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BACKGROUND Whether initial invasive management in older vs younger adults with chronic coronary disease and moderate or severe ischemia improves health status or clinical outcomes is unknown. OBJECTIVES The goal of this study was to examine the impact of age on health status and clinical outcomes with invasive vs conservative management in the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial. METHODS One-year angina-specific health status was assessed with the 7-item Seattle Angina Questionnaire (SAQ) (score range 0-100; higher scores indicate better health status). Cox proportional hazards models estimated the treatment effect of invasive vs conservative management as a function of age on the composite clinical outcome of cardiovascular death, myocardial infarction, or hospitalization for resuscitated cardiac arrest, unstable angina, or heart failure. RESULTS Among 4,617 participants, 2,239 (48.5%) were aged

Supplemental material, sj-pdf-1-vmj-10.1177_1358863X221098097 for Variability in 30-day major amputation rates following endovascular peripheral vascular intervention for critical limb ischemia by Jeremy B Provance, John A Spertus, Philip G Jones, Mark A Hoffman, Matthew C Bunte, Todd R Vogel, Carlos Mena-Hurtado and Kim G Smolderen in Vascular Medicine

Supplemental material, sj-pdf-1-vmj-10.1177_1358863X221098097 for Variability in 30-day major amputation rates following endovascular peripheral vascular intervention for critical limb ischemia by Jeremy B Provance, John A Spertus, Philip G Jones, Mark A Hoffman, Matthew C Bunte, Todd R Vogel, Carlos Mena-Hurtado and Kim G Smolderen in Vascular Medicine

BackgroundHealth status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available.MethodsWe built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites' unadjusted and adjusted rates.ResultsAmong 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment.ConclusionsThrough leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients' perspectives.

Additional file 1: Table S1. Patient characteristics according to documentation of heart failure, stratified by physician specialty.

Supplemental material, VMJ785026_Supplemental_Table_1 for Associations of exercise ankle–brachial index, pain-free walking distance and maximum walking distance with the Peripheral Artery Questionnaire: Finding from the PORTRAIT PAD Registry by Tarek A Hammad, Kim G Smolderen, John A Spertus, Philip G Jones and Mehdi H Shishehbor in Vascular Medicine

ObjectivesThe Stroke-Thrombolytic Predictive Instrument (Stroke-TPI) predicts the probability of good and bad outcomes with and without recombinant tissue plasminogen activator (rtPA). We sought to rebuild and externally validate a simpler Stroke-TPI to support implementation in routine clinical care.MethodsUsing the original derivation cohort of 1,983 patients from a combined database of randomized clinical trials (NINDS [National Institute of Neurological Disorders and Stroke] 1 and 2; ATLANTIS [Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke] A and B; and ECASS [European Cooperative Acute Stroke Study] II), we simplified the Stroke-TPI by reducing variables and interaction terms and by exploring simpler (3- and 8-item) stroke severity scores. External validation was performed in the ECASS III trial (n = 821).ResultsThe following 6 variables were most predictive of good outcomes: age, systolic blood pressure, diabetes, stroke severity, symptom onset to treatment time, and rtPA therapy. Treatment effect modifiers included onset to treatment time and systolic blood pressure. For the models predicting a bad outcome (modified Rankin Scale [mRS] score ≥5), significant variables included age, stroke severity, and serum glucose. rtPA therapy did not change the risk of a poor outcome. Compared with models using the full NIH Stroke Scale, models using the 3-item severity score showed similar discrimination and excellent calibration. External validation on ECASS III showed similar performance (C statistics 0.75 [mRS score ≤1] and 0.80 [mRS score ≤2]).ConclusionA simpler model using a 3-item stroke severity score, instead of the 15-item NIH Stroke Scale, has similar prognostic value and may be easier to use in routine care. Future studies are needed to test whether it can improve process and clinical outcomes.