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Key Points: Question: Among people receiving care in opioid treatment programs, does facilitated telemedicine for hepatitis C treatment increase cure rates compared with standard-of-care referral to hepatitis specialists? Findings: Cure percentages were 90.2% in telemedicine and 39.4% in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9. Among cured participants, illicit drug use decreased significantly. We observed minimal reinfections during 2 years of follow-up. Meaning: Facilitated telemedicine integrated into opioid treatment programs resulted in significantly higher cure rates, with significant reductions in illicit drug use and minimal reinfections; facilitated telemedicine increases hepatitis C treatment access for underserved populations. Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, Setting, and Participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C–infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main Outcomes and Measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P <.001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P =.001; telemedicine: 95% CI, 0.3-1.0; P <.001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and Relevance: Opioid treatment program–integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial Registration: ClinicalTrials.gov Identifier: NCT02933970 This study discusses whether facilitated telemedicine for hepatitis C treatment increases cure rates compared with standard-of-care referral to hepatitis specialists. [ABSTRACT FROM AUTHOR]

Key Points: Questions: Do US government officials and their family members involved in anomalous health incidents (AHIs) differ from control participants with respect to clinical, biomarker, and research assessments? Findings: In this exploratory study that included 86 participants reporting AHIs and 30 vocationally matched control participants, there were no significant differences in most tests of auditory, vestibular, cognitive, visual function, or blood biomarkers between the groups. Participants with AHIs performed significantly worse on self-reported and objective measures of balance, and had significantly increased symptoms of fatigue, posttraumatic stress disorder, and depression compared with the control participants; 24 participants (28%) with AHIs presented with functional neurological disorders. Meaning: In this exploratory study, there were no significant differences between individuals reporting AHIs and matched control participants with respect to most clinical, research, and biomarker measures, except for self-reported and objective measures of imbalance; symptoms of fatigue, posttraumatic stress, and depression; and the development of functional neurological disorders in some. Importance: Since 2015, US government and related personnel have reported dizziness, pain, visual problems, and cognitive dysfunction after experiencing intrusive sounds and head pressure. The US government has labeled these anomalous health incidents (AHIs). Objective: To assess whether participants with AHIs differ significantly from US government control participants with respect to clinical, research, and biomarker assessments. Design, Setting, and Participants: Exploratory study conducted between June 2018 and July 2022 at the National Institutes of Health Clinical Center, involving 86 US government staff and family members with AHIs from Cuba, Austria, China, and other locations as well as 30 US government control participants. Exposures: AHIs. Main Outcomes and Measures: Participants were assessed with extensive clinical, auditory, vestibular, balance, visual, neuropsychological, and blood biomarkers (glial fibrillary acidic protein and neurofilament light) testing. The patients were analyzed based on the risk characteristics of the AHI identifying concerning cases as well as geographic location. Results: Eighty-six participants with AHIs (42 women and 44 men; mean [SD] age, 42.1 [9.1] years) and 30 vocationally matched government control participants (11 women and 19 men; mean [SD] age, 43.8 [10.1] years) were included in the analyses. Participants with AHIs were evaluated a median of 76 days (IQR, 30-537) from the most recent incident. In general, there were no significant differences between participants with AHIs and control participants in most tests of auditory, vestibular, cognitive, or visual function as well as levels of the blood biomarkers. Participants with AHIs had significantly increased fatigue, depression, posttraumatic stress, imbalance, and neurobehavioral symptoms compared with the control participants. There were no differences in these findings based on the risk characteristics of the incident or geographic location of the AHIs. Twenty-four patients (28%) with AHI presented with functional neurological disorders. Conclusions and Relevance: In this exploratory study, there were no significant differences between individuals reporting AHIs and matched control participants with respect to most clinical, research, and biomarker measures, except for objective and self-reported measures of imbalance and symptoms of fatigue, posttraumatic stress, and depression. This study did not replicate the findings of previous studies, although differences in the populations included and the timing of assessments limit direct comparisons. This study assesses whether participants with anomalous health incidents (AHIs) differ significantly from US government control participants with respect to clinical, research, and biomarker assessments. [ABSTRACT FROM AUTHOR]

Key Points: Question: Is anticoagulation superior to antiplatelet therapy for prevention of recurrent stroke in patients with cryptogenic stroke and evidence of atrial cardiopathy? Findings: In this randomized clinical trial that included 1015 patients, the rate of recurrent stroke did not significantly differ between the apixaban group (annualized rate, 4.4%) and the aspirin group (annualized rate, 4.4%). Meaning: In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, apixaban did not significantly reduce recurrent stroke risk compared with aspirin. Importance: Atrial cardiopathy is associated with stroke in the absence of clinically apparent atrial fibrillation. It is unknown whether anticoagulation, which has proven benefit in atrial fibrillation, prevents stroke in patients with atrial cardiopathy and no atrial fibrillation. Objective: To compare anticoagulation vs antiplatelet therapy for secondary stroke prevention in patients with cryptogenic stroke and evidence of atrial cardiopathy. Design, Setting, and Participants: Multicenter, double-blind, phase 3 randomized clinical trial of 1015 participants with cryptogenic stroke and evidence of atrial cardiopathy, defined as P-wave terminal force greater than 5000 μV × ms in electrocardiogram lead V1, serum N-terminal pro-B-type natriuretic peptide level greater than 250 pg/mL, or left atrial diameter index of 3 cm/m2 or greater on echocardiogram. Participants had no evidence of atrial fibrillation at the time of randomization. Enrollment and follow-up occurred from February 1, 2018, through February 28, 2023, at 185 sites in the National Institutes of Health StrokeNet and the Canadian Stroke Consortium. Interventions: Apixaban, 5 mg or 2.5 mg, twice daily (n = 507) vs aspirin, 81 mg, once daily (n = 508). Main Outcomes and Measures: The primary efficacy outcome in a time-to-event analysis was recurrent stroke. All participants, including those diagnosed with atrial fibrillation after randomization, were analyzed according to the groups to which they were randomized. The primary safety outcomes were symptomatic intracranial hemorrhage and other major hemorrhage. Results: With 1015 of the target 1100 participants enrolled and mean follow-up of 1.8 years, the trial was stopped for futility after a planned interim analysis. The mean (SD) age of participants was 68.0 (11.0) years, 54.3% were female, and 87.5% completed the full duration of follow-up. Recurrent stroke occurred in 40 patients in the apixaban group (annualized rate, 4.4%) and 40 patients in the aspirin group (annualized rate, 4.4%) (hazard ratio, 1.00 [95% CI, 0.64-1.55]). Symptomatic intracranial hemorrhage occurred in 0 patients taking apixaban and 7 patients taking aspirin (annualized rate, 1.1%). Other major hemorrhages occurred in 5 patients taking apixaban (annualized rate, 0.7%) and 5 patients taking aspirin (annualized rate, 0.8%) (hazard ratio, 1.02 [95% CI, 0.29-3.52]). Conclusions and Relevance: In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, apixaban did not significantly reduce recurrent stroke risk compared with aspirin. Trial Registration: ClinicalTrials.gov Identifier: NCT03192215 This clinical trial compares the effectiveness of anticoagulation vs antiplatelet therapy for secondary stroke prevention in patients with cryptogenic stroke and evidence of atrial cardiopathy. [ABSTRACT FROM AUTHOR]

This Medical News article discusses a new US National Institutes of Health study of patients with the chronic—and chronically misunderstood—disease. [ABSTRACT FROM AUTHOR]

The article presents an interview with George Church, professor of genetics at Harvard Medical School in Boston, Massachusetts. Church offers an overview the Human Genome Project launched at the U.S. National Institutes of Health (NIH). He discusses the synthesis of a human genome and the difference between a gene editing tool like CRISPR-Cas9 and his proposed genome-scale engineering.

The article reports on the 29 million dollar grants provided by the U.S. National Institutes of Health (NIH) as of June 2021 to organizations to address COVID-19 disparities among ethnic and racial minorities.

A reprint of the article "Communication and the Journals," which originally appeared in a 1967 issue of the journal, is presented. A question about whether medical journals aid communication is addressed, along with a symposium on Biomedical Communications which was held in New York, New York on April 4-6, 1966. The number of medical periodicals that are available for physicians and others to read is examined, along with research about the value of small Information Exchange Groups.

This Viewpoint from directors at the CDC and NIH describes measures that federal agencies are taking to rapidly characterize emerging coronavirus variants and monitor their implications for national pandemic response and control, including assessment of ongoing effectiveness of current diagnostics, therapeutics, and vaccines. [ABSTRACT FROM AUTHOR]

Proposes several approaches to the recruitment and retention of patient-oriented translational clinical researchers. Lack of medical school graduates interested in research; History of the profession; Efforts of the U.S. National Institutes of Health to increase interest in clinical research; Suggestion that clinical researchers should work together in order to relieve the burden of having to be an expert in all areas they are studying.

This Viewpoint uses the case of an NIH trial funded by alcohol manufacturers and designed to determine the effects of moderate alcohol consumption on health outcomes to discuss the need for transparency in NIH-private partnerships and ways the NIH can administer those partnerships to preserve its integrity and trustworthiness. [ABSTRACT FROM AUTHOR]

Discusses why physicians should conduct clinical research on an active basis. How the National Institutes of Health (NIH) is trying to stimulate clinical research; The NIH's initiatives K23, K24, and K30 awards; Obstacles that complicate clinical research; Resistance in the Medical Scientist Training Program (MSTP).

A letter to the editor in response to the article "The Undiagnosed Disease Network of the National Institutes of Health: A National Extension" by W.A. Gahl, A.L. Wise, and E.A. Ashley which was published in a previous issue is presented.

The article discusses the Lasker Awards, an annual awards given by the Lasker Foundation in recognition of the innovations in the basic, clinical, and population health in the U.S. Information regarding the U.S. National Institute of Health's (NIH) decision to adjust the federal funding for medical research, a commitment towards improving the biomedicine for cardiovascular disease (CVD), and the central role of cholesterol in atherogenesis, are also discussed.

This section offers news briefs on the health care industry in the U.S. as of November 22, 2016. The National Institutes of Health (NIH) has launched an initiative to understand the effect of environmental factors on children's health. President Barack Obama reported a decline in the percentage of uninsured people because of reforms under the Affordable Care Act (ACA). An NIH panel has proposed a plan to prevent youth suicide.

In this article, the author reflects on the status of the National Children's Study (NCS) by the U.S. National Institutes of Health (NIH). Need of the cohort analysis for the diseases to be studied in NCS is mentioned as the diseases are rare. It is mentioned that use of prenatal environment by dietary assessments, environmental sampling of home and collection of biological specimen during pregnancy is favored by study investigators.

The authors reflect on the prospects of the U.S. National Institute of Health (NIH) K-series training grants. The mention that these grants help in developing new generation of clinical researchers and also enable new investigators to prepare for R01-level funding. They further discuss the need for strong and active mentorship for the academic success of institutions that have implemented several strategies to support and train K scholars. They inform that institutional strategies including financial support are important to support clinical research mentors.

The article discusses an Internet site created by the U.S. National Institutes of Health organization the National Heart, Lung, and Blood Institute which provides parents with information about pediatric clinical trials. The site includes risks, benefits, processes involved, and advice related to the trials. The difficulty in recruiting families for pediatric trials is discussed.