Category: Nevin Manimala

Pediatr Nephrol. 2023 Jul 11. doi: 10.1007/s00467-023-06055-0. Online ahead of print.

ABSTRACT

BACKGROUND: Angiotensin II type-1 receptor antibody (AT1R-Ab) has been associated with vascular injury and kidney dysfunction in pediatric kidney transplant recipients. The role of AT1R-Ab in the development of chronic kidney disease in pediatric liver and intestinal transplant recipients has not been explored.

METHODS: Twenty-five pediatric intestinal transplant recipients and 79 pediatric liver transplant recipients had AT1R-Ab levels measured at varying time points in the post-transplant period. Estimated glomerular filtration rate (eGFR) was determined using creatinine based CKiD U25 equation and measured at time of AT1R-Ab measurement, at 1 year post-AT1R-Ab measurement, at 5 years post-AT1R-Ab measurement, and at the most recent routine clinic visit. The prevalence of hypertension and antihypertensive medication use were also evaluated.

RESULTS: Younger age at time of AT1R-Ab measurement was associated with AT1R-Ab positivity in liver transplant recipients. There was no association between AT1R-Ab status and change in eGFR, prevalence of hypertension, or use of antihypertensive medications at the described time points.

CONCLUSIONS: AT1R-Ab positivity was not associated with a decline in eGFR or hypertension in pediatric liver and intestinal transplant recipients. Further studies are needed using other markers of kidney function, such as cystatin C, to validate this finding. A higher resolution version of the Graphical abstract is available as Supplementary information.

PMID:37432534 | DOI:10.1007/s00467-023-06055-0

Pediatr Surg Int. 2023 Jul 11;39(1):231. doi: 10.1007/s00383-023-05509-8.

ABSTRACT

PURPOSE: This study aimed to assess our bowel management program (BMP) and identify predictive factors for bowel control in patients with Spina Bifida (SB) and Spinal Cord Injuries (SCI). Additionally, in patients with SB, we examined the impact of fetal repair (FRG) on bowel control.

METHODS: We included all patients with SB and SCI seen in the Multidisciplinary Spinal Defects Clinic at Children’s Hospital Colorado from 2020 to 2023.

RESULTS: 336 patients included. Fecal incontinence was present in 70% and bowel control in 30%. All patients with urinary control also had bowel control. Fecal incontinence prevalence was higher in patients with ventriculoperitoneal (VP) shunt (84%), urinary incontinence (82%), and wheelchair users (79%) compared to those who did not need a VP shunt (56%), had urinary continence (0%) and non-wheelchair users (52%), respectively (p = < 0.001 in all three scenarios). After completing BMP, 90% remained clean for stool. There was no statistical significance when comparing bowel control in FRG with non-fetal repair group.

CONCLUSIONS: Urinary continence predicts bowel control in patients with SB and SCI. Risk factors for fecal incontinence were the need for a VP shunt, urinary incontinence, and wheelchair usage. We did not find any positive impact of fetal repair on bowel and urinary control.

PMID:37432519 | DOI:10.1007/s00383-023-05509-8

Rheumatol Int. 2023 Jul 11. doi: 10.1007/s00296-023-05385-4. Online ahead of print.

ABSTRACT

Calcinosis is a sequela of Juvenile Dermatomyositis (JDM) with significant morbidity. A retrospective study observing risk factors for JDM calcinosis, including a possible association between higher intensity of subcutaneous and myofascial edema in initial magnetic resonance imaging (MRI) and development of calcinosis was performed at a tertiary pediatric medical center. Data from the past 20 years on JDM patients with MRIs at the time of JDM diagnosis were obtained. MRIs were individually evaluated by two pediatric musculoskeletal radiologists who blindly graded the intensity of edema on a 0-4 Likert scale. Clinical data and edema scores were compared between patients who developed calcinosis and who did not. Forty-three patients (14 with calcinosis and 29 without calcinosis) were identified. The calcinosis group contained more racial and ethnic minorities, younger ages of JDM onset and longer time to reach JDM diagnosis. Muscle enzyme levels at JDM diagnosis were lower in the calcinosis group, especially Creatinine Kinase (CK) (p = 0.047) and Alanine Aminotransferase (ALT) (p = 0.015). The median score for edema in both groups was 3 (p = 0.39) with an inter-rater reliability of 95%. There was no association between increased subcutaneous and myofascial edema in MRIs at the time of JDM diagnosis and development of calcinosis. Earlier age of JDM onset, racial and ethnic minority, and delay in JDM diagnosis could be risks for developing calcinosis. The calcinosis group presented with lower muscle enzyme levels at the time of JDM diagnosis, especially CK and ALT with statistical significance. This could reflect delay in diagnosis and treatment.

PMID:37432516 | DOI:10.1007/s00296-023-05385-4

Clin Child Fam Psychol Rev. 2023 Jul 11. doi: 10.1007/s10567-023-00440-9. Online ahead of print.

ABSTRACT

Extant research suggests that digital stress (DS) and its various components (Hall et al. in Psychol Assess 33(3):230-242, 2021) may mediate the association between social media use and psychosocial distress among adolescents and young adults. Yet no systematic review and meta-analysis has been conducted to examine the direct associations among DS components (i.e., approval anxiety, availability stress, fear of missing out [FOMO], connection overload, and online vigilance) and psychological outcomes. Thus, we aimed to comprehensively synthesize and quantify the association between these five DS components and psychosocial distress, and to examine whether these associations were statistically different from one another. Our search of PubMed, PsycINFO, and Communication and Mass Media Complete yielded a wide range of article abstracts across the five DS components. After reviewing inclusion and exclusion criteria, 7, 73, 60, 19, and 16 studies were included for availability stress, approval anxiety, FOMO, connection overload, and online vigilance, respectively. The results suggested that all five digital stress components had significant medium association with psychosocial distress (r = .26 to .34; p < .001). Age and sex did not significantly moderate the association between most digital stress components and psychosocial distress. However, age moderated the association between connection overload and psychosocial distress. Our findings further suggested no statistical differences among the associations between the five digital stress components and psychosocial distress. Notwithstanding its limitations, our outcomes help integrate the disparate effect sizes in the literature, indicate the strength of associations, and suggest directions for clinical intervention and future research.

PMID:37432506 | DOI:10.1007/s10567-023-00440-9

Arch Orthop Trauma Surg. 2023 Jul 11. doi: 10.1007/s00402-023-04980-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Peripheral nerve blocks are frequently used in anterior cruciate ligament (ACL) reconstruction. While femoral nerve block (FNB) has been associated with knee extensor strength reduction in the early postoperative period, no consistent view of knee extensor strength several months after ACL reconstruction exists. This study aimed to compare the impact of intraoperative FNB and adductor canal block (ACB) during ACL reconstruction on knee extensor strength at 3 and 6 months postoperatively.

MATERIALS AND METHODS: This retrospective study included 108 patients divided into FNB (70 patients) and ACB (38 patients) groups based on their postoperative pain management methods. Knee joint extensor and flexor strength were measured at 3 and 6 months postoperatively, using BIODEX at angular velocities of 60°/s and 180°/s. From these results, peak torque, limb symmetry index (LSI), peak knee extensor torque (time to peak torque and angle of peak torque), hamstrings-to-quadriceps (HQ) ratio, and amount of work were computed for two-group comparison.

RESULTS: There were no statistically significant differences in peak torque, LSI of knee extensor strength, HQ ratio, and amount of work between the two groups. However, maximum knee extension torque at 60°/s occurred significantly later in the FNB than in the ACB group at 3 months postoperatively. Additionally, the LSI of the knee flexor at 6 months postoperatively was significantly lower in the ACB group.

CONCLUSIONS: In ACL reconstruction, FNB may delay the time to peak torque for knee extension at 3 months postoperatively, which is likely to improve over the treatment course. In contrast, ACB may result in unexpected loss of knee flexor strength at 6 months postoperatively and should be considered with caution.

LEVEL OF EVIDENCE: Level III.

PMID:37432497 | DOI:10.1007/s00402-023-04980-1

Stat Methods Med Res. 2023 Jul 11:9622802231184634. doi: 10.1177/09622802231184634. Online ahead of print.

ABSTRACT

Traditional methods based on the assumption that the treatment distribution is a pure shift of the control distribution may not always hold. The possibility that an individual from the treatment group may not respond to the treatment motivates the use of a mixture distribution for the treatment group. This paper considers two test procedures based on the Wilcoxon rank-sum statistic for a group sequential design to detect the one-sided mixture alternative. Error spending functions are used for the allocation of error rates at each stage. The two tests are evaluated individually in determination of critical values and arm sizes and asymptotic multivariate normality is shown to hold for both. Upon comparison, the tests are presented to be asymptotically equivalent. Both test statistics maintain the Type I error rate even if $F$ is misspecified in the design alternative. A more general definition of the treatment effect is used with the mixture distribution. Method of moments estimators and constrained $k$-means estimators for the treatment effect are evaluated.

PMID:37431736 | DOI:10.1177/09622802231184634

J Appl Clin Med Phys. 2023 Jul 11:e14093. doi: 10.1002/acm2.14093. Online ahead of print.

ABSTRACT

BACKGROUND: Dynamic tumor motion tracking is used in robotic radiosurgery for targets subject to respiratory motion, such as lung and liver cancers. Different methods of measuring tracking error have been reported, but the differences among these methods have not been studied, and the optimal method is unknown.

PURPOSE: The purpose of this study was to assess and compare tracking errors encountered with individual patients using different evaluation methods for method optimization.

METHODS: We compared the beam’s eye view (BEV), machine learning (ML), log (addition error: AE), and log (root sum square: RSS) methods. Log (AE) and log (RSS) were calculated from log files. These tracking errors were compared, and the optimal evaluation method was ascertained. A t-test was performed to evaluate statistically significant differences. Here, the significance level was set at 5%.

RESULTS: The mean values of BEV, log (AE), log (RSS), and ML were 2.87, 3.91, 2.91, and 3.74 mm, respectively. The log (AE) and ML were higher than BEV (p < 0.001), and log (RSS) was equivalent to the BEV, suggesting that the log (RSS) calculated with the log file method can substitute for the BEV calculated with the BEV method. As RSS error calculation is simpler than BEV calculation, using it may improve clinical practice throughput.

CONCLUSION: This study clarified differences among three tracking error evaluation methods for dynamic tumor tracking radiotherapy using a robotic radiosurgery system. The log (RSS) calculated by the log file method was found to be the best alternative to BEV method, as it can calculate tracking errors more easily than the BEV method.

PMID:37431706 | DOI:10.1002/acm2.14093

Pharm Stat. 2023 Jul 11. doi: 10.1002/pst.2325. Online ahead of print.

ABSTRACT

The role and value of statistical contributions in drug development up to the point of health authority approval are well understood. But health authority approval is only a true ‘win’ if the evidence enables access and adoption into clinical practice. In today’s complex and evolving healthcare environment, there is additional strategic evidence generation, communication, and decision support that can benefit from statistical contributions. In this article, we describe the history of medical affairs in the context of drug development, the factors driving post-approval evidence generation needs, and the opportunities for statisticians to optimize evidence generation for stakeholders beyond health authorities in order to ensure that new medicines reach appropriate patients.

PMID:37431704 | DOI:10.1002/pst.2325

Hypertension. 2023 Jul 11. doi: 10.1161/HYPERTENSIONAHA.122.20361. Online ahead of print.

ABSTRACT

BACKGROUND: Early delivery in preterm preeclampsia may reduce the risks for the patient, but consequences of prematurity may be substantial for the baby. This trial evaluated whether the implementation of a risk stratification model could safely reduce prematurity.

METHODS: This was a stepped-wedge cluster-randomized trial in seven clusters. Patients presenting with suspected or confirmed preeclampsia between 20⁺⁰ and 36⁺⁶ gestational weeks were considered eligible. At the start of the trial, all centers were allocated in the preintervention phase, and patients enrolled in this phase were managed according to local treatment guidance. Subsequently, every 4 months, 1 randomly allocated cluster transitioned to the intervention. Patients enrolled in the intervention phase had sFlt-1 (soluble fms-like tyrosine kinase-1)/PlGF (placental growth factor) ratio and preeclampsia integrated estimate of risk assessments performed. If sFlt-1/PlGF ≤38 and preeclampsia integrated estimate of risk <10%, patients were considered low risk and clinicians received recommendations to defer delivery. If sFlt-1/PlGF >38 and preeclampsia integrated estimate of risk ≥10%, patients were considered not low risk, and clinicians received recommendations to increase surveillance. The primary outcome was the proportion of patients with preterm preeclampsia delivered prematurely out of total deliveries.

RESULTS: Between March 25, 2017 and December 24, 2019, 586 and 563 patients were analyzed in the intervention and usual care groups, respectively. The event rate was 1.09% in the intervention group, and 1.37% in the usual care group. After prespecified adjustments for variation between and within clusters over time, the adjusted risk ratio was 1.45 ([95% CI, 1.04-2.02]; P=0.029), indicating a higher risk of preterm deliveries in the intervention group. Post hoc analysis including calculation of risk differences did not show evidence of statistical differences. Abnormal sFlt-1/PlGF was associated with a higher rate of identifying preeclampsia with severe features.

CONCLUSIONS: The introduction of an intervention based on biomarkers and clinical factors for risk stratification did not lead to reductions in preterm deliveries. Further training on the interpretation of disease severity in preeclampsia and the development of additional risk stratification is needed before adoption into clinical practice.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT03073317.

PMID:37431663 | DOI:10.1161/HYPERTENSIONAHA.122.20361

Nucl Med Rev Cent East Eur. 2023;26(0):85-95. doi: 10.5603/NMR.2023.0011.

ABSTRACT

INTRODUCTION: Nuclear medicine (NM) methods play an important role in the evaluation of renal function in a wide range of clinical indications. The aim of our study was to evaluate the correlation between measured GFR (mGFR) obtained by the three-plasma sample slope-intercept NM method (TPSM) – reference method vs. estimated GFR (eGFR) using Fleming’s single plasma sample method (SPSM) at 120 min, 180 min, and 240 min and correlation of reference method with eGFR with camera-based Gates’ protocol.

MATERIAL AND METHODS: A total of 82 subjects (33 male/49 female) with a mean age of 54.87 ± 15.65 years were included and mGFR value was obtained by the three-plasma sample slope-intercept NM method and eGFR was obtained with Fleming’s single sample method. eGFR was also quantified with the camera-based Gates’ protocol after i.v. application of [99mTc]Tc-DTPA.

RESULTS: Our study revealed a very strong positive significant correlation between all three SPSMs with the TPSM as the reference method. Between the Gates’ method and the TPSM in the group of patients with mGFR ≥ 61-84 mL/min/1.73 m2 and mGFR ≥ 84 mL/min/1.73 m2, a moderate positive statistically significant correlation was obtained.

CONCLUSIONS: The SPSM method shows a very strong correlation with the reference and low bias in all three groups of patients and can be routinely used for GFR estimation.

PMID:37431648 | DOI:10.5603/NMR.2023.0011