Screening for depression in pregnant women with HIV infection

OBJECTIVE: To determine the utility of screening for depression in pregnant women with human immunodeficiency virus (HIV) infection. STUDY DESIGN: Women with HIV infection who received prenatal care at an inner-city institution between March 2004 and March 2006 were offered the Beck Depression Inventory (BDI), a screening tool to detect depressive symptomatology. Scores >9 were considered positive. RESULTS: Of 51 subjects who participated, 53% had positive screening scores for depression. Of those whose scores were positive, 33% had no prior history of psychiatric illness. Those in whom HIV was diagnosed during pregnancy had higher mean and median BDI scores than those with HIV diagnosed before pregnancy (21.2 vs. 13.3 and 21 vs. 9.5, respectively; p = 0.049). Two factors were associated with positive screenings: history of psychiatric disease (p = 0.001) and history of substance abuse (p = 0.042). Patients with positive screenings first presented for prenatal care at a later gestational age and had fewer prenatal visits than those without evidence of depression (14.9 vs. 12.0, p = 0.035 and 9.2 vs. 11.3, p = 0.045). More than half (56%) who screened positive received psychological care during the prenatal period. CONCLUSION: Women with HIV infection should routinely be screened for depression during pregnancy. Those with positive screens should be offered formal psychological evaluation.     

Factors associated with 5-year risk of hip fracture in postmenopausal women

Context  The 329 000 hip fractures that annually occur in the United States are associated with high morbidity, mortality, and cost. Identification of those at high risk is a step toward prevention. Objective  To develop an algorithm to predict the 5-year risk of hip fracture in postmenopausal women. Design, Setting, and Participants  A total of 93 676 women who participated in the observational component of the Women's Health Initiative (WHI), a multiethnic longitudinal study, were used to develop a predictive algorithm based on commonly available clinical features. Selected factors that predicted hip fracture were then validated by 68 132 women who participated in the clinical trial. The model was tested in a subset of 10 750 women who had undergone dual-energy x-ray absorptiometry (DXA) scans for bone mass density assessment. Main Outcome Measure  The prediction of centrally adjudicated hip fracture, measured by the area under the receiver operator characteristic (ROC) curves. Results  During a mean (SD) follow-up of 7.6 (1.7) years, 1132 hip fractures were identified among women participating in the observational study (annualized rate, 0.16%), whereas during a mean follow-up of 8.0 (1.7) years, 791 hip fractures occurred among women participating in the clinical trial (annualized rate, 0.14%). Eleven factors predicted hip fracture within 5 years: age, self-reported health, weight, height, race/ethnicity, self-reported physical activity, history of fracture after age 54 years, parental hip fracture, current smoking, current corticosteroid use, and treated diabetes. Receiver operating characteristic curves showed that the algorithm had an area under the curve of 80% (95% confidence interval [CI], 0.77%-0.82%) when tested in the cohort of different women who were in the clinical trial. A simplified point score was developed for the probability of hip fracture. Receiver operating characteristic curves comparing DXA-scan prediction based on a 10% subset of the cohort and the algorithm among those who participated the clinical trial were similar, with an area under the curve of 79% (95% CI, 73%-85%) vs 71% (95% CI, 66%-76%). Conclusion  This algorithm, based on 11 clinical factors, may be useful to predict the 5-year risk of hip fracture among postmenopausal women of various ethnic backgrounds. Further studies are needed to assess the clinical implication of the algorithm in general and specifically to identify treatment benefits.      

Advancing an agile regulatory ecosystem to respond to the rapid development of innovative technologies

Technological advancements are dramatically changing the landscape of therapeutic development. The convergence of advances in computing power, analytical methods, artificial intelligence, novel digital health tools, and cloud‐based platforms has the potential to power an exponential acceleration of evidence generation. For regulatory agencies responsible for evidence evaluation and oversight of medical products, these advances present both promises and challenges. Ultimately, realizing the translation and impact of these innovations that could potentially enhance therapeutic development and improve the health of individuals and the public will require a nimble and responsive regulatory approach. Supporting an adaptive policy‐making infrastructure that is poised to address novel regulatory considerations, creating a workforce to ensure relevant expertise, and fostering more diverse collaborations with a broader group of stakeholders are steps toward the goal of modernizing the regulatory ecosystem. This article outlines approaches that can help provide the flexibility and tools needed to foster innovation, while ensuring the safety and effectiveness of medical products.     

University-Associated SARS-CoV-2 Omicron BA.2 Infections,Maricopa County,Arizona, USA, 2022

We investigated a university-affiliated cohort of SARS-CoV-2 Omicron BA.2 infections in Arizona, USA. Of 44 cases, 43 were among students; 26 persons were symptomatic, 8 sought medical care, but none were hospitalized. Most (55%) persons had completed a primary vaccine series; 8 received booster vaccines. BA.2 infection was mild in this young cohort.     

Surgical Management of Craniovertebral Junction Schwannomas: A Systematic Review

Background: Craniovertebral junction (CVJ) schwannomas are rare, with surgery and stereotactic radiosurgery (SRS) being effective yet challenging options. We systematically reviewed the literature on CVJ schwannomas. Methods: PubMed, Scopus, Web-of-Science, and Cochrane were searched following the PRISMA statement to include studies reporting CVJ schwannomas. Clinical features, management, and outcomes were analyzed. Results: We collected 353 patients from 101 included articles. Presenting symptoms were mostly neck pain (30.3%) and headache (26.3%), with most cranial neuropathies involving the XII (31.2%) and X (24.4%) nerves. Most tumors originated from C2 (30.9%) and XII (29.4%) nerves, being extracranial (45.1%) and intradural-extradural (44.2%). Erosion of C1–C2 vertebrae (37.1%), the hypoglossal canal (28.3%), and/or jugular foramen (20.1%) were noted. All tumors were operated, preferably with the retrosigmoid approach (36.5%), with the far-lateral approach (29.7%) or with the posterior approach and cervical laminectomy (26.9%), far-lateral approaches (14.2%), or suboccipital craniotomy with concurrent cervical laminectomy (14.2%). Complete tumor resection was obtained most frequently (61.5%). Adjuvant post-surgery stereotactic radiosurgery was delivered in 5.9% patients. Median follow-up was 27 months (range, 12–252). Symptom improvement was noted in 88.1% of cases, and cranial neuropathies showed improvement in 10.2%. Post-surgical complications occurred in 83 patients (23.5%), mostly dysphagia (7.4%), new cranial neuropathies (6.2%), and cerebrospinal fluid leak (5.9%). A total of 16 patients (4.5%) had tumor recurrence and 7 died (2%), with median overall survival of 2.7 months (range, 0.1–252). Conclusions: Microsurgical resection is safe and effective for CVJ schwannomas. Data on SRS efficacy and indications are still lacking, and its role deserves further evaluation.