Category: Statistics

Orthop Surg. 2022 Sep 30. doi: 10.1111/os.13524. Online ahead of print.

ABSTRACT

OBJECTIVE: Early prediction of stem version aids in optimization of combined version during total hip arthroplasty (THA). This study aimed to analyze the discrepancy between stem version and native femoral version measured by different methods, and to explore which method can better predict the stem version.

METHODS: We retrospectively reviewed 26 patients (39 hips) treated with robot-assisted THA in our hospital between September 2019 and December 2019. A straight, single-wedge, cementless stem (Accolade II) was used in all cases. Preoperative femoral version was measured at three levels on computerized tomography (CT) scan from the top to the middle level of femoral neck (Level 1 to Level 3). During THA, the version on cutting surface was measured prior to femoral broaching based on two reference lines: mid-cortical line and T line (trochanteric fossa to the middle of medial cortex). After femoral broaching, stem version was measured based on the femoral neck trial using Mako system (Stryker). In the statistical analysis, the difference and absolute discrepancy between stem version and femoral version measured with various methods were examined using paired t-test, and the relationship between stem version and various femoral versions were examined using correlation analysis.

RESULTS: Mean femoral neck version (Level 1) was 9.5° ± 2.6° (range, -16.8°-42.5°), while mean stem version measured by Mako system was 19.9° ± 2.0° (range, -8.0°-49.0°). Femoral version measured with each method showed a moderate correlation with stem version (p < 0.05). There was a significant difference between stem version and femoral version except at Level 3, with a mean difference of 0.8° ± 13.6° (p = 0.729). With regard to the intraoperative estimation, stem version significantly increased compared to the value based on mid-cortical line, with a mean difference of 8.4° ± 13.1° (p < 0.001). However, the mean value of stem version was a little smaller than that of femoral version measured by reference to T line, but without statistical significance (p = 0.156). No postoperative dislocations occurred during the study period. No revision was required for any component.

CONCLUSIONS: The middle level of femoral neck on CT scan and T line on cutting surface are better references to measure femoral version for predicting postoperative stem version. However, the relationship between stem version and predictive value was flexible. Therefore, further three-dimensional studies of postoperative CT are needed to validate the press-fit fixation and rotational freedom of the single-wedge stem.

PMID:36177805 | DOI:10.1111/os.13524

Dermatol Ther. 2022 Sep 30:e15871. doi: 10.1111/dth.15871. Online ahead of print.

ABSTRACT

INTRODUCTION: Tofacitinib is a pan-janus kinase inhibitor (JAK) which has been tested off-label in alopecia areata (AA) with promising results. However, evidence of tofacitinib in real-life setting is still poor. We evaluated long-term efficacy and safety of tofacitinib for refractory AA.

MATERIAL AND METHODS: This is a prospective, open-label, observational, single-center cohort study conducted between January 2018 and December 2020. Primary end point was the percent change in Severity of Alopecia Tool (SALT) at the basal visit and at the most recent follow-up visit. Three categories of treatment response were analysed.

RESULTS: Data on 47 participants of Arab-Asian heritage were analysed. A complete and partial regrowth was observed in 18 patients (41.86%) and 11 patients (25.58%), respectively. In 12 patients (27.9%), no response was obtained. Most of the non-responders belonged to the alopecia universalis group (66.67%). No statistical differences were observed in rates of regrowth between pediatric and adult individuals (p=0.52), nor between women and men. Significant differences in the average duration of tofacitinib treatment were obtained among the three categories of regrowth (p<.003), notably duration of AA did not impact the clinical regrowth (p=0.62).

CONCLUSION: To the best of our knowledge, this is the first prospective, observational, long-term study using tofacitinib in refractory AA. Rates of regrowth and side effects are analogous to previous works. Length of tofacinitib therapy should last for 12 months before considering any discontinuation or chang, since early cessation can lead to treatment failures or incomplete regrowth. Maintenance therapy after complete regrowth has demonstrated to be safe and effective to prevent recurrences of hair loss. This article is protected by copyright. All rights reserved.

PMID:36177791 | DOI:10.1111/dth.15871

Clin Anat. 2022 Sep 30. doi: 10.1002/ca.23955. Online ahead of print.

ABSTRACT

INTRODUCTION: Safe intubation of newborns remains a challenge. This investigates the upper airway anatomy of (pre-)term infants was investigated to improve airway management and the development of airway devices.

MATERIALS AND METHODS: Angles and diameters of both oral and nasal intubation pathways of twenty-two cadavers of premature and term stillborn infants were measured, relative to their gestational age (GA) and tested for statistical significance. The systematic influence of sex on the distribution of values was examined. Cast models of the oral and nasal intubation pathway were (produced using a silicone dental impression material) 3D-scanned.

RESULTS: No significant correlation with GA was seen in the angles studied. However, four distances around the hard and soft palate did show statistically significant positive correlations with GA. Regarding differences between the sexes, only the angle between the entrance of the trachea and the esophagus was greater for male cadavers.

CONCLUSION: The angles of the ventilation pathway of (pre-)term infants do not depend systematically on GA. Anatomically, laryngeal masks might therefore also be well-suited ventilators for preterm infants. Alterations in the size but not the shape of laryngeal masks for small preterm infants is recommended. The data obtained may thus be used as a basis for the development of airway devices and airway simulators for medical education and clinical training. This article is protected by copyright. All rights reserved.

PMID:36177789 | DOI:10.1002/ca.23955

Ital J Dermatol Venerol. 2022 Sep 30. doi: 10.23736/S2784-8671.22.07386-8. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with atopic dermatitis (AD) display a defective skin barrier, consequently they may experience inflammatory flares with different exposures, including masks. Actually, beside scattering case reports, no study focused on the possible AD flaring due to masks.

METHODS: In this multicenter prospective study AD patients with facial manifestation were followed with teledermatology and evaluated by two board-certified dermatologists at the baseline (T0) and after 1 month (T1) in which patients started to wear masks >6 hours per day. Demographics and clinical parameters, included and not limited to Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI), were carefully collected and analyzed.

RESULTS: We enrolled 57 AD patients (M/F 28/29, 33.91 ± 12.26 yoa) that wore surgical masks (38 (66.7%)), community masks (11 (19.3%) and N95 (8 (14.0%)). Both DLQI and EASI increase during the time period (p<0.0001). DLQI variation was not influenced by age, BMI, and gender, mask type used and AD therapy (p=0.99), whilst EASI variation was significantly influenced by BMI, gender, and therapy (p=0.004).

CONCLUSIONS: Mask wearing may prove detrimental to patients with atopic eczema and the same may not necessarily be the case for asthma patients.

PMID:36177781 | DOI:10.23736/S2784-8671.22.07386-8

Mil Med. 2022 Jul 26:usac234. doi: 10.1093/milmed/usac234. Online ahead of print.

ABSTRACT

INTRODUCTION: The National Defense Authorization Act of 2017 indicated the need for a national strategy to improve trauma care among military treatment facilities (MTFs). Part of the proposed strategy to improve trauma outcomes was to convert identified MTFs into verified trauma centers. The American College of Surgeons (ACS) verifies trauma centers through an evaluation process based on available resources at a facility. It has been proven that trauma centers, specifically those verified by the ACS, have improved trauma outcomes. In 2017, we implemented steps to become a level III trauma program, according to the standards for designation by the state and verification through the ACS. The goal of this retrospective review is to evaluate the impact of this implementation with regard to both patient care and the MTF.

MATERIALS AND METHODS: Data from a single-MTF trauma registry from 2018, at the initiation of the trauma program, to present were reviewed. Outcomes were selected based upon the ACS verification criteria. Specifically, emergency department length of stay (ED LOS), nonsurgical admissions, injury severity score, diversion rates, and time to operating room were reviewed. Statistical analyses were performed using Student’s t-tests. Institutional review board (IRB) approval was not required for this study as it was performed as a quality improvement project using deidentified data.

RESULTS: ED LOS decreased significantly after implementation of the trauma program from an average of 6.43 h in 2018 to 4.73 h in 2019 and 4.6 h in 2020 (P < .04). Nonsurgical admissions decreased significantly from 57.8% in 2018, with rates of <20% in all subsequent years (P < .01). The average injury severity score increased from 5.61 in 2018 to 7.52 in 2020 (P < .01) and 7.27 in 2021 (P < .01). Diversion rates also decreased from >5% in 2018 to 0% in 2021.

CONCLUSIONS: The establishment of a trauma program in accordance with the standards of the ACS for verification improved metrics of care for trauma patients at our MTF. This implementation as part of the local trauma system also led to increased injury severity seen by the MTF, which enhances readiness for its providers.

PMID:36177765 | DOI:10.1093/milmed/usac234

Am J Sports Med. 2022 Oct;50(12):3198-3209. doi: 10.1177/03635465221120388. Epub 2022 Sep 13.

ABSTRACT

BACKGROUND: Femoroacetabular impingement syndrome is characterized by chondrolabral damage and hip pain. The specific biomechanics used by people with femoroacetabular impingement syndrome during daily activities may exacerbate their symptoms. Femoroacetabular impingement syndrome can be treated nonoperatively or surgically; however, differential treatment effects on walking biomechanics have not been examined.

PURPOSE: To compare the 12-month effects of physical therapist-led care or arthroscopy on trunk, pelvis, and hip kinematics as well as hip moments during walking.

STUDY DESIGN: Secondary analysis of multi-centre, pragmatic, two-arm superiority randomized controlled trial subsample; Level of evidence, 1.

METHODS: A subsample of 43 participants from the Australian Full randomised controlled trial of Arthroscopic Surgery for Hip Impingement versus best cONventional (FASHIoN trial) underwent gait analysis and completed the International Hip Outcome Tool (iHOT-33) at both baseline and 12 months after random allocation to physical therapist-led care (personalized hip therapy; n = 22; mean age 35; 41% female) or arthroscopy (n = 21; mean age 36; 48% female). Changes in trunk, pelvis, and hip biomechanics were compared between treatment groups across the gait cycle using statistical parametric mapping. Associations between changes in iHOT-33 and changes in hip kinematics across 3 planes of motion were examined.

RESULTS: As compared with the arthroscopy group, the personalized hip therapy group increased its peak hip adduction moments (mean difference = 0.35 N·m/body weight·height [%] [95% CI, 0.05-0.65]; effect size = 0.72; P = .02). Hip adduction moments in the arthroscopy group were unchanged in response to treatment. No other between-group differences were detected. Improvements in iHOT-33 were not associated with changes in hip kinematics.

CONCLUSION: Peak hip adduction moments were increased in the personalized hip therapy group and unchanged in the arthroscopy group. No biomechanical changes favoring arthroscopy were detected, suggesting that personalized hip therapy elicits greater changes in hip moments during walking at 12-month follow-up. Twelve-month changes in hip-related quality of life were not associated with changes in hip kinematics.

PMID:36177759 | DOI:10.1177/03635465221120388

Stat Med. 2022 Sep 30. doi: 10.1002/sim.9575. Online ahead of print.

ABSTRACT

The safety of medical products due to adverse events (AE) from drugs, therapeutic biologics, and medical devices is a major public health concern worldwide. Likelihood ratio test (LRT) approaches to pharmacovigilance constitute a class of rigorous statistical tools that permit objective identification of AEs of a specific drug and/or a class of drugs cataloged in spontaneous reporting system databases. However, the existing LRT approaches encounter certain theoretical and computational challenges when an underlying Poisson model assumption is violated, including in cases of zero-inflated data. We briefly review existing LRT approaches and propose a novel class of (pseudo-) LRT methods to address these challenges. Our approach uses an alternative parametrization to formulate a unified framework with a common test statistic that can handle both Poisson and zero-inflated Poisson (ZIP) models. The proposed framework is computationally efficient, and it reveals deeper insights into the comparative behaviors of the Poisson and the ZIP models for handling AE data. Our extensive simulation studies document notably superior performances of the proposed methods over existing approaches particularly under zero-inflation, both in terms of statistical (eg, much better control of the nominal level and false discovery rate with substantially enhanced power) and computational ( $\sim$ 100-500-fold gains in average running times) performance metrics. An application of our method on the statin drug class from the FDA FAERS database reveals interesting insights on potential AEs. An R package, pvLRT, implementing our methods has been released in the public domain.

PMID:36177750 | DOI:10.1002/sim.9575

Acta Psychiatr Scand. 2022 Sep 30. doi: 10.1111/acps.13506. Online ahead of print.

ABSTRACT

INTRODUCTION: Alcohol, tobacco and coffee are commonly used substances and use in adolescence has previously been linked to mood disorders. However, few large prospective studies have investigated adolescent use in relation to mental health outcomes in adulthood. The main aim of this study was to examine the prospective associations between alcohol use, cigarette smoking and coffee consumption at age 16 and subsequent mood disorders up to 33 years of age.

METHODS: Data from The Northern Finland Birth Cohort 1986 Study were used and a total of 7,660 participants (49.9% male) were included. Associations between alcohol use, cigarette smoking and coffee consumption at age 16 and later diagnoses of major depression and bipolar disorder were examined using multinomial logistic regression analyses.

RESULTS: Mean number of cigarettes/day (OR=1.23 (95% CI 1.01-1.50)) and mean volume of alcohol consumption (OR = 1.22 (95% CI 1.01-1.47)), but not frequency of excessive drinking, in adolescence were associated with increased risk for subsequent bipolar disorder after adjustment for sex, parental psychiatric disorders, family structure, illicit substance use, and emotional and behavioral problems at age 16. An association between cigarette smoking and major depression attenuated to statistically non-significant when adjusted for emotional and behavioral problems. No associations were observed between adolescent coffee consumption and subsequent mood disorders.

CONCLUSIONS: This is the first study to report an association of adolescent cigarette smoking and subsequent bipolar disorder diagnosis providing grounds for further research and pointing to a place for preventive measures among adolescents.

PMID:36177725 | DOI:10.1111/acps.13506

Biometrics. 2022 Sep 30. doi: 10.1111/biom.13766. Online ahead of print.

ABSTRACT

In the COVID-19 pandemic, workplace transmission plays an important role. For this type of transmission, the longitudinal 14-day incidence curve of SARS-CoV-2 infections per economic sector is a proxy. In Belgium, a census of confirmed 14-day incidences per NACE-BEL sector level three is available from September 2020 until June 2021, encompassing two waves of infections. However, these high-dimensional data, with a relatively small number of NACE-BEL sectors, are challenging to analyze. We propose a non-linear Gaussian-Gaussian model that combines parametric and semi-parametric elements to describe the incidence curves with a small set of meaningful parameters. These parameters are further analyzed with conventional statistical methods, such as canonical correlation analysis and linear models, to provide insight into predictive characteristics of the first wave for the second wave. Those non-linear models classify economic sectors into three groups: sectors with two regular waves of infections, sectors with only a first wave and sectors with a more irregular profile, which may indicate a clear effect of COVID-19 vaccination. The Gaussian-Gaussian model thus allows for analyzing and comparing incidence curves and to bring out key characteristics of such curves. Finally, we consider in which other settings the proposed approach could be applied, together with possible pitfalls. This article is protected by copyright. All rights reserved.

PMID:36177715 | DOI:10.1111/biom.13766

J Cardiovasc Electrophysiol. 2022 Sep 30. doi: 10.1111/jce.15697. Online ahead of print.

ABSTRACT

AIM: We conducted a systematic review and meta-analysis of randomized and observational studies with a control group to evaluate the effectiveness and safety of a time to isolation (TTI)-based strategy of cryoballoon ablation (CBA) in the treatment of atrial fibrillation (AF).

METHODS: Three electronic databases (MEDLINE, Cochrane Central Register of Controlled Trials and Embase) without language restrictions were searched. The intervention assessed was a TTI-based strategy of CBA in the treatment of AF. TTI was defined as the time from the start of freezing to the last recorded pulmonary veins’ potential. The comparison of interest was intended conventional protocol of CBA. The primary end point was freedom from atrial arrhythmia.

RESULTS: Nine studies were deemed eligible (N= 2289 patients). Eight studies reported freedom from atrial arrhythmia and pooled results showed a marginally similar success rate between two protocols (OR: 1.24; 95% CI: 0.98 – 1.56). A prespecified subgroup analysis verified that a high dose TTI strategy (with >120s duration of cryotherapy post TTI) compared to conventional protocol could significantly increase the patients without atrial arrhythmia during follow-up (OR: 1.39; 95% CI: 1.05 – 1.83). TTI strategy could also significantly decrease total procedure time (SMD: – 26.24 minutes; 95% CI: – 36.90 to – 15.57) and phrenic nerve palsy incidence (OR: 0.49; 95% CI 0.29 – 0.84).

CONCLUSION: Moderate confidence evidence suggests that an individualized CBA dosing strategy based on TTI and extended (> 2 minutes post TTI) duration of CBA is accompanied by fewer recurrences post AF ablation. This article is protected by copyright. All rights reserved.

PMID:36177697 | DOI:10.1111/jce.15697