Tag: statistics

Clin Pharmacol Drug Dev. 2021 Jul 9. doi: 10.1002/cpdd.989. Online ahead of print.

ABSTRACT

This single-center, randomized, 3-way crossover thorough QT study evaluated the effect of steady-state supratherapeutic venlafaxine (Effexor) on cardiac repolarization. Fifty-four healthy adults received double-blinded extended-release venlafaxine 450 mg/d and placebo and open-label positive-control moxifloxacin 400 mg. The postdose QT intervals corrected for heart rate using the Fridericia formula (QTcF) were assessed on day 14 with an analysis of covariance using a mixed-effects model. At each time, the upper bound of the 2-sided 90%CI for time-matched least-squares (LS) mean difference between venlafaxine and placebo did not exceed the predefined cutoff of 10 milliseconds; the highest 90%CI upper bound was 5.8 milliseconds 24 hours postdose, demonstrating the lack of effect of venlafaxine on the QTc interval (primary objective). Assay sensitivity was established because the lower bound of the 2-sided 90%CI for LS mean difference in QTcF between moxifloxacin and placebo was 7.413 milliseconds on day 14 (postdose 3 hours). The exposure-response analysis demonstrated no evidence of increase in QTcF with increase in venlafaxine and desvenlafaxine concentrations. Also, supratherapeutic venlafaxine was found to be safe and well tolerated. Overall, the results demonstrated the lack of significant prolongation of the QTc interval with supratherapeutic venlafaxine 450 mg/d.

PMID:34242472 | DOI:10.1002/cpdd.989

Clin Pharmacol Ther. 2021 Jul 9. doi: 10.1002/cpt.2362. Online ahead of print.

ABSTRACT

The association between the use of Vitamin K antagonists (VKA) and cancer risk reduction remains unclear. We aimed to assess the association between the use of VKA or DOAC and the incidence of cancer in a large cohort of AF patients by meaans of a population-based, propensity-weighted cohort study using population-wide databases including patients diagnosed with non-valvular AF (NVAF) followed for up of 5 years (median 2.94 years). We created two cohorts based on the initiation therapy (VKA or DOAC). Initiation with VKA or DOAC was defined as filling a prescription with no previous exposure in the preceding 12 months. Cancer diagnoses of any type and for specific tumours (lung, colon, prostate, bladder, breast). We included 39,989 patients, 31,200 (78.0%) in the VKA cohort. Incidence rate for any cancer was 12.45 per 1000 person-year in the DOAC cohort, vs. 14.55 in the VKA cohort (adjusted HR: 1.16, 95% CI: 1.02-1.32). In secondary outcomes, no differences were found for specific types of cancer such as lung (HR: 1.28, CI: 0.89-1.83), colon (HR: 0.84, CI: 0.62-1.13), prostate (HR: 1.40, CI: 0.94-2.10), bladder (HR: 1.07, CI: 0.76-1.52), breast (HR: 1.05, CI: 0.66-1.69). Sensitivity analyses yielded similar results. Subgroup analyses also produced consistent findings, except for men, for whom VKA was associated with a lower risk of colon cancer (HR: 0.68; 95%CI: 0.48-0.96). Our results do not confirm a chemoprotective effect of VKA when compared to DOAC in a large, real-world cohort of NVAF patients followed for up to 5 years.

PMID:34242404 | DOI:10.1002/cpt.2362

Hepatology. 2021 Jul 9. doi: 10.1002/hep.32052. Online ahead of print.

ABSTRACT

The research by Liao et al.⁽¹⁾ showed that postdiagnosis aspirin use improved the mortality of various subtypes of biliary tract cancer (BTC). The results were impressive, with the adjusted hazard ratios of mortality ranging from 0.51 to 0.58, and all subgroup analyses were statistically significant. However, we think that some other aspects should be discussed.

PMID:34242426 | DOI:10.1002/hep.32052

Neuromodulation. 2021 Jul 9. doi: 10.1111/ner.13477. Online ahead of print.

ABSTRACT

OBJECTIVES: The purpose of the ongoing follow-up of ReActiv8-A clinical trial is to document the longitudinal benefits of episodic stimulation of the dorsal ramus medial branch and consequent contraction of the lumbar multifidus in patients with refractory mechanical chronic low back pain (CLBP). We report the four-year outcomes of this trial.

MATERIALS AND METHODS: ReActiv8-A is a prospective, single-arm trial performed at nine sites in the United Kingdom, Belgium, and Australia. Eligible patients had disabling CLBP (low back pain Numeric Rating Scale [NRS] ≥6; Oswestry Disability Index [ODI] ≥25), no indications for spine surgery or spinal cord stimulation, and failed conventional management including at least physical therapy and medications for low back pain. Fourteen days postimplantation, stimulation parameters were programmed to elicit strong, smooth contractions of the multifidus, and participants were given instructions to activate the device for 30-min stimulation-sessions twice daily. Annual follow-up through four years included collection of NRS, ODI, and European Quality of Life Score on Five Dimensions (EQ-5D). Background on mechanisms, trial design, and one-year outcomes were previously described.

RESULTS: At baseline (N = 53) (mean ± SD) age was 44 ± 10 years; duration of back pain was 14 ± 11 years, NRS was 6.8 ± 0.8, ODI 44.9 ± 10.1, and EQ-5D 0.434 ± 0.185. Mean improvements from baseline were statistically significant (p < 0.001) and clinically meaningful for all follow-ups. Patients completing year 4 follow-up, reported mean (±standard error of the mean) NRS: 3.2 ± 0.4, ODI: 23.0 ± 3.2, and EQ-5D: 0.721 ± 0.035. Moreover, 73% of participants had a clinically meaningful improvement of ≥2 points on NRS, 76% of ≥10 points on ODI, and 62.5% had a clinically meaningful improvement in both NRS and ODI and 97% were (very) satisfied with treatment.

CONCLUSIONS: In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality-of-life are clinically meaningful and durable through four years.

PMID:34242440 | DOI:10.1111/ner.13477

PLoS One. 2021 Jul 9;16(7):e0254460. doi: 10.1371/journal.pone.0254460. eCollection 2021.

ABSTRACT

This study aimed to evaluate the link between health problems, demographic factors, and the indoor environment quality of residents in Indonesia. We conducted a cross-sectional design study through a questionnaire survey with 443 respondents aged between 12 and 81 years. The questionnaire was concerned with previous health problem occurrences associated with thermal discomfort experiences, indoor environments, economic conditions, and basic anthropometric factors. Logistic regression with the odds ratio (OR) was applied to evaluate the tendency of different respondent groups to suffer from certain health problems, when compared to reference groups. Furthermore, structural equation modelling (SEM) was used to incorporate certain factors (economic conditions, thermal discomfort experiences, and perceived indoor environments) into a single model to understand their direct and indirect effects on health conditions. The results indicate that economic conditions are the most significantly associated with health problems. Furthermore, we found that the low-income group was the most vulnerable to health problems, including coughing, puking, diarrhoea, odynophagia, headaches, fatigue, rheumatism, fidgeting, skin rashes, muscle cramps, and insomnia (OR: 1.94-6.04, p <0.05). Additionally, the SEM suggested that the respondents’ economic conditions and thermal discomfort experiences had significant direct effects on their health problems with standardized estimates of -0.29 and 0.55, respectively. Additionally, perceived indoor environment quality, which is possible to cause thermal discomfort experience, indirectly affect health problems. These findings contribute an insightful and intuitive knowledge base which can aid health assessments associated with demographic and physical environments in developing sustainable and healthy environment strategies for the future.

PMID:34242376 | DOI:10.1371/journal.pone.0254460

PLoS One. 2021 Jul 9;16(7):e0254446. doi: 10.1371/journal.pone.0254446. eCollection 2021.

ABSTRACT

INTRODUCTION: From the outset of the COVID-19 pandemic, guidance from WHO has promoted social distancing, wearing face masks, frequent hand washing, and staying-at-home as measures to prevent the spread of COVID-19. For many across Africa, compliance can be difficult. The aim of this study was to 1) understand the impact of student’s household’s ability to comply with COVID-19 mitigation strategies, 2) identify predictors of mitigation strategy compliance, and 3) describe the impact of COVID-19 on household economics, food-security, and mental well-being.

MATERIALS AND METHODS: We conducted an email-based survey among current medical and pharmacy students of the University of Liberia College of Health Sciences between July and October 2020. The questionnaire was designed to explore their household’s ability to comply with current mitigation strategies, as well as the pandemic´s impact on the student’s household’s finances and food security. Descriptive statistics were used to delineate demographic characteristics. Logistic regression was used to model factors associated with ability to comply with COVID-19 mitigation strategies, as well as participant’s food security.

RESULTS: 113 persons responded to the questionnaire. Seventy-six (67∙3%) reported income losses as a result of the pandemic, with 93 (82∙3%) reporting being “somewhat” or “very worried” about their households’ finances. Seventy-seven (68∙1%) participants reported food stocks that were sufficient for one-week or less. Forty (35%) participants reported eating less preferred foods or skipping meals in the past week. Overall, 20 participants (19∙4%) had a positive depression screen.

CONCLUSIONS: Study participants showed mixed results in being able to adhere to national COVID-19 mitigation strategies, with household level stressors experienced around finances and food security. Until Liberia has access to vaccinations for most of its citizens, COVID-19 response measures need to provide social protections that address basic needs (shelter, clothing and food), and which specifically targets food insecurity. Preventative interventions for mental health problems must be incorporated into Liberia’s response to the pandemic.

PMID:34242378 | DOI:10.1371/journal.pone.0254446

PLoS One. 2021 Jul 9;16(7):e0254108. doi: 10.1371/journal.pone.0254108. eCollection 2021.

ABSTRACT

In current clinical settings, typically pain is measured by a patient’s self-reported information. This subjective pain assessment results in suboptimal treatment plans, over-prescription of opioids, and drug-seeking behavior among patients. In the present study, we explored automatic objective pain intensity estimation machine learning models using inputs from physiological sensors. This study uses BioVid Heat Pain Dataset. We extracted features from Electrodermal Activity (EDA), Electrocardiogram (ECG), Electromyogram (EMG) signals collected from study participants subjected to heat pain. We built different machine learning models, including Linear Regression, Support Vector Regression (SVR), Neural Networks and Extreme Gradient Boosting for continuous value pain intensity estimation. Then we identified the physiological sensor, feature set and machine learning model that give the best predictive performance. We found that EDA is the most information-rich sensor for continuous pain intensity prediction. A set of only 3 features from EDA signals using SVR model gave an average performance of 0.93 mean absolute error (MAE) and 1.16 root means square error (RMSE) for the subject-independent model and of 0.92 MAE and 1.13 RMSE for subject-dependent. The MAE achieved with signal-feature-model combination is less than 1 unit on 0 to 4 continues pain scale, which is smaller than the MAE achieved by the methods reported in the literature. These results demonstrate that it is possible to estimate pain intensity of a patient using a computationally inexpensive machine learning model with 3 statistical features from EDA signal which can be collected from a wrist biosensor. This method paves a way to developing a wearable pain measurement device.

PMID:34242325 | DOI:10.1371/journal.pone.0254108

PLoS One. 2021 Jul 9;16(7):e0254090. doi: 10.1371/journal.pone.0254090. eCollection 2021.

ABSTRACT

To those involved in discussions about rigor, reproducibility, and replication in science, conversation about the “reproducibility crisis” appear ill-structured. Seemingly very different issues concerning the purity of reagents, accessibility of computational code, or misaligned incentives in academic research writ large are all collected up under this label. Prior work has attempted to address this problem by creating analytical definitions of reproducibility. We take a novel empirical, mixed methods approach to understanding variation in reproducibility discussions, using a combination of grounded theory and correspondence analysis to examine how a variety of authors narrate the story of the reproducibility crisis. Contrary to expectations, this analysis demonstrates that there is a clear thematic core to reproducibility discussions, centered on the incentive structure of science, the transparency of methods and data, and the need to reform academic publishing. However, we also identify three clusters of discussion that are distinct from the main body of articles: one focused on reagents, another on statistical methods, and a final cluster focused on the heterogeneity of the natural world. Although there are discursive differences between scientific and popular articles, we find no strong differences in how scientists and journalists write about the reproducibility crisis. Our findings demonstrate the value of using qualitative methods to identify the bounds and features of reproducibility discourse, and identify distinct vocabularies and constituencies that reformers should engage with to promote change.

PMID:34242331 | DOI:10.1371/journal.pone.0254090

PLoS One. 2021 Jul 9;16(7):e0254404. doi: 10.1371/journal.pone.0254404. eCollection 2021.

ABSTRACT

Is it possible to achieve a collaboration between Infectious Diseases (ID) Specialists and General Practitioners (GPs) in the management of chronic HIV infection? A cross sectional survey was conducted among People Living with HIV (PLWHIV) attending the outpatient services of four Italian Infectious Diseases Centers to understand to which extent patients trust their GPs and involve them in the management of their chronic condition. Information about level of communication with GPs, subjective perception of the disease, and presence of co-medications were collected and matched with socio-demographic data using χ2statistics. A p<0.05 was considered statistically significant. From December 2019 to February 2020, 672 patients completed the survey, 59% males and 56% >50 years. Overall, 508 patients (76%) had informed GPs about HIV-positivity. Communication of diagnosis was significantly associated with age >50years, lower education level, history of disease >10 years and residency in Northern Italy. The “Undetectable = Untrasmittable” (U = U) concept was investigated as an indirect measure of perceived stigma. 23% of subjects was unaware of its meaning. Despite undetectable status, 50% of PLWHIV found difficult to communicate their condition to GPs, especially married (52% vs 48% of unmarried, p = 0.003), well-educated patients (51% vs 48, p = 0.007), living in Southern vs Northern Italy (52% vs 46%, p< 0.001). More than 75% of the participants consulted the ID specialist for co-medications and DDIs management, often complaining a lack of communication of the former with GPs. Overall, a good level of communication between PLWHIV and GPs was outlined, even if a wider involvement of the latter in HIV care is desirable.

PMID:34242341 | DOI:10.1371/journal.pone.0254404

PLoS One. 2021 Jul 9;16(7):e0254185. doi: 10.1371/journal.pone.0254185. eCollection 2021.

ABSTRACT

BACKGROUND: Binge drinking is a pattern of harmful use of alcohol and it is defined as four drinks for women and five drinks for men in about 2 hours. This behavior causes public health problems like damaging different body organs.

OBJECTIVE: To assess binge drinking and associated factors among Bahir Dar University students in Northwest Ethiopia.

METHOD: A cross sectional study was conducted in November 2017. Systematic sampling technique was used to select 422 participants. Structured questionnaire was used to collect data. Linear and Logistic regression models were used to predict the role of explanatory variables on behavioral intention and binge drinking, respectively. Independent variables with a p-value of <0.05 at 95% confidence interval were considered as statistically significant in the final model.

RESULT: A total of 413 students participated in this study and 33.4%(95% CI: 28.3-38.9) were engaged in binge drinking. Experiential attitude, instrumental attitude, and self-efficacy were found to be significant predictors of intention to binge drinking (p<0.05). Experiential attitude, environmental constraint, injunctive norm, and knowledge predictors were significantly associated with binge drinking (p<0.05).

CONCLUSION: Our study indicated that one-third of the students practiced binge drinking. This behavior was associated with experiential attitude, injunctive norm, environmental constraints, and knowledge factors. Additionally, experiential attitude, instrumental attitude, and self-efficacy constructs had explained behavioral intention. This implies focusing on the abovementioned determinant factors is imperative while designing intervention strategy.

PMID:34242321 | DOI:10.1371/journal.pone.0254185