Race-based reporting and participation of Black individuals in registered pain clinical trials, United States, 2000 to 2019.

ABSTRACT: There are numerous, well-established racial disparities in the management of pain. The degree to which these are evident at the stage of conducting clinical trials is unknown. To address this knowledge gap, we examined race-based reporting, participation of Black individuals, and the factors associated with reporting and participation in pain clinical trials in the United States. Data were extracted from Clinicaltrials.gov and published articles. One thousand two hundred trials met our inclusion criteria; 482 (40.2%) reported participant race. More recent, publicly funded, and larger trials were more likely to report race. Of 82,468 participants included in pain clinical trials that reported race, 15,101 were Black individuals (18.3%). Participation of Black individuals was significantly associated with pain type (ß = +27% in cardiovascular disease pain compared with acute pain, P < 0.05), study population (ß = +33% and +7% in pain in minoritized populations and women, respectively, compared with general population, P < 0.05), pain intervention (ß = +7.5% for trials of opioid interventions compared with nonopioid interventions, P < 0.05), and a diverse team of investigators (ß = +8.0% for studies incorporating a visible non-White investigator compared with those that did not, P < 0.05). Our results indicate that representation of Black participants in pain clinical trials generally aligns with national demographics in the United States. Increased representation corresponds with health conditions more prevalent among Black individuals (eg, cardiovascular disease) and with a diverse study team composition. Despite these encouraging results, less than half of pain trials reported race, which introduces potential publication bias and limits external validity.

A numerical study on the ship-bank interaction at various water depths of a surface ship.

Ship maneuvering in restricted waters is a significant challenge in navigation safety due to the complex flow around the ship. In particular, when a ship travels close to a lateral bank and shallow water, the hydrodynamic interaction forces significantly influence the maneuvering motion of the ship. Maneuverability in restricted water is even more difficult for an autonomous surface ship. Therefore, it is necessary to assess the effects of maneuvering near a bank and in shallow water for an autonomous surface ship. In this study, maneuvering simulations considering the bank effect at various water depths are implemented based on hydrodynamic forces estimated using computational fluid dynamics simulation. First, virtual captive model tests at various water depths and simulations of various lateral distances to the banks are performed to estimate the hydrodynamic forces using computational fluid dynamics simulation. The simulation method is validated by comparing the simulation results of the static drift test in deep water with the measured one in the experimental method. Second, the maneuvering simulations for the turning circle test and zig-zag test at various water depths are conducted using the obtained hydrodynamic coefficients. Then, the maneuvering simulations in deep water are compared with the experiment results, and a good agreement is observed. Finally, the simulation considering the bank effects at various water depths is evaluated and discussed.

Motor Recovery Depends on Timing of Surgery in Patients With Lumbar Disk Herniation.

BACKGROUND: Although approximately half of the patients undergoing lumbar disk surgery present with motor deficits, timing of surgery for radicular weakness is largely unclear. OBJECTIVE: To evaluate the impact of surgical timing on motor recovery in patients with lumbar disk herniation (LDH) and to identify an ideal time window for intervention. METHODS: In a single-center observational trial, 390 patients with LDH-associated motor deficits were prospectively followed for a minimum of 12 months after nonelective microscopic disk surgery. The duration of motor deficit before surgery was documented. Motor function was graded according to the Medical Research Council (MRC) scale. Statistical analysis of motor recovery applied unbiased recursive partitioning conditional inference tree to determine cutoff times for optimal surgical intervention. The slope of recovery calculated as the change of the MRC grade over time served as the primary outcome. RESULTS: A preoperative motor deficit of MRC ≤2/5 and the duration of paresis were identified as the most important predictors of recovery ( P < .001). Surgery within 3 days was associated with a better recovery for both severe and moderate/mild deficits ( P = .017 for MRC ≤ 2/5; P < .001 for MRC > 2/5; number needed to treat [NNT] <2). A sensitivity analysis in mild motor deficits indicated a cutoff of 8 days. CONCLUSION: Timing of surgery is crucial for motor recovery in LDH-associated deficits. Immediate diagnosis, imaging, and referral should be aimed for to allow disk surgery within 3 days in patients with severe and moderate radicular weakness. If functionally disabling, even mild deficits may warrant decompression within a week.

Natural Progression of Routine Laboratory Markers after Spinal Trauma: A Longitudinal, Multi-Cohort Study.

Our objective was to track and quantify the natural course of serological markers over the 1st year following spinal cord injury. For that purpose, data on serological markers, demographics, and injury characteristics were extracted from medical records of a clinical trial (Sygen) and an ongoing observational cohort study (Murnau study). The primary outcomes were concentration/levels/amount of commonly collected serological markers at multiple time points. Two-way analysis of variance (ANOVA) and mixed-effects regression techniques were used to account for the longitudinal data and adjust for potential confounders. Trajectories of serological markers contained in both data sources were compared using the slope of progression. Our results show that, at baseline (≤ 2 weeks post-injury), most serological markers were at pathological levels, but returned to normal values over the course of 6-12 months post-injury. The baseline levels and longitudinal trajectories were dependent on injury severity. More complete injuries were associated with more pathological values (e.g., hematocrit, ANOVA test; χ2 = 68.93, df = 3, adjusted p value <0.001, and χ2 = 73.80, df = 3, adjusted p value <0.001, in the Sygen and Murnau studies, respectively). Comparing the two databases revealed some differences in the serological markers, which are likely attributable to differences in study design, sample size, and standard of care. We conclude that because of trauma-induced physiological perturbations, serological markers undergo marked changes over the course of recovery, from initial pathological levels that normalize within a year. The findings from this study are important, as they provide a benchmark for clinical decision making and prospective clinical trials. All results can be interactively explored on the Haemosurveillance web site (https://jutzelec.shinyapps.io/Haemosurveillance/) and GitHub repository (https://github.com/jutzca/Systemic-effects-of-Spinal-Cord-Injury).

Routine Blood Chemistry Predicts Functional Recovery After Traumatic Spinal Cord Injury: A Post Hoc Analysis.

BACKGROUND: Spinal cord injury (SCI) leads to various degrees of lifelong functional deficits. Most individuals with incomplete SCI experience a certain degree of functional recovery, especially within the first-year postinjury. However, this is difficult to predict, and surrogate biomarkers are urgently needed. OBJECTIVE: We aimed to (1) determine if routine blood chemistry parameters are related to neurological recovery after SCI, (2) evaluate if such parameters could predict functional recovery, and (3) establish cutoff values that could inform clinical decision-making. METHODS: We performed a post hoc analysis of routine blood chemistry parameters in patients with traumatic SCI (n = 676). Blood samples were collected between 24 and 72 hours as well as at 1, 2, 4, 8, and 52 weeks postinjury. Linear mixed models, regression analysis, and unbiased recursive partitioning (URP) of blood chemistry data were used to relate to and predict walking recovery 1 year postinjury. RESULTS: The temporal profile of platelet counts and serum levels of albumin, alkaline phosphatase, and creatinine differentiated patients who recovered walking from those who remained wheelchair bound. The 4 blood chemistry parameters from the sample collection 8 weeks postinjury predicted functional recovery observed 1 year after incomplete SCI. Finally, URP defined a cutoff for serum albumin at 3.7 g/dL, which in combination with baseline injury severity differentiates individuals who regain ambulation from those not able to walk. Specifically, about 80% of those with albumin >3.7 g/dL recovered walking. CONCLUSIONS: Routine blood chemistry data from the postacute phase, together with baseline injury severity, predict functional outcome after incomplete SCI.