Mercy Medical Center (Cedar Rapids, Iowa)

Various "arbitrary factors" shaped healthcare chaplains' experiences during the early phase of the COVID-19 pandemic. The author's reflection provides personal recollection, uniquely situated in the particular local organizational dynamics and inter-personal relationships among the professionals, supplementing the qualitative survey articles by the field's on-going effort to collect, organize, and interpret the pandemic's impact on the spiritual care practitioners.

Nonoperative treatment is the preferred initial intervention for plantar fasciitis. However, some patients fail to respond and present with continued pain. This study investigated the effectiveness of concentrated bone marrow aspirate concentrate (BMAC) injections in the treatment of recalcitrant plantar fasciitis. Retrospective chart review was performed to identify patients diagnosed with chronic plantar fasciitis that underwent treatment with BMAC injection. Bone marrow aspirate was harvested from the iliac crest, concentrated, and injected into the site of maximal tenderness in the plantar fascia. Visual analogue scale (VAS) pain scores were collected before and after the BMAC injection at six, ten, 24, and 48 weeks. Postoperative complications were recorded. A total of 19 patients (19 feet) with chronic plantar fasciitis were treated with BMAC injection. Average age was 52.6 (SD, ± 7.5) years with an average BMI of 26.4 (SD, ± 4.6) kg/m2. The average duration of pain prior to the BMAC injection was 2.5 (SD, ± 1.3) years. Preoperatively, average VAS was 7.5 (SD, ± 2.3), with significant improvement at six weeks (mean, 2.3; SD, ± 1.2), ten weeks (mean, 2.2; SD, ± 1.2), 24 weeks (mean 1.7; SD, ± 1.1), and at 48 weeks (mean, 1.1; SD, ± 0.7) postoperatively (all p < 0.05). No complications were observed at the surgical or donor site. Patients with recalcitrant plantar fasciitis treated with BMAC injection demonstrated and maintained a statistically significant decrease in VAS pain score upon assessment at each postoperative follow-up up to 48 weeks, with no adverse effects at the donor or injection site. These findings suggest that BMAC injection may be a safe treatment option offering early pain relief.

Acute-on-chronic liver failure (ACLF) is a condition associated with high mortality in the absence of liver transplantation. There have been various definitions proposed worldwide. The first consensus report of the working party of the Asian Pacific Association for the Study of the Liver (APASL) set in 2004 on ACLF was published in 2009, and the "APASL ACLF Research Consortium (AARC)" was formed in 2012. The AARC database has prospectively collected nearly 10,500 cases of ACLF from various countries in the Asia-Pacific region. This database has been instrumental in developing the AARC score and grade of ACLF, the concept of the 'Golden Therapeutic Window', the 'transplant window', and plasmapheresis as a treatment modality. Also, the data has been key to identifying pediatric ACLF. The European Association for the Study of Liver-Chronic Liver Failure (EASL CLIF) and the North American Association for the Study of the End Stage Liver Disease (NACSELD) from the West added the concepts of organ failure and infection as precipitants for the development of ACLF and CLIF-Sequential Organ Failure Assessment (SOFA) and NACSELD scores for prognostication. The Chinese Group on the Study of Severe Hepatitis B (COSSH) added COSSH-ACLF criteria to manage hepatitis b virus-ACLF with and without cirrhosis. The literature supports these definitions to be equally effective in their respective cohorts in identifying patients with high mortality. To overcome the differences and to develop a global consensus, APASL took the initiative and invited the global stakeholders, including opinion leaders from Asia, EASL and AASLD, and other researchers in the field of ACLF to identify the key issues and develop an evidence-based consensus document. The consensus document was presented in a hybrid format at the APASL annual meeting in Kyoto in March 2024. The 'Kyoto APASL Consensus' presented below carries the final recommendations along with the relevant background information and areas requiring future studies.

STUDY DESIGN:Secondary data analysis of the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS). OBJECTIVES:The purpose of this study is to perform a cost-effectiveness analysis comparing operative (Op) versus non-operative (Non-Op) care for ASLS 8 years after enrollment. BACKGROUND:A prior cost-effectiveness analysis of the current cohort comparing Op to Non-Op care at 5 years after enrollment showed an incremental cost-effectiveness ratio (ICER) of $44,033 in the as-treated analysis and an ICER of $27,480 in the intent-to-treat analysis. MATERIALS AND METHODS:Data were collected every 3 months for the first 2 years, and then every 6 months for the remainder of the study. Data included the use of Non-Op modalities, medications, and employment status. Costs for index and revision surgeries and Non-Op modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Quality-adjusted life years (QALYs) were determined using the Short Form-6 Dimensions. RESULTS:There were 101 cases in the Op and 103 in the Non-Op group with complete 8-year data. Thirty-eight patients (37%) in the Non-Op group had surgery from 3 to 72 months after enrollment. An as-treated analysis including only cases who never had surgery (N = 65) or cases with complete 8-year postoperative data (N = 101) showed that Op treatment was favored with an ICER of $20,569 per QALY gained, which is within willingness-to-pay thresholds. An intent-to-treat analysis demonstrated greater QALY gains and lower costs in the Op group (ICER = -$13,911). However, intent-to-treat analysis is influenced by Non-Op patients who crossed over to Op treatment at variable times during follow-up. CONCLUSION:Op treatment was more cost-effective than Non-Op treatment for ASLS at 8-year follow-up. The ICER continued to improve as compared with the 5-year values ($20,569 vs . $44,033).

661 Background: RYZ101 ( 225 Ac-DOTATATE) is an alpha-emitting radiopharmaceutical in development for SSTR2+ solid tumors. Alpha-particles have a shorter path length/higher linear energy transfer than beta-particles, causing more frequent double-strand DNA breaks and potentially improving the therapeutic index. ACTION-1 (NCT05477576) is a two-part, global, randomized, controlled, open-label, phase 1b/3 trial of RYZ101 in advanced, well-differentiated SSTR+ GEP-NETs progressing after 177 Lu-SSA therapy. Herein, we report updated results from the phase 1b portion of the trial. Methods: The phase 1b portion of the ACTION-1 trial had a dose de-escalation/Bayesian optimal interval design with boundaries based on a dose-limiting toxicity (DLT) rate of 25%. Patients received RYZ101 IV every 8 weeks for 4 cycles. Planned dose levels (n=6/level): Level 0 (starting dose) 120 kBq/kg; Level 1 90 kBq/kg; Level 2 60 kBq/kg. DLTs were assessed for 56 days after the first RYZ101 dose. Treatment-emergent adverse events (TEAEs) were graded by NCI-CTCAE v5.0. A Data Review Committee oversaw dose de-escalation decisions/safety data. Tumor response was assessed locally by RECIST v1.1. Results: Seventeen patients received at least one dose of RYZ101 at 120 kBq/kg (4 doses: 15 patients; 2 doses: 2 patients; median 8.3 MBq). Baseline patient characteristics: median age 63 years; male (n=11); ECOG PS 0/1 (n=10/7); primary tumor site GI/pancreas (n=12/5). As of 14 December 2023, the most frequent TEAEs were anemia (58.8%), nausea (58.8%), and fatigue (52.9%). Serious adverse events (SAEs) were observed in 6 patients (35.3%, none were treatment-related); grade ≥3 TEAEs occurred in 9 patients (5 were treatment-related, 29.4%). No TEAEs led to treatment discontinuation. Four patients had TEAEs leading to dose modification, dose hold, and/or dose delays. There was one grade 5 TEAE of hepatic failure that was deemed unrelated to the study drug. The confirmed objective response rate was 29.4% (n=5; 1 complete response, 4 partial responses). One additional patient had an unconfirmed partial response at the time of data cutoff, which was subsequently confirmed. Seven patients (41.2%) had stable disease and 3 (17.6%) had progressive disease. The median duration of response was not estimable (95% CI 9.26 months, not estimable), and the median progression-free survival was not estimable (95% CI 12.16 months, not estimable). Conclusions: RYZ101 was well tolerated, and a fixed dose of 10.2 MBq was declared the recommended phase 3 dose. Initial data suggest promising efficacy and a manageable safety profile. Part 2 (phase 3) of the ACTION-1 trial is enrolling and will compare RYZ101 at 10.2 MBq every 8 weeks for 4 cycles with standard of care in patients with advanced SSTR2+ GEP-NETs progressing after 177 Lu-labeled SSAs. Clinical trial information: NCT05477576 .