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Nevin Manimala Statistics

Prevalence and Severity of Molar Incisor Hypomineralization in Brazilian Children

Pediatr Dent. 2021 Jul 15;43(4):270-275.

ABSTRACT

Purpose: The purpose of this study was to evaluate the prevalence, severity, and distribution of molar incisor hypomineralization (MIH) and its association with socioeconomic characteristics among eight-year-old students from public schools in Petrópolis, Rio de Janeiro, Brazil. Methods: This cross-sectional study evaluated 450 eight-year-old Brazilian children. A questionnaire was used to assess socioeconomic factors (family income, maternal education, and person per household). MIH was diagnosed based on European Academy of Paediatric Dentistry criteria. The severity of MIH was evaluated at patient and tooth levels. The examinations were conducted in school environments. Descriptive analysis, chi-square, Fisher’s exact, and Kruskal-Wallis tests were performed. Results: The prevalence of MIH was 28.7 percent. The average of affected molars and incisors was 2.25 (standard deviation [SD] equals 1.03) and 0.84 (1.22 SD). The maxillary molars were the most affected, but mandibular molars showed greater severity. The majority of MIH-children had white-creamy opacities (51.9 percent). There was no association between MIH and socioeconomic factors. MIH was more prevalent in boys (P=0.025). The number of incisors with MIH rose with the increasing number of affected molars (P=0.02). A significant association between severity and the mean number of affected molars was observed (P=0.004). Conclusions: The prevalence of molar incisor hypomineralization was 28.7 percent. MIH severity at the individual level was significantly associated with the number of affected teeth and the occurrence of affected incisors.

PMID:34467841

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A machine learning approach to predict progression on active surveillance for prostate cancer

Urol Oncol. 2021 Aug 28:S1078-1439(21)00366-5. doi: 10.1016/j.urolonc.2021.08.007. Online ahead of print.

ABSTRACT

PURPOSE: Robust prediction of progression on active surveillance (AS) for prostate cancer can allow for risk-adapted protocols. To date, models predicting progression on AS have invariably used traditional statistical approaches. We sought to evaluate whether a machine learning (ML) approach could improve prediction of progression on AS.

PATIENTS AND METHODS: We performed a retrospective cohort study of patients diagnosed with very-low or low-risk prostate cancer between 1997 and 2016 and managed with AS at our institution. In the training set, we trained a traditional logistic regression (T-LR) classifier, and alternate ML classifiers (support vector machine, random forest, a fully connected artificial neural network, and ML-LR) to predict grade-progression. We evaluated model performance in the test set. The primary performance metric was the F1 score.

RESULTS: Our cohort included 790 patients. With a median follow-up of 6.29 years, 234 developed grade-progression. In descending order, the F1 scores were: support vector machine 0.586 (95% CI 0.579 – 0.591), ML-LR 0.522 (95% CI 0.513 – 0.526), artificial neural network 0.392 (95% CI 0.379 – 0.396), random forest 0.376 (95% CI 0.364 – 0.380), and T-LR 0.182 (95% CI 0.151 – 0.185). All alternate ML models had a significantly higher F1 score than the T-LR model (all p <0.001).

CONCLUSION: In our study, ML methods significantly outperformed T-LR in predicting progression on AS for prostate cancer. While our specific models require further validation, we anticipate that a ML approach will help produce robust prediction models that will facilitate individualized risk-stratification in prostate cancer AS.

PMID:34465541 | DOI:10.1016/j.urolonc.2021.08.007

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Nevin Manimala Statistics

Adequacy of the prescription of vitamin D in Primary Care

Semergen. 2021 Aug 29:S1138-3593(21)00226-4. doi: 10.1016/j.semerg.2021.07.010. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the adequacy of vitamin D treatment based on clinic evidence in a Primary Care Center as well as to analyze some characteristics of the prescriptions made.

MATERIALS AND METHODS: Descriptive cross-sectional study. Primary Care. Patients above 14 years old with vitamin D prescription. Main variable was the therapeutic adequacy with vitamin D compounds (adequacy was considered when there was a clinical indication for treatment and blood vitamin D levels below 20ng/ml). Other clinical variables were collected. Frequency and association measures were used for statistical analysis. Level of statistical significance was considered <0.05.

RESULTS: 430 patients, 346 women (80.5%, 95% CI=77-84). Record of vitamin D values in 216 (50.2%, 95% CI=45-55). Screening/treatment indications in 219 patients (50.9%, 95% CI=46-56), of those in 150 patients vitamin D values were recorded (68.5%, 95% CI=62-75), average (±SD) was 21.22±12ng/ml, deficiency criteria in 86 (57.3%, 95% CI=51-64), insufficiency in 37 (24.7%, 95% CI=19-30) and sufficiency in 27 (18%, 95% CI=13-23). 86 patients (20%, 95% CI=16-24) had treatment indications plus vitamin D deficiency with no differences between genders.

CONCLUSIONS: Only 20% of the patients had treatment indications plus vitamin D deficiency. Female predominance. Just over half had indications for screening of serological vitamin D values and/or indications for treatment with vitamin D compounds.

PMID:34465546 | DOI:10.1016/j.semerg.2021.07.010

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Significance of regional population HLA immunogenetic datasets in the efficacy of umbilical cord blood banks and marrow donor registries: a study of Cretan HLA genetic diversity

Cytotherapy. 2021 Aug 28:S1465-3249(21)00745-3. doi: 10.1016/j.jcyt.2021.07.010. Online ahead of print.

ABSTRACT

BACKGROUND AIMS: The high genetic diversity of HLA across populations significantly confines the effectiveness of a donor or umbilical cord blood search for allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to probe the HLA immunogenetic profile of the population of Crete, a Greek region with specific geographic and historical characteristics, and to investigate potential patterns in HLA distribution following comparison with the Deutsche Knochenmarkspenderdatei (DKMS) donor registry. It also aims to highlight the importance of regional public cord blood banks (PCBBs) in fulfilling HSCT needs, especially in countries with significant genetic diversity.

METHODS: A cohort of 1835 samples representative of the Cretan population was typed for HLA class I (HLA-A, HLA-B, HLA-C) and class II (HLA-DRB1, HLA-DQB1, HLA-DPB1) loci by high-resolution second field next-generation sequencing. Data were compared with the respective HLA profiles of 12 DKMS populations (n = 20 032). Advanced statistical and bioinformatics methods were employed to assess specific intra- and inter-population genetic indexes associated with the regional and geographic distribution of HLA alleles and haplotypes.

RESULTS: A considerable HLA allelic and haplotypic diversity was identified among the Cretan samples and between the latter and the pooled DKMS cohort. Even though the HLA allele and haplotype frequency distribution was similar to regions of close geographic proximity to Crete, a clinal distribution pattern from the northern to southern regions was identified. Significant differences were also observed between Crete and the Greek population of DKMS.

CONCLUSIONS: This study provides an in-depth characterization of the HLA immunogenetic profile in Crete and reveals the importance of demographic history in HLA heterogeneity and donor selection. The novel HLA allele and haplotype frequency comparative data between the Cretan and other European populations signify the importance of regional PCBBs in prioritizing HLA diversity to efficiently promote the HSCT program at the national level and beyond.

PMID:34465516 | DOI:10.1016/j.jcyt.2021.07.010

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Sliding Oblique Metatarsal Osteotomy Fixated With a K-Wire Without Cheilectomy for Hallux Rigidus

J Foot Ankle Surg. 2021 Aug 6:S1067-2516(21)00289-1. doi: 10.1053/j.jfas.2021.07.022. Online ahead of print.

ABSTRACT

The current study aimed to assess the outcomes of sliding oblique metatarsal osteotomy fixated with a K-wire without cheilectomy for hallux rigidus. Pre- and postoperative variables, including dorsiflexion angle, visual analog scale score, and Japanese Society for Surgery of the Foot scale score, were assessed using the Wilcoxon signed-rank test. In addition, the surgical effects among the four grades were compared using the Kruskal-Wallis test. In total, 43 patients, including 11, 11, 15, and 6 with grade 1, 2, 3, and 4 hallux rigidus, respectively, were enrolled in this analysis. The mean age of the participants was 56.2 years, and the mean follow-up period was 3.0 years. Mean pre- and postoperative dorsiflexion angles were as follows: overall, 53.0° to 66.5° (p < .001); grade 1, 66.8° to 79.1°; grade 2, 59.1° to 68.6°; grade 3, 43.3° to 61.0°; and grade 4, 40.8° to 53.3°. Mean pre- and postoperative visual analog scale scores were as follows: overall, 70.1 to 6.5 (p < .001); grade 1, 74.2 to 3.0; grade 2, 66.4 to 7.6; grade 3, 69.5 to 8.4; and grade 4, 71.2 to 6.0. Finally, mean pre- and postoperative Japanese Society for Surgery of the Foot scale scores were as follows: overall, 61.2 to 86.6 (p < .001); grade 1, 63.8 to 93.6; grade 2, 68.3 to 85.9; grade 3, 54.4 to 83.1; and grade 4, 60.5 to 83.5. There was no statistically significant difference in the surgical effects among the four grades. Decompressive metatarsal osteotomy without cheilectomy was found to be effective. Moreover, the procedure could be performed for all grades of hallux rigidus.

PMID:34465523 | DOI:10.1053/j.jfas.2021.07.022

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Accuracy of risk models used for public reporting of heart transplant center performance

J Heart Lung Transplant. 2021 Aug 6:S1053-2498(21)02446-3. doi: 10.1016/j.healun.2021.07.027. Online ahead of print.

ABSTRACT

BACKGROUND: Heart transplant programs and regulatory entities require highly accurate performance metrics to support internal quality improvement activities and national oversight of transplant programs, respectively. We assessed the accuracy of publicly reported performance measures.

METHODS: We used the United Network for Organ Sharing registry to study patients who underwent heart transplantation between January 1, 2016 and June 30, 2018. We used tests of calibration to compare the observed rate of 1-year graft failure to the expected risk of 1-year graft failure, which was calculated for each recipient using the July 2019 method published by the Scientific Registry of Transplant Recipients (SRTR). The primary study outcome was the joint test of calibration, which accounts for both the total number of events predicted (calibration-in-the-large) and dispersion of risk predictions (calibration slope).

RESULTS: 6,528 heart transplants were analyzed. The primary test of calibration failed (p <0.0001), indicating poor accuracy of the SRTR model. The calibration-in-the-large statistic (0.63, 95% confidence interval [CI] 0.58-0.68, p < 0.0001) demonstrated overestimation of event rates while the calibration slope statistic (0.56, 95% CI 0.49-0.62, p <0.0001) indicated over-dispersion of event rates. Pre-specified subgroup analyses demonstrated poor calibration for all subgroups (each p <0.01). After recalibration, program-level observed/expected ratios increased by a median of 0.14 (p <0.0001).

CONCLUSIONS: Risk models employed for publicly-reported graft survival at U.S. heart transplant centers lack accuracy in general and in all subgroups tested. The use of disease-specific models may improve the accuracy of program performance metrics.

PMID:34465530 | DOI:10.1016/j.healun.2021.07.027

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The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study

Eur Urol. 2021 Aug 28:S0302-2838(21)01946-1. doi: 10.1016/j.eururo.2021.08.002. Online ahead of print.

ABSTRACT

BACKGROUND: Multiparametric magnetic resonance imaging (MRI) is validated for the detection of clinically significant prostate cancer (csPCa), although patients with negative/equivocal MRI undergo biopsy for false negative concerns. In addition, 68Ga-PSMA-11 positron emission tomography/computed tomography (prostate-specific membrane antigen [PSMA]) may also identify csPCa accurately.

OBJECTIVE: This trial aimed to determine whether the combination of PSMA + MRI was superior to MRI in diagnostic performance for detecting csPCa.

DESIGN, SETTING, AND PARTICIPANTS: A prospective multicentre phase II imaging trial was conducted. A total of 296 men were enrolled with suspected prostate cancer, with no prior biopsy or MRI, recent MRI (6 mo), and planned transperineal biopsy based on clinical risk and MRI. In all, 291 men underwent MRI, pelvic-only PSMA, and systematic ± targeted biopsy.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Sensitivity, specificity, and predictive values (negative predictive value [NPV] and positive predictive value) for csPCa were determined for MRI, PSMA, and PSMA + MRI. PSMA + MRI was defined as negative for PSMA negative Prostate Imaging Reporting and Data System (PI-RADS) 2/3 and positive for either MRI PI-RADS 4/5 or PSMA positive PI-RADS 2/3; csPCa was any International Society of Urological Pathology (ISUP) grade group ≥2 malignancy.

RESULTS AND LIMITATIONS: Of the patients, 56% (n = 162) had csPCa; 67% had PI-RADS 3-5, 73% were PSMA positive, and 81% were combined PSMA + MRI positive. Combined PSMA + MRI improved NPV compared with MRI alone (91% vs 72%, test ratio = 1.27 [1.11-1.39], p < 0.001). Sensitivity also improved (97% vs 83%, p < 0.001); however, specificity was reduced (40% vs 53%, p = 0.011). Five csPCa cases were missed with PSMA + MRI (four ISUP 2 and one ISUP 3). Of all men, 19% (56/291) were PSMA + MRI negative (38% of PI-RADS 2/3) and could potentially have avoided biopsy, risking delayed csPCa detection in 3.1% men with csPCa (5/162) or 1.7% (5/291) overall.

CONCLUSIONS: PSMA + MRI improved NPV and sensitivity for csPCa in an MRI triaged population. Further randomised studies will determine whether biopsy can safely be omitted in men with a high clinical suspicion of csPCa but negative combined imaging.

PATIENT SUMMARY: The combination of magnetic resonance imaging (MRI) + prostate-specific membrane antigen positron emission tomography reduces false negatives for clinically significant prostate cancer (csPCa) compared with MRI, potentially allowing a reduction in the number of prostate biopsies required to diagnose csPCa.

PMID:34465492 | DOI:10.1016/j.eururo.2021.08.002

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COVID-19 vaccination in the Federal Bureau of Prisons, December 2020-April 2021

Vaccine. 2021 Aug 14:S0264-410X(21)01078-1. doi: 10.1016/j.vaccine.2021.08.045. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe COVID-19 vaccine distribution operations in United States Federal Bureau of Prisons (BOP) institutions and offices from December 16, 2020-April 14, 2021, report vaccination coverage among staff and incarcerated people, and identify factors associated with vaccination acceptance among incarcerated people.

METHODS: The BOP COVID-19 vaccination plan and implementation timeline are described. Descriptive statistics and vaccination coverage were calculated for the BOP incarcerated population using data from the BOP electronic medical record. Coverage among staff was calculated using data from the Centers for Disease Control and Prevention Vaccination Administration Management System. Vaccination coverage in the BOP versus the overall United States adult population was compared by state/territory. Univariate and multivariable logistic regression models were developed to identify demographic, health-related, and institution-level factors associated with vaccination acceptance among incarcerated people, using hierarchical linear modeling to account for institution-level clustering.

RESULTS: By April 14, 2021, BOP had offered COVID-19 vaccination to 37,870 (100%) staff and 88,173/126,413 (69.8%) incarcerated people, with acceptance rates of 50.2% and 64.2%, respectively. At the time of analysis, vaccination coverage in BOP was comparable to coverage in the overall adult population in the states and territories where BOP institutions and offices are located. Among incarcerated people, factors associated with lower vaccination acceptance included younger age, female sex, non-Hispanic Black and Asian race/ethnicity, and having few underlying medical conditions; factors associated with higher acceptance included having a prior SARS-CoV-2 infection, being born outside the United States, and being assigned to a Federal Detention Center.

CONCLUSIONS: Early COVID-19 vaccination efforts in BOP have achieved levels of coverage similar to the general population. To build on this initial success, BOP can consider strategies including re-offering vaccination to people who initially refused and tailoring communication strategies to groups with lower acceptance rates.

PMID:34465473 | DOI:10.1016/j.vaccine.2021.08.045

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The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study

Int J Oral Maxillofac Surg. 2021 Aug 28:S0901-5027(21)00293-9. doi: 10.1016/j.ijom.2021.08.018. Online ahead of print.

ABSTRACT

Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, the mean reported difference in bleeding was moderate, and the clinical relevance of this blood-sparing effect remains debated. We therefore conducted a prospective, double-blind, randomized, placebo-controlled equivalence study of the effect of TA in patients undergoing Lefort I or bimaxillary osteotomies. Our main outcome measure was total blood loss on postoperative day 1. The equivalence margin was ± 250 ml for the difference in blood loss and its 95% confidence interval. One hundred and forty-seven patients were randomized, of which 122 underwent bimaxillary osteotomies. Blood loss in the treatment group was 682 ± 323 vs. 875 ± 492 ml. The mean difference in bleeding was -132 [-243; -21] ml as per-protocol, but -193 [-329; -57] ml in intention-to-treat: the limits of this confidence interval exceeded the margin of equivalence. Similar results were obtained when analysing only patients undergoing bimaxillary osteotomy. Haemoglobin decreased by 1.8 ± 1.2 g/dl with TA, vs. 2.6 ± 1.1 g/dl with placebo (p<0.001). Our study did not demonstrate equivalence between TA and placebo on perioperative blood loss in orthognathic surgery. TA may reduce blood loss but without evidence of clinical consequences.

PMID:34465477 | DOI:10.1016/j.ijom.2021.08.018

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Audiological profile and handicap levels in people with vestibular disorders at Centro Equilibra, Vértigo and Equilibrio, San José, Costa Rica

Acta Otorrinolaringol Esp. 2021 Aug 28:S0001-6519(21)00084-4. doi: 10.1016/j.otorri.2021.04.004. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Vestibular disorders are linked to a group of pathologies that can affect the vestibular part, the auditory part, or both parts of the inner ear. The problem in this study is the little information that exists about the audiological profile of people suffering from vestibular disorders in Costa Rica. There are international research studies on this topic, but there are no records of studies conducted in the Costa Rican population. This is why there is interest in developing this research which aims to characterize the audiological profile and the levels of handicap in people with vestibular disorders under Centro Equilibra, Vertigo and Equilibrio consultation during the months of September to November 2019.

PATIENTS AND METHODS: A descriptive, cross-sectional, quantitative, and observational analytical study with patients over 18years old who attended Centro Equilibra. The main variables analysed were sex, age, personal pathological history, medical diagnosis, main vestibular symptoms, auditory manifestations, and levels of handicap.

RESULTS: The data was obtained from 177 people; vestibular disorders occurred more in the female sex (ratio 2.6:1). The mean age was 56years. Fifty-three point seven percent presented slight sensorineural hearing loss, gradually decreasing. Of the population, 33.9% presented tinnitus, mostly at high frequencies. In the adult population, 52% presented some level of hearing handicap, unlike older adults, where the majority (77%) did not present any level of handicap. People with vestibular disorders perceive greater physical handicap (83%).

CONCLUSIONS: Hearing loss was the most common hearing manifestation and although statistical analysis shows that it is not directly related to vestibular disorders, it is related to concomitant metabolic diseases. For this reason, it is necessary to promote the prevention of metabolic diseases as one of the measures to improve hearing health, even from an early age.

PMID:34465442 | DOI:10.1016/j.otorri.2021.04.004