Cardiovascular risk profile in individuals initiating treatment for overactive bladder - Challenges and learnings for comparative analysis using linked claims and electronic medical record databases.

For managing overactive bladder (OAB), mirabegron, a ß3 adrenergic receptor agonist, is typically used as second-line pharmacotherapy after antimuscarinics. Therefore, patients initiating treatment with mirabegron and antimuscarinics may differ, potentially impacting associated clinical outcomes. When using observational data to evaluate real-world safety and effectiveness of OAB treatments, residual bias due to unmeasured confounding and/or confounding by indication are important considerations. Falsification analysis, in which clinically irrelevant endpoints are tested as a reference, can be used to assess residual bias. The objective in this study was to compare baseline cardiovascular risk among OAB patients by treatment, and assess the presence of residual bias via falsification analysis of OAB patients treated with mirabegron or antimuscarinics, to determine whether clinically relevant comparisons across groups would be feasible. Linked electronic health record and claims data (Optum/Humedica) for OAB patients in the United States from 2011-2015 were available, with index defined as first date of OAB treatment during this period. Unadjusted characteristics were compared across groups at index and propensity-matching conducted. Falsification endpoints (hepatitis C, shingles, community-acquired pneumonia) were compared between groups using odds ratios (ORs) and 95% confidence intervals (CI). The study identified 10,311 antimuscarinic- and 408 mirabegron-treated patients. Mirabegron patients were predominantly older males, with more comorbidities. The analytic sample included 1,188 antimuscarinic patients propensity-matched to 396 mirabegron patients; after matching, no significant baseline differences remained. Estimates of falsification ORs were 0.7 (CI:0.3-1.7) for shingles, 1.5 (CI:0.3-8.2) for hepatitis C, 0.8 (CI:0.4-1.8) and 0.9 (CI:0.6-1.4) for pneumonia. While propensity matching successfully balanced observed covariates, wide CIs prevented definitive conclusions regarding residual bias. Accordingly, further observational comparisons by treatment group were not pursued. In real-world analysis, bias-detection methods could not confirm that differences in cardiovascular risk in patients receiving mirabegron versus antimuscarinics were fully adjusted for, precluding clinically relevant comparisons across treatment groups.

Ischaemic symptoms, quality of care and mortality during myocardial infarction.

OBJECTIVE: To study in myocardial infarction (MI) whether documentation of ischaemic symptoms is associated with quality of care and outcomes, and to compare patient reports of ischaemic symptoms during interviews with chart documentation. DESIGN: Observational acute MI study from 2003 to 2004 (Prospective Registry Evaluating Myocardial Infarction: Event and Recovery). SETTING: 19 diverse US hospitals. PATIENTS: 2094 consecutive patients with MI (10 911 patients screened; 3953 patients were eligible and enrolled) with both positive cardiac enzymes and other evidence of infarction (eg, symptoms, electrocardiographic changes). Transferred patients and those with confounding non-cardiac comorbidity were not included (n = 1859). MAIN OUTCOME MEASURES: Quality of care indicators and adjusted in-hospital survival. RESULTS: The records of 10% of all patients with MI (217/2094) contained no documented ischaemic symptoms at presentation. Patients without documented symptoms were less likely (p<0.05) to receive aspirin (89% vs 96%) or beta-blockers (77% vs 90%) within 24 hours, reperfusion therapy for ST-elevation MI (7% vs 58%) or to survive their hospitalisation (adjusted odds ratio = 3.2, 95% CI 1.8 to 5.8). Survivors without documented symptoms were also less likely (p<0.05) to be discharged with aspirin (87% vs 93%), beta-blockers (81% vs 91%), ACE/ARB (67% vs 80%), or smoking cessation counselling (46% vs 66%). In the subset of 1356 (65%) interviewed patients, most of those without documented ischaemic symptoms (75%) reported presenting symptoms consistent with ischaemia. CONCLUSIONS: Failure to document patients' presenting MI symptoms is associated with poorer quality of care from admission to discharge, and higher in-hospital mortality. Symptom recognition may represent an important opportunity to improve the quality of MI care.

Changes in health-related quality of life following coronary artery bypass graft surgery.

BACKGROUND: There are limited data to help clinicians identify patients likely to have an improvement in quality of life following CABG surgery. We evaluated the relationship between preoperative health status and changes in quality of life following CABG surgery. METHODS: We evaluated 1,744 patients enrolled in the VA Cooperative Processes, Structures, and Outcomes in Cardiac Surgery study who completed preoperative and 6-month postoperative Short Form-36 (SF-36) surveys. The primary outcome was change in the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores from the SF-36. RESULTS: On average, physical and mental health status improved following the operation. Preoperative health status was the major determinant of change in quality of life following surgery, independent of anginal burden and other clinical characteristics. Patients with MCS scores less than 44 or PCS scores less than 38 were most likely to have an improvement in quality of life. Patients with higher preoperative scores were unlikely to have an improvement in quality of life. CONCLUSIONS: Patients with preoperative health status deficits are likely to have an improvement in their quality of life following CABG surgery. Alternatively, patients with relatively good preoperative health status are unlikely to have a quality of life benefit from surgery and the operation should primarily be performed to improve survival.

Risk factors for intermediate-term survival after coronary artery bypass grafting.

BACKGROUND: Risk factors for short-term mortality after coronary artery bypass grafting are well established, but little is known about risk factors for intermediate-term mortality. METHODS: We analyzed the outcomes of 11,815 patients undergoing coronary artery bypass grafting in one of the 43 cardiac surgery programs of the Department of Veteran Affairs. Risk factors for intermediate- and short-term mortality were determined using Cox proportional hazards regression models. Effects of risk factors during these two periods were explicitly compared. RESULTS: We found important differences in mortality risk-factor sets between the intermediate- and short-term periods after coronary artery bypass grafting. The majority of predictors of intermediate-term mortality were noncardiac-related variables, whereas the majority of predictors of short-term mortality were cardiac-related variables. Impaired functional status, chronic obstructive pulmonary disease, and renal dysfunction had greater effects in the intermediate-term period. Previous heart operation, angina class III or IV, previous myocardial infarction, and preoperative use of an intraaortic balloon pump had greater effects in the short-term period. CONCLUSIONS: The risk factors for intermediate-term mortality identified in this study can augment preoperative risk assessment and counseling of patients. Clinicians should be aware of the importance of noncardiac-related variables as predictors of mortality in the intermediate-term period after coronary artery bypass grafting.

Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy.

CONTEXT: Institutional experience with primary angioplasty has been suggested as a factor in selecting a reperfusion strategy for patients with acute myocardial infarction (AMI). However, no large studies have directly compared outcomes of primary angioplasty vs thrombolytic therapy as a function of institutional experience. OBJECTIVE: To compare outcomes among patients with AMI who were treated with primary angioplasty vs thrombolytic therapy at hospitals with different volumes of primary angioplasty. DESIGN: Retrospective cohort. SETTING: A total of 446 acute care hospitals with 112 classified as low volume (/=49 procedures) based on their annual primary angioplasty volume. PATIENTS: A total of 62 299 patients with AMI treated with primary angioplasty or thrombolytic therapy from June 1, 1994, through July 31, 1999. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: Mortality was lower among patients who received primary angioplasty compared with those who received thrombolysis at hospitals with intermediate volumes (4.5% vs 5.9%; P<.001) and high volumes (3.4% vs 5.4%; P<.001) of primary angioplasty. At low-volume hospitals, there was no significant difference in mortality between patients treated with primary angioplasty vs those treated with thrombolysis (6.2% vs 5.9%; P =.58). Adjusting for differences in demographic, medical history, clinical presentation, treatment, and hospital characteristics did not significantly alter these findings. CONCLUSIONS: In this study, patients with AMI treated at hospitals with high or intermediate volumes of primary angioplasty had lower mortality with primary angioplasty than with thrombolysis, whereas patients with AMI treated at hospitals with low angioplasty volumes had similar mortality outcomes with primary angioplasty or thrombolysis.

Health-related quality of life as a predictor of mortality following coronary artery bypass graft surgery. Participants of the Department of Veterans Affairs Cooperative Study Group on Processes, Structures, and Outcomes of Care in Cardiac Surgery.

CONTEXT: Health-related quality of life has not been evaluated as a predictor of mortality following coronary artery bypass graft (CABG) surgery. Evaluation of health status as a mortality predictor may be useful for preoperative risk stratification. OBJECTIVE: To determine whether the Physical and Mental Component Summary scores from the preoperative Short-Form 36 (SF-36) health status survey predict mortality following CABG surgery after adjustment for known clinical risk variables. DESIGN: Prospective cohort study conducted between September 1992 and December 1996. SETTING: Fourteen Veterans Affairs hospitals. PATIENTS: Of the 3956 patients undergoing CABG surgery only and who were enrolled in the Processes, Structures, and Outcomes of Care in Cardiac Surgery study, the 2480 who completed a preoperative SF-36. MAIN OUTCOME MEASURE: All-cause mortality within 180 days after surgery. RESULTS: A total of 117 deaths (4.7%) occurred within 180 days of CABG surgery. The Physical Component Summary of the preoperative SF-36 was a statistically significant risk factor for 6-month mortality after adjustment for known clinical risk factors for mortality following CABG surgery. In multivariate analysis, a 10-point lower SF-36 Physical Component Summary score had an odds ratio (OR) of 1.39 (95% confidence interval [CI], 1.11-1.77; P=.006) for predicting mortality. The SF-36 Mental Component Summary score was not associated with 6-month mortality in multivariate analyses (OR, 1.09; 95% CI, 0.92-1.29; P=.31). CONCLUSIONS: The Physical Component Summary score from the preoperative SF-36 is an independent risk factor for mortality following CABG surgery. The baseline Mental Component Summary score does not appear to be predictive of mortality. Preoperative patient self-report of the physical component of health status may be helpful for risk stratification and clinical decision making for patients undergoing CABG surgery.