Tag: statistics

Clin Oral Implants Res. 2021 Sep 8. doi: 10.1111/clr.13832. Online ahead of print.

ABSTRACT

OBJECTIVES: The primary objective of this study was to assess whether giving postoperative antibiotics to healthy patients after straightforward platform-switched implant placement would influence peri-implant crestal bone levels and postoperative morbidity after one year.

METHODS: Thirty-eight healthy individuals were recruited in this pilot, randomized, double-blinded, placebo-controlled clinical trial. The intervention group (n=18) received two grams of amoxicillin one hour before implant placement followed by a seven-day postoperative regimen (500 mg tid). The control group (n=20) took the same preoperative dose of amoxicillin and an identical placebo postoperatively. Mesial and distal peri-implant crestal bone levels were measured at baseline, four months and one year later with standardised periapical radiographs. Postoperative pain severity was assessed through self-administered questionnaires for seven days. Surgery-associated morbidities were evaluated after one, three, 16 weeks and one year. Descriptive and bivariate analyses were used.

RESULTS: Thirty-seven participants completed the trial. At the one-year follow-up, the mean combined peri-implant crestal bone changes for the intervention (n=18) and control (n=19) groups were – 0.44 ± 0.41 mm and – 0.27 ± 0.56 mm, respectively. The difference between the groups (intervention-control) for mean combined crestal bone level changes was not statistically significant. There were no significant differences in surgery-associated morbidities between the intervention and control groups. The one-year implant survival rate was 100% in both groups.

CONCLUSIONS: Study results suggest that a routine postoperative antibiotic regimen for healthy patients undergoing straightforward platform-switched implant placement might not be necessary to prevent postoperative peri-implant bone loss and complications.

PMID:34496085 | DOI:10.1111/clr.13832

Phytother Res. 2021 Sep 8. doi: 10.1002/ptr.7259. Online ahead of print.

ABSTRACT

This study aimed to investigate the effect of nanomicelle curcumin (CUR), Nigella sativa oil (NS), and CUR and NS on the plasma levels of miR-21, miR-422a, and miR-503 expression in postmenopausal women with low bone mass density (BMD). This randomized, triple-blind, placebo-controlled clinical trial with a factorial design was conducted on 120 postmenopausal women from the integrated healthcare system, Tabriz-Iran. The BMD was determined using dual-energy X-ray absorptiometry (DEXA). Women were randomly divided into four groups of 30 participants: (a) CUR (80 mg) and placebo of NS, (b) NS (1,000 mg) and placebo of CUR, (c) CUR (80 mg) and NS (1,000 mg), and (d) both placebos (containing microcrystalline cellulose). The plasma level of miRNA-21, miRNA-422a, and miRNA-503 was determined by qRT-PCR. The expression level of miRNAs at the baseline was similar. At the end of the intervention, only the expression level of miRNA-21 changed statistically significantly between the four groups (p = .037) and between the NS and placebo groups (p = .005). Also, its expression in the two groups receiving NS (p = .037) and NS-CUR (p = .043) was significantly increased. NS and NS-CUR supplementation can increase the expression level of miRNA-21 in postmenopausal women with low bone density, and bring perspective to further studies of the target.

PMID:34496087 | DOI:10.1002/ptr.7259

Acta Paediatr. 2021 Sep 8. doi: 10.1111/apa.16099. Online ahead of print.

ABSTRACT

AIM: The aim of this cohort study was to evaluate doctor-diagnosed and self-reported asthma in young adults after early-childhood hospitalisation for wheezing.

METHODS: In this prospective controlled follow-up, questionnaires were sent to 95 subjects aged 24-28 years, who had been hospitalised for their first episodes of wheezing under 24 months of age. Fifty-eight cases and 100 controls returned the questionnaires.

RESULTS: The risk of doctor-diagnosed asthma was 2.14-fold (95% confidence interval 0.61-7.41) and the risk of self-reported asthma 2.39-fold (1.14-4.99) in cases compared to controls. The increased risk of self-reported asthma remained as statistically significant in analyses adjusted for current smoking, overweight and allergic rhinitis. Study subjects presented with wheezing symptoms, use of bronchodilators and inhaled corticosteroids, and with seasonal symptoms presumptive for allergic rhinitis during the last 12 months, more often than controls. The identification of respiratory syncytial virus or rhinovirus during hospitalisation in early childhood was not anymore associated with asthma risk in adulthood. As expected, previous asthma during early childhood was a strong risk factor for asthma in young adulthood.

CONCLUSION: In this controlled questionnaire study, early-childhood hospitalisation for lower respiratory infection with wheezing was an independently significant risk factor of asthma in young adults.

PMID:34496079 | DOI:10.1111/apa.16099

Histopathology. 2021 Sep 8. doi: 10.1111/his.14562. Online ahead of print.

ABSTRACT

AIMS: The introduction of immunotherapy in head and neck squamous cell carcinoma (HNSCC) raises the need for harmonization between different types of antibodies and immunohistochemistry platforms for evaluating the expression of (Programmed death-ligand 1) PD-L1 with Combined Positive Score (CPS) in this tumor. We compare the expression of PD-L1, using the CPS and two widely used antibody (22C3 pharma Dx and SP263 assay) in a cohort of HNSCC.

METHODS AND RESULTS: We analyzed forty-three whole sections of HNSCC with two different anti-PD-L1 antibodies, 22C3 pharma Dx and SP263 assay. Results, expressed as CPS, were evaluated by ten trained pathologists and statistical analyses, including interobserver agreement, were performed. We found a very similar distribution for PD-L1 expression between 22C3 pharmaDx assay and SP263 assay in our cohort and a strong significant correlation between the two assays for all specimens (Spearman r= 0.945; p<0.0001). The interobserver reliability among pathologists for the continuous scores of CPS with ICC and the correlation between the two assays was both good. Moreover, the agreement rate between assays was high at all cut-offs and was best for the most relevant cut-off of CPS ≥1, while the kappa values were always in the range of almost perfect.

CONCLUSIONS: Two different assays (22C3 pharmaDx assay and SP263 assay) for PD-L1 in HNSCC showed high agreement. This data suggests the interchangeability of these two antibodies in the selection of patients with HNSCC for immunotherapy.

PMID:34496080 | DOI:10.1111/his.14562

J Med Virol. 2021 Sep 8. doi: 10.1002/jmv.27325. Online ahead of print.

ABSTRACT

With this Letter we would like to point out the importance of a good and reliable communication of predictions, scenarios and projections about COVID-19, focusing on the Italian case. This article is protected by copyright. All rights reserved.

PMID:34496053 | DOI:10.1002/jmv.27325

Hepatology. 2021 Sep 8. doi: 10.1002/hep.32142. Online ahead of print.

ABSTRACT

BACKGROUND & AIMS: Chronic hepatitis B (CHB) affects over 290 million people globally and only 10% have been diagnosed, presenting a severe gap that must be addressed. We developed logistic regression and machine learning (random forest) models to accurately identify patients with HBV, using only easily-obtained demographic data from a population-based data set.

APPROACH & RESULTS: We identified participants with data on hepatitis B surface antigen (HBsAg), birth year, sex, race/ethnicity, and birthplace from 10 cycles of the National Health and Nutrition Examination Survey (NHANES, 1999-2018) and divided them into two cohorts: training (cycles 2, 3, 5, 6, 8, 10; n = 39,119) and validation (cycles 1, 4, 7, 9; n = 21,569). We then developed and tested our two models. The overall cohort was 49.2% male, 39.7% White, 23.2% Black, 29.6% Hispanic, and 7.5% Asian/Other, with a median birth year of 1973. In multivariable logistic regression, the following factors were associated with HBV infection: birth year 1991 or after (adjusted OR [aOR] of 0.28, P < 0.001), male sex (aOR 1.49, P = 0.0080), Black and Asian/Other vs. White (aOR 5.23 and 9.13, P < 0.001 for both), and being United States-born (vs. foreign-born) (aOR 0.14, P < 0.001). We found that the machine learning model consistently outperformed the logistic regression model, with higher AUROC values (0.83 vs. 0.75 in validation cohort, P < 0.001) and better differentiation of high and low risk individuals.

CONCLUSIONS: Our machine learning model provides a simple, targeted approach to HBV screening, using only easily-obtained demographic data.

PMID:34496066 | DOI:10.1002/hep.32142

PLoS One. 2021 Sep 8;16(9):e0256515. doi: 10.1371/journal.pone.0256515. eCollection 2021.

ABSTRACT

BACKGROUND: The epidemiological transition, touted as occurring in Ghana, requires research that tracks the changing patterns of diseases in order to capture the trend and improve healthcare delivery. This study examines national trends in mortality rate and cause of death at health facilities in Ghana between 2014 and 2018.

METHODS: Institutional mortality data and cause of death from 2014-2018 were sourced from the Ghana Health Service’s District Health Information Management System. The latter collates healthcare service data routinely from government and non-governmental health institutions in Ghana yearly. The institutional mortality rate was estimated using guidelines from the Ghana Health Service. Percent change in mortality was examined for 2014 and 2018. In addition, cause of death data were available for 2017 and 2018. The World Health Organisation’s 11th International Classification for Diseases (ICD-11) was used to group the cause of death.

RESULTS: Institutional mortality decreased by 7% nationally over the study period. However, four out of ten regions (Greater Accra, Volta, Upper East, and Upper West) recorded increases in institutional mortality. The Upper East (17%) and Volta regions (13%) recorded the highest increase. Chronic non-communicable diseases (NCDs) were the leading cause of death in 2017 (25%) and 2018 (20%). This was followed by certain infectious and parasitic diseases (15% for both years) and respiratory infections (10% in 2017 and 13% in 2018). Among the NCDs, hypertension was the leading cause of death with 2,243 and 2,472 cases in 2017 and 2018. Other (non-ischemic) heart diseases and diabetes were the second and third leading NCDs. Septicaemia, tuberculosis and pneumonia were the predominant infectious diseases. Regional variations existed in the cause of death. NCDs showed more urban-region bias while infectious diseases presented more rural-region bias.

CONCLUSIONS: This study examined national trends in mortality rate and cause of death at health facilities in Ghana. Ghana recorded a decrease in institutional mortality throughout the study. NCDs and infections were the leading causes of death, giving a double-burden of diseases. There is a need to enhance efforts towards healthcare and health promotion programmes for NCDs and infectious diseases at facility and community levels as outlined in the 2020 National Health Policy of Ghana.

PMID:34496000 | DOI:10.1371/journal.pone.0256515

Med Phys. 2021 Sep 8. doi: 10.1002/mp.15214. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to design and evaluate a novel method for the registration of 2D lateral cephalograms and 3D craniofacial cone-beam computed tomography (CBCT) images, providing patient-specific 3D structures from a 2D lateral cephalogram without additional radiation exposure.

METHODS: We developed a cross-modal deformable registration model based on a deep convolutional neural network. Our approach took advantage of a low-dimensional deformation field encoding and an iterative feedback scheme to infer coarse-to-fine volumetric deformations. In particular, we constructed a statistical subspace of deformation fields and parameterized the nonlinear mapping function from an image pair, consisting of the target 2D lateral cephalogram and the reference volumetric CBCT, to a latent encoding of the deformation field. Instead of the one-shot registration by the learned mapping function, a feedback scheme was introduced to progressively update the reference volumetric image and to infer coarse-to-fine deformations fields, accounting for the shape variations of anatomical structures. A total of 220 clinically obtained CBCTs were used to train and validate the proposed model, among which 120 CBCTs were used to generate a training dataset with 24k paired synthetic lateral cephalograms and CBCTs. The proposed approach was evaluated on the deformable 2D-3D registration of clinically obtained lateral cephalograms and CBCTs from growing and adult orthodontic patients.

RESULTS: Strong structural consistencies were observed between the deformed CBCT and the target lateral cephalogram in all criteria. The proposed method achieved state-of-the-art performances with the mean contour deviation of 0.41±0.12 mm on the anterior cranial base, 0.48±0.17 mm on the mandible, and 0.35±0.08 mm on the maxilla, respectively. The mean surface mesh ranged from 0.78 mm to 0.97 mm on various craniofacial structures, and the landmark registration errors ranged from 0.83 mm to 1.24 mm on the growing datasets regarding 14 landmarks. The proposed iterative feedback scheme handled the structural details and improved the registration. The resultant deformed volumetric image was consistent with the target lateral cephalogram in both 2D projective planes and 3D volumetric space regarding the multi-category craniofacial structures.

CONCLUSIONS: The results suggest that the deep learning-based 2D-3D registration model enables the deformable alignment of 2D lateral cephalograms and CBCTs and estimates patient-specific 3D craniofacial structures.

PMID:34496039 | DOI:10.1002/mp.15214

PLoS One. 2021 Sep 8;16(9):e0256980. doi: 10.1371/journal.pone.0256980. eCollection 2021.

ABSTRACT

BACKGROUND: A DNA-prime/human adenovirus serotype 5 (HuAd5) boost vaccine encoding Plasmodium falciparum (Pf) circumsporozoite protein (PfCSP) and Pf apical membrane antigen-1 (PfAMA1), elicited protection in 4/15 (27%) of subjects against controlled human malaria infection (CHMI) that was statistically associated with CD8+ T cell responses. Subjects with high level pre-existing immunity to HuAd5 were not protected, suggesting an adverse effect on vaccine efficacy (VE). We replaced HuAd5 with chimpanzee adenovirus 63 (ChAd63), and repeated the study, assessing both the two-antigen (CSP, AMA1 = CA) vaccine, and a novel three-antigen (CSP, AMA1, ME-TRAP = CAT) vaccine that included a third pre-erythrocytic stage antigen [malaria multiple epitopes (ME) fused to the Pf thrombospondin-related adhesive protein (TRAP)] to potentially enhance protection.

METHODOLOGY: This was an open label, randomized Phase 1 trial, assessing safety, tolerability, and VE against CHMI in healthy, malaria naïve adults. Forty subjects (20 each group) were to receive three monthly CA or CAT DNA priming immunizations, followed by corresponding ChAd63 boost four months later. Four weeks after the boost, immunized subjects and 12 infectivity controls underwent CHMI by mosquito bite using the Pf3D7 strain. VE was assessed by determining the differences in time to parasitemia as detected by thick blood smears up to 28-days post CHMI and utilizing the log rank test, and by calculating the risk ratio of each treatment group and subtracting from 1, with significance calculated by the Cochran-Mantel-Haenszel method.

RESULTS: In both groups, systemic adverse events (AEs) were significantly higher after the ChAd63 boost than DNA immunizations. Eleven of 12 infectivity controls developed parasitemia (mean 11.7 days). In the CA group, 15 of 16 (93.8%) immunized subjects developed parasitemia (mean 12.0 days). In the CAT group, 11 of 16 (63.8%) immunized subjects developed parasitemia (mean 13.0 days), indicating significant protection by log rank test compared to infectivity controls (p = 0.0406) and the CA group (p = 0.0229). VE (1 minus the risk ratio) in the CAT group was 25% compared to -2% in the CA group. The CA and CAT vaccines induced robust humoral (ELISA antibodies against CSP, AMA1 and TRAP, and IFA responses against sporozoites and Pf3D7 blood stages), and cellular responses (IFN-γ FluoroSpot responses to CSP, AMA1 and TRAP) that were not associated with protection.

CONCLUSIONS: This study demonstrated that the ChAd63 CAT vaccine exhibited significant protective efficacy, and confirmed protection was afforded by adding a third antigen (T) to a two-antigen (CA) formulation to achieve increased VE. Although the ChAd63-CAT vaccine was associated with increased frequencies of systemic AEs compared to the CA vaccine and, historically, compared to the HuAd5 vectored malaria vaccine encoding CSP and AMA1, they were transient and associated with increased vector dosing.

PMID:34495988 | DOI:10.1371/journal.pone.0256980

PLoS One. 2021 Sep 8;16(9):e0256831. doi: 10.1371/journal.pone.0256831. eCollection 2021.

ABSTRACT

Current approach for the detection of cancer is based on identifying genetic mutations typical to tumor cells. This approach is effective only when cancer has already emerged, however, it might be in a stage too advanced for effective treatment. Cancer is caused by the continuous accumulation of mutations; is it possible to measure the time-dependent information of mutation accumulation and predict the emergence of cancer? We hypothesize that the mutation history derived from the tandem repeat regions in blood-derived DNA carries information about the accumulation of the cancer driver mutations in other tissues. To validate our hypothesis, we computed the mutation histories from the tandem repeat regions in blood-derived exomic DNA of 3874 TCGA patients with different cancer types and found a statistically significant signal with specificity ranging from 66% to 93% differentiating Glioblastoma patients from other cancer patients. Our approach and findings offer a new direction for future cancer prediction and early cancer detection based on information derived from blood-derived DNA.

PMID:34495981 | DOI:10.1371/journal.pone.0256831