In a Perspective article, Sigrid Carlsson and Michael Kattan discuss Gnanapragasam and colleagues' accompanying research study on refining risk stratification in early prostate cancer.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The objective of this study was to compare the accuracy of clinical judgment in predicting seizure outcome after resective epilepsy surgery relative to two recently published statistical tools the ...Epilepsy Surgery Nomogram (ESN) and the modified Seizure-Freedom score (m-SFS).
Details of presurgical evaluations of 20 patients who underwent epilepsy surgery were presented to 20 epilepsy experts. The final surgical treatment was also disclosed. The clinicians were asked to predict the likelihood of a good outcome (Engel 1) at 2 and 5 years in each case. The ESN and the m-SFS predictions were calculated with the data provided to the clinicians. The discriminative ability of clinical judgment, ESN, and m-SFS was assessed by calculating a concordance index (C-index). Expert opinion, the m-SFS and the ESN performances were compared using a Receiver Operating Characteristic (ROC) curve analysis.
The mean age at surgery was 29 years (standard deviation SD = 14); 40% were male; 70% were right-handed, and thirteen (65%) had an Engel outcome 1 at 2 and 5 years. The mean C-index for the mean physician's prediction was 0.478 with a variance of 0.012. The ESN had an area under the curve (AUC) of 0.528 and 0.533 for the 2-year and 5-year predictions in comparison with the clinicians' predictions that was 0.476, and 0.466, respectively. For the m-SFS, the AUC at 2 years and 5 years was 0.539 and 0.539, respectively. No statistical difference was noted between the ESN and the clinicians or between m-SFS and the ESN, but there is a moderate statistical difference favoring the m-SFS to the clinicians (p 0.0960 and 0.0514, for 2 and 5 years).
Clinical judgment was not superior to the ESN nor to the m-SFS. Together with the interphysician's prediction variability, our findings reinforce the need for better tools to predict postoperative outcomes.
•Prediction of success of resective surgery for intractable epilepsy has been elusive to clinicians.•The best current strategy to predict success of epilepsy surgery is to use the clinician's knowledge.•In our study, clinical judgment was not superior to our 2 developed tools to predict surgical outcomes.•An effective instrument to predict success in epilepsy surgery. to support the decision-making process prior to surgery.•Comprehensive models which include clinical and nonclinical variables are needed to guide the decision making process.
Many institutions would like to harness their electronic health record (EHR) data for research. However, with many EHR systems, this process is remarkably difficult. We have been using our vast EHR ...system for research very effectively, with substantial research support and many publications. Herein we share our process and provide recommendations for others wanting to utilize their EHR data for research.
SUMMARY
We show that the widely used concordance index for time to event outcome is not proper when interest is in predicting a $t$-year risk of an event, for example 10-year mortality. In the ...situation with a fixed prediction horizon, the concordance index can be higher for a misspecified model than for a correctly specified model. Impropriety happens because the concordance index assesses the order of the event times and not the order of the event status at the prediction horizon. The time-dependent area under the receiver operating characteristic curve does not have this problem and is proper in this context.
Considerable heterogeneity persists in the conduct and reporting of statistical analyses in the medical literature. Authors submitting manuscripts to CHEST are encouraged to adhere to the following ...guidelines where possible.
To determine which one of the two most common metabolic surgical procedures is associated with greater reduction in risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes ...mellitus (T2DM) and obesity.
A total of 13,490 patients including 1,362 Roux-en-Y gastric bypass (RYGB), 693 sleeve gastrectomy (SG), and 11,435 matched nonsurgical patients with T2DM and obesity who received their care at the Cleveland Clinic (1998-2017) were analyzed, with follow-up through December 2018. With multivariable Cox regression analysis we estimated time to incident extended MACE, defined as first occurrence of coronary artery events, cerebrovascular events, heart failure, nephropathy, atrial fibrillation, and all-cause mortality.
The cumulative incidence of the primary end point at 5 years was 13.7% (95% CI 11.4-15.9) in the RYGB groups and 24.7% (95% CI 19.0-30.0) in the SG group, with an adjusted hazard ratio (HR) of 0.77 (95% CI 0.60-0.98,
= 0.04). Of the six individual end points, RYGB was associated with a significantly lower cumulative incidence of nephropathy at 5 years compared with SG (2.8% vs. 8.3%, respectively; HR 0.47 95% CI 0.28-0.79,
= 0.005). Furthermore, RYGB was associated with a greater reduction in body weight, glycated hemoglobin, and use of medications to treat diabetes and cardiovascular diseases. Five years after RYGB, patients required more upper endoscopy (45.8% vs. 35.6%,
< 0.001) and abdominal surgical procedures (10.8% vs. 5.4%,
= 0.001) compared with SG.
In patients with obesity and T2DM, RYGB may be associated with greater weight loss, better diabetes control, and lower risk of MACE and nephropathy compared with SG.
Investigators submitting clinical research to European Urology are encouraged to follow guidelines for the reporting of statistics. Adoption of the guidelines will not only increase the quality of ...published papers, but also improve statistical knowledge in urology in general.
The long-term risk of prostate cancer-specific mortality (PCSM) after radical prostatectomy is poorly defined for patients treated in the era of widespread prostate-specific antigen (PSA) screening. ...Models that predict the risk of PCSM are needed for patient counseling and clinical trial design.
A multi-institutional cohort of 12,677 patients treated with radical prostatectomy between 1987 and 2005 was analyzed for the risk of PCSM. Patient clinical information and treatment outcome was modeled using Fine and Gray competing risk regression analysis to predict PCSM.
Fifteen-year PCSM and all-cause mortality were 12% and 38%, respectively. The estimated PCSM ranged from 5% to 38% for patients in the lowest and highest quartiles of predicted risk of PSA-defined recurrence, based on a popular nomogram. Biopsy Gleason grade, PSA, and year of surgery were associated with PCSM. A nomogram predicting the 15-year risk of PCSM was developed, and the externally validated concordance index was 0.82. Neither preoperative PSA velocity nor body mass index improved the model's accuracy. Only 4% of contemporary patients had a predicted 15-year PCSM of greater than 5%.
Few patients will die from prostate cancer within 15 years of radical prostatectomy, despite the presence of adverse clinical features. This favorable prognosis may be related to the effectiveness of radical prostatectomy (with or without secondary therapy) or the low lethality of screen-detected cancers. Given the limited ability to identify contemporary patients at substantially elevated risk of PCSM on the basis of clinical features alone, the need for novel markers specifically associated with the biology of lethal prostate cancer is evident.
Predictive nomograms are becoming increasingly used to define and predict outcome. They can be developed at presentation or following treatment and include variables not conventionally used in ...standard staging systems.
We use a predictive nomogram based on prospectively collected data from 555 pancreatic resections for adenocarcinoma at a single institution. At last follow-up, 481 (87%) had died, defining a mature and comprehensive database. We used a 1-, 2-, and 3-year follow-up, as the number of patients alive beyond 3 years is sufficiently limited to provide insufficient events.
Based on a Cox model, we then developed a nomogram that predicts the probability that a patient will survive pancreatic cancer for 1, 2, and 3 years from the time of the initial resection, assuming that there is not death from an alternate cause. Calibration between observed and corrected is good, and variables not conventionally associated with standard staging systems improved the predictivity of the model.
This nomogram can serve as a basis for investigating other potentially predictive variables that are proposed of prognostic importance for patients undergoing resection for adenocarcinoma of the pancreas.
Overdiagnosis and overtreatment of indolent prostate cancer (PCA) is a serious health issue in most developed countries. There is an unmet clinical need for noninvasive, easy to administer, ...diagnostic assays to help assess whether a prostate biopsy is warranted.
To determine the performance of a novel urine exosome gene expression assay (the ExoDx Prostate IntelliScore urine exosome assay) plus standard of care (SOC) (ie, prostate-specific antigen PSA level, age, race, and family history) vs SOC alone for discriminating between Gleason score (GS)7 and GS6 and benign disease on initial biopsy.
In training, using reverse-transcriptase polymerase chain reaction (PCR), we compared the urine exosome gene expression assay with biopsy outcomes in 499 patients with prostate-specific antigen (PSA) levels of 2 to 20 ng/mL. The derived prognostic score was then validated in 1064 patients from 22 community practice and academic urology clinic sites in the United States. Eligible participants included PCA-free men, 50 years or older, scheduled for an initial or repeated prostate needle biopsy due to suspicious digital rectal examination (DRE) findings and/or PSA levels (limit range, 2.0-20.0 ng/mL).
Evaluate the assay using the area under receiver operating characteristic curve (AUC) in discrimination of GS7 or greater from GS6 and benign disease on initial biopsy.
In 255 men in the training target population (median age 62 years and median PSA level 5.0 ng/mL, and initial biopsy), the urine exosome gene expression assay plus SOC was associated with improved discrimination between GS7 or greater and GS6 and benign disease: AUC 0.77 (95% CI, 0.71-0.83) vs SOC AUC 0.66 (95% CI, 0.58-0.72) (P < .001). Independent validation in 519 patients' urine exosome gene expression assay plus SOC AUC 0.73 (95% CI, 0.68-0.77) was superior to SOC AUC 0.63 (95% CI, 0.58-0.68) (P < .001). Using a predefined cut point, 138 of 519 (27%) biopsies would have been avoided, missing only 5% of patients with dominant pattern 4 high-risk GS7 disease.
This urine exosome gene expression assay is a noninvasive, urinary 3-gene expression assay that discriminates high-grade (≥GS7) from low-grade (GS6) cancer and benign disease. In this study, the urine exosome gene expression assay was associated with improved identification of patients with higher-grade prostate cancer among men with elevated PSA levels and could reduce the total number of unnecessary biopsies.
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