Faculty Bibliography

BACKGROUND/UNASSIGNED:Somapacitan is a once-weekly GH treatment that has shown efficacy and safety profiles equivalent to daily GH in children with GH deficiency (GHD). OBJECTIVE/UNASSIGNED:To investigate long-term safety, efficacy, and treatment burden associated with somapacitan after 7 years (364 weeks) of treatment. METHODS/UNASSIGNED:REAL 3 (NCT02616562) was a phase 2, randomized, open-label trial investigating the efficacy and safety of somapacitan vs daily GH in children with GHD. After 156 weeks, participants entered a 208-week safety extension. Children in cohort I (age 2.5-10.0 years) previously completed 3 years in the trial; cohort II (age <2.5 years) and cohort III (age 9.0-17.0 years) entered the trial at week 156 for safety-only assessment. All participants received somapacitan 0.16 mg/kg/week. Height velocity (HV), HV SD score (SDS), height SDS, IGF-I SDS, incidence of adverse events (AEs), and treatment burden were assessed. RESULTS/UNASSIGNED:Overall, 43 participants (73%) in cohort I, 1 participant (100%) in cohort II, and 11 participants (69%) in cohort III completed the 208-week safety extension. Consistent increments in HV and HV SDS were seen in cohort I, and height SDSs at week 364 were close to 0. The incidence of AEs was aligned with previous investigations across all cohorts; 3 serious AEs in cohort I were considered probably/possibly related to treatment. Treatment burden was reduced in children who switched from daily GH to somapacitan. CONCLUSION/UNASSIGNED:After 7 years of treatment, children with GHD receiving somapacitan experienced consistent increases in height SDS and reduced treatment burden. No new safety concerns were identified.

BACKGROUND:Guidelines do not recommend routine screening for thyroid nodules when starting a glucagon-like peptide-1 receptor agonist. Patients, however, increasingly present with incidental nodules from imaging ordered at glucagon-like peptide-1 receptor agonist initiation. METHODS:This retrospective case-control study examined patients in a single academic health system from 1 January 2019 to 31 December, 2024 who underwent thyroid ultrasound, fine-needle aspiration biopsy, molecular testing, and/or surgery with glucagon-like peptide-1 receptor agonist initiation compared with patients not prescribed a glucagon-like peptide-1 receptor agonist. Patient, prescription, and intervention data were collected. Chart review was also performed for a subset of patients. RESULTS:From 2019 to 2024, 2,523 patients prescribed a glucagon-like peptide-1 receptor agonist underwent thyroid ultrasound; from 2020 to 2023, there was a higher growth rate of ultrasound scans ordered for them. A random sample of 415 patients prescribed a glucagon-like peptide-1 receptor agonist showed that most ultrasounds were ordered for "thyroid nodules" by the endocrinologist who prescribed glucagon-like peptide-1 receptor agonist. In this subset, 757 nodules were detected on ultrasound; 10.6% (80/757) had fine-needle aspiration biopsy. Cytology showed 3.8% were Bethesda I (3/80), 72.5% Bethesda II (58/80), 15% Bethesda III (12/80), 0% Bethesda IV (0/80), 2.5% Bethesda V (2/80), and 6.6% Bethesda VI (5/80). Of 15 indeterminate nodules, 11 had molecular testing: 5 were positive or suspicious, including fusions, alterations, RAS and BRAF mutations. Sixteen patients had thyroid surgery after glucagon-like peptide-1 receptor agonist initiation (8 total thyroidectomies, 8 hemithyroidectomies, 1 completion). Final pathology demonstrated 6 benign, 10 malignant, 1 NIFTP. The rate of malignancy in the subset was 2.4% (10/415). CONCLUSION/CONCLUSIONS:The malignancy rate in patients prescribed a glucagon-like peptide-1 receptor agonist remains low, but ultrasound screening rates increased for a period. Strong clinical suspicion should govern screening.

Osteotomies around the knee are an effective procedure that shifts the weight-bearing axis from the pathologic side to the uninvolved side to alleviate pain, unload cartilage transplantations, slow down the progression of arthritis, and protect ligament reconstructions. The advancement in plates from nonlocking to locking have increased the stability of constructs to allow for early mobilization and maintained corrections. Further developments with patient-specific instrumentation have made these techniques more reproducible and accurate. Bone grafting and biologics remain a topic of debate but likely a helpful adjuvant in the context of larger corrections or joint preservation surgeries.

OBJECTIVE:Preeclampsia remains one of the leading causes of perinatal mortality worldwide. Little is known of the modifiable risk factors that can be identified and addressed early in pregnancy to reduce the risk of preeclampsia and its associated adverse outcomes. We sought to determine if there is a synergistic effect of pre-pregnancy body-mass index and obstructive sleep apnea on the risk of preeclampsia. STUDY DESIGN/METHODS:We conducted a retrospective cohort study of singleton pregnancies delivered in Kaiser Permanente Southern California hospitals between January 1, 2010, and December 31, 2020 (n=342,349). Preeclampsia and sleep apnea were ascertained using clinical diagnosis codes. Body-mass index in kg/m2 measured during prenatal care visits was categorized as normal (18.5 to 24.9), overweight (25 to 29.9), and obese (≥30). Multivariable logistic regression was used to estimate adjusted relative risks (adjusted RR) and 95% confidence intervals (CI). RESULTS:Compared to normal weight in a pregnancy, overweight (adjusted RR: 1.6; 95% CI: 1.5, 1.7) and obese body mass index (adjusted RR: 2.5; 95% CI: 2.4, 2.6) were associated with an increased risk of preeclampsia. Independent of pre-pregnancy body-mass index, a pregnancy with obstructive sleep apnea was associated with an increased risk of preeclampsia (adjusted RR: 2.2; 95% CI: 1.8, 2.6). Compared to normal weight without the diagnosis of obstructive sleep apnea in a pregnancy, overweight (adjusted RR: 4.6; 95% CI: 2.9, 7.4) and obese body mass index (adjusted RR: 3.8; 95% CI: 3.2, 4.6) with the diagnosis of obstructive sleep apnea were associated with an increased risk of preeclampsia. CONCLUSIONS:Obstructive sleep apnea and elevated body-mass index have independent and additive relationship with preeclampsia. Overweight women at-risk of preeclampsia should be advised of a higher likelihood of developing preeclampsia when both conditions occur together and may benefit from close monitoring and early interventions for these modifiable risk factors.

Tibial tuberosity osteotomy (TTO) is a well-described treatment option for a broad range of patellofemoral joint disorders, including patellofemoral instability, focal chondral lesions of the patellofemoral joint, and patellofemoral arthritis. The purpose of this article is to review the indications and highlight the surgical technique for the more commonly performed TTO procedures and discuss outcomes, as well as surgical pearls for this technique.

Obstructed hemivagina and ipsilateral renal anomaly is a Mullerian anomaly with variable presentations. A patient with this syndrome had a superinfected fluid collection in an obstructed hemivagina after mifepristone and misoprostol administration for an embryonic demise, identifying a potential complication in this population.

BACKGROUND:The COVID-19 pandemic had a significant impact on healthcare delivery. Older adults with multimorbidities were at risk of healthcare disruptions for the management of their chronic conditions. OBJECTIVE:To characterize healthcare disruptions during the COVID-19 healthcare shutdown and recovery period (March 7, 2020-October 6, 2020) and their effects on disease management among older adults with multimorbidities who were patients of NYC Health + Hospitals (H + H), the largest municipal safety-net system in the United States. DESIGN/METHODS:Observational. PATIENTS/METHODS:Patients aged 50 + with hypertension or diabetes and at least one other comorbidity, at least one H + H ambulatory visit in the six months before COVID-19 pandemic onset (March 6, 2020), and at least one visit in the post-acute shutdown period (October 7, 2020 to December 31, 2023). MAIN MEASURES/METHODS:We characterized disruption in care (defined as no ambulatory or telehealth visits during the acute shutdown) and estimated the effect of disruption on blood pressure control, hemoglobin A1c (HbA1c), and low-density lipoprotein (LDL) cholesterol using difference-in-differences models. KEY RESULTS/RESULTS:Out of 73,889 individuals in the study population, 12.5% (n = 9,202) received no ambulatory or telehealth care at H + H during the acute shutdown. Low pre-pandemic healthcare utilization, Medicaid insurance, and self-pay were independent predictors of care disruption. In adjusted analyses, the disruption group had a 3.0-percentage point (95% CI: 1.2-4.8) greater decrease in blood pressure control compared to those who received care. Disruption did not have a significant impact on mean HbA1c or LDL. CONCLUSIONS:Care disruption was associated with declines in blood pressure control, which while clinically modest, could impact risk of cardiovascular outcomes if sustained. Disruption did not affect HbA1c or LDL. Telehealth mitigated impacts of the pandemic on care disruption and subsequent disease management. Targeted outreach to those at risk of care disruption is needed during future crises.

OBJECTIVES/OBJECTIVE:There are few standards for what information about an infectious disease outbreak should be reported to the public and when. To address this problem, we undertook a consensus process to develop recommendations for what epidemiological information public health authorities should report to the public during an outbreak. STUDY DESIGN/METHODS:We conducted a Delphi study following the steps outlined in the ACcurate COnsensus Reporting Document (ACCORD) for health-related activities or research. METHODS:We assembled a steering committee of nine experts representing federal and state public health, academia, and international partners to develop a candidate list of reporting items. We then invited 45 experts, 35 of whom agreed to participate in a Delphi panel. Of those, 25 participated in voting in the first round, 25 in the second round, and 25 in the third round, demonstrating consistent engagement in the consensus-building process. The final stage of the Delphi process consisted of a hybrid consensus meeting to finalize the voting items. RESULTS:The Delphi process yielded nine core reporting items representing a minimum standard for public outbreak reporting: numbers of new confirmed cases, new hospital admissions, new deaths, cumulative confirmed cases, cumulative hospital admissions, and cumulative deaths, each reported weekly and at Administrative Level 1 (typically state or province), and stratified by sex, age group, and race/ethnicity. CONCLUSIONS:This minimum reporting standard creates a strong framework for uniform sharing of outbreak information and promotes consistency of data between jurisdictions, enabling effective response by promoting access to information about an unfolding epidemic.

BACKGROUND AND AIMS/OBJECTIVE:Endoscopic submucosal dissection (ESD) is preferred over endoscopic mucosal resection (EMR) for resection of colon cancer with suspected superficial invasion. Data on appropriate utilization of ESD such as rates of cancer and non-curative resection (NCR) are under-reported. METHODS:Retrospective multicenter study of 547 consecutive colonic lesions undergoing ESD was performed. Outcomes were rates of cancer, NCR, surgery and predictors of NCR. RESULTS:Of all lesions, histopathology demonstrated cancer in 12% (n = 66). Overall, NCR was seen in 59.1% (n = 39) patients and 24.6% (n = 135) lesions contained high-grade dysplasia. For NCR, patients underwent surgery in 7.6% (n = 3) and adverse events were observed in 8.8% (n = 48). CONCLUSIONS:In our large multicenter Western cohort, the pathology was found to be benign in most of the colon ESDs and there was high NCR for resected lesions with cancer. The overall surgery rate, however, remained low. This study highlights the need to refine lesion selection criteria while continuing to optimize ESD technique to match the efficiency and safety of EMR.