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Nevin Manimala Statistics

A clinical study to assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice

Am J Dent. 2021 Apr;34(2):87-90.

ABSTRACT

PURPOSE: To assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice relative to a negative control.

METHODS: 100 generally healthy adults with 10 or more gingival bleeding sites based on the Mazza Modification of the Papillary Bleeding Index (Mazza GI) were enrolled into a 2-week randomized, controlled, double-blind, single-center, two-treatment, parallel group clinical study. The subjects were randomly assigned to the stannous-containing dentifrice group (experimental group) or the sodium fluoride dentifrice group (negative control group). An oral examination and Mazza GI examination were conducted at Baseline, Day 3 and Week 2 post-baseline by a qualified dental examiner.

RESULTS: 98 subjects completed the study. The experimental group provided a significant reduction in Mazza GI scores and number of bleeding sites relative to baseline at Day 3 and Week 2 (P< 0.0001). The negative control did not provide significant reductions versus baseline for either measure at either timepoint (P> 0.3). At Day 3, the experimental group provided a statistically significant reduction of Mazza GI scores and number of bleeding sites compared with the negative control group (P< 0.0001). At Week 2, the experimental group showed 24.11% lower Mazza GI scores and 54.81% fewer bleeding sites than the negative control group (P< 0.0001).

CLINICAL SIGNIFICANCE: The results demonstrated that the novel stannous-containing fluoride dentifrice had a superior anti-gingivitis effect compared to the sodium fluoride negative control dentifrice, which was evident as quickly as 3 days after use and further improved after 2 weeks of usage.

PMID:33940665

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Nevin Manimala Statistics

Incidence of Hypertensive Disorders of Pregnancy in Women with COVID-19

Am J Perinatol. 2021 May 3. doi: 10.1055/s-0041-1727167. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to examine the incidence of hypertensive disorders of pregnancy in women diagnosed with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, also known as COVID-19).

STUDY DESIGN: This was a retrospective cohort study of all women who delivered at MedStar Washington Hospital Center in Washington, DC from April 8, 2020 to July 31, 2020. Starting April 8, 2020, universal testing for COVID-19 infection was initiated for all women admitted to labor and delivery. Women who declined universal testing were excluded. Hypertensive disorders of pregnancy were diagnosed based on American College of Obstetricians and Gynecologists Task Force definitions.1 Maternal demographics, clinical characteristics, and labor and delivery outcomes were examined. Neonatal outcomes were also collected. Laboratory values from admission were evaluated. Our primary outcome was the incidence of hypertensive disorders of pregnancy among women who tested positive for COVID-19. The incidence of hypertensive disorders of pregnancy was compared between women who tested positive for COVID-19 and women who tested negative.

RESULTS: Of the 1,008 women included in the analysis, 73 (7.2%) women tested positive for COVID-19, of which 12 (16.4%) were symptomatic at the time of admission. The incidence of hypertensive disorders of pregnancy was 34.2% among women who tested positive for COVID-19 and 22.9% women who tested negative for COVID-19 (p = 0.03). After adjusting for race, antenatal aspirin use, chronic hypertension, and body mass index >30, the risk of developing any hypertensive disorder of pregnancy was not statistically significant (odds ratio: 1.58 [0.91-2.76]).

CONCLUSION: After adjusting for potential confounders, the risk of developing a hypertensive disorder of pregnancy in women who tested positive for COVID-19 compared with women who tested negative for COVID-19 was not significantly different.

KEY POINTS: · There is an increased incidence of hypertensive disorders in women who test positive for COVID-19.. · Characteristics of pregnant women with COVID-19 are similar to those with hypertensive disorders.. · Liver function tests were similar between pregnant women with COVID-19 and women without COVID-19..

PMID:33940651 | DOI:10.1055/s-0041-1727167

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Nevin Manimala Statistics

Prenatal Low-Dose Aspirin Use Associated with Reduced Incidence of Postpartum Hypertension among Women with Preeclampsia

Am J Perinatol. 2021 May 3. doi: 10.1055/s-0041-1728826. Online ahead of print.

ABSTRACT

OBJECTIVE: Postpartum hypertension (PP-HTN), defined as systolic/diastolic blood pressure (SBP/DBP) ≥140/90, on two occasions at least 4 hours apart after delivery occurs in up to 50% of preeclamptic pregnancies, and is associated with adverse maternal outcomes. Excessive production of antiangiogenic factors (i.e., soluble fms-like tyrosine kinase 1 [sFLT1]) and reduced levels of proangiogenic factors (i.e., placental growth factor [PlGF]) are associated with preeclamptic pregnancies. The aim of this study was to identify clinical risk factors and/or serum biomarkers associated with PP-HTN in preeclampsia.

STUDY DESIGN: Preeclamptic women (n = 82, aged ≥18 years) were prospectively enrolled in an observational study. Serial blood pressures were obtained through the labor course and until 48 hours postpartum, and serum was obtained within 24 hours postpartum. Statistical analysis was performed by using Student’s two-tailed t-test and Fisher’s exact test.

RESULTS: Baseline comorbidities and antihypertensive use were similar among those who developed PP-HTN and those who did not. Among preeclamptic patients, 33% developed PP-HTN; these had significantly more severe preeclampsia features versus no PP-HTN (96 vs. 78%, p = 0.05). PP-HTN was associated with higher re-hospitalization rates (26 vs. 6%, p = 0.01). Among those taking low-dose aspirin (ASA) for preeclampsia prophylaxis (n = 12), PP-HTN was significantly less frequent versus those not taking low-dose ASA (0 vs. 22%, p = 0.007). Low-dose ASA use was associated with significantly lower peripartum sFLT1 levels (4,650 ± 2,335 vs. 7,870 ± 6,282 pg/mL, p = 0.03) and sFLT1/PlGF ratio (397 ± 196 vs. 1,527 ± 2,668, p = 0.03).

CONCLUSION: One-third of women with preeclampsia develop PP-HTN; these patients have more severe preeclampsia and have higher re-hospitalization rates. Prenatal low-dose ASA use was associated with significantly lower incidence of PP-HTN, reduced levels of antiangiogenic factors, and lower 6-week re-hospitalization rates. These findings, if replicated, may have clinical implications on the use of low-dose ASA during pregnancy to reduce incidence of postpartum HTN.

KEY POINTS: · Postpartum hypertension is common in preeclampsia.. · Prenatal aspirin may reduce postpartum hypertension.. · Prenatal aspirin may reduce sFLT1 levels..

PMID:33940641 | DOI:10.1055/s-0041-1728826

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Nevin Manimala Statistics

Evaluation of Vgc Analyzer by Comparison With Gold Standard Roc Software and Analysis of Simulated Visual Grading Data

Radiat Prot Dosimetry. 2021 May 3:ncab066. doi: 10.1093/rpd/ncab066. Online ahead of print.

ABSTRACT

The purpose of the present work was to evaluate the use of resampling statistical methods for analysis of visual grading data-implemented in the software VGC Analyzer-by comparing the reanalyzed results from previously performed visual grading studies with the results calculated by gold standard receiver operating characteristic (ROC) methodology, Obuchowski-Rockette (OR)-Dorfman-Berbaum-Metz (DBM) multiple-readers and multiple-case (MRMC) and by analysis of simulated visual grading data where the true distribution was presumed to be known. The reanalysis was performed on two multiple-reader studies with non-paired data and paired data, respectively. The simulation study was performed by simulating a large number of visual grading characteristics (VGC) studies and by analyzing the statistical distribution of null hypothesis (H0) rejection rate. The comparison with OR-DBM MRMC showed good agreement when analyzing non-paired data for both fixed-reader and random-reader settings for the calculated area under the curve values and the confidence intervals (CIs). For paired data analysis, VGC Analyzer showed significantly lower CIs compared with the ROC software. This effect was also illustrated by the simulation study, where the VGC Analyzer, in general, showed good accuracy for simulated studies with stable statistical basis. For simulated studies with unstable statistics, the accuracy in the H0 rejection rate decreased. The present study has shown that resampling methodology can be used to accurately perform the statistical analysis of a VGC study, although the resampling technique used makes the method sensitive to small data sets.

PMID:33940628 | DOI:10.1093/rpd/ncab066

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Nevin Manimala Statistics

Analysis of trends in lumbar disc degeneration using kinematic MRI

Clin Imaging. 2021 Apr 29;79:136-141. doi: 10.1016/j.clinimag.2021.04.028. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the current study was to classify and analyze trends in lumbar disc degeneration across age, sex, and disc level using weightbearing kinematic MRI.

MATERIALS AND METHODS: Between January 2019 and July 2019, 1198 cases were retrospectively analyzed with kinematic MRI. Patients were divided into 5 groups based on age (20-29, 30-39, 40-49, 50-59, and 60+) and evaluated using the Pfirrmann classification to assess for disc degeneration at 5 vertebral levels: L1/2, L2/3, L3/4, L4/5, and L5/S1. Trends in degeneration were analyzed with regression and time series.

RESULTS: The L5/S1 vertebral disc had the highest prevalence of severe degeneration across all age groups. The most common multi-level degeneration combinations were L4/5 and L5/S1 for two levels and L3/4, L4/5, and L5/S1 for three levels. All vertebral levels showed significant difference in mean Pfirrmann grade among the age groups (p < 0.001 at all levels). Statistically significant differences in mean Pfirmmann grade among males and females were found only in ages 20-29 and 30-39, in which males showed more degeneration.

CONCLUSION: Our findings using kinematic MRI demonstrate that degeneration increases with age and is most severe in the L5/S1 disc. In multi-level degeneration the most prevalent combinations are those that are contiguous and include L5/S1. Young males were more likely to have degeneration than young females, but there was no significant difference from the fifth decade of life on.

PMID:33940491 | DOI:10.1016/j.clinimag.2021.04.028

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Nevin Manimala Statistics

Characterization of common breast MRI abnormalities: comparison between abbreviated and full MRI protocols

Clin Imaging. 2021 Apr 29;79:125-132. doi: 10.1016/j.clinimag.2021.04.013. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: To evaluate the diagnostic performance of abbreviated MRI (AB-MRI) in comparison to a full protocol MRI (FP-MRI) when evaluating common MRI abnormalities of a mass, non-mass enhancement and focus.

MATERIALS AND METHODS: This retrospective reader study was Institutional Review Board approved and Health Insurance Portability and Accountability Act (HIPAA) compliant. AB-MRIs were reviewed from May 2018-December 2019 to identify women with an abnormal AB-MRI, FP-MRI within six months of the AB-MRI and an elevated risk for breast cancer. Six breast radiologists initially interpreted and recorded findings from the AB-MRI. Immediately after reviewing the AB-MRI, the same radiologists interpreted and recorded findings from the FP-MRI. Findings were recorded in an electronic data collection form. Cohen’s Kappa test was used to calculate agreement. P < 0.05 was considered statistically significant.

RESULTS: Of 119 patients who had an AB-MRI, our final study comprised of 32 patients who had 64 breast MRIs (32 AB-MRI and 32 FP-MRI). The amount of fibroglandular tissue for AB-MRI and FP-MRI showed excellent intra-reader agreement [Kappa: 0.89-1.00 (P < 0.0001)]. Substantial to excellent intra-reader agreement [Kappa: 0.74-0.93 (P < 0.0001)] was demonstrated for all 6 readers when identifying abnormalities seen on AB-MRI and FP-MRI. Moderate to excellent intra-reader agreement [Kappa: 0.41-0.87(P < 0.0001)] was demonstrated between the AB-MRI and FP-MRI for the final BI-RADS assessment.

CONCLUSION: AB-MRI has acceptable intra-reader agreement with FP-MRI when characterizing common MRI abnormalities such as a mass, non-mass enhancement and focus suggesting that subsequent FP-MRI may not be needed.

PMID:33940489 | DOI:10.1016/j.clinimag.2021.04.013

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Nevin Manimala Statistics

Parent-child attachment security is associated with preschoolers’ memory accuracy for emotional life events through sensitive parental reminiscing

J Exp Child Psychol. 2021 Apr 30;209:105168. doi: 10.1016/j.jecp.2021.105168. Online ahead of print.

ABSTRACT

There is considerable controversy regarding the accuracy and suggestibility of children’s autobiographical memory for emotionally salient life events. Attachment perspectives of autobiographical memory development identify the attachment security of parent-child dyads and parents’ emotional support and coherence during reminiscing with their children as critical mechanisms underlying children’s memory accuracy and suggestibility. In the current investigation, 72 preschool-aged children (M = 4.01 years, SD = 0.85; 44 female) reminisced with their parents about times they felt happy, sad, scared, and angry. Children were then independently interviewed about these experiences by an unfamiliar researcher using free recall, specific questions (i.e., questions about factual details), and misleading questions (i.e., questions suggesting false details). Parents completed an assessment of their children’s attachment security within the parent-child relationship. Results revealed significant indirect effects of parent-child attachment security on children’s memory accuracy through parental sensitive guidance during reminiscing when cognitive (i.e., intelligence) and behavioral (i.e., temperament, behavior problems) covariates were statistically controlled. Parent-child attachment security was positively associated with parental sensitive guidance during reminiscing, which, in turn, was positively associated with the accuracy of children’s independent reports. The findings support attachment perspectives of autobiographical memory by identifying emotionally sensitive and coherent reminiscing as a parenting behavior that explains in part associations between parent-child attachment security and children’s independent memory accuracy for emotional life events.

PMID:33940484 | DOI:10.1016/j.jecp.2021.105168

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Nevin Manimala Statistics

Comparison of the effect of reinforcement with question-answer and kahoot method on the success and motivation levels of nursing students: A quasi-experimental review

Nurse Educ Today. 2021 Apr 24;102:104930. doi: 10.1016/j.nedt.2021.104930. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aims to compare the effect of question-answer and Kahoot method reinforcement on nursing students’ success and motivation levels.

MATERIALS AND METHODS: This quasi-experiment study was carried out with 65 students studying at the nursing department at a state university in Turkey. The research data were obtained between November 2019 and February 2020. The study sample was divided into two groups as question-answer and Kahoot. In the first stage of the research, 8 h of training were given to all 65 students on the subject “Infection Control and Precautions,” applying the method of teaching by presentation. Shortly after the training, the Kahoot group was reinforced on the Kahoot platform and the Question-answer group in PowerPoint, using the same questions for 30 min. In the second stage of the study, one day after the training, “Student Information Form” and “Instructional Materials Motivation Scale” were filled out, and “Achievement Test 1” was implemented. In the third stage, “Achievement Test 2” was executed two months after the training to test longer term knowledge retention.

RESULTS: The Kahoot group students had a score of 66.63 ± 11.02 in the “Achievement Test 1” and 67.76 ± 15.62 in the question-answer group. It was determined that the total score average of the students in the Kahoot group “Achievement Test 2” was 51.25 ± 13.42, and the students in the question-answer group were 47.03 ± 12.61. Accordingly, there was no statistically significant difference between the “Achievement Test 1” and “Achievement Test 2” mean scores of the students in the question-answer and Kahoot group (p > 0.05). The total score average of the question-answer group for “Instructional Materials Motivation Scale” was 127.88 ± 13.64, while the Kahoot group was 126.28 ± 16.88. It was determined that there was no statistically significant relationship between the “Achievement Test 1”, “Achievement Test 2” and the “Instructional Materials Motivation Scale” total score and sub-dimensions of the students in the Question-Answer group and Kahoot group (p > 0.05).

CONCLUSION: In the study analyzing the effect of reinforcement by the question-answer or Kahoot method on nursing students’ success and motivation levels, it was concluded that no method was superior.

PMID:33940482 | DOI:10.1016/j.nedt.2021.104930

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Nevin Manimala Statistics

Radiographic and plantar pressure assessment of pes planovalgus severity in children with cerebral palsy

Clin Biomech (Bristol, Avon). 2021 Apr 27;85:105364. doi: 10.1016/j.clinbiomech.2021.105364. Online ahead of print.

ABSTRACT

BACKGROUND: Pes planovalgus is common in children with cerebral palsy. Although severity influences treatment, there still lacks standard clinical measurements to objectively quantify pes planovalgus in this population. The comparison of pedobarographic data and radiographic measurements to clinical evaluation has not been reported in this population.

METHODS: 395 feet were identified from a population of ambulatory pediatric patients with cerebral palsy. Each patient initially underwent clinical evaluation by an experienced physical therapist who classified feet as: 136 controls, 116 mild, 100 moderate, and 43 severe pes planovalgus. Quantitative measurements were then calculated from antero-posterior and lateral radiographs of the foot. Pedobarographic analysis included the arch index, center of pressure index, and a newly defined medial index.

FINDINGS: A multivariate analysis was performed on the radiographic and pedobarographic measurements collected. It identified seven variables that improved objective classification of pes planovalgus severity when utilized together. These include the foot progression angle, initial contact force, arch index, medial index, antero-posterior talonavicular coverage, lateral calcaneal pitch and lateral Meary’s angle. While the lateral calcaneal pitch angle statistically differed amongst all severity classes, no pedobarographic value statistically differed between all severity classes.

INTERPRETATION: Overall, the combination of radiographic and pedobarographic measurements provides valuable information for objectively classifying severity of pes planovalgus in children with cerebral palsy by utilizing these values together rather than independently. In a clinical setting, radiographs and pedobarographic data may be obtained to enhance assessment of severity and guide treatment.

PMID:33940478 | DOI:10.1016/j.clinbiomech.2021.105364

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Effectiveness of antenatal corticosteroids at term: Can we trust the data that ‘inform’ us?

Eur J Obstet Gynecol Reprod Biol. 2021 Apr 24;261:144-147. doi: 10.1016/j.ejogrb.2021.04.031. Online ahead of print.

ABSTRACT

Randomized controlled trials (RCTs) are a cornerstone for the assessment of the effectiveness of interventions. Appropriate randomization, design, sample size, statistical analyses, and conduct that reduces the risk of bias, enhance the chance they will deliver true research findings. The credibility of RCTs is difficult to assess without objective evidence of compliance with Good Clinical Practice standards. Remarkably, no mechanisms are in place both in the initial peer review process and during meta-analysis to assess these, and little guidance on how to assess data where research integrity cannot be confirmed (e.g. where data originated from a setting without established infrastructure or an era preceding current standards). We describe the case of the use of antenatal steroids. When these drugs are used in early preterm birth, their benefits outweigh the harms. However, later in pregnancy, and specifically at term, this balance is less clear. We describe that the four randomised clinical trials that inform clinical practice through the Cochrane meta-analysis, for various reasons, lack clear governance which makes it difficult to verify provenance and reliability of the data. We conclude that transparency and assessment of data credibility need to be inbuilt both at the time of publication and at the time of meta-analysis. This will drive up standards and encourage appropriate interpretation of results and the context from which they were derived.

PMID:33940424 | DOI:10.1016/j.ejogrb.2021.04.031