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Nevin Manimala Statistics

The impact of Covid-19 on the initiation of clinical trials in Europe and the United States

Clin Pharmacol Ther. 2022 Jan 28. doi: 10.1002/cpt.2534. Online ahead of print.

ABSTRACT

The Covid-19 pandemic has a major impact not only on public health and daily living, but also on clinical trials worldwide. To investigate the potential impact of the Covid-19 pandemic on the initiation of clinical trials, we have descriptively analysed the longitudinal change in phase II and III interventional clinical trials initiated in Europe and in the United States. Based on the public clinical trial register EU Clinical Trials Register and clinicaltrials.gov, we conducted (a) a yearly comparison of the number of initiated trials from 2010 to 2020 and (b) a monthly comparison from January 2020 to February 2021 of the number of initiated trials. The analyses indicate that the Covid-19 pandemic affected both the initiation of clinical trials overall and the initiation of non-Covid-19 trials. An increase in the overall numbers of clinical trials could be observed both in Europe and the US in 2020 as compared to 2019. However, the number of non-Covid-19 trials initiated is reduced as compared to the previous decade, with a slightly larger relative decrease in the US as compared to Europe. Additionally, the monthly trend for the initiation of non-Covid-19 trials differs between regions. In the US, after a sharp decrease in April 2020, trial numbers reached the levels of 2019 from June 2020 onwards. In Europe, the decrease was less pronounced, but trial numbers mainly remained below the 2019 average until February 2021.

PMID:35090044 | DOI:10.1002/cpt.2534

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Nevin Manimala Statistics

Conspiracy endorsement and its associations with personality functioning, anxiety, loneliness, and sociodemographic characteristics during the COVID-19 pandemic in a representative sample of the German population

PLoS One. 2022 Jan 28;17(1):e0263301. doi: 10.1371/journal.pone.0263301. eCollection 2022.

ABSTRACT

BACKGROUND: In the context of the COVID-19 pandemic, many individuals have been found to endorse conspiracy beliefs. Socio-demographic variables, personality functioning, anxiety, and loneliness could be risk factors for this endorsement.

METHODS: In a representative sample of the German population (N = 2,503) measures of conspiracy mentality, conspiracy-related beliefs toward COVID-19, personality functioning (OPD-SQS), anxiety (HADS), and loneliness (UCLA) were assessed. Pearson product-moment correlations and multiple linear regression analyses were conducted.

RESULTS: Conspiracy mentality and conspiracy-related beliefs toward COVID-19 were strongly correlated. Regression analyses found younger age, male gender, lower education, and lower income to be associated with conspiracy mentality. The subscales relationship model and self-perception of the OPD-SQS were positively related to conspiracy mentality whereas interpersonal contact was negatively associated. Higher levels of anxiety were statistically predictive for conspiracy mentality.

CONCLUSION: Our findings indicate a contribution of personality functioning to the understanding of conspiracy mentality and thus to the advancement of interventions during the pandemic.

PMID:35089987 | DOI:10.1371/journal.pone.0263301

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Nevin Manimala Statistics

Lower limb biomechanics during drop jump landing in individuals with chronic ankle instability

J Athl Train. 2022 Jan 28. doi: 10.4085/1062-6050-0399.21. Online ahead of print.

ABSTRACT

CONTEXT: Individuals with chronic ankle instability (CAI) exhibit impaired lower limb biomechanics during unilateral drop jump landing on a flat surface. However, lower limb biomechanical adaptations during unilateral drop jump landing on more challenging surfaces such as unstable or inclined are yet to be described.

OBJECTIVE: Determine how unilateral drop jump landing surfaces (flat, unstable and inclined) influence lower limb EMG, kinematics and kinetics in individuals with CAI.

DESIGN: Descriptive laboratory study.

SETTING: Biomechanics laboratory.

PATIENTS OR OTHER PARTICIPANTS: Twenty-two young adults with CAI.

INTERVENTIONS: Participants completed five trials of unilateral drop jump landing from a 46 cm height platform on flat (DROP), unstable (FOAM) and laterally inclined (WEDGE) surfaces.

MAIN OUTCOME MEASURE(S): EMG of gluteus medius, vastus lateralis, gastrocnemius medialis, peroneus longus and tibialis anterior muscles were recorded. Knee and ankle angles and moments were calculated using a three-dimensional motion analysis system and a force plate. Biomechanical variables were compared between tasks using one-dimensional statistical nonparametric mapping.

RESULTS: During DROP, greater ankle dorsiflexion angles, knee extension moments and vastus lateralis muscle activity (FOAM only) were observed compared to FOAM and WEDGE. Greater ankle inversion angles were observed during FOAM and WEDGE compared to DROP. Peroneus longus muscle activity was greater during DROP compared to FOAM. During FOAM, greater ankle inversion and knee extension angles, ankle inversion and internal rotation moments as well as smaller peroneus longus muscle activity were observed compared to WEDGE.

CONCLUSIONS: The greater ankle inversion and plantarflexion angles as well as the lack of increase in peroneus longus muscle activation during FOAM and WEDGE could increase the risk of recurrent LAS in individuals with CAI. The results of this study improve our understanding of lower limb biomechanics changes when landing on more challenging surfaces and will help clinicians better targeting deficits associated with CAI during rehabilitation.

PMID:35090022 | DOI:10.4085/1062-6050-0399.21

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Nevin Manimala Statistics

A randomized controlled trial on the effects of blue-blocking glasses compared to partial blue-blockers on sleep outcomes in the third trimester of pregnancy

PLoS One. 2022 Jan 28;17(1):e0262799. doi: 10.1371/journal.pone.0262799. eCollection 2022.

ABSTRACT

OBJECTIVE: Sleep disturbances are common in pregnancy. Blocking blue light has been shown to improve sleep and may be a suitable intervention for sleep problems during pregnancy. The present study investigated the effects of blue light blocking in the evening and during nocturnal awakenings among pregnant women on primary sleep outcomes in terms of total sleep time, sleep efficiency and mid-point of sleep.

METHODS: In a double-blind randomized controlled trial, 60 healthy nulliparous pregnant women in the beginning of the third trimester were included. They were randomized, using a random number generator, either to a blue-blocking glass intervention (n = 30) or to a control glass condition constituting partial blue-blocking effect (n = 30). Baseline data were recorded for one week and outcomes were recorded in the last of two intervention/control weeks. Sleep was measured by actigraphy, sleep diaries, the Bergen Insomnia Scale, the Karolinska Sleepiness Scale and the Pre-Sleep Arousal Scale.

RESULTS: The results on the primary outcomes showed no significant mean difference between the groups at posttreatment, neither when assessed with sleep diary; total sleep time (difference = .78[min], 95%CI = -19.7, 21.3), midpoint of sleep (difference = -8.9[min], 95%CI = -23.7, 5.9), sleep efficiency (difference = -.06[%], 95%CI = -1.9, 1.8) and daytime functioning (difference = -.05[score points], 95%CI = -.33, .22), nor by actigraphy; total sleep time (difference = 13.0[min], 95%CI = -9.5, 35.5), midpoint of sleep (difference = 2.1[min], 95%CI = -11.6, 15.8) and sleep efficiency (difference = 1.7[%], 95%CI = -.4, 3.7). On the secondary outcomes, the Bergen Insomnia Scale, the Karolinska Sleepiness Scale and the Pre-Sleep Arousal Scale the blue-blocking glasses no statistically significant difference between the groups were found. Transient side-effects were reported in both groups (n = 3).

CONCLUSIONS: The use of blue-blocking glasses compared to partially blue-blocking glasses in a group of healthy pregnant participants did not show statistically significant effects on sleep outcomes. Research on the effects of blue-blocking glasses for pregnant women with sleep-problems or circadian disturbances is warranted.

TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT03114072).

PMID:35089982 | DOI:10.1371/journal.pone.0262799

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Nevin Manimala Statistics

Causes of delays in construction projects in the Province of Aceh, Indonesia

PLoS One. 2022 Jan 28;17(1):e0263337. doi: 10.1371/journal.pone.0263337. eCollection 2022.

ABSTRACT

Implementations of construction projects in Indonesia, especially in Aceh Province, are often delayed. Time, quality, and cost are three important components of planning a construction project. The benchmark for a successful construction project is the project completion time being in accordance with the time period specified in the contract. In project implementation, there is often a risk of delays in completing construction projects that can cause losses and fines; therefore, it is necessary to know the risk factors potentially causing project delays. The purpose of this study was to identify the risk factors causing delays greatly affecting construction projects in Aceh Province. The data used in this study were questionnaire data distributed to 68 respondents. The data processing methods included validity tests, reliability tests, and the construction of descriptive statistics. Ultimately, 60 delay factors were obtained; of these, 30 risk indicators were included in the very influential category with a mode value of (= 5), 29 delay risk indicators were in the high influence category with a mode value of (= 4), and one indicator was included in the category of medium influence (= 3).

PMID:35089971 | DOI:10.1371/journal.pone.0263337

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Nevin Manimala Statistics

Deep learning via LSTM models for COVID-19 infection forecasting in India

PLoS One. 2022 Jan 28;17(1):e0262708. doi: 10.1371/journal.pone.0262708. eCollection 2022.

ABSTRACT

The COVID-19 pandemic continues to have major impact to health and medical infrastructure, economy, and agriculture. Prominent computational and mathematical models have been unreliable due to the complexity of the spread of infections. Moreover, lack of data collection and reporting makes modelling attempts difficult and unreliable. Hence, we need to re-look at the situation with reliable data sources and innovative forecasting models. Deep learning models such as recurrent neural networks are well suited for modelling spatiotemporal sequences. In this paper, we apply recurrent neural networks such as long short term memory (LSTM), bidirectional LSTM, and encoder-decoder LSTM models for multi-step (short-term) COVID-19 infection forecasting. We select Indian states with COVID-19 hotpots and capture the first (2020) and second (2021) wave of infections and provide two months ahead forecast. Our model predicts that the likelihood of another wave of infections in October and November 2021 is low; however, the authorities need to be vigilant given emerging variants of the virus. The accuracy of the predictions motivate the application of the method in other countries and regions. Nevertheless, the challenges in modelling remain due to the reliability of data and difficulties in capturing factors such as population density, logistics, and social aspects such as culture and lifestyle.

PMID:35089976 | DOI:10.1371/journal.pone.0262708

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Nevin Manimala Statistics

Effects of non-aversive versus tail-lift handling on breeding productivity in a C57BL/6J mouse colony

PLoS One. 2022 Jan 28;17(1):e0263192. doi: 10.1371/journal.pone.0263192. eCollection 2022.

ABSTRACT

Non-aversive handling is a well-documented refinement measure for improving rodent welfare. Because maternal stress is related to reduced productivity, we hypothesized that welfare benefits associated with non-aversive handling would translate to higher production and fewer litters lost in a laboratory mouse breeding colony. We performed a randomized controlled trial to examine the effects of a standard method of handling (tail-lift with forceps) versus non-aversive handling with transfer tunnels (‘tunnel-handled’) on breeding performance in 59 C57BL/6J mouse pairs. Intervention assignments could not be concealed from technicians, but were concealed from assessors and data analyst. An operationally significant effect of tunnel-handling (large enough differences to warrant programmatic change) was defined before study initiation as a 5% increase in productivity, or one extra pup over the reproductive lifetime of each pair. Pairs were randomly allocated to handling intervention and cage rack location, and monitored over an entire 6-month breeding cycle. For each group, we measured number of pups born and weaned, and number of entire litters lost prior to weaning. Differences between transfer methods were estimated by two-level hierarchical mixed models adjusted for parental effects and parity. Compared to tail-lift mice, tunnel-handled mice averaged one extra pup per pair born (+1.0; 95% CI 0.9, 1.1; P = 0.41) and weaned (+1.1, 95% CI 0.9, 1.2; P = 0.33). More tunnel-handled pairs successfully weaned all litters produced (13/29 pairs, 45% vs 4/30 pairs, 13%; P = 0.015), averaged fewer litter losses prior to weaning (11/29 pairs [38%] vs 26/30 pairs [87%]; P <0.001), and had a 20% lower risk of recurrent litter loss. The increase in numbers of pups produced and weaned with tunnel handling met threshold requirement for operational significance. These data and projected cost savings persuaded management to incorporate tunnel handling as standard of care across the institution. These data also suggest that overlooked husbandry practices such as cage transfer may be major confounders in studies of mouse models.

PMID:35089969 | DOI:10.1371/journal.pone.0263192

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Nevin Manimala Statistics

Prevalence and factors associated with failed induction of labor in Worabe Comprehensive Specialized Hospital, Southern Ethiopia

PLoS One. 2022 Jan 28;17(1):e0263371. doi: 10.1371/journal.pone.0263371. eCollection 2022.

ABSTRACT

BACKGROUND: Induction of labor is one of the most used obstetric procedures in the world. It is performed in around 20% of all pregnancies. Failed induction of labor, on the other hand, has been associated with poorer mother and newborn health outcomes. Besides, there is a scarcity of data on the current burden and drivers. Therefore, this study aimed to assess the prevalence and factors associated with failed induction in Worabe Comprehensive Specialized Hospital, Southern Ethiopia.

METHODS: A retrospective cross-sectional study was conducted on medical records of mothers who delivered through induction of labor during September 1st, 2018 to August 30th, 2020. The samples were collected using a systematic sampling technique. The data was extracted using a checklist. Data were entered into EpiData (version 3.1) and analyzed using SPSS (version 24). Multivariable logistic regression analyses were used to decide the association of explanatory variables with the outcome variable. Odds ratio with their 95% CI were calculated to identify the presence and strength of an association. A p-value of < 0.05 was used to declare statistical significance.

RESULTS: In this study, the prevalence of failed induction was observed to be 22.2%. The associated factors included rural residence (AOR = 5.7, 95% CI: 3.12-11.02), primiparity (AOR = 8.4, 95% CI: 2.72-22.36) and unfavourable bishop score (AOR = 5.9, 95% CI: 4.52-16.12).

CONCLUSIONS: In comparison to the rate reported in developed countries, the study area had a high rate of failed induction. Being rural residence, primiparity and unfavourable bishop score were the associated factors of failed induction. Therefore, to reduce of the rate of failed induction, health care practitioners should analyze cervical status (using Bishop Score) to decide the possibility of successful induction, with a focus on associated factors like parity.

PMID:35089970 | DOI:10.1371/journal.pone.0263371

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Nevin Manimala Statistics

Understanding the role of village fund and administrative capacity in stunting reduction: Empirical evidence from Indonesia

PLoS One. 2022 Jan 28;17(1):e0262743. doi: 10.1371/journal.pone.0262743. eCollection 2022.

ABSTRACT

The Indonesian government launched various programs to handle stunting cases, including village funds. This paper examined the effects of village fund programs and village apparatuses’ capacities to combat stunting based on aggregate data at the district level in Indonesia. Using descriptive data analysis and fixed effect panel regression, we observed that village fund programs could significantly reduce Indonesia’s stunting prevalence, especially outside Java. It also revealed that the increasing education of regional leaders does not necessarily positively impact leaders’ skills in handling stunting. At the same time, the number of village officials has a statistically significant influence on reducing stunting prevalence. It advised that the village budget fund can support national priorities in tackling the prevalence of stunting. Furthermore, it is essential to build the capacity of the village head for increasing awareness of health activities, especially early prevention of stunting, in addition to an adequate number of officials.

PMID:35089957 | DOI:10.1371/journal.pone.0262743

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Nevin Manimala Statistics

Metformin exposure, maternal PCOS status and fetal venous liver circulation: A randomized, placebo-controlled study

PLoS One. 2022 Jan 28;17(1):e0262987. doi: 10.1371/journal.pone.0262987. eCollection 2022.

ABSTRACT

BACKGROUND: Metformin is prescribed to women with polycystic ovary syndrome (PCOS) to prevent pregnancy complications. Children exposed to metformin vs. placebo in utero, have increased head circumference at birth and are more overweight and obese at 8 years of age. Also, maternal PCOS-status seems to alter the long-term cardio-metabolic health of offspring. We hypothesized that the long-term effects of metformin-exposure and/or maternal PCOS may be mediated by circulatory adaptations during fetal life.

MATERIAL AND METHODS: This is a sub-study of a larger double-blinded, placebo-controlled trial, where women with PCOS were randomized to metformin (2g/day) or placebo in pregnancy, a total of 487 women. A sub-group of participants (N = 58) took part in this sub-study and had an extended ultrasound examination at gestational week 32, including blood flow velocity and diameter measurements of the umbilical vein (UV), the ductus venosus (DV) and the portal vein (PV). Blood flow volume was calculated and adjusted for estimated fetal weight (EFW) (normalized flow). Metformin exposed fetuses were compared to placebo exposed fetuses. Fetuses of mothers with PCOS (metformin [n = 30] and placebo [n = 28]) were compared to a low-risk reference population (N = 160) by z-score statistics.

RESULTS: There was no difference in fetal liver flow between metformin vs. placebo-exposed fetuses. Fetuses of mothers with PCOS had higher EFW (0.63 [95% CI 0.44-0.83] p<0.001), lower normalized UV, DV, PV, and lower total venous liver blood flows than the reference population.

CONCLUSION: Metformin during pregnancy did not affect fetal liver blood-flow. In our population, maternal PCOS-status was associated with reduced total venous liver blood-flow, which may explain altered growth and metabolism later in life.

PMID:35089960 | DOI:10.1371/journal.pone.0262987