Tag: statistics

Pediatr Nephrol. 2023 Jan 9. doi: 10.1007/s00467-022-05855-0. Online ahead of print.

ABSTRACT

BACKGROUND: Pediatric ANCA vasculitis is a rare group of diseases with a scarcity of data in children. Annual incidence appeared to increase in the last several years, placing higher interest in the clinical and therapeutical outcomes of the disorder. Also, the growing use of rituximab questions the latest outcomes in these diseases. We therefore conducted a retrospective study to better understand the current characteristics, management, and the latest outcomes of the disorder.

METHODS: We conducted a 9-year retrospective study of 46 children in 14 different centers across France to describe their clinical and laboratory presentations, therapeutic regimens, and kidney outcome.

RESULTS: P-ANCA appeared to be a potential marker for higher relapse risk. Compared to adults, we found that ear-nose-throat presentations were frequent (45.7%) and more severe. Despite an evolution in the treatment management, kidney outcome remained poor with a substantial proportion of chronic kidney disease (54.8% at 1 year). Mortality stays low with 3 patients (6.5%) deceased at the end of our study.

CONCLUSION: Clinical presentation was as previously described and time to diagnosis remains long. P-ANCA is a statistically significant marker for increased relapse risk. We observed a modification in the treatment regimens over the past several years with a growing use of rituximab and a decreasing use of cyclophosphamide. Despite these changes, kidney outcome remains poor and prospective studies should be conducted to assess the most appropriate therapeutic modality for each patient. A higher resolution version of the Graphical abstract is available as Supplementary information.

PMID:36622443 | DOI:10.1007/s00467-022-05855-0

Eur J Pediatr. 2023 Jan 9. doi: 10.1007/s00431-022-04769-1. Online ahead of print.

ABSTRACT

An undescended testis is the most common genitourinary disease in boys. The German guidelines, first published in 2009, proposed the timing of orchidopexy to be before 12 months of age. The aim of the study was to analyze the implementation of these guidelines 10 years after publication. The national cumulative statistics of hospital admissions, provided by the Institute for the Remuneration System in Hospitals (InEK), and the statistics concerning procedures performed in private pediatric surgical practices of the professional association of pediatric surgeons (BNKD) regarding the time of surgeries for the year 2019 were analyzed. Data from InEK included all German hospital admissions. Data from BNKD included data from 48 private pediatric surgical practices. The hospitals treated 6476 inpatients with undescended testis, and 3255 patients were operated in private practices. Regarding the age at treatment, 15% of the hospital patients and 5% of the private practice patients were younger than 1 year and fulfilled the guideline recommendations. Forty percent of the hospital patients and 29% of the private practice patients were 1 or 2 years of age. All other patients were 3 years of age or older at the time of orchidopexy. Conclusions: The rate of orchidopexy within the first 12 months of life is remarkably low even 10 years after the publication of the guidelines. Awareness of the existing guideline must be increased for both referring pediatric and general practitioners. What is Known: • In Germany, orchidopexy is performed by pediatric surgeons and urologists either in hospital settings or in private practices. • Most international guidelines set the age for surgical treatment of undescended testis between 12 and 18 months of age. The German guidelines, published in 2009, sets the time-limit at one year of age. Until five years after publication of the German guidelines, the number of patients treated before the first year of life was low; studies show an orchidopexy ratebetween 8% and 19% during this time. What is New: • This study the first to cover all administered hospital patients in Germany and a large group of patients treated in private practices. It contains the largest group of German patients with undescended testis. • Although almost all children participate in the routine check-up at the age of seven months, which includes investigation for undescended testis, adherence to the orchidopexy guidelines is still low. Only 15% of the hospital patients and 5% of the patients in private practice were treated before their first birthdays.

PMID:36622430 | DOI:10.1007/s00431-022-04769-1

Eur Radiol. 2023 Jan 9. doi: 10.1007/s00330-022-09378-y. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the diagnostic performance of a commercial artificial intelligence (AI)-assisted ultrasonography (US) for thyroid nodules and to validate its value in real-world medical practice.

MATERIALS AND METHODS: From March 2021 to July 2021, 236 consecutive patients with 312 suspicious thyroid nodules were prospectively enrolled in this study. One experienced radiologist performed US examinations with a real-time AI system (S-Detect). US images and AI reports of the nodules were recorded. Nine residents and three senior radiologists were invited to make a “benign” or “malignant” diagnosis based on recorded US images without knowing the AI reports. After referring to AI reports, the diagnosis was made again. The diagnostic performance of AI, residents, and senior radiologists with and without AI reports were analyzed.

RESULTS: The sensitivity, accuracy, and AUC of the AI system were 0.95, 0.84, and 0.753, respectively, and were not statistically different from those of the experienced radiologists, but were superior to those of the residents (all p < 0.01). The AI-assisted resident strategy significantly improved the accuracy and sensitivity for nodules ≤ 1.5 cm (all p < 0.01), while reducing the unnecessary biopsy rate by up to 27.7% for nodules > 1.5 cm (p = 0.034).

CONCLUSIONS: The AI system achieved performance, for cancer diagnosis, comparable to that of an average senior thyroid radiologist. The AI-assisted strategy can significantly improve the overall diagnostic performance for less-experienced radiologists, while increasing the discovery of thyroid cancer ≤ 1.5 cm and reducing unnecessary biopsies for nodules > 1.5 cm in real-world medical practice.

KEY POINTS: • The AI system reached a senior radiologist-like level in the evaluation of thyroid cancer and could significantly improve the overall diagnostic performance of residents. • The AI-assisted strategy significantly improved ≤ 1.5 cm thyroid cancer screening AUC, accuracy, and sensitivity of the residents, leading to an increased detection of thyroid cancer while maintaining a comparable specificity to that of radiologists alone. • The AI-assisted strategy significantly reduced the unnecessary biopsy rate for thyroid nodules > 1.5 cm by the residents, while maintaining a comparable sensitivity to that of radiologists alone.

PMID:36622410 | DOI:10.1007/s00330-022-09378-y

Graefes Arch Clin Exp Ophthalmol. 2023 Jan 9. doi: 10.1007/s00417-022-05944-8. Online ahead of print.

ABSTRACT

PURPOSE: The study aims to evaluate changes in contrast sensitivity (CS) during therapy with intravitreal vascular endothelial growth factor (VEGF) inhibitors in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

METHODS: Prospective, uncontrolled, multicenter study on patients with neovascular AMD or DME who underwent intravitreal injection therapy with Ranibizumab, Aflibercept, or Bevacizumab was conducted. Best corrected visual acuity (BCVA) and CS measured by Mars Letter Contrast Sensitivity Test (MLCS) and Freiburg Visual Acuity and Contrast Test (FrACT) in logCS were evaluated before 3 consecutive VEGF inhibitor injections, which followed the pro renata regimen in treatment-naïve and pretreated eyes with a maximum of 9 injections. Correlation of MLCS and FrACT was calculated by the Spearman’s rank correlation coefficient.

RESULTS: Eighty eyes of 74 patients (mean age 72.7; SD ± 9.96) were included. BCVA improved significantly from 0.44 (SD ± 0.21) logMAR to 0.38 (SD ± 0.23) logMAR by 0.06 (SD ± 0.14) logMAR values (p < 0.001). CS measured by MLCS increased significantly from 1.27 (SD ± 0.25) logCS to 1.39 (SD ± 0.22) logCS (p < 0.001). CS measured by FrACT also improved significantly from 1.22 (SD ± 0.32) logCS to 1.30 (SD ± 0.29) logCS (p = 0.035). A positive correlation between MLCS and FrACT was found (r = 0.389; p < 0.001). Despite statistical significance, results for BCVA, MLCS, and FrACT failed clinical significance. Overall best test results were achieved with MLCS.

CONCLUSIONS: Intravitreal injection therapy with VEGF inhibitors led to an improvement of BCVA and CS measured by MLCS and FrACT. MLCS was superior and more sensitive compared to FrACT and even BCVA to evaluate CS in elderly patients with macular pathology.

PMID:36622409 | DOI:10.1007/s00417-022-05944-8

Brain Behav. 2023 Jan 9:e2885. doi: 10.1002/brb3.2885. Online ahead of print.

ABSTRACT

BACKGROUND: Side effects in psychotherapy are common and have a negative impact on patients or clients. However, effective evaluation tools are still lacking and have not been fully studied. The present study aims to develop a scale with good reliability and validity to measure the side effects of psychotherapy.

METHODS: The 25 items in the Psychotherapy Side Effects Scale (PSES) were condensed and distributed to 420 subjects online to test its psychometric properties.

RESULTS: The internal consistency of the PSES was satisfactory to excellent (Cronbach’s ɑ coefficient was .95, and the Guttman split-half coefficient was 0.88). A statistically significant negative correlation between the satisfaction score and the total score of the PSES was shown (r = -0.51, p < .001). The PSES could effectively discriminate between two groups with and without side effects (F = 250.95, p < .001) and was able to predict the occurrence of side effects in psychotherapy with an area under curve of 0.932 and a 95% confidence interval of 0.900-0.964 (p < .001). A cutoff was set at 36 points in total PSES score, from which the maximum Youden’s index (= 0.72) could be obtained. The positive rate of the PSES was 24% (101/420).

CONCLUSION: The PSES showed good internal consistency, content validity, concurrent validity, discriminant validity and predictive validity in evaluating and identifying side effects in psychotherapy. More advanced reliability testing methods and structural validity testing for PESE need to be practiced in the future to better serve clinical practice.

PMID:36621871 | DOI:10.1002/brb3.2885

Brain Behav. 2023 Jan 9:e2888. doi: 10.1002/brb3.2888. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Periodontitis has been implicated in the incidence of ischemic stroke. However, the generalizability of results to individuals with different subtypes of periodontitis is unknown. We aimed to investigate the causal relationship of chronic periodontitis (CP) and aggressive periodontitis (AgP) with ischemic stroke and its subtypes in the Mendelian randomization framework.

METHODS: The genetic proxies of CP were derived from large-scale summary statistics from the UK Biobank datasets (950 cases and 455,398 controls). The genetic associations of AgP were selected from another large genome-wide association study of European ancestry (851 cases and 6836 controls). The instruments of ischemic stroke (34,217 cases and 406,111 controls) and its subtypes were selected from the MEGASTROKE consortium of European ancestry. The inverse variant weighted method was performed to determine the causal inference and a comprehensive set of sensitivity analyses to test the robustness of the results.

RESULTS: In population-wide genetic analysis, there was no association of genetically predicted AgP (odds ratio [OR], 0.982; 95% confidence interval [CI], 0.956-1.009; p = .197) with ischemic stroke or its subtypes. For patients with CP, there was also no significant causal inference on ischemic stroke (OR, 1.017; 95% CI, 0.992-1.043; p = .184). However, regarding the stroke subtypes, the genetic analysis provided evidence of a causal relationship of CP with cardioembolic stroke (OR, 1.052; 95% CI, 1.002-1.104; p = .042), but not with large artery atherosclerosis (OR, 1.005; 95% CI, 0.944-1.069; p = .875) or small vessel occlusion (OR, 1.039; 95% CI, 0.981-1.101; p = .193).

CONCLUSION: This study suggested that there was a potential causal effect of CP on cardioembolic stroke.

PMID:36621868 | DOI:10.1002/brb3.2888

Eur J Anaesthesiol. 2023 Jan 10. doi: 10.1097/EJA.0000000000001796. Online ahead of print.

ABSTRACT

BACKGROUND: Monitoring peri-operative body temperature in children is currently mainly achieved through invasive devices. The Temple Touch Pro Temperature Monitoring System estimates core temperature noninvasively based on heat flux thermometry.

OBJECTIVE: To investigate the agreement of this noninvasive sensor against standard oesophageal core temperature.

DESIGN: A prospective observational study.

SETTING: University hospital recruiting between April and July 2021.

PATIENTS: One hundred children (32 girls) aged 6 years or younger scheduled for noncardiac surgery, resulting in 6766 data pairs. Exclusion criteria were contraindication for the insertion of an oesophageal temperature probe, and procedures in which one of the measurement methods would interfere with the surgical field.

MAIN OUTCOME MEASURES: Primary outcome was the agreement analysis by a Bland-Altman comparison with multiple measurements. Posthoc, we performed another agreement analysis after exclusion of a statistically determined equilibration time. Secondary outcomes were the temperature differences over time and subgroup analysis of hypothermic, normothermic and hyperthermic temperature ranges, age, sex and sensor’s side by type III analysis of variance. Further, we correlated the sonographically determined depth of the artery with trueness.

RESULTS: The mean difference was -0.07°C (95% CI -0.15 to +0.05) with limits of agreement of -1.00 and +0.85°C. After adjusting for an equilibration time of 13 min, the mean difference improved to -0.04°C (95% CI -0.08 to +0.01) with limits of agreement of -0.68 and +0.60°C. Concordance correlation coefficient was 0.83 (95% CI 0.82 to 0.84). Differences between the skin sensor and oesophageal reference increased over time by -0.05°C per hour. Subgroup analysis showed no clinically relevant differences. Depth of artery negatively correlated with trueness by 0.03°C per millimetre.

CONCLUSIONS: Although the Temple Touch Pro sensor showed acceptable accuracy after allowing for an equilibration time, it still needs further investigation for routine use in children. This particularly affects accuracy in hypothermic ranges, imprecise positioning and applicability in children with immature or vulnerable skin.

TRIAL REGISTRATION: German Clinical Trials Register, identifier: DRKS00024703.

PMID:36621856 | DOI:10.1097/EJA.0000000000001796

Vet Radiol Ultrasound. 2023 Jan 9. doi: 10.1111/vru.13209. Online ahead of print.

ABSTRACT

Sternal carina damage (keel bone damage, KBD) is an important welfare concern for laying hen producers and backyard flock owners. Quantitative radiographic measures of KBD severity are helpful for researchers who study causes for this problem and the effects of novel interventions. The objectives of the current retrospective secondary analysis study were to develop and test intraobserver repeatability for a standardized protocol to quantify three categories of radiographic KBD using open-source image analysis software and discrete and continuous variables. The standardized protocol was developed and evaluated using triplicate measurements of 470 keel bone radiographs that had been previously acquired for a prospective study. Intraobserver repeatability was assessed using intra-class correlation coefficient (ICC) and control chart methods. Based on control chart analyses, measures within the acceptable range of intra-observer variation using the standardized protocol were the number of complete cranial fractures (97.02%), incomplete cranial fractures (96.38%), complete caudal fractures (95.32%), incomplete caudal fractures (98.09%), cranial calluses (99.79%), and caudal calluses (98.09%); proportion of deviation (POD) measurements (97.87%); and angle of displacement (AOD) measurements (93.60%). Findings can be used as background to support future research studies on KBD in laying hens.

PMID:36621852 | DOI:10.1111/vru.13209

Cancer Med. 2023 Jan 9. doi: 10.1002/cam4.5486. Online ahead of print.

ABSTRACT

BACKGROUND: Stomach hemorrhage and perforation are very severe and common complications in patients with primary gastric diffuse large B-cell lymphoma (PG-DLBCL) during treatment with immunochemotherapy. However, no relevant clinical studies have been performed on the prevention of these serious complications.

METHODS: Patients diagnosed with PG-DLBCL were enrolled in this retrospective study. The prevention group received standard rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) treatment without prednisone combined with antacids and anti-Helicobacter pylori (Hp) therapy. These patients received R-CHOP-based treatment until the complete recovery of gastric ulcers, as proven by gastroscopy. The control group received a standard R-CHOP regimen. Toxicity and survival were the main endpoints.

RESULTS: A total of 52 patients received preventative treatment, while 146 patients did not. Among patients with stage I, II-1, and II-2 disease, the prevention group had a lower rate of hemorrhage and perforation (0/40) than the control group (10/78, p = 0.044). At a median follow-up time of 25 months, the 5-year event-free survival (EFS) rates were 97.1% in the prevention group and 66.1% in the control group (p = 0.025), and the 5-year overall survival (OS) rates were 100% and 72.0%, respectively (p = 0.021). However, the differences in the 5-year EFS and OS of patients with disseminated disease were not statistically significant.

CONCLUSIONS: Preventative treatment can decrease the risk of hemorrhage and perforation in patients with localized PG-DLBCL during immunochemotherapy, leading to better EFS and OS in these patients. However, preventative treatment failed to reduce the risk of gastric hemorrhage and perforation and did not improve survival (EFS and OS) in advanced-stage patients.

PMID:36621835 | DOI:10.1002/cam4.5486

J Psychosoc Oncol. 2023 Jan 9:1-14. doi: 10.1080/07347332.2022.2160943. Online ahead of print.

ABSTRACT

OBJECTIVE: To present the initial assessment of psychosocial adaptation among Greek parents whose children were newly diagnosed with cancer amidst the turmoil of an ongoing financial crisis.

STUDY DESIGN: This prospective observational study used a quantitative approach.

PARTICIPANTS: Sixty-one parents of children with cancer treated at a large urban tertiary-care children’s hospital were prospectively recruited to participate in our study during the first week of their child’s diagnosis (2013-2016).

METHODS: The parents were asked to complete the psychosocial assessment tool (PAT 2.0), Zung Depression Scale, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, and World Health Organization Quality of Life-Bref Instrument; Moreover, three female healthcare providers (the physician oncologist, the head nurse and a senior nurse) completed the relevant PAT 2.0 -Staff Perceptions questionnaire the results of which were then compared to those of the child’s parent.

FINDINGS: The majority of parents had PAT 2.0 scores indicative of increased psychosocial risk :54% were stratified into the “Targeted” (moderate risk) and 15% into the “Clinical” (highest risk) categories, whereas healthcare providers underestimated psychosocial risk in 57%-59% of the cases. The subscales that most contributed to the increased scores were Parental Stress Reaction, Family Structure and Resources, and Family Social Support. The PAT 2.0 had statistically significant correlations with most of the anxiety and depression scales, with Zung having the strongest correlation (r-value: +0.5, p-value <0.01). Our cohort presented more anxiety and depression compared to the general Greek population (14% for depression versus 2,9% for the general population and 46% for anxiety compared to 4,1%) in the years of financial recession in Greece.

CONCLUSIONS: The parents of children newly diagnosed with cancer in Greece are at increased risk for developing anxiety and depression in the years of financial recession in Greece compared to general population.

IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS: Parental stress reaction to diagnosis as well as lack of family resources and social support may contribute to this difference. Screening for psychosocial risk factors is essential for the early identification of these families and for the optimal utilization of the limited available resources in times of economic hardship.

PMID:36621825 | DOI:10.1080/07347332.2022.2160943