Tag: pubmed

J Endocrinol Invest. 2022 Oct 21. doi: 10.1007/s40618-022-01935-y. Online ahead of print.

ABSTRACT

PURPOSE: Adrenal cortical adenomas (ACAs) represent one of the most common endocrine neoplasms. Recently, a genetic syndrome, characterized by tumor-suppressor ARMC5-gene mutations and causing primary macronodular bilateral adrenal hyperplasia with concomitant meningiomas of the central nervous system, has been described. Apart from this rare disorder and despite the well-known influence of steroid hormones on meningiomas, no data are available about the association between ACAs and meningiomas.

METHODS: We investigated the prevalence of ACAs in a group of patients with cerebral meningioma undergoing unenhanced chest CT scans before attending surgical treatment. Patients with meningioma were age- and sex-matched in a 1:3 ratio with hospitalized patients for COVID-19.

RESULTS: Fifty-six patients with meningioma were included and matched with 168 control patients with COVID-19. One-hundred forty-four (66.1%) were female and the median age was 63 years. Twenty ACAs were detected in the overall population (8.9% of the subjects): 10 in patients with meningioma (18%) and the remaining 10 (6%) in the control group (p = 0.007). Multivariate analysis showed that age and presence of meningioma were statistically associated with the presence of ACAs (p = 0.01, p = 0.008).

CONCLUSION: We report, for the first time, a higher prevalence of ACAs in patients with meningioma as compared to age- and sex-matched controls. Larger studies are needed to confirm our data and to clarify the characteristics of the ACAs in patients with meningioma. Whether the detection of ACAs should prompt a neuroimaging evaluation to exclude the presence of meningiomas needs also to be considered.

PMID:36269557 | DOI:10.1007/s40618-022-01935-y

Ther Innov Regul Sci. 2022 Oct 21. doi: 10.1007/s43441-022-00470-5. Online ahead of print.

ABSTRACT

BACKGROUND: Central monitoring, which typically includes the use of key risk indicators (KRIs), aims at improving the quality of clinical research by pro-actively identifying and remediating emerging issues in the conduct of a clinical trial that may have an adverse impact on patient safety and/or the reliability of trial results. However, there has to-date been a relative lack of direct quantitative evidence published supporting the claim that central monitoring actually leads to improved quality.

MATERIAL AND METHODS: Nine commonly used KRIs were analyzed for evidence of quality improvement using data retrieved from a large central monitoring platform. A total of 212 studies comprising 1676 sites with KRI signals were used in the analysis, representing central monitoring activity from 23 different sponsor organizations. Two quality improvement metrics were assessed for each KRI, one based on a statistical score (p-value) and the other based on a KRI’s observed value.

RESULTS: Both KRI quality metrics showed improvement in a vast majority of sites (82.9% for statistical score, 81.1% for observed KRI value). Additionally, the statistical score and the observed KRI values improved, respectively by 66.1% and 72.4% on average towards the study average for those sites showing improvement.

CONCLUSION: The results of this analysis provide clear quantitative evidence supporting the hypothesis that use of KRIs in central monitoring is leading to improved quality in clinical trial conduct and associated data across participating sites.

PMID:36269551 | DOI:10.1007/s43441-022-00470-5

J Gastrointest Cancer. 2022 Oct 21. doi: 10.1007/s12029-022-00866-4. Online ahead of print.

ABSTRACT

PURPOSE: Anal cancer is a rare form of gastrointestinal malignancy, and treatment is often confined to specialist centres. It has a high cure rate with non-surgical approach resulting in organ preservation. The current accepted schedule is chemo-radiotherapy (CRT) with 5-fluorouracil and mitomycin with radiotherapy doses between 50.4 and 53.2 Gray in 28 fractions.

METHODS: This study included patients who had histological confirmation of squamous cell carcinoma and had completed the full CRT course for anal cancer between 2008 and 2018 in our centre. Data was collected retrospectively assessing demographics, staging, surgery, relapse, latest follow-up, date of death, CRT regimen and TNM stage. Outcome data and stoma reversal rate were analysed.

RESULTS: Overall, 87 patients were included in the study. At diagnosis 94.3% of patients had T2-T4 disease, and 44.8% had involvement of positive loco-regional lymph nodes. Overall survival (OS) probability at 1, 3 and 5 years were 98.8%, 87.4% and 83.7%, respectively. Results also revealed a statistically significant effect of time from diagnosis to the start of radiotherapy on OS (p = 0.039). Sixty-nine (79.3%) patients achieved complete remission at last follow-up. Twenty-one patients (24%) underwent surgery for a de-functioning stoma, and only five of these patients subsequently received stoma reversal surgery.

CONCLUSIONS: Our data reflects the efficacy of CRT as the primary modality of treatment in the management of anal squamous cell carcinoma with effective organ preservation and disease control. Early stoma reversal may also enhance quality of life.

PMID:36269537 | DOI:10.1007/s12029-022-00866-4

Breast Cancer Res Treat. 2022 Oct 21. doi: 10.1007/s10549-022-06763-5. Online ahead of print.

ABSTRACT

PURPOSE: The use of the Oncotype DX recurrence score (RS) to predict chemotherapy benefit in patients with hormone receptor-positive/HER2 negative (HR+/HER2-) breast cancer has recently expanded to include postmenopausal patients with N1 disease. RS availability is limited in resource-poor settings, however, prompting the development of statistical models that predict RS using clinicopathologic features. We sought to assess the performance of our supervised machine learning model in a cohort of patients > 50 years of age with N1 disease.

METHODS: We identified patients > 50 years of age with pT1-2N1 HR+/HER2- breast cancer and applied the statistical model previously developed in a node-negative cohort, which uses age, pathologic tumor size, histology, progesterone receptor expression, lymphovascular invasion, and tumor grade to predict RS. We measured the model’s ability to predict RS risk category (low: RS ≤ 25; high: RS > 25).

RESULTS: Our cohort included 401 patients, 60.6% of whom had macrometastases, with a median of 1 positive node. The majority of patients had a low-risk observed RS (85.8%). For predicting RS category, the model had specificity of 97.3%, sensitivity of 31.8%, a negative predictive value of 87.9%, and a positive predictive value of 70.0%.

CONCLUSION: Our model, developed in a cohort of node-negative patients, was highly specific for identifying cN1 patients > 50 years of age with a low RS who could safely avoid chemotherapy. The use of this model for identifying patients in whom genomic testing is unnecessary would help decrease the cost burden in resource-poor settings as reliance on RS for adjuvant treatment recommendations increases.

PMID:36269526 | DOI:10.1007/s10549-022-06763-5

Oral Radiol. 2022 Oct 21. doi: 10.1007/s11282-022-00660-9. Online ahead of print.

ABSTRACT

This study aimed at performing a systematic review of the literature on the application of artificial intelligence (AI) in dental and maxillofacial cone beam computed tomography (CBCT) and providing comprehensive descriptions of current technical innovations to assist future researchers and dental professionals. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) Statement was followed. The study’s protocol was prospectively registered. Following databases were searched, based on MeSH and Emtree terms: PubMed/MEDLINE, Embase and Web of Science. The search strategy enrolled 1473 articles. 59 publications were included, which assessed the use of AI on CBCT images in dentistry. According to the PROBAST guidelines for study design, seven papers reported only external validation and 11 reported both model building and validation on an external dataset. 40 studies focused exclusively on model development. The AI models employed mainly used deep learning models (42 studies), while other 17 papers used conventional approaches, such as statistical-shape and active shape models, and traditional machine learning methods, such as thresholding-based methods, support vector machines, k-nearest neighbors, decision trees, and random forests. Supervised or semi-supervised learning was utilized in the majority (96.62%) of studies, and unsupervised learning was used in two (3.38%). 52 publications included studies had a high risk of bias (ROB), two papers had a low ROB, and four papers had an unclear rating. Applications based on AI have the potential to improve oral healthcare quality, promote personalized, predictive, preventative, and participatory dentistry, and expedite dental procedures.

PMID:36269515 | DOI:10.1007/s11282-022-00660-9

Matern Child Health J. 2022 Oct 21. doi: 10.1007/s10995-022-03506-2. Online ahead of print.

ABSTRACT

OBJECTIVES: Social and structural barriers drive disparities in prenatal care utilization among minoritized women in the United States. This study examined the impact of Arizona’s Health Start Program, a community health worker (CHW) home visiting intervention, on prenatal care utilization among an ethno-racially and geographically diverse cohort of women.

METHODS: We used Health Start administrative and state birth certificate data to identify women enrolled in the program during 2006-2016 (n = 7,117). Propensity score matching was used to generate a statistically-similar comparison group (n = 53,213) of women who did not participate in the program. Odds ratios were used to compare rates of prenatal care utilization. The process was repeated for select subgroups, with post-match regression adjustments applied where necessary.

RESULTS: Health Start participants were more likely to report any (OR 1.24, 95%CI 1.02-1.50) and adequate (OR 1.08, 95%CI 1.01-1.16) prenatal care, compared to controls. Additional specific subgroups were significantly more likely to receive any prenatal care: American Indian women (OR 2.22, 95%CI 1.07-4.60), primipara women (OR 1.64, 95%CI 1.13-2.38), teens (OR 1.58, 95%CI 1.02-2.45), women in rural border counties (OR 1.45, 95%CI 1.05-1.98); and adequate prenatal care: teens (OR 1.31, 95%CI 1.11-1.55), women in rural border counties (OR 1.18, 95%CI 1.05-1.33), primipara women (OR 1.18, 95%CI 1.05-1.32), women with less than high school education (OR 1.13, 95%CI 1.00-1.27).

CONCLUSIONS FOR PRACTICE: A CHW-led perinatal home visiting intervention operated through a state health department can improve prenatal care utilization among demographically and socioeconomically disadvantaged women and reduce maternal and child health inequity.

PMID:36269498 | DOI:10.1007/s10995-022-03506-2

Hist Philos Life Sci. 2022 Oct 21;44(4):49. doi: 10.1007/s40656-022-00528-5.

ABSTRACT

This paper contributes to the ongoing reassessment of the controversy between William Bateson and Karl Pearson by characterising what we call “Batesonian Mendelism” and “Pearsonian biometry” as coherent and competing scientific outlooks. Contrary to the thesis that such a controversy stemmed from diverging theoretical commitments on the nature of heredity and evolution, we argue that Pearson’s and Bateson’s alternative views on those processes ultimately relied on different appraisals of the methodological value of the statistical apparatus developed by Francis Galton. Accordingly, we contend that Bateson’s belief in the primacy of cross-breeding experiments over statistical analysis constituted a minimal methodological unifying condition ensuring the internal coherence of Batesonian Mendelism. Moreover, this same belief implied a view of the study of heredity and evolution as an experimental endeavour and a conception of heredity and evolution as fundamentally discontinuous processes. Similarly, we identify a minimal methodological unifying condition for Pearsonian biometry, which we characterise as the view that experimental methods had to be subordinate to statistical analysis, according to methodological standards set by biometrical research. This other methodological commitment entailed conceiving the study of heredity and evolution as subsumable under biometry and primed Pearson to regard discontinuous hereditary and evolutionary processes as exceptions to a statistical norm. Finally, we conclude that Batesonian Mendelism and Pearsonian biometry represented two potential versions of a single genetics-based evolutionary synthesis since the methodological principles and the phenomena that played a central role in the former were also acknowledged by the latter-albeit as fringe cases-and conversely.

PMID:36269490 | DOI:10.1007/s40656-022-00528-5

J Robot Surg. 2022 Oct 21. doi: 10.1007/s11701-022-01462-1. Online ahead of print.

ABSTRACT

Laparoscopic rectal surgery within the confines of a narrow pelvis may be associated with a high rate of open conversion. In the obese and morbidly obese patient, the complexity of laparoscopic surgery increases substantially. Robotic technology is known to reduce the risk of conversion, but it is unclear if it can overcome the technical challenges associated with obesity. The ACS NSQIP database was used to identify obese patients who underwent elective laparoscopic or robotic-assisted rectal resection from 2015 to 2016. Obesity was defined as a body mass index (BMI) greater than or equal to 30 kg/m². Morbid obesity was defined as a BMI greater than or equal to 35 kg/m². The primary outcome was unplanned conversions to open. Other outcomes measures assessed included anastomotic leak, operative time, surgical site infections, length of hospital stay, readmissions and mortality. Statistical analyses were performed using SPSS 22.0 (IBM SPSS, USA). 1490 patients had robotic-assisted and 4967 patients had laparoscopic rectal resections between 2015 and 2016. Of those patients, 561 obese patients had robotic-assisted rectal resections and 1824 patients underwent laparoscopic rectal surgery. In the obese cohort, the rate of unplanned conversion to open in the robotic group was 14% compared to 24% in the laparoscopic group (P < 0.0001). Median operative time was significantly longer in the robotic group (248 min vs. 215 min, P < 0.0001). There was no difference in anastomotic leak or systemic sepsis between the laparoscopic and robotic rectal surgery groups. In morbidly obese patients (BMI ≥ 35 kg/m²), the rate of unplanned conversion to open in the robotic group was 19% compared to 26% in the laparoscopic group (P < 0.027). There was no difference in anastomotic leak, systemic sepsis or surgical site infection rates between robotic and laparoscopic rectal resection. Multivariate analysis showed that robotic-assisted surgery was associated with fewer unplanned conversions to open (OR 0.28, P < 0.0001). Robotic-assisted surgery is associated with a decreased risk of conversion to open in obese and morbidly obese patients when compared to conventional laparoscopic surgery. However, robotic surgery was associated with longer operative time and despite improvement in the rate of conversion to open, there was no difference in complications or length of stay. Our findings are limited by the retrospective non-randomised nature of the study, demographic differences between the two groups, and the likely difference in surgeon experience between the two groups. Large randomised controlled studies are needed to further explore the role of robotic rectal surgery in obese and morbidly obese patients.

PMID:36269488 | DOI:10.1007/s11701-022-01462-1

Clin Oral Investig. 2022 Oct 21. doi: 10.1007/s00784-022-04717-1. Online ahead of print.

ABSTRACT

OBJECTIVES: This study evaluates the impact of systemic medications and polypharmacy on unstimulated (UWS) and chewing-stimulated whole saliva (SWS) flow rates in patients with xerostomia.

MATERIAL AND METHODS: This cross-sectional multicenter study is based on data of patients referred to five oral medicine outpatient practices in Europe and USA from January 2000 and April 2014. Relevant demographic, social, medical history and current medications were collected.

RESULTS: The study included 1144 patients, 972 (85%) females, with a mean (SD) age of 59 (14.1) years. In unmatched patients, the UWS flow rate was lower in patients taking a medication (vs. not taking a medication) from the following drug categories: opioid analgesics, anticonvulsants, antidepressants, antihypertensives, benzodiazepines, corticosteroids, diuretics, disease-modifying antirheumatic drugs (DMARDs) and hormones. There was a greater negative effect on SWS flow rate in patients taking (vs. not taking) anticonvulsants, antidepressants, benzodiazepines, corticosteroids, and DMARDs. In matched patients, both UWS (0.22 vs. 0.19 ml/min; p = 0.03) and SWS (0.97 vs. 0.85 ml/min; p = .017) flow rates were higher in patients on non-opioid analgesics (vs. not taking). The UWS flow rate was lower in patients taking antidepressants (vs. not taking) (0.16 vs. 0.22 ml/min p = .002) and higher (and within normal range) in patients taking sex hormones (vs. not taking) (0.25 vs. 0.16 ml/min; p = .005). On the other hand, SWS was lower in patients taking corticosteroid (vs. not taking) (0.76 vs. 1.07 ml/min; p = .002), and in patients taking DMARDs (vs. not taking) (0.71 vs. 0.98 ml/min; p = .021). Finally, differences in medians of both UWS and SWS were statistically significant in patients taking 1 or more than 1 opioid analgesic (vs. not taking, p ≤ .0001 and p = .031, respectively), 1 or more than 1 anticonvulsants (vs. not taking, p = .008 and p = .007), 1 or more than 1 antidepressants (vs. not taking, p < .0001 for both), 1 or more than 1 DMARDs (vs. not taking, p = .042, and p = .003).

CONCLUSIONS: A greater negative impact on UWS and SWS flow rates was seen in patients taking more than one medication from the same drug class. Intake of antidepressants, corticosteroids and DMARDs is associated with lower whole saliva flow rates.

CLINICAL RELEVANCE: Salivary flow rate can be modified by some specific medications, mostly by polypharmacy.

PMID:36269468 | DOI:10.1007/s00784-022-04717-1

Environ Monit Assess. 2022 Oct 17;194(12):899. doi: 10.1007/s10661-022-10585-9.

ABSTRACT

Total hardness (TH) is an important index representing the water suitability for domestic purpose. TH is represented mainly by Ca²⁺ and Mg²⁺ which are essential elements for human bone development. Between 2000 and 2015, the TH values of groundwater in major cities of the Guanzhong Plain varied significantly. The study was carried out to investigate TH variation over 16 years and to examine how effective the grey Markov model was in predicting TH concentrations in time series datasets. The hydrochemical parameters determining TH concentration and their origins were investigated using statistical analysis and geochemical models. The grey Markov model, which is effective in short time series prediction, was used to forecast the multi-time series of TH. The findings demonstrated a prevalence of HCO₃^– and SO₄^2- in the groundwater types combined with calcite precipitation, gypsum, and dolomite dissolution that increased the concentration of Ca²⁺, Mg²⁺, and HCO₃^–, influencing TH variation. The predicted TH values of the eight monitoring wells for the year 2016 were 1213.66, 124.30, 203.66, 103.01, 349.56, 251.23, 453.31, and 471.81 mg/L, respectively. Datasets with low TH variation were more accurately predicted than datasets with high TH variation. This was especially observed on sample B557 where TH concentration in 2010 was 400.33 mg/L and suddenly dropped to 90.1, 82.6, 85.1, 87.6, and 75.1 mg/L in 2011, 2012, 2013, 2014, and 2015, respectively. The study also shows that the Markov chain model can optimize the GM(1,1) model and improve the prediction accuracy significantly. All samples in Weinan City and one sample in Xi’an City showed a significant decrease in TH concentration. Except one sample in Xi’an City, TH concentrations tended to rise in the other cities (Baoji, Xianyang) of the Guanzhong Plain. This study verified the reliability of the grey Markov model in terms of forecasting time series datasets with high variability, and the results can be referential to similar studies in the world.

PMID:36269437 | DOI:10.1007/s10661-022-10585-9