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Nevin Manimala Statistics

Validation of the motion sickness severity scale: Secondary analysis of a randomized, double-blind, placebo-controlled study of a treatment for motion sickness

PLoS One. 2023 Jan 5;18(1):e0280058. doi: 10.1371/journal.pone.0280058. eCollection 2023.

ABSTRACT

BACKGROUND: Motion sickness is characterized by nausea and vomiting among a constellation of symptoms. Symptom severity is dynamic and distressing. Most validated motion sickness scales are time-intensive and effortful, with alternative scales having uncertain performance or non-specific measures. A validated instrument allowing for facile, rapid assessment of core motion sickness symptom severity would therefore be valuable. We assessed the performance of the Motion Sickness Severity Scale (MSSS), a six-item questionnaire designed to measure real-time motion sickness symptoms.

METHODS: MSSS construct validity was assessed as a secondary analysis of data from 63 healthy participants without antiemetic treatment in a clinical trial (Unique Identifier = NCT03772340) conducted to evaluate the safety and efficacy of Tradipitant-a novel neurokinin-1 receptor antagonist-in the treatment of motion sickness. Clinical outcome assessments included the MSSS, the Patient Global Impression of Severity (PGI-S), and the Motion Sickness Assessment Questionnaire (MSAQ). The performance of the MSSS through Pearson correlation coefficients, within-group analysis of variance, empirical cumulative distribution functions, and Kolmogorov-Smirnov tests.

RESULTS: The MSSS correlated very highly with the PGI-S (r = 0.93, p-value<0.0001) and highly with the MSAQ (r = 0.83, p-value<0.0001). Mean MSSS scores between increasing PGI-S severity levels increased significantly in all four increments (None-to-Mild: p-value = 0.006, Mild-to-Moderate: p-value<0.0001, Moderate-to-Severe: p-value = 0.006, Severe-to-Very-Severe: p-value = 0.002). There were statistically significant differences in MSSS score distributions stratified by PGI-S severity level, with higher MSSS scores associated with higher PGI-S severity levels and lower MSSS scores associated with lower PGI-S severity levels.

DISCUSSION: The MSSS is a valid instrument for the assessment of the core motion sickness symptoms and is reflective of global disease severity. Implementation of the MSSS and comparable simplified, short questionnaires in motion sickness research will provide rapid and accurate measures of disease severity. These measures will enable further elucidation of motion sickness as an illness and inform the development and evaluation of motion sickness therapies.

PMID:36602998 | DOI:10.1371/journal.pone.0280058

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Nevin Manimala Statistics

US and EU Free Trade Agreements and implementation of policies to control tobacco, alcohol, and unhealthy food and drinks: A quasi-experimental analysis

PLoS Med. 2023 Jan 5;20(1):e1004147. doi: 10.1371/journal.pmed.1004147. eCollection 2023 Jan.

ABSTRACT

BACKGROUND: Identifying and tackling the factors that undermine regulation of unhealthy commodities is an essential component of effective noncommunicable disease (NCD) prevention. Unhealthy commodity producers may use rules in US and EU Free Trade Agreements (FTAs) to challenge policies targeting their products. We aimed to test whether there was a statistical relationship between US and EU FTA participation and reduced implementation of WHO-recommended policies.

METHODS AND FINDINGS: We performed a statistical analysis assessing the probability of at least partially implementing 10 tobacco, alcohol, and unhealthy food and drink policies in 127 countries in 2014, 2016, and 2019. We assessed differences in implementation of these policies in countries with and without US/EU FTAs. We used matching to conduct 48 covariate-adjusted quasi-experimental comparisons across 27 matched US/EU FTA members (87 country-years) and performed additional analyses and robustness checks to assess alternative explanations for our results. Out of our 48 tests, 19% (9/48) identified a statistically significant decrease in the predicted probability of at least partially implementing the unhealthy commodity policy in question, while 2% (1/48) showed an increase. However, there was marked heterogeneity across policies. At the level of individual policies, US FTA participation was associated with a 37% reduction (95%CI: -0.51 to -0.22) in the probability of fully implementing graphic tobacco warning policies, and a 53% reduction (95%CI: -0.63 to -0.43) in the probability of at least partially implementing smoke-free place policies. EU FTA participation was associated with a 28% reduction (95%CI: -0.45 to -0.10) in the probability of fully implementing graphic tobacco warning policies, and a 25% reduction (95%CI: -0.47 to -0.03) in the probability of fully implementing restrictions on child marketing of unhealthy food and drinks. There was a positive association with implementing fat limits and bans, but this was not robust. Associations with other outcomes were not significant. The main limitations included residual confounding, limited ability to discern precise mechanisms of influence, and potentially limited generalisability to other FTAs.

CONCLUSIONS: US and EU FTA participation may reduce the probability of implementing WHO-recommended tobacco and child food marketing policies by between a quarter and a half-depending on the FTA and outcome in question. Governments negotiating or participating in US/EU FTAs may need to establish robust health protections and mitigation strategies to achieve their NCD mortality reduction targets.

PMID:36602976 | DOI:10.1371/journal.pmed.1004147

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Nevin Manimala Statistics

Ten simple rules for implementing open and reproducible research practices after attending a training course

PLoS Comput Biol. 2023 Jan 5;19(1):e1010750. doi: 10.1371/journal.pcbi.1010750. eCollection 2023 Jan.

ABSTRACT

Open, reproducible, and replicable research practices are a fundamental part of science. Training is often organized on a grassroots level, offered by early career researchers, for early career researchers. Buffet style courses that cover many topics can inspire participants to try new things; however, they can also be overwhelming. Participants who want to implement new practices may not know where to start once they return to their research team. We describe ten simple rules to guide participants of relevant training courses in implementing robust research practices in their own projects, once they return to their research group. This includes (1) prioritizing and planning which practices to implement, which involves obtaining support and convincing others involved in the research project of the added value of implementing new practices; (2) managing problems that arise during implementation; and (3) making reproducible research and open science practices an integral part of a future research career. We also outline strategies that course organizers can use to prepare participants for implementation and support them during this process.

PMID:36602968 | DOI:10.1371/journal.pcbi.1010750

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Nevin Manimala Statistics

Food insecurity in the Eastern Indo-Gangetic plain: Taking a closer look

PLoS One. 2023 Jan 5;18(1):e0279414. doi: 10.1371/journal.pone.0279414. eCollection 2023.

ABSTRACT

OBJECTIVE: Food security is an important policy issue in India. As India recently ranked 107th out of 121 countries in the 2022 Global Hunger Index, there is an urgent need to dissect, and gain insights into, such a major decline at the national level. However, the existing surveys, due to small sample sizes, cannot be used directly to produce reliable estimates at local administrative levels such as districts.

DESIGN: The latest round of available data from the Household Consumer Expenditure Survey (HCES 2011-12) done by the National Sample Survey Office of India used stratified multi-stage random sampling with districts as strata, villages as first stage and households as second stage units.

SETTING: Our Small Area Estimation approach estimated food insecurity prevalence, gap, and severity of each rural district of the Eastern Indo-Gangetic Plain (EIGP) region by modeling the HCES data, guided by local covariates from the 2011 Indian Population Census.

PARTICIPANTS: In HCES, 5915 (34429), 3310 (17534) and 3566 (15223) households (persons) were surveyed from the 71, 38 and 18 districts of the EIGP states of Uttar Pradesh, Bihar and West Bengal respectively.

RESULTS: We estimated the district-specific food insecurity indicators, and mapped their local disparities over the EIGP region. By comparing food insecurity with indicators of climate vulnerability, poverty and crop diversity, we shortlisted the vulnerable districts in EIGP.

CONCLUSIONS: Our district-level estimates and maps can be effective for informed policy-making to build local resiliency and address systemic vulnerabilities where they matter most in the post-pandemic era.

ADVANCES: Our study computed, for the Indian states in the EIGP region, the first area-level small area estimates of food insecurity as well as poverty over the past decade, and generated a ranked list of districts upon combining these data with measures of crop diversity and climatic vulnerability.

PMID:36602961 | DOI:10.1371/journal.pone.0279414

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Nevin Manimala Statistics

Relationship of mental health and burnout with empathy among medical students in Thailand: A multicenter cross-sectional study

PLoS One. 2023 Jan 5;18(1):e0279564. doi: 10.1371/journal.pone.0279564. eCollection 2023.

ABSTRACT

OBJECTIVES: To explore mental health, burnout, and the factors associated with the level of empathy among Thai medical students.

BACKGROUND: Empathy is an important component of a satisfactory physician-patient relationship. However, distress, including burnout and lack of personal well-being, are recognized to affect a lower level of empathy.

MATERIAL AND METHODS: A cross-sectional study surveyed sixth-year medical students at three faculties of medicine in Thailand at the end of the 2020 academic year. The questionnaires utilized were: 1) Personal and demographic information questionnaire, 2) Thai Mental Health Indicator-15, 3) The Maslach Burnout Inventory-Thai version, and 4) The Toronto Empathy Questionnaire. All data were analyzed using descriptive statistics, and factors associated with empathy level were analyzed via the Chi-square test or Fisher’s exact test, logistic regression., and linear regression.

RESULTS: There were 336 respondents with a response rate of 70.3%. The majority were female (61.9%). Most participants reported a below-average level of empathy (61%) with a median score (IQR) of 43 (39-40). Assessment of emotion comprehension in others and altruism had the highest median empathy subgroup scores, whereas behaviors engaging higher-order empathic responses had the lowest median empathy subgroup score. One-third of participants (32.1%) had poor mental health, and two-thirds (62.8%) reported a high level of emotional exhaustion even though most of them perceived having a high level of personal accomplishment (97%). The multivariate analysis indicated that mental health was statistically significantly associated with the level of empathy. The participants with higher levels of depersonalization had statistically lower scores of demonstrating appropriate sensitivity, altruism, and behaviors engaging higher-order empathic responding.

CONCLUSIONS: Most medical students had below-average empathy levels, and two-thirds of them had high emotional exhaustion levels, yet most of them reported having a high level of personal accomplishment and good mental health. There was an association between mental health and the level of empathy. Higher levels of depersonalization related to lower scores of demonstrating sensitivity, altruism, and behaviors responding. Therefore, medical educators should pay close attention to promoting good mental health among medical students.

PMID:36602955 | DOI:10.1371/journal.pone.0279564

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Nevin Manimala Statistics

QuickStats: Percentage of Mothers with Gestational Diabetes,* by Maternal Age – National Vital Statistics System, United States, 2016 and 2021

MMWR Morb Mortal Wkly Rep. 2023 Jan 6;72(1):16. doi: 10.15585/mmwr.mm7201a4.

NO ABSTRACT

PMID:36602935 | DOI:10.15585/mmwr.mm7201a4

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Nevin Manimala Statistics

Physical exercise for people with Parkinson’s disease: a systematic review and network meta-analysis

Cochrane Database Syst Rev. 2023 Jan 5;1:CD013856. doi: 10.1002/14651858.CD013856.pub2.

ABSTRACT

BACKGROUND: Physical exercise is effective in managing Parkinson’s disease (PD), but the relative benefit of different exercise types remains unclear.

OBJECTIVES: To compare the effects of different types of physical exercise in adults with PD on the severity of motor signs, quality of life (QoL), and the occurrence of adverse events, and to generate a clinically meaningful treatment ranking using network meta-analyses (NMAs).

SEARCH METHODS: An experienced information specialist performed a systematic search for relevant articles in CENTRAL, MEDLINE, Embase, and five other databases to 17 May 2021. We also searched trial registries, conference proceedings, and reference lists of identified studies up to this date.

SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing one type of physical exercise for adults with PD to another type of exercise, a control group, or both.

DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. A third author was involved in case of disagreements. We categorized the interventions and analyzed their effects on the severity of motor signs, QoL, freezing of gait, and functional mobility and balance up to six weeks after the intervention using NMAs. Two review authors independently assessed the risk of bias using the risk of bias 2 (RoB 2) tool and rated the confidence in the evidence using the CINeMA approach for results on the severity of motor signs and QoL. We consulted a third review author to resolve any disagreements. Due to heterogeneous reporting of adverse events, we summarized safety data narratively and rated our confidence in the evidence using the GRADE approach.

MAIN RESULTS: We included 156 RCTs with a total of 7939 participants with mostly mild to moderate disease and no major cognitive impairment. The number of participants per study was small (mean 51, range from 10 to 474). The NMAs on the severity of motor signs and QoL included data from 71 (3196 participants), and 55 (3283 participants) trials, respectively. Eighty-five studies (5192 participants) provided safety data. Here, we present the main results. We observed evidence of beneficial effects for most types of physical exercise included in our review compared to a passive control group. The effects on the severity of motor signs and QoL are expressed as scores on the motor scale of the Unified Parkinson Disease Rating Scale (UPDRS-M) and the Parkinson’s Disease Questionnaire 39 (PDQ-39), respectively. For both scales, higher scores denote higher symptom burden. Therefore, negative estimates reflect improvement (minimum clinically important difference: -2.5 for UPDRS-M and -4.72 for PDQ-39). Severity of motor signs The evidence from the NMA (71 studies; 3196 participants) suggests that dance has a moderate beneficial effect on the severity of motor signs (mean difference (MD) -10.32, 95% confidence interval (CI) -15.54 to -4.96; high confidence), and aqua-based, gait/balance/functional, and multi-domain training might have a moderate beneficial effect on the severity of motor signs (aqua-based: MD -7.77, 95% CI -13.27 to -2.28; gait/balance/functional: MD -7.37, 95% CI -11.39 to -3.35; multi-domain: MD -6.97, 95% CI -10.32 to -3.62; low confidence). The evidence also suggests that mind-body training and endurance training might have a small beneficial effect on the severity of motor signs (mind-body: MD -6.57, 95% CI -10.18 to -2.81; endurance: MD -6.43, 95% CI -10.72 to -2.28; low confidence). Flexibility training might have a trivial or no effect on the severity of motor signs (MD 2.01, 95% CI -4.82 to 8.98; low confidence). The evidence is very uncertain about the effects of strength/resistance training and “Lee Silverman Voice training BIG” (LSVT BIG) on the severity of motor signs (strength/resistance: MD -6.97, 95% CI -11.93 to -2.01; LSVT BIG: MD -5.49, 95% CI -14.74 to 3.62; very low confidence). Quality of life The evidence from the NMA (55 studies; 3283 participants) suggests that aqua-based training probably has a large beneficial effect on QoL (MD -14.98, 95% CI -23.26 to -6.52; moderate confidence). The evidence also suggests that endurance training might have a moderate beneficial effect, and that gait/balance/functional and multi-domain training might have a small beneficial effect on QoL (endurance: MD -9.16, 95% CI -15.68 to -2.82; gait/balance/functional: MD -5.64, 95% CI -10.04 to -1.23; multi-domain: MD -5.29, 95% CI -9.34 to -1.06; low confidence). The evidence is very uncertain about the effects of mind-body training, gaming, strength/resistance training, dance, LSVT BIG, and flexibility training on QoL (mind-body: MD -8.81, 95% CI -14.62 to -3.00; gaming: MD -7.05, 95% CI -18.50 to 4.41; strength/resistance: MD -6.34, 95% CI -12.33 to -0.35; dance: MD -4.05, 95% CI -11.28 to 3.00; LSVT BIG: MD 2.29, 95% CI -16.03 to 20.44; flexibility: MD 1.23, 95% CI -11.45 to 13.92; very low confidence). Adverse events Only 85 studies (5192 participants) provided some kind of safety data, mostly only for the intervention groups. No adverse events (AEs) occurred in 40 studies and no serious AEs occurred in four studies. AEs occurred in 28 studies. The most frequently reported events were falls (18 studies) and pain (10 studies). The evidence is very uncertain about the effect of physical exercise on the risk of adverse events (very low confidence). Across outcomes, we observed little evidence of differences between exercise types.

AUTHORS’ CONCLUSIONS: We found evidence of beneficial effects on the severity of motor signs and QoL for most types of physical exercise for people with PD included in this review, but little evidence of differences between these interventions. Thus, our review highlights the importance of physical exercise regarding our primary outcomes severity of motor signs and QoL, while the exact exercise type might be secondary. Notably, this conclusion is consistent with the possibility that specific motor symptoms may be treated most effectively by PD-specific programs. Although the evidence is very uncertain about the effect of exercise on the risk of adverse events, the interventions included in our review were described as relatively safe. Larger, well-conducted studies are needed to increase confidence in the evidence. Additional studies recruiting people with advanced disease severity and cognitive impairment might help extend the generalizability of our findings to a broader range of people with PD.

PMID:36602886 | DOI:10.1002/14651858.CD013856.pub2

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Nevin Manimala Statistics

Adjusting for publication bias in meta-analysis via inverse probability weighting using clinical trial registries

Biometrics. 2023 Jan 5. doi: 10.1111/biom.13822. Online ahead of print.

ABSTRACT

Publication bias is a major concern in conducting systematic reviews and meta-analyses. Various sensitivity analysis or bias-correction methods have been developed based on selection models, and they have some advantages over the widely used trim-and-fill bias-correction method. However, likelihood methods based on selection models may have difficulty in obtaining precise estimates and reasonable confidence intervals, or require a rather complicated sensitivity analysis process. Herein, we develop a simple publication bias adjustment method by utilizing the information on conducted but still unpublished trials from clinical trial registries. We introduce an estimating equation for parameter estimation in the selection function by regarding the publication bias issue as a missing data problem under the missing not at random assumption. With the estimated selection function, we introduce the inverse probability weighting (IPW) method to estimate the overall mean across studies. Furthermore, the IPW versions of heterogeneity measures such as the between-study variance and the measure are proposed. We propose methods to construct confidence intervals based on asymptotic normal approximation as well as on parametric bootstrap. Through numerical experiments, we observed that the estimators successfully eliminated bias, and the confidence intervals had empirical coverage probabilities close to the nominal level. On the other hand, the confidence interval based on asymptotic normal approximation is much wider in some scenarios than the bootstrap confidence interval. Therefore, the latter is recommended for practical use. This article is protected by copyright. All rights reserved.

PMID:36602873 | DOI:10.1111/biom.13822

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Nevin Manimala Statistics

Paediatric HIV slow-progression is associated with early CD8+ T-cell PD-1 expression and a stem-like phenotype

JCI Insight. 2023 Jan 5:e156049. doi: 10.1172/jci.insight.156049. Online ahead of print.

ABSTRACT

HIV non-progression despite persistent viraemia is rare among antiretroviral therapy (ART)-naïve adults, but relatively common among ART-naïve children. Previous studies indicate that ART-naïve paediatric slow-progressors (PSPs) adopt immune evasion strategies similar to those described in the SIV natural hosts. However, the mechanisms underlying this immunophenotype are not well understood. In a cohort of early-treated infants who underwent analytical treatment interruption (ATI) after 12 months of ART, expression of PD-1 on CD8+ T-cells immediately prior to ATI was the main predictor of slow progression during ATI (r=0.77, p=0.002). PD-1+ CD8+ T-cell frequency was also negatively correlated with CCR5 (r=-0.74, p=0.005) and HLA-DR (r=-0.63, p=0.02) expression on CD4+ T-cells and predicted stronger HIV-specific T-lymphocyte responses. In the CD8+ T-cell compartment of PSPs, we identified an enrichment of stem-like TCF-1+PD-1+ memory cells, whereas paediatric progressors and viraemic adults were populated with a terminally exhausted PD-1+CD39+ population. TCF-1+PD-1+ expression on CD8+ T-cells was associated with higher proliferative activity (r=0.41, p=0.03) and stronger Gag-specific effector functionality. These data prompt the hypothesis that the proliferative burst potential of stem-like HIV-specific cytotoxic cells could be exploited in therapeutic strategies to boost the antiviral response and facilitate remission in early-ART-treated infants with a preserved and non-exhausted T-cell compartment.

PMID:36602861 | DOI:10.1172/jci.insight.156049

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Nevin Manimala Statistics

Clinical characteristics and 12-month outcomes in MINOCA patients before and during the COVID-19 pandemic

Pol Arch Intern Med. 2023 Jan 5:16405. doi: 10.20452/pamw.16405. Online ahead of print.

ABSTRACT

INTRODUCTION: The SARS-CoV-2 infection is associated with an increased risk of thromboembolic complications.

OBJECTIVES: We aimed to compare patient characteristics, and 12-month clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) before and during the COVID-19 pandemic.

PATIENTS AND METHODS: We retrospectively analyzed data of 51,734 patients with acute myocardial infarction registered in the nationwide PL-ACS database in 2019 and 2020, finally including 3,178 MINOCA patients. We compared baseline characteristics, management strategies, and 12-month clinical outcomes of MINOCA patients before (2019) and during (2020) the COVID-19 pandemic.

RESULTS: The MINOCA percentage was higher in 2019 than 2020 (6.3% vs. 5.9%, P = 0.03). The groups did not differ apart from the higher hypercholesterolemia rate before the pandemic (33.9% vs. 28.2%, P < 0.001). We observed in-hospital stroke more frequently during pandemic (0 vs. 0.3%, P = 0.01). However, other in-hospital complications were similar between groups. Most patients were discharged on aspirin (85.6%), beta-blocker (73.1%), angiotensin convertase enzyme inhibitor/angiotensin receptor blocker (70.2%), and statin (62.7%), but only 50.6% of patients received P2Y12 inhibitor. There was no statistical difference in 12-month all-cause mortality in patients with MINOCA before and during pandemic (total population 9.9%; 9.2% [2019] vs. 11.0% [2020], P = 0.09).

CONCLUSIONS: We observed a lower percentage of MINOCA cases and higher in-hospital stroke rates in MINOCA patients during the COVID-19 pandemic. The possible association between worse clinical outcomes of MINOCA patients during the COVID-19 pandemic and thromboembolic complications of SARS-CoV-2 infection needs further evaluation.

PMID:36602860 | DOI:10.20452/pamw.16405