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Background: Determining lung cancer (LC) risk using personalized risk stratification may improve screening effectiveness. While the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) is a well-established stratification model for LC screening, it was derived from a predominantly Caucasian population and its effectiveness in a safety net hospital (SNH) population is unknown. We have developed a model more tailored to the SNH population and compared its performance to the PLCO model in a SNH setting. Methods: Retrospective dataset was compiled from patients screened for LC at SNH from 2015 to 2019. Descriptive statistics were calculated using the following variables: age, sex, race, education, body mass index (BMI), smoking history, personal cancer history, family LC history, chronic obstructive pulmonary disease (COPD), and emphysema. Variables distribution was compared using t- and chi-square tests. LC risk scores were calculated using SNH and PLCO models and categorized as low (scores <0.65%), moderate (0.65-1.49%), and high (>1.5%). Linear regression was applied to evaluate the relationship between models and covariates. Results: Of 896 individuals, 38 were diagnosed with LC. Data reflected the SNH patient demographics, which predominantly were African American (53.5%), current smokers (69.9%), and with emphysema (70.1%). Among the non-LC cohort, SNH model most frequently categorized patients as low risk, while PLCO model most frequently classified patients as moderate risk. Among the LC cohort, there was no significant difference between mean scores or risk stratification. SNH model showed 92.1% sensitivity and 96.8% specificity while PLCO model showed 89.4% sensitivity and 26.1% specificity. Emphysema demonstrated a strong association in SNH model (P<0.001) while race showed no relation. Conclusions: SNH model demonstrated greater specificity for characterizing LC risk in a SNH population. The results demonstrated the importance of study sample representation when identifying risk factors in a stratification model.
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BACKGROUND: Perform literature review to analyze current practices in imaging patient with peripheral arterial disease (PAD) and examine patterns in our practice in order to assess whether a lower extremity computed tomography angiography (CTA) in addition to digital subtraction angiography enhanced the assessment of vessel calcification, percentage of stenosis, and affected outcomes in patients with PAD. METHODS: The study included patients who underwent lower extremity imaging and were followed up to 12 months. This population was divided into cases who had both an angiogram and CTA performed within 30 days (n = 20), and controls who underwent angiography only (n = 19). Baseline characteristics, imaging results, and clinical outcomes were analyzed. RESULTS: Thirty-nine patients met study criteria (mean age was 58.4 years, 69.2% were males, and 33.3% had diabetes). Patients mostly presented with tissue loss/rest pain (10.3%), claudication (15.4%), acute limb (10.3%), and trauma (15.4%). We have not observed any statistically significant differences in various examined blood vessels when their features (e.g., vessel diameter, stenosis, calcifications) were assessed by CTA combined with angiography versus angiography alone. The exceptions were external iliac artery, superficial femoral artery and dorsalis pedis vessels. In external iliac artery percentage of stenosis was 1.11% as determined by computed tomography (CT) scan versus 30% by angiography (P = 0.009). For superficial femoral artery stenosis, the percentage determined by CT was 48.68% vs. 81.41% by angiography, and observed difference between 2 modalities was statistically significant (P = 0.025). For dorsalis pedis percentage of stenosis detected by CT scan was 60.63% vs. 22.73% by angiography, and the differences in findings by these modalities were statistically significant (P = 0.039). The most frequent perioperative complication was cardiac-related (35.5%). Nineteen patients were readmitted and 8 had reinterventions within 12 months. CONCLUSIONS: Both imaging modalities yielded similar results for assessing vessel calcification and percentage of stenosis regardless of anatomic vessel location. Overall, utilization of CTA in addition to angiography for large vessels above the knee (e.g., iliac artery, superficial femoral artery) and below the knee for dorsalis pedis provided more detailed information on the properties of these vessels. Therefore, during preoperative assessments, CTA may be helpful in addition to angiography for planning surgical and endovascular interventions for symptomatic PAD treatment in larger vessels.
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BACKGROUND: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research. METHODS: IRB stipulations for 48 surgical studies were analyzed. Various factors were assessed: surgical specialty, type of study by design, clinical trial phase, type of investigational product, type of IRB utilized (local or centralized), study complexity score, type of review (e.g., exempt, expedited, or full board), turnaround time, and number of stipulations received. Statistical analyses were performed to examine associations between the number/type of stipulations received during the IRB review process and any of the aforementioned study-related factors. RESULTS: For analyzed surgical studies, the number of stipulations allotted to a study and time taken for approval had moderate association with the complexity of the study. The turnaround time for approval was the highest for randomized, controlled trials and studies undergoing full board review. CONCLUSION: This study elucidates characteristics that are associated with increased time for IRB approval. Analysis of IRB stipulations can help improve the turnaround time for the approval process, increase efficiency of startup phase, and transition to execution phase faster, which will allow more time for enrollment of research subjects, and increase return on investment made into research and development programs.
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Ethics Committees, Research , Research Design , Humans , Time FactorsABSTRACT
Background: Smoking relapse after surgical resection for lung cancer (LC) remains a health concern. This study aims to determine various factors associated with postoperative smoking relapse in patients undergoing surgical resection for stage I non-small cell lung cancer (NSCLC) at an urban safety net hospital. Methods: We analyzed the demographic and clinical variables of all patients who underwent surgical resection for stage I NSCLC from 2002 to 2016 at our institution. Based on the post-operative smoking history, we segregated the cohort into two groups: relapse and abstinent. Chi-squared and analysis of variance tests were used to identify the variables that registered a significant difference between the two groups. Further, we used univariable and multivariable logistic regression to determine association between variables and smoking relapse. Results: We analyzed data from 168 patients, excluding those with inadequate smoking history and never smokers. In total, 64 (38.1%) patients experienced smoking relapse, and 104 (61.9%) remained abstinent. The age, annual income, and race showed significant differences between the two groups. Multivariable logistic regression reflected that black patients had higher odds of relapse than white patients [odds ratio (OR) =3.26, confidence interval (CI): 1.54-6.89, P=0.002] and the chances of relapse decreased as the age increased (5-year age gap, OR =0.70, CI: 0.58-0.85, P<0.001). Conclusions: Black race and younger age at the time of surgery are associated with smoking relapse after surgery for stage I NSCLC. Targeted smoking cessation programs catered towards these patient groups may help reduce the prevalence of post-operative smoking.
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Chronic kidney disease (CKD) is characterized by the accumulation of uremic toxins and renal tubular damage. Tryptophan-derived uremic toxins [indoxyl sulfate (IS) and kynurenine (Kyn)] are well-characterized tubulotoxins. Emerging evidence suggests that transmembrane and immunoglobulin domain-containing 1 (TMIGD1) protects tubular cells and promotes survival. However, the direct molecular mechanism(s) underlying how these two opposing pathways crosstalk remains unknown. We posited that IS and Kyn mediate tubular toxicity through TMIGD1 and the loss of TMIGD1 augments tubular injury. Results from the current study showed that IS and Kyn suppressed TMIGD1 transcription in tubular cells in a dose-dependent manner. The wild-type CCAAT enhancer-binding protein ß (C/EBPß) enhanced, whereas a dominant-negative C/EBPß suppressed, TMIGD1 promoter activity. IS down-regulated C/EBPß in primary human renal tubular cells. The adenine-induced CKD, unilateral ureteric obstruction, and deoxycorticosterone acetate salt unilateral nephrectomy models showed reduced TMIGD1 expression in the renal tubules, which correlated with C/EBPß expression. C/EBPß levels negatively correlated with the IS and Kyn levels. Inactivation of TMIGD1 in mice significantly lowered acetylated tubulin, decreased tubular cell proliferation, caused severe tubular damage, and worsened renal function. Thus, the current results demonstrate that TMIGD1 protects renal tubular cells from renal injury in different models of CKD and uncovers a novel mechanism of tubulotoxicity of tryptophan-based uremic toxins.
