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Nevin Manimala Statistics

Assessing the impact of COVID-19 on psychiatric clinical trials

J Psychiatr Res. 2022 Jan 15;148:127-130. doi: 10.1016/j.jpsychires.2022.01.017. Online ahead of print.

ABSTRACT

OBJECTIVE: COVID-19 and associated measures to control the spread of the COVID-19 has significantly impacted clinical research. This study aimed to determine the impact COVID-19 has had on psychiatric clinical trials and to assess whether certain trial areas or trial types were differentially affected.

METHODS: We used information from ClinicalTrials.gov, the largest online database of clinical trial information, to examine changes in psychiatric clinical trials from January 2010-December 2020.

RESULTS: Clinical trial initiation decreased in 2020, with a year-on-year percent change in trial initiation of -5.4% versus an expected percent change based on forecasting observed trends from 2010 to 2019 of 8.6%. When broken down by disease area, the distribution of trials observed in 2020 was significantly different from the predicted distribution (p < 0.00001). The greatest decrease in trial initiation was seen in Schizophrenia-specific trials, with an observed percent change of -29.2% versus an expected percent change of 3.2%. Conversely, anxiety trials saw a significant increase in trial initiation during 2020, with an observed percent change of 24.6% versus an expected percent change of 16.0%. When assessing interventional versus observational studies, data showed a significant increase in initiation of observational psychiatric clinical trials (p < 0.05), and a significant decrease in initiation of interventional psychiatric clinical trials (p < 0.01). When data was analyzed on a month-by-month time scale, 7/12 months in 2020 showed significant decreases when compared to initiation during matching months over prior years, and a single month, June, showed a significant increase.

CONCLUSION: COVID-19 has had significant impacts on the initiation of psychiatric clinical trials over 2020, and this decrease in trial initiation may have long-term impacts on the development and assessment of psychiatric treatments and therapeutics.

PMID:35123324 | DOI:10.1016/j.jpsychires.2022.01.017

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Nevin Manimala Statistics

A tutorial on the use of temporal principal component analysis in developmental ERP research – Opportunities and challenges

Dev Cogn Neurosci. 2022 Jan 15;54:101072. doi: 10.1016/j.dcn.2022.101072. Online ahead of print.

ABSTRACT

Developmental researchers are often interested in event-related potentials (ERPs). Data-analytic approaches based on the observed ERP suffer from major problems such as arbitrary definition of analysis time windows and regions of interest and the observed ERP being a mixture of latent underlying components. Temporal principal component analysis (PCA) can reduce these problems. However, its application in developmental research comes with the unique challenge that the component structure differs between age groups (so-called measurement non-invariance). Separate PCAs for the groups can cope with this challenge. We demonstrate how to make results from separate PCAs accessible for inferential statistics by re-scaling to original units. This tutorial enables readers with a focus on developmental research to conduct a PCA-based ERP analysis of amplitude differences. We explain the benefits of a PCA-based approach, introduce the PCA model and demonstrate its application to a developmental research question using real-data from a child and an adult group (code and data openly available). Finally, we discuss how to cope with typical challenges during the analysis and name potential limitations such as suboptimal decomposition results, data-driven analysis decisions and latency shifts.

PMID:35123341 | DOI:10.1016/j.dcn.2022.101072

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Nevin Manimala Statistics

Wilcoxon-Mann-Whitney odds ratio: A statistical measure for ordinal outcomes such as EDSS

Mult Scler Relat Disord. 2022 Jan 10;59:103516. doi: 10.1016/j.msard.2022.103516. Online ahead of print.

ABSTRACT

BACKGROUND: In many clinical situations, ordinal scales afford the primary method of semi-quantifying patient outcomes. In the field of multiple sclerosis, the primary ordinal scale is the Expanded Disability Status Scale. Predominant methods of ordinal scale statistical analysis provide a p-value without effect size or rely heavily on the assumption of proportionality of odds, subjecting them to lack of power and error. The Wilcoxon-Manny-Whitney Odds is a statistical method which provides significant information such as p-value, effect size, number needed to treat, confidence intervals, and is largely assumption-free. However, its utility has not been demonstrated in the field of multiple sclerosis.

METHODS: Three clinical studies in the field of multiple sclerosis were selected which utilized ordinal scale outcomes at group or individual levels. Data from these studies was extracted using WebPlotDigitizer, and a custom Wilxocon-Mann-Whitney Odds software was applied to each dataset to re-analyze the main outcomes of the studies.

RESULTS: Re-analysis of the manuscript by Muraro et al., 2017 demonstrated that autologous stem cell transplantation for relapsing remitting multiple sclerosis resulted in a 65% chance of improving from any Expanded Disability Status Scale category, although not significant. Re-analysis of the manuscript by Songthammawat et al., 2019 demonstrated chance of improvement with intravenous methylprednisolone and concurrent plasma exchange was 185% versus 32% in intravenous methylprednisolone with add-on plasma exchange, although not significant. Re-analysis of Kister et al., 2012 demonstrated the chances of mobility or cognition scores generally favored decline at every 5-year increment of study, and although statistically significant, these were smaller effect sizes ranging from an 11% chance of improvement to a 66% chance of decline over a 5-year interval.

DISCUSSION: The Wilcoxon-Mann-Whitney Odds simplifies ordinal data analysis with its robust largely assumption-free nature. In the place of numerous statistical tests, this single test provides effect size estimate, number needed to treat, p-values, and confidence intervals. Importantly, the Wilcoxon-Mann-Whitney Odds effect size calculation is intuitively applicable to both individual and population-levels. Further, the Wilcoxon-Mann-Whitney Odds allows intuitive description of the progression of large cohorts over time, and we were able to clearly convey the odds of mobility and cognitive decline over 30 years in a large multiple sclerosis cohort. Overall, the Wilcoxon-Mann-Whitney Odds is a powerful and robust statistical test with significant promise within the field of multiple sclerosis.

PMID:35123291 | DOI:10.1016/j.msard.2022.103516

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Nevin Manimala Statistics

Comorbidity in multiple sclerosis: Emphasis on patient-reported outcomes

Mult Scler Relat Disord. 2022 Jan 31;59:103558. doi: 10.1016/j.msard.2022.103558. Online ahead of print.

ABSTRACT

BACKGROUND: Aim of our study was to estimate the prevalence of comorbid conditions and adverse health behaviors in relapsing-remitting multiple sclerosis (RRMS) patients and evaluate association between comorbidity and MS outcomes (relapse rate, fatigue and quality of life) in Lithuanian setting.

METHODS: A prospective cohort study was carried out in the MS center of Lithuanian University of Health Sciences Hospital Kaunas clinics from November 2016 to March 2021. People with MS filled a self-report comorbidity and adverse health behavior questionnaire, visual analogue fatigue scale (VAFS), a Short Form 36 (SF-36) v2 health related quality of life questionnaire (QoL). Information about disability and relapses was acquired from medical documentation and Lithuanian MS registry at baseline and after 24-month observational period. Chi square, t-test, ANOVA, Mann-Whitney U were used for basic statistical evaluation. Multivariable logistic regression models were used to prognose MS outcomes in association to comorbidity and adverse health behaviors, adjusting for age and baseline disability.

RESULTS: Of 230 RRMS patients, 167 (72.6%) were women, average age was 42 years. 207 persons were followed through the observational period and included into relapse analysis. 112 (48.7%) of participants reported having at least one comorbidity, the most prevalent were arterial hypertension (19.1%) depression (16.5%) and anxiety (14.8%). People with comorbidities had higher fatigue (6.6 vs. 5.3, p < 0.001) and lower quality of life (overall SF-36 46.3 vs 59.1, p < 0.001). People consuming alcohol had fewer relapses per 24 months (0.56 vs. 0.82, p = 0.01), lower fatigue (5.7 vs. 6.4, p = 0.03), better quality of life (overall SF-36: 56.8 vs. 45.6, p < 0.001), compared to abstinents. In regression models, comorbidities were associated with severe (>7 VAFS) fatigue (Exp(B)=1.98, 95% CI [1.02, 3.86], p = 0.043), diminished (<50 SF-36) QoL (Exp(B)=3.50, 95% CI [1.72, 7.09], p = 0.001). Depression was independently associated with lower QoL (Exp(B)= 2.86, 95% CI [1.04, 7.88], p = 0.042) and severe fatigue (Exp(B)=4.65, 95% CI [2.39, 9.01], p < 0.001); anxiety with diminished QoL (Exp(B)= 4.99, 95%CI [1.67, 14.92], p = 0.002). Light alcohol consumption (compared to abstinents) was associated with decreased risk for: relapse during 24 months (Exp(B)=0.44, 95% CI[0.24, 0.77], p = 0.005), severe fatigue (Exp(B)=0.48, 95% CI [0.24, 0.98], p = 0.042) and lower QoL (Exp(B)= 0.32, 95% CI [0.16, 0.65], p = 0.002).

CONCLUSION: Comorbidity is a relevant issue in multiple sclerosis as half of people with MS report concomitant conditions. Hypertension, depression, and anxiety are especially prevalent in MS. In our study, comorbidity is associated with quality of life and fatigue, but not relapse rate. Depression and anxiety are independently associated with lower quality of life and higher fatigue. Light alcohol consumption is associated with reduced relapse risk, less fatigue and better quality of life. Overweight and tobacco smoking do not seem to have negative impact on MS outcomes in our sample.

PMID:35123292 | DOI:10.1016/j.msard.2022.103558

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Nevin Manimala Statistics

Dialectical behavior therapy skills training for individuals with multiple sclerosis and their support partners: A pilot randomized controlled trial

Mult Scler Relat Disord. 2022 Jan 8;59:103481. doi: 10.1016/j.msard.2021.103481. Online ahead of print.

ABSTRACT

BACKGROUND: Symptoms of anxiety, depression, and emotion dysregulation are common among individuals with MS and their support partners. Dialectical behavior therapy (DBT) – a type of cognitive behavioral intervention – may be a promising treatment for individuals affected by MS. This pilot randomized controlled trial (RCT) assessed the effects and feasibility of remotely delivered DBT skills on anxiety and depression symptoms and emotion dysregulation in individuals with MS and their support partners.

METHODS: This study featured a single-masked, two-arm, parallel group design. Twenty pairs of individuals with MS and their support partners (n = 40) were randomized to 12 weeks of DBT or facilitated peer support (FPS). Masked assessments were completed at weeks 0 (baseline), 13 (post-intervention), and 26 (follow-up).

RESULTS: At post-intervention (primary endpoint), participants randomized to DBT exhibited significantly greater reductions in anxiety and depression symptoms compared to FPS (B = 4.45, p = .04, Cohen’s d = 0.57). Secondary outcomes of emotion dysregulation and well-being favored the DBT group but did not reach statistical significance (ds = 0.51, ps = 0.07). Effects were not maintained at follow-up. Most (86%) individuals screened were eligible for the trial, and retention (70%) did not differ between study arms.

CONCLUSIONS: This pilot RCT provides encouraging evidence that DBT skills is feasible and may improve depression, anxiety, and emotion dysregulation for individuals with MS and their support partners. Future research is needed to optimize maintenance of DBT skills, investigate mechanisms for these improvements, and replicate these promising effects in a fully powered trial.

PMID:35123290 | DOI:10.1016/j.msard.2021.103481

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Nevin Manimala Statistics

Transmissibility and pathogenicity of the severe acute respiratory syndrome coronavirus 2: A systematic review and meta-analysis of secondary attack rate and asymptomatic infection

J Infect Public Health. 2022 Jan 31;15(3):297-306. doi: 10.1016/j.jiph.2022.01.015. Online ahead of print.

ABSTRACT

BACKGROUND: Understanding the transmissibility and pathogenicity of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is crucial for control policies, but evidence remains limited.

METHODS: We presented a systematic and meta-analytic summary concerning the transmissibility and pathogenicity of COVID-19.

RESULTS: A total of 105 studies were identified, with 35042 infected cases and 897912 close contacts. 48.6% (51/105) of studies on secondary transmissions were from China. We estimated a total SIR of 7.8% (95% confidence interval [CI], 6.8%-8.8%), SAR of 6.6% (95% CI, 5.7%-7.5%), and symptomatic infection ratio of 86.9% (95%CI, 83.9%-89.9%) with a disease series interval of 5.84 (95%CI, 4.92-6.94) days. Household contacts had a higher risk of both symptomatic and asymptomatic infection, and transmission was driven between index cases and second-generation cases, with little transmission occurring in second-to-later-generation cases (SIR, 12.4% vs. 3.6%). The symptomatic infection ratio was not significantly different in terms of infection time, generation, type of contact, and index cases.

CONCLUSIONS: Our results suggest a higher risk of infection among household contacts. Transmissibility decreased with generations during the intervention. Pathogenicity of SARS-CoV-2 varied among territories, but didn’t change over time. Strict isolation and medical observation measures should be implemented.

PMID:35123279 | DOI:10.1016/j.jiph.2022.01.015

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Nevin Manimala Statistics

Multi-type childhood maltreatment exposure and substance use development from adolescence to early adulthood: A GxE study

Child Abuse Negl. 2022 Feb 2;126:105508. doi: 10.1016/j.chiabu.2022.105508. Online ahead of print.

ABSTRACT

BACKGROUND: Childhood maltreatment types can co-occur and are associated with increased substance use during adolescence and early adulthood. There is also a strong genetic basis for substance use which interacts with environmental factors (e.g., childhood maltreatment) to influence substance use phenotype.

OBJECTIVE: This research aimed to identify childhood maltreatment sub-groups based on type and chronicity, and their association with substance use change from adolescence to early adulthood, while accounting for the influence of substance use polygenic risk (i.e., genetic risk based on the combined effects of multiple genes).

PARTICIPANTS: We used a sample of unrelated European-origin Americans with genetic and childhood maltreatment data (n = 2,664) from the National Longitudinal Study of Adolescent to Adult Health.

METHODS: Latent profile analysis was used for sub-group identification and direct and interaction effects were tested for longitudinal trajectories of substance use utilizing generalized estimating equations.

RESULTS: Three sub-groups with co-occurring childhood maltreatment exposures were identified: a high sexual abuse sub-group, a high physical abuse sub-group, and a normative sub-group (with low maltreatment exposure). At high polygenic risk, the high physical abuse sub-group had faster increases in substance use over time. In comparison, the high sexual abuse sub-group had faster progression in substance use only at low and medium polygenic risk.

CONCLUSIONS: Findings provide initial evidence for biological and environmental differences among maltreatment sub-groups on trajectories of substance use.

PMID:35123282 | DOI:10.1016/j.chiabu.2022.105508

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Nevin Manimala Statistics

Assessment and sources identification of microplastics, PAHs and OCPs in the Luoyuan Bay, China: Based on multi-statistical analysis

Mar Pollut Bull. 2022 Feb 2;175:113351. doi: 10.1016/j.marpolbul.2022.113351. Online ahead of print.

ABSTRACT

Luoyuan Bay is a mariculture influenced water body located in southeastern China. Multi-statistical techniques were applied to 21 sampling locations in the bay to identify the sources of microplastics and other pollutants in the sediment. In microplastics detection, fragment was the most abundant shape (~36%), and rayon was the dominant polymer (~59%). The size of more than 48% of total microplastics observed was less than 200 μm. The study showed that the upper part of Luoyuan Bay was dominated by microplastic pollution, while the lower part of the bay was dominated by persistent organic pollutants (PAHs, OCPs). Mariculture is one of the main sources of pollution in Luoyuan Bay. Apart from mariculture, there were additional sources such as industry, land reclamation, port, and so on; industry and land reclamation were the leading sources of microplastics, while port, industry, and mariculture were the primary sources of PAHs and OCPs.

PMID:35123274 | DOI:10.1016/j.marpolbul.2022.113351

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Nevin Manimala Statistics

Reconstruction of full femora from partial bone fragments for anthropological analyses using statistical shape modeling

Forensic Sci Int. 2022 Jan 29;332:111196. doi: 10.1016/j.forsciint.2022.111196. Online ahead of print.

ABSTRACT

OBJECTIVES: Due to taphonomic processes such as burial, fire, or animal activity, bones are often found incomplete, which can pose problematic for establishing the biological profile of the deceased using anthropological methods. The aim of this study is to test the feasibility of using statistical shape modeling (SSM) to reconstruct full femora from simulated partial femora and determine the accuracy of the reconstruction. Moreover, we assess the accuracy of sex estimation and the degree of stature error added based on the reconstructed femur using different anthropological methods.

METHODS: A total of 42 (28 female, 14 female) 3D models of left femora extracted from computed tomography (CT) scans were used. We performed a leave-one-out cross-validation (LOOCV) where 41 bones were used to build the SSM and one bone was used for testing. This bone was cut in 1 cm steps proximally, distally and from both ends up to 10 cm, reconstructed using SSM, and tested using the methods established by Stewart and Purkait (2005), Trotter and Gleser (1952), as well as a method based on SSM. with landmarks being automatically identified.

RESULTS: The error induced by reconstructing the femur to the length measurements was low, which translated into useful stature estimations (single sided cuts up to 10 cm: 0.4-1.1%, double sided<2% for cuts shorter than 6 cm). Using Purkaits method for sex estimation on reconstructed bones looked promising as well (single sided: 90.5% when compared to applying Purkaits method on the original bone, double sided 78.6% (10 cm cut) to 97.6% (1-3 cm cuts)) Using SSM for sex classification looked promising as well (single sided cut: 81-85.7%, double sided cut: 59.5-85.3%) CONCLUSION: SSM can be used to reconstruct fragmented femora. These reconstructions can be used for sex and stature estimations, at the cost of lower accuracy. Using SSM might give investigators an additional tool to gain information about the biological profile of a deceased in cases where the fragmentation of a femur does not allow for using other anthropological methods.

PMID:35123259 | DOI:10.1016/j.forsciint.2022.111196

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Nevin Manimala Statistics

Investigation of factors associated with stigma and social support in patients with epilepsy in Turkey: A cross-sectional study

Epilepsy Behav. 2022 Feb 2;128:108572. doi: 10.1016/j.yebeh.2022.108572. Online ahead of print.

ABSTRACT

AIM: The purpose of this study was to identify the stigma and multidimensional perceived social support levels of patients with epilepsy, as well as the factors affecting them.

METHOD: The sample of the study consisted of 115 patients with epilepsy followed up in a university hospital in eastern Turkey. The data of the study were collected using the descriptive information form, the Jacoby Stigma Scale, and the Multidimensional Scale of Perceived Social Support. Data analysis was performed using t-test, one-way analysis of variance (ANOVA), and Pearson correlation coefficient.

RESULTS: The rate of exposure to stigma of the patients in the study was 62.4%. Those under 30 years of age, single, with low economic status, and living with their parents and siblings had higher stigma scale mean scores than the other groups (p = 0.001, p < 0.001, p = 0.001, p = 0.019, respectively). Multidimensional Scale of Perceived Social Support total scores were higher in women and married people (p = 0.020, p = 0.01, respectively). A statistically significant negative moderate correlation was found between the patients’ Stigma scale mean values and Multidimensional Perceived Social Support Scale mean values (r = -0.568. p < 0.01).

CONCLUSION: According to the study’s findings, stigma is prevalent among patients with epilepsy. Increasing social awareness in order to augment social support in patients with epilepsy and providing the patient with positive coping strategies may be effective in reducing stigma in patients with epilepsy.

PMID:35123241 | DOI:10.1016/j.yebeh.2022.108572