Category: Statistics

Chest. 2021 Nov 13:S0012-3692(21)04288-4. doi: 10.1016/j.chest.2021.11.005. Online ahead of print.

ABSTRACT

BACKGROUND: Definitions for central lung cancer have been ambiguous in guidelines, causing difficulty in selecting candidates for invasive mediastinal staging among patients with radiologically node-negative, early-stage lung cancer.

RESEARCH QUESTION: What is the optimal definition for central lung cancer, which is robust to inter-reader and institutional variation, to select candidates for invasive mediastinal staging among those with clinical T1N0M0 lung cancer?

STUDY DESIGN AND METHODS: Two retrospective cohorts were evaluated for the associations of central lung cancer according to 13 definitions based on chest CT with occult nodal metastasis. Univariable and multivariable ordinal logistic regression analyses were performed with the pathological N category as an ordinal outcome. Robust definitions, which retained statistical significance across multi-reader, dual-institutional datasets, were identified. For these definitions, binary diagnostic performance and inter-reader agreement were investigated.

RESULTS: In the two cohorts, 807 patients (median age, 63 years; interquartile range, 56-71 years; 410 women; 33 pN1, 48 pN2, and 1 pN3) and 510 patients (median age, 65 years; interquartile range, 58-71 years; 267 women; 33 pN1, 20 pN2, and no pN3) were included, respectively. Three definitions robust to inter-reader variation and dataset heterogeneity were identified: definition 7 (concentric lines arising from the midline, inner one-third, medial margin; adjusted odds ratio [OR], 2.01; 95% confidence interval [CI], 1.13-3.51; P=0.02), definition 10 (location index-based inner one-third, center; adjusted OR, 3.60; 95% CI, 1.49-8.25; P=0.003), and definition 12 (location index-based inner one-third, medial margin; adjusted OR, 3.57; 95% CI, 1.91-6.52; P<0.001). Definition 12 showed higher inter-reader agreement than definition 7 (Cohen κ, 0.80 vs. 0.66; P=0.005). Nevertheless, the sensitivity and positive predictive value of the three definitions were below 50%.

INTERPRETATION: Three definitions exhibited robust associations with occult nodal metastasis. However, selecting candidates for invasive mediastinal staging solely based on a central tumor location would be suboptimal.

PMID:34785237 | DOI:10.1016/j.chest.2021.11.005

Eur Urol Oncol. 2021 Nov 13:S2588-9311(21)00184-X. doi: 10.1016/j.euo.2021.10.002. Online ahead of print.

ABSTRACT

BACKGROUND: Local ablative radiotherapy (aRT) of oligometastatic prostate cancer (PCa) is very promising and has become a focus of current clinical research.

OBJECTIVE: We hypothesize that aRT is safe and effective in gallium-68 prostate-specific membrane antigen targeted positron emission tomography (PSMA-PET)-staged oligometastatic PCa patients.

DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized, prospective, investigator-initiated phase 2 trial recruited patients with oligometastatic PCa (five or fewer lymph node or osseous metastases) after local curative therapy, without significant comorbidity and androgen deprivation therapy (ADT), at two German centers from 2014 to 2018.

INTERVENTION: All PSMA-PET-positive metastases were treated with aRT. No systemic therapy was initiated.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was treatment-related toxicity (grade ≥2) 24 mo after aRT. A one-sided single-sample test of proportions was planned to test whether the endpoint occurs in <15% of the patients. Key secondary endpoints were time to progression of prostate-specific antigen (PSA) and time to ADT, which were associated with potential prognostic factors by Cox regression.

RESULTS AND LIMITATIONS: Of 72 patients, 63 received aRT (13% dropout rate). The median follow-up was 37.2 mo. No treatment-related grade ≥2 toxicity was observed 2 yr after treatment. The median time to PSA progression and time to ADT were 13.2 and 20.6 mo, respectively. Of the patients, 21.4% were free of PSA progression after 3 yr.

CONCLUSIONS: It was observed that aRT is safe, and midterm PSA progression and ADT-free time were achieved in one of five patients. Randomized clinical trials are indicated to further evaluate the option of delaying ADT in selected patients.

PATIENT SUMMARY: In this clinical trial, 63 patients with up to five metastases of prostate cancer without androgen deprivation therapy were included. We showed that local ablative radiotherapy is safe and that one in five patients had no recurrent prostate-specific antigen value after 3 yr. Local ablative radiotherapy might be an option to avoid systemic therapy in selected patients.

PMID:34785189 | DOI:10.1016/j.euo.2021.10.002

J Voice. 2021 Nov 13:S0892-1997(21)00312-X. doi: 10.1016/j.jvoice.2021.09.021. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate whether actors’ and actresses’ voices post an Intensive Lessac Kinesensic Training Workshop – ILKTW can be perceptually identified as more resonant, and to assess if the Acoustic Voice Quality Index (AVQI), the Acoustic Breathing Index (ABI), and their acoustic measures are able to indicate the classified voices as more resonant.

METHODS: Eight vocally healthy English first-language actors and actresses, participants of the same ILKTW, were asked to sustain the vowel /a/ and to read a piece of the Rainbow Passage, pre and postworkshop, at a self-selected habitual frequency and intensity. The readings were divided into initial and final parts, both with 34 syllables, and combined with the vowel /a/ (3s). The pre and postworkshop recordings (pairs of the initial and final parts followed by the /a/ vowel) of each participant were randomly presented to a voice expert who rated the samples as more resonant or similar. The same samples were analyzed using the AVQI and ABI scripts.

RESULTS: 87,5% of the initial parts and 100% of the final in postworkshop were rated by the voice expert as more resonant. Tilt was higher for the postworkshop initial parts (P = 0.036), but a correlation with the perceptual rating wasn’t found. HNR was higher (P = 0.018) and jitter was lower (P = 0.017) for the postworkshop final parts. The statistical analysis comparing the perceptive and acoustic data for the final samples couldn’t be applied.

CONCLUSION: It seems that the ILKTW has a positive impact on the development of a resonant voice and that the perceptual auditory rating was more effective to describe resonant voices than the AVQI, ABI, and its acoustic measures.

PMID:34785115 | DOI:10.1016/j.jvoice.2021.09.021

J Voice. 2021 Nov 13:S0892-1997(21)00300-3. doi: 10.1016/j.jvoice.2021.09.002. Online ahead of print.

ABSTRACT

PURPOSE: To identify vocal sensory symptoms, vocal fatigue, and vocal habits, compare and correlate them in university professors who have passed or failed a screening related to vocal symptoms.

STUDY DESIGN: Cross-sectional, quantitative, non-randomized study.

METHODS: The professors responded to four vocal self-assessment Patient-Reported Outcome Measures (PROM): the Brazilian validated version of the Voice Symptom Scale (VoiSS), the Brazilian version (not validated) of the Vocal Tract Discomfort Scale, the Brazilian validated version of the Vocal Fatigue Index and the validated version of the Vocal Health and Hygiene Questionnaire (“Questionário de Saúde e Higiene Vocal – QSHV,” in Portuguese). After the PROM’s application, the professors were divided into two groups from the VoiSS cutoff point. G1 was formed by professors who passed in the VoiSS screening, that is, those who achieved a total score below 16 points, and G2, formed by professors who failed, that is, those who achieved 16 points or more. The Mann-Whitney U test was used to compare the values of PROM between G1 and G2 groups, and the Spearman correlation test was used to correlate the PROM with one another.

RESULTS: One hundred and two professors filled in the PROM, 23 from G1 and 79 from G2. Results showed that the total scores of all PROM used exceeded their cutoff scores in the overall sample. It was also observed that professors who failed the screening through VoiSS presented higher scores of vocal sensory symptoms and vocal fatigue, however no differences regarding knowledge on vocal health and hygiene were noticed. In G1, the protocols showed significant correlations ranging from moderate to very strong with one another, but the QSHV showed no correlation with any of the instruments. In G2, the protocols presented weak to strong correlation ratios, and the QSHV reported correlation with all protocols, except for Vocal Fatigue Index.

CONCLUSION: University professors presented scores higher than the cut-off point suggested by the literature for vocal sensory symptoms, vocal fatigue and knowledge on vocal health and hygiene. Professors who failed the screening performed through VoiSS achieved higher scores of vocal discomfort and fatigue, but also presented a high score for knowledge on vocal hygiene. There was a moderate to very strong statistical correlation among the vocal symptoms, discomforts, vocal fatigue and vocal habits in professors who failed the screening through VoiSS, however among those professors who passed the screening, knowledge on vocal health and hygiene showed no correlation with the PROM analyzed.

PMID:34785114 | DOI:10.1016/j.jvoice.2021.09.002

Thromb Haemost. 2021 Nov 16. doi: 10.1055/a-1698-6506. Online ahead of print.

ABSTRACT

BACKGROUND: Venous thromboembolism (VTE) prophylaxis is recommended for hospitalized medical patients at high risk for VTE. Multiple risk assessment models exist, but few have been compared in large data sets.

METHODS: We constructed a derivation cohort using 6 years of data from 13 hospitals to identify risk factors associated with developing VTE within 14 days of admission. VTE was identified using a complex algorithm combining administrative codes and clinical data. We developed a multivariable prediction model and applied it to 2 validation cohorts: a temporal cohort, including two additional years and a cross-validation, in which we refit the model excluding one hospital at a time, and applied the refitted model to the holdout hospital. Performance was evaluated using the C-statistic.

RESULTS: The derivation cohort included 160,928 patients with a 14-day VTE rate of 0.79%. The final multivariable model contained 13 patient risk factors. The model had an optimism corrected C-statistic of 0.80 and good calibration. The temporal validation cohort included 55,301 patients, with a VTE rate of 0.74%. Based on the c-statistic, the Cleveland Clinic Model (CCM) outperformed the Padua model (0.76 vs. 0.72, p<0.01). The CCM was more sensitive (65.8% vs. 60.4%, p=0.05) and more specific (74.9% vs. 71.4%, p<.001), with higher positive (1.9% vs. 1.5%, p<.001) and negative predictive values (99.7% vs. 99.6%, p=0.01). C-statistics for the CCM at individual hospitals ranged from 0.64 to 0.76.

CONCLUSION: A new VTE risk assessment model outperformed the Padua model. After further validation it could be recommended for widespread use.

PMID:34784645 | DOI:10.1055/a-1698-6506

Rev Bras Ginecol Obstet. 2021 Oct;43(10):728-735. doi: 10.1055/s-0041-1735985. Epub 2021 Nov 16.

ABSTRACT

OBJECTIVE: The role of breast milk in the physical and mental health of infants and in the prevention of infant death is widely known. The benefits of breastfeeding for mothers and infants have been proven, but several factors can affect breastfeeding. Childbirth is one of the most influential factors. The present study aimed to investigate the effect of the type of delivery (natural childbirth and cesarean section) on breastfeeding based on the latch, audible swallowing, type of nipple, comfort, hold (LATCH) scoring system.

METHODS: The present cross-sectional observational study was performed using the census method among women who referred to Afzalipour Hospital for delivery in May 2020; the breastfeeding pattern was completed by observation and the in-case information, by LATCH checklist. Data were analyzed using the Statistical Package for the Social Sciences (IBM SPSS Statistics for Windows, IBM Corp., Armonk, NY, United States) software, version 19.0, analysis of variance (ANOVA), and the Chi-squared statistical test.

RESULTS: Out of a total of 254 deliveries (127 natural childbirths and 127 cesarean deliveries), there was no statistically significant difference between the 2 study groups in terms of age, maternal employment status, and infant weight, but there was a statistically significant relationship between the type of delivery, the maternal level of schooling, and the appearance, pulse, grimace, activity, and respiration (Apgar) score in the first minute. The mean score of breastfeeding patterns among the natural childbirth group (9.33) was higher than that of the cesarean section group (7.21).

CONCLUSION: The type of delivery affects the mother’s performance during breastfeeding, and mothers submitted to cesarean sections need more support and help in breastfeeding.

PMID:34784628 | DOI:10.1055/s-0041-1735985

Rev Bras Ginecol Obstet. 2021 Oct;43(10):736-742. doi: 10.1055/s-0041-1736172. Epub 2021 Nov 16.

ABSTRACT

OBJECTIVE: Thyroid diseases are the second most common endocrine disorders in the reproductive period of women. They can be associated with intrauterine growth restriction (IUGR), preterm delivery, low Apgar score, low birthweight (LBW) or fetal death. The aim of the present study is to explore thyroid dysfunction and its relationship with some poor perinatal outcomes (Apgar Score, low birthweight, and preterm delivery).

METHODS: Dried blood spot samples from 358 healthy pregnant women were analyzed for thyroid stimulating hormone (TSH), total thyroxine (TT4), and thyroglobulin (Tg). Neonatal data were collected upon delivery. Four groups were formed based on thyroid function tests (TFTs).

RESULTS: Of the 358 tested women, 218 (60.72%) were euthyroid. Isolated hypothyroxinemia was present in 132 women (36.76%), subclinical hyperthyroidism in 7 women (1.94%), and overt hypothyroidism in 1 (0.28%). The perinatal outcomes IUGR (p = 0.028) and Apgar score 1 minute (p = 0.015) were significantly different between thyroid function test [TFT]-distinct groups. In the multiple regression analysis, TT4 showed a statistically significant inverse predictive impact on LBW (p < 0.0001), but a positive impact of Tg on LBW (p = 0.0351).

CONCLUSION: Thyroid hormones alone do not have a direct impact on neonatal outcomes, but the percentage of their participation in the total process cannot be neglected. Based on the regression analysis, we can conclude that TT4 and Tg can be used as predictors of neonatal outcome, expressed through birthweight and Apgar score. The present study aims to contribute to determine whether a test for thyroid status should become routine screening during pregnancy.

PMID:34784629 | DOI:10.1055/s-0041-1736172

Eur J Dent. 2021 Nov 16. doi: 10.1055/s-0041-1735434. Online ahead of print.

ABSTRACT

OBJECTIVES: Interferon-gamma (IFNg) is an immune-regulatory cytokine with a role in host responses to periodontitis. Genetic factors have been reported to modify the corresponding protein expression. The objective of this study was to evaluate the association and role of IFNg polymorphisms, such as IFNg +874 A/T, and the susceptibility to periodontitis.

MATERIALS AND METHODS: A total of 100 unrelated subjects were included in the present study. Genomic deoxyribonucleic acid (DNA) was obtained from peripheral blood of 43 patients with mild periodontitis and 57 patients with severe periodontitis. The determined clinical parameters of periodontitis included probing depth, clinical attachment loss, and papilla bleeding index. The oral hygiene indicators were also assessed. The level of IFNg was determined from the gingival crevicular fluid by enzyme-linked immunosorbent assay technique. The IFNg +874 A/T polymorphisms were analyzed from peripheral blood by the method of restriction fragment length polymorphism-polymerase chain reaction.

STATISTICAL ANALYSIS: Statistical analysis of the results was conducted using chi-squared testing for categorical data. Independent t-tests and Mann-Whitney U tests were used for numeric data. Kruskal-Wallis testing was used to compare genotypes concerning for IFNg +874 A/T polymorphism. A p-value < 0.05 was assumed for statistical significance.

RESULTS: Analysis of the IFNg +874 A/T polymorphism showed no significant differences with the level of IFNg. No significant differences were observed either in IFNg +874 A/T polymorphism between the subjects with mild periodontitis and those with severe periodontitis (p > 0.05). The subjects with severe periodontitis showed marginally but not significantly higher levels of IFNg compared with subjects with mild periodontitis (p > 0.05).

CONCLUSION: The polymorphism of IFNg +874 A/T was not associated with the level of IFNg nor with the risk of periodontitis in this study.

PMID:34784626 | DOI:10.1055/s-0041-1735434

Eur J Dent. 2021 Nov 16. doi: 10.1055/s-0041-1735442. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the effect of immediate dentin sealing (IDS) technique using universal adhesive under simulated pulp pressure on microtensile bond strength (µTBS) of indirect resin composite restorations and dentin permeability.

MATERIALS AND METHODS: Fifty extracted caries-free human third molars were used for specimens’ preparation. Each molar’s occlusal table was abraded flat and their roots were separated under continuous water cooling. Forty specimens were used for microtensile bond strength test (µTBST) evaluation. The µTBST specimens were randomly assigned to two groups according to the dentin sealing time; Immediate dentin sealing (IDS) and delayed dentin sealing (DDS). Each group was further subdivided into two subgroups according to the adhesive system used for dentin sealing: iBOND self-etch adhesive and GLUMA Bond Universal. All specimens were exposed to simulated pulp pressure for 1 week then restored using computer-aided design/computer-aided manufacturing (CAD/CAM) resin composite blocks. The µTBS was evaluated for all tested subgroups after 24 hours and 6 months of water storage. The remaining 10 teeth were used for the preparation of dentin discs for dentin permeability evaluation. They were divided into two groups according to type of self-etch adhesive used. Fluid filtration rate was evaluated after etching, with smear layer and after adhesive application. Results obtained were statistically analyzed using Shapiro-Wilk test and Weibull analysis.

RESULTS: Statistically significant difference was recorded between μTBS mean values of both IDS and DDS techniques at 24 hours and after 6 months of water storage. GLUMA Bond Universal adhesive had significantly higher bond strength compared with iBond at both IDS and DDS techniques, but both adhesives showed a significant reduction in the Weibull characteristic strength after 6 months of water storage. Significant reduction in dentin permeability was recorded by both adhesives without any significant difference between them.

CONCLUSIONS: The IDS technique using universal adhesive in self-etch mode is an effective strategy for improving the final bond strength of CAD/CAM resin composite restorations and reducing dentin permeability.

PMID:34784624 | DOI:10.1055/s-0041-1735442

Eur J Dent. 2021 Nov 16. doi: 10.1055/s-0041-1734470. Online ahead of print.

ABSTRACT

OBJECTIVES: The present study aims to investigate the effect of the COVID-19 pandemic on people’s mental and physical balance, oral hygiene habits, type of diet, perceived safety of returning to the dentist, and aesthetics with the use of masks.

MATERIALS AND METHODS: An online questionnaire was submitted to the Italian population between December 2020 and January 2021. It was sent via online platforms and included 21 questions.

STATISTICAL ANALYSIS: Differences in rates were calculated by using the Chi-square test. The level of significance was set at p <0.05.

RESULTS: A total of 1,008 individuals completed the questionnaire. About 72% of participants were not concerned about returning to the dentist. Approximately 45% of the individuals intensified their oral hygiene and preventive rules. About 38% of participants increased their carbohydrate intake, while 28% increased their fat consumption. Furthermore, 75% of the participants felt that the mask did not diminish the beauty of their smile.

CONCLUSIONS: Most participants felt comfortable returning to the dentist but only for more urgent treatment. However, most people reported that they had not stepped up their home oral hygiene measures. The biggest changes in the population’s eating habits involved increased carbohydrate and fat consumption. Finally, most participants responded that mask use did not compromise their aesthetics.

PMID:34784625 | DOI:10.1055/s-0041-1734470