Category: Statistics

Paediatr Anaesth. 2021 Aug 7. doi: 10.1111/pan.14269. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Previous blood product exposures may result in the development of antibodies to human leukocyte antigens (HLA). Pediatric heart transplant recipients who have these antibodies experience increased morbidity and mortality after transplantation. In this study, our aims were to confirm the association of previous allogeneic blood product exposures with the formation of anti-HLA antibodies, determine which blood components pose the greatest risk of developing antibodies, and assess differences in outcomes after transplantation between patients who had anti-HLA antibodies and those who did not.

METHODS: This retrospective investigation included all children who underwent cardiac transplantation at Children’s Healthcare of Atlanta from January 1, 2015, through December 31, 2018. Chart reviews were performed to collect pertinent data. Anti-HLA antibodies were detected by single antigen bead testing. Antibody burden was tabulated using the calculated panel reactive antibody (cPRA) score immediately prior to transplantation. Statistical analyses were conducted to examine differences based on HLA antibody status and identify associations with outcomes of interest.

RESULTS: Our results show a significant association between pre-transplant blood product exposures and HLA antibody status. Children with a pre-transplant blood product exposure had 7.98 times the odds of developing an anti-HLA antibody compared to those without a pre-transplant blood product exposure (p=0.01). We also found a significant association between a previous red blood cell (RBC) exposure and HLA antibody status (p=0.01) which was not found for other blood component exposures. Patients who were HLA antibody positive were more likely to develop a donor specific antibody (DSA) after transplantation (p=0.04).

CONCLUSIONS: Exposure to previous allogeneic blood products affects the development of anti-HLA antibodies in children presenting for heart transplantation. Previous RBC exposures resulted in HLA antibody positivity more than other blood component exposures. Importantly, the presence of HLA antibodies was associated with the development of DSAs post-transplantation. Developing transfusion strategies to reduce allogeneic blood product exposures in children who may need future cardiac transplantation should be a high priority.

PMID:34363427 | DOI:10.1111/pan.14269

Electrophoresis. 2021 Aug 7. doi: 10.1002/elps.202100098. Online ahead of print.

ABSTRACT

Electrokinetic micro peristaltic pumps are important biomechanical devices that help in targeted drugging of sick body parts. The current article is written to focus on mathematical modelling and analysis of some important aspect of such flows in a rectangular duct with wall properties. Effects of zeta potential, heat source and deby length are focused. Carbon nanotubes (CNTs) in the Newtonian base fluid is assumed as drugging material. A comparison of single-walled CNTs (SWCNTs) and multiwalled CNTs (MWCNTs) is also presented. It is considered that the walls are flexible and encapsulating the region with limited permeability. The defined flow problem is modelled and analyzed analytically for the transport of CNT-water nanofluid. It is accepted that the flow is steady, nonturbulent and propagating waves do have a considerably longer wavelength when compared to amplitude. The conditions and assumptions lead to a model of coupled partial differential equations of order two. The exact results by Eigenfunction expansion method are procured and shown accordingly. The predictions about the behaviour of important appearing parameters are displayed for SWCNT and MWCNT -water nanofluid behaviour using figures. The impact of sundry parameters is analyzed. The application of the current study involved transporting/ targeted drug delivery system using Peristaltic micropumps and magnetic field in pharmacological engineering. This article is protected by copyright. All rights reserved.

PMID:34363409 | DOI:10.1002/elps.202100098

Mov Disord. 2021 Aug 7. doi: 10.1002/mds.28738. Online ahead of print.

ABSTRACT

BACKGROUND: Objective diagnostic biomarkers are needed to support a clinical diagnosis.

OBJECTIVES: To analyze markers in various neurodegenerative disorders to identify diagnostic biomarker candidates for mainly α-synuclein (aSyn)-related disorders (ASRD) in serum and/or cerebrospinal fluid (CSF).

METHODS: Upon initial testing of commercially available kits or published protocols for the quantification of the candidate markers, assays for the following were selected: total and phosphorylated aSyn (pS129aSyn), neurofilament light chain (NfL), phosphorylated neurofilament heavy chain (pNfH), tau protein (tau), ubiquitin C-terminal hydrolase L1 (UCHL-1), glial fibrillary acidic protein (GFAP), calcium-binding protein B (S100B), soluble triggering receptor expressed on myeloid cells 2 (sTREM-2), and chitinase-3-like protein 1 (YKL-40). The cohort comprised participants with Parkinson’s disease (PD, n = 151), multiple system atrophy (MSA, n = 17), dementia with Lewy bodies (DLB, n = 45), tau protein-related neurodegenerative disorders (n = 80, comprising patients with progressive supranuclear palsy (PSP, n = 38), corticobasal syndrome (CBS, n = 16), Alzheimer’s disease (AD, n = 11), and frontotemporal degeneration/amyotrophic lateral sclerosis (FTD/ALS, n = 15), as well as healthy controls (HC, n = 20). Receiver operating curves (ROC) with area under the curves (AUC) are given for each marker.

RESULTS: CSF total aSyn was decreased. NfL, pNfH, UCHL-1, GFAP, S100B, and sTREM-2 were increased in patients with neurodegenerative disease versus HC (P < 0.05). As expected, some of the markers were highest in AD (i.e., UCHL-1, GFAP, S100B, sTREM-2, YKL-40). Within ASRD, CSF NfL levels were higher in MSA than PD and DLB (P < 0.05). Comparing PD to HC, interesting serum markers were S100B (AUC: 0.86), sTREM2 (AUC: 0.87), and NfL (AUC: 0.78). CSF S100B and serum GFAP were highest in DLB.

CONCLUSIONS: Levels of most marker candidates tested in serum and CSF significantly differed between disease groups and HC. In the stratification of PD versus other tau- or aSyn-related conditions, CSF NfL levels best discriminated PD and MSA. CSF S100B and serum GFAP best discriminated PD and DLB. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson Movement Disorder Society.

PMID:34363416 | DOI:10.1002/mds.28738

Am J Ind Med. 2021 Aug 6. doi: 10.1002/ajim.23282. Online ahead of print.

ABSTRACT

BACKGROUND: Exoskeleton (EXO) technologies are a promising ergonomic intervention to reduce the risk of work-related musculoskeletal disorders, with efficacy supported by laboratory- and field-based studies. However, there is a lack of field-based evidence on long-term effects of EXO use on physical demands.

METHODS: A longitudinal, controlled research design was used to examine the effects of arm-support exoskeleton (ASE) use on perceived physical demands during overhead work at nine automotive manufacturing facilities. Data were collected at five milestones (baseline and at 1, 6, 12, and 18 months) using questionnaires. Linear mixed models were used to understand the effects of ASE use on perceived work intensity and musculoskeletal discomfort (MSD). Analyses were based on a total of 41 participants in the EXO group and 83 in a control group.

RESULTS: Across facilities, perceived work intensity and MSD scores did not differ significantly between the EXO and control groups. In some facilities, however, neck and shoulder MSD scores in the EXO group decreased over time. Wrist MSD scores in the EXO group in some facilities remained unchanged, while those scores increased in the control group overtime. Upper arm and low back MSD scores were comparable between the experimental groups.

CONCLUSION: Longitudinal effects of ASE use on perceived physical demands were not found, though some suggestive results were evident. This lack of consistent findings is discussed, particularly supporting the need for systematic and evidence-based ASE implementation approaches in the field that can guide the optimal selection of a job for ASE use.

PMID:34363229 | DOI:10.1002/ajim.23282

J Clin Ultrasound. 2021 Aug 6. doi: 10.1002/jcu.23052. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to evaluate whether corpus callosum length (CCL), corpus callosum-fastigium length (CCFL) and the angle between CCL-CCFL (CCFA) were altered in growth-restricted fetuses.

METHODS: This prospective case-control study was conducted in a tertiary center. A total of 80 singleton fetuses were included in the study, classified as 36 late-onset growth-restricted fetuses and 44 adequate-for-gestational-age fetuses. All biometric measurements and Doppler assessments of umbilical artery, middle cerebral artery, and ductus venosus were performed via the trans-abdominal route. CCL, CCLF, and CCFA were assessed via the trans-vaginal route.

RESULTS: Late-onset growth-restricted fetuses showed significantly reduced CCL and CCFL. There was no statistically significant differences in terms of CCFA. Moderate-high correlations between CCL and biparietal diameter, head circumference, abdominal circumference, FL and gestational age were detected (r: 0.482 p: 0.000; r: 0.537 p: 0.000; r: 0.488 p: 0.000; r: 0.519 p: 0.000; and r: 0.472 p: 0.000, respectively).

CONCLUSION: This study adds to the literature that CCFA has not changed despite the decrease in CCL and CCFL in late-onset fetal growth restriction that might be a result of the redistribution of cerebral blood flow. To clarify the prognostic implications of these results in terms of neural and cognitive functions in postnatal life, there is a need for larger prospective studies.

PMID:34363232 | DOI:10.1002/jcu.23052

Acta Paediatr. 2021 Aug 7. doi: 10.1111/apa.16062. Online ahead of print.

ABSTRACT

AIM: This study examined the associations between prenatal smoking and speech and language, scholastic, coordination and mixed developmental disorders in offspring, using sibling and population controls.

METHODS: National Finnish registers were used to identify all 690,654 singletons born between 1996-2007 and any cases diagnosed with speech and language, scholastic, coordination and mixed developmental disorders by the end of 2012. Cases were compared to population controls, biological full-siblings and maternal half-siblings born during the same period. Conditional logistic regression was used to assess any associations between smoking during pregnancy and the selected developmental disorders.

RESULTS: Prenatal smoking was higher in the mothers of the 27,297 cases (21.7%) than the 99,876 population controls (14.5%). The adjusted odds ratio for smoking throughout pregnancy, and any diagnosis of speech and language, scholastic, coordination or mixed developmental disorders, was 1.29 (95% confidence interval 1.24-1.34). However, when we compared a subsample of 15,406 cases and their 20,657 siblings, the association was no longer statistically significant (odds ratio 1.09, 95% confidence interval 0.98-1.21).

CONCLUSION: The sibling comparisons suggested that the associations between prenatal smoking and speech and language, scholastic, coordination and mixed developmental disorders were confounded by familial factors shared by differentially exposed siblings.

PMID:34363238 | DOI:10.1111/apa.16062

Reprod Sci. 2021 Aug 6. doi: 10.1007/s43032-021-00705-0. Online ahead of print.

ABSTRACT

The Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant) Trial (clinicaltrials.gov no. NCT04173169) was designed to test the hypothesis that 60-day pre-treatment with an oral GnRH antagonist in women with documented endometriosis and planning an IVF cycle will result in a superior live birth rate to placebo. Eight hundred fourteen women are required from 4 national sites. To determine the feasibility of using an electronic medical record (EMR)-based strategy to recruit 204 participants at the Colorado site, we conducted a survey of women within the UCHealth system. Eligible women, identified using relevant ICD-10 codes, were invited to complete a 6-question survey to assess planned utilization of IVF, potential interest in participation, and whether delays in treatment due to COVID-19 would influence their decision to participate. Of 6354 age-eligible women with an endometriosis diagnosis, 421 had a concurrent infertility diagnosis. After eliminating duplicates, 212 were emailed a survey; 76 (36%) responded, 6 of whom reported no endometriosis diagnosis. Of the remaining 70, 29 (41%) were planning fertility treatment; only 19 planned IVF. All 19 expressed interest in participation. COVID-19 delays in treatment were not considered as a factor affecting participation by 8/19; the remaining 11 felt that it would “somewhat” affect their decision. None reported that they would not consider participation because of COVID-19. EMR-based recruitment for an endometriosis clinical trial is feasible although the overall yield of participants is low. Delays in treatment due to COVID-19 did not appear to overly influence potential recruitment.

PMID:34363198 | DOI:10.1007/s43032-021-00705-0

Acta Anaesthesiol Scand. 2021 Aug 7. doi: 10.1111/aas.13966. Online ahead of print.

ABSTRACT

BACKGROUND: Hip fracture is a common osteoporotic fracture with great morbidity and mortality. The utility of ASA classification is limited, as most patients are ≥ ASA 3. A reliable predictor of mortality risk could support decision-making. We aimed to evaluate Nottingham hip fracture score (NHFS) for the prediction of 30-day mortality and then to recalibrate the formula converting NHFS to risk of 30-day mortality.

METHODS: All patients > 60 years with surgically treated hip fracture surgery during 2015-16 were assessed. Data was extracted manually from routinely collected clinical data in registry and medical records. Discriminative performance of NHFS and ASA was assessed with C-statistics. The conversion formula from NHFS to risk of 30-day mortality was recalibrated using logistic binominal regression. Observed vs expected ratios of 30-day mortality were compared with the 2012 NHFS-formula and recalibration was performed in a split dataset.

RESULTS: 1864 patients were included, with 213 deaths within 30 days. C-statistic were 0.64 for NHFS and 0.62 for ASA. Comparing expected values from the 2012-revision with our observed deaths gave a ratio of 1.37. Relating predicted levels of 30-day mortality based on 70% of our cohort vs 30% test portion of our Swedish dataset gave a ratio of 0.97.

DISCUSSION: NHFS underestimated mortality in our cohort and showed poor discrimination. Revision of the formula based on a split dataset improved calibration. We suggest NHFS to be routinely implemented to support clinical judgements, expand preoperative assessment and escalate intraoperative monitoring.

PMID:34363201 | DOI:10.1111/aas.13966

Int J Clin Pharm. 2021 Aug 6. doi: 10.1007/s11096-021-01314-2. Online ahead of print.

ABSTRACT

Background The American Diabetes Association recommends basal insulin or basal plus correctional insulin regimen for non-critically ill patients with type 2 diabetes mellitus unable to eat. There is limited evidence available examining ideal basal insulin dose reductions in this patient population. Aim This study aimed to determine the percent reduction of maintenance basal insulin that would provide the least hypoglycemic incidence in patients with type 2 diabetes mellitus in the non-intensive care unit setting. Methods This retrospective cohort study evaluated adult patients with type 2 diabetes mellitus prescribed outpatient basal insulin with a minimum unable to eat status of two hours. Patients were divided into four groups; <25%, 25-50%, 51-75%, > 75% of basal insulin administered compared to home dose. The primary endpoint was the incidence of hypoglycemia while unable to eat. Secondary endpoints included incidence of hyperglycemia, severe hypoglycemia, median daily blood glucose and hospital length of stay. Results A total of 173 patients were included. The primary outcome of hypoglycemia (5.9% vs. 8.8% vs. 14.3% vs. 12.3%; P = 0.578) was similar in all groups. There were no differences in hyperglycemia (P = 0.0701), severe hypoglycemia (P = 0.578) and median daily blood glucose (P = 0.428). Patients receiving 25-50% of home basal insulin had the longest unable to eat duration (11.5 h; P = 0.026); however, this was not statistically significant when adjusted using the Bonferroni correction for multiple tests. Conclusions No differences were observed in hypoglycemic events for patients unable to eat receiving various basal insulin dose reductions.

PMID:34363191 | DOI:10.1007/s11096-021-01314-2

Int J Clin Pharm. 2021 Aug 7. doi: 10.1007/s11096-021-01310-6. Online ahead of print.

ABSTRACT

Background Intravenous admixture preparation errors (IAPEs) may lead to patient harm. Insight into the prevalence as well as the determinants associated with these IAPEs is needed to elicit preventive measures. Aim The primary aim of this study was to assess the prevalence of IAPEs. Secondary aims were to identify the type, severity, and determinants of IAPEs. Method A prospective observational study was performed in a Dutch university hospital. IAPE data were collected by disguised observation. The primary outcome was the proportion of admixtures with one or more IAPEs. Descriptive statistics were used for the prevalence, type, and severity of IAPEs. Mixed-effects logistic regression analyses were used to estimate the determinants of IAPEs. Results A total of 533 IAPEs occurred in 367 of 614 admixtures (59.8%) prepared by nursing staff. The most prevalent errors were wrong preparation technique (n = 257) and wrong volume of infusion fluid (n = 107). Fifty-nine IAPEs (11.1%) were potentially harmful. The following variables were associated with IAPEs: multistep versus single-step preparations (adjusted odds ratio [OR_adj] 4.08, 95% confidence interval [CI] 2.27-7.35); interruption versus no interruption (OR_adj 2.32, CI 1.13-4.74); weekend versus weekdays (OR_adj 2.12, CI 1.14-3.95); time window 2 p.m.-6 p.m. versus 7 a.m.-10 a.m. (OR_adj 3.38, CI 1.60-7.15); and paediatric versus adult wards (OR_adj 0.14, CI 0.06-0.37). Conclusion IAPEs, including harmful IAPEs, occurred frequently. The determinants associated with IAPEs point to factors associated with preparation complexity and working conditions. Strategies to reduce the occurrence of IAPEs and therefore patient harm should target the identified determinants.

PMID:34363192 | DOI:10.1007/s11096-021-01310-6