determination of death have raised questions that need to be addressed. This American College of Physicians position paper addresses current controversies and supports a clarification to the Uniform Determination of Death Act; maintaining the 2 current independent standards of determining death, cardiorespiratory and neurologic; retaining the whole brain death standard; aligning medical testing with the standards; keeping issues about the determination of death separate from organ transplantation; reaffirming the importance and role of the dead donor rule; and engaging in educational efforts for health professionals, patients, and the public on these issues. Physicians should advocate for policies and practices on the determination of death that are consistent with the profession's fundamental and timeless commitment to individual patients and the public.
162. Factors Associated With Circulating Sex Hormones in Men : Individual Participant Data Meta-analyses.
作者: Ross J Marriott.;Kevin Murray.;Robert J Adams.;Leen Antonio.;Christie M Ballantyne.;Douglas C Bauer.;Shalender Bhasin.;Mary L Biggs.;Peggy M Cawthon.;David J Couper.;Adrian S Dobs.;Leon Flicker.;David J Handelsman.;Graeme J Hankey.;Anke Hannemann.;Robin Haring.;Benjumin Hsu.;Magnus Karlsson.;Sean A Martin.;Alvin M Matsumoto.;Dan Mellström.;Claes Ohlsson.;Terence W O'Neill.;Eric S Orwoll.;Matteo Quartagno.;Molly M Shores.;Antje Steveling.;Åsa Tivesten.;Thomas G Travison.;Dirk Vanderschueren.;Gary A Wittert.;Frederick C W Wu.;Bu B Yeap.
来源: Ann Intern Med. 2023年176卷9期1221-1234页
Various factors modulate circulating testosterone in men, affecting interpretation of testosterone measurements.
163. Real-Time Computer-Aided Detection of Colorectal Neoplasia During Colonoscopy : A Systematic Review and Meta-analysis.
作者: Cesare Hassan.;Marco Spadaccini.;Yuichi Mori.;Farid Foroutan.;Antonio Facciorusso.;Paraskevas Gkolfakis.;Georgios Tziatzios.;Konstantinos Triantafyllou.;Giulio Antonelli.;Kareem Khalaf.;Tommy Rizkala.;Per Olav Vandvik.;Alessandro Fugazza.;Emanuele Rondonotti.;Jeremy R Glissen-Brown.;Shunsuke Kamba.;Marcello Maida.;Loredana Correale.;Pradeep Bhandari.;Rodrigo Jover.;Prateek Sharma.;Douglas K Rex.;Alessandro Repici.
来源: Ann Intern Med. 2023年176卷9期1209-1220页
Artificial intelligence computer-aided detection (CADe) of colorectal neoplasia during colonoscopy may increase adenoma detection rates (ADRs) and reduce adenoma miss rates, but it may increase overdiagnosis and overtreatment of nonneoplastic polyps.
164. The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence.
作者: Liam Bendicksen.;Diana M Zuckerman.;Jerry Avorn.;Sophia Phillips.;Aaron S Kesselheim.
来源: Ann Intern Med. 2023年176卷9期1251-1256页
The U.S. Food and Drug Administration (FDA) approved eteplirsen (Exondys 51) for Duchenne muscular dystrophy in 2016 via its accelerated approval program on the basis of a study of 12 boys. After a contentious review process and a high-profile meeting of an external advisory committee, FDA leaders concluded that very small increases in treated patients' levels of dystrophin, a muscle protein, were reasonably likely to predict clinical benefit. The eteplirsen approval, which was followed by approvals of other drugs in the same class via the same pathway, has been controversial because of the questionable evidence underlying these decisions, delays in mandated postapproval testing, and high U.S. prices. Questions remain about the effectiveness and long-term safety of these products. Although the FDA initially set a November 2020 deadline for eteplirsen's manufacturer to complete a clinical trial determining whether the drug has clinical benefit, the company will not complete the trial until 2024 or later. The relationship between levels of truncated dystrophin, the muscle protein studied in eteplirsen's pivotal trial, and clinical outcomes remains uncertain. Despite recent legislative and regulatory changes to the FDA's accelerated approval pathway, the history of eteplirsen and similar drugs points to the need for additional reforms to better balance evidence generation with patient safety and access to promising medications. Lawmakers and regulators should take further action to limit excessive spending on unproven therapies and ensure that drug sponsors conduct robust and timely confirmatory trials after receiving accelerated approval.
165. The Medicare Appropriate Use Criteria Program: A Review of Recommendations for Testing in Coronary Artery Disease.
作者: David E Winchester.;Friederike K Keating.;Krishna K Patel.;Nishant R Shah.
来源: Ann Intern Med. 2023年176卷9期1235-1239页
Congress established the Appropriate Use Criteria (AUC) Program to reduce unnecessary advanced imaging studies. Organizations that wish to develop AUC can apply to the Centers for Medicare & Medicaid Services (CMS) to qualify as provider-led entities (PLEs) under this program. Variable methods, content, and formatting of PLE-generated AUC could lead to clinician uncertainty about whether an advanced imaging test is appropriate or not.
166. Contraception.
作者: Rachel Cannon.;Kelly Treder.;Elisabeth J Woodhams.
来源: Ann Intern Med. 2023年176卷8期ITC113-ITC128页
Contraception counseling and provision are vital components of comprehensive health care. An unplanned pregnancy can be particularly challenging for patients with chronic illness. Internal medicine physicians are uniquely positioned to assess pregnancy readiness and provide contraception, as they often intersect with pregnancy-capable patients at the moment of a new diagnosis or when providing ongoing care for a chronic medical condition. A shared decision-making counseling approach engages patients, ensures patient-centered care, and supports their choice of a contraceptive method that aligns with their reproductive plans and medical needs.
167. Preparing for Future Pandemics and Public Health Emergencies: An American College of Physicians Policy Position Paper.
作者: Josh Serchen.;Katelan Cline.;Suja Mathew.;David Hilden.; .
来源: Ann Intern Med. 2023年176卷9期1240-1244页
The onset of the COVID-19 pandemic revealed significant gaps in the United States' pandemic and public health emergency response system. At the federal level, government responses were undercut by a lack of centralized coordination, inadequately defined responsibilities, and an under-resourced national stockpile. Contradictory and unclear guidance throughout the early months of the pandemic, along with inconsistent funding to public health agencies, also created notable variance in state and local responses. The lack of a coordinated response added pressure to an already overwhelmed health care system, which was forced to resort to rationing care and personal protective equipment, creating moral distress and trauma for health care workers and their patients. Despite these severe shortcomings, the COVID-19 pandemic also highlighted successful policies and approaches, such as Operation Warp Speed, which led to the fastest development and distribution of a vaccine in history. In this position paper, the American College of Physicians (ACP) offers several policy recommendations for enhancing federal, state, and local preparedness for future pandemic and public health emergencies. This policy paper builds on various statements produced by ACP throughout the COVID-19 pandemic, including on the ethical distribution of vaccinations and resources, conditions to resume economic and social activity, and efforts to protect the health and well-being of medical professionals, among others.
168. Modernizing the United States' Public Health Infrastructure: A Position Paper From the American College of Physicians.
The United States' public health sector plays a crucial role in preventing illness and promoting health. Public health drove massive gains in life expectancy during the 20th century by supporting vaccination campaigns, promoting motor vehicle safety, and preventing and treating tobacco use. However, public health is underfunded and underappreciated, forcing the field to do more with fewer resources. In this position paper, the American College of Physicians (ACP) updates its 2012 policy recommendations on strengthening the nation's public health infrastructure. ACP calls for effective coordination of public health activities, robust and stable year-to-year funding of public health services, a renewed and well-supported public health workforce, action to address health-related dis- and misinformation, modernized public health data systems, and greater coordination between public health and medical sectors.
169. Moving Naloxone Over the Counter Is Necessary but Not Sufficient.
作者: John C Messinger.;Leo Beletsky.;Aaron S Kesselheim.;Rachel E Barenie.
来源: Ann Intern Med. 2023年176卷8期1109-1112页
Naloxone is an opioid antagonist that is available in numerous formulations and can be easily administered to avert death from opioid overdose. Amid a historic overdose crisis in the United States, naloxone has a crucial role in stemming the loss of life. However, it remains largely inaccessible to the public. Recently, the U.S. Food and Drug Administration announced the approval of the first over-the-counter formulation of naloxone. Although this historic change provides an important opportunity to increase distribution of naloxone, we must take careful steps during this transition so that it does not paradoxically threaten overall access to this life-saving medication. Specifically, we must ensure that a larger supply of naloxone will meet the newly increased demand at a sustainable price for consumers who are most in need. We must also continue to prioritize comprehensive methods of distribution, such as overdose education and naloxone distribution programs, that serve as important tools to reach the most vulnerable populations. In addition, simultaneous investment in harm-reduction strategies, such as supervised consumption spaces, is critical to ensure that naloxone is available in settings where its life-saving potential can be most fully realized.
170. Addressing Viral Medical Rumors and False or Misleading Information.
作者: Hussain S Lalani.;Renée DiResta.;Richard J Baron.;David Scales.
来源: Ann Intern Med. 2023年176卷8期1113-1120页
The rapid spread of medical rumors and false or misleading information on social media during times of uncertainty is a vexing challenge that threatens public health. Understanding the information ecosystem, social media networks, and the scope of incentives that drive users and social media platforms can provide critical insights for strong coordination between stakeholders and funders to address this challenge. The COVID-19 pandemic created an opportunity to demonstrate the role of media monitoring and counter-messaging efforts in responding to dangerous medical rumors, misinformation, and disinformation. It also highlighted the challenges. The efforts of ThisIsOurShot and VacunateYa to spread accurate health information about COVID-19 and COVID-19 vaccines are described and lessons learned are discussed. These lessons include the need for substantial financial investments at the local and national levels to sustain and scale these types of programs. Examples in other fields that offer a path forward include Information Sharing and Analysis Centers and Public Health Emergency Operations Centers. Understanding the scale and scope of what it takes to address viral medical rumors, misinformation, and disinformation in a networked information environment should inspire elected leaders to consider policy and regulatory reforms. Our transformed information ecosystem requires new public health infrastructure to address information that threatens personal safety and population health.
171. Atrial Fibrillation.
Evidence for diagnosis and treatment of atrial fibrillation (AF) has expanded substantially since 2017, when In the Clinic last considered this subject. Direct oral anticoagulants have become the predominant therapy for thromboembolic disease, and antidotes for these drugs are now available. Device-based left atrial appendage occlusion is frequently used in patients who cannot tolerate systemic anticoagulation, and growing evidence suggests that early rhythm control improves outcomes. Catheter ablation is now frequently performed to prevent recurrent AF. Managing risk factors for AF, such as hypertension, diabetes, and obesity, remains paramount in prevention of this condition.
172. Dyslipidemia.
Dyslipidemia is an important risk factor for coronary artery disease and stroke. All persons with dyslipidemia should be advised to focus on lifestyle interventions, including regular aerobic exercise, a healthy diet, maintenance of a healthy weight, and abstinence from smoking. In addition to lifestyle interventions, lipid-lowering therapy should be considered for persons at moderate to high risk for atherosclerotic cardiovascular disease based on validated risk equations. Statin therapy is the first-line medical treatment for dyslipidemia due to its effectiveness and favorable adverse effect profile, but newer treatments provide additional tools for clinicians to effectively treat dyslipidemia.
173. Diagnostic Strategies for the Assessment of Suspected Stable Coronary Artery Disease : A Systematic Review and Meta-analysis.
作者: Andrea Zito.;Mattia Galli.;Giuseppe Biondi-Zoccai.;Antonio Abbate.;Pamela S Douglas.;Giuseppe Princi.;Domenico D'Amario.;Cristina Aurigemma.;Enrico Romagnoli.;Carlo Trani.;Francesco Burzotta.
来源: Ann Intern Med. 2023年176卷6期817-826页
There is uncertainty about which diagnostic strategy for detecting coronary artery disease (CAD) provides better outcomes.
174. Improving COVID-19 Disease Severity Surveillance Measures: Statewide Implementation Experience.
作者: Shira Doron.;Paul A Monach.;Catherine M Brown.;Westyn Branch-Elliman.
来源: Ann Intern Med. 2023年176卷6期849-852页
Measurement of the burden of COVID-19 on U.S. hospitals has been an important element of the public health response to the pandemic. However, because of variation in testing density and policies, the metric is not standardized across facilities. Two types of burdens exist, one related to the infection control measures that patients who test positive for SARS-CoV-2 require and one from the care of severely ill patients receiving treatment of COVID-19. With rising population immunity from vaccination and infection, as well as the availability of therapeutics, severity of illness has declined. Prior research showed that dexamethasone administration was highly correlated with other disease severity metrics and sensitive to the changing epidemiology associated with the emergence of immune-evasive variants. On 10 January 2022, the Massachusetts Department of Public Health began requiring hospitals to expand surveillance to include reports of both the total number of "COVID-19 hospitalizations" daily and the number of inpatients who received dexamethasone at any point during their hospital stay. All 68 acute care hospitals in Massachusetts submitted COVID-19 hospitalization and dexamethasone data daily to the Massachusetts Department of Public Health over a 1-year period. A total of 44 196 COVID-19 hospitalizations were recorded during 10 January 2022 to 9 January 2023, of which 34% were associated with dexamethasone administration. The proportion of patients hospitalized with COVID-19 who had received dexamethasone was 49.6% during the first month of surveillance and decreased to a monthly average of approximately 33% by April 2022, where it has remained since (range, 28.7% to 33%). Adding a single data element to mandated reporting to estimate the frequency of severe COVID-19 in hospitalized patients was feasible and provided actionable information for health authorities and policy makers. Updates to surveillance methods are necessary to match data collection with public health response needs.
175. Major Update: Masks for Prevention of SARS-CoV-2 in Health Care and Community Settings-Final Update of a Living, Rapid Review.
Optimal use of masks for preventing COVID-19 is unclear.
176. Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea : A Systematic Review and Network Meta-analysis.
作者: Tyler Pitre.;Jasmine Mah.;Sarah Roberts.;Kairavi Desai.;Yusing Gu.;Clodagh Ryan.;Jason W Busse.;Dena Zeraatkar.
来源: Ann Intern Med. 2023年176卷5期676-684页
Excessive daytime sleepiness (EDS) is common among patients with obstructive sleep apnea (OSA). The comparative effectiveness of pharmacologic agents is unknown.
177. Care of the Patient With Abnormal Kidney Test Results.
Blood and urine tests are commonly performed by clinicians in both ambulatory and hospital settings that detect chronic and acute kidney disease. Thresholds for these tests have been established that signal the presence and severity of kidney injury or dysfunction. In the appropriate clinical context of a patient's history and physical examination, an abnormal test result should trigger specific actions for clinicians, including reviewing patient medication use, follow-up testing, prescribing lifestyle modifications, and specialist referral. Tests for kidney disease can also be used to determine the future risk for kidney failure as well as cardiovascular death.
178. The New European Medical Device Regulation: Balancing Innovation and Patient Safety.
作者: Michael Bretthauer.;Sara Gerke.;Cesare Hassan.;Omer F Ahmad.;Yuichi Mori.
来源: Ann Intern Med. 2023年176卷6期844-848页
The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New "expert panels" have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous "notified bodies" (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.
179. Performance Measures for Physicians Providing Clinical Care Using Telemedicine: A Position Paper From the American College of Physicians.
作者: Amir Qaseem.;Catherine H MacLean.;Samantha Tierney.;J Thomas Cross.;Scott T MacDonald.;Caroline L Goldzweig.;Nick Fitterman.; .;Rebecca Andrews.;Peter Basch.;Suja M Mathew.;Robert M McLean.;Cristin A Mount.;Rhea E Powell.;Sameer D Saini.
来源: Ann Intern Med. 2023年176卷5期694-698页
There has been an exponential growth in the use of telemedicine services to provide clinical care, accelerated by the COVID-19 pandemic. Clinical care delivered via telemedicine has become a major and accepted method of health care delivery for many patients. There is an urgent need to understand quality of care in the telemedicine environment. This American College of Physicians position paper presents 6 recommendations to ensure the appropriate use of performance measures to evaluate quality of clinical care provided in the telemedicine environment.
180. Periprocedural Anticoagulation.
Management of patients taking anticoagulants around the time of a procedure is a common and complex clinical scenario. Providing evidence-based care requires estimation of risk for thrombosis and bleeding, knowledge of commonly used medications, multidisciplinary communication and collaboration, and patient engagement and education. This review provides a standardized, evidence-based approach to periprocedural management of anticoagulation, based on current evidence and expert clinical guidelines.
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