Malhotra A, Schwartz AR, Lovett E
… +9 more, Juran N, Nguyen SA, Barrera JE, Bogan RK, Mickelson SA, Boghara H, Miller M, Jacobowitz O, OSPREY Investigators
Ann Intern Med
· 2026 Jun · PMID 42008810
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BACKGROUND: Hypoglossal nerve stimulation (HGNS) is used to treat obstructive sleep apnea (OSA); however, evidence is limited for patients who cannot tolerate positive airway pressure therapy. Proximal HGNS (pHGNS) provi...BACKGROUND: Hypoglossal nerve stimulation (HGNS) is used to treat obstructive sleep apnea (OSA); however, evidence is limited for patients who cannot tolerate positive airway pressure therapy. Proximal HGNS (pHGNS) provides multicontact stimulation of proximal nerve portions, with easier electrode implantation than distal nerve stimulation. OBJECTIVE: To evaluate the efficacy and safety of pHGNS in patients with moderate-to-severe OSA. DESIGN: 7-month randomized controlled trial followed by a 6-month open-label extension. (ClinicalTrials.gov: NCT04950894). SETTING: 23 U.S. health centers. PATIENTS: Adults aged 22 years or older with moderate-to-severe OSA. INTERVENTION: All patients underwent implantation with pHGNS at baseline and were randomly assigned in a 2:1 ratio to treatment or control. Therapy began at month 1 (treatment) or month 7 (control). MEASUREMENTS: Assessments included the proportion of patients achieving greater than 50% improvement from baseline in the apnea-hypopnea index (AHI) and AHI below 20 events/h at month 7 (primary end point), improvements in oxygen desaturation index (ODI) and patient-reported outcomes (for example, Epworth Sleepiness Scale [ESS]), and safety. RESULTS: The 104 randomly assigned patients had a mean age of 55.6 years (SD, 9.0), body mass index of 30.6 kg/m (SD, 3.0), a preimplantation AHI of 35.7 events/h (SD, 12.8), and a preimplantation ODI of 36.7 events/h (SD, 13.4). At month 7, 58.2% (95% CI, 45.5% to 70.2%) of patients assigned to treatment ( = 67) versus 13.5% (CI, 4.5% to 28.8%) assigned to control ( = 37) achieved the primary end point, and ODI was reduced by at least 25% in 68.7% (CI, 56.2% to 79.4%) versus 37.8% (CI, 22.5% to 55.2%) of patients, respectively. Median ESS score improved from baseline to month 7 in the treatment group (10.0 [IQR, 7.0 to 14.0] to 6.0 [IQR, 5.0 to 9.0]) but not in the control group (9.0 [IQR, 7.0 to 11.0] to 9.0 [IQR, 6.0 to 11.0]). No serious procedure-related adverse events were reported. LIMITATIONS: Lack of blinding, small sample size, and short follow-up. CONCLUSION: pHGNS for OSA yielded clinically significant responses versus control at month 7, supporting pHGNS as a therapeutic option for OSA. PRIMARY FUNDING SOURCE: LivaNova PLC.
Fritz JM, Skolasky RL, Brennan G
… +17 more, Minick K, Wegener ST, Lane E, Garland EL, Aaron RV, Bardsley T, Fino N, Zhang Y, Shen J, Conroy MB, Hunter S, Hanley A, Thackeray A, Rassu FS, McLaughlin K, Cook D, Greene T
Ann Intern Med
· 2026 Jun · PMID 42008809
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BACKGROUND: Many treatments are recommended for chronic low back pain (cLBP), but comparative effectiveness and adaptive interventions have not been adequately studied. OBJECTIVE: To compare the effectiveness of physical...BACKGROUND: Many treatments are recommended for chronic low back pain (cLBP), but comparative effectiveness and adaptive interventions have not been adequately studied. OBJECTIVE: To compare the effectiveness of physical therapy (PT) and cognitive behavioral therapy (CBT) as first-stage treatment and switching treatments versus mindfulness as second-stage treatment. DESIGN: Multisite sequential, multiple-assignment, randomized trial with 52-week follow-up. (ClinicalTrials.gov: NCT03859713). SETTING: Three health care systems. PARTICIPANTS: Adults with cLBP. INTERVENTION: Eight weeks of PT or CBT in stage I. Nonresponders were randomly assigned again to 8 weeks of stage II treatment. MEASUREMENTS: Co-primary outcomes were function measured with the Oswestry Disability Index (ODI; range, 0 to 100) and pain intensity (range, 0 to 10) at 10 (stage I), 26, and 52 (stage II) weeks. RESULTS: The sample comprised 749 participants. After 10 weeks, there was greater improvement in function in the PT group (adjusted mean ODI difference, 2.8 [96% CI, 0.38 to 5.1]) and no difference in pain intensity (adjusted mean difference, 0.32 [99% CI, -0.07 to 0.71]). The mean difference in ODI was below the minimum important difference of 6. After 52 weeks, there were no differences in stage II treatments for nonresponders for either function (adjusted mean ODI difference, 0.43 [96% CI, -0.29 to 2.4]) or pain intensity (adjusted mean difference, -0.05 [96% CI, -0.58 to 0.48]). LIMITATIONS: Treatment initiation was lower than expected, particularly for CBT and for nonresponders. Participants were not blinded. Sample size was reduced due to the COVID-19 pandemic. CONCLUSION: Patients with cLBP may benefit from PT as first-line treatment. Among nonresponders, there were no differences in second-stage treatment with mindfulness or switching. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PCORI).
Serchen J, Beachy MW, Carr PW
… +1 more, Health and Public Policy Committee of the American College of Physicians
Ann Intern Med
· 2026 Jun · PMID 42008805
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The United States pays some of the highest prices for prescription drugs in the world, with drug prices and overall spending increasing year-over-year. Ballooning prescription drug costs can result in low rates of medica...The United States pays some of the highest prices for prescription drugs in the world, with drug prices and overall spending increasing year-over-year. Ballooning prescription drug costs can result in low rates of medication adherence, negatively affecting public health and straining national health care systems and resources. The 340B Drug Pricing Program (340B Program), which allows health care safety-net settings to purchase prescription drugs at deep discounts, has long sought to function as a bulwark against increasing drug prices for institutions serving those most vulnerable in society. Savings from the program have facilitated expanded access to health care services for low-income and uninsured patients. However, shortcomings in the program's design, implementation, and oversight obscure to what degree low-income and uninsured patients are realizing program benefits and create incentives for institutions to undertake profit-seeking behaviors at the expense of patients. To strengthen the 340B Program and ensure it is best serving its intended audience, reforms are needed within the program to promote transparency in how drug savings are reinvested into patient care and mandate demonstrated benefit to low-income and uninsured populations. Access to contract pharmacies-that is, the specialty or community-based pharmacies that 340B Program "covered entities" have an agreement with to distribute medications to patients-should be preserved, with appropriate guardrails to prevent unauthorized diversion. Federal regulators should be empowered with the resources and clear statutory authority necessary to engage in meaningful oversight of all program participants.
Qaseem A, Powell RE, Watts B
… +13 more, Campos K, Tierney S, Basch P, Performance Measurement Committee of the American College of Physicians, Chou R, Andrews RA, Alkhairw H, Barkoudah E, Ganz-Lord FA, Khetan RS, MacDonald ST, Miller NL, Pardo-Hernandez H
Ann Intern Med
· 2026 Jun · PMID 42008806
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Migraine is a chronic condition that affects about 15% of the population in the United States and is characterized by recurrent, debilitating headache that lasts somewhere between 4 and 72 hours. Only 1 performance measu...Migraine is a chronic condition that affects about 15% of the population in the United States and is characterized by recurrent, debilitating headache that lasts somewhere between 4 and 72 hours. Only 1 performance measure for migraine is currently in use in pay-for-performance programs. Although the American College of Physicians (ACP) broadly supports the role of performance measurement in performance improvement, this support is based on the principle that only measures that are evidence-based and meet high standards of methodological soundness are appropriate given their potential impact on patient care. ACP's Performance Measurement Committee reviews performance measures using a rigorous process to recognize high-quality performance measures, address gaps and areas for improvement in performance measures, and help reduce reporting burden. This article presents a review of 1 performance measure that includes migraine and considers a potential core performance measure using ACP's process to inform physicians, payers, and policymakers.
Reddy A, Gunnink E, Wheat CL
… +8 more, Pawlikowski S, Payne CM, Wiltz S, Hubert TL, Kirsh S, Carey E, Hill D, Nelson KM
Ann Intern Med
· 2026 Jun · PMID 41996184
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BACKGROUND: Ambient artificial intelligence (AI) scribes can reduce the burden of administrative documentation. Prior evaluations have been vendor specific and not focused on measures of documentation quality. OBJECTIVE:...BACKGROUND: Ambient artificial intelligence (AI) scribes can reduce the burden of administrative documentation. Prior evaluations have been vendor specific and not focused on measures of documentation quality. OBJECTIVE: To compare the quality of AI-generated clinical notes with that of human-produced notes. DESIGN: Cross-sectional evaluation of notes generated from standardized primary care clinical cases. SETTING: Veterans Health Administration (VHA). PARTICIPANTS: 11 AI scribe tools, 18 human note takers, and 30 human raters. INTERVENTION: Five standardized primary care cases were audio recorded using standardized patients (for example, new patient, back pain, chest pain, pharmacy, and nurse care manager). Vendors and human clinicians generated encounter notes from the audio files. MEASUREMENTS: Blinded raters assessed all notes using the modified Physician Documentation Quality Instrument (PDQI-9), which measures 10 domains of note quality on a 5-point Likert scale (maximum score 50). RESULTS: Across all 5 clinical cases, human-generated notes received higher overall modified PDQI-9 scores than AI-generated notes. The largest difference was seen in the acute low back pain case (human: 43.8 [95% CI, 37.4 to 50.3] vs. AI: 20.3 [CI, 15.4 to 25.2]; difference -23.5 [CI, -29.2 to -17.9]). Pooled domain analysis showed lower AI scores across all 10 domains, with the largest deficits in domains related to being thorough (-1.23 [CI, -1.82 to -0.65]), organized (-1.06 [CI, -1.65 to -0.47]), and useful (-1.03 [CI, -1.61 to -0.44]). LIMITATION: Cases were simulated; human-generated notes were not generated under real-world constraints. CONCLUSION: Notes generated by AI had lower-quality scores than human-generated notes across 5 standardized care cases. Although ambient AI scribes hold promise for reducing clinician burden, independent, vendor-neutral evaluations of note quality are essential before large-scale clinical deployment. PRIMARY FUNDING SOURCE: VHA.
Qaseem A, Harrod CS, Balk EM
… +3 more, Etxeandia-Ikobaltzeta I, Crandall CJ, Clinical Guidelines Committee of the American College of Physicians
Ann Intern Med
· 2026 Jun · PMID 41996183
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DESCRIPTION: The purpose of this updated guidance statement is to guide internal medicine physicians and other clinicians on screening for breast cancer in asymptomatic, average-risk adult females. METHODS: The American...DESCRIPTION: The purpose of this updated guidance statement is to guide internal medicine physicians and other clinicians on screening for breast cancer in asymptomatic, average-risk adult females. METHODS: The American College of Physicians updated its guidance statement on screening for breast cancer using high-quality clinical guidelines from national guideline developers around the world. GUIDANCE STATEMENT 1: GUIDANCE STATEMENT 2: GUIDANCE STATEMENT 3: GUIDANCE STATEMENT 4: GUIDANCE STATEMENT 5:
Batsis JA, Gavras A, Gross DC
… +12 more, Cheever CR, Da Silva BR, Meira Filho LF, Jones EP, Batchek D, Khandpekar S, Patel R, Awkal B, Pape A, Bahna M, Zamboni M, Prado CM
Ann Intern Med
· 2026 Apr · PMID 41996180
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BACKGROUND: Incretin-based therapies induce substantial weight loss and are widely prescribed; disproportionate losses in fat-free mass (FFM) and skeletal muscle are a concern. PURPOSE: To evaluate body composition chang...BACKGROUND: Incretin-based therapies induce substantial weight loss and are widely prescribed; disproportionate losses in fat-free mass (FFM) and skeletal muscle are a concern. PURPOSE: To evaluate body composition changes associated with incretin therapies in adults with obesity. DATA SOURCES: Scopus, Embase (Elsevier), PubMed (National Institutes of Health, National Library of Medicine), CINAHL, PsycINFO (EBSCOhost), and ClinicalTrials.gov from January 2003 to February 2026. STUDY SELECTION: English-language randomized controlled trials reporting body composition outcomes of liraglutide, semaglutide, tirzepatide, or dulaglutide therapy in adults (aged ≥18 years). DATA EXTRACTION: Primary outcomes included changes in fat mass, FFM, lean soft tissue (LST), muscle-related indices, and visceral adiposity measured by bioelectrical impedance analysis (BIA), dual-energy x-ray absorptiometry (DXA), computed tomography (CT), or magnetic resonance imaging (MRI). Prespecified benchmarks were applied to contextualize expected muscle-related losses (about 25% of total weight loss for FFM or LST derived from BIA or DXA, and about 15% for skeletal muscle measured by CT or MRI). DATA SYNTHESIS: Among 8102 titles and abstracts, 35 primary studies met criteria (median duration, 26 weeks; median of 78 participants); 42.9% were at low risk of bias and 10 (28.6%) prespecified body composition as a primary outcome. Mean participant age ranged from 20 to 63.7 years and mean body mass index from 27.9 to 41.6 kg/m. Weight loss was consistently larger in the incretin intervention groups than in placebo or lifestyle intervention comparators and was consistently accompanied by reductions in total fat mass and visceral adiposity. The degree of muscle-based losses varied widely; no study reported objective physical function outcomes. Within the incretin groups across agents and measurement methods, the median proportion of total weight loss attributable to reductions in muscle-based indices was 28.3% (IQR, 15.9% to 39.9%), with 65% exceeding the benchmark of about 25%; among studies using BIA or DXA, the median was about 29% (IQR, 16.6% to 43.1%) of total weight loss, with 67% exceeding the 25% benchmark, and in studies using CT or MRI, the median was about 25.3% (IQR, 16.7% to 27.2%), two thirds exceeding the 15% benchmark. In contrast, the 13 studies reporting weight loss in the lifestyle or placebo comparator groups accounted for a median weight loss of -2.5% (IQR, -4.5% to -0.9%), 38% of which exceeded the respective benchmark. LIMITATION: Heterogeneous body composition methods and reporting precluded meta-analysis. CONCLUSION: Loss of muscle-related indices exceeded prespecified benchmarks in about two thirds of incretin-based interventions and in nearly half of nonpharmacologic interventions that produced weight loss. Future trials are needed to better understand mechanisms underlying these changes and their clinical implications. PRIMARY FUNDING SOURCE: None. (Open Science Framework: https://doi.org/10.17605/OSF.IO/S3A5E).