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Background: Older age is associated with less aggressive treatment and higher short-term mortality due to serious illness. It is not known whether less aggressive care contributes to this survival disadvantage in elderly persons.Objective: To determine the effect of age on short-term survival, independent of baseline patient characteristics and aggressiveness of care.Design: Secondary analysis of data from a prospective cohort study.Setting: Five academic medical centers participating in SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments).Patients: 9105 adults hospitalized with one of nine serious illnesses associated with an average 6-month mortality rate of 50%.Measurements: Survival through 180 days of follow-up. In Cox proportional hazards modeling, adjustment was made for patient sex; ethnicity; income; baseline physical function; severity of illness; intensity of hospital resource use; presence of do-not-resuscitate orders on study day 1; and presence and timing of decisions to withhold transfer to the intensive care unit, major surgery, dialysis, blood transfusion, vasopressors, and tube feeding.Results: The mean (+/- SD) patient age was 63 +/- 16 years, 44% of patients were female, and 16% were black. Overall survival to 6 months was 53%. In analyses that adjusted for sex, ethnicity, income, baseline functional status, severity of illness, and aggressiveness of care, each additional year of age increased the hazard of death by 1.0% (hazard ratio, 1.010 [95% CI, 1.007 to 1.013]) for patients 18 to 70 years of age and by 2.0% (hazard ratio, 1.020 [CI, 1.013 to 1.026]) for patients older than 70 years of age. Adjusted estimates of age-specific 6-month mortality rates were 44% for 55-year-old patients, 48% for 65-year-old patients, 53% for 75-year-old patients, and 60% for 85-year-old patients. Similar results were obtained in analyses that did not adjust for aggressiveness of care. Acute physiology and diagnosis had much larger relative contributions to prognosis than age.Conclusions: We found a modest independent association between patient age and short-term survival of serious illness. This age effect was not explained by the current practice of providing less aggressive care to elderly patients. [ABSTRACT FROM AUTHOR]

Purpose: To develop and validate a predictive model that would allow clinicians to determine whether an electrophysiologic (EP) study is likely to result in useful diagnostic information for a patient who has unexplained syncope.Patients: One hundred seventy-nine consecutive patients with unexplained syncope who underwent EP studies at two university medical centers comprised the training sample. A test sample to validate the model was made up of 138 patients from the clinical literature who had undergone EP studies for syncope.Design: Retrospective analysis of patients undergoing EP studies for syncope. The data collector was blinded to the study hypothesis; the electrophysiologist assessing outcomes was blinded to clinical and historical data. Clinical predictor variables available from the history, the physical examination, electrocardiography (ECG), and Holter monitoring were analyzed via two multivariable predictive modeling strategies (ordinal logistic regression and recursive partitioning) for their abilities to predict the results of EP studies, namely tachyarrhythmic and bradyarrhythmic outcomes. These categories were further divided into full arrhythmia and borderline arrhythmia groups.Results: Important outcomes were 1) sustained monomorphic ventricular tachycardia (VT) and 2) bradyarrhythmias, including sinus node and atrioventricular (AV) conducting disease. The results of the logistic regression (in this study, the superior strategy) showed that the presence of organic heart disease [odds ratio (OR) = 3.0, p less than 0.001] and frequent premature ventricular contractions on ECG (OR = 6.7, p less than 0.004) were associated with VT, while the following abnormal ECG findings were associated with bradyarrhythmias: first-degree heart block (OR = 7.9, p less than 0.001), bundle-branch block (OR = 3.0, p less than 0.02), and sinus bradycardia (OR = 3.5, p less than 0.03). Eighty-seven percent of the 31 patients with important outcomes at EP study had at least one of these clinical risk factors, while 95% of the patients with none of these risk factors had normal or nondiagnostic EP studies. In the validation sample, the presence of one or more risk factors would have correctly identified 88% of the test VT patients and 65% of the test bradyarrhythmia patients as needing EP study.Conclusion: These five identified predictive factors, available from the history, the physical examination, and the initial ECG, could be useful to clinicians in selecting those patients with unexplained syncope who will have a serious arrhythmia identified by EP studies. [ABSTRACT FROM AUTHOR]

Randomized trials typically estimate average relative treatment effects, but decisions on the benefit of a treatment are possibly better informed by more individualized predictions of the absolute treatment effect. In case of a binary outcome, these predictions of absolute individualized treatment effect require knowledge of the individual's risk without treatment and incorporation of a possibly differential treatment effect (ie, varying with patient characteristics). In this article, we lay out the causal structure of individualized treatment effect in terms of potential outcomes and describe the required assumptions that underlie a causal interpretation of its prediction. Subsequently, we describe regression models and model estimation techniques that can be used to move from average to more individualized treatment effect predictions. We focus mainly on logistic regression-based methods that are both well-known and naturally provide the required probabilistic estimates. We incorporate key components from both causal inference and prediction research to arrive at individualized treatment effect predictions. While the separate components are well known, their successful amalgamation is very much an ongoing field of research. We cut the problem down to its essentials in the setting of a randomized trial, discuss the importance of a clear definition of the estimand of interest, provide insight into the required assumptions, and give guidance with respect to modeling and estimation options. Simulated data illustrate the potential of different modeling options across scenarios that vary both average treatment effect and treatment effect heterogeneity. Two applied examples illustrate individualized treatment effect prediction in randomized trial data., (© 2021 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.)

Object: The goal of this study was to evaluate the effectiveness and limitations of gamma knife surgery (GKS) in the treatment of intracranial breast carcinoma lesions., Methods: A retrospective analysis of the GKS database at the University of Virginia Health System identified 43 patients with a total of 84 lesions who were treated between 1989 and 2000. All patients who received treatment were included in this study. Imaging studies were available in 35 patients with 67 treated lesions. The overall duration of median survival was 13 months (95% confidence interval [CI] 7-16 months) after radiosurgery. A univariable Cox regression analysis revealed that a single lesion (p = 0.035), a high Karnofsky Performance Scale (KPS) score (p = 0.019), and a high Score Index for Radiosurgery (SIR) in Brain Metastases (p = 0.036) were associated with a significantly lengthened time to local treatment failure. The median duration of survival for patients grouped according to the SIR as low, middle, and high was 3, 8, and 21 months, respectively (p = 0.00033). A multivariable analysis showed that a high KPS score (p = 0.006), a high SIR (p = 0.014), and advanced age (0.038) were predictive of survival. The 1-, 2-, 3-, and 5-year survival rates were 49, 23, 12, and 2%, respectively. The overall median time to local treatment failure was 10 months (95% CI 6-14 months) after GKS. A univariable analysis demonstrated that a single lesion, higher KPS score, and a higher SIR were associated with a significantly longer time until local treatment failure. A multivariable analysis showed that a higher KPS score and SIR and patients who had received chemotherapy were associated with a significantly longer time to local treatment failure. Neuroimaging scores given for the enhancement pattern (ring-enhancing, heterogeneous, and homogeneous signal), amount of necrosis (none, < 50%, and > 50%), and mass effect (none, mild, moderate, and severe) of each treated lesion did not correlate with survival or local treatment failure., Conclusions: The SIR and the KPS score are prognostic factors in patients whose intracranial breast cancer metastases are treated with GKS. The SIR, which includes the KPS score, patient age, systemic disease status, largest lesion volume, and number of lesions, can be used to identify those patients with breast cancer metastasis who would benefit from GKS better than KPS score alone. The contribution of whole-brain radiation therapy to GKS with regard to local tumor control or survival could not be identified.

Purpose: We present a contemporary review of patients with renal cell carcinoma (RCC) in whom renal vein/inferior vena caval thrombus was treated with radical nephrectomy and thrombectomy., Materials and Methods: A total of 220 patients underwent radical nephrectomy for RCC at our institution from 1998 to 2002. Of them 49 patients with renal vein/inferior vena caval involvement (T3b/c) were selected for review. We evaluated demographics, presenting symptoms, imaging modalities, clinical staging, pathological features, adjuvant treatment and clinical outcomes. We also evaluated surgical incisions, liver mobilization procedures, blood loss, transfusion requirements and perioperative mortality/morbidity., Results: Gross hematuria was the most common presenting symptom, seen in 22 patients (45%), followed by constitutional symptoms in 8 (16%). Stage T3b/c was clinically diagnosed in 44 patients, while 2 had T2 and 2 had T4 disease. A subcostal incision was made in 30 patients, a chevron incision was made in 18, and a sternotomy and flank incision were made in 1. Liver mobilization was necessary in 13 patients and 2 required a Pringle maneuver. Cardiopulmonary bypass was performed in a single patient. Lymph node involvement was seen in 4 patients (8%) and distant metastases were present in 10 (20%). Median tumor size was 10 cm. Clear cell carcinoma was most common, as seen in 42 patients. Early (30-day) mortality in this series was 8%. At a median followup of 15 months 21 patients (43%) were without evidence of disease, 14 (29%) had disease, 8 (16%) had died of disease and 2 (4%) had died of other causes. None of the patients with lymph node involvement survived beyond 8 months after surgery. Tumor grade and T stage were found to be significant negative predictors of survival on univariate analysis., Conclusion: Most patients with RCC and tumor thrombus are symptomatic at presentation and metastatic disease at presentation is not uncommon. These results support the role of aggressive surgical treatment as the best initial management of these tumors. The majority of tumors can be approached and safely controlled without the need for a thoracoabdominal incision. While surgery provides modest disease-free survival, most patients should be offered immunotherapy, particularly those with advanced stage, grade, nodal involvement or metastases.

Troubling aspects of the experiences of patients at the ends of their lives have fueled interest in special benefits or privileges for this group. There is a presumption that being "at the end of life" is discernible. This study examines this presumption using data from two previously collected databases: the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) and the Acute Physiology and Chronic Health Evaluation III (APACHE III). Both studies generated multivariable estimates of survival prognosis for hospitalized patients. SUPPORT included 9,105 patients with one of nine serious illnesses in five hospitals over 4 yrs, of whom 2,360 died in the hospital and 4,537 died within 180 days of entry into the study. The APACHE III database describes 2,750 deaths in 16,622 ICU patients in 40 hospitals. The relationship of median estimates with time to death were examined for each source of data, for different diseases, and for ICU settings of care. In SUPPORT, the median predicted chance of survival for 2 months on the day before actual death was .17 (interquartile range, .02-.40) and was .51 (.31-.66) 1 wk before death. Median prognoses varied substantially among diseases: the median for congestive heart failure patients was a .62 chance of living 2 months on the day before death, while lung cancer had only a .17 chance and coma patients only an .11 chance. Median prognostication estimates were not much different when given by physicians and were only a little more pessimistic in APACHE (median estimate for hospital survival on the day before death was .14 and 7 days before was .45). To make plans about care and to optimally support most dying persons and families, conversations must occur while the patient still has a considerable chance of surviving the current episode of illness. Using statistical estimates of prognosis to designate a category of "terminally ill" patients for public policy purposes is unavoidably arbitrary, will often be contested, and will have differential effects upon those dying with differing diseases.

Purpose: To develop and validate a predictive model that would allow clinicians to determine whether an electrophysiologic (EP) study is likely to result in useful diagnostic information for a patient who has unexplained syncope., Patients: One hundred seventy-nine consecutive patients with unexplained syncope who underwent EP studies at two university medical centers comprised the training sample. A test sample to validate the model was made up of 138 patients from the clinical literature who had undergone EP studies for syncope., Design: Retrospective analysis of patients undergoing EP studies for syncope. The data collector was blinded to the study hypothesis; the electrophysiologist assessing outcomes was blinded to clinical and historical data. Clinical predictor variables available from the history, the physical examination, electrocardiography (ECG), and Holter monitoring were analyzed via two multivariable predictive modeling strategies (ordinal logistic regression and recursive partitioning) for their abilities to predict the results of EP studies, namely tachyarrhythmic and bradyarrhythmic outcomes. These categories were further divided into full arrhythmia and borderline arrhythmia groups., Results: Important outcomes were 1) sustained monomorphic ventricular tachycardia (VT) and 2) bradyarrhythmias, including sinus node and atrioventricular (AV) conducting disease. The results of the logistic regression (in this study, the superior strategy) showed that the presence of organic heart disease [odds ratio (OR) = 3.0, p less than 0.001] and frequent premature ventricular contractions on ECG (OR = 6.7, p less than 0.004) were associated with VT, while the following abnormal ECG findings were associated with bradyarrhythmias: first-degree heart block (OR = 7.9, p less than 0.001), bundle-branch block (OR = 3.0, p less than 0.02), and sinus bradycardia (OR = 3.5, p less than 0.03). Eighty-seven percent of the 31 patients with important outcomes at EP study had at least one of these clinical risk factors, while 95% of the patients with none of these risk factors had normal or nondiagnostic EP studies. In the validation sample, the presence of one or more risk factors would have correctly identified 88% of the test VT patients and 65% of the test bradyarrhythmia patients as needing EP study., Conclusion: These five identified predictive factors, available from the history, the physical examination, and the initial ECG, could be useful to clinicians in selecting those patients with unexplained syncope who will have a serious arrhythmia identified by EP studies.