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Nevin Manimala Statistics

Intrinsic foot muscle size and quality in a single leg weight bearing position across foot posture types in individuals with Patellofemoral Pain compared to healthy

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

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NEAR: An artifact removal pipeline for human newborn EEG data

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

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Determination of a guidance value for the communication of individual-level biomonitoring data for urinary arsenic

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

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Clinical and Patient Reported Outcomes Pre- and Post-Surgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-Up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation (LAP-RFA) and Myomectomy

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

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Methadone exposures reported to poison control centers in the United States following the COVID-19-related loosening of federal methadone regulations

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

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Nevin Manimala Statistics

A likely responder approach for the analysis of randomized controlled trials

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

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Erratum and corrigendum in Neurosurgical publications: an in-depth analysis and inference

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

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Longitudinal comparison of automated SARS-CoV-2 serology assays in assessing virus neutralization capacity in COVID-19 convalescent sera

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

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A retrospective multi-center study of treatment, outcome, and prognostic factors in 34 dogs with disseminated aspergillosis in Australia

J Vet Intern Med. 2022 Jan 27. doi: 10.1111/jvim.16366. Online ahead of print.

ABSTRACT

BACKGROUND: Disseminated aspergillosis (DA) in dogs has a guarded prognosis and there is a lack of a gold standard treatment protocol.

OBJECTIVE: To retrospectively assess survival times and factors influencing survival times.

ANIMALS: Dogs diagnosed with DA from January 2007 to June 2017.

METHODS: Disseminated aspergillosis case data were retrieved from 13 Australian veterinary referral centers, with a diagnosis confirmed with culture or PCR. Factors influencing survival time after diagnosis were quantified using a Cox proportional hazards regression model.

RESULTS: Thirty-four dogs met the study inclusion criteria. Twenty-two dogs were treated with antifungal treatment and 12 dogs received no antifungal treatment. Accounting for censoring of dogs that were either still alive on the date of data collection or were loss to follow-up, dogs treated with itraconazole alone (n = 8) had a median survival time (MST) of 63 (95% CI: 20-272) days compared to 830 (95% CI: 267-1259) days for the n = 14 dogs that received multimodal antifungal therapy ( χ2 test statistic 8.6; df = 1; P < .01). The daily hazard of death (DHOD) for dogs with abnormally high serum creatinine concentration at the time of diagnosis was 7.4 (95% CI: 1.9-29) times that of dogs with serum creatinine within the reference interval.

CONCLUSION AND CLINICAL IMPORTANCE: Serum creatinine concentration at the time of diagnosis is a useful prognostic indicator for survival after a diagnosis of DA. The MST for dogs treated with multimodal antifungal therapy is longer than itraconazole alone and warrant further investigation (P < .01).

PMID:35085412 | DOI:10.1111/jvim.16366

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Prevalence of type-2 diabetes and prediabetes in Malaysia: A systematic review and meta-analysis

PLoS One. 2022 Jan 27;17(1):e0263139. doi: 10.1371/journal.pone.0263139. eCollection 2022.

ABSTRACT

OBJECTIVE: The main purpose of this study was to investigate the pooled prevalence of prediabetes and type-2 diabetes in the general population of Malaysia.

METHOD: We systematically searched Medline (PubMed), Embase, Web of Science, Google Scholar and Malaysian Journals Online to identify relevant studies published between January 1, 1995, and November 30, 2021, on the prevalence of type-2 diabetes in Malaysia. Random-effects meta-analyses were used to obtain the pooled prevalence of diabetes and prediabetes. Subgroup analyses also used to analyze to the potential sources of heterogeneity. Meta- regression was carried to assess associations between study characteristics and diabetes prevalence. Three independent authors selected studies and conducted the quality assessment. The quality of the final evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

RESULTS: Of 2689 potentially relevant studies, 786 titles and abstract were screened. Fifteen studies with 103063 individuals were eligible to be included in the meta-analyses. The pooled prevalence of diabetes was 14.39% (95% CI, 12.51%-16.38%; I2 = 98.4%, 103063 participants from 15 studies). The pooled prevalence of prediabetes was 11.62% (95% CI, 7.17%-16.97%; I2 = 99.8, 88702 participants from 9 studies). The subgroup analysis showed statistically significant differences in diabetes prevalence by the ethical sub-populations with highest in Indians (25.10%; 95% CI, 20.19%-30.35%), followed by Malays (15.25%; 95% CI, 11.59%-19.29%), Chinese (12.87%; 95% CI, 9.73%-16.37%), Bumiputeras (8.62%; 95% CI, 5.41%-12.47%) and others (6.91%; 95% CI, 5.71%-8.19%). There was no evidence of publication bias, although heterogeneity was high (I2 ranged from 0.00% to 99·8%). The quality of evidence based on GRADE was low.

CONCLUSIONS: Results of this study suggest that a high prevalence of prediabetes and diabetes in Malaysia. The diabetes prevalence is associated with time period and increasing age. The Malaysian government should develop a comprehensive approach and strategy to enhance diabetes awareness, control, prevention, and treatment.

TRIAL REGISTRATION: Trial registration no. PROSPERO CRD42021255894; https://clinicaltrials.gov/.

PMID:35085366 | DOI:10.1371/journal.pone.0263139