Journal: Ann Intern Med

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<div><h4>Cost-Effectiveness of First- and Second-Step Treatment Strategies for Major Depressive Disorder : A Rapid Review.</h4><i>Dobrescu A, Chapman A, Affengruber L, Persad E, ... Emprechtinger R, Gartlehner G</i><br /><b>Background</b><br />Major depressive disorder (MDD) is the most prevalent, disabling form of depression, with a high economic effect.<br /><b>Purpose</b><br />To assess evidence on cost-effectiveness of pharmacologic and nonpharmacologic interventions as first- and second-step treatments in patients with MDD.<br /><b>Data sources</b><br />Multiple electronic databases limited to English language were searched (1 January 2015 to 29 November 2022).<br /><b>Study selection</b><br />Two investigators independently screened the literature. Seven economic modeling studies fulfilled the eligibility criteria.<br /><b>Data extraction</b><br />Data abstraction by a single investigator was confirmed by a second; 2 investigators independently rated risk of bias. One investigator determined certainty of evidence, and another checked for plausibility.<br /><b>Data synthesis</b><br />Seven modeling studies met the eligibility criteria. In a U.S. setting over a 5-year time horizon, cognitive behavioral therapy (CBT) was cost-effective compared with second-generation antidepressants (SGAs) as a first-step treatment from the societal and health care sector perspectives. However, the certainty of evidence is low, and the findings should be interpreted cautiously. For second-step treatment, only switch strategies between SGAs were assessed. The evidence is insufficient to draw any conclusions.<br /><b>Limitations</b><br />Methodologically heterogeneous studies, which compared only CBT and some SGAs, were included. No evidence on other psychotherapies or complementary and alternative treatments as first-step treatment or augmentation strategies as second-step treatment was available.<br /><b>Conclusion</b><br />Although CBT may be cost-effective compared with SGAs as a first-step treatment at a 5-year time horizon from the societal and health care sector perspectives, the certainty of evidence is low, and the findings need to be interpreted cautiously. For other comparisons, the evidence was entirely missing or insufficient to draw conclusions.<br /><b>Primary funding source</b><br />American College of Physicians.<br /><br /><br /><br /><small>Ann Intern Med: 24 Jan 2023; epub ahead of print</small></div>
Dobrescu A, Chapman A, Affengruber L, Persad E, ... Emprechtinger R, Gartlehner G
Ann Intern Med: 24 Jan 2023; epub ahead of print | PMID: 36689742
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<div><h4>High- Versus Low-Dose Exercise Therapy for Knee Osteoarthritis : A Randomized Controlled Multicenter Trial.</h4><i>Torstensen TA, Østerås H, LoMartire R, Rugelbak GM, Grooten WJA, Äng BO</i><br /><b>Background</b><br />The benefits of exercise in patients with knee osteoarthritis are well documented, but the optimal exercise dose remains unknown.<br /><b>Objective</b><br />To compare high-dose versus low-dose exercise therapy with regard to knee function, pain, and quality of life (QoL) in patients with long-term symptomatic knee osteoarthritis.<br /><b>Design</b><br />A Swedish and Norwegian multicenter randomized controlled superiority trial with multiple follow-ups up to 12 months after the intervention. (ClinicalTrials.gov: NCT02024126).<br /><b>Setting</b><br />Primary health care facilities.<br /><b>Patients</b><br />189 patients with diagnosed knee osteoarthritis and a history of pain and decreased knee function were assigned to high-dose therapy (<i>n</i> = 98; 11 exercises; 70 to 90 minutes) or low-dose therapy (<i>n</i> = 91; 5 exercises; 20 to 30 minutes).<br /><b>Intervention</b><br />Patient-tailored exercise programs according to the principles of medical exercise therapy. Global (aerobic), semiglobal (multisegmental), and local (joint-specific) exercises were performed 3 times a week for 12 weeks under supervision of a physiotherapist.<br /><b>Measurements</b><br />The Knee Injury and Osteoarthritis Outcome Score (KOOS) was measured biweekly during the 3-month intervention period and at 6 and 12 months after the intervention. The primary end point was the mean difference in KOOS scores between groups at the end of the intervention (3 months). Secondary outcomes included pain intensity and QoL. The proportion of patients with minimal clinically important changes in primary and secondary outcomes was compared between groups.<br /><b>Results</b><br />Both groups improved over time, but there were no benefits of high-dose therapy in most comparisons. One exception was the KOOS score for function in sports and recreation, where high-dose therapy was superior at the end of treatment and at 6-month follow-up. A small benefit in QoL at 6 and 12 months was also observed.<br /><b>Limitation</b><br />There was no control group that did not exercise.<br /><b>Conclusion</b><br />The results do not support the superiority of high-dose exercise over low-dose exercise for most outcomes. However, small benefits with high-dose exercise were found for knee function in sports and recreation and for QoL.<br /><b>Primary funding source</b><br />Swedish Rheumatic Fund.<br /><br /><br /><br /><small>Ann Intern Med: 24 Jan 2023; epub ahead of print</small></div>
Torstensen TA, Østerås H, LoMartire R, Rugelbak GM, Grooten WJA, Äng BO
Ann Intern Med: 24 Jan 2023; epub ahead of print | PMID: 36689746
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<div><h4>Values and Preferences of Patients With Depressive Disorders Regarding Pharmacologic and Nonpharmacologic Treatments : A Rapid Review.</h4><i>Affengruber L, Wagner G, Dobrescu A, Toromanova A, ... Klerings I, Gartlehner G</i><br /><b>Background</b><br />Developers of clinical practice guidelines need to take patient values and preferences into consideration when weighing benefits and harms of treatment options for depressive disorder.<br /><b>Purpose</b><br />To assess patient values and preferences regarding pharmacologic and nonpharmacologic treatments of depressive disorder.<br /><b>Data sources</b><br />MEDLINE (Ovid) and PsycINFO (EBSCO) were searched for eligible studies published from 1 January 2014 to 30 November 2022.<br /><b>Study selection</b><br />Pairs of reviewers independently screened 30% of search results. The remaining 70% of the abstracts were screened by single reviewers; excluded abstracts were checked by a second reviewer. Pairs of reviewers independently screened full texts.<br /><b>Data extraction</b><br />One reviewer extracted data and assessed the certainty of evidence, and a second reviewer checked for completeness and accuracy. Two reviewers independently assessed risk of bias.<br /><b>Data synthesis</b><br />The review included 11 studies: 4 randomized controlled trials, 5 cross-sectional studies, and 2 qualitative studies. In 1 randomized controlled trial, participants reported at the start of therapy that they expected supportive-expressive psychotherapy and antidepressants to yield similar improvements. A cross-sectional study reported that non-Hispanic White participants and men generally preferred antidepressants over talk therapy, whereas Hispanic and non-Hispanic Black participants and women generally did not have a preference. Another cross-sectional study reported that the most important nonserious adverse events for patients treated with antidepressants were insomnia, anxiety, fatigue, weight gain, agitation, and sexual dysfunction. For other comparisons and outcomes, no conclusions could be drawn because of the insufficient certainty of evidence.<br /><b>Limitations</b><br />The main limitation of this review is the low or insufficient certainty of evidence for most outcomes. No evidence was available on second-step depression treatment or differences in values and preferences based on gender, race/ethnicity, age, and depression severity.<br /><b>Conclusion</b><br />Low-certainty evidence suggests that there may be some differences in preferences for talk therapy or pharmacologic treatment of depressive disorders based on gender or race/ethnicity. In addition, low-certainty evidence suggests that insomnia, anxiety, fatigue, weight gain, agitation, and sexual dysfunction may be the most important nonserious adverse events for patients treated with antidepressants. Evidence is lacking or insufficient to draw any further conclusions about patients\' weighing or valuation of the benefits and harms of depression treatments.<br /><b>Primary funding source</b><br />American College of Physicians. (PROSPERO: CRD42020212442).<br /><br /><br /><br /><small>Ann Intern Med: 24 Jan 2023; epub ahead of print</small></div>
Affengruber L, Wagner G, Dobrescu A, Toromanova A, ... Klerings I, Gartlehner G
Ann Intern Med: 24 Jan 2023; epub ahead of print | PMID: 36689749
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<div><h4>Nonpharmacologic and Pharmacologic Treatments of Adult Patients With Major Depressive Disorder : A Systematic Review and Network Meta-analysis for a Clinical Guideline by the American College of Physicians.</h4><i>Gartlehner G, Dobrescu A, Chapman A, Toromanova A, ... Klerings I, Wagner G</i><br /><b>Background</b><br />Primary care patients and clinicians may prefer alternative options to second-generation antidepressants for major depressive disorder (MDD).<br /><b>Purpose</b><br />To compare the benefits and harms of nonpharmacologic treatments with second-generation antidepressants as first-step interventions for acute MDD, and to compare second-step treatment strategies for patients who did not achieve remission after an initial attempt with antidepressants.<br /><b>Data sources</b><br />English-language studies from several electronic databases from 1 January 1990 to 8 August 2022, trial registries, gray literature databases, and reference lists to identify unpublished research.<br /><b>Study selection</b><br />2 investigators independently selected randomized trials of at least 6 weeks\' duration.<br /><b>Data extraction</b><br />Reviewers abstracted data about study design and conduct, participants, interventions, and outcomes. They dually rated the risk of bias of studies and the certainty of evidence for outcomes of interest.<br /><b>Data synthesis</b><br />65 randomized trials met the inclusion criteria; eligible data from nonrandomized studies were not found. Meta-analyses and network meta-analyses indicated similar benefits of most nonpharmacologic treatments and antidepressants as first-step treatments. Antidepressants had higher risks for discontinuation because of adverse events than most other treatments. For second-step therapies, different switching and augmentation strategies provided similar symptomatic relief. The certainty of evidence for most comparisons is low; findings should be interpreted cautiously.<br /><b>Limitations</b><br />Many studies had methodological limitations or dosing inequalities; publication bias might have affected some comparisons. In some cases, conclusions could not be drawn because of insufficient evidence.<br /><b>Conclusion</b><br />Although benefits seem to be similar among first- and second-step MDD treatments, the certainty of evidence is low for most comparisons. Clinicians and patients should focus on options with the most reliable evidence and take adverse event profiles and patient preferences into consideration.<br /><b>Primary funding source</b><br />American College of Physicians. (PROSPERO: CRD42020204703).<br /><br /><br /><br /><small>Ann Intern Med: 24 Jan 2023; epub ahead of print</small></div>
Gartlehner G, Dobrescu A, Chapman A, Toromanova A, ... Klerings I, Wagner G
Ann Intern Med: 24 Jan 2023; epub ahead of print | PMID: 36689750
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<div><h4>Nonpharmacologic and Pharmacologic Treatments of Adults in the Acute Phase of Major Depressive Disorder: A Living Clinical Guideline From the American College of Physicians.</h4><i>Qaseem A, Owens DK, Etxeandia-Ikobaltzeta I, Tufte J, ... Wilt TJ, Clinical Guidelines Committee of the American College of Physicians†</i><br /><b>Description</b><br />The purpose of this guideline from the American College of Physicians (ACP) is to present updated clinical recommendations on nonpharmacologic and pharmacologic interventions as initial and second-line treatments during the acute phase of a major depressive disorder (MDD) episode, based on the best available evidence on the comparative benefits and harms, consideration of patient values and preferences, and cost.<br /><b>Methods</b><br />The ACP Clinical Guidelines Committee based these recommendations on an updated systematic review of the evidence.<br /><b>Audience and patient population</b><br />The audience for this guideline includes clinicians caring for adult patients in the acute phase of MDD in ambulatory care. The patient population includes adults in the acute phase of MDD.<br /><b>Recommendation 1a</b><br /><i>ACP recommends monotherapy with either cognitive behavioral therapy or a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (strong recommendation; moderate-certainty evidence).</i><br /><b>Recommendation 1b</b><br /><i>ACP suggests combination therapy with cognitive behavioral therapy and a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (conditional recommendation; low-certainty evidence).</i> <i>The informed decision on the options of monotherapy with cognitive behavioral therapy versus second-generation antidepressants or combination therapy should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients\' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences.</i><br /><b>Recommendation 2</b><br /><i>ACP suggests monotherapy with cognitive behavioral therapy as initial treatment in patients in the acute phase of mild major depressive disorder (conditional recommendation; low-certainty evidence).</i><br /><b>Recommendation 3</b><br /><i>ACP suggests one of the following options for patients in the acute phase of moderate to severe major depressive disorder who did not respond to initial treatment with an adequate dose of a second-generation antidepressant:</i> • <i>Switching to or augmenting with cognitive behavioral therapy (conditional recommendation; low-certainty evidence)</i> • <i>Switching to a different second-generation antidepressant or augmenting with a second pharmacologic treatment (see Clinical Considerations) (conditional recommendation; low-certainty evidence)</i> <i>The informed decision on the options should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients\' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences.</i><br /><br /><br /><br /><small>Ann Intern Med: 24 Jan 2023; epub ahead of print</small></div>
Qaseem A, Owens DK, Etxeandia-Ikobaltzeta I, Tufte J, ... Wilt TJ, Clinical Guidelines Committee of the American College of Physicians†
Ann Intern Med: 24 Jan 2023; epub ahead of print | PMID: 36689752
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<div><h4>Epstein-Barr Viral Load Monitoring Strategy and the Risk for Posttransplant Lymphoproliferative Disease in Adult Liver Transplantation : A Cohort Study.</h4><i>Ruijter BN, Wolterbeek R, Hew M, van Reeven M, ... Vossen ACTM, van Hoek B</i><br /><b>Background</b><br />Primary infection with or reactivation of Epstein-Barr virus (EBV) can occur after liver transplant (LT) and can lead to posttransplant lymphoproliferative disease (PTLD). In pediatric LT, an EBV-DNA viral load (EBV VL) monitoring strategy, including the reduction of immunosuppression, has led to a lower incidence of PTLD. For adult LT recipients with less primary infection and more EBV reactivation, it is unknown whether this strategy is effective.<br /><b>Objective</b><br />To examine the effect of an EBV VL monitoring strategy on the incidence of PTLD after LT in adults.<br /><b>Design</b><br />Cohort study.<br /><b>Setting</b><br />Two university medical centers in the Netherlands.<br /><b>Patients</b><br />Adult recipients of first LT in Leiden between September 2003 and January 2017 with an EBV VL monitoring strategy formed the monitoring group (M1), recipients of first LT in Rotterdam between January 2003 and January 2017 without such a strategy formed the contemporary control group (C1), and those who had transplants in Leiden between September 1992 and September 2003 or Rotterdam between 1986 and January 2003 formed the historical control groups (M0 and C0, respectively).<br /><b>Measurements</b><br />Influence of EBV VL monitoring on incidence of PTLD.<br /><b>Results</b><br />After inverse probability of treatment weighting of the 4 groups to achieve a balance among the groups for important patient characteristics, differences within hospitals between the historical and recent era in cumulative incidences-expressed as the number of events per 1000 patients measured at 5-, 10-, and 15-year follow-up-showed fewer events in the contemporary era in both centers. This difference was considerably larger in the monitoring center, whereas the 95% CI included the null value of 0 for point estimates.<br /><b>Limitation</b><br />Retrospective, low statistical power, and incompletely balanced groups, and non-EBV PTLD cannot be prevented.<br /><b>Conclusion</b><br />Monitoring EBV VL may reduce PTLD incidence after LT in adults; larger studies are warranted.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 17 Jan 2023; epub ahead of print</small></div>
Ruijter BN, Wolterbeek R, Hew M, van Reeven M, ... Vossen ACTM, van Hoek B
Ann Intern Med: 17 Jan 2023; epub ahead of print | PMID: 36645888
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<div><h4>Hydroxychloroquine Dose and Risk for Incident Retinopathy : A Cohort Study.</h4><i>Melles RB, Jorge AM, Marmor MF, Zhou B, ... Zhang Y, Choi HK</i><br /><b>Background</b><br />Hydroxychloroquine is recommended for all patients with systemic lupus erythematosus and is often used for other inflammatory conditions, but a critical long-term adverse effect is vision-threatening retinopathy.<br /><b>Objective</b><br />To characterize the long-term risk for incident hydroxychloroquine retinopathy and examine the degree to which average hydroxychloroquine dose within the first 5 years of treatment predicts this risk.<br /><b>Design</b><br />Cohort study.<br /><b>Setting</b><br />U.S. integrated health network.<br /><b>Participants</b><br />All patients aged 18 years or older who received hydroxychloroquine for 5 or more years between 2004 and 2020 and had guideline-recommended serial retinopathy screening.<br /><b>Measurements</b><br />Hydroxychloroquine dose was assessed from pharmacy dispensing records. Incident hydroxychloroquine retinopathy was assessed by central adjudication of spectral domain optical coherence tomography with severity assessment (mild, moderate, or severe). Risk for hydroxychloroquine retinopathy was estimated over 15 years of use according to hydroxychloroquine weight-based dose (>6, 5 to 6, or ≤5 mg/kg per day) using the Kaplan-Meier estimator.<br /><b>Results</b><br />Among 3325 patients in the primary study population, 81 developed hydroxychloroquine retinopathy (56 mild, 17 moderate, and 8 severe), with overall cumulative incidences of 2.5% and 8.6% at 10 and 15 years, respectively. The cumulative incidences of retinopathy at 15 years were 21.6% for higher than 6 mg/kg per day, 11.4% for 5 to 6 mg/kg per day, and 2.7% for 5 mg/kg per day or lower. The corresponding risks for moderate to severe retinopathy at 15 years were 5.9%, 2.4%, and 1.1%, respectively.<br /><b>Limitation</b><br />Possible misclassifications of dose due to nonadherence to filled prescriptions.<br /><b>Conclusion</b><br />In this large, contemporary cohort with active surveillance retinopathy screening, the overall risk for hydroxychloroquine retinopathy was 8.6% after 15 years, and most cases were mild. Higher hydroxychloroquine dose was associated with progressively greater risk for incident retinopathy.<br /><b>Primary funding source</b><br />National Institutes of Health.<br /><br /><br /><br /><small>Ann Intern Med: 17 Jan 2023; epub ahead of print</small></div>
Melles RB, Jorge AM, Marmor MF, Zhou B, ... Zhang Y, Choi HK
Ann Intern Med: 17 Jan 2023; epub ahead of print | PMID: 36645889
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<div><h4>Colinet-Caplan Syndrome: History of an Outbreak of Autoimmune Disease in Scouring Powder Workers.</h4><i>Ronsmans S, Blanc PD</i><br /><AbstractText>The first modern description linking rheumatoid arthritis to occupational dust exposure is generally attributed to the British physician Anthony Caplan. In 1953, Caplan reported on a \"peculiar\" nodular pattern on chest radiographs of Welsh coal miners with rheumatoid arthritis that differed from the typical coal workers\' pneumoconiosis. However, as early as 1950, the Belgian rheumatologist Émile Colinet described a similar case of rheumatoid arthritis and concomitant pulmonary opacities in a 30-year-old woman with silica exposure. Soon after, he published a second case. Although this condition initially was called Colinet-Caplan syndrome in the Francophone biomedical literature, Colinet\'s name was later dropped from the eponym. Because Colinet never clearly described the specific occupational context of his cases, Caplan syndrome has been misconstrued as uniquely a disease of coal miners. We attempted to reconstruct the working conditions of Colinet\'s patients and found that they were packing Vim, a silica-based scouring powder, at the Savonneries Lever Frères factory in Brussels, Belgium. Colinet\'s cases were only the first 2 in a series of reports of rheumatoid arthritis and other autoimmune diseases, mainly among young women, in those who worked in the production of silica-based scouring powder between the 1930s and 1980s across Europe. The largest outbreak involved 32 cases of autoimmune disease among 50 former workers of a Spanish scouring powder manufacturing facility. After silica in scouring powders was replaced with less hazardous materials later in the 20th century, no further cases have been reported. Although scouring powder disease is a historical phenomenon, autoimmune disorders linked to occupational exposure to silica and coal dust have not disappeared but instead are reemerging among those who work with silica-based artificial stone and in other dusty trades.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 10 Jan 2023; epub ahead of print</small></div>
Ronsmans S, Blanc PD
Ann Intern Med: 10 Jan 2023; epub ahead of print | PMID: 36623284
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<div><h4>Diabetes Management in Chronic Kidney Disease: Synopsis of the KDIGO 2022 Clinical Practice Guideline Update.</h4><i>Navaneethan SD, Zoungas S, Caramori ML, Chan JCN, ... de Boer IH, Khunti K</i><br /><b>Description</b><br />The KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease is an update of the 2020 guideline from Kidney Disease: Improving Global Outcomes (KDIGO).<br /><b>Methods</b><br />The KDIGO Work Group updated the guideline, which included reviewing and grading new evidence that was identified and summarized. As in the previous guideline, the Work Group used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of recommendations and expert judgment to develop consensus practice points. New evidence led to updating of recommendations in the chapters Comprehensive Care in Patients With Diabetes and CKD (Chapter 1) and Glucose-Lowering Therapies in Patients With T2D and CKD (Chapter 4). New evidence did not change recommendations in the chapters Glycemic Monitoring and Targets in Patients With Diabetes and CKD (Chapter 2), Lifestyle Interventions in Patients With Diabetes and CKD (Chapter 3), and Approaches to Management of Patients With Diabetes and CKD (Chapter 5).<br /><b>Recommendations</b><br />The updated guideline includes 13 recommendations and 52 practice points for clinicians caring for patients with diabetes and chronic kidney disease (CKD). A focus on preserving kidney function and maintaining well-being is recommended using a layered approach to care, starting with a foundation of lifestyle interventions, self-management, and first-line pharmacotherapy (such as sodium-glucose cotransporter-2 inhibitors) demonstrated to improve clinical outcomes. To this are added additional drugs with heart and kidney protection, such as glucagon-like peptide-1 receptor agonists and nonsteroidal mineralocorticoid receptor antagonists, and interventions to control risk factors for CKD progression and cardiovascular events, such as blood pressure, glycemia, and lipids.<br /><br /><br /><br /><small>Ann Intern Med: 10 Jan 2023; epub ahead of print</small></div>
Navaneethan SD, Zoungas S, Caramori ML, Chan JCN, ... de Boer IH, Khunti K
Ann Intern Med: 10 Jan 2023; epub ahead of print | PMID: 36623286
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<div><h4>Migraine.</h4><i>Zhang N, Robbins MS</i><br /><AbstractText>Migraine affects about 1 billion people worldwide, and up to 15% of adults in the United States have migraine attacks in any given year. Migraine is associated with substantial adverse socioeconomic and personal effects. It is the second leading cause of years lived with disability worldwide for all ages and the leading cause in women aged 15 to 49 years. Diagnostic uncertainty increases the likelihood of unnecessary investigations and suboptimal management. This article advises clinicians about diagnosing migraine, ruling out secondary headache disorders, developing acute and preventive treatment plans, and deciding when to refer the patient to a specialist.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 10 Jan 2023; epub ahead of print</small></div>
Zhang N, Robbins MS
Ann Intern Med: 10 Jan 2023; epub ahead of print | PMID: 36623287
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<div><h4>Effectiveness and Safety of Treatments to Prevent Fractures in People With Low Bone Mass or Primary Osteoporosis : A Living Systematic Review and Network Meta-analysis for the American College of Physicians.</h4><i>Ayers C, Kansagara D, Lazur B, Fu R, Kwon A, Harrod C</i><br /><b>Background</b><br />The prevalence of osteoporosis is increasing in the United States.<br /><b>Purpose</b><br />To evaluate low bone mass and osteoporosis treatments to prevent fractures.<br /><b>Data sources</b><br />Ovid MEDLINE ALL, Ovid Evidence Based Medicine Reviews: Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov from 2014 through February 2022.<br /><b>Study selection</b><br />Adults receiving eligible interventions for low bone mass or osteoporosis. Randomized controlled trials (RCTs) for fracture outcomes, and RCTs and large observational studies (<i>n</i> ≥1000) for harms.<br /><b>Data extraction</b><br />Abstracted by 1 reviewer and verified by a second. Independent, dual assessments of risk of bias and certainty of evidence (CoE).<br /><b>Data synthesis</b><br />We included 34 RCTs (in 100 publications) and 36 observational studies. Bisphosphonates and denosumab reduced hip, clinical and radiographic vertebral, and other clinical fractures in postmenopausal females with osteoporosis (moderate to high CoE). Bisphosphonates for 36 months or more may increase the risk for atypical femoral fractures (AFFs) and osteonecrosis of the jaw (ONJ), but the absolute risks were low. Abaloparatide and teriparatide reduced clinical and radiographic vertebral fractures but increased the risk for withdrawals due to adverse events (WAEs; moderate to high CoE). Raloxifene and bazedoxifene for 36 months or more reduced radiographic vertebral but not clinical fractures (low to moderate CoE). Abaloparatide, teriparatide, and sequential romosozumab, then alendronate, may be more effective than bisphosphonates in reducing clinical fractures for 17 to 24 months in older postmenopausal females at very high fracture risk (low to moderate CoE). Bisphosphonates may reduce clinical fractures in older females with low bone mass (low CoE) and radiographic vertebral fractures in males with osteoporosis (low to moderate CoE).<br /><b>Limitation</b><br />Few studies examined participants with low bone mass, males, or Black-identifying persons, sequential therapy, or treatment beyond 3 years.<br /><b>Conclusion</b><br />Bisphosphonates, denosumab, abaloparatide, teriparatide, and romosozumab, followed by alendronate, reduce clinical fractures in postmenopausal females with osteoporosis. Abaloparatide and teriparatide increased WAEs; longer duration bisphosphonate use may increase AFF and ONJ risk though these events were rare.<br /><b>Primary funding source</b><br />American College of Physicians. (PROSPERO: CRD42021236220).<br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
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<div><h4>Pharmacologic Treatment of Primary Osteoporosis or Low Bone Mass to Prevent Fractures in Adults: A Living Clinical Guideline From the American College of Physicians.</h4><i>Qaseem A, Hicks LA, Etxeandia-Ikobaltzeta I, Shamliyan T, Cooney TG, Clinical Guidelines Committee of the American College of Physicians</i><br /><b>Description</b><br />This guideline updates the 2017 American College of Physicians (ACP) recommendations on pharmacologic treatment of primary osteoporosis or low bone mass to prevent fractures in adults.<br /><b>Methods</b><br />The ACP Clinical Guidelines Committee based these recommendations on an updated systematic review of evidence and graded them using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.<br /><b>Audience and patient population</b><br />The audience for this guideline includes all clinicians. The patient population includes adults with primary osteoporosis or low bone mass.<br /><b>Recommendation 1a</b><br /><i>ACP recommends that clinicians use bisphosphonates for initial pharmacologic treatment to reduce the risk of fractures in postmenopausal females diagnosed with primary osteoporosis (strong recommendation; high-certainty evidence).</i><br /><b>Recommendation 1b</b><br /><i>ACP suggests that clinicians use bisphosphonates for initial pharmacologic treatment to reduce the risk of fractures in males diagnosed with primary osteoporosis (conditional recommendation; low-certainty evidence).</i><br /><b>Recommendation 2a</b><br /><i>ACP suggests that clinicians use the RANK ligand inhibitor (denosumab) as a second-line pharmacologic treatment to reduce the risk of fractures in postmenopausal females diagnosed with primary osteoporosis who have contraindications to or experience adverse effects of bisphosphonates (conditional recommendation; moderate-certainty evidence).</i><br /><b>Recommendation 2b</b><br /><i>ACP suggests that clinicians use the RANK ligand inhibitor (denosumab) as a second-line pharmacologic treatment to reduce the risk of fractures in males diagnosed with primary osteoporosis who have contraindications to or experience adverse effects of bisphosphonates (conditional recommendation; low-certainty evidence).</i><br /><b>Recommendation 3</b><br /><i>ACP suggests that clinicians use the sclerostin inhibitor (romosozumab, moderate-certainty evidence) or recombinant PTH (teriparatide, low-certainty evidence), followed by a bisphosphonate, to reduce the risk of fractures only in females with primary osteoporosis with very high risk of fracture (conditional recommendation).</i><br /><b>Recommendation 4</b><br /><i>ACP suggests that clinicians take an individualized approach regarding whether to start pharmacologic treatment with a bisphosphonate in females over the age of 65 with low bone mass (osteopenia) to reduce the risk of fractures (conditional recommendation; low-certainty evidence).</i><br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
Qaseem A, Hicks LA, Etxeandia-Ikobaltzeta I, Shamliyan T, Cooney TG, Clinical Guidelines Committee of the American College of Physicians
Ann Intern Med: 03 Jan 2023; epub ahead of print | PMID: 36592456
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<div><h4>Short-Term Adverse Outcomes After Mifepristone-Misoprostol Versus Procedural Induced Abortion : A Population-Based Propensity-Weighted Study.</h4><i>Liu N, Ray JG</i><br /><b>Background</b><br />Prior studies comparing first-trimester pharmaceutical induced abortion (IA) with procedural IA were prone to selection bias, were underpowered to assess serious adverse events (SAEs), and did not account for confounding by indication. Starting in 2017, mifepristone-misoprostol was dispensed at no cost in outpatient pharmacies across Ontario, Canada.<br /><b>Objective</b><br />To compare short-term risk for adverse outcomes after early IA by mifepristone-misoprostol versus by procedural IA.<br /><b>Design</b><br />Population-based cohort study.<br /><b>Setting</b><br />Ontario, Canada.<br /><b>Patients</b><br />All women who had first-trimester IA.<br /><b>Measurements</b><br />A total of 39 856 women dispensed mifepristone-misoprostol as outpatients were compared with 65 176 women undergoing procedural IA at 14 weeks\' gestation or earlier within nonhospital outpatient clinics (comparison 1). A total of 39 856 women prescribed mifepristone-misoprostol were compared with 8861 women undergoing ambulatory hospital-based procedural IA at an estimated 9 weeks\' gestation or less (comparison 2). The primary composite outcome was any SAE within 42 days after IA, including severe maternal morbidity, end-organ damage, intensive care unit admission, or death. A coprimary broader outcome comprised any SAE, hemorrhage, retained products of conception, infection, or transfusion. Stabilized inverse probability of treatment weighting accounted for confounding between exposure groups.<br /><b>Results</b><br />Mean age at IA was about 29 years (SD, 7); 33% were primigravidae. Six percent resided in rural areas, and 25% resided in low-income neighborhoods. In comparison 1, SAEs occurred among 133 women after mifepristone-misoprostol IA (3.3 per 1000) versus 114 after procedural IA (1.8 per 1000) (relative risk [RR], 1.87 [95% CI, 1.44 to 2.43]; absolute risk difference [ARD], 1.5 per 1000 [CI, 0.9 to 2.2]). The respective rates of any adverse event were 28.9 versus 12.4 per 1000 (RR, 2.33 [CI, 2.11 to 2.57]; ARD, 16.5 per 1000 [CI, 14.5 to 18.4]). In comparison 2, SAEs occurred among 133 (3.4 per 1000) and 27 (3.3 per 1000) women, respectively (RR, 1.04 [CI, 0.61 to 1.78]). The respective rates of any adverse event were 31.2 versus 24.9 per 1000 (RR, 1.25 [CI, 1.04 to 1.51]).<br /><b>Limitation</b><br />A woman prescribed mifepristone-misoprostol may not have taken the medication, and the exact gestational age at IA was not always known.<br /><b>Conclusion</b><br />Although rare, short-term adverse events are more likely after mifepristone-misoprostol IA than procedural IA, especially for less serious adverse outcomes.<br /><b>Primary funding source</b><br />Canadian Institutes of Health Research.<br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
Abstract
<div><h4>In type 2 diabetes, the BT-001 smartphone app reduced HbA more than a control app at 90 d.</h4><i>Greenblatt LH</i><br /><AbstractText>Hsia J, Guthrie NL, Lupinacci P, et al. <b>Randomized, controlled trial of a digital behavioral therapeutic application to improve glycemic control in adults with type 2 diabetes.</b> Diabetes Care. 2022;45:2976-81. 36181554.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
Greenblatt LH
Ann Intern Med: 03 Jan 2023; epub ahead of print | PMID: 36592462
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Abstract
<div><h4>In glucocorticoid-dependent polymyalgia rheumatica, tocilizumab improved a composite clinical outcome at 24 wk.</h4><i>Pisetsky DS</i><br /><AbstractText>Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, et al. <b>Effect of tocilizumab on disease activity in patients with active polymyalgia rheumatica receiving glucocorticoid therapy: a randomized clinical trial.</b> JAMA. 2022;328:1053-62. 36125471.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
Pisetsky DS
Ann Intern Med: 03 Jan 2023; epub ahead of print | PMID: 36592464
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Abstract
<div><h4>Statins increase muscle pain or weakness at 1 y, with an absolute excess of 11 events/1000 person-y.</h4><i>Bavishi C</i><br /><AbstractText>Cholesterol Treatment Trialists\' Collaboration. <b>Effect of statin therapy on muscle symptoms: an individual participant data meta-analysis of large-scale, randomised, double-blind trials.</b> Lancet. 2022;400:832-45. 36049498.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 03 Jan 2023; epub ahead of print</small></div>
Bavishi C
Ann Intern Med: 03 Jan 2023; epub ahead of print | PMID: 36592471
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Abstract
<div><h4>Anticoagulant Therapy for Cancer-Associated Thrombosis : A Cost-Effectiveness Analysis.</h4><i>Gulati S, Eckman MH</i><br /><b>Background</b><br />Direct oral anticoagulants (DOACs) offer an alternative to low-molecular-weight heparin (LMWH) and warfarin for treating cancer-associated thrombosis (CAT).<br /><b>Objective</b><br />To determine the cost and effectiveness of DOACs versus LMWH.<br /><b>Design</b><br />Cohort-state transition decision analytic model.<br /><b>Data sources</b><br />Network meta-analysis comparing DOACs versus LMWH.<br /><b>Target population</b><br />Adult patients with cancer at the time they develop thrombosis.<br /><b>Time horizon</b><br />Lifetime.<br /><b>Perspective</b><br />Health care sector.<br /><b>Intervention</b><br />Strategies of 1) enoxaparin, 2) apixaban, 3) edoxaban, and 4) rivaroxaban for treatment of CAT.<br /><b>Outcome measures</b><br />Incremental cost-effectiveness ratio (ICER) in 2022 U.S. dollars per quality-adjusted life-year (QALY) gained.<br /><b>Results of base-case analysis</b><br />In the base-case scenario, using drug prices from the U.S. Department of Veterans Affairs Federal Supply Schedule, apixaban dominated enoxaparin and edoxaban by being less costly and more effective. Rivaroxaban was slightly more effective than apixaban, with an ICER of $493 246. In a scenario analysis using \"real-world\" drug prices from GoodRx, rivaroxaban was cost-effective with an ICER of $50 053 per QALY.<br /><b>Results of sensitivity analysis</b><br />Results were highly sensitive to monthly drug costs. Probabilistic sensitivity analyses showed that at a willingness-to-pay threshold of $50 000 per QALY, apixaban was preferred in 80% of simulations. However, sensitivity analyses also demonstrated that apixaban only remained cost-effective if monthly medication costs were below $530. Above this, rivaroxaban became cost-effective.<br /><b>Limitations</b><br />An assumption was made that patients would continue anticoagulation indefinitely unless they suffered a major bleed. Nonmedical costs such as patient and caregiver loss of productivity were not accounted for, and long-term thrombotic complications were not explicitly modeled.<br /><b>Conclusion</b><br />The 3 DOACs are more effective and more cost-effective than LMWH. The most cost-effective DOAC depends on the relative cost of each of these agents. These are important considerations for treating physicians and health policymakers.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 27 Dec 2022; epub ahead of print</small></div>
Gulati S, Eckman MH
Ann Intern Med: 27 Dec 2022; epub ahead of print | PMID: 36571839
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Abstract
<div><h4>Assessing Performance and Clinical Usefulness in Prediction Models With Survival Outcomes: Practical Guidance for Cox Proportional Hazards Models.</h4><i>McLernon DJ, Giardiello D, Van Calster B, Wynants L, ... Steyerberg EW, topic groups 6 and 8 of the STRATOS Initiative</i><br /><AbstractText>Risk prediction models need thorough validation to assess their performance. Validation of models for survival outcomes poses challenges due to the censoring of observations and the varying time horizon at which predictions can be made. This article describes measures to evaluate predictions and the potential improvement in decision making from survival models based on Cox proportional hazards regression. As a motivating case study, the authors consider the prediction of the composite outcome of recurrence or death (the \"event\") in patients with breast cancer after surgery. They developed a simple Cox regression model with 3 predictors, as in the Nottingham Prognostic Index, in 2982 women (1275 events over 5 years of follow-up) and externally validated this model in 686 women (285 events over 5 years). Improvement in performance was assessed after the addition of progesterone receptor as a prognostic biomarker. The model predictions can be evaluated across the full range of observed follow-up times or for the event occurring by the end of a fixed time horizon of interest. The authors first discuss recommended statistical measures that evaluate model performance in terms of discrimination, calibration, or overall performance. Further, they evaluate the potential clinical utility of the model to support clinical decision making according to a net benefit measure. They provide SAS and R code to illustrate internal and external validation. The authors recommend the proposed set of performance measures for transparent reporting of the validity of predictions from survival models.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 27 Dec 2022; epub ahead of print</small></div>
McLernon DJ, Giardiello D, Van Calster B, Wynants L, ... Steyerberg EW, topic groups 6 and 8 of the STRATOS Initiative
Ann Intern Med: 27 Dec 2022; epub ahead of print | PMID: 36571841
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Abstract
<div><h4>Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial.</h4><i>Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, ... Rossi A, Weiner DE</i><br /><b>Background</b><br />Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences.<br /><b>Objective</b><br />To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care.<br /><b>Design</b><br />Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT03522740).<br /><b>Setting</b><br />8 outpatient nephrology clinics associated with 4 U.S. centers.<br /><b>Participants</b><br />English-fluent patients, 70 years and older with nondialysis CKD stages 4 to 5 recruited from 2018 to 2020.<br /><b>Intervention</b><br />DART (Decision-Aid for Renal Therapy) is an interactive, web-based decision aid for older adults with CKD. Both groups received written education about treatments.<br /><b>Measurements</b><br />Change in the decisional conflict scale (DCS) score from baseline to 3, 6, 12, and 18 months. Secondary outcomes included change in prognostic and treatment knowledge and change in uncertainty.<br /><b>Results</b><br />Among 400 participants, 363 were randomly assigned: 180 to usual care, 183 to DART. Decisional quality improved with DART with mean DCS declining compared with control (mean difference, -8.5 [95% CI, -12.0 to -5.0]; <i>P</i> < 0.001), with similar findings at 6 months, attenuating thereafter. At 3 months, knowledge improved with DART versus usual care (mean difference, 7.2 [CI, 3.7 to 10.7]; <i>P</i> < 0.001); similar findings at 6 months were modestly attenuated at 18 months (mean difference, 5.9 [CI, 1.4 to 10.3]; <i>P</i> = 0.010). Treatment preferences changed from 58% \"unsure\" at baseline to 28%, 20%, 23%, and 14% at 3, 6, 12, and 18 months, respectively, with DART, versus 51% to 38%, 35%, 32%, and 18% with usual care.<br /><b>Limitation</b><br />Latinx patients were underrepresented.<br /><b>Conclusion</b><br />DART improved decision quality and clarified treatment preferences among older adults with advanced CKD for 6 months after the DART intervention.<br /><b>Primary funding source</b><br />Patient-Centered Outcomes Research Institute (PCORI).<br /><br /><br /><br /><small>Ann Intern Med: 20 Dec 2022; epub ahead of print</small></div>
Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, ... Rossi A, Weiner DE
Ann Intern Med: 20 Dec 2022; epub ahead of print | PMID: 36534976
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Abstract
<div><h4>Left Atrial Mechanical Dysfunction and the Risk for Ischemic Stroke in People Without Prevalent Atrial Fibrillation or Stroke : A Prospective Cohort Study.</h4><i>Maheshwari A, Norby FL, Inciardi RM, Wang W, ... Shah AM, Chen LY</i><br /><b>Background</b><br />Atrial myopathy-characterized by changes in left atrial function and size-may precede and promote atrial fibrillation (AF) and cardiac thromboembolism. In people without prior AF or stroke, whether analysis of left atrial function and size can improve ischemic stroke prediction is unknown.<br /><b>Objective</b><br />To evaluate the association of echocardiographic left atrial function (reservoir, conduit, and contractile strain) and left atrial size (left atrial volume index) with ischemic stroke and determine whether these measures can improve the stroke prediction achieved by CHA<sub>2</sub>DS<sub>2</sub>-VASc score variables.<br /><b>Design</b><br />Prospective cohort study.<br /><b>Setting</b><br />ARIC (Atherosclerosis Risk in Communities) study.<br /><b>Participants</b><br />4917 ARIC participants without prevalent stroke or AF.<br /><b>Measurements</b><br />Ischemic stroke events (2011 to 2019) were adjudicated by physicians. Left atrial strain was measured using speckle-tracking echocardiography.<br /><b>Results</b><br />Over 5 years, the cumulative incidences of ischemic stroke in the lowest quintiles of left atrial reservoir, conduit, and contractile strain were 2.99% (95% CI, 1.89% to 4.09%), 3.18% (CI, 2.14% to 4.22%), and 2.15% (CI, 1.09% to 3.21%), respectively, and that of severe left atrial enlargement was 1.99% (CI, 0.23% to 3.75%). On the basis of the Akaike information criterion, left atrial reservoir strain plus CHA<sub>2</sub>DS<sub>2</sub>-VASc variables was the best predictive model. With the addition of left atrial reservoir strain to CHA<sub>2</sub>DS<sub>2</sub>-VASc variables, 11.6% of the 112 participants with stroke after 5 years were reclassified to higher risk categories and 1.8% to lower risk categories. Among the 4805 participants who did not develop stroke, 12.2% were reclassified to lower and 12.7% to higher risk categories. Decision curve analysis showed a predicted net benefit of 1.34 per 1000 people at a 5-year risk threshold of 5%.<br /><b>Limitation</b><br />Underascertainment of subclinical AF.<br /><b>Conclusion</b><br />In people without prior AF or stroke, when added to CHA<sub>2</sub>DS<sub>2</sub>-VASc variables, left atrial reservoir strain improves stroke prediction and yields a predicted net benefit, as shown by decision curve analysis.<br /><b>Primary funding source</b><br />National Heart, Lung, and Blood Institute of the National Institutes of Health.<br /><br /><br /><br /><small>Ann Intern Med: 20 Dec 2022; epub ahead of print</small></div>
Maheshwari A, Norby FL, Inciardi RM, Wang W, ... Shah AM, Chen LY
Ann Intern Med: 20 Dec 2022; epub ahead of print | PMID: 36534978
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<div><h4>Monkeypox in Montréal: Epidemiology, Phylogenomics, and Public Health Response to a Large North American Outbreak.</h4><i>Harrison LB, Bergeron G, Cadieux G, Charest H, ... Klein MB, Barkati S</i><br /><b>Background</b><br />Monkeypox, a viral zoonotic disease, is causing a global outbreak outside of endemic areas.<br /><b>Objective</b><br />To characterize the outbreak of monkeypox in Montréal, the first large outbreak in North America.<br /><b>Design</b><br />Epidemiologic and laboratory surveillance data and a phylogenomic analysis were used to describe and place the outbreak in a global context.<br /><b>Setting</b><br />Montréal, Canada.<br /><b>Patients</b><br />Probable or confirmed cases of monkeypox.<br /><b>Measurements</b><br />Epidemiologic, clinical, and demographic data were aggregated. Whole-genome sequencing and phylogenetic analysis were performed for a set of outbreak sequences. The public health response and its evolution are described.<br /><b>Results</b><br />Up to 18 October 2022, a total of 402 cases of monkeypox were reported mostly among men who have sex with men (MSM), most of which were suspected to be acquired through sexual contact. All monkeypox genomes nested within the B.1 lineage. Montréal Public Health worked closely with the affected communities to control the outbreak, becoming the first jurisdiction to offer 1 dose of the Modified Vaccinia Ankara-Bavarian Nordic vaccine as preexposure prophylaxis (PrEP) to those at risk in early June 2022. Two peaks of cases were seen in early June and July (43 and 44 cases per week, respectively) followed by a decline toward near resolution of the outbreak in October. Reasons for the biphasic peak are not fully elucidated but may represent the tempo of vaccination and/or several factors related to transmission dynamics and case ascertainment.<br /><b>Limitations</b><br />Clinical data are self-reported. Limited divergence among sequences limited genomic epidemiologic conclusions.<br /><b>Conclusion</b><br />A large outbreak of monkeypox occurred in Montréal, primarily among MSM. Successful control of the outbreak rested on early and sustained engagement with the affected communities and rapid offer of PrEP vaccination to at-risk persons.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 13 Dec 2022; epub ahead of print</small></div>
Harrison LB, Bergeron G, Cadieux G, Charest H, ... Klein MB, Barkati S
Ann Intern Med: 13 Dec 2022; epub ahead of print | PMID: 36508736
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<div><h4>Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial.</h4><i>Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, ... Israelsen M, Krag A</i><br /><b>Background</b><br />It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.<br /><b>Objective</b><br />To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.<br /><b>Design</b><br />6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).<br /><b>Setting</b><br />Odense University Hospital in Denmark from November 2016 until June 2020.<br /><b>Participants</b><br />165 participants with T2DM.<br /><b>Intervention</b><br />Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.<br /><b>Measurements</b><br />Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.<br /><b>Results</b><br />The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A<sub>1c</sub> (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.<br /><b>Limitation</b><br />Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.<br /><b>Conclusion</b><br />Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention.<br /><b>Primary funding source</b><br />Novo Nordisk Foundation.<br /><br /><br /><br /><small>Ann Intern Med: 13 Dec 2022; epub ahead of print</small></div>
Hansen CD, Gram-Kampmann EM, Hansen JK, Hugger MB, ... Israelsen M, Krag A
Ann Intern Med: 13 Dec 2022; epub ahead of print | PMID: 36508737
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<div><h4>How Would You Manage This Patient With Chronic Insomnia? : Grand Rounds Discussion From Beth Israel Deaconess Medical Center.</h4><i>Libman H, Zhou ES, Heckman E, Smetana GW</i><br /><AbstractText>Insomnia, which is characterized by persistent sleep difficulties in association with daytime dysfunction, is a common concern in clinical practice. Chronic insomnia disorder is defined as symptoms that occur at least 3 times per week and persist for at least 3 months. The American Academy of Sleep Medicine (AASM) published recent guidelines on behavioral and psychological treatment as well as pharmacologic therapy for chronic insomnia disorder. Regarding behavioral and psychological approaches, the only intervention strongly recommended was multicomponent cognitive behavioral therapy for insomnia. Regarding pharmacologic treatment, the AASM, based on weak evidence, suggested a limited number of medications that might be useful and others that probably are not. Here, 2 clinicians with expertise in sleep disorders-one a clinical psychologist and the other a physician-debate the management of a patient with chronic insomnia who has been treated with medications. They discuss the role of behavioral and psychological interventions and pharmacologic therapy for chronic insomnia and how the primary care practitioner should approach such a patient.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 13 Dec 2022; epub ahead of print</small></div>
Libman H, Zhou ES, Heckman E, Smetana GW
Ann Intern Med: 13 Dec 2022; epub ahead of print | PMID: 36508740
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<div><h4>Monoclonal Gammopathy of Undetermined Significance.</h4><i>Gonsalves WI, Rajkumar SV</i><br /><AbstractText>Monoclonal gammopathy of undetermined significance (MGUS) is of considerable clinical importance to primary care physicians given its high prevalence in the general population. MGUS has a variable but lifelong risk for progression to hematologic cancer, such as multiple myeloma, Waldenström macroglobulinemia, or light-chain amyloidosis. In addition, MGUS has been associated with several nonmalignant yet symptomatic disorders that require therapy directed toward eliminating the monoclonal gammopathy. Thus, it is important not only to understand the essentials of diagnosing and monitoring patients with MGUS but also to recognize when to refer patients with MGUS to a specialist.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 13 Dec 2022; epub ahead of print</small></div>
Gonsalves WI, Rajkumar SV
Ann Intern Med: 13 Dec 2022; epub ahead of print | PMID: 36508741
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<div><h4>Nirmatrelvir Plus Ritonavir for Early COVID-19 in a Large U.S. Health System : A Population-Based Cohort Study.</h4><i>Dryden-Peterson S, Kim A, Kim AY, Caniglia EC, ... Baden LR, Woolley AE</i><br /><b>Background</b><br />In the EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, nirmatrelvir plus ritonavir led to an 89% reduction in hospitalization or death among unvaccinated outpatients with early COVID-19. The clinical impact of nirmatrelvir plus ritonavir among vaccinated populations is uncertain.<br /><b>Objective</b><br />To assess whether nirmatrelvir plus ritonavir reduces risk for hospitalization or death among outpatients with early COVID-19 in the setting of prevalent SARS-CoV-2 immunity and immune-evasive SARS-CoV-2 lineages.<br /><b>Design</b><br />Population-based cohort study analyzed to emulate a clinical trial using inverse probability-weighted models to account for anticipated bias in treatment.<br /><b>Setting</b><br />A large health care system providing care for 1.5 million patients in Massachusetts and New Hampshire during the Omicron wave (1 January to 17 July 2022).<br /><b>Patients</b><br />44 551 nonhospitalized adults (90.3% with ≥3 vaccine doses) aged 50 years or older with COVID-19 and no contraindications for nirmatrelvir plus ritonavir.<br /><b>Measurements</b><br />The primary outcome was a composite of hospitalization within 14 days or death within 28 days of a COVID-19 diagnosis.<br /><b>Results</b><br />During the study period, 12 541 (28.1%) patients were prescribed nirmatrelvir plus ritonavir, and 32 010 (71.9%) were not. Patients prescribed nirmatrelvir plus ritonavir were more likely to be older, have more comorbidities, and be vaccinated. The composite outcome of hospitalization or death occurred in 69 (0.55%) patients who were prescribed nirmatrelvir plus ritonavir and 310 (0.97%) who were not (adjusted risk ratio, 0.56 [95% CI, 0.42 to 0.75]). Recipients of nirmatrelvir plus ritonavir had lower risk for hospitalization (adjusted risk ratio, 0.60 [CI, 0.44 to 0.81]) and death (adjusted risk ratio, 0.29 [CI, 0.12 to 0.71]).<br /><b>Limitation</b><br />Potential residual confounding due to differential access to COVID-19 vaccines, diagnostic tests, and treatment.<br /><b>Conclusion</b><br />The overall risk for hospitalization or death was already low (1%) after an outpatient diagnosis of COVID-19, but nirmatrelvir plus ritonavir reduced this risk further.<br /><b>Primary funding source</b><br />National Institutes of Health.<br /><br /><br /><br /><small>Ann Intern Med: 13 Dec 2022; epub ahead of print</small></div>
Dryden-Peterson S, Kim A, Kim AY, Caniglia EC, ... Baden LR, Woolley AE
Ann Intern Med: 13 Dec 2022; epub ahead of print | PMID: 36508742
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<div><h4>In CV disease, clopidogrel reduces nonfatal MI and MACE vs. aspirin but not stroke or mortality.</h4><i>Goel A, Malik AH</i><br /><AbstractText>Tasoudis PT, Kyriakoulis IG, Sagris D, et al. <b>Clopidogrel monotherapy versus aspirin monotherapy in patients with established cardiovascular disease: systematic review and meta-analysis.</b> Thromb Haemost. 2022;122:1879-87. 35577054.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Goel A, Malik AH
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469913
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<div><h4>Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease : A Post Hoc Analysis of DAPA-CKD.</h4><i>Schechter M, Jongs N, Chertow GM, Mosenzon O, ... Wheeler DC, Heerspink HJL</i><br /><b>Background</b><br />Acute hospitalizations are common in patients with chronic kidney disease (CKD) and often lead to decreases in health-related quality of life and increased care costs.<br /><b>Objective</b><br />To determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations.<br /><b>Design</b><br />Post hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150).<br /><b>Setting</b><br />386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020.<br /><b>Participants</b><br />Adults with an estimated glomerular filtration rate of 25 to 75 mL/min/1.73 m<sup>2</sup> and a urinary albumin-creatinine ratio of 200 to 5000 mg/g, with and without type 2 diabetes.<br /><b>Intervention</b><br />Dapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio).<br /><b>Measurements</b><br />The effects of dapagliflozin on first hospitalizations for any cause, all hospitalizations, and cause-specific (first and recurrent) hospitalizations were determined. The reported system organ class was used to evaluate reasons for admission. Hospitalizations were analyzed using Cox proportional hazards regression models (first hospitalization), the Lin-Wei-Yang-Ying method (all hospitalizations or death), and negative binomial models (cause-specific hospitalizations).<br /><b>Results</b><br />The study included 4304 patients (mean age, 61.8 years; 33.1% women). During a median follow-up of 2.4 years, 2072 hospitalizations were reported among 1224 (28.4%) participants. Compared with placebo, dapagliflozin reduced risk for a first hospitalization (hazard ratio, 0.84 [95% CI, 0.75 to 0.94]) and all hospitalizations or death (rate ratio, 0.79 [CI, 0.70 to 0.89]). There was no evidence that the effects of dapagliflozin on first and all hospitalizations varied by baseline presence of type 2 diabetes (<i>P</i> for interaction = 0.60 for each). Compared with placebo, dapagliflozin reduced the rate of admissions due to cardiac disorders, renal and urinary disorders, metabolism and nutrition disorders, and neoplasms.<br /><b>Limitations</b><br />This was a post hoc analysis and should be viewed as hypothesis-generating. Hospitalizations and causes were reported by site investigators and were not centrally adjudicated.<br /><b>Conclusion</b><br />Dapagliflozin reduced the risk for hospitalization for any cause in patients with CKD with and without type 2 diabetes.<br /><b>Primary funding source</b><br />AstraZeneca.<br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Schechter M, Jongs N, Chertow GM, Mosenzon O, ... Wheeler DC, Heerspink HJL
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469914
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<div><h4>Comparative Effectiveness of Team-Based Care With and Without Clinical Decision Support System for Diabetes Management : A Cluster Randomized Trial.</h4><i>Shi X, He J, Lin M, Liu C, ... Yao G, Li X</i><br /><b>Background</b><br />Uncontrolled hyperglycemia, hypercholesterolemia, and hypertension are common in persons with diabetes.<br /><b>Objective</b><br />To compare the effectiveness of team-based care with and without a clinical decision support system (CDSS) in controlling glycemia, lipids, and blood pressure (BP) among patients with type 2 diabetes.<br /><b>Design</b><br />Cluster randomized trial. (ClinicalTrials.gov: NCT02835287).<br /><b>Setting</b><br />38 community health centers in Xiamen, China.<br /><b>Patients</b><br />11 132 persons aged 50 years or older with uncontrolled diabetes and comorbid conditions, 5475 receiving team-based care with a CDSS and 5657 receiving team-based care alone.<br /><b>Intervention</b><br />Team-based care was delivered by primary care physicians, health coaches, and diabetes specialists in all centers. In addition, a computerized CDSS, which generated individualized treatment recommendations based on clinical guidelines, was implemented in 19 centers delivering team-based care with a CDSS.<br /><b>Measurements</b><br />Coprimary outcomes were mean reductions in hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) level, low-density lipoprotein cholesterol (LDL-C) level, and systolic BP over 18 months and the proportion of participants with all 3 risk factors controlled at 18 months.<br /><b>Results</b><br />During the 18-month intervention, HbA<sub>1c</sub> levels, LDL-C levels, and systolic BP significantly decreased by -0.9 percentage point (95% CI, -0.9 to -0.8 percentage point), -0.49 mmol/L (CI, -0.53 to -0.45 mmol/L) (-19.0 mg/dL [CI, -20.4 to -17.5 mg/dL]), and -9.1 mm Hg (CI, -9.9 to -8.3 mm Hg), respectively, in team-based care with a CDSS and by -0.6 percentage point (CI, -0.7 to -0.5 percentage point), -0.32 mmol/L (CI, -0.35 to -0.29 mmol/L) (-12.5 mg/dL [CI, -13.6 to -11.3 mg/dL]), and -7.5 mm Hg (CI, -8.4 to -6.6 mm Hg), respectively, in team-based care alone. Net differences were -0.2 percentage point (CI, -0.3 to -0.1 percentage point) for HbA<sub>1c</sub> level, -0.17 mmol/L (CI, -0.21 to -0.12 mmol/L) (-6.5 mg/dL [CI, -8.3 to -4.6 mg/dL]) for LDL-C level, and -1.5 mm Hg (CI, -2.8 to -0.3 mm Hg) for systolic BP. The proportion of patients with controlled HbA<sub>1c</sub>, LDL-C, and systolic BP was 16.9% (CI, 15.7% to 18.2%) in team-based care with a CDSS and 13.0% (CI, 11.7% to 14.3%) in team-based care alone.<br /><b>Limitation</b><br />There was no usual care control, and clinical outcome assessors were unblinded; the analysis did not account for multiple comparisons.<br /><b>Conclusion</b><br />Compared with team-based care alone, team-based care with a CDSS significantly reduced cardiovascular risk factors in patients with diabetes, but the effect was modest.<br /><b>Primary funding source</b><br />Xiamen Municipal Health Commission.<br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Shi X, He J, Lin M, Liu C, ... Yao G, Li X
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469915
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<div><h4>In monkeypox, risk for some symptoms was greater in MSM with vs. without receptive anal contact.</h4><i>Lakhana M, Fenster M, Glatt AE</i><br /><AbstractText>Tarín-Vicente EJ, Alemany A, Agud-Dios M, et al. <b>Clinical presentation and virological assessment of confirmed human monkeypox virus cases in Spain: a prospective observational cohort study.</b> Lancet. 2022;400:661-9. 35952705.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Lakhana M, Fenster M, Glatt AE
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469917
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<div><h4>BP-lowering drugs reduced major CV events by similar amounts in patients with and without type 2 diabetes.</h4><i>Carr JC</i><br /><AbstractText>Nazarzadeh M, Bidel Z, Canoy D, et al. <b>Blood pressure-lowering treatment for prevention of major cardiovascular diseases in people with and without type 2 diabetes: an individual participant-level data meta-analysis.</b> Lancet Diabetes Endocrinol. 2022;10:645-54. 35878651.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Carr JC
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469918
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<div><h4>Long-Term Stability of Coverage Among Michigan Medicaid Beneficiaries : A Cohort Study.</h4><i>Ndumele CD, Lollo A, Krumholz HM, Schlesinger M, Wallace J</i><br /><b>Background</b><br />Medicaid, the primary source of insurance coverage for disadvantaged Americans, was originally designed as a temporary safety-net program. No studies have used long-run data to assess the recent use of the program by beneficiaries.<br /><b>Objective</b><br />To assess patterns of short- and long-term enrollment among beneficiaries, using a 10-year longitudinal panel of Michigan Medicaid eligibility data.<br /><b>Design</b><br />Primary analyses assessing trends in Medicaid enrollment among cohorts of existing and new beneficiaries.<br /><b>Setting</b><br />Administrative records from Michigan Medicaid for the period 2011 to 2020.<br /><b>Participants</b><br />3.97 million Medicaid beneficiaries.<br /><b>Measurements</b><br />Short- and long-term enrollment in the program.<br /><b>Results</b><br />The sample includes 3.97 million unique beneficiaries enrolled at some point between 2011 and 2020. Among a cohort of 1.23 million beneficiaries enrolled in 2011, over half (53%) were also enrolled in Medicaid in June 2020, spending, on average, two-thirds of that period (67%) on Medicaid. These beneficiaries, however, experienced substantial lapses in coverage, as only 25% were continuously enrolled throughout the period. Enrollment was less stable when assessed from the perspective of newly enrolled beneficiaries, of whom only 37% remained enrolled at the end of the study period.<br /><b>Limitation</b><br />Primary estimates from a single state.<br /><b>Conclusion</b><br />For many beneficiaries, Medicaid has served as their primary source of coverage for at least a decade. This pattern would justify increasing investments in the program to improve long-term health outcomes.<br /><b>Primary funding source</b><br />Self-funded.<br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Ndumele CD, Lollo A, Krumholz HM, Schlesinger M, Wallace J
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469920
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<div><h4>In THA or TKA, risk for symptomatic VTE was higher with aspirin vs. enoxaparin at 90 d.</h4><i>Garcia D</i><br /><AbstractText>CRISTAL Study Group; Sidhu VS, Kelly TL, Pratt N, et al. <b>Effect of aspirin vs enoxaparin on symptomatic venous thromboembolism in patients undergoing hip or knee arthroplasty: the CRISTAL randomized trial.</b> JAMA. 2022;328:719-27. 35997730.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 06 Dec 2022; epub ahead of print</small></div>
Garcia D
Ann Intern Med: 06 Dec 2022; epub ahead of print | PMID: 36469926
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<div><h4>Outpatient Treatment of Confirmed COVID-19 : A Living, Rapid Review for the American College of Physicians.</h4><i>Sommer I, Dobrescu A, Ledinger D, Moser I, ... Klerings I, Gartlehner G</i><br /><b>Background</b><br />Clinicians and patients want to know the benefits and harms of outpatient treatment options for SARS-CoV-2 infection.<br /><b>Purpose</b><br />To assess the benefits and harms of 12 different COVID-19 treatments in the outpatient setting.<br /><b>Data sources</b><br />Epistemonikos COVID-19 L·OVE Platform, searched on 4 April 2022.<br /><b>Study selection</b><br />Two reviewers independently screened abstracts and full texts against a priori-defined criteria. Randomized controlled trials (RCTs) that compared COVID-19 treatments in adult outpatients with confirmed SARS-CoV-2 infection were included.<br /><b>Data extraction</b><br />One reviewer extracted data and assessed risk of bias and certainty of evidence (COE). A second reviewer verified data abstraction and assessments.<br /><b>Data synthesis</b><br />The 26 included studies collected data before the emergence of the Omicron variant. Nirmatrelvir-ritonavir and casirivimab-imdevimab probably reduced hospitalizations (1% vs. 6% [1 RCT] and 1% vs. 4% [1 RCT], respectively; moderate COE). Nirmatrelvir-ritonavir probably reduced all-cause mortality (0% vs. 1% [1 RCT]; moderate COE), and regdanvimab probably improved recovery (87% vs. 72% [1 RCT]; moderate COE). Casirivimab-imdevimab reduced time to recovery by a median difference of 4 days (10 vs. 14 median days [1 RCT]; high COE). Molnupiravir may reduce all-cause mortality, sotrovimab may reduce hospitalization, and remdesivir may improve recovery (low COE). Lopinavir-ritonavir and azithromycin may have increased harms, and hydroxychloroquine may result in lower recovery rates (low COE). Other treatments had insufficient evidence or no statistical difference in efficacy and safety versus placebo.<br /><b>Limitation</b><br />Many outcomes had few events and small samples.<br /><b>Conclusion</b><br />Some antiviral medications and monoclonal antibodies may improve outcomes for outpatients with mild to moderate COVID-19. However, the generalizability of the findings to the currently dominant Omicron variant is limited.<br /><b>Primary funding source</b><br />American College of Physicians. (PROSPERO: CRD42022323440).<br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Sommer I, Dobrescu A, Ledinger D, Moser I, ... Klerings I, Gartlehner G
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442056
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<div><h4>Comparative Effectiveness of Mask Type in Preventing SARS-CoV-2 in Health Care Workers: Uncertainty Persists.</h4><i>Chou R</i><br /><AbstractText>Two and a half years after the emergence of the COVID-19 pandemic, Loeb and colleagues reported the first randomized trial of N95 respirators versus medical masks in health care workers. The editorialist discusses the findings and highlights remaining areas of uncertainty about optimal mask type.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Chou R
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442057
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<div><h4>Ongoing Need for Clinical Trials and Contemporary End Points for Outpatient COVID-19.</h4><i>Lee TC, Boulware DR</i><br /><AbstractText>The American College of Physicians presents recommendations for the outpatient treatment of COVID-19 based on Sommer and colleagues\' systematic review. The editorialists commend the authors of the recommendations and review for trying to summarize the rapidly evolving literature into clear practice points and discuss the challenges of continually updating reviews and associated recommendations as new evidence emerges and relevant outcomes evolve.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Lee TC, Boulware DR
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442058
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<div><h4>Major Update 2: Antibody Response and Risk for Reinfection After SARS-CoV-2 Infection-Final Update of a Living, Rapid Review.</h4><i>Holmer HK, Mackey K, Fiordalisi CV, Helfand M</i><br /><b>Background</b><br />The durability of the antibody response after SARS-CoV-2 infection and the role of antibodies in protection against reinfection are unclear.<br /><b>Purpose</b><br />To synthesize evidence on the SARS-CoV-2 antibody response and reinfection risk with a focus on gaps identified in our prior reports.<br /><b>Data sources</b><br />MEDLINE (Ovid), EMBASE, CINAHL, World Health Organization Research Database, and reference lists from 16 December 2021 through 8 July 2022, with surveillance through 22 August 2022.<br /><b>Study selection</b><br />English-language, cohort studies evaluating IgG antibody duration at least 12 months after SARS-CoV-2 infection, the antibody response among immunocompromised adults, predictors of nonseroconversion, and reinfection risk.<br /><b>Data extraction</b><br />Two investigators sequentially extracted study data and rated quality.<br /><b>Data synthesis</b><br />Most adults had IgG antibodies after SARS-CoV-2 infection at time points greater than 12 months (low strength of evidence [SoE]). Although most immunocompromised adults develop antibodies, the overall proportion with antibodies is lower compared with immunocompetent adults (moderate SoE for organ transplant patients and low SoE for patients with cancer or HIV). Prior infection provided substantial, sustained protection against symptomatic reinfection with the Delta variant (high SoE) and reduced the risk for severe disease due to Omicron variants (moderate SoE). Prior infection was less protective against reinfection with Omicron overall (moderate SoE), but protection from earlier variants waned rapidly (low SoE).<br /><b>Limitation</b><br />Single review for abstract screening and sequential review for study selection, data abstraction, and quality assessment.<br /><b>Conclusion</b><br />Evidence for a sustained antibody response to SARS-CoV-2 infection is considerable for both Delta and Omicron variants. Prior infection protected against reinfection with both variants, but, for Omicron, protection was weaker and waned rapidly. This information may have limited clinical applicability as new variants emerge.<br /><b>Primary funding source</b><br />Agency for Healthcare Research and Quality. (PROSPERO: CRD42020207098).<br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Holmer HK, Mackey K, Fiordalisi CV, Helfand M
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442059
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<div><h4>Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 1).</h4><i>Qaseem A, Yost J, Miller MC, Andrews R, ... Humphrey LL, Scientific Medical Policy Committee of the American College of Physicians</i><br /><AbstractText><b>Description:</b> Strategies to manage COVID-19 in the outpatient setting continue to evolve as new data emerge on SARS-CoV-2 variants and the availability of newer treatments. The Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) developed these living, rapid practice points to summarize the best available evidence on the treatment of adults with confirmed COVID-19 in an outpatient setting. These practice points do not evaluate COVID-19 treatments in the inpatient setting or adjunctive COVID-19 treatments in the outpatient setting. <br /><b>Methods:</b><br/>The SMPC developed these living, rapid practice points on the basis of a living, rapid review done by the ACP Center for Evidence Reviews at Cochrane Austria at the University for Continuing Education Krems (Danube University Krems). The SMPC will maintain these practice points as living by monitoring and assessing the impact of new evidence. <b>Practice Point 1:</b> <i>Consider molnupiravir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 to 7 days of the onset of symptoms and at high risk for progressing to severe disease.</i> <b>Practice Point 2:</b> <i>Consider nirmatrelvir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at high risk for progressing to severe disease.</i> <b>Practice Point 3:</b> <i>Consider remdesivir to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 7 days of the onset of symptoms and at high risk for progressing to severe disease.</i> <b>Practice Point 4:</b> <i>Do not use azithromycin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 5:</b> <i>Do not use chloroquine or hydroxychloroquine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 6:</b> <i>Do not use ivermectin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 7:</b> <i>Do not use nitazoxanide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 8:</b> <i>Do not use lopinavir-ritonavir combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 9:</b> <i>Do not use casirivimab-imdevimab combination therapy to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation.</i> <b>Practice Point 10:</b> <i>Do not use regdanvimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation.</i> <b>Practice Point 11:</b> <i>Do not use sotrovimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting unless it is considered effective against a SARS-CoV-2 variant or subvariant locally in circulation.</i> <b>Practice Point 12:</b> <i>Do not use convalescent plasma to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 13:</b> <i>Do not use ciclesonide to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i> <b>Practice Point 14:</b> <i>Do not use fluvoxamine to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.</i></AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Qaseem A, Yost J, Miller MC, Andrews R, ... Humphrey LL, Scientific Medical Policy Committee of the American College of Physicians
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442061
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<div><h4>Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial.</h4><i>Potter GE, Bonnett T, Rubenstein K, Lindholm DA, ... Tomashek KM, Tebas P</i><br /><b>Background</b><br />The COVID-19 standard of care (SOC) evolved rapidly during 2020 and 2021, but its cumulative effect over time is unclear.<br /><b>Objective</b><br />To evaluate whether recovery and mortality improved as SOC evolved, using data from ACTT (Adaptive COVID-19 Treatment Trial).<br /><b>Design</b><br />ACTT is a series of phase 3, randomized, double-blind, placebo-controlled trials that evaluated COVID-19 therapeutics from February 2020 through May 2021. ACTT-1 compared remdesivir plus SOC to placebo plus SOC, and in ACTT-2 and ACTT-3, remdesivir plus SOC was the control group. This post hoc analysis compared recovery and mortality between these comparable sequential cohorts of patients who received remdesivir plus SOC, adjusting for baseline characteristics with propensity score weighting. The analysis was repeated for participants in ACTT-3 and ACTT-4 who received remdesivir plus dexamethasone plus SOC. Trends in SOC that could explain outcome improvements were analyzed. (ClinicalTrials.gov: NCT04280705 [ACTT-1], NCT04401579 [ACTT-2], NCT04492475 [ACTT-3], and NCT04640168 [ACTT-4]).<br /><b>Setting</b><br />94 hospitals in 10 countries (86% U.S. participants).<br /><b>Participants</b><br />Adults hospitalized with COVID-19.<br /><b>Intervention</b><br />SOC.<br /><b>Measurements</b><br />28-day mortality and recovery.<br /><b>Results</b><br />Although outcomes were better in ACTT-2 than in ACTT-1, adjusted hazard ratios (HRs) were close to 1 (HR for recovery, 1.04 [95% CI, 0.92 to 1.17]; HR for mortality, 0.90 [CI, 0.56 to 1.40]). Comparable patients were less likely to be intubated in ACTT-2 than in ACTT-1 (odds ratio, 0.75 [CI, 0.53 to 0.97]), and hydroxychloroquine use decreased. Outcomes improved from ACTT-2 to ACTT-3 (HR for recovery, 1.43 [CI, 1.24 to 1.64]; HR for mortality, 0.45 [CI, 0.21 to 0.97]). Potential explanatory factors (SOC trends, case surges, and variant trends) were similar between ACTT-2 and ACTT-3, except for increased dexamethasone use (11% to 77%). Outcomes were similar in ACTT-3 and ACTT-4. Antibiotic use decreased gradually across all stages.<br /><b>Limitation</b><br />Unmeasured confounding.<br /><b>Conclusion</b><br />Changes in patient composition explained improved outcomes from ACTT-1 to ACTT-2 but not from ACTT-2 to ACTT-3, suggesting improved SOC. These results support excluding nonconcurrent controls from analysis of platform trials in rapidly changing therapeutic areas.<br /><b>Primary funding source</b><br />National Institute of Allergy and Infectious Diseases.<br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Potter GE, Bonnett T, Rubenstein K, Lindholm DA, ... Tomashek KM, Tebas P
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442063
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<div><h4>Medical Masks Versus N95 Respirators for Preventing COVID-19 Among Health Care Workers : A Randomized Trial.</h4><i>Loeb M, Bartholomew A, Hashmi M, Tarhuni W, ... Pullenayegum E, Conly J</i><br /><b>Background</b><br />It is uncertain if medical masks offer similar protection against COVID-19 compared with N95 respirators.<br /><b>Objective</b><br />To determine whether medical masks are noninferior to N95 respirators to prevent COVID-19 in health care workers providing routine care.<br /><b>Design</b><br />Multicenter, randomized, noninferiority trial. (ClinicalTrials.gov: NCT04296643).<br /><b>Setting</b><br />29 health care facilities in Canada, Israel, Pakistan, and Egypt from 4 May 2020 to 29 March 2022.<br /><b>Participants</b><br />1009 health care workers who provided direct care to patients with suspected or confirmed COVID-19.<br /><b>Intervention</b><br />Use of medical masks versus fit-tested N95 respirators for 10 weeks, plus universal masking, which was the policy implemented at each site.<br /><b>Measurements</b><br />The primary outcome was confirmed COVID-19 on reverse transcriptase polymerase chain reaction (RT-PCR) test.<br /><b>Results</b><br />In the intention-to-treat analysis, RT-PCR-confirmed COVID-19 occurred in 52 of 497 (10.46%) participants in the medical mask group versus 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14 [95% CI, 0.77 to 1.69]). An unplanned subgroup analysis by country found that in the medical mask group versus the N95 respirator group RT-PCR-confirmed COVID-19 occurred in 8 of 131 (6.11%) versus 3 of 135 (2.22%) in Canada (HR, 2.83 [CI, 0.75 to 10.72]), 6 of 17 (35.29%) versus 4 of 17 (23.53%) in Israel (HR, 1.54 [CI, 0.43 to 5.49]), 3 of 92 (3.26%) versus 2 of 94 (2.13%) in Pakistan (HR, 1.50 [CI, 0.25 to 8.98]), and 35 of 257 (13.62%) versus 38 of 261 (14.56%) in Egypt (HR, 0.95 [CI, 0.60 to 1.50]). There were 47 (10.8%) adverse events related to the intervention reported in the medical mask group and 59 (13.6%) in the N95 respirator group.<br /><b>Limitation</b><br />Potential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination.<br /><b>Conclusion</b><br />Among health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR-confirmed COVID-19 for medical masks when compared with HRs of RT-PCR-confirmed COVID-19 for N95 respirators. The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity.<br /><b>Primary funding source</b><br />Canadian Institutes of Health Research, World Health Organization, and Juravinski Research Institute.<br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Loeb M, Bartholomew A, Hashmi M, Tarhuni W, ... Pullenayegum E, Conly J
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442064
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<div><h4>Living, Rapid Reviews in a Rapidly Evolving World.</h4><i>Chang S</i><br /><AbstractText>In their article, Holmer and colleagues reported the final update of a living review that examined the duration of IgG antibody response, the role of previous SARS-CoV-2 infection to prevent reinfection, and the role of antibodies in protection from reinfection. The editorialist discusses the challenge of living reviews as new evidence emerges and the relevant clinical questions evolve.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 29 Nov 2022; epub ahead of print</small></div>
Chang S
Ann Intern Med: 29 Nov 2022; epub ahead of print | PMID: 36442066
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<div><h4>Health Care During Incarceration: A Policy Position Paper From the American College of Physicians.</h4><i>Kendig NE, Butkus R, Mathew S, Hilden D, Health and Public Policy Committee of the American College of Physicians</i><br /><AbstractText>The American College of Physicians (ACP) has a long-standing commitment to improving the health of all Americans and opposes any form of discrimination in the delivery of health care services. ACP is committed to working toward fully understanding and supporting the unique needs of the incarcerated population and eliminating health disparities for these persons. In this position paper, ACP offers recommendations to policymakers and administrators to improve the health and well-being of persons incarcerated in adult correctional facilities.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 22 Nov 2022; epub ahead of print</small></div>
Kendig NE, Butkus R, Mathew S, Hilden D, Health and Public Policy Committee of the American College of Physicians
Ann Intern Med: 22 Nov 2022; epub ahead of print | PMID: 36410006
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<div><h4>Participant Recruitment From Low- and Middle-Income Countries for Pivotal Trials of Drugs Approved by the U.S. Food and Drug Administration : A Cross-Sectional Analysis.</h4><i>Awan FA, Becker AB, Wang Y, Kimmelman J</i><br /><b>Background</b><br />Many participants in clinical trials supporting U.S. Food and Drug Administration (FDA) drug approvals are recruited from outside the United States, including from low- and middle-income countries (LMICs). Where participants are recruited for pivotal trials has implications for ethical research conduct and generalizability.<br /><b>Objective</b><br />To describe LMIC recruitment for pivotal trials of newly approved drugs for cancer, neurologic disease, and cardiovascular disease.<br /><b>Design</b><br />Cross-sectional analysis.<br /><b>Setting</b><br />Pivotal trials of new cancer, cardiovascular, and neurologic drugs approved from 2012 to 2019 matched to ClinicalTrials.gov, FDA records, and publications.<br /><b>Measurements</b><br />Host countries and available per country enrollments were extracted. The primary end point was the proportion of pivotal trials enrolling participants in LMICs. The secondary end point was the proportion of pivotal trial participants contributed by LMICs for each indication area.<br /><b>Results</b><br />Data were obtained from 66 new drugs and 144 pivotal clinical trials. All cardiovascular approvals (12 drugs, 29 trials) and neurologic approvals (26 drugs, 54 trials) were analyzed, as well as a random sample of cancer approvals (28 of 85 drugs [33%]) matched to their pivotal trials (61 of 210 trials [29%]). Among the trials, 56% in cancer, 79% in cardiovascular disease, and 56% in neurology recruited from an LMIC. For multicountry trials, country-level enrollment figures were not available for 71 trials (55%). For those reporting per country enrollment, the percentage of participants recruited from LMICs was 8% for cancer trials, 36% for cardiovascular trials, and 17% for neurology trials.<br /><b>Limitations</b><br />The study was limited to FDA-approved drugs in 3 areas, including a sample of cancer drugs. Pivotal trials of nonapproved drugs or drugs for other indications were not captured.<br /><b>Conclusion</b><br />Most pivotal trials for FDA-approved drugs recruit from LMICs. Publications and FDA documents generally do not provide country-level data on recruitment.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 22 Nov 2022; epub ahead of print</small></div>
Awan FA, Becker AB, Wang Y, Kimmelman J
Ann Intern Med: 22 Nov 2022; epub ahead of print | PMID: 36410007
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<div><h4>Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis : A Randomized Controlled Trial.</h4><i>Goldberg AJ, Chowdhury K, Bordea E, Hauptmannova I, ... Doré CJ, TARVA Study Group†</i><br /><b>Background</b><br />End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF).<br /><b>Objective</b><br />To determine which treatment is superior in terms of clinical scores and adverse events.<br /><b>Design</b><br />A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307).<br /><b>Setting</b><br />17 National Health Service trusts across the United Kingdom.<br /><b>Patients</b><br />Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure.<br /><b>Intervention</b><br />Patients were randomly assigned to TAR or AF surgical treatment.<br /><b>Measurements</b><br />The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible.<br /><b>Results</b><br />Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]).<br /><b>Limitation</b><br />Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques.<br /><b>Conclusion</b><br />Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%.<br /><b>Primary funding source</b><br />National Institute for Health and Care Research Heath Technology Assessment Programme.<br /><br /><br /><br /><small>Ann Intern Med: 15 Nov 2022; epub ahead of print</small></div>
Goldberg AJ, Chowdhury K, Bordea E, Hauptmannova I, ... Doré CJ, TARVA Study Group†
Ann Intern Med: 15 Nov 2022; epub ahead of print | PMID: 36375147
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Abstract
<div><h4>Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy : A Cohort Study.</h4><i>McCreary EK, Lemon L, Megli C, Oakes A, Seymour CW, UPMC Magee Monoclonal Antibody Treatment Group</i><br /><b>Background</b><br />Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared with no mAb treatment.<br /><b>Objective</b><br />To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19-related hospital admission or emergency department (ED) visit, COVID-19-associated delivery, or mortality.<br /><b>Design</b><br />Retrospective, propensity score-matched, cohort study.<br /><b>Setting</b><br />UPMC Health System from 30 April 2021 to 21 January 2022.<br /><b>Participants</b><br />Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test).<br /><b>Intervention</b><br />Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment.<br /><b>Measurements</b><br />Drug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19-related hospital admission or ED visit, COVID-19-associated delivery, or mortality.<br /><b>Results</b><br />Among 944 pregnant persons (median age [interquartile range (IQR)], 30 years [26 to 33 years]; White (79.5%; <i>n</i> = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]), 552 received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR, 123 to 227), and most persons received sotrovimab (69%; <i>n</i> = 382). Of those with known vaccination status, 392 (62%) were fully vaccinated. Drug-related adverse events were uncommon (<i>n</i> = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19-associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score-matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19-related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, there was no difference in the propensity score-matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%).<br /><b>Limitations</b><br />Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients.<br /><b>Conclusion</b><br />In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. There was no difference in 28-day COVID-19-associated outcomes and non-COVID-19-related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score-matched cohort.<br /><b>Primary funding source</b><br />No funding was received for this study.<br /><br /><br /><br /><small>Ann Intern Med: 15 Nov 2022; epub ahead of print</small></div>
McCreary EK, Lemon L, Megli C, Oakes A, Seymour CW, UPMC Magee Monoclonal Antibody Treatment Group
Ann Intern Med: 15 Nov 2022; epub ahead of print | PMID: 36375150
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Abstract
<div><h4>Characteristics of High-Need, High-Cost Patients : A \"Best-Fit\" Framework Synthesis.</h4><i>Berkman ND, Chang E, Seibert J, Ali R</i><br /><b>Background</b><br />Accurately identifying high-need, high-cost (HNHC) patients to reduce their preventable or modifiable health care use for their chronic conditions is a priority and a challenge for U.S. policymakers, health care delivery systems, and payers.<br /><b>Purpose</b><br />To identify characteristics and criteria to distinguish HNHC patients.<br /><b>Data sources</b><br />Searches of multiple databases and gray literature from 1 January 2000 to 22 January 2022.<br /><b>Study selection</b><br />English-language studies of characteristics and criteria to identify HNHC adult patients, defined as those with high use (emergency department, inpatient, or total services) or high cost.<br /><b>Data extraction</b><br />Independent, dual-review extraction and quality assessment.<br /><b>Data synthesis</b><br />The review included 64 studies comprising multivariate exposure studies (<i>n</i> = 47), cluster analyses (<i>n</i> = 11), and qualitative studies (<i>n</i> = 6). A National Academy of Medicine (NAM) taxonomy was an initial \"best-fit\" framework for organizing the synthesis of the findings. Patient characteristics associated with being HNHC included number and severity of comorbid conditions and having chronic clinical conditions, particularly heart disease, chronic kidney disease, chronic lung disease, diabetes, cancer, and hypertension. Patients\' risk for being HNHC was often amplified by behavioral health conditions and social risk factors. The reviewers revised the NAM taxonomy to create a final framework, adding chronic pain and prior patterns of high health care use as characteristics associated with an increased risk for being HNHC.<br /><b>Limitation</b><br />Little evidence distinguished potentially preventable or modifiable health care use from overall use.<br /><b>Conclusion</b><br />A combination of characteristics can be useful for identifying HNHC patients. Because of the complexity of their conditions and circumstances, improving their quality of care will likely also require an individualized assessment of care needs and availability of support services.<br /><b>Primary funding source</b><br />Agency for Healthcare Research and Quality. (PROSPERO: CRD42020161179).<br /><br /><br /><br /><small>Ann Intern Med: 08 Nov 2022; epub ahead of print</small></div>
Berkman ND, Chang E, Seibert J, Ali R
Ann Intern Med: 08 Nov 2022; epub ahead of print | PMID: 36343343
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Abstract
<div><h4>Preoperative Evaluation for Noncardiac Surgery.</h4><i>Modha K, Whinney C</i><br /><AbstractText>The previous In the Clinic that addressed preoperative evaluation for noncardiac surgery was published in December 2016. This update reaffirms much of the information in the previous version and provides new information that has accumulated since then. The goal of preoperative assessment is to identify the risk for postoperative complications so health care teams can more fully understand how to implement strategies to mitigate risks before and after the operation.</AbstractText><br /><br /><br /><br /><small>Ann Intern Med: 08 Nov 2022; epub ahead of print</small></div>
Modha K, Whinney C
Ann Intern Med: 08 Nov 2022; epub ahead of print | PMID: 36343344
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Abstract
<div><h4>Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial.</h4><i>Healey JS, Krahn AD, Bashir J, Amit G, ... Mondesert B, ATLAS Investigators*</i><br /><b>Background</b><br />Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications.<br /><b>Objective</b><br />To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia).<br /><b>Design</b><br />Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255).<br /><b>Setting</b><br />The ATLAS trial.<br /><b>Patients</b><br />544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5).<br /><b>Measurements</b><br />The primary outcome was perioperative major lead-related complications.<br /><b>Results</b><br />There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9; <i>P</i> = 0.001). There was a trend for more inappropriate shocks with the S-ICD (hazard ratio [HR], 2.37; 95% CI, 0.98 to 5.77), but no increase in failed appropriate ICD shocks (HR, 0.61 (0.15 to 2.57). Patients in the S-ICD group had more ICD site pain, measured on a 10-point numeric rating scale, on the day of implant (4.2 ± 2.8 vs. 2.9 ± 2.2; <i>P</i> < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; <i>P</i> = 0.035).<br /><b>Limitation</b><br />At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing.<br /><b>Conclusion</b><br />The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks.<br /><b>Primary funding source</b><br />Boston Scientific.<br /><br /><br /><br /><small>Ann Intern Med: 08 Nov 2022; epub ahead of print</small></div>
Healey JS, Krahn AD, Bashir J, Amit G, ... Mondesert B, ATLAS Investigators*
Ann Intern Med: 08 Nov 2022; epub ahead of print | PMID: 36343346
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Abstract
<div><h4>Contact Tracing and Exposure Investigation in Response to the First Case of Monkeypox Virus Infection in the United States During the 2022 Global Monkeypox Outbreak.</h4><i>Shenoy ES, Wright SB, Barbeau DN, Foster LA, ... Madoff LC, Brown CM</i><br /><b>Background</b><br />In May 2022, the first case of monkeypox virus (MPXV) infection in the United States in the current global outbreak was identified. As part of the public health and health care facility response, a contact tracing and exposure investigation was done.<br /><b>Objective</b><br />To describe the contact tracing, exposure identification, risk stratification, administration of postexposure prophylaxis (PEP), and exposure period monitoring for contacts of the index patient, including evaluation of persons who developed symptoms possibly consistent with MPXV infection.<br /><b>Design</b><br />Contact tracing and exposure investigation.<br /><b>Setting</b><br />Multiple health care facilities and community settings in Massachusetts.<br /><b>Participants</b><br />Persons identified as contacts of the index patient.<br /><b>Intervention</b><br />Contact notification, risk stratification, and symptom monitoring; PEP administration in a subset of contacts.<br /><b>Measurements</b><br />Epidemiologic and clinical data collected through standard surveillance procedures at each facility and then aggregated and analyzed.<br /><b>Results</b><br />There were 37 community and 129 health care contacts identified, with 4 at high risk, 49 at intermediate risk, and 113 at low or uncertain risk. Fifteen health care contacts developed symptoms during the monitoring period. Three met criteria for MPXV testing, with negative results. Two community contacts developed symptoms. Neither met criteria for MPXV testing, and neither showed disease progression consistent with monkeypox. Among 4 persons with high-risk exposures offered PEP, 3 elected to receive PEP. Among 10 HCP with intermediate-risk exposures for which PEP was offered as part of informed clinical decision making, 2 elected to receive PEP. No transmissions were identified at the conclusion of the 21-day monitoring period, despite the delay in recognition of monkeypox in the index patient.<br /><b>Limitation</b><br />Descriptions of exposures are subject to recall bias, which affects risk stratification.<br /><b>Conclusion</b><br />In a contact tracing investigation involving 166 community and health care contacts of a patient with monkeypox, no secondary cases were identified.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 08 Nov 2022; epub ahead of print</small></div>
Shenoy ES, Wright SB, Barbeau DN, Foster LA, ... Madoff LC, Brown CM
Ann Intern Med: 08 Nov 2022; epub ahead of print | PMID: 36343347
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Abstract
<div><h4>Oral ENT-01 Targets Enteric Neurons to Treat Constipation in Parkinson Disease : A Randomized Controlled Trial.</h4><i>Camilleri M, Subramanian T, Pagan F, Isaacson S, ... Zasloff M, Barbut D</i><br /><b>Background</b><br />Parkinson disease (PD) is associated with α-synuclein (αS) aggregation within enteric neurons. ENT-01 inhibits the formation of αS aggregates and improved constipation in an open-label study in patients with PD.<br /><b>Objective</b><br />To evaluate the safety and efficacy of oral ENT-01 for constipation and neurologic symptoms in patients with PD and constipation.<br /><b>Design</b><br />Randomized, placebo-controlled phase 2b study. (ClinicalTrials.gov: NCT03781791).<br /><b>Setting</b><br />Outpatient.<br /><b>Patients</b><br />150 patients with PD and constipation.<br /><b>Intervention</b><br />ENT-01 or placebo daily for up to 25 days. After baseline assessment of constipation severity, daily dosing was escalated to the prokinetic dose, the maximum dose (250 mg), or the tolerability limit, followed by a washout period.<br /><b>Measurements</b><br />The primary efficacy end point was the number of complete spontaneous bowel movements (CSBMs) per week. Neurologic end points included dementia (assessed using the Mini-Mental State Examination [MMSE]) and psychosis (assessed using the Scale for the Assessment of Positive Symptoms adapted for PD [SAPS-PD]).<br /><b>Results</b><br />The weekly CSBM rate increased from 0.7 to 3.2 in the ENT-01 group versus 0.7 to 1.2 in the placebo group (<i>P</i> < 0.001). Improvement in secondary end points included SBMs (<i>P</i> = 0.002), stool consistency (<i>P</i> < 0.001), ease of passage (<i>P</i> = 0.006), and laxative use (<i>P</i> = 0.041). In patients with dementia, MMSE scores improved by 3.4 points 6 weeks after treatment in the ENT-01 group (<i>n</i> = 14) versus 2.0 points in the placebo group (<i>n</i> = 14). Among patients with psychosis, SAPS-PD scores improved from 6.5 to 1.7 six weeks after treatment in the ENT-01 group (<i>n</i> = 5) and from 6.3 to 4.4 in the placebo group (<i>n</i> = 6). ENT-01 was well tolerated, with no deaths or drug-related serious adverse events. Adverse events were predominantly gastrointestinal, including nausea (34.4% [ENT-01] vs. 5.3% [placebo]; <i>P</i> < 0.001) and diarrhea (19.4% [ENT-01] vs. 5.3% [placebo]; <i>P</i> = 0.016).<br /><b>Limitation</b><br />Longer treatment periods need to be investigated in future studies.<br /><b>Conclusion</b><br />ENT-01 was safe and significantly improved constipation.<br /><b>Primary funding source</b><br />Enterin, Inc.<br /><br /><br /><br /><small>Ann Intern Med: 08 Nov 2022; epub ahead of print</small></div>
Camilleri M, Subramanian T, Pagan F, Isaacson S, ... Zasloff M, Barbut D
Ann Intern Med: 08 Nov 2022; epub ahead of print | PMID: 36343348
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Abstract
<div><h4>In degenerative meniscal tears, PT was noninferior to arthroscopic partial meniscectomy for knee function at 5 y.</h4><i>Hunter DJ</i><br /><b>Source citation</b><br />Noorduyn JCA, van de Graaf VA, Willigenburg NW, et al. <b>Effect of physical therapy vs arthroscopic partial meniscectomy in people with degenerative meniscal tears: five-year follow-up of the ESCAPE randomized clinical trial.</b> JAMA Netw Open. 2022;5:e2220394. 35802374.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Hunter DJ
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315941
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Abstract
<div><h4>In adults using oral anticoagulants, PPI use may be associated with lower risk for upper GI bleeding.</h4><i>Stein DJ, Feuerstein JD</i><br /><b>Source citation</b><br />Kurlander JE, Barnes GD, Fisher A, et al. <b>Association of antisecretory drugs with upper gastrointestinal bleeding in patients using oral anticoagulants: a systematic review and meta-analysis.</b> Am J Med. 2022;135:1231-43.e8. 35679879.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Stein DJ, Feuerstein JD
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315943
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Abstract
<div><h4>Challenged Urine Bicarbonate Excretion as a Measure of Cystic Fibrosis Transmembrane Conductance Regulator Function in Cystic Fibrosis.</h4><i>Berg P, Sorensen MV, Rousing AQ, Olesen HV, ... Jeppesen M, Leipziger J</i><br /><b>Background</b><br />In cystic fibrosis (CF), renal base excretion is impaired. Accordingly, challenged urine bicarbonate excretion may be an in vivo biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function.<br /><b>Objective</b><br />To evaluate the association between challenged bicarbonate excretion and clinical characteristics at baseline, quantify the CFTR modulator drug elexacaftor/tezacaftor/ivacaftor-induced changes of challenged bicarbonate excretion after 6 months of treatment, and characterize the intraindividual variation in healthy adults.<br /><b>Design</b><br />Prospective observational study.<br /><b>Setting</b><br />Cystic fibrosis clinic, Aarhus University Hospital, Denmark.<br /><b>Patients</b><br />Fifty adult patients with CF starting CFTR modulator therapy with elexacaftor/tezacaftor/ivacaftor between May 2020 and June 2021.<br /><b>Measurements</b><br />Quantification of urine bicarbonate excretion after an acute oral sodium bicarbonate challenge before and 6 months after elexacaftor/tezacaftor/ivacaftor treatment.<br /><b>Results</b><br />At baseline, challenged urine bicarbonate excretion was associated with several CF disease characteristics. Bicarbonate excretion was higher in patients with residual function mutations. A higher bicarbonate excretion was associated with better lung function, pancreatic sufficiency, and lower relative risk for chronic pseudomonas infections. Elexacaftor/tezacaftor/ivacaftor treatment increased bicarbonate excretion by 3.9 mmol/3 h (95% CI, 1.6 to 6.1 mmol/3 h), reaching about 70% of that seen in healthy control participants. In healthy control participants, individual bicarbonate excretion at each visit correlated with the individual mean bicarbonate excretion. The median coefficient of variation was 31%.<br /><b>Limitation</b><br />Single-center study without a placebo-controlled group.<br /><b>Conclusion</b><br />Although further studies are needed to address the performance and sensitivity of this approach, this early-stage evaluation shows that challenged urine bicarbonate excretion may offer a new, simple, and safe quantification of CFTR function and the extent of its pharmacologic improvement. Elexacaftor/tezacaftor/ivacaftor partially restores renal CFTR function in patients with CF, likely resulting in decreased risk for electrolyte disorders and metabolic alkalosis.<br /><b>Primary funding source</b><br />Innovation Fund Denmark.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Berg P, Sorensen MV, Rousing AQ, Olesen HV, ... Jeppesen M, Leipziger J
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315944
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Abstract
<div><h4>In asymptomatic adults, a COVID-19 Ag-RDT with combined nasal and throat samples had 82% to 89% positive percent agreement.</h4><i>Fekete T</i><br /><b>Source citation</b><br />Goodall BL, LeBlanc JJ, Hatchette TF, et al. <b>Investigating the sensitivity of nasal or throat swabs: combination of both swabs increases the sensitivity of SARS-CoV-2 rapid antigen tests.</b> Microbiol Spectr. 2022;10:e0021722 35762772.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Abstract
<div><h4>In acute ischemic stroke, early IV tenecteplase was noninferior to alteplase for excellent functional outcome.</h4><i>Ferguson E, Lang E</i><br /><b>Source citation</b><br />Menon BK, Buck BH, Singh N, et al. <b>Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial.</b> Lancet. 2022;400:161-9. 35779553.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Ferguson E, Lang E
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315948
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<div><h4>Ticagrelor-Aspirin Versus Clopidogrel-Aspirin Among Loss-of-Function Carriers With Minor Stroke or Transient Ischemic Attack in Relation to Renal Function: A Post Hoc Analysis of the CHANCE-2 Trial.</h4><i>Wang A, Xie X, Tian X, Johnston SC, ... Meng X, Wang Y</i><br /><b>Background</b><br />Evidence on the risk-benefit ratio of dual antiplatelet therapies among patients with stroke and impaired renal function is limited and inconsistent.<br /><b>Objective</b><br />To investigate the effect of renal function on the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin treatment.<br /><b>Design</b><br />Post hoc analysis of a multicenter, randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT04078737).<br /><b>Setting</b><br />202 centers in China.<br /><b>Patients</b><br /><i>CYP2C19</i> loss-of-function allele carriers with minor stroke or transient ischemic attack.<br /><b>Intervention</b><br />Ticagrelor-aspirin and clopidogrel-aspirin.<br /><b>Measurements</b><br />Renal function was evaluated by estimated glomerular filtration rate (eGFR) levels. The primary efficacy and safety outcomes were recurrent stroke and severe or moderate bleeding within 90 days, respectively.<br /><b>Results</b><br />Among 6378 patients, 4050 (63.5%) had normal (eGFR ≥90 mL/min/1.73 m<sup>2</sup>), 2010 (31.5%) had mildly decreased (eGFR 60 to 89 mL/min/1.73 m<sup>2</sup>), and 318 (5.0%) had moderately to severely decreased (eGFR <60 mL/min/1.73 m<sup>2</sup>) renal function. The corresponding differences in recurrent stroke between ticagrelor-aspirin and clopidogrel-aspirin for normal, mildly decreased, and moderately to severely decreased renal function was -2.8 percentage points (95% CI, -4.4 to -1.3 percentage points) (hazard ratio [HR], 0.63 [CI, 0.49 to 0.81]), -0.2 percentage point (CI, -2.4 to 2.0 percentage points) (HR, 0.98 [CI, 0.69 to 1.39]), and 3.7 percentage points (CI, -2.3 to 10.1 percentage points) (HR, 1.31 [CI, 0.48 to 3.55]), respectively. Rates of severe or moderate bleeding did not substantially differ by treatment assignments across eGFR categories.<br /><b>Limitation</b><br />Renal function was only evaluated by using eGFR, and the proportion of patients with severely decreased renal function was low.<br /><b>Conclusion</b><br />Patients with normal, rather than impaired, renal function received greater benefit from ticagrelor-aspirin versus clopidogrel-aspirin.<br /><b>Primary funding source</b><br />Ministry of Science and Technology of the People\'s Republic of China.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Abstract
<div><h4>Comparative Effectiveness and Safety Between Apixaban, Dabigatran, Edoxaban, and Rivaroxaban Among Patients With Atrial Fibrillation : A Multinational Population-Based Cohort Study.</h4><i>Lau WCY, Torre CO, Man KKC, Stewart HM, ... Wei L, Wong ICK</i><br /><b>Background</b><br />Current guidelines recommend using direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), but head-to-head trial data do not exist to guide the choice of DOAC.<br /><b>Objective</b><br />To do a large-scale comparison between all DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) in routine clinical practice.<br /><b>Design</b><br />Multinational population-based cohort study.<br /><b>Setting</b><br />Five standardized electronic health care databases, which covered 221 million people in France, Germany, the United Kingdom, and the United States.<br /><b>Participants</b><br />Patients who were newly diagnosed with AF from 2010 through 2019 and received a new DOAC prescription.<br /><b>Measurements</b><br />Database-specific hazard ratios (HRs) of ischemic stroke or systemic embolism, intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and all-cause mortality between DOACs were estimated using a Cox regression model stratified by propensity score and pooled using a random-effects model.<br /><b>Results</b><br />A total of 527 226 new DOAC users met the inclusion criteria (apixaban, <i>n</i> = 281 320; dabigatran, <i>n</i> = 61 008; edoxaban, <i>n</i> = 12 722; and rivaroxaban, <i>n</i> = 172 176). Apixaban use was associated with lower risk for GIB than use of dabigatran (HR, 0.81 [95% CI, 0.70 to 0.94]), edoxaban (HR, 0.77 [CI, 0.66 to 0.91]), or rivaroxaban (HR, 0.72 [CI, 0.66 to 0.79]). No substantial differences were observed for other outcomes or DOAC-DOAC comparisons. The results were consistent for patients aged 80 years or older. Consistent associations between lower GIB risk and apixaban versus rivaroxaban were observed among patients receiving the standard dose (HR, 0.72 [CI, 0.64 to 0.82]), those receiving a reduced dose (HR, 0.68 [CI, 0.61 to 0.77]), and those with chronic kidney disease (HR, 0.68 [CI, 0.59 to 0.77]).<br /><b>Limitation</b><br />Residual confounding is possible.<br /><b>Conclusion</b><br />Among patients with AF, apixaban use was associated with lower risk for GIB and similar rates of ischemic stroke or systemic embolism, ICH, and all-cause mortality compared with dabigatran, edoxaban, and rivaroxaban. This finding was consistent for patients aged 80 years or older and those with chronic kidney disease, who are often underrepresented in clinical trials.<br /><b>Primary funding source</b><br />None.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Lau WCY, Torre CO, Man KKC, Stewart HM, ... Wei L, Wong ICK
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315950
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Impact:
Abstract
<div><h4>In acute ischemic stroke, thrombectomy was not noninferior to alteplase + thrombectomy for 90-d functional independence.</h4><i>Donato AA, Goswami V</i><br /><b>Source citation</b><br />Fischer U, Kaesmacher J, Strbian D, et al. <b>Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.</b> Lancet. 2022;400:104-15. 35810756.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Donato AA, Goswami V
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315954
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Impact:
Abstract
<div><h4>In ASCVD, moderate-intensity statin + ezetimibe was noninferior to high-intensity statin alone at 3 y.</h4><i>Kelsey MD, Newby LK</i><br /><b>Source citation</b><br />Kim BK, Hong SJ, Lee YJ, et al. <b>Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial.</b> Lancet. 202;400:380-90. 35863366.<br /><br /><br /><br /><small>Ann Intern Med: 01 Nov 2022; epub ahead of print</small></div>
Kelsey MD, Newby LK
Ann Intern Med: 01 Nov 2022; epub ahead of print | PMID: 36315955
Go to: DOI | PubMed | PDF | Google Scholar |
Impact:

This program is still in alpha version.