The association between adverse childhood experiences and treatment response for adults with alcohol and other drug use disorders.

BACKGROUND AND OBJECTIVES: Adverse events during childhood increase the risk for the development of substance use disorders (SUDs). This study examined the association between adverse childhood experiences (ACEs) and SUD treatment response. METHODS: This cohort analysis included data from longitudinal clinical assessments extracted from the records of 438 consenting individuals undergoing SUD treatment (63% male; 88.8% White). Mixed effects models evaluated the relationship between scores on the ACE questionnaire and indicators of treatment response (i.e., alcohol and drug abstinence self-efficacy; symptoms of depression, anxiety, and posttraumatic stress disorder) for individuals with alcohol-related (n = 332) and other drug-related (n = 275) diagnoses, with some participants included in both groups. RESULTS: Treatment response varied as a function of ACEs, with the magnitude of differences varying across time in treatment. Relative to those with no ACE history, those who experienced ≥2 ACEs reported worse depression, anxiety, PTSD symptoms, and alcohol/drug abstinence self-efficacy at baseline, with many differences remaining at the 30-day assessment. All differences abated by discharge, with the exception of PTSD symptoms among those in the drug use group with a history of ≥4 ACEs. Male gender and older age were generally associated with lower symptomology and higher abstinence self-efficacy. DISCUSSION AND CONCLUSIONS: Assessing ACE history early in SUD treatment may improve treatment planning and prognosis. Future studies should evaluate the role of trauma-informed programming and individual interventions to improve treatment response. SCIENTIFIC SIGNIFICANCE: This study demonstrates the association between adverse childhood experiences and symptom severity among patients across participation in SUD treatment.

Steerable Ureteroscopic Renal Evacuation (SURE) for Large Renal Stones: A Multi-Institutional Center Study.

BACKGROUND: The results of a recent pilot study suggest that steerable ureteroscopic renal evacuation (SURE) is safe and more effective in stone removal than basketing following laser lithotripsy. The objective of this retrospective study was to further assess the safety and efficacy of SURE using the CVAC® Aspiration System (Calyxo, Inc., Pleasanton, CA) in patients with large stone burdens. MATERIALS AND METHODS: Patients with a baseline stone burden of ≥10 mm who underwent SURE were identified. Subject demographics, secondary procedures, complications, and stone clearance (defined as percent baseline volume reduction) were evaluated. Sub-analyses were performed to explore patients identified as high-risk for percutaneous nephrolithotomy (PCNL) because 1) they were on anticoagulation or antiplatelet therapy at the time of procedure, or 2) they had limited mobility due to neurological conditions. RESULTS: Identified patients (N=43) had a mean pre-operative stone burden of 29±12 mm and mean stone volume of 3,092±5,002 mm3. Approximately one-half of patients (n=24, 55.8%) had computerized tomography (CT) imaging at follow-up, and of those, eight (33.3%) had no residual stones, 22 (91.7%) had >90% stone clearance, 23 (95.8%) had >80% stone clearance and 24 (100%) had >60% stone clearance. Stone clearance based on baseline stone burden varied between 93.8% and 98.9%. At baseline, 21 patients were anticipated to require staged ureteroscopy; however, only two of those (9.5%) needed secondary procedures. High-risk patients (n=22) were on anticoagulation or antiplatelet therapy (n=12) or had neurologic conditions (n=10). Stone clearance was 97% among patients in the anticoagulated cohort with postoperative CT imaging, and 83% in patients with neurologic conditions. There were no device-related complications and no post-operative admissions. CONCLUSIONS: The CVAC® Aspiration System is safe and effective for treating large stone burdens, including in high-risk patients, and may decrease the need for PCNL or secondary procedures.

The availability of gonadotropin therapy from FDA-approved pharmacies for men with hypogonadism and infertility.

Background: Recent changes to the Biologics Price Competition and Innovation Act of 2009 have created barriers to accessing therapy for men utilizing gonadotropins for hypogonadism and infertility. Aim: In this study we sought to investigate ways to decrease disparities in the treatment of male hypogonadism by increasing access to gonadotropin therapy by identifying 503b outsourcing pharmacies which currently provide gonadotropin therapy. Methods: A review of 503b compounding pharmacies was performed using the online published registry available from the US Food and Drug Administration (FDA). Each pharmacy was contacted regarding their ability to provide gonadotropin therapy. Pharmacies were also queried regarding the impact of FDA-related legal changes and cost considerations. Outcomes: The study outcomes were the number and location of FDA-approved 503b compounding pharmacies supplying human chorionic gonadotrophin (hCG) and/or follicle-stimulating hormone (FSH) for the treatment of male hypogonadism and infertility. Results: The 81 503b-compounding pharmacies approved by the FDA to produce hCG and FSH therapy were identified using the FDA registry. Seventy-five of the 81 pharmacies responded to the survey (response rate 92.6%). Of the contacted pharmacies, 5 provided hCG (6.67%). Of the pharmacies offering compounded hCG, 4 offered FSH. No additional pharmacies offered compounded FSH. Eight pharmacies had previously provided hCG and FSH. Six of the 8 pharmacies that stopped making hCG and FSH cited the 2020 FDA mandate as the reason for halting compounding services. Of the 75 pharmacies that responded, only 1 pharmacy provided the cost for FSH ($287 per 100-IU vial), and 3 pharmacies provided the cost for hCG ($50-$83 per 10 000-IU vial). Clinical Implications: There are few FDA-approved outsourcing pharmacies currently providing male gonadotropin therapy, and increasing awareness of these pharmacies may decrease barriers to care for patients with male hypogonadism and infertility. Strengths and Limitations: The strengths of this article are the clinical utility of the data presented, as this article may serve as a tool for clinicians to increase patient access to therapy. All FDA-approved 503b outsourcing pharmacies were contacted, and 92.6% participated in this project. Limitations of this article were the following: no non-FDA-approved compounding pharmacies such as 503a pharmacies were contacted, participant-reported outcomes were utilized, and only 3 contacted outsourcing pharmacies provided a cost for FSH or hCG, allowing for an unknown degree of cost variability between outsourcing pharmacies. Conclusions: There currently exists limited access to FDA-approved compounded gonadotropin therapies for hypogonadism and male infertility, and these results demonstrate the barriers to hCG and FSH access and the need for additional treatment options for this vulnerable patient population.