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Patterns of Clinical Trial Enrollment for Pediatric Patients With Hepatoblastoma and Wilms Tumor: A Report From the Children\u27s Oncology Group.
No full textBACKGROUND: Published childhood cancer studies have observed differences in therapeutic trial enrollment by race, ethnicity, socioeconomic status (SES), and age at diagnosis. Our study investigates patterns of enrollment for pediatric oncology clinical trials.
METHODS: We analyzed differences in Children\u27s Oncology Group clinical trial enrollment in a cohort of pediatric patients with hepatoblastoma (n = 212) and Wilms tumor (n = 1107). Relative risks (RRs) and 95% confidence intervals (95% CIs) were estimated for trial enrollment by patient characteristics. Odds ratios (ORs) and 95% CIs were estimated to examine associations between characteristics and three outcomes (therapeutic trial [referent], exclusively non-therapeutic study, no trial or study). Statistical significance tests were two-sided.
RESULTS: Approximately half of all cases enrolled in therapeutic trials for both tumor types (Wilms: 48%; hepatoblastoma: 51%). For Wilms tumor, patients diagnosed at ages 3-5 years were more likely to enroll compared to those diagnosed at age \u3c 1 year (RR = 1.06; 95% CI = 1.01, 1.13) and had lower odds of joining exclusively a non-therapeutic study compared to those diagnosed at age \u3c 1 years (OR = 0.63; 95% CI = 0.44, 0.90). There was no association between race, ethnicity, or SES and enrollment. For hepatoblastoma, no variables indicated any statistically significant difference in enrollment.
CONCLUSIONS: Few differences in clinical trial enrollment were observed during periods when trials were available for all risk groups, a promising sign of equity in pediatric oncology clinical trial recruitment. Among Wilms tumor cases, differences in enrollment were observed for age at diagnosis, a potential proxy for disease acuity, which may influence decision making
Single-Center Experience of Omitting Preprocedure Transesophageal Echo for MitraClip Patients.
No full text•Mitral transcatheter edge-to-edge repair requires preprocedure echocardiography.•In certain circumstances, timeliness of transesophageal echos can be a limitation.•Using transthoracic echo results, heart teams may decide to proceed with repair.•Safety, procedural, and valve outcomes are not compromised for these patients
Surgical Approach and Complications of Stand-alone Lateral Trans-Psoas Interbody Fusion.
No full textInterbody fusion of the lumbar spine is a standard procedure for symptomatic degenerative lumbar spine disease if conservative treatment fails. Surgical decompression and fusion of the segment can be achieved using several different techniques. Over the last decades, minimally invasive techniques, such as lateral interbody fusion (LLIF), have been developed to reduce tissue damage and complications and allow quicker patient recovery. With growing popularity, indications for LLIF have expanded to treat spinal deformities and foraminal/central stenosis. Mechanically, it allows for an unsurpassed fixation through the left-to-right apophyseal ring placement of the cage. LLIF utilizes a minimally disruptive retroperitoneal corridor and includes both trans-psoas and pre-psoas approaches. For the pre-psoas approach, the risk of damage from manipulation of the intramuscular lumbar plexus is reduced compared to a trans-psoas approach. However, increased risks of major vascular, ureteral, bowel injury and sympathetic plexus damage are reported. This article aims to provide a detailed and comprehensive guide on stand-alone lateral trans-psoas interbody fusion, including its indications, surgical procedure, potential complications, and outcomes based on a decade of experience from a single center
CNM-Au8 in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
No full textIMPORTANCE: Bioenergetic failure has been proposed as a driver of amyotrophic lateral sclerosis (ALS). CNM-Au8 is a suspension of gold nanocrystals that catalyzes the conversion of nicotinamide adenine dinucleotide hydride into NAD+, resulting in an increase of cellular adenosine triphosphate production.
OBJECTIVE: To determine the effects of CNM-Au8 on ALS disease progression.
DESIGN, SETTING, AND PARTICIPANTS: CNM-Au8 was tested as a regimen of the HEALEY ALS Platform Trial, a phase 2/3, multicenter, randomized, double-blind platform trial. The study was conducted at 54 sites in the US from July 2020 to March 2022 (final follow-up, March 17, 2022). A total of 161 participants with ALS were randomized to receive CNM-Au8 (n = 120) or regimen-specific placebo (n = 41). Data from 123 concurrently randomized placebo participants in other regimens were combined for analyses.
INTERVENTIONS: Eligible participants were randomized in a 3:3:2 ratio to receive CNM-Au8 60 mg daily (n = 61), CNM-Au8 30 mg daily (n = 59), or matching placebo (n = 41) for 24 weeks.
MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was change from baseline through week 24 in ALS disease severity measured by a bayesian shared parameter model of function (based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) and survival, which provided an estimate of the rate of disease progression measured by the disease rate ratio (DRR), with a DRR of less than 1 indicating treatment benefit. Secondary end points included a Combined Assessment of Function and Survival using a joint-rank test, rate of decline in slow vital capacity (percent predicted), and survival free of permanent assisted ventilation.
RESULTS: Among 161 participants who were randomized within the CNM-Au8 regimen (mean age, 58.4 years; 61 [37.9%] female), 145 (90%) completed the trial. In the primary analysis comparing the combined CNM-Au8 dosage groups vs the combined placebo groups, the primary end point (DRR, 0.97 [95% credible interval, 0.783-1.175]; posterior probability of DRR \u3c 1, 0.65) and the 3 secondary end points suggested no benefit or harm of CNM-Au8. In the active (n = 120) vs placebo (n = 163) groups, the most common adverse events were diarrhea (23 [19%] vs 12 [7%]), nausea (17 [14.2%] vs 14 [8.6%]), fatigue (12 [10.8%] vs 30 [18.4%]), and muscular weakness (24 [20%] vs 45 [27.6%]).
CONCLUSIONS AND RELEVANCE: No benefit of CNM-Au8 on ALS disease progression was observed at 24 weeks.
TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT04297683, NCT04414345
Differences in door-to-device times in a retrospective cohort of patients with ischemic stroke who received CTA only or CTA and CTP imaging.
No full textBackground: In the treatment of acute ischemic stroke, there are differing views about the utility of computerized tomography perfusion (CTP). Two approaches are employed depending on hospital preference. The first approach is to perform non-contrast computed tomography (CT) scans followed by vascular imaging with computed tomography angiography (CTA) for patients arriving within 6 h of last known well. In the first approach, CTP is reserved for patients who arrive 6-24 h after last known well. The second approach is to utilize both CTA and CTP regardless of the time window in which the patient presents. In this study, we sought to answer whether patients triaged with CTP and CTA had increased door-to-device times compared to those only triaged with CTA.
Methods: We investigated a retrospective cohort of 1,357 patients with ischemic stroke who received endovascular therapy (EVT) and were triaged with CTA only or CTA and CTP. Patients were stratified by when they arrived at the hospital (\u3c 6 h and 6-24 h from last known well). Linear mixed-effects models (LMM) were used to investigate the association between door-to-device times and CTA/CTP usage.
Results: Our results showed that using CTP and CTA was not associated with increased time to treat compared to CTA alone. There was no increase in time from door to device in patients presenting within 6 h. Furthermore, for patients who arrived 6-24 h of last known well, the use of CTP and CTA was associated with an accelerated time to treatment with EVT.
Conclusions: CTA and CTP usage was not associated with added time costs with respect to door-to-device in this patient cohort. Our results are consistent with other data showing that radiologists have faster read times when given both CTP and CTA. It is noteworthy that the majority of EVT patients in our dataset (70.6 %) presented in the \u3c 6-hour time window
