Category: Nevin Manimala

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

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 ( ${\chi }^2$ test statistic 8.6; $\mathrm{df}$ = 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

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

PLoS One. 2022 Jan 27;17(1):e0263336. doi: 10.1371/journal.pone.0263336. eCollection 2022.

ABSTRACT

BACKGROUND: Gestational diabetes mellitus (GDM) in pregnancy leads to a range of perinatal complications. Although several randomized controlled trials (RCT) have tested the effect of non-pharmacological standard GDM care adjuncts on these outcomes, there is no agglomerated statistical evidence on how their occurrence risk varies across interventions and with placebo. Therefore, a systematic review and network meta-analysis (NMA) protocol is proposed here to address this evidence gap.

MATERIALS AND METHODS: A search for above RCTs published in the English language will transpire in PubMed, Embase, and Scopus databases irrespective of date and geographic boundary. The RCTs must test nutritional supplementation, digital intervention, structured exercise program, educational program, counseling service, or a combination of these prenatally in GDM patients. These should report ≥1 of the following outcomes- cesarean section, pre-eclampsia, polyhydramnios, preterm birth, macrosomia, prolonged labor, gestational hypertension, premature rupture of membranes, congenital anomaly, Apgar scores, birth weight, birth length, gestational age at birth, neonatal hypoglycemia, neonatal hyperbilirubinemia, and neonatal Corpulence Index. The risk of bias assessment of the recruited trials will transpire using the Revised Cochrane risk-of-bias tool. Determination of the comparative effectiveness between interventions will occur by the frequentist method NMA for respective outcomes. The categorical and continuous outcomes effect size will get calculated in risk ratio and weighted or standardized mean difference, respectively. For each NMA model, network maps and league tables will show the connections between interventions and effect sizes with their 95% confidence intervals for each intervention pair compared, respectively. The publication bias assessment will occur using comparison-adjusted funnel plots. Best intervention prediction for NMA models with statistically significant intervention effect will happen by determining the surface under the cumulative ranking curve values. Statistical analysis will ensue using Stata software (v16). The statistical significance estimation will happen at p<0.05 and 95% confidence interval.

TRIAL REGISTRATION: PROSPERO registration no: CRD42021271199; https://clinicaltrials.gov/.

PMID:35085374 | DOI:10.1371/journal.pone.0263336

PLoS One. 2022 Jan 27;17(1):e0263130. doi: 10.1371/journal.pone.0263130. eCollection 2022.

ABSTRACT

OBJECTIVE: To evaluate the cost-effectiveness of the Cardiac Care Bridge (CCB) nurse-led transitional care program in older (≥70 years) cardiac patients compared to usual care.

METHODS: The intervention group (n = 153) received the CCB program consisting of case management, disease management and home-based cardiac rehabilitation in the transition from hospital to home on top of usual care and was compared with the usual care group (n = 153). Outcomes included a composite measure of first all-cause unplanned hospital readmission or mortality, Quality Adjusted Life Years (QALYs) and societal costs within six months follow-up. Missing data were imputed using multiple imputation. Statistical uncertainty surrounding Incremental Cost-Effectiveness Ratios (ICERs) was estimated by using bootstrapped seemingly unrelated regression.

RESULTS: No significant between group differences in the composite outcome of readmission or mortality nor in societal costs were observed. QALYs were statistically significantly lower in the intervention group, mean difference -0.03 (95% CI: -0.07; -0.02). Cost-effectiveness acceptability curves showed that the maximum probability of the intervention being cost-effective was 0.31 at a Willingness To Pay (WTP) of €0,00 and 0.14 at a WTP of €50,000 per composite outcome prevented and 0.32 and 0.21, respectively per QALY gained.

CONCLUSION: The CCB program was on average more expensive and less effective compared to usual care, indicating that the CCB program is dominated by usual care. Therefore, the CCB program cannot be considered cost-effective compared to usual care.

PMID:35085361 | DOI:10.1371/journal.pone.0263130

PLoS One. 2022 Jan 27;17(1):e0263051. doi: 10.1371/journal.pone.0263051. eCollection 2022.

ABSTRACT

With the development of measurement technology, data on the movements of actual games in various sports can be obtained and used for planning and evaluating the tactics and strategy. Defense in team sports is generally difficult to be evaluated because of the lack of statistical data. Conventional evaluation methods based on predictions of scores are considered unreliable because they predict rare events throughout the game. Besides, it is difficult to evaluate various plays leading up to a score. In this study, we propose a method to evaluate team defense from a comprehensive perspective related to team performance by predicting ball recovery and being attacked, which occur more frequently than goals, using player actions and positional data of all players and the ball. Using data from 45 soccer matches, we examined the relationship between the proposed index and team performance in actual matches and throughout a season. Results show that the proposed classifiers predicted the true events (mean F1 score > 0.483) better than the existing classifiers which were based on rare events or goals (mean F1 score < 0.201). Also, the proposed index had a moderate correlation with the long-term outcomes of the season (r = 0.397). These results suggest that the proposed index might be a more reliable indicator rather than winning or losing with the inclusion of accidental factors.

PMID:35085344 | DOI:10.1371/journal.pone.0263051

PLoS One. 2022 Jan 27;17(1):e0262890. doi: 10.1371/journal.pone.0262890. eCollection 2022.

ABSTRACT

Identifying genes with the largest expression changes (gene selection) to characterize a given condition is a popular first step to drive exploration into molecular mechanisms and is, therefore, paramount for therapeutic development. Reproducibility in the sciences makes it necessary to emphasize objectivity and systematic repeatability in biological and informatics analyses, including gene selection. With these two characteristics in mind, in previous works our research team has proposed using multiple criteria optimization (MCO) in gene selection to analyze microarray datasets. The result of this effort is the MCO algorithm, which selects genes with the largest expression changes without user manipulation of neither informatics nor statistical parameters. Furthermore, the user is not required to choose either a preference structure among multiple measures or a predetermined quantity of genes to be deemed significant a priori. This implies that using the same datasets and performance measures (PMs), the method will converge to the same set of selected differentially expressed genes (repeatability) despite who carries out the analysis (objectivity). The present work describes the development of an open-source tool in RStudio to enable both: (1) individual analysis of single datasets with two or three PMs and (2) meta-analysis with up to five microarray datasets, using one PM from each dataset. The capabilities afforded by the code include license-free portability and the possibility to carry out analyses via modest computer hardware, such as personal laptops. The code provides affordable, repeatable, and objective detection of differentially expressed genes from microarrays. It can be used to analyze other experiments with similar experimental comparative layouts, such as microRNA arrays and protein arrays, among others. As a demonstration of the capabilities of the code, the analysis of four publicly-available microarray datasets related to Parkinson´s Disease (PD) is presented here, treating each dataset individually or as a four-way meta-analysis. These MCO-supported analyses made it possible to identify MMP9 and TUBB2A as potential PD genetic biomarkers based on their persistent appearance across each of the case studies. A literature search confirmed the importance of these genes in PD and indeed as PD biomarkers, which evidences the code´s potential.

PMID:35085348 | DOI:10.1371/journal.pone.0262890