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AbstractIntroductionFor patients with catecholamine‐resistant vasoplegic syndrome (VS) during liver transplantation (LT), treatment with methylene blue (MB) and/or hydroxocobalamin (B12) has been an acceptable therapy. However, data on the effectiveness of B12 is limited to case reports and case series.MethodsWe retrospectively reviewed records of patients undergoing LT from January 2016 through March 2022. We identified patients with VS treated with vasopressors and MB, and abstracted hemodynamic parameters, vasopressor requirements, and B12 administration from the records. The primary aim was to describe the treatment efficacy of B12 for VS refractory to vasopressors and MB, measured as no vasopressor requirement at the conclusion of the surgery.ResultsOne hundred one patients received intraoperative VS treatment. For the 35 (34.7%) patients with successful VS treatment, 14 received MB only and 21 received both MB and B12. Of the 21 patients with VS resolution after receiving both MB and B12, 17 (89.5%) showed immediate, but transient, hemodynamic improvements at the time of MB administration and later showed sustained response to B12.ConclusionImmediate but transient hemodynamic response to MB in VS patients during LT supports the diagnosis of VS and should prompt B12 administration for sustained treatment response.

AimsPrior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients.MethodsLifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated.ResultsFor treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467.ConclusionThe use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness.Cite this article: Bone Jt Open 2024;5(3):218–226.

PURPOSE Accurate understanding of the genomic and transcriptomic data provided by next-generation sequencing (NGS) is essential for the effective utilization of precision oncology. Molecular tumor boards (MTBs) aim to translate the complex data in NGS reports into effective clinical interventions. Often, MTB treatment recommendations differ from those in the NGS reports. In this study, we analyze the discordance between these recommendations and the rationales behind the discordances, in a non–high-income setting, with international input to evaluate the necessity of MTB in clinical practice. METHODS We collated data from MTB that were virtually hosted in Chennai, India. We included patients with malignancies who had NGS reports on solid tissue or liquid biopsies, and excluded those with incomplete data. MTB forms and NGS reports of each clinical case were analyzed and evaluated for recommendation concordance. Concordance was defined as an agreement between the first recommendation in the MTB forms and the therapeutic recommendations suggested in the NGS report. Discordance was the absence of the said agreement. The rationales for discordance were identified and documented. RESULTS Seventy MTB reports were analyzed with 49 cases meeting the inclusion criteria. The recommendation discordance was 49% (24 of 49). Discordant recommendations were mainly due to low level of evidence for the drug (75% of cases). CONCLUSION The discordance between MTB and NGS vendor recommendations highlights the clinical utility of MTB. The educational experiences provided by this initiative are an example of how virtual academic collaborations can enhance patient care and provider education across geographic borders.

Abstract Background Despite the lack of proven therapies for recurrent high-grade glioma (HGG), only 8%–11% of patients with glioblastoma participate in clinical trials, partly due to stringent eligibility criteria. Prior bevacizumab treatment is a frequent exclusion criterion, due to difficulty with response assessment and concerns for rebound edema following antiangiogenic discontinuation. There are no standardized trial eligibility rules related to prior antiangiogenic use. Methods We reviewed ClinicalTrials.gov listings for glioma studies starting between May 2009 and July 2022 for eligibility rules related to antiangiogenics. We also reviewed the literature pertaining to bevacizumab withdrawal. Results Two hundred and ninety-seven studies for patients with recurrent glioma were reviewed. Most were phase 1 (n = 145, 49%), non-randomized (n = 257, 87%), evaluated a drug-only intervention (n = 223, 75%), and had a safety and tolerability primary objective (n = 181, 61%). Fifty-one (17%) excluded participants who received any antiangiogenic, one (0.3%) excluded participants who received any non-temozolomide systemic therapy. Fifty-nine (20%) outlined washout rules for bevacizumab (range 2–24 weeks, 4-week washout n = 35, 12% most common). Seventy-eight required a systemic therapy washout (range 1–6 weeks, 4-week washout n = 34, 11% most common). Nine permitted prior bevacizumab use with limitations, 18 (6%) permitted any prior bevacizumab, 5 (2%) were for bevacizumab-refractory disease, and 76 (26%) had no rules regarding antiangiogenic use. A literature review is then presented to define standardized eligibility criteria with a 6-week washout period proposed for future trial design. Conclusions Interventional clinical trials for patients with HGG have substantial heterogeneity regarding eligibility criteria pertaining to bevacizumab use, demonstrating a need for standardizing clinical trial design.

Importance Racial and ethnic disparities exist in urogynecologic surgery; however, literature identifying specific disparities after sling operations for stress incontinence are limited. Objective The objective of this study was to evaluate racial and ethnic disparities in surgical complications within 30 days of midurethral sling operations. Study Design This retrospective cohort study identified women who underwent an isolated midurethral sling operation between 2014 and 2021 using the American College of Surgeons National Surgical Quality Improvement Program database. Women were stratified by racial and ethnic category to assess the primary outcome, 30-day surgical complications, and the secondary outcome, comparison of urinary tract infections (UTIs). Results There were 20,066 patients included. Mean age and body mass index were 53.9 years and 30.8, respectively. More Black or African American women had diabetes and hypertension, and more American Indian or Alaska Native women used tobacco. The only difference in 30-day complications was stroke/cerebrovascular accident, which occurred in only 1 Asian, Native Hawaiian or other Pacific Islander patient (0.1%, P < 0.0001). The most frequent complication was UTI (3.3%). Black or African American women were significantly less likely to have a diagnosis of UTI than non-Hispanic White (P = 0.04), Hispanic White (P = 0.03), and American Indian or Alaska Native women (P = 0.04). Conclusions Surgical complications within 30 days of sling operations are rare. No clinically significant racial and ethnic differences in serious complications were observed. Urinary tract infection diagnoses were lower among Black or African American women than in non-Hispanic White, Hispanic White, and American Indian or Alaska Native women despite a greater comorbidity burden. No known biologic reason exists to explain lower UTI rates in this population; therefore, this finding may represent a disparity in diagnosis and treatment.

Objective To evaluate the clinical outcomes of a remote mental health program for managing anxiety and depression, primarily using asynchronous digital communication. Methods This retrospective cohort study examined U.S. adults seeking remote care for anxiety and depression from January 2021 to May 2022. The program involves clinician-led assessment, patient education, medication management, and ongoing monitoring, primarily via text. Anxiety and depression were measured using Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scores. Outcomes examined were changes in scores, 50% score improvement rate, and remission rate (score <5) at 1, 3, and 6 months. Results During the period evaluated, 11,844 program participants met the inclusion criteria. Most were female (n = 8328, 70.3%); their age ranged from 18–82 years (median 31 years). At baseline, median PHQ-9 and GAD-7 scores were 13 (IQR 9–17); 67% and 69% met score criteria for depression and anxiety, respectively. Most participants (80%) were prescribed a selective serotonin reuptake inhibitor (SSRI). By one month, average PHQ-9 and GAD-7 scores decreased significantly by 9.2 and 9.1 points (both p < .01). At 1-month follow-up, the 50% score improvement rate was 66% for PHQ-9 and 69% GAD-7 ( p < .01). Scores continued to decrease with follow-up. At 3 months, over half achieved remission (percent [95% CI]: 52% [51–54] for anxiety, 53% [52–55] for depression). Similar improvement was observed at 6 months and in sensitivity analyses accounting for loss to follow-up. Conclusions Use of a remote mental health program with digital tools was associated with significant clinical improvement in anxiety and depression. Challenges remain in maintaining patient engagement and ensuring appropriate care quality monitoring in digital mental health programs. Additional research comparing remote digital care to traditional in-person models is warranted. Studies should examine long-term outcomes, optimal care protocols, and the challenges to integrating these programs into existing healthcare systems and ensuring equitable access.