Category: Statistics

J Am Acad Orthop Surg Glob Res Rev. 2024 Jul 10;8(7). doi: 10.5435/JAAOSGlobal-D-23-00278. eCollection 2024 Jul 1.

ABSTRACT

BACKGROUND: A recent database study found that 15.2% of clavicle fractures underwent surgical treatment. Recent evidence accentuates the role of smoking in predicting nonunion. The purpose of this study was to further elucidate the effect of smoking on the 30-day postoperative outcomes after surgical treatment of clavicle fractures.

METHODS: The authors queried the American College of Surgeons National Surgical Quality Improvement Program database for all patients who underwent open reduction and internal fixation of clavicle fracture between 2015 and 2020. Multivariate logistic regression, adjusted for notable patient demographics and comorbidities, was used to identify associations between current smoking status and postoperative complications.

RESULTS: In total, 6,132 patients were included in this study of whom 1,510 (24.6%) were current smokers and 4,622 (75.4%) were nonsmokers. Multivariate analysis found current smoking status to be significantly associated with higher rates of deep incisional surgical-site infection (OR, 7.87; 95% CI, 1.51 to 41.09; P = 0.014), revision surgery (OR, 2.74; 95% CI, 1.67 to 4.49; P < 0.001), and readmission (OR, 3.29; 95% CI, 1.84 to 5.89; P < 0.001).

CONCLUSION: Current smoking status is markedly associated with higher rates of deep incisional surgical-site infection, revision surgery, and readmission within 30 days after open reduction and internal fixation of clavicle fracture.

PMID:38996220 | DOI:10.5435/JAAOSGlobal-D-23-00278

J Am Acad Orthop Surg Glob Res Rev. 2024 Jul 10;8(7). doi: 10.5435/JAAOSGlobal-D-24-00119. eCollection 2024 Jul 1.

ABSTRACT

INTRODUCTION: The purpose of this systematic review and meta-analysis was to provide an update of the recent literature comparing clinical outcomes of surgically treated fibular fractures using intramedullary nailing (IMN) with open reduction and internal plate fixation (ORIF).

METHODS: A literature search reporting clinical outcomes after IMN or ORIF of the distal fibula was conducted on PubMed. Inclusion criteria consisted of original studies; studies focusing on clinical outcomes after IMN or IMN and ORIF published before May 11, 2022; studies with at least 5 patients; and studies reporting union rates, complication rates, and patient-reported outcomes such as American Orthopaedic Foot and Ankle Society (AOFAS) and Olerud-Molander scores.

RESULTS: Of 2,394 studies identified, a total of 29 studies (4 LOE-I, 2 LOE-II, 6 LOE-III, 17 LOE-IV) were included consisting of 1,850 IMN patients and 514 plate patients. The pooled mean age of IMN patients was 58 years (95% confidence interval [CI], 54 to 62, I2 = 42%) versus 57 years (95% CI, 53 to 62, I2 = 49%) in ORIF. Union rates for IMN patients revealed a 99% union rate (95% CI, 0.98 to 1.00, I2 = 20%) versus 97% union rate for ORIF patients (95% CI, 0.94 to 0.99, I2 = 0%). Studies that compared IMN with ORIF revealed no difference in union rates (risk ratio [RR] = 0.99, 95% CI, 0.96 to 1.02, I2 = 0%). IMN patients showed a 15% complication rate (95% CI, 0.09 to 0.23, I2 = 89%), whereas plate patients had a complication rate of 30% (95% CI, 0.18 to 0.46, I2 = 63%). When comparing studies with both treatments, IMN patients had a significantly lower risk of complications (RR = 0.49, 95% CI, 0.29 to 0.82, I2 = 50%). The IMN group trended toward a higher mean AOFAS and Olerud-Molander score than the plate group by 4.53 (95% CI, -14.58 to 23.65, I2 = 85%) and 3.54 (95% CI, -2.32 to 9.41, I2 = 76%) points, respectively.

CONCLUSION: Current literature reveals near equivalence in union rates and a markedly lower risk of complications when comparing IMN with plate fixation. While IMN patients had higher AOFAS and Olerud-Molander scores, these differences were not statistically significant. Notably, subgroup analyses indicated that rates of symptomatic implant and removal of implant were comparable between IMN and ORIF, which may indicate that wound-related complications were reduced in the minimally invasive IMN technique. While the high cost of IMN implants remains a barrier to their widespread adoption, the long-term benefits of reducing complications, specifically associated with wound complications in high-risk populations, may greatly improve quality of care for patients with distal fibula fractures. Additional research and cost-effectiveness analyses are warranted to fully assess the long-term benefits and economic feasibility of using IMN fixation for distal fibula fractures.

LEVEL OF EVIDENCE: Therapeutic Level IV.

PMID:38996216 | DOI:10.5435/JAAOSGlobal-D-24-00119

JCO Clin Cancer Inform. 2024 Jul;8:e2300192. doi: 10.1200/CCI.23.00192.

ABSTRACT

PURPOSE: Patients with epithelial ovarian cancer (EOC) have an elevated risk for venous thromboembolism (VTE). To assess the risk of VTE, models were developed by statistical or machine learning algorithms. However, few models have accommodated deep learning (DL) algorithms in realistic clinical settings. We aimed to develop a predictive DL model, exploiting rich information from electronic health records (EHRs), including dynamic clinical features and the presence of competing risks.

METHODS: We extracted EHRs of 1,268 patients diagnosed with EOC from January 2007 through December 2017 at the National Cancer Center, Korea. DL survival networks using fully connected layers, temporal attention, and recurrent neural networks were adopted and compared with multi-perceptron-based classification models. Prediction accuracy was independently validated in the data set of 423 patients newly diagnosed with EOC from January 2018 to December 2019. Personalized risk plots displaying the individual interval risk were developed.

RESULTS: DL-based survival networks achieved a superior area under the receiver operating characteristic curve (AUROC) between 0.95 and 0.98 while the AUROC of classification models was between 0.85 and 0.90. As clinical information benefits the prediction accuracy, the proposed dynamic survival network outperformed other survival networks for the test and validation data set with the highest time-dependent concordance index (0.974, 0.975) and lowest Brier score (0.051, 0.049) at 6 months after a cancer diagnosis. Our visualization showed that the interval risk fluctuating along with the changes in longitudinal clinical features.

CONCLUSION: Adaption of dynamic patient clinical features and accounting for competing risks from EHRs into the DL algorithms demonstrated VTE risk prediction with high accuracy. Our results show that this novel dynamic survival network can provide personalized risk prediction with the potential to assist risk-based clinical intervention to prevent VTE among patients with EOC.

PMID:38996199 | DOI:10.1200/CCI.23.00192

Egypt J Immunol. 2024 Jul;31(3):81-94.

ABSTRACT

Inflammatory bowel disease is a chronic immune-mediated disorder with a relapsing and remitting course. It leads to disabling gastrointestinal symptoms, low quality of life, and a significant burden for healthcare utilization and associated costs. Therefore, non-invasive biomarkers are needed for early diagnosis and follow up to avoid the complications of invasive diagnostic procedures. Calgranulin C is a calcium binding protein with proinflammatory properties. The aim of this study was to evaluate the role of serum calgranulin C as a non-invasive biomarker for diagnosis and prediction of activity in comparison to different biomarkers and endoscopic activity scores in inflammatory bowel disease. The study included 80 inflammatory bowel disease patients (50 Ulcerative colitis and 30 Chron’s patients) and 20 normal controls. Complete blood picture, C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and serum calgranulin C were measured. Colonoscopies with histopathological examination were done and different activity scoring systems assessed. Among ulcerative colitis group, serum calgranulin C was statistically significantly higher in comparison to control group [723.640±529.055 ng/ml versus 80.850±24.416 ng/ml]. Depending on the American college of gastroenterology ulcerative colitis activity index, fecal calprotectin and serum calgranulin C were statistically significantly higher among moderate to severe ulcerative colitis than those with mild activity and those in remission (p < 0.001, for both). Regarding Crohn’s disease group, serum calgranulin C was statistically significantly higher in comparison to control group [759.233±797.963 ng/ml versus 80.850±24.416 ng/mL]. Depending on Crohn’s disease activity index, both serum calgranulin C and fecal calprotectin were statistically significantly higher among active disease than those in remission (p < 0.001, for both). In conclusion, serum calgranulin C could be used as a non-invasive marker to predict activity and severity and to ensure remission among inflammatory bowel disease patients.

PMID:38995671

JAMA Netw Open. 2024 Jul 1;7(7):e2421491. doi: 10.1001/jamanetworkopen.2024.21491.

NO ABSTRACT

PMID:38995648 | DOI:10.1001/jamanetworkopen.2024.21491

JAMA Netw Open. 2024 Jul 1;7(7):e2421547. doi: 10.1001/jamanetworkopen.2024.21547.

NO ABSTRACT

PMID:38995647 | DOI:10.1001/jamanetworkopen.2024.21547

JAMA Netw Open. 2024 Jul 1;7(7):e2419881. doi: 10.1001/jamanetworkopen.2024.19881.

ABSTRACT

IMPORTANCE: Excessive screen media use has been associated with poorer mental health among children and adolescents in several observational studies. However, experimental evidence supporting this hypothesis is lacking.

OBJECTIVE: To investigate the effects of a 2-week screen media reduction intervention on children’s and adolescents’ mental health.

DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a cluster randomized clinical trial with a 2-week follow-up included 89 families (with 181 children and adolescents) from 10 Danish municipalities in the region of Southern Denmark. All study procedures were carried out in the home of the participants. Enrollment began on June 6, 2019, and ended on March 30, 2021. This analysis was conducted between January 1 and November 30, 2023.

INTERVENTION: Families were randomly allocated to a screen media reduction group or a control group. The 2-week screen media reduction intervention was designed to ensure a high level of compliance to the reduction in leisure-time screen media use. Participants allocated to the intervention group had to reduce their leisure-time screen media use to 3 hours per week or less per person and hand over smartphones and tablets.

MAIN OUTCOMES AND MEASURES: The main outcome was the between-group mean difference in change in total behavioral difficulties, measured by the Strengths and Difficulties Questionnaire at 2-week follow-up. Results were estimated using mixed-effects tobit regression models. Analyses were carried out as both intention to treat and complete case.

RESULTS: In the sample of 89 families including 181 children and adolescents (intervention group [45 families]: 86 children; mean [SD] age, 8.6 [2.7] years; 42 girls [49%]; control group [44 families]: 95 children; mean [SD] age, 9.5 [2.5] years; 57 girls [60%]), there was a statistically significant between-group mean difference in the total difficulties score, favoring the screen media reduction intervention (-1.67; 95% CI, -2.68 to -0.67; Cohen d, 0.53). The greatest improvements were observed for internalizing symptoms (emotional symptoms and peer problems; between-group mean difference, -1.03; 95% CI, -1.76 to -0.29) and prosocial behavior (between-group mean difference, 0.84; 95% CI, 0.39-1.30).

CONCLUSIONS AND RELEVANCE: This secondary analysis of a randomized clinical trial found that a short-term reduction in leisure-time screen media use within families positively affected psychological symptoms of children and adolescents, particularly by mitigating internalizing behavioral issues and enhancing prosocial behavior. More research is needed to confirm whether these effects are sustainable in the long term.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04098913.

PMID:38995646 | DOI:10.1001/jamanetworkopen.2024.19881

JAMA Netw Open. 2024 Jul 1;7(7):e2420458. doi: 10.1001/jamanetworkopen.2024.20458.

ABSTRACT

IMPORTANCE: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation.

OBJECTIVES: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials.

DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024.

MAIN OUTCOMES AND MEASURES: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking.

RESULTS: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence.

CONCLUSIONS AND RELEVANCE: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

PMID:38995645 | DOI:10.1001/jamanetworkopen.2024.20458

JAMA Netw Open. 2024 Jul 1;7(7):e2421903. doi: 10.1001/jamanetworkopen.2024.21903.

ABSTRACT

IMPORTANCE: African American men experience greater prostate cancer incidence and mortality than White men. Growing literature supports associations of neighborhood disadvantage, which disproportionately affects African American men, with aggressive prostate cancer; chronic stress and downstream biological impacts (eg, increased inflammation) may contribute to these associations.

OBJECTIVE: To examine whether several neighborhood disadvantage metrics are associated with prostate tumor RNA expression of stress-related genes.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study leveraged prostate tumor transcriptomic data for African American and White men with prostate cancer who received radical prostatectomy at the University of Maryland Medical Center between August 1992 and January 2021. Data were analyzed from May 2023 to April 2024.

EXPOSURES: Using addresses at diagnosis, 2 neighborhood deprivation metrics (Area Deprivation Index [ADI] and validated bayesian Neighborhood Deprivation Index) as well as the Racial Isolation Index (RI) and historical redlining were applied to participants’ addresses. Self-reported race was determined using electronic medical records.

MAIN OUTCOMES AND MEASURES: A total of 105 stress-related genes were evaluated with each neighborhood metric using linear regression, adjusting for race, age, and year of surgery. Genes in the Conserved Transcriptional Response to Adversity (CTRA) and stress-related signaling genes were included.

RESULTS: A total of 218 men (168 [77%] African American, 50 [23%] White) with a median (IQR) age of 58 (53-63) years were included. African American participants experienced greater neighborhood disadvantage than White participants (median [IQR] ADI, 115 [100-130] vs 92 [83-104]; median [IQR] RI, 0.68 [0.34-0.87] vs 0.11 [0.06-0.14]). ADI was positively associated with expression for 11 genes; HTR6 (serotonin pathway) remained significant after multiple-comparison adjustment (β = 0.003; SE, 0.001; P < .001; Benjamini-Hochberg q value = .01). Several genes, including HTR6, were associated with multiple metrics. We observed higher expression of 5 proinflammatory genes in the CTRA with greater neighborhood disadvantage (eg, CXCL8 and ADI, β = 0.008; SE, 0.003; P = .01; q value = .21).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, the expression of several stress-related genes in prostate tumors was higher among men residing in disadvantaged neighborhoods. This study is one of the first to suggest associations of neighborhood disadvantage with prostate tumor RNA expression. Additional research is needed in larger studies to replicate findings and further investigate interrelationships of neighborhood factors, tumor biology, and aggressive prostate cancer to inform interventions to reduce disparities.

PMID:38995644 | DOI:10.1001/jamanetworkopen.2024.21903

JAMA Netw Open. 2024 Jul 1;7(7):e2422189. doi: 10.1001/jamanetworkopen.2024.22189.

ABSTRACT

IMPORTANCE: Adolescence is a critical developmental phase when mental health disorders, such as anxiety and depression, often emerge. Stringent public health measures and quarantine mandates during the COVID-19 pandemic could threaten adolescent mental health.

OBJECTIVE: To investigate the associations of public health measures and quarantine experiences with mental distress among Norwegian adolescents and to explore if certain vulnerability factors moderate these associations.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal cohort study used repeated measures to capture variations in mental distress explained by the stringency of public health measures and quarantine experiences. Data from the Norwegian Mother, Father, and Child cohort study were linked to national health registries and a national stringency index from April 1, 2020, to February 17, 2021. Participant included 7787 Norwegian adolescents aged 16 to 18 years. Data were analyzed from October 2022 to October 2023.

EXPOSURES: Stringency index of public health measures and quarantine experiences including recent quarantine (within the last 2 weeks) and quarantine frequency (cumulative number of quarantine episodes).

MAIN OUTCOME AND MEASURES: Mental distress was measured using the Hopkins Symptom Checklist across 6 data collection waves.

RESULTS: In this study, 7787 participants were included in the analysis (4473 female [57%]; mean [SD] age, 17.0 [0.6] years). Stringent public health measures (β = 0.18; SE, 0.02; P < .001), recent quarantine (β = 0.11; SE, 0.02; P < .001), and frequent quarantine (β = 0.08; SE, 0.01; P < .001) were associated with higher levels of mental distress. The associations between public health measures and mental distress were not moderated by sex, age, prepandemic anxiety or depression, or genetic liability for mental health conditions. Frequency of quarantine appeared to be more strongly associated with mental distress among younger adolescents (β = -0.04; SE, 0.01; P = .008), those with parents with lower education (β = -0.04; SE, 0.01; P = .007), and those with lower genetic risk for depression (β = -0.03; SE, 0.01; P = .006).

CONCLUSIONS AND RELEVANCE: In this study, younger adolescents, those with parents with lower education, or those with low genetic liability for depression appeared more vulnerable when being quarantined several times. These findings emphasize the need for targeted support strategies to better protect adolescent well-being during future crises. Adolescents who experienced increased mental distress during the COVID-19 pandemic may be at risk of continued mental health problems and in need of ongoing support.

PMID:38995642 | DOI:10.1001/jamanetworkopen.2024.22189