Tag: statistics

Obstet Gynecol. 2021 Aug 5. doi: 10.1097/AOG.0000000000004515. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the relationship between umbilical artery cord gas values and fetal tolerance of labor, as reflected by Apgar score. We hypothesized the existence of wide biological variability in fetal tolerance of metabolic acidemia, which, if present, would weaken one fundamental assumption underlying the use of electronic fetal heart rate (FHR) monitoring.

METHODS: We conducted a retrospective cohort study of term, singleton, nonanomalous fetuses delivered in our institution between March 2012 and July 2020. Universally obtained umbilical cord gas values and Apgar scores were extracted. We calculated Spearman correlation coefficients and receiver operating characteristic curves for various levels of umbilical artery pH, base excess, and Apgar scores.

RESULTS: We analyzed data from 29,787 deliveries. The statistical correlation between umbilical artery pH and base excess and both 1- and 5-minute Apgar scores was weak or nonexistent in all pH range subgroups (range 0.064-0.213). Receiver operating characteristic curve analysis suggested umbilical artery pH value of 7.22 yields the best discrimination for prediction of a severely depressed newborn (5-minute Apgar score less than 4), but sensitivity and specificity for this predictive value remains poor to moderate.

CONCLUSION: The use of electronic FHR monitoring is predicated on a documented relationship between FHR patterns and umbilical artery pH, and an assumed correlation between pH and fetal outcomes, reflecting fetal tolerance of labor and delivery. Our data demonstrate a weak-to-absent correlation between metabolic acidemia and even short-term fetal condition, thus significantly weakening this latter assumption. No amount of future modification of FHR pattern interpretation to better predict newborn pH is likely to lead to improved newborn outcomes, given this weakness in a fundamental assumption on which FHR monitoring is based.

PMID:34352847 | DOI:10.1097/AOG.0000000000004515

Cir Cir. 2021;89(4):520-527. doi: 10.24875/CIRU.200007601.

ABSTRACT

OBJETIVO: Determinar la tasa de recurrencia del cáncer de próstata localizado después de la prostatectomía radical según la clasificación D’Amico.

MÉTODOS: Estudio de cohorte retrospectivo comparativo de 5 años. Se obtuvieron datos de registros clínicos de pacientes con cáncer de próstata localizado, que se sometieron a prostatectomía radical y se evaluó la tasa de recurrencia de la enfermedad. Se analizó con pruebas estadísticas descriptivas y comparativas. Una p < 0.05 se consideró significativo.

RESULTADOS: Se analizó 108 pacientes, la edad promedio 65.3 años. Acerca de la clasificación de riesgo de D’Amico, 33.33% de bajo riesgo, 55.56% riesgo intermedio y 11.11% alto riesgo. La tasa de recurrencia de APE fue 14,81%. Los pacientes de bajo riesgo tuvieron recurrencia del 13.89%, riesgo intermedio 18.33% y alto riesgo no tuvieron recurrencia. Sobre piezas quirúrgicas, el 25.93% presentaron características adversas. La escala de Gleason postoperatoria muestra un aumento de 44.44% en bajo riesgo, 26.67% en riesgo intermedio y 41.67% en alto riesgo.

CONCLUSIONES: La prostatectomía radical ofrece un control adecuado del cáncer de próstata localizado. La tasa de recurrencia del APE fue menor que otros informes internacionales. Asimismo, la recurrencia bioquímica del riesgo bajo, intermedio y alto fue similar a la tendencia global.

OBJECTIVE: The objective of the study was to determine the recurrence rate of localized prostate cancer after radical prostatectomy according to the D’Amico classification.

METHODS: This was a observational and 5-year comparative retrospective cohort study. Data were obtained from clinical records of patients with localized prostate cancer who underwent radical prostatectomy and the recurrence rate of the disease was evaluated. It was analyzed with descriptive and comparative statistical tests, p<0.05 was considered significant.

RESULTS: One hundred and eight patients were analyzed, and the average age was 65.3 years. About D’Amico’s risk classification, 33.33% low risk, 55.56% intermediate risk, and 11.11% high risk. The prostate-specific antigen (PSA) recurrence rate was 14.81%. Low-risk patients had recurrence of 13.89%, intermediate risk 18.33%, and high risk had no recurrence. Regarding surgical pieces, 25.93% presented adverse characteristics. The post-operative Gleason scale shows an increase of 44.44% in low risk, 26.67% in intermediate risk, and 41.67% in high risk.

CONCLUSIONS: Radical prostatectomy offers adequate control of localized prostate cancer. The PSA recurrence rate was lower than other international reports. Likewise, the biochemical recurrence of low, intermediate, and high risk was similar to the global trend.

PMID:34352860 | DOI:10.24875/CIRU.200007601

Invest Radiol. 2021 Aug 4. doi: 10.1097/RLI.0000000000000813. Online ahead of print.

ABSTRACT

OBJECTIVES: Chest radiographs (CXRs) are commonly performed in emergency units (EUs), but the interpretation requires radiology experience. We developed an artificial intelligence (AI) system (precommercial) that aims to mimic board-certified radiologists’ (BCRs’) performance and can therefore support non-radiology residents (NRRs) in clinical settings lacking 24/7 radiology coverage. We validated by quantifying the clinical value of our AI system for radiology residents (RRs) and EU-experienced NRRs in a clinically representative EU setting.

MATERIALS AND METHODS: A total of 563 EU CXRs were retrospectively assessed by 3 BCRs, 3 RRs, and 3 EU-experienced NRRs. Suspected pathologies (pleural effusion, pneumothorax, consolidations suspicious for pneumonia, lung lesions) were reported on a 5-step confidence scale (sum of 20,268 reported pathology suspicions [563 images × 9 readers × 4 pathologies]) separately by every involved reader. Board-certified radiologists’ confidence scores were converted into 4 binary reference standards (RFSs) of different sensitivities. The RRs’ and NRRs’ performances were statistically compared with our AI system (trained on nonpublic data from different clinical sites) based on receiver operating characteristics (ROCs) and operating point metrics approximated to the maximum sum of sensitivity and specificity (Youden statistics).

RESULTS: The NRRs lose diagnostic accuracy to RRs with increasingly sensitive BCRs’ RFSs for all considered pathologies. Based on our external validation data set, the AI system/NRRs’ consensus mimicked the most sensitive BCRs’ RFSs with areas under ROC of 0.940/0.837 (pneumothorax), 0.953/0.823 (pleural effusion), and 0.883/0.747 (lung lesions), which were comparable to experienced RRs and significantly overcomes EU-experienced NRRs’ diagnostic performance. For consolidation detection, the AI system performed on the NRRs’ consensus level (and overcomes each individual NRR) with an area under ROC of 0.847 referenced to the BCRs’ most sensitive RFS.

CONCLUSIONS: Our AI system matched RRs’ performance, meanwhile significantly outperformed NRRs’ diagnostic accuracy for most of considered CXR pathologies (pneumothorax, pleural effusion, and lung lesions) and therefore might serve as clinical decision support for NRRs.

PMID:34352804 | DOI:10.1097/RLI.0000000000000813

Spine (Phila Pa 1976). 2021 Aug 7. doi: 10.1097/BRS.0000000000004188. Online ahead of print.

ABSTRACT

MINI: Telemedicine in spine care is evolving; patient valuation of virtual care is critical to its utility and longevity. Our mixed methods investigation revealed that patients prefer in person care, particularly for first time visits. However, patients also envision the effective integration of telemedicine and in person care.

STUDY DESIGN: Survey-based study.

OBJECTIVE: We performed a mixed methods study involving patients using telemedicine for spine care. We sought to understand factors influencing the utilization and evaluation of this modality.

SUMMARY OF BACKGROUND DATA: Telemedicine has been integrated into routine spine care; its long-term viability will depend not only on optimizing its safety, efficiency, and cost-effectiveness, but also on understanding patient valuation of its benefits and limitations.

METHODS: We used a clinical registry to identify spine patients seen virtually by providers at our tertiary academic medical center between March and September of 2020. We distributed an online survey that queried patients’ experiences with telemedicine. We performed statistical analyses of Likert-scale questions and a thematic analysis of free-form responses. Sociodemographic data were abstracted and analyzed.

RESULTS: Overall, we evaluated 139 patient surveys. High levels of patient-rated care and patient-rated experience were observed for both in-person and telemedicine visits; however, in-person visits were rated significantly higher in both respects (9.3/10 vs. 8.7/10 for patient-rated care, p < 0.001; 9.0/10 vs. 8.4/10 for patient-rated experience, p = 0.006). A preference for in-person first-time visits was observed which was not maintained for follow up appointments. Both patient and clinical factors influenced perceptions of telemedicine. Thematic analysis of free-form responses provided by 113 patients (81%) generated favorable, unfavorable, and reflective themes, each further contextualized by subthemes. Responders were not significantly different from nonresponders across sociodemographic characteristics.

CONCLUSION: Our quantitative and qualitative findings yield insight into the patient experience of telemedicine in spine care. A preference for in-person visits was notable, particularly for new patient evaluations. This preference was not maintained for follow-up care. Patients acknowledged the benefits of telemedicine and reflected on its effective integration with in-person care. These results may guide best practices to improve access and patient satisfaction in the future.Level of Evidence: 4.

PMID:34352842 | DOI:10.1097/BRS.0000000000004188

Pediatr Neurosurg. 2021 Aug 5;56(5):416-423. doi: 10.1159/000515515. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aims to assess the impact of early diagnosis and surgery on children with congenital dermal sinus, investigate the relationship between MRI findings and extent of surgical exploration, and summarize our clinical experience with the surgical management in cases with central nervous system (CNS) infection.

METHODS: The skin features, preoperative MRI images, intraoperative findings, postoperative pathological characteristics, and prognoses of 56 children with congenital dermal sinus were analyzed retrospectively.

RESULTS: All the children had a pinpoint ostium in the skin, and 52 out of the 56 children (92.9%) had intraspinal dermoid cysts or epidermoid cysts. Before surgery, MRI did not show intraspinal lesions in 13 children, and surgery revealed intradural lesions in 9 of these children (69.2%). Among 46 children without CNS infection, 16 children had neurological impairment before surgery. After surgery, recovery was complete in 36 children, partial in 9 children, and absent in 3 children. All children with CNS infection had neurological impairment before surgery. After surgery, the condition improved in 8 children and exacerbated in 2 children. Children without CNS infection had statistically significantly better prognosis than children with CNS infection (p = 0.03).

CONCLUSION: A pinpoint ostium in the dorsal midline is the characteristic feature of congenital dermal sinus. In cases without intraspinal lesions on MRI, the spinal canal should be explored intraoperatively to ensure complete removal of the lesion and prevent recurrences. In cases without CNS infection, early diagnosis and timely surgery are beneficial to the recovery of nerve function.

PMID:34352798 | DOI:10.1159/000515515

Gynecol Obstet Invest. 2021 Aug 5:1-21. doi: 10.1159/000516517. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to evaluate whether endometriosis could disturb the mental health and health-related quality of life (HRQoL) of patients and to provide a new prospective for further treatment of endometriosis.

METHODS: A comprehensive literature review was conducted among 4 international databases (PubMed, Embase, Web of Science, and Cochrane Library) and 2 of the largest Chinese databases (the China National Knowledge Infrastructure and Wangfang). The Newcastle-Ottawa Scale was used to assess the quality of the included articles. Six effect sizes were synthesized through a meta-analysis, and a subgroup analysis was performed to identify potential moderating factors, including types of control groups, methods of assessment, number of study groups, and origin of the study. Potential publication bias was examined using a funnel plot.

RESULTS: This meta-analysis pooled 44 articles from 4 continents and 13 countries and compared 6 types of main effect sizes (the odds ratio [OR] for depression, the OR for anxiety, the standardized mean difference [SMD] for depression, the SMD for anxiety, the SMD for the physical component summary [PCS] and the SMD for the mental component summary [MCS]) between endometriosis patients and controls. Except for the SMD for depression, all other effect sizes revealed statistically significant differences between the study group and the controls. The main effect size outcomes of the subgroup analysis were also similar. The type of control group (I2 = 35% in non-endometriosis control groups for the SMD of anxiety; I2 = 47% in non-endometriosis control groups for the MCS of the 36-Item Short Form Health Survey) and the continent of origin (I2 = 0% in studies from South America for the OR of depression; I2 = 47% in studies from Europe for the SMD of anxiety) may influence heterogeneity in this analysis. Additionally, depression and anxiety symptoms in patients seemed to be more apparent compared with healthy controls when the sample was smaller and when a questionnaire was used. The publication bias of the articles was acceptable.

CONCLUSION: Endometriosis can disturb mental health (specifically depression and anxiety) and decrease both the mental and physical HRQoL of patients. There may be some moderating factors that we were unable to identify in the subgroup analysis, but more research is necessary to develop proper management and improve the prognosis of endometriosis patients.

PMID:34352799 | DOI:10.1159/000516517

Phys Med Biol. 2021 Aug 5. doi: 10.1088/1361-6560/ac1b1b. Online ahead of print.

ABSTRACT

Iterative reconstruction framework shows predominance in low dose and incomplete data situation. In the iterative reconstruction framework, there are two components, i.e., fidelity term aims to maintain the structure details of the reconstructed object, and the regularization term uses prior information to suppress the artifacts such as noise. A regularization parameter balances them, aiming to find a good trade-off between noise and resolution. Currently, the regularization parameters are selected as a rule of thumb or some prior knowledge assumption is required, which limits practical uses. Furthermore, the computation cost of regularization parameter selection is also heavy. In this paper, we address this problem by introducing CT image quality assessment (IQA) into the iterative reconstruction framework. Several steps are involved during the study. First, we analyze the CT image statistics using the dual dictionary method. Regularities are observed and concluded, revealing the relationship among the regularization parameter, iterations, and CT image quality. Second, with derivation and simplification of DDL procedure, a CT IQA metric named SODVAC is designed. The SODVAC locates the optimal regularization parameter that results in the reconstructed image with distinct structures and with no noise or little noise. Third, we introduce SODVAC into the iterative reconstruction framework and then propose a general image-quality-guided iterative reconstruction (QIR) framework and give a specific framework example (sQIR) by introducing SODVAC into the iterative reconstruction framework. sQIR simultaneously optimizes the reconstructed image and the regularization parameter during the iterations. Results confirm the effectiveness of the proposed method. No prior information needed and low computation cost are the advantages of our method compared with existing state-of-theart L-curve and ZIP selection strategies.

PMID:34352735 | DOI:10.1088/1361-6560/ac1b1b

Respiration. 2021 Aug 5:1-9. doi: 10.1159/000517527. Online ahead of print.

ABSTRACT

BACKGROUND: Current guidelines for the treatment of noncystic fibrosis bronchiectasis (NCFB) recommend pulmonary rehabilitation (PR), but to date, there are few studies that have proven its effectiveness.

OBJECTIVE: The main objective of this study was to examine the effect of PR on pulmonary function tests and exercise capacity.

METHOD: The aim of this study was to systematically review the effects of PR in NCFB on (1) forced expiratory volume in the first second (FEV1) and (2) exercise capacity evaluated by the 6-min walk test (6MWT) and the incremental shuttle walk test (ISWT). This meta-analysis was undertaken according to PRISMA recommendations.

RESULTS: This pair-wise meta-analysis included data obtained from studies that enrolled 529 NCFB patients. The FEV1 assessment after PR between the active and control group did not show any significant increase (FEV1 difference 0.084 mL; CI: -0.064, +0.233; p = 0.264), and there was an increasing trend (188 mL; CI: -0 to 0.009, +0.384) at the limits of statistical significance (p = 0.061). Walked distance showed a significant increase in the PR group compared to the control group (ISWT distance difference 070.0 m; CI: 55.2, 84.8; p < 0.001), and this finding was confirmed before and after PR both by the ISWT (68.85 m greater than baseline; CI: 40.52, 97.18; p < 0.001) and by the 6MWT (37.7 m greater than baseline; CI: 20.22, 55.25; p < 0.001).

CONCLUSIONS: PR improves exercise tolerance in NCFB patients, but it has a modest impact on respiratory function.

PMID:34352795 | DOI:10.1159/000517527

ESMO Open. 2021 Aug 2;6(4):100222. doi: 10.1016/j.esmoop.2021.100222. Online ahead of print.

ABSTRACT

BACKGROUND: Despite its proven activity as third-line treatment in gastrointestinal stromal tumors (GIST), regorafenib can present a poor tolerability profile which often leads to treatment modifications and transient or permanent discontinuation; thus, in clinical practice physicians usually adopt various dosing and interval schedules to counteract regorafenib-related adverse events and avoid treatment interruption. The aim of this real-world study was to investigate the efficacy and safety of personalized schedules of regorafenib in patients with metastatic GIST, in comparison with the standard schedule (160 mg daily, 3-weeks-on, 1-week-off).

PATIENTS AND METHODS: Institutional registries across seven Italian reference centers were retrospectively reviewed and data of interest retrieved to identify patients with GIST who had received regorafenib from February 2013 to January 2021. The Kaplan-Meier method was used to estimate survival and the log-rank test to make comparisons.

RESULTS: Of a total of 152 patients with GIST, 49 were treated with standard dose, while 103 received personalized schedules. At a median follow-up of 36.5 months, median progression-free survival was 5.6 months [95% confidence interval (CI) 3.73-11.0 months] versus 9.7 months (95% CI 7.9-14.5 months) in the standard-dose and the personalized schedule groups, respectively [hazard ratio (HR) 0.51; 95% CI 0.34-0.75; P = 0.00052]. Median overall survival was 16.6 months (95% CI 14.1-21.8 months) versus 20.5 months (95% CI 15.0-25.4 months), respectively (HR 0.75; 95% CI 0.49-1.22; P = 0.16).

CONCLUSIONS: Regorafenib-personalized schedules are commonly adopted in daily clinical practice of high-volume GIST expert centers and correlate with significant improvement of therapeutic outcomes. Therefore, regorafenib treatment optimization in patients with GIST may represent the best strategy to maximize long-term therapy.

PMID:34352702 | DOI:10.1016/j.esmoop.2021.100222

Drug Metab Pharmacokinet. 2021 May 29;40:100407. doi: 10.1016/j.dmpk.2021.100407. Online ahead of print.

ABSTRACT

We evaluated the impact of vonoprazan on blood concentrations of tacrolimus via a retrospective analysis of 52 renal transplant recipients who took tacrolimus and converted from rabeprazole to vonoprazan between August 2018 and September 2019. We compared tacrolimus trough levels upon conversion among groups that were classified based on cytochrome P450 (CYP) gene polymorphisms. CYP3A5 groups were heterozygous or homozygous for CYP3A5∗1 and CYP3A5∗3 alleles. CYP2C19 genotypes were classified as extensive (∗1/∗1), intermediate (∗1/∗2 and ∗1/∗3) or poor metabolizers (∗2/∗2, ∗2/∗3 and ∗3/∗3). Tacrolimus trough levels increased only 0.3 ng/mL upon conversion in the CYP3A5∗3/∗3 group: 5.8 [3.4-7.2] vs 6.1 [3.8-7.9]; p = 0.06. No statistically significance changes in tacrolimus levels also occurred in the CYP3A5∗1/∗1 or CYP3A5∗1/∗3 groups. Subgroup analyses of CYP3A5∗3/∗3 demonstrated low changes for all three CYP2C19 subgroups: 5.2 [4.3-6.5] vs 6.2 [4.3-7.9]; p = 0.07, 6.1 [3.4-7.2] vs 6.7 [4.6-7.9]; p = 0.12 and 5.4 [3.6-6.5] vs 4.7 [3.8-6.3]; p = 1.00, respectively. Conversion to vonoprazan thus resulted in little increase of tacrolimus trough levels, even in the group predicted to be most susceptible (CYP3A5∗3/∗3 and 2C19∗1/∗1), thus supporting the safety of concomitant use of vonoprazan with tacrolimus.

PMID:34352707 | DOI:10.1016/j.dmpk.2021.100407