Tag: statistics

Midwifery. 2022 Jan 10;106:103248. doi: 10.1016/j.midw.2021.103248. Online ahead of print.

ABSTRACT

AIM: This study was performed to assess the impact of a mobile and web-based software system named Midwifery Clinical Automation (EBEKO) and designed by researchers to be used in clinical practices on motivation, time management and anxiety level.

METHOD: The sample of this randomized controlled trial consisted of 60 midwifery students who were randomly and equally assigned to the experimental and control groups. Data were collected between February and May 2019 using “Student Introduction Form”, “Motivation Resources and Problems Scale (MRPS)”, “Time Management Inventory (TMI)” and “Spielberger’s State-Trait Anxiety Inventory (STAI I-II). EBEKO application was designed as a software system ensuring mutual interaction between students and instructors. Students in the experimental group and all instructors of the department of midwifery were trained in terms of using the system. Students were asked to upload the data regarding midwifery care, monitoring and trainings utilized within the clinical practices to the EBEKO. Data uploaded to the system were transferred to the screen designed for the instructors who were in charge. Instructors assessed these forms (for pregnant women/puerperal women/newborns etc.), demanded revisions, approved or returned. Approved forms corresponded to the number of forms needed by the students in the study to graduate. All students in the experimental group used EBEKO system throughout their education period (14 weeks). No interventions were made on the students in the control group. Data were analyzed through the descriptive statistics (frequency, percentage, mean, standard deviation, min-max values), and t-test in the dependent and independent groups.

RESULTS: Students in the experimental and control groups were found to have similar motivation, time management and anxiety level prior to the use of EBEKO. However, after the use of the application, the mean post-test motivation and time management scores of the students in the experimental group significantly increased compared to the control group (p<0.001, p<0.05), but no significant difference regarding the anxiety levels was present between the groups (p>0.05).

CONCLUSION: EBEKO was found to positively affect the motivation and time management of midwifery students.

PMID:35085912 | DOI:10.1016/j.midw.2021.103248

Epilepsy Behav. 2022 Jan 24;128:108513. doi: 10.1016/j.yebeh.2021.108513. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the occurrence of sleep disorders (SD) and attention deficit hyperactivity disorder (ADHD) symptoms in children with typical absence seizures (TAS) compared to control children and to evaluate the impact of epilepsy-related factors on sleep and attention in children with TAS.

METHODS: The Sleep Disturbance Scale for Children (SDSC) and the ADHD rating scale were filled in by parents of a cohort composed by 82 children aged from 5 to 15.6 years, 49% of boys (41 with TAS with a syndromic diagnosis of childhood absence epilepsy and 41 controls). For children with TAS, the Pediatric Epilepsy Side Effects Questionnaire was completed. Statistical analyses were conducted in order to compare sleep and attention scores between groups. In children with TAS, a correlation was computed between these scores. Logistics regression models were conducted to identify predictors of excessive diurnal sleepiness and inattention in children with TAS.

RESULTS: Compared to controls, children with TAS had higher total scores for subjective sleep (mean 42.9 vs 38.3, p = 0.05) and attention disorders (mean 16.8 vs 11.6, p = 0.01), especially for excessive diurnal sleepiness (mean 3.9 vs 3.2, p = 0.02) and inattention (mean 9.3 vs 5.6, p = 0.003) components. In children with TAS, sleep problems were significantly under-reported by parents. Sleep disorders symptoms as breathing-related sleep disturbance, excessive diurnal sleepiness or naps at or after 7 years of age were reported. Subjective sleep and attention disorders were significantly correlated (r = 0.43, p = 0.01). Subjective excessive diurnal sleepiness may be the result of a polytherapy (p = 0.05) or a side effect of anti-seizure medication (ASM) (p = 0.03) but children without medication side effects also reported subjective SD. In children with TAS, the risk of inattention symptoms was increased in boys (p = 0.02), with a high BMI (p = 0.05), or with ASM side effects (p = 0.03).

CONCLUSIONS: This study demonstrates that children with TAS are at risk of sleep and attention disorder symptoms. If attention disorders in a context of epilepsy are now widely assessed and identified, sleep disorders are still under-estimated. An accurate identification and management of sleep disorders could improve academic performances, quality of life, and seizure management in children with TAS.

PMID:35085916 | DOI:10.1016/j.yebeh.2021.108513

Phys Ther Sport. 2022 Jan 19;54:58-64. doi: 10.1016/j.ptsp.2022.01.002. Online ahead of print.

ABSTRACT

OBJECTIVE: To identify if any differences exist in IFM size and quality in single leg weight bearing position between healthy and PFP participants based on foot posture.

DESIGN: Cross-sectional, matched case-comparison study SETTING: University Laboratory Setting PARTICIPANTS: 35 PFP (age:20.46 ± 3.79yrs, mass:73.28 ± 26.58 kg, height:170.80 ± 11.91 cm) and 35 healthy (age:20.40 ± 3.16yrs, mass:64.76 ± 11.52 kg, height:169.55 ± 9.10 cm) participants METHODS: After measuring Foot Posture Index (FPI), ultrasound images (USI) of Abductor Hallucis (AH), Flexor Digitorum Brevis (FDB) and Quadratus Plantae (QP) were taken in a single limb weight bearing position. Cross-sectional area (CSA) and echogenicity were measured on the USI.

RESULTS: FPI was not different between groups (PFP:2.34 ± 3.76, Healthy:2.34 ± 3.10, 9 pronated and 26 non-pronated in both groups). AH CSA was smaller in PFP than healthy group (PFP:0.030 ± 0.01 cm (Smith et al., 2018)/kg, Healthy:0.042 ± 0.01 cm (Smith et al., 2018)/kg, P < 0.001) with a large effect (d = -1.20(-1.71, -0.69). There were no other significant group main effects or group-by-FP interactions in AH/FDB/QP CSA or echogenicity.

CONCLUSION: AH CSA was smaller in PFP than healthy controls, but no difference in CSA or echogenicity of FDB/QP exist, as well as no difference in foot posture between groups. While single limb weight bearing, the PFP group presented with a smaller IFM which provides eccentric control of medial longitudinal arch, which may have implications up the chain during weight bearing functional tasks.

PMID:35085911 | DOI:10.1016/j.ptsp.2022.01.002

Dev Cogn Neurosci. 2022 Jan 15;54:101068. doi: 10.1016/j.dcn.2022.101068. Online ahead of print.

ABSTRACT

Electroencephalography (EEG) is arising as a valuable method to investigate neurocognitive functions shortly after birth. However, obtaining high-quality EEG data from human newborn recordings is challenging. Compared to adults and older infants, datasets are typically much shorter due to newborns’ limited attentional span and much noisier due to non-stereotyped artifacts mainly caused by uncontrollable movements. We propose Newborn EEG Artifact Removal (NEAR), a pipeline for EEG artifact removal designed explicitly for human newborns. NEAR is based on two key steps: 1) A novel bad channel detection tool based on the Local Outlier Factor (LOF), a robust outlier detection algorithm; 2) A parameter calibration procedure for adapting to newborn EEG data the algorithm Artifacts Subspace Reconstruction (ASR), developed for artifact removal in mobile adult EEG. Tests on simulated data showed that NEAR outperforms existing methods in removing representative newborn non-stereotypical artifacts. NEAR was validated on two developmental populations (newborns and 9-month-old infants) recorded with two different experimental designs (frequency-tagging and ERP). Results show that NEAR artifact removal successfully reproduces established EEG responses from noisy datasets, with a higher statistical significance than the one obtained by existing artifact removal methods. The EEGLAB-based NEAR pipeline is freely available at https://github.com/vpKumaravel/NEAR.

PMID:35085870 | DOI:10.1016/j.dcn.2022.101068

Int J Hyg Environ Health. 2022 Jan 24;240:113927. doi: 10.1016/j.ijheh.2022.113927. Online ahead of print.

ABSTRACT

Available guidance values to interpret individual-level biomonitoring data (ILBD) for the sum of urinary inorganic-related arsenic species (SUIAS) are generally based on population statistical descriptors and not on a predetermined exposure level that should not be exceeded. The objective of this study was thus to propose a range of SUIAS concentrations, reflecting an exposure corresponding to WHO’s provisional guideline value (PGV) for arsenic in drinking water (10 μg/L), within which an exposure-based biomonitoring guidance value can be identified. METHOD A comprehensive literature review was carried out in order to identify studies that were relevant to the determination of a guidance value. Drinking water arsenic exposure and urinary biomonitoring concentrations obtained from selected studies were used to conduct a structural equation modeling meta-analysis, from which regression coefficients were obtained to derive an interpretative guidance range. RESULTS Individuals exposed to the arsenic background level comparable to North American and European countries and to a water source contaminated at the WHO’s PGV, would have, on average, urinary SUIAS between 9 and 20 μg/L, with the most probable value being 15 μg/L. To address the associated uncertainty, the final guidance value selection within this range may be based on a targeted sensitivity and specificity towards detecting overexposed individuals. Indeed, spans of sensitivity of 60-82%, and of specificity of 58-85%, were estimated for the proposed range based on drinking water exposure raw data from the literature. CONCLUSION The range of guidance values obtained appears suitable for interpreting and communicating ILBD in any population biomonitoring studies in which background exposure is comparable to the North American and European context. Before selecting a single value within the proposed range, it will be important for Public Health officials to assess the possible consequences of this selection on the management and communication of the biomonitoring results.

PMID:35085883 | DOI:10.1016/j.ijheh.2022.113927

J Minim Invasive Gynecol. 2022 Jan 24:S1553-4650(22)00037-1. doi: 10.1016/j.jmig.2022.01.009. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: The objective of this study was to determine the efficacy, safety, and healthcare resource utilization of laparoscopic radiofrequency ablation (LAP-RFA) compared to myomectomy in patients with symptomatic uterine leiomyomas (ULs).

DESIGN: This was a secondary analysis of the original post-market randomized, prospective, multi-center, longitudinal, comparative TRUST US trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period.

SETTING: Multi-center trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine fibroids PARTICIPANTS: A total of 57 patients were randomized to either LAP-RFA (n=30) or myomectomy (n=27) INTERVENTIONS: LAP-RFA or myomectomy (laparoscopic or abdominal) MAIN OUTCOME MEASURES: The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient reported outcomes (PRO) scores over time. Secondary outcomes included hospitalization post-procedure, length of stay, complications, reinterventions and recovery time.

RESULTS: There was a significant improvement in UL symptoms at 3- and 12-months post-procedure within each treatment group and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months post-procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all PRO scores over time for both groups. At 3- and 12-months post-procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than laparoscopic myomectomy at 3 and 12 months, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly lower in the LAP-RFA group compared to Myomectomy (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p<0.05). Doctors recommended taking significantly less time off before returning to work in the LAP-RFA group compared to myomectomy (10.3 ± 5.1 days vs 14.5 ± 5.4 days, p<0.05) and the total days until back to normal activity was significantly lower in the LAP-RFA group compared to myomectomy (16.3 ± 15.2 days vs 26.5 ± 15.9 days, p<0.05).

CONCLUSION: The results from this 12-month follow up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource utilization overall, including lower post-procedure hospitalization rate and length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.

TRIAL REGISTRATION: NCT02163525 (https://clinicaltrials.gov/ct2/show/NCT02163525) STUDY TYPE: Interventional (clinical trial) ENROLLMENT: 114 participants ALLOCATION: Randomized INTERVENTION MODEL: Parallel assignment MASKING: None (open label) PRIMARY PURPOSE: Treatment STUDY START DATE: June 2014 ACTUAL PRIMARY COMPLETION DATE: July 2019 ESTIMATED STUDY COMPLETION DATE: June 2024 DATA REPOSITORY: https://pfgmed.box.com/v/TRUSTDataRep.

PMID:35085837 | DOI:10.1016/j.jmig.2022.01.009

Int J Drug Policy. 2022 Jan 20;102:103591. doi: 10.1016/j.drugpo.2022.103591. Online ahead of print.

ABSTRACT

BACKGROUND: Methadone is a highly effective treatment for opioid use disorder. Its use in the United States is highly regulated at both the federal and state level. The regulations related to take-home doses were loosened because of the 2019 Novel Coronavirus public health emergency declaration. The aim was to assess the effect of loosened regulations on methadone-related exposures reported to poison control centers.

METHODS: Retrospective analysis of population-based intentional methadone exposures (in persons 18 years of age and older) reported to the American Association of Poison Control Centers’ National Poison Data System. A quasi-experimental design looking at one year before and after the March 16, 2020 loosening of methadone take-home regulations. Severity of exposure was assessed by: disposition (discharged from emergency department, admitted to non-critical care versus critical care units), medical treatments received, and medical outcomes (no effect, minor effect, moderate effect, major effect, death). One tail Student t-test and Chi Square were used; p significance was <0.05.

RESULTS: The number of adult intentional exposures involving methadone increased by 5.3% in the year following the change in federal regulations (p<0.05). There was no statistically significant difference in distribution of age, gender, whether exposures involved methadone-only or methadone plus other substances, therapies administered or hospitalizations. There was no difference in overall distribution of medical outcomes, including deaths.

CONCLUSIONS: Although the number of exposures involving methadone increased post-regulation change, the severity of exposures remained unchanged. Various additional factors (Medicare and Medicaid expansion; increased number of opioid treatment programs) may have also contributed to this increase. As federal officials consider possible permanent changes to the methadone regulations, it is important to evaluate potential related risks and benefits. This study lends support to the consideration that loosening of methadone regulations does not necessarily lead to a substantial increase in severity of exposures.

PMID:35085855 | DOI:10.1016/j.drugpo.2022.103591

Contemp Clin Trials. 2022 Jan 24:106688. doi: 10.1016/j.cct.2022.106688. Online ahead of print.

ABSTRACT

OBJECTIVE: To further the precision medicine goal of tailoring medical treatment to individual patient characteristics by providing a method of analysis of the effect of test treatment, T, compared to a reference treatment, R, in participants in a RCT who are likely responders to T.

METHODS: Likely responders to T are individuals whose expected response at baseline exceeds a prespecified minimum. A prognostic score, the expected response predicted as a function of baseline covariates, is obtained at trial completion. It is a balancing score that can be used to match likely responders randomized to T with those randomized to R; the result is comparable treatment groups that have a common covariance distribution. Treatments are compared based on observed outcomes in this enriched sample. The approach is illustrated in a RCT comparing two treatments for opioid use disorder.

RESULTS: A standard statistical analysis of the opioid use disorder RCT found no treatment difference in the total sample. However, a subset of likely responders to T were identified and in this group, T was statistically superior to R.

CONCLUSION: The causal treatment effect of T relative to R among likely responders may be more important than the effect in the whole target population. The prognostic score function provides quantitative information to support patient specific treatment decision regarding T furthering the goal of precision medicine.

PMID:35085831 | DOI:10.1016/j.cct.2022.106688

World Neurosurg. 2022 Jan 24:S1878-8750(22)00083-3. doi: 10.1016/j.wneu.2022.01.070. Online ahead of print.

ABSTRACT

OBJECTIVES: There has been an increasing number of reported errors in neurosurgical publications. Subsequent published correction details in the form of errata and corrigenda has not been analysed previously. Our study aims to review the published errata and corrigenda in neurosurgical literature, and we discuss the characteristics and future implications of post-publication errors.

METHODS: PUBMED and EMBASE databases were screened using a designed search strategy for errata and corrigenda in neurosurgical articles published between 1990 to March 2021. Data including journal impact factor, number of authors and citations, country of origin, study design, level of evidence, category, severity and timing of correction of errors were extracted for summary and analysis.

RESULTS: 768 included articles contributed to 918 error corrections in total. 563(73.31%) articles acknowledged the correction in the original record. Median journal impact factor was 3.114(IQR 2.139). Median correction time was 3(IQR 5) month, with no statistically significant difference in timing of correction across different error severities (Kruskal-Wallis test p=0.058). 398(51.82%) studies were level 3 evidence. Errors with minimal severity most commonly occurred in author list 197(82.43%) with typographical mistake being the predominant cause. Errors with high severity most commonly occurred in the results section. 8(0.87%) errors prompted modification of study conclusions.

CONCLUSION: Observations of post-publication corrections across a wide range of studies prompted more awareness of errors in neurosurgical literature regardless of impact factors and level of evidence. More standardisation in the recognition and acknowledgement of errors, with active engagements from authors, readers, editors and publishers is recommended.

PMID:35085807 | DOI:10.1016/j.wneu.2022.01.070

Arch Pathol Lab Med. 2022 Jan 27. doi: 10.5858/arpa.2021-0604-SA. Online ahead of print.

ABSTRACT

CONTEXT.–: Serological tests on automated immunology analyzers are increasingly used to monitor the acquired immunity against SARS-CoV-2. The heterogeneity of assays raises concerns about their diagnostic performance and comparability.

OBJECTIVE.–: To test sera from formerly infected individuals for SARS-Cov-2 antibodies utilizing six automated serology assays and a pseudoneutralization test (PNT).

DESIGN.–: Six SARS-CoV-2 serology assays were utilized to assess 954 samples collected during a 12 months period from 315 COVID-19 convalescents. The tests determined either antibodies against the viral nucleocapsid (anti-NC) or spike protein (anti-S). Two assays did not distinguish between antibody classes whereas the others selectively measured immunoglubulins G (IgG) antibodies. PNT was used to detect the presence of neutralizing antibodies.

RESULTS.–: Comparison of qualitative results showed only slight to moderate concordance between the assays (Cohen’s kappa < 0.57). Significant correlations (P < .001) were observed between the antibody titers from all quantitative assays. However, titer changes were not detected equally. A total anti-S assay measured an increase in 128 out of 172 cases (74%) of a suitable subset, whereas all IgG anti-S tests reported decreases in at least 118 (69%). Regarding the PNT results, diagnostic sensitivities ≥89% were achieved with PPVs ≥93%. In contrast, specificity changed substantially over time varying from 20 to 100%.

CONCLUSIONS.–: Comparability of serological SARS-CoV-2 antibody tests is rather poor. Due to different diagnostic specificities, the tested assays were not equally capable of capturing changes in antibody titers. However, with thoroughly validated cut-offs, IgG-selective anti-S assays are a reliable surrogate test for SARS-CoV-2 neutralizing antibodies in former COVID-19 patients.

PMID:35085385 | DOI:10.5858/arpa.2021-0604-SA