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Screening for Anxiety in Adolescent and Adult Women: A Recommendation From the Women's Preventive Services Initiative
Description: The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient representatives, developed a recommendation on screening for anxiety in adolescent and adult women to improve detection; achieve earlier diagnosis and treatment; and improve health, function, and well-being. The WPSI's recommendations are intended to guide clinical practice and coverage of services for the Health Resources and Services Administration and other stakeholders. The target audience for this recommendation includes all clinicians providing preventive health care to women, particularly in primary care settings. This recommendation applies to women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women. Methods: The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness of screening, accuracy of screening instruments, and benefits and harms of treatments in adolescent girls and adult women. No studies directly evaluated the overall effectiveness or harms of screening for anxiety. Twenty-seven screening instruments and their variations were moderately to highly accurate in identifying anxiety (33 individual studies and 2 systematic reviews; 171 studies total). Symptoms improved and relapse rates decreased with psychological therapies (246 randomized controlled trials [RCTs] in 5 systematic reviews) and with selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors (126 RCTs in 3 systematic reviews). The WPSI also considered the effect of screening on symptom progression and identification of associated and underlying conditions, as well as implementation factors. Recommendation: The WPSI recommends screening for anxiety in women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women. Optimal screening intervals are unknown, and clinical judgment should be used to determine frequency. When screening suggests the presence of anxiety, further evaluation is necessary to establish the diagnosis and determine appropriate treatment and follow-up.
Screening for Anxiety in Adolescent and Adult Women: A Systematic Review for the Women's Preventive Services Initiative: Annals of Internal Medicine: Vol 173, No 1
Background: Anxiety disorders are infrequently recognized during routine health care even though they are common in adolescent girls and adult women. Purpose: To evaluate evidence on the effectiveness of screening for anxiety disorders in primary care in improving symptoms, function, and quality of life; harms of screening; accuracy of screening instruments; and effectiveness and harms of treatments. Data Sources: English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Health and Psychosocial Instruments (1 January 1996 to 4 November 2019); ClinicalTrials.gov (November 2019); and reference lists of studies and reviews. Study Selection: Studies that enrolled adolescent girls and adult women not currently diagnosed with anxiety disorders, including pregnant or postpartum women, and compared clinical outcomes and harms between women who were and were not screened; diagnostic accuracy studies of screening instruments; and systematic reviews of randomized trials of behavioral and pharmacologic treatments. Data Extraction: Dual extraction and quality assessment of individual studies. Data Synthesis: No studies evaluated the overall effectiveness or harms of screening. Thirty-three studies and 2 systematic reviews (171 studies; 112 574 participants) evaluated the diagnostic accuracy of 27 screening instruments and their variations against a clinical diagnosis or other instruments. Most demonstrated moderate to high accuracy for adults (Generalized Anxiety Disorder scale: sensitivity, 70% to 97%; specificity, 50% to 89%), pregnant and postpartum women (Edinburgh Postnatal Depression Scale: sensitivity, 74%; specificity, 64%), and adolescents (Screen for Child Anxiety Related Emotional Disorders: sensitivity, 64% to 74%; specificity, 64% to 73%). Anxiety symptoms improved with cognitive behavioral therapy (246 randomized controlled trials; 17 209 participants) and antianxiety medications (126 randomized controlled trials; 8225 participants). Limitation: Limited data on long-term harms of treatment and no treatment trials in pregnant or postpartum women. Conclusion: Evidence on the overall effectiveness and harms of screening for anxiety is insufficient. Most screening instruments are moderately to highly accurate. Behavioral therapies and antianxiety medications effectively improve anxiety symptoms. Primary Funding Source: Health Resources and Services Administration.
Should You Treat This Acutely Ill Medical Inpatient With Venous Thromboembolism Chemoprophylaxis?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 172, No 7
Venous thromboembolism (VTE), which includes both deep venous thrombosis and pulmonary embolism, is a common and potentially fatal condition. Medical inpatients are at high risk for VTE because of immobility as well as acute and chronic illness. Several randomized trials demonstrated that chemoprophylaxis, or low-dose anticoagulation, prevents VTE in selected medical inpatients. The 2018 American Society of Hematology clinical practice guideline on prophylaxis for hospitalized and nonhospitalized medical patients conditionally recommends chemoprophylaxis for non–critically ill medical inpatients, leaving much to the discretion of the treating physician. Here, 2 experts, a hematologist and a hospitalist, reflect on the care of a woman hospitalized with a rheumatologic disorder. They consider the risks and benefits of chemoprophylaxis, discuss VTE risk stratification, and recommend which patients should receive chemoprophylaxis and with which agents.
Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018
Background: Little is known about the evidence required by the U.S. Food and Drug Administration (FDA) for new approvals of opioid analgesics. Objective: To characterize the quality of safety and efficacy data in new drug applications (NDAs) for opioid analgesics approved by the FDA between 1997 and 2018. Design: Cross-sectional analysis. Setting: Data from ClinicalTrials.gov, FDA reviews, and peer-reviewed publications. Participants: Patients with pain who participated in phase 3 pivotal trials. Intervention: FDA-approved opioid analgesics. Measurements: Key characteristics of each NDA, including the number, size, and duration of pivotal trials; trial control groups; the use of enriched trial populations; and systematically measured safety outcomes. Results: Most of the 48 NDAs evaluated were for new dosage forms (n = 25 [52.1%]) or new formulations (n = 9 [18.8%]); only 1 (2.1%) was for a new molecular entity. Of 39 NDAs approved for treating chronic pain, only 21 products were supported by at least 1 pivotal trial; these trials (n = 28) had a median duration of 84 days (interquartile range [IQR], 25 to 84 days) and enrolled a median of 299 patients (IQR, 174 to 525 patients). Seventeen (81%) of these products were approved on the basis of designs that excluded patients who could not tolerate the drugs, had early adverse effects, or reported few immediate benefits. Among NDAs for chronic pain, 8 (20.5%) included pooled safety reviews that reported systematic assessment of diversion, 7 (17.9%) reported systematic measurement of nonmedical use, and 15 (38.5%) assessed development of tolerance. Eight of 9 products for acute pain were supported by at least 1 pivotal trial; the pivotal trials (n = 19) had a median duration of 1 day (IQR, 1 to 2 days) and enrolled a median of 329 patients (IQR, 199 to 456 patients). Although all but 1 of the 48 approved NDAs were for previously approved moieties, analysis of available NDAs for referent products yielded similar findings. Limitations: The analysis was limited to approved opioids. Animal studies and nonpivotal trials were excluded. Evidence for safety in NDAs was presented for chronic pain only. Conclusion: Between 1997 and 2018, the FDA approved opioids on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug. Systematic collation of certain important safety outcomes was rare. Primary Funding Source: None.
Accuracy of Biomarker Testing for Neuropathologically Defined Alzheimer Disease in Older Adults With Dementia: A Systematic Review: Annals of Internal Medicine: Vol 172, No 10
Background: Biomarker accuracy for Alzheimer disease (AD) is uncertain. Purpose: To summarize evidence on biomarker accuracy for classifying AD in older adults with dementia. Data Sources: Electronic bibliographic databases (searched from January 2012 to November 2019 for brain imaging and cerebrospinal fluid [CSF] tests and from inception to November 2019 for blood tests), ClinicalTrials.gov (to November 2019), and systematic review bibliographies. Study Selection: English-language studies evaluating the accuracy of brain imaging, CSF testing, or blood tests for distinguishing neuropathologically defined AD from non-AD among older adults with dementia. Studies with low or medium risk of bias were analyzed. Data Extraction: Two reviewers rated risk of bias. One extracted data; the other verified accuracy. Data Synthesis: Fifteen brain imaging studies and 9 CSF studies met analysis criteria. Median sensitivity and specificity, respectively, were 0.91 and 0.92 for amyloid positron emission tomography (PET), 0.89 and 0.74 for 18F-labeled fluorodeoxyglucose (18F-FDG) PET, 0.64 and 0.83 for single-photon emission computed tomography, and 0.91 and 0.89 for medial temporal lobe atrophy on magnetic resonance imaging (MRI). Individual CSF biomarkers and ratios had moderate sensitivity (range, 0.62 to 0.83) and specificity (range, 0.53 to 0.69); in the few direct comparisons, β-amyloid 42 (Aβ42)/phosphorylated tau (p-tau) ratio, total tau (t-tau)/Aβ42 ratio, and p-tau appeared more accurate than Aβ42 and t-tau alone. Single studies suggested that amyloid PET, 18F-FDG PET, and CSF test combinations may add accuracy to clinical evaluation. Limitations: Studies were small, biomarker cut points and neuropathologic AD were inconsistently defined, and methods with uncertain applicability to typical clinical settings were used. Few studies directly compared biomarkers, assessed test combinations, evaluated whether biomarkers improved classification accuracy when added to clinical evaluation, or reported harms. Conclusion: In methodologically heterogeneous studies of uncertain applicability to typical clinical settings, amyloid PET, 18F-FDG PET, and MRI were highly sensitive for neuropathologic AD. Amyloid PET, 18F-FDG PET, and CSF test combinations may add accuracy to clinical evaluation. Primary Funding Source: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018117897)
Caring for the Transgender Patient: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 172, No 3
The term transgender refers to persons whose gender identity is different from that recorded at birth. Similar to other marginalized populations, transgender patients commonly experience discrimination in the health care setting, and they may not have access to medical professionals who can provide competent care. In addition to primary medical and preventive health care, transgender patients need access to gender-affirming interventions, including hormone therapy and surgeries. In 2017, the Endocrine Society updated its clinical practice guideline for the care of transgender persons on the basis of the best available evidence from systematic reviews and individual studies. Among its general requirements for adolescents and recommendations for adults were the following: Involvement of a mental health professional who is knowledgeable about the diagnostic criteria for gender dysphoria and criteria for gender-affirming treatment, has training and experience in assessing psychopathology, and is willing to participate in ongoing care. Hormone therapy should be offered to transgender adult patients, with levels maintained within the normal range for gender identity and treatment appropriately monitored. Clinicians involved in the care of transgender adult patients should be knowledgeable about diagnostic criteria for gender dysphoria/gender incongruence, the use of medical and surgical gender-affirming interventions, and appropriate monitoring for reproductive organ cancer risk. Here, 2 clinicians with expertise in this area debate whether psychological evaluation is warranted in a transgender patient requesting gender-affirming hormones or surgery, the potential risks and benefits of estrogen therapy, and the role of the primary care practitioner in the care of transgender persons.
Dual Versus Triple Therapy for Atrial Fibrillation After Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 172, No 7
Background: The safety and effectiveness of dual therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) versus triple therapy (vitamin K antagonist plus aspirin and P2Y12 inhibitor) in patients with nonvalvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI) is unclear. Purpose: To examine the effects of dual versus triple therapy on bleeding and ischemic outcomes in adults with AF after PCI. Data Sources: Searches of PubMed, EMBASE, and the Cochrane Library (inception to 31 December 2019) and ClinicalTrials.gov (7 January 2020) without language restrictions; journal Web sites; and reference lists. Study Selection: Randomized controlled trials that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events in adults with AF after PCI. Data Extraction: Two independent investigators abstracted data, assessed the quality of evidence, and rated the certainty of evidence. Data Synthesis: Four trials encompassing 7953 patients were selected. At the median follow-up of 1 year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], −0.013 [95% CI, −0.025 to −0.002]). Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004 [CI, −0.010 to 0.017]), cardiovascular mortality (RD, 0.001 [CI, −0.011 to 0.013]), myocardial infarction (RD, 0.003 [CI, −0.010 to 0.017]), stent thrombosis (RD, 0.003 [CI, −0.005 to 0.010]), and stroke (RD, −0.003 [CI, −0.010 to 0.005]). The upper bounds of the CIs for these effects were compatible with possible increased risks with dual therapy. Limitation: Heterogeneity of study designs, dosages of DOACs, and types of P2Y12 inhibitors. Conclusion: In adults with AF after PCI, dual therapy reduces risk for bleeding compared with triple therapy, whereas its effects on risks for death and ischemic end points are still unclear. Primary Funding Source: None.
Predictors of Prolonged Opioid Use After Initial Prescription for Acute Musculoskeletal Injuries in Adults: A Systematic Review and Meta-analysis of Observational Studies: Annals of Internal Medicine: Vol 173, No 9
Background: Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms. Purpose: To explore factors associated with persistent opioid use after its prescription for acute musculoskeletal injury. Data Sources: Searches of multiple electronic databases, without language restrictions, from inception to 6 January 2020, and reference lists of selected articles. Study Selection: Observational studies of adults with opioid prescriptions for outpatient acute musculoskeletal injuries, in an adjusted model, that explored risk factors for prolonged use. Data Extraction: 6 reviewers, working in pairs, independently extracted data, rated the quality of studies, and evaluated the certainty of evidence. Data Synthesis: 14 cohorts with 13 263 393 participants were included. The overall prevalence of prolonged opioid use after musculoskeletal injury for high-risk populations (that is, patients receiving workers' compensation benefits, Veterans Affairs claimants, or patients with high rates of concurrent substance use disorder) was 27% (95% CI, 18% to 37%). The prevalence among low-risk populations was 6% (CI, 4% to 8%; P for interaction < 0.001). Moderate-certainty evidence showed increased odds of persistent opioid use with older age (absolute risk increase [ARI] for every 10-year increase, 1.1% [CI, 0.7% to 1.5%]) and physical comorbidity (ARI, 0.9% [CI, 0.1% to 1.7%]). Low-certainty evidence suggested increased risk for persistent opioid use with past or current substance use disorder (ARI, 10.5% [CI, 4.2% to 19.8%]), prescriptions lasting more than 7 days (median ARI, 4.5%), and higher morphine milligram equivalents per day. Limitation: Sparse, heterogeneous data with suboptimal adjustment for potential confounders. Conclusion: Avoiding prescribing opioids for acute musculoskeletal injuries to patients with past or current substance use disorder, and restricting duration to 7 days or less and using lower doses when they are prescribed, are potentially important targets to reduce rates of persistent opioid use. Primary Funding Source: National Safety Council. (PROSPERO: CRD42018104968)