Category: Statistics

Urologia. 2023 Dec 2:3915603231216141. doi: 10.1177/03915603231216141. Online ahead of print.

ABSTRACT

INTRODUCTION: The presence of ureteral stones can cause pain, infections of urinary tract and hydronephrosis, resulting in the loss of renal function. For two decades, Ureteroscopy and laser stone fragmentation (URSL) attained a big rise and is the first line management for large ureteric stones and renal stones up to 2 cm. The present study was conducted to assess the success rate of ureteroscopic lithotripsy in treatment of ureteric calculus after local administration of aminophylline.

MATERIALS AND METHODS: 100 patients having ureteric calculi <20 mm in size, aged 20-60 years were included in the study and randomly divided into Group A (n = 50) with administration of local aminophylline and Group B (n = 50) with administration of saline infusion. Ureteroscopy was performed after 5 min of administration of the solution. URSL was done using pneumatic lithoclast and/or laser. Various parameters like duration of procedure, ease of ureteral access, requirement of DJ Stent and need of further operative interventions were compared between case and control groups. The data was collected and then subjected to statistical analysis using IBM SPSS 20.0 version at significance level of p < 0.05.

RESULTS: The mean age of study subjects having ureteral stones was found to be between 31 and 40 years of age with males being more affected. We observed less mean duration of surgery, higher success rate, easy ureteral access (p-value < 0.05) with aminophylline use than control group. The need of ureteral stent and Auxiliary procedures was significantly higher in the control than in the case group (38%).

CONCLUSION: The use of aminophylline has been found to be highly useful and effective in reducing the need of stents and secondary surgery, decreased pain, and increased success rate. Thus, the use of aminophylline is recommended during URSL procedure for the successful management of ureteral calculi.

PMID:38041571 | DOI:10.1177/03915603231216141

Epilepsia. 2023 Dec 2. doi: 10.1111/epi.17844. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this study was to identify risk factors associated with surgery-related neurological morbidity in patients with drug-resistant epilepsy undergoing supra-sylvian operculo-insular resections. As secondary outcomes, we also analyzed the risk factors for ischemic lesions (IL) of corona radiata and seizure recurrence.

METHODS: A retrospective analysis was conducted on a cohort of patients underwent supra-sylvian operculo-insular resections for drug-resistant epilepsy. The association of several presurgical, surgical and post-surgical factors with both primary (persistent neurological deficits) and secondary (structural abnormalities on postoperative MR imaging and seizure recurrence) postoperative outcomes, were investigated with univariate and multivariate statistical analysis.

RESULTS: The study included a total of 65 patients. 46.2% of patients exhibited postoperative neurological deficits only 12.3% experienced persistent deficits. On postoperative MRI, IL in the corona radiata and cortico-spinal tract Wallerian degeneration (CSTWd) were seen in 68% and 29% of cases, respectively. Only CSTWd was significantly associated with persistent neurological deficits (RR 2.6). Combined operculo-insular resection (RR 3.62) and surgery performed on left hemisphere (RR 0.37) were independently associated with IL in the corona radiata. Variables independently associated with CSTWd were the presence of malacic components in the IL (RR 1.96), right central operculum resection (RR 1.79) and increasing age at surgery (RR 1.03). Sixty-two patients had a postoperative follow-up >12 months [median 56 (IQR 30.75-73.5)] and 62.9% were in Engel’s class I at last outpatient control. The risk of seizure recurrence was reduced by selective opercular resection (RR 0.25) and increased by the histological diagnosis of aspecific gliosis (RR 1.39).

SIGNIFICANCE: This study provides insights into the risk factors associated with surgery-related neurological morbidity, as well as further evidence on the postoperative occurrence of subcortical injury and seizure recurrence in epileptic patients undergoing supra-sylvian operculo-insular resections. The findings highlighted in this study may be useful to better understand the processes supporting the increased surgical risk in the operculo-insular region.

PMID:38041557 | DOI:10.1111/epi.17844

J Eur Acad Dermatol Venereol. 2023 Dec 2. doi: 10.1111/jdv.19669. Online ahead of print.

ABSTRACT

BACKGROUND: Baricitinib treatment in adults with moderate-to-severe atopic dermatitis (AD) has demonstrated rapid improvements in itch as well as AD sign severity and affected body surface area as assessed by the Eczema Area and Severity Index (EASI) total score, whether administered as monotherapy or in combination with topical corticosteroids (TCS). As EASI clinical signs differ in time course and associated antecedents, the effects of baricitinib on each individual clinical sign are of interest.

OBJECTIVES: In this post hoc analysis, we aimed to investigate the effects of baricitinib on individual EASI subscores, namely excoriation, oedema/papulation, erythema and lichenification, in both monotherapy and TCS combination therapy trials.

METHODS: We analysed the percent change from baseline in individual EASI subscores from three phase-III, double-blind, 16-week trials of baricitinib in monotherapy (BREEZE-AD1/BREEZE-AD2) and TCS combination therapy (BREEZE-AD7) cohorts via mixed model repeated measures (MMRM).

RESULTS: Baricitinib 4 mg showed rapid and sustained improvements in all four clinical signs in both cohorts. Significant effects emerged at week 1 for excoriation, oedema/papulation and erythema scores in monotherapy (p < 0.001) and TCS combination therapy (p < 0.001, p < 0.01, p < 0.001), plateaued at week 4, and remained significant versus placebo through week 16. The effect on lichenification scores also emerged early, at week 1 in monotherapy (p < 0.05) and week 2 in combination therapy (p < 0.001), with scores continuously improving without a clear plateau. Effect magnitude was highest in excoriation scores, exhibiting near-maximal reduction in week 1 of monotherapy and remaining highest across all timepoints in combination therapy.

CONCLUSIONS: Rapid and sustained improvements were observed across clinical signs of inflammation and particularly on excoriation following baricitinib treatment. Our findings suggest that selective inhibition of janus kinases 1 and 2 leads to rapid and sustained control of skin inflammation, and that rapid reductions in itch translate into early disruption of the itch-scratch cycle.

PMID:38041556 | DOI:10.1111/jdv.19669

Mol Ecol Resour. 2023 Dec 2. doi: 10.1111/1755-0998.13898. Online ahead of print.

ABSTRACT

Testing the association between objects is central in ecology, evolution, and quantitative sciences in general. Two types of variables can describe the relationships between objects: point variables (measured on individual objects), and distance variables (measured between pairs of objects). The Mantel test and derived methods have been extensively used for distance variables. Yet, these methods have been criticized due to low statistical power and inflated type I error when spatial autocorrelation is present. Here, we assessed the statistical power between different types of tested variables and the type I error rate over a wider range of autocorrelation intensities than previously assessed, both on univariate and multivariate data. We also illustrated the performance of distance matrix statistics through computational simulations of genetic diversity. We show that the Mantel test and derived methods are not affected by inflated type I error when spatial autocorrelation affects only one variable when investigating correlations, or when either the response or the explanatory variable(s) is affected by spatial autocorrelation while investigating causal relationships. As previously noted, with autocorrelation affecting more variables, inflated type I error could be reduced by modifying the significance threshold. Additionally, the Mantel test has no problem of statistical power when the hypothesis is formulated in terms of distance variables. We highlight that transformation of variable types should be avoided because of the potential information loss and modification of the tested hypothesis. We propose a set of guidelines to help choose the appropriate method according to the type of variables and defined hypothesis.

PMID:38041538 | DOI:10.1111/1755-0998.13898

Brain Behav. 2023 Dec 2:e3334. doi: 10.1002/brb3.3334. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose of the study is to investigate, by T2 relaxation, non-lesional white matter (WM) in relapsing-remitting (RR) multiple sclerosis (MS).

METHODS: Twenty stable RR MS patients underwent 1.5T Magnetic Resonance Imaging (MRI) with 3D Fluid-Attenuated Inversion-Recovery (FLAIR), 3D-T1-weighted, and T2-relaxation multi-echo sequences. The Lesion Segmentation Tool processed FLAIR images to identify focal lesions (FLs), whereas T1 images were segmented to identify WM and FL sub-volumes with T1 hypo-intensity. Non-lesional WM was obtained as the segmented WM, excluding FL volumes. The multi-echo sequence allowed decomposition into myelin water, intra-extracellular water, and free water (Fw), which were evaluated on the segmented non-lesional WM. Correlation analysis was performed between the non-lesional WM relaxation parameters and Expanded Disability Status Scale (EDSS), disease duration, patient age, and T1 hypo-intense FL volumes.

RESULTS: The T1 hypo-intense FL volumes correlated with EDSS. On the non-lesional WM, the median Fw correlated with EDSS, disease duration, age, and T1 hypo-intense FL volumes. Bivariate EDSS correlation of FL volumes and WM T2-relaxation parameters did not improve significance.

CONCLUSION: T2 relaxation allowed identifying subtle WM alterations, which significantly correlated with EDSS, disease duration, and age but do not seem to be EDSS-predictors independent from FL sub-volumes in stable RR patients. Particularly, the increase in the Fw component is suggestive of an uninvestigated prodromal phenomenon in brain degeneration.

PMID:38041516 | DOI:10.1002/brb3.3334

ACR Open Rheumatol. 2023 Dec 1. doi: 10.1002/acr2.11622. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess tofacitinib and self-injectable tumor necrosis factor inhibitor (TNFi) adherence using the Medication Event Monitoring System (MEMS) and characterize association with adherence in patients with rheumatoid arthritis (RA).

METHODS: Eligible patients were enrolled from the Forward Databank within 6 months of initiating tofacitinib or injectable TNFi or from participating clinics where these were first prescribed. MEMS caps and patient diaries were used to compile dosing over 9 months. Demographics and disease characteristics were collected every 6 months, and the Beliefs about Medicines Questionnaire only at baseline. Adherence along with its components, initiation, implementation, and persistence, were calculated.

RESULTS: Of the 112 consented to participate, 82 (73%) remained in the final analysis with recruitment from clinics 47 (57%) and Forward 35 (43%). Sixty-two (76%) initiated tofacitinib with 87% taking it quaque die and twenty (24%) TNFi. At 9 months, 77% of tofacitinib were persistent versus 70% for TNFi (P = 0.65), and implementation was similar (0.84 vs. 0.82; P = 0.57). In multivariable models, increased baseline patient global assessment was consistently associated with discontinuation (hazard ratio 1.31 [1.07-1.61]). There was increased adherence to methotrexate (MTX) when taking tofacitinib that led to higher combined adherence for tofacitinib than TNFi (0.81 vs. 0.69; P = 0.03), but no significant differences remained in multivariable models. In sensitivity analysis, consistent morning intake for tofacitinib and evening intake for MTX was associated with improved adherence.

CONCLUSION: We found no statistical differences in adherence between patients with RA initiating tofacitinib and self-injectable TNFi, although 15% to 30% were nonadherent. Concomitant MTX, patient global assessment, and a consistent time of day intake were associated with adherence.

PMID:38041515 | DOI:10.1002/acr2.11622

Paediatr Anaesth. 2023 Dec 1. doi: 10.1111/pan.14808. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze the optimal postextubation respiratory support in pediatric cardiac surgery patients.

DESIGN: Systematic review of randomized controlled trials.

SETTING: Pediatric or neonatal intensive care units.

PARTICIPANTS: All aged children (<16 years) having cardiac surgery and postoperative invasive ventilation.

INTERVENTION: Noninvasive respiratory support, including high flow nasal cannula (HFNC), conventional oxygen therapy (COT), noninvasive positive pressure ventilation (NIPPV), continuous positive pressure (CPAP), and noninvasive high-frequency oscillatory ventilation (NHFOV).

MEASUREMENT AND MAIN RESULTS: Studies were not pooled for statistical synthesis due to the limited number and quality of the included studies. Risk ratios with 95% confidence intervals were calculated for individual studies. A total of 167 studies were screened and six were included. The risk of bias was low in one, high in one, and had some concerns in four of the studies. Extubation failure (defined as reintubation) was the main outcome of interest. Risk ratio for reintubation was 0.10 (CI 0.02-0.40) and 1.07 (CI 0.16-7.26) in HFNC versus COT, 0.49 (CI 0.05-5.28) in HFNC versus NIPPV, 0.40 (CI 0.08-1.94) in HFNOV versus CPAP, 0.75 (CI 0.26-2.18) in HFNOV versus NIPPV, and 1.37 (CI 0.33-5.73) in CPAP versus NIPPV. Treatment durations did not differ between the groups.

CONCLUSION: We did not find clear evidence of a difference in reintubation rates and other clinical outcomes between different noninvasive ventilation strategies. Evidence certainty was assessed to be very low due to the risk of bias, the small number of included studies, and high imprecision. Future quality studies are needed to determine the optimal postextubation support in pediatric cardiac surgery patients.

PMID:38041510 | DOI:10.1111/pan.14808

Orthop Surg. 2023 Dec 1. doi: 10.1111/os.13950. Online ahead of print.

ABSTRACT

OBJECTIVE: Closed reduction combined with external fixation is a frequently utilized approach for treating distal radial fractures in adults. Nonetheless, the potential for re-displacement following external fixation remains. Analyzing the factors influencing re-displacement after nonsurgical treatment of distal radial fractures in adults is vital for preventing re-displacement and making prognostic assessments.

METHODS: A retrospective analysis was performed on 884 patients who underwent nonsurgical treatment for distal radius fractures in the reduction room of the Orthopedics and Traumatology Department of Integrated Traditional Chinese and Western Medicine at Tianjin Hospital, Tianjin, China, between July 2019 and December 2022. Patients were categorized into two groups, namely displaced and nondisplaced, based on radiographic outcomes. Factors affecting fracture re-displacement were examined, including sex, age, side, AO/OTA type, external fixation, and radiographic outcomes at pre-reduction and immediate reduction. Logistic regression analysis was employed to identify the risk factors for fracture re-displacement, and ROC curves were constructed.

RESULTS: Among the 884 patients, 563 (63.69%) experienced re-displacement after fracture reduction. There were no statistically significant differences (p > 0.05) between the two groups in terms of gender, external fixation method, and palmar tilt angle at pre-reduction and immediate reduction, while significant differences (p < 0.05) were observed in age, side, AO/OTA type, and radial inclination, radial length, and radiographic outcomes of ulnar variance at pre-reduction and immediate reduction. Multifactorial logistic regression analysis revealed that age (odds ratio [OR] = 1.027, p < 0.001), AO/OTA type (OR = 2.327, p = 0.005), ulnar variance at pre-reduction (OR = 1.142, p = 0.048), and ulnar variance at immediate reduction (OR = 1.685, p < 0.001) were significant factors (p < 0.05) associated with re-displacement following nonoperative treatment of adult distal radius fractures. For patients aged ≥60 years, the amount of missing radiographic outcomes was positively correlated with age. The receiver operating characteristic curve demonstrated that age ≥65.5 years, ulnar variance >3.26 mm at pre-reduction, and ulnar variance >2.055 mm at immediate reduction were high-risk factors for fracture re-displacement.

CONCLUSIONS: Nonsurgical treatment of distal radius fractures exhibits a higher rate of re-displacement. Age, AO/OTA type, pre-reduction, and immediate reduction ulnar variance are key factors predicting fracture re-displacement.

PMID:38041507 | DOI:10.1111/os.13950

Hum Brain Mapp. 2023 Dec 2. doi: 10.1002/hbm.26544. Online ahead of print.

ABSTRACT

Neuromelanin-sensitive magnetic resonance imaging quantitative analysis methods have provided promising biomarkers that can noninvasively quantify degeneration of the substantia nigra in patients with Parkinson’s disease. However, there is a need to systematically evaluate the performance of manual and automated quantification approaches. We evaluate whether spatial, signal-intensity, or subject specific abnormality measures using either atlas based or manually traced identification of the substantia nigra better differentiate patients with Parkinson’s disease from healthy controls using logistic regression models and receiver operating characteristics. Inference was performed using bootstrap analyses to calculate 95% confidence interval bounds. Pairwise comparisons were performed by generating 10,000 permutations, refitting the models, and calculating a paired difference between metrics. Thirty-one patients with Parkinson’s disease and 22 healthy controls were included in the analyses. Signal intensity measures significantly outperformed spatial and subject specific abnormality measures, with the top performers exhibiting excellent ability to differentiate patients with Parkinson’s disease and healthy controls (balanced accuracy = 0.89; area under the curve = 0.81; sensitivity =0.86; and specificity = 0.83). Atlas identified substantia nigra metrics performed significantly better than manual tracing metrics. These results provide clear support for the use of automated signal intensity metrics and additional recommendations. Future work is necessary to evaluate whether the same metrics can best differentiate atypical parkinsonism, perform similarly in de novo and mid-stage cohorts, and serve as longitudinal monitoring biomarkers.

PMID:38041476 | DOI:10.1002/hbm.26544

Int J Epidemiol. 2023 Dec 1:dyad161. doi: 10.1093/ije/dyad161. Online ahead of print.

ABSTRACT

BACKGROUND: Pertussis is a contagious respiratory disease. Maternal tetanus-diphtheria-acellular pertussis vaccination during pregnancy has been recommended by the United States Centres for Disease Control (US CDC) Advisory Committee on Immunization Practices (ACIP) for unvaccinated pregnant women since October 2011 to prevent infection among infants; in 2012, ACIP extended this recommendation to every pregnancy, regardless of previous vaccination status. The population-level effect of these recommendations on infant pertussis is unknown. This study aimed to examine the impact of the 2011/2012 ACIP pertussis recommendation on pertussis incidence and mortality among US infants.

METHODS: We used monthly data on pertussis deaths among infants aged <1 year between January 2005 and December 2017 in the CDC Death Data and yearly infant pertussis incidence data from the CDC National Notifiable Disease Surveillance System to perform an interrupted time series analysis, accounting for the passage of the Affordable Care Act.

RESULTS: This study included 156 months of data. A potential decline in trend in infant pertussis incidence was noted during the post-recommendations period. No appreciable differences in trend were found in population-level infant pertussis mortality after the guideline changes in both adjusted and unadjusted models. Results were similar for all mortality sensitivity analyses.

CONCLUSIONS: The 2011/2012 ACIP maternal pertussis vaccination recommendations were not associated with a population-level change in the trend in mortality, but were potentially associated with a decrease in incidence in the USA between 2005 and 2017.

PMID:38041469 | DOI:10.1093/ije/dyad161