Annals of Internal Medicine最新文献

Background: Guideline questions are typically proposed by experts.

Objective: To assess how large language models (LLMs) can support the development of guideline questions, providing insights on approaches and lessons learned.

Design: Two approaches for guideline question generation were assessed: 1) identification of questions conveyed by online search queries and 2) direct generation of guideline questions by LLMs. For the former, the researchers retrieved popular queries on allergic rhinitis using Google Trends (GT) and identified those conveying questions using both manual and LLM-based methods. They then manually structured as guideline questions the queries that conveyed relevant questions. For the second approach, they tasked an LLM with proposing guideline questions, assuming the role of either a patient or a clinician.

Setting: Allergic Rhinitis and its Impact on Asthma (ARIA) 2024 guidelines.

Participants: None.

Measurements: Frequency of relevant questions generated.

Results: The authors retrieved 3975 unique queries using GT. From these, they identified 37 questions, of which 22 had not been previously posed by guideline panel members and 2 were eventually prioritized by the panel. Direct interactions with LLMs resulted in the generation of 22 unique relevant questions (11 not previously suggested by panel members), and 4 were eventually prioritized by the panel. In total, 6 of 39 final questions prioritized for the 2024 ARIA guidelines were not initially thought of by the panel. The researchers provide a set of practical insights on the implementation of their approaches based on the lessons learned.

Limitation: Single case study (ARIA guidelines).

Conclusion: Approaches using LLMs can support the development of guideline questions, complementing traditional methods and potentially augmenting questions prioritized by guideline panels.

Primary funding source: Fraunhofer Cluster of Excellence for Immune-Mediated Diseases.

Background: Use of a gestational ("surrogate") carrier is increasingly common. Risk for maternal and neonatal adversity is largely unknown in this birthing population.

Objective: To determine the risk for severe maternal morbidity (SMM) and severe neonatal morbidity (SNM) in gestational carriers.

Design: Population-based cohort study.

Setting: All of Ontario, Canada.

Participants: All singleton births at more than 20 weeks' gestation, from 2012 to 2021.

Measurements: Exposure was type of conception, namely, gestational carriage (main exposure), unassisted conception (comparison group 1), and in vitro fertilization (IVF) (comparison group 2). Main composite outcomes were SMM and SNM. Modified Poisson regression models generated weighted relative risks (wRRs) using propensity score-based overlap weighting. Secondary outcomes included hypertensive disorders of pregnancy, cesarean delivery, preterm birth, and postpartum hemorrhage.

Results: Of all eligible singleton births, 846 124 (97.6%) were by unassisted conception, 16 087 (1.8%) by IVF, and 806 (0.1%) by gestational carriage. Respective risks for SMM were 2.3%, 4.3%, and 7.8%. The wRRs were 3.30 (95% CI, 2.59 to 4.20) comparing gestational carriage with unassisted conception and 1.86 (CI, 1.36 to 2.55) comparing gestational carriage with IVF. Respective risks for SNM were 5.9%, 8.9%, and 6.6%, generating wRRs of 1.20 (CI, 0.92 to 1.55) for gestational carriage versus unassisted conception and 0.81 (CI, 0.61 to 1.08) for gestational carriage versus IVF. Hypertensive disorders, postpartum hemorrhage, and preterm birth at less than 37 weeks were also significantly higher contrasting gestational carriers to either comparison group.

Limitation: Absence of information about indications for choosing a gestational carrier, and oocyte or sperm donor source.

Conclusion: Among singleton births of more than 20 weeks' gestation, a higher risk for SMM and adverse pregnancy outcomes was seen among gestational carriers compared with women who conceived with and without assistance. Although gestational carriage was associated with preterm birth, there was less clear evidence of severe neonatal morbidity. Potential mechanisms for higher maternal morbidity among gestational carriers require elucidation, alongside developing special care plans for gestational carriers.

Primary funding source: The Canadian Institutes of Health Research.

Source citation: Kingsbury SR, Tharmanathan P, Keding A, et al. Pain reduction with oral methotrexate in knee osteoarthritis: a randomized, placebo-controlled clinical trial. Ann Intern Med. 2024;177:1145-1156. 39074374.

Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.

Source citation: Usman MS, Bhatt DL, Hameed I, et al. Effect of SGLT2 inhibitors on heart failure outcomes and cardiovascular death across the cardiometabolic disease spectrum: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2024;12:447-461. 38768620.