Category: Statistics

Curr Probl Cardiol. 2021 Nov 13:101047. doi: 10.1016/j.cpcardiol.2021.101047. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with advanced chronic kidney disease (CKD) have largely been excluded from randomized control trials (RCTs) in heart failure (HF). This creates a paucity of high quality evidence for guideline directed medical therapy (GDMT), particularly in patients with heart failure with reduced ejection fraction (HFrEF) and CKD.

METHODS: This is a systematic review looking at the patterns and rates of inclusion of CKD in RCTs among patients with HFrEF. The search included RCTs from January 2010 to December 2020. A heat map was constructed to reflect the stages of CKD stages. The percentage of studies that included advanced CKD (stages 4 to 5) was recorded and log transformed, and then fitted into a time regression model. A p value of <0.05 was considered statistically significant.

RESULTS: Out of the 3052 screened, 706 studies were included in the analysis. Only 61% of the RCTs reported at least some information on kidney function. There was a trend of increase in percentage of studies that included CKD stages 4 to 5 from years 2010 to 2020. This was confirmed with a statistically significant linear trend p=0.02 while the percentage of studies that included dialysis and kidney transplant recipients remained consistently low.

CONCLUSION: There is a paucity of high-quality evidence for GDMT in the HFrEF population with CKD, particularly in those with advanced non-dialytic CKD, those on maintenance dialysis and kidney transplant recipients. There is a pressing need for wider inclusion of patients with advanced CKD in RCTs of GDMT in HFrEF.

PMID:34785259 | DOI:10.1016/j.cpcardiol.2021.101047

Arthroscopy. 2021 Nov 13:S0749-8063(21)00982-8. doi: 10.1016/j.arthro.2021.11.007. Online ahead of print.

ABSTRACT

PURPOSE: To compare the biomechanical effects of superior capsule reconstruction graft fixation length determined at 20° and 40° glenohumeral (GH) abduction. .

METHODS: Humeral translation, rotational range of motion (ROM) and subacromial contact pressure were quantified at 0°, 30°, and 60° of GH abduction in the scapular plane in 6 cadaveric shoulders for: intact; massive rotator cuff tear; SCR with a dermal allograft fixed at 20° GH abduction (SCR 20); and SCR fixed at 40° GH abduction (SCR 40). Statistical analysis was conducted using repeated measures ANOVA and paired t-test (P < 0.05).

RESULTS: Massive cuff tear significantly increased total ROM compared to intact at 0° and 60° abduction. SCR 20 or SCR 40 did not affect ROM. Compared to intact, the massive cuff tear significantly increased superior translation an average of 4.6 ± 0.5 mm at 9/12 positions (P ≤ 0.002). Both SCR 20 and SCR 40 reduced superior translation compared to massive cuff tear (P < 0.05); however, SCR 40 significantly decreased superior translation compared to SCR 20 at 0° abduction (P ≤ 0.046). Peak subacromial pressure for massive cuff tear increased an average of 486.8 ± 233.9 kPa relative to intact at 5/12 positions (P ≤ 0.037).; SCR 20 reduced peak subacromial pressure at 2/12 positions (P ≤ 0.012) while SCR 40 achieved this at 6/12 (P ≤ 0.024).

CONCLUSION: SCR with dermal allograft fixed at 20° or 40° of GH abduction decreases GH translation and subacromial pressure without decreasing range of motion.

PMID:34785299 | DOI:10.1016/j.arthro.2021.11.007

Sci Total Environ. 2021 Nov 13:151496. doi: 10.1016/j.scitotenv.2021.151496. Online ahead of print.

ABSTRACT

Biodiversity measures deliver valuable ecological information by reflecting a range of ecosystem processes. However, the accuracy of environmental assessment based on species patterns may often be affected by insufficient survey details. The comprehensive evaluation of plant taxa richness in rivers requires an extensive sampling effort. The use of Hill numbers and Chao estimators improves species diversity assessment based on a feasible number of samples. The aim of this work was to identify macrophyte groups, associated with various species traits, which are rich in species, as well as those whose detection is particularly difficult as it requires an exceptional sampling effort (sources of dark diversity). Analyses were performed with the use of Hill numbers and Chao estimators. It was shown that the field identification of all estimated macrophytes is particularly difficult for low trophy indicators and generally submerged plants, as well as for small-leaved species. A field survey encompassing the full (expected) macrophyte diversity encountered within a river is easiest to perform in the case of free-floating plants and large-leaved macrophytes, as well as for species with high trophic tolerance. The study proved that ecological assessment of rivers based on a small number of sampling units may lead to incorrect diversity estimates. Conversely, the estimation of diversity patterns at the level of the Shannon and Simpson indices does not require extensive sampling, and the extrapolation approach is not needed. The effectiveness of diversity assessment in fluvial ecosystems can be increased by extrapolation of gray diversity which can be considered in planning of monitoring programs. Moreover even estimated dark diversity bight be already efficient to identify ecological pattern and when comparing biodiversity across regions and ecosystems.

PMID:34785227 | DOI:10.1016/j.scitotenv.2021.151496

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