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Nevin Manimala Statistics

Protocol and statistical analysis plan for the Pragmatic Investigation of optimaL Oxygen Targets (PILOT) clinical trial

BMJ Open. 2021 Oct 28;11(10):e052013. doi: 10.1136/bmjopen-2021-052013.

ABSTRACT

INTRODUCTION: Mechanical ventilation of intensive care unit (ICU) patients universally involves titration of the fraction of inspired oxygen to maintain arterial oxygen saturation (SpO2). However, the optimal SpO2 target remains unknown.

METHODS AND ANALYSIS: The Pragmatic Investigation of optimaL Oxygen Targets (PILOT) trial is a prospective, unblinded, pragmatic, cluster-crossover trial being conducted in the emergency department (ED) and medical ICU at Vanderbilt University Medical Center in Nashville, Tennessee, USA. PILOT compares use of a lower SpO2 target (target 90% and goal range: 88%-92%), an intermediate SpO2 target (target 94% and goal range: 92%-96%) and a higher SpO2 target (target 98% and goal range: 96%-100%). The study units are assigned to a single SpO2 target (cluster-level allocation) for each 2-month study block, and the assigned SpO2 target switches every 2 months in a randomly generated sequence (cluster-level crossover). The primary outcome is ventilator-free days (VFDs) to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of invasive mechanical ventilation through 28 days after enrolment.

ETHICS AND DISSEMINATION: The trial was approved by the Vanderbilt Institutional Review Board. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

TRIAL REGISTRATION NUMBER: The trial protocol was registered with ClinicalTrials.gov on 25 May 2018 prior to initiation of patient enrolment (ClinicalTrials.gov identifier: NCT03537937).

PMID:34711597 | DOI:10.1136/bmjopen-2021-052013

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Nevin Manimala Statistics

Development of critical thinking skills of undergraduate students throughout the 4 years of nursing degree at a public university in Spain: a descriptive study

BMJ Open. 2021 Oct 28;11(10):e049950. doi: 10.1136/bmjopen-2021-049950.

ABSTRACT

OBJECTIVE: To analyse the critical thinking skills of students enrolled in the four academic years of the nursing degree at a public university belonging to the European Higher Education Area.

DESIGN: Cross-sectional, quantitative, descriptive study. Using the Critical Thinking Questionnaire to analyse the critical thinking skills in their substantive and dialogic dimension.

SETTING: Faculty of Nursing, Valladolid Public University in Spain, belonging to the European Higher Education Area.

PARTICIPANTS: The sample consisted of 215 first-year, second-year, third-year and fourth-year undergraduate nursing students.

MAIN OUTCOMES: The students of the four academic years were positively disposed towards critical thinking. The students of the final courses obtained higher average scores.

RESULTS: The study sample was 215 students, 19.1% men/80.9% women. The average score in the substantive dimension (3.81±0.53 points) was higher than that in the dialogic dimension (3.48±0.51 points) (p<0.001). They had a greater ability in listening and speaking (3.77±0.61 points) with respect to writing (3.65±0.61 points) and reading (3.52±0.43 points) (p<0.001). There are significant differences in the critical thinking average scores across academic years.

CONCLUSIONS: Nursing students displayed a greater critical thinking ability in its substantive dimension compared with the dialogic one. This reflects a greater ability in actions related to provide reasons and evidence that support their point of view. Identifying critical thinking skills in nursing students will help establish specific teaching methodologies focused on improving these skills.

PMID:34711594 | DOI:10.1136/bmjopen-2021-049950

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Nevin Manimala Statistics

Baseline IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes: a multi-site discovery and validation study

Eur Respir J. 2021 Oct 28:2100905. doi: 10.1183/13993003.00905-2021. Online ahead of print.

ABSTRACT

Pre-treatment IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes independent of disease severity and, improves the performance of risk-prediction models comprising of established clinical predictors.

BACKGROUND: Biomarkers of unfavorable tuberculosis treatment outcomes are needed to accelerate new drug and regimen development. Whether plasma cytokine levels can predict unfavorable tuberculosis treatment outcomes is unclear.

METHODS: We identified and internally validated the association between 20 a-priori selected plasma inflammatory markers and unfavorable treatment outcomes of failure, recurrence and all-cause mortality among adults with drug-sensitive pulmonary tuberculosis in India. We externally validated these findings in two independent cohorts of predominantly diabetic and HIV coinfected tuberculosis patients in India and South Africa, respectively.

RESULTS: Pre-treatment IFN-γ, IL-13 and IL-6 were associated with treatment failure in the discovery analysis. Internal validation confirmed higher pre-treatment IL-6 concentrations among failure cases compared to controls. External validation among predominantly diabetic tuberculosis patients found an association between pre-treatment IL-6 concentrations and subsequent recurrence and death. Similarly, external validation among predominantly HIV coinfected tuberculosis patients found an association between pre-treatment IL-6 concentrations and subsequent treatment failure and death. In a pooled analysis of 363 tuberculosis cases from the Indian and South African validation cohorts, high pre-treatment IL-6 concentrations were associated with higher risk of failure (adjusted odds ratio [aOR]=2.16, 95%CI 1.08-4.33, p=0.02), recurrence (aOR=5.36, 95%CI 2.48-11.57, p<0.001) and death (aOR=4.62, 95%CI 1.95-10.95, p<0.001). Adding baseline IL-6 to a risk-prediction model comprising of low BMI, high smear grade and cavitation improved model performance by 15 percent (C-statistic of 0.66 versus 0.76, p=0.02).

CONCLUSION: Pre-treatment IL-6 is a biomarker for unfavorable tuberculosis treatment outcomes. Future studies should identify optimal IL-6 concentrations for point-of-care risk prediction.

PMID:34711538 | DOI:10.1183/13993003.00905-2021

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Elevated blood favipiravir levels are inversely associated with ferritin levels and induce the elevation of uric acid levels in COVID-19 treatment: A retrospective single-center study

J Infect Chemother. 2021 Oct 19:S1341-321X(21)00280-4. doi: 10.1016/j.jiac.2021.10.011. Online ahead of print.

ABSTRACT

INTRODUCTION: Measurement of blood Favipiravir (FPV) levels and accumulation of data in COVID-19 patients are critical for assessing FPV efficacy and safety. We performed a retrospective study based on measurements of blood levels of FPV and related factors in COVID-19 patients admitted to our hospital. Furthermore, we also investigated the association between blood FPV levels and uric acid level alterations before and after FPV administration.

METHODS: We enrolled 27 COVID-19 patients who had received FPV treatment at Hokushin General Hospital from April 1 to December 31, 2020. Age, gender, COVID-19 severity, presence of comorbidities, and laboratory data for each subject were investigated to identify factors that correlate with blood FPV levels. Uric acid levels were measured before and after FPV administration and a difference between the levels (i.e., a change of uric acid level) was evaluated.

RESULTS: When a significant univariate variable was input by the stepwise method and a combination of variables that maintained statistical superiority was searched, serum ferritin was the only factor that independently affected blood FPV level. Furthermore, in the high-FPV group (20 μg/mL or more), a significant increase in uric acid levels was observed after FPV administration. The increment value was significantly larger than that in the low-FPV group (less than 20 μg/mL).

CONCLUSIONS: Ferritin level was an important independent factor inversely affecting blood FPV level. Furthermore, a high blood FPV level induced the elevation of uric acid levels in COVID-19 treatment.

PMID:34711508 | DOI:10.1016/j.jiac.2021.10.011

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Nevin Manimala Statistics

Use of an intravaginal spacer in young girls treated with brachytherapy for bladder neck rhabdomyosarcoma: Dosimetric impact for organs at risk sparing and acute tolerance

Cancer Radiother. 2021 Oct 25:S1278-3218(21)00255-9. doi: 10.1016/j.canrad.2021.09.010. Online ahead of print.

ABSTRACT

PURPOSE: Interstitial brachytherapy is indicated as part of a conservative strategy for children with bladder and/or prostate rhabdomyosarcoma (RMS), providing high local control probability with acceptable functional results. Vaginal and/or rectal complications were however reported, due to the close proximity to the implanted volume. We investigated the dosimetric impact of a vaginal spacer in terms of rectal and vaginal doses.

METHODS AND PATIENTS: Medical records of 12 consecutive female patients with bladder neck RMS, median age 32 months (range: 1.3-6 years), were reviewed. Five patients were treated prior to 2017 without a vaginal spacer and seven patients treated after 2017 had their brachytherapy delivered with a vaginal spacer placed at time of implant.

RESULTS: Minimal doses delivered to the most exposed 2cm3, 1cm3, and 0.5cm3 of the rectum were all statistically significantly lower among patients treated with a vaginal spacer, as compared to those treated without a spacer. Median rectal D2cm3 was 22GyEQD2 versus 38GyEQD2 (P=0.02), D1cm3 was 29GyEQD2 versus 51GyEQD2 (P=0.013), and D0.5cm3 was 32GyEQD2 versus 61GyEQD2 (P=0.017), with and without the vaginal spacer, respectively. The posterior vaginal wall D0.5cm3 dose was also significantly decreased, with median D0.5cm3 of 92GyEQD2 versus 54GyEQD2 (P<0.0001), with and without the spacer, respectively. Acute tolerance was excellent in all patients, with no need for replanning and no acute complication.

CONCLUSIONS: The use of vaginal spacers in brachytherapy of female pediatric patients with bladder neck RMS resulted in significantly decreased doses to the rectum and the posterior vaginal wall. Though the clinical impact of such dose reduction remains undemonstrated, routine utilization of a vaginal spacer could be a method to decrease long-term morbidity in these patients.

PMID:34711484 | DOI:10.1016/j.canrad.2021.09.010

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Treatment with L-Citrulline in patients with post-polio syndrome: A single center, randomized, double blind, placebo-controlled trial

Neuromuscul Disord. 2021 Aug 24:S0960-8966(21)00617-9. doi: 10.1016/j.nmd.2021.08.011. Online ahead of print.

ABSTRACT

This single-centered, randomized, double-blind, placebo-controlled study reports the results of L-Citrulline treatment for 24 weeks in patients with post-polio syndrome (PPS). Twenty-nine patients were randomized and assigned into receiving a treatment of 15 g L-Citrulline or placebo. The primary endpoint was the change of the 6 min walking distance test. Secondary endpoints included motor function measure, quantitative muscle strength, quantitative MRI and self-reported impairment questionnaires. Patients receiving L-Citrulline walked 17.5 longer in the 6 min walking distance test when compared to placebo group, however not statistically significant (95% CI = -14.69; 49.68, p = 0.298). None of the secondary endpoints showed a statistically significant change in the L-Citrulline group when compared to placebo group. The motor function measure showed a change of -0.78 (95% CI= [-3.39; 1.83] p = 0.563). Muscle degeneration of leg muscles assessed with quantitative MRI indicated no significant change (estimate= -0.01, 95% CI =-0.13; 0.11, p = 0.869). L-Citrulline was safe and well tolerated. In conclusion, administration of 15 g L-Citrulline daily for 24 weeks to patients with PPS showed no beneficial treatment effect in timed muscle function.

PMID:34711479 | DOI:10.1016/j.nmd.2021.08.011

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Nevin Manimala Statistics

The relationship between the care burden and quality of life of parents who have children with hematological problems and their perceived social support

J Pediatr Nurs. 2021 Oct 25:S0882-5963(21)00301-8. doi: 10.1016/j.pedn.2021.10.004. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to examine the interrelationship of the caregiver burden, perceived social support, and quality of life of parents who have children with hematological problems.

DESIGN AND METHODS: The design and methods included a descriptive study with 141 parents of children with hematological problems. The introductory information form, the Zarit Burden Interview (ZBI), multidimensional scale of perceived social support (MSPSS), and the EUROHIS-QOL.8 (WHOQOL-8) scale were used as data collection tools. The data obtained were analyzed using descriptive statistics and structural equation models.

RESULTS: As a result of the conducted correlation analysis, it was determined that there was a positive correlation between parents’ perceptions of social support and their quality of life, and a negative correlation between their perceptions of social support and the caregiver burden (p < 0.05). As a result of the structural equation model, it was determined that the social support received by the parents had a significant effect on their caregiver burden (β = -0.40; p < 0.05), and their quality of life (β = 0.42; p < 0.05).

CONCLUSIONS: The conclusion formed was that it can be said that parents’ perceptions of social support affect their caregiver burden and quality of life. Parents with high perceptions of social support perceive the burden of caregiver to be low and their quality of life to be high.

PRACTICE IMPLICATIONS: The practice implications are that healthcare professionals can contribute to reducing the caregiver burden and improving the quality of life of parents, by strengthening the social support systems of parents with sick children.

PMID:34711471 | DOI:10.1016/j.pedn.2021.10.004

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Effects of Speaking Rate on Breathing and Voice Behavior

J Voice. 2021 Oct 25:S0892-1997(21)00305-2. doi: 10.1016/j.jvoice.2021.09.005. Online ahead of print.

ABSTRACT

OBJECTIVES: The objective of this study was to investigate the effects of speaking rate (habitual and fast) and speech task (reading and spontaneous speech) on seven dependent variables: Breath group size (in syllables), Breath group duration (in seconds), Lung volume at breath group initiation, Lung volume at breath group termination, Lung volume excursion for each breath group (in % vital capacity), Lung volume excursion per syllable (in % vital capacity) and mean speaking Fundamental frequency (fO).

METHODS: Ten women and seven men were included as subjects. Lung volume and breathing behaviors were measured by respiratory inductance plethysmography and fO was measured from audio recordings by the Praat software. Statistical significance was tested by analysis of variance.

RESULTS: For both reading and spontaneous speech, the group increased mean breath group size and breath group duration significantly in the fast speaking rate condition. The group significantly decreased lung volume excursion per syllable in fast speech. Females also showed a significant increase of fO in fast speech. The lung volume levels for initiation and termination of breath groups, as well as lung volume excursions in % vital capacity, showed great individual variations and no significant effects of rate. Significant effects of speech task were found for breath group size and lung volume excursion per syllable, where reading induced more syllables produced per breath group and less % VC spend per syllable as compared to spontaneous speech. Interaction effects showed that the increases in breath group size and breath group duration associated with fast rate were significantly larger in reading than in spontaneous speech.

CONCLUSION: Our data from 17 vocally untrained, healthy subjects showed great individual variations but still significant group effects regarding increased speaking rate, where the subjects seemed to spend less air per syllable and inhaled less often as a consequence of greater breath group sizes in fast speech. Subjects showed greater changes in breath group patterns as a consequence of fast speech in reading than in spontaneous speech, indicating that effects of speaking rate are dependent on the speech task.

PMID:34711460 | DOI:10.1016/j.jvoice.2021.09.005

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Nevin Manimala Statistics

Diagnostic value of liquid-based cytology test in intrathoracic lymph nodes and lung lesions sampled by endobronchial ultrasonography-transbronchial needle aspiration

Diagn Cytopathol. 2021 Oct 28. doi: 10.1002/dc.24898. Online ahead of print.

ABSTRACT

BACKGROUNDS: Liquid-based cytology (LBC) has begun to be used in non-gynecological samples such as endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). This study aims to investigate the diagnostic value of LBC in intrathoracic lymph nodes and lung lesions sampled with EBUS-TBNA.

METHODS: In total, 174 cases that underwent EBUS-TBNA between July 2020 and February 2021 were included (75 and 99 cases were prepared using conventional and LBC methods, respectively). The two groups were compared in terms of diagnostic categories, number of slides, cell blocks, slides per location, locations sampled, immunohistochemical studies, sensitivity, specificity, and diagnostic accuracy.

RESULTS: The percentages of malignant, suspicious for malignancy, benign, and non-diagnostic (ND) cases were 51.8%, 1.1%, 39.6%, and 7.5%, respectively. The LBC and conventional group (CG) had similar rates in the diagnostic categories, except for ND (3.0% and 13.3%, respectively). The sensitivity of LBC and CG were 90.4% and 85.7%, respectively. There were no differences in the specificity and diagnostic accuracy between groups. There was a statistically significant difference between groups in terms of the number of slides, number of slides per location, number of cell blocks, and locations sampled (p < .001, p < .001, p < .05, p < .05).

CONCLUSION: The LBC technique can be used for samples taken with EBUS-TBNA. Rapid fixation and the absence of artificial problems greatly reduce the rate of ND samples in LBC slides. Other important advantages are a lower number of slides to examine and a greater number of cell blocks.

PMID:34709736 | DOI:10.1002/dc.24898

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The Value of Chinese Thyroid Imaging Report and Data System Combined With Contrast-Enhanced Ultrasound Scoring in Differential Diagnosis of Benign and Malignant Thyroid Nodules

J Ultrasound Med. 2021 Oct 28. doi: 10.1002/jum.15858. Online ahead of print.

ABSTRACT

OBJECTIVES: To explore the diagnostic value of contrast-enhanced ultrasound (CEUS) combined with the Chinese Thyroid Imaging Reporting and Data System (C-TIRADS) for differentiation of benign and malignant thyroid nodules.

METHODS: A retrospective analysis of the conventional ultrasound and CEUS data of 388 nodules in 355 patients who had undergone thyroid nodule resection was conducted. All nodules had clear pathological results. The CEUS observation indexes included the enhancement degree in the arterial phase (no enhancement, scant punctate-linear enhancement, mild enhancement, moderate enhancement, and high enhancement) and wash-out patterns (rapid wash-out, slow wash-out, and isochronous wash-out). Chi-square test between groups and receiver operating characteristic curves (ROC) were used to determine the malignant (+1 point) and benign (-1 point) observation indexes that were statistically significant for the differentiation between benign and malignant thyroid nodules. The CEUS and C-TIRADS malignant and benign indexes were combined to score and draw the ROC curve, which was compared with the ROC curve scored by C-TIRADS alone to compare the diagnostic efficacy of the two methods for differentiating between benign and malignant thyroid nodules.

RESULTS: Among the CEUS observation indexes, mild enhancement and rapid wash-out were malignant indexes, while isochronous wash-out was a benign index. The best diagnostic cut-off value for the differentiation of benign and malignant thyroid nodules using the C-TIRADS score and the C-TIRADS and CEUS combined score (C-TIRADS + CEUS score) was 2. The sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of the two methods were 79.97, 75.48, 82.9, 70.5%, and 89.7, 72.9, 83.3, 82.5%, respectively. The area under the curve values were 0.840 and 0.877 (P < .001), respectively.

CONCLUSIONS: The CEUS feature of mild enhancement in the arterial phase and rapid wash-out pattern are suggestive of malignancy and isochronous wash-out pattern is suggestive of benignity. The C-TIRADS + CEUS score has a higher value for distinguishing benign from malignant thyroid nodules than the C-TIRADS score alone.

PMID:34709672 | DOI:10.1002/jum.15858