Category: Statistics

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

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

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

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

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

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

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

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

J Acad Nutr Diet. 2021 Aug 27:S2212-2672(21)01034-0. doi: 10.1016/j.jand.2021.07.008. Online ahead of print.

ABSTRACT

BACKGROUND: In 2020, San Francisco, CA, amended an ordinance requiring warning labels on advertisements for sugary drinks to update the warning message. No studies have evaluated consumer responses to the revised message.

OBJECTIVES: To evaluate responses to the 2020 San Francisco sugary drink warning label and to assess whether these responses differ by demographic characteristics.

DESIGN: Randomized experiment.

PARTICIPANTS AND SETTING: During 2020, a convenience sample of US parents of children aged 6 months to 5 years (N = 2,160 included in primary analyses) was recruited via an online panel to complete a survey. Oversampling was used to achieve a diverse sample (49% Hispanic/Latino[a], 34% non-Hispanic Black, and 9% non-Hispanic White).

METHODS: Participants were randomly assigned to view a control label (“Always read the Nutrition Facts Panel”) or the 2020 San Francisco sugary drink warning label (“SAN FRANCISCO GOVERNMENT WARNING: Drinking beverages with added sugar(s) can cause weight gain, which increases the risk of obesity and type 2 diabetes.”). Messages were shown in white text on black rectangular labels.

MAIN OUTCOME MEASURES: Participants rated the labels on thinking about health harms of sugary drink consumption (primary outcome) and perceived discouragement from wanting to consume sugary drinks. The survey was available in English and Spanish.

STATISTICAL ANALYSES PERFORMED: Ordinary least squares regression.

RESULTS: The San Francisco warning label elicited more thinking about health harms (Cohen’s d = 0.24; P < 0.001) than the control label. The San Francisco warning label also led to more discouragement from wanting to consume sugary drinks than the control label (d = 0.31; P < 0.001). The warning label’s influence on thinking about harms did not differ by any participant characteristics, including age, gender, race/ethnicity, education, income, or language of survey administration (all P values for interactions > 0.12).

CONCLUSIONS: San Francisco’s 2020 sugary drink warning label may be a promising policy for informing consumers and encouraging healthier beverage choices across groups with diverse demographic characteristics.

PMID:34465443 | DOI:10.1016/j.jand.2021.07.008

J Bus Contin Emer Plan. 2021 Jan 1;15(1):87-104.

ABSTRACT

Small-to-medium enterprises (SMEs) are vulnerable to disasters because of their limited ability to duplicate, separate and diversify their risk. SMEs must therefore rely on local personnel and resources to plan for, respond to, and recover from disasters. Unfortunately, community-level planning does not readily incorporate SMEs effectively. SMEs are thus forced to plan in isolation as current hazard risk analysis (HRA) models do not adequately account for the capacity of local personnel to respond to emergent hazards. Accordingly, this study posits an easy-to-use SME disaster impact model for HRA that combines probability theory and statistical analysis to integrate local personnel capacity. The model is designed specifically for SME usage; although, it can be applied to any organisation regardless of size. This study proposes a standardised HRA probability and consequence sequence based on the analysis of over 400 locations and risks that determined the model’s reliability in practice. The posited SME disaster impact model for HRA effectively integrates vulnerability and local personnel capacity with services, personnel and equipment to optimise SME disaster response and recovery capacity.

PMID:34465413