Category: Statistics

JMIR Diabetes. 2023 Aug 23;8:e46880. doi: 10.2196/46880.

ABSTRACT

BACKGROUND: There is evidence in the literature that the use of sensor-augmented insulin pumps in patients with high-complexity diabetes improves metabolic control. However, there is no long-term information on clinical outcomes such as hospitalization or admission to the emergency room. This study describes outcomes for metabolic control, incidence of hospitalizations, and emergency room visits in a specific population using this technology.

OBJECTIVE: We aimed to assess long-term glycemic and clinical outcomes after the use of continuous subcutaneous insulin infusion and continuous glucose monitoring in people with diabetes.

METHODS: A retrospective cohort study was carried out in patients with diabetes previously treated with an intensive insulin regimen at a specialized diabetes treatment center who required a sensor-augmented insulin pump due to nonoptimal glycemic control. Glycated hemoglobin, severe hypoglycemic episodes, nonsevere hypoglycemic episodes, perception of hypoglycemia, and the incidence of emergency room visits and hospitalizations before and after treatment were evaluated.

RESULTS: Between January 2013 and August 2020, 74 patients with a median age of 36 (IQR 27-46) years were included in the study with a median 4 (IQR 2-7) years of follow-up. We found a statistically significant reduction in glycated hemoglobin (8.35% vs 7%; P<.001), nonsevere hypoglycemic episodes (71/74, 96% vs 62/74, 84%; P=.01), emergency room visits (42/73, 58% vs 4/62, 6%; P<.001), and hospitalizations (36/72, 50% vs 10/72, 14%; P<.001) after use of continuous subcutaneous insulin infusion.

CONCLUSIONS: The use of a sensor-augmented insulin pump associated with a strict follow-up program for patients with high-complexity diabetes led to a significant and sustained reduction in glycated hemoglobin and hypoglycemic episodes, as well as in the rate of emergency room visits and hospitalizations. These results encourage the adoption of this technology in patients who do not achieve metabolic control with optimal management of diabetes.

PMID:37610810 | DOI:10.2196/46880

JAMA Dermatol. 2023 Aug 23. doi: 10.1001/jamadermatol.2023.2626. Online ahead of print.

ABSTRACT

IMPORTANCE: Older adults with atopic dermatitis (AD) face unique treatment challenges, including comorbidities, polypharmacy, and a higher risk for infections (eg, herpes zoster). Furthermore, limited data are available from clinical trials for treatments in this population. In phase 3 studies, tralokinumab showed superior efficacy in moderate-to-severe AD vs placebo, but results were not stratified by age group.

OBJECTIVE: To evaluate the safety and efficacy of tralokinumab in older (≥65 years) patients with moderate-to-severe AD.

DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis for adults 65 years or older was conducted from a subset of patients in the US, Canada, Europe, and Asia in 3 randomized, placebo-controlled, phase 3 trials (ECZTRA 1 and 2 [monotherapy] and ECZTRA 3 [tralokinumab + topical corticosteroids as needed]). The post hoc data were analyzed in 2022.

MAIN OUTCOMES AND MEASURES: Pooled data from up to 16 weeks of treatment from ECZTRA 1, 2, and 3 were used to assess safety. Statistical analyses followed prespecifications of primary end points. Separate efficacy analyses were conducted in these trials respectively at 16 weeks.

RESULTS: A total of 75 older adults (42 women [56%]) treated with tralokinumab from the ECZTRA 1, 2, and 3 trials were included in this post hoc analysis. Similar proportions of patients reported adverse events (AEs) with tralokinumab and placebo (44 [58%]). Three patients (4%) in the tralokinumab arm and 3 (10.3%) in the placebo arm experienced severe AEs, and 4 (5.3%) and 2 (6.9%), respectively, had AEs leading to discontinuation. More patients achieved 75% or greater improvement in Eczema Area and Severity Index scores with tralokinumab than placebo (33.9% vs 4.8%; P < .001) in ECZTRA 1 and 2. Similar trends, although not statistically significant, were seen in ECZTRA 3. Safety and efficacy outcomes in this population were similar compared with the younger patient cohorts. The small sample size limited generalizations from this analysis.

CONCLUSION AND RELEVANCE: The results of this post hoc analysis suggest that tralokinumab is well tolerated and efficacious in patients 65 years or older with moderate-to-severe AD.

PMID:37610789 | DOI:10.1001/jamadermatol.2023.2626

JAMA Netw Open. 2023 Aug 1;6(8):e2330489. doi: 10.1001/jamanetworkopen.2023.30489.

ABSTRACT

IMPORTANCE: Contraception and abortion services are essential health care, and family medicine (FM) physicians are an important part of the workforce providing this care. Residency could inform the reproductive health services FM physicians provide.

OBJECTIVE: To determine which residency training factors are associated with FM physicians’ provision of reproductive health services to Medicaid beneficiaries.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional, population-based observational study of inpatient and outpatient FM physicians who completed residency between 2008 and 2018 and treated at least 1 Medicaid beneficiary in 2019 was conducted from November 2022 to March 2023. The study used 2019 American Medical Association Masterfile and Historical Residency file, as well as the 2019 Transformed Medicaid Statistical Information System claims.

EXPOSURES: Residency training in community-based or reproductive health-focused programs.

MAIN OUTCOMES AND MEASURES: The outcomes were providing the following to at least 1 Medicaid beneficiary in 2019: prescription contraception (pill, patch, and/or ring), intrauterine device (IUD) and/or contraceptive implant, and dilation and curettage (D&C). Odds of providing each outcome were measured using correlated random-effects regression models adjusted for physician, residency program, and county characteristics.

RESULTS: In the sample of 21 904 FM physician graduates from 410 FM residency programs, 12 307 were female (56.3%). More than half prescribed contraception to Medicaid beneficiaries (13 373 physicians [61.1%]), with lower proportions providing IUD or implant (4059 physicians [18.5%]) and D&C (152 physicians [.7%]). FM physicians who graduated from a Reproductive Health Education in Family Medicine program, which fully integrates family planning into residency training, had significantly greater odds of providing prescription contraception (odds ratio [OR], 1.23; 95% CI, 1.07-1.42), IUD or implant (OR, 1.79; 95% CI, 1.28-2.48), and D&C (OR, 3.61; 95% CI, 2.02-6.44). Physicians who completed residency at a Teaching Health Center, which emphasizes community-based care, had higher odds of providing an IUD or implant (OR, 1.51; 95% CI, 1.19-1.91).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of FM physicians providing Medicaid service, characteristics of residency training including community-based care and integration of family planning training are associated with greater odds of providing reproductive health services. With growing reproductive health policy restrictions, providing adequate training in reproductive health is critical to maintaining access to care, especially for underserved populations.

PMID:37610750 | DOI:10.1001/jamanetworkopen.2023.30489

JAMA Netw Open. 2023 Aug 1;6(8):e2330617. doi: 10.1001/jamanetworkopen.2023.30617.

ABSTRACT

IMPORTANCE: Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal disorder. Routine physical examinations by trained personnel are critical to diagnose severity and monitor curve progression in AIS. In the presence of concerning malformation, radiographs are necessary for diagnosis or follow-up, guiding further management, such as bracing correction for moderate malformation and spine surgery for severe malformation. If left unattended, progressive deterioration occurs in two-thirds of patients, leading to significant health concerns for growing children.

OBJECTIVE: To assess the ability of an open platform application (app) using a validated deep learning model to classify AIS severity and curve type, as well as identify progression.

DESIGN, SETTING, AND PARTICIPANTS: This diagnostic study was performed with data from radiographs and smartphone photographs of the backs of adolescent patients at spine clinics. The ScolioNets deep learning model was developed and validated in a prospective training cohort, then incorporated and tested in the AlignProCARE open platform app in 2022. Ground truths (GTs) included severity, curve type, and progression as manually annotated by 2 experienced spine specialists based on the radiographic examinations of the participants’ spines. The GTs and app results were blindly compared with another 2 spine surgeons’ assessments of unclothed back appearance. Data were analyzed from October 2022 to February 2023.

EXPOSURE: Acquisitions of unclothed back photographs using a mobile app.

MAIN OUTCOMES AND MEASURES: Outcomes of interest were classification of AIS severity and progression. Quantitative statistical analyses were performed to assess the performance of the deep learning model in classifying the deformity as well as in distinguishing progression during 6-month follow-up.

RESULTS: The training data set consisted of 1780 patients (1295 [72.8%] female; mean [SD] age, 14.3 [3.3] years), and the prospective testing data sets consisted of 378 patients (279 [73.8%] female; mean [SD] age, 14.3 [3.8] years) and 376 follow-ups (294 [78.2%] female; mean [SD] age, 15.6 [2.9] years). The model recommended follow-up with an area under receiver operating characteristic curve (AUC) of 0.839 (95% CI, 0.789-0.882) and considering surgery with an AUC of 0.902 (95% CI, 0.859-0.936), while showing good ability to distinguish among thoracic (AUC, 0.777 [95% CI, 0.745-0.808]), thoracolumbar or lumbar (AUC, 0.760 [95% CI, 0.727-0.791]), or mixed (AUC, 0.860 [95% CI, 0.834-0.887]) curve types. For follow-ups, the model distinguished participants with or without curve progression with an AUC of 0.757 (95% CI, 0.630-0.858). Compared with both surgeons, the model could recognize severities and curve types with a higher sensitivity (eg, sensitivity for recommending follow-up: model, 84.88% [95% CI, 75.54%-91.70%]; senior surgeon, 44.19%; junior surgeon, 62.79%) and negative predictive values (NPVs; eg, NPV for recommending follow-up: model, 89.22% [95% CI, 84.25%-93.70%]; senior surgeon, 71.76%; junior surgeon, 79.35%). For distinguishing curve progression, the sensitivity and NPV were comparable with the senior surgeons (sensitivity, 63.33% [95% CI, 43.86%-80.87%] vs 77.42%; NPV, 68.57% [95% CI, 56.78%-78.37%] vs 72.00%). The junior surgeon reported an inability to identify curve types and progression by observing the unclothed back alone.

CONCLUSIONS: This diagnostic study of adolescent patients screened for AIS found that the deep learning app had the potential for out-of-hospital accessible and radiation-free management of children with scoliosis, with comparable performance as spine surgeons experienced in AIS management.

PMID:37610748 | DOI:10.1001/jamanetworkopen.2023.30617

JAMA Surg. 2023 Aug 23. doi: 10.1001/jamasurg.2023.2293. Online ahead of print.

ABSTRACT

IMPORTANCE: The use of artificial intelligence (AI) in clinical medicine risks perpetuating existing bias in care, such as disparities in access to postinjury rehabilitation services.

OBJECTIVE: To leverage a novel, interpretable AI-based technology to uncover racial disparities in access to postinjury rehabilitation care and create an AI-based prescriptive tool to address these disparities.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from the 2010-2016 American College of Surgeons Trauma Quality Improvement Program database for Black and White patients with a penetrating mechanism of injury. An interpretable AI methodology called optimal classification trees (OCTs) was applied in an 80:20 derivation/validation split to predict discharge disposition (home vs postacute care [PAC]). The interpretable nature of OCTs allowed for examination of the AI logic to identify racial disparities. A prescriptive mixed-integer optimization model using age, injury, and gender data was allowed to “fairness-flip” the recommended discharge destination for a subset of patients while minimizing the ratio of imbalance between Black and White patients. Three OCTs were developed to predict discharge disposition: the first 2 trees used unadjusted data (one without and one with the race variable), and the third tree used fairness-adjusted data.

MAIN OUTCOMES AND MEASURES: Disparities and the discriminative performance (C statistic) were compared among fairness-adjusted and unadjusted OCTs.

RESULTS: A total of 52 468 patients were included; the median (IQR) age was 29 (22-40) years, 46 189 patients (88.0%) were male, 31 470 (60.0%) were Black, and 20 998 (40.0%) were White. A total of 3800 Black patients (12.1%) were discharged to PAC, compared with 4504 White patients (21.5%; P < .001). Examining the AI logic uncovered significant disparities in PAC discharge destination access, with race playing the second most important role. The prescriptive fairness adjustment recommended flipping the discharge destination of 4.5% of the patients, with the performance of the adjusted model increasing from a C statistic of 0.79 to 0.87. After fairness adjustment, disparities disappeared, and a similar percentage of Black and White patients (15.8% vs 15.8%; P = .87) had a recommended discharge to PAC.

CONCLUSIONS AND RELEVANCE: In this study, we developed an accurate, machine learning-based, fairness-adjusted model that can identify barriers to discharge to postacute care. Instead of accidentally encoding bias, interpretable AI methodologies are powerful tools to diagnose and remedy system-related bias in care, such as disparities in access to postinjury rehabilitation care.

PMID:37610746 | DOI:10.1001/jamasurg.2023.2293

Biochem Genet. 2023 Aug 23. doi: 10.1007/s10528-023-10479-6. Online ahead of print.

ABSTRACT

As one of the most frequent intracranial tumors, glioma showed invasive development and poor prognosis. lncRNAs have been illustrated to serve as biomarkers in various cancers. Whether the long non-coding RNA Prader Willi/Angelman region RNA 6 (PWAR6) was involved in glioma development and the underlying mechanism was investigated. PWAR6 in glioma was evaluated by polymerase chain reaction and its clinical significance was assessed with a series of statistical analyses. The biological function of PWAR6 was investigated with the cell counting kit 8 and Transwell assay. The potential underlying mechanism was studied with the luciferase reporter assay. The significant downregulation of PWAR6 was observed in glioma, which showed a close relationship with the major clinicopathological features and poor prognosis of patients. PWAR6 restrained cell growth, migration and invasion of glioma, which was alleviated by the overexpression of microRNA-106a-5p (miR-106a-5p). PWAR6 functioned as a prognostic biomarker and tumor suppressor of glioma through regulating miR-106a-5p.

PMID:37610693 | DOI:10.1007/s10528-023-10479-6

Eur Arch Paediatr Dent. 2023 Aug 23. doi: 10.1007/s40368-023-00830-1. Online ahead of print.

ABSTRACT

PURPOSE: To assess the coverage of information about early childhood caries (ECC) available on YouTube videos in three different languages, regarding technical characteristics of videos and interaction metrics.

METHODS: Search strategies were developed in English, Spanish, and Portuguese to make a comprehensive collection of videos from YouTube, encompassing 60 samples for each language, regarding all video types. The videos were assessed by a thematic checklist regarding 17 items on ECC. Videos were dichotomized according to the median of the thematic score and the nature of their authorship (health and non-health authors) to compare groups. The statistical analysis was performed using the Statistical Package for Social Science (version 25.0), applying Spearman’s rank correlation coefficient and Mann-Whitney U test. P < 0.05 values were considered significant.

RESULTS: Among 120 videos meeting inclusion criteria, ECC aetiology and prevention information proved incomplete, with a median score of 5 (Q1-Q3 = 3-7). No correlation emerged between this score and other video characteristics. However, interaction metrics like views, likes, dislikes, and viewing rates displayed significant correlations. Health authors primarily created these videos, yet non-health author channels had more subscribers. Surprisingly, videos focused on the impact of regular sugary food and beverage consumption on ECC progression received the most attention.

CONCLUSIONS: Videos that presented information about the aetiology and prevention of ECC invariably focused on partial aspects of the disease. This highlights the need for better-quality educational videos and the importance of dental professionals in guiding patients toward reliable sources of information.

PMID:37610682 | DOI:10.1007/s40368-023-00830-1

J Cancer Res Clin Oncol. 2023 Aug 23. doi: 10.1007/s00432-023-05278-w. Online ahead of print.

ABSTRACT

BACKGROUND: Retroperitoneal soft tissue sarcoma (RPS) is a quite rare disease,and new nomograms need to be constructed to predict the overall survival (OS) and cancer specific survival (CSS) of RPS patients.

METHODS: The clinical data of patients with RPS were extracted from the Surveillance, Epidemiology, and End Results (SEER) database and authors’ hospital. The LASSO method and COX proportional hazard regression were used to screen independent risk factors which were used to develop nomograms. Nomograms was evaluated in terms of discrimination by consistency index (C-index) and calibration curve. Decision curve analysis (DCA) and integrated discrimination index (IDI) were performed to assess net benefit and the improvement of model, respectively. Kaplan-Meier method and log-rank test were applied to compare the survival difference between groups.

RESULTS: A total of 1164 cases were enrolled which were divided into training cohort (n = 814) and internal validation cohort (n = 350) at a 7:3 ratio. The discrimination of nomograms were good with C-index of 0.728 (95%CI = 0.704-0.752, R² = 0.270), 0.754 (95%CI = 0.729-0.779, R² = 0.281) for OS and CSS, respectively. Calibration curve showed good predictive accuracy of nomograms both in internal and external validation cohort, and IDI indicated that nomograms perform well than AJCC stage. Kaplan Meier curve and log-rank test uncovered statistically significance survival difference between high- and low-risk groups with P < 0.001 in terms of OS and CSS.

CONCLUSION: Novel nomograms predicting the OS and CSS of RPS patients perform well in discrimination, calibration, clinical benefit and IDI. These nomograms may facilitate risk stratification and making clinical decision.

PMID:37610674 | DOI:10.1007/s00432-023-05278-w

Chirurgie (Heidelb). 2023 Aug 23. doi: 10.1007/s00104-023-01933-7. Online ahead of print.

ABSTRACT

INTRODUCTION: Currently, there is an increase in severe stages of peripheral arterial occlusive disease (PAOD) with critical ischemia. This seems to correspond to the general demographic change as well as a consequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic of the last 3 years. The now established and accepted interventional/endovascular approach for severe lower leg PAOD in experienced hands is still considered the first-line treatment but from the authors’ perspective crural/pedal venous bypass is experiencing a renaissance.

MATERIAL AND METHODS: Compact narrative review of the current state of crural/pedal bypass surgery in Germany and Saxony-Anhalt (SA) combined with selective references from the current scientific medical literature and own clinical experiences.

RESULTS: The current statistics of case-related diagnosis-related groups (DRG) data show that, especially with the occurrence of the corona pandemic, a decrease in inpatient case numbers of patients with PAOD stage IIB can be observed nationwide and also in SA. The severe PAOD stages have remained approximately the same in case numbers but increased in SA. The risk stratification based on the wound, ischemia and foot infection (WIFI) classification offers the possibility to be able to make statements about the risk of amputation, benefits and type of revascularization measures. The length of the occlusion, occlusion site of the affected vessels and degree of calcification are taken into account in the global limb anatomic staging system (GLASS) to assess the prognosis. The evaluation of the case-based hospital statistics from 2015 to 2020 showed a constant use of femorocrural/femoropedal bypass surgery in Germany as well as a slight increase in reconstruction using femorocrural bypasses in SA, which seems to correlate with the tendency for an increase in the number of cases of severe PAOD. Parameter-based objectification of the severity of critical limb ischemia should be included in the indications for placement of a crural/pedal bypass. The WIFI classification and GLASS are suitable for this purpose as a relative prognosis of success is also possible. The treatment of critical limb ischemia by crural/pedal bypass surgery continues to find a constant application in Germany and SA.

PMID:37610660 | DOI:10.1007/s00104-023-01933-7

Oral Radiol. 2023 Aug 23. doi: 10.1007/s11282-023-00707-5. Online ahead of print.

ABSTRACT

OBJECTIVES: Diabetes mellitus is a chronic disease characterized by dysregulation of glucose metabolism, with characteristic long-term complications accompanied by changes in bone quality. The purpose of this study is to compare the results with a control group by performing radiomorphometric analyses on panoramic radiographs obtained 5 years apart to examine changes in the mandibular bone cortex and microstructures of type 2 diabetes mellitus (T2DM) patients.

METHODS: Two panoramic radiographs that were taken 5 years (mean 5.26 ± 0.134) apart from 52 patients with T2DM (n:26) and a control group (n:26) were used. A total of 104 images were evaluated. Analyses were done from the condyle (FD1), angulus (FD2), distal second premolar apex (FD3), and anterior to the mental foramen (FD4) for fractal dimension (FD) in the mandible. Symphysis index (SI), anterior index (AI), molar index (MI), posterior index (PI), and panoramic mandibular index (PMI) measurements were taken for cortical analysis. Three-way ANOVA, three-way robust ANOVA, two-way ANOVA, and two-way robust ANOVA tests were used for statistical analysis (p < 0.05).

RESULTS: After a 5-year period, there was a significant decrease in all FD measures of the mandible in both T2DM and control groups (p < 0.05). This resulted in a statistical difference in the main effect of time. After a 5-year period, no significant difference in mandibular cortical measures was identified between the T2DM and control groups (p > 0.05).

CONCLUSION: According to panoramic radiography, the mandibular trabecular structure deteriorated after 5 years, whereas cortical values remained the same. It concluded that T2DM had no effect on these results.

PMID:37610653 | DOI:10.1007/s11282-023-00707-5