Gender dysphoria and gender-affirming surgery: The New York state experience.

BACKGROUND: Transgender and gender nonconforming (TGNC) individuals experience incongruence between their self-identified gender versus their birth-assigned sex. In some cases, TGNC patients undergo gender-affirming surgical (GAS) procedures. Although GAS is an evolving surgical field, there is currently limited literature documenting patient characteristics and procedures. Addressing this knowledge gap, this retrospective cohort analysis described the characteristics of New York State's TGNC residents with gender dysphoria (GD) diagnosis, including patients undergoing at least one gender-affirming surgical procedure. METHODS: Using the New York Statewide Planning and Research Cooperative System (SPARCS) database from 2002 to 2018, we identified patients' first-time TCNC records and their risk characteristics. Patients who received GAS procedures were sub-classified as top-only, bottom-only, or combined top/bottom procedures and were compared with TGNC patients who did not receive GAS. RESULTS: Of 24,615 records extracted from TGNC SPARCS database, 11,427 (46.4%) were transmasculine (female-to-male) and 13,188 (53.6%) were transfeminine (male-to-female). Overall, 2.73% of transgender patients received at least one GAS procedure. Of these patients, 78.2% had masculinizing and 21.8% had feminizing surgeries. After a diagnosis of GD, the positive predictors for a GAS-based procedure included female birth sex, pediatric age (<18 years) or older age (60+ years), commercial insurance coverage, and Hispanic race. In contrast, negative GAS predictors included male birth sex and government insurance coverage (i.e., Medicare and Medicaid). CONCLUSIONS: Compared with transgender women, transgender men were more likely to receive at least one GAS procedure. Because the race, ethnicity, and payor status of TGNC patients can impact GAS treatment rates, additional research is warranted to examine post-diagnosis GAS treatment disparities among TGNC patients.

New-onset postoperative atrial fibrillation impact on 5-year clinical outcomes and costs.

OBJECTIVE: The impact of new-onset postoperative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) surgery on long-term clinical outcomes and costs is not known. This subanalysis of the Veterans Affairs "Randomized On/Off Bypass Follow-up Study" compared 5-year outcomes and costs between patients with and without POAF. METHODS: Of the 2203 veterans in the study, 100 with pre-CABG atrial fibrillation (93) or missing data (7) were excluded (4.8%). Unadjusted and risk-adjusted outcomes were compared between new-onset POAF (n = 551) and patients without POAF (n = 1552). Five-year clinical outcomes included mortality, major adverse cardiovascular events (MACE, comprising mortality, repeat revascularization, and myocardial infarction), MACE subcomponents, stroke, and costs. A stringent P value of ≤.01 was required to identify statistical significance. RESULTS: Patients with POAF were older and had more complex comorbidities. Unadjusted 5-year all-cause mortality was 16.3% POAF versus 11.9% no-POAF, P = .008. Unadjusted cardiac-mortality was 7.4% versus 4.8%, P = .022. There were no differences between groups in any other unadjusted outcomes including MACE or stroke. After risk adjustment, there were no significant differences between groups in 5-year all-cause mortality (POAF odds ratio, 1.19; 99% confidence interval, 0.81-1.75) or cardiac mortality (odds ratio, 1.51, 99% confidence interval, 0.88-2.60). Adjusted first-year post-CABG costs were $15,300 greater for patients with POAF, but 2- through 5-year costs were similar. CONCLUSIONS: No 5-year risk-adjusted outcome differences were found between patients with and without POAF after CABG. Although first-year costs were greater in patients with POAF, this difference did not persist in subsequent years.

Regional variations in cardiovascular risk factors and access to care among US veterans with cardiovascular disease.

BACKGROUND: It remains unclear whether cardiovascular risk factors and access to healthcare for veterans with cardiovascular disease (CVD) vary among US regions. This study sought to determine the extent of regional variations in cardiovascular risk factors and access to medical care in a cohort of veterans with CVD in the USA. METHODS: The 2016 Centers for Disease Control Behavioral Risk Factor Surveillance Survey was utilized to identify a cohort of veteran patients with CVD. Participants were classified based on four US regions: (1) Northeast, (2) Midwest, (3) South, and (4) West. We compared demographic data, medical history, and access to care for veterans of each US region. The outcomes of interest included financial barriers to medical care and annual medical checkup. RESULTS: Among the 13 835 veterans, 18.3% were from the Northeast, while 23.5, 37.1, and 21.1% were from the Midwest, South, and West, respectively. Veterans of each region differed significantly with respect to demographic characteristics, prior medical history, and access to care. Rates of financial barriers to medical care were similar across the four regions (7.3 vs. 7.1 vs. 8.0 vs. 6.9%, P = 0.203). Veterans from the West had the lowest rates of medical checkup within the past year (91.7 vs. 89.5 vs. 91.4 vs. 86.6%). On multivariate analysis, the Midwest [odds ratio (OR) 0.69; 95% CI, 0.53-0.89] and West (OR 0.53; 95% CI 0.41-0.68) regions were independently associated with lower rates of medical checkup within the past year compared to the Northeast. CONCLUSIONS: In this observational study involving US veterans with CVD, cardiovascular risk factors and frequency of annual medical checkup differed amongst each US region. Further large-scale studies examining the prevalence of impaired access to care and quality of care in US veterans with CVD are warranted.

Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.

Costs Five Years After Off-Pump or On-Pump Coronary Artery Bypass Surgery.

BACKGROUND: Coronary artery bypass grafting (CABG) is a common surgical treatment for ischemic heart disease. Little is known about the long-term costs of conducting the surgery on-pump or off-pump. METHODS: As part of the Randomized On/Off Bypass follow-up study, we followed 2,203 participants randomized to on-pump (n = 1,099) and off-pump (n = 1,104) CABG for 5 years using Department of Veterans Affairs and Medicare administrative data. We examined annual costs through 5 years, standardized to 2016 dollars, using multivariate regression models, controlling for site and baseline patient factors. RESULTS: In the first year, including the CABG surgery, annual average costs were $66,599 (SE, $1,946) for the on-pump group and $70,552 (SE, $1,954) for the off-pump group. In years 2 to 5, average costs ranged from $15,000 to $20,000 per year. There was no significant difference between on-pump and off-pump across the 5 years. We explored differences among high-risk subgroups (diabetes, chronic obstructive pulmonary disease, peripheral vascular disease, cerebrovascular disease, renal dysfunction, ejection fraction < 35%, over age 70 years), and found no treatment assignment by time interactions, except for a nonsignificant trend in patients with diabetes. CONCLUSIONS: At 5 years, the average costs of off-pump and on-pump CABG patients did not statistically differ. Costs do not favor one approach and the decision should be based on clinical risks, especially in subgroups. Future research is warranted to examine post-CABG costs and outcomes for diabetic patients over time.

Comparison of Outcomes and Costs Associated With Aspirin ± Clopidogrel After Coronary Artery Bypass Grafting.

Optimal antiplatelet therapy after coronary artery bypass graft (CABG) surgery remains controversial. This study evaluated the role of dual antiplatelet therapy using aspirin and clopidogrel (DAPT) versus antiplatelet therapy using aspirin only (ASA) on post-CABG clinical outcomes and costs. In the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) trial, clopidogrel use after CABG was prospectively collected beginning in year 2 of this study to include 1,525 of the 2,203 original ROOBY patients who received aspirin after CABG. Discretionarily, surgeons after CABG administered either DAPT or ASA treatments. The ROOBY trial's primary 30-day composite (mortality or perioperative morbidity), 1-year composite (all-cause death, repeat revascularization, or nonfatal myocardial infarction), and costs were compared for these 2 strategies. Of the 1,525 subjects, 511 received DAPT and 1,014 received ASA. DAPT subjects, compared with ASA subjects, had lower rates of preoperative left ventricular ejection fraction of ≥45% (78.8% vs 85.7%, p <0.001), on-pump CABG (36.6% vs 57.1%, p = 0.001), and endoscopic vein harvesting (30.0% vs 42.8%, p <0.001). ASA patients were more likely to have earlier aspirin administration and receive 325 versus 81 mg dosages. The 30-day composite outcome rate was significantly lower for DAPT patients compared with ASA patients (3.3% vs 7.1%, p = 0.003), but the 1-year composite outcome was equal between the 2 groups (12.0% vs12.0%, p = 1.0). At 1 year, there were no cost differences between the 2 groups. Propensity analyses did not significantly alter the results. In conclusion, DAPT appeared safe and was associated with fewer 30-day adverse outcomes than aspirin only and with no 1-year outcome or cost differences.

Long-Term Post-CABG Survival: Performance of Clinical Risk Models Versus Actuarial Predictions.

BACKGROUND/AIM: Clinical risk models are commonly used to predict short-term coronary artery bypass grafting (CABG) mortality but are less commonly used to predict long-term mortality. The added value of long-term mortality clinical risk models over traditional actuarial models has not been evaluated. To address this, the predictive performance of a long-term clinical risk model was compared with that of an actuarial model to identify the clinical variable(s) most responsible for any differences observed. METHODS: Long-term mortality for 1028 CABG patients was estimated using the Hannan New York State clinical risk model and an actuarial model (based on age, gender, and race/ethnicity). Vital status was assessed using the Social Security Death Index. Observed/expected (O/E) ratios were calculated, and the models' predictive performances were compared using a nested c-index approach. Linear regression analyses identified the subgroup of risk factors driving the differences observed. RESULTS: Mortality rates were 3%, 9%, and 17% at one-, three-, and five years, respectively (median follow-up: five years). The clinical risk model provided more accurate predictions. Greater divergence between model estimates occurred with increasing long-term mortality risk, with baseline renal dysfunction identified as a particularly important driver of these differences. CONCLUSIONS: Long-term mortality clinical risk models provide enhanced predictive power compared to actuarial models. Using the Hannan risk model, a patient's long-term mortality risk can be accurately assessed and subgroups of higher-risk patients can be identified for enhanced follow-up care. More research appears warranted to refine long-term CABG clinical risk models.

Postoperative atrial fibrillation impacts on costs and one-year clinical outcomes: the Veterans Affairs Randomized On/Off Bypass Trial.

BACKGROUND: New-onset postoperative atrial fibrillation (POAF) after coronary artery bypass graft surgery (CABG) is associated with worse in-hospital morbidity and mortality, extended hospital stays, and higher costs. Beyond the initial hospital discharge, the cost and outcomes of POAF have not been well studied. METHODS: For CABG patients with and without new-onset POAF, a retrospective propensity-matched, multivariable regression analysis was performed to compare 1-year outcomes (including health-related quality of life [HRQoL] scores and mortality rates) and costs (standardized to 2010 dollars). Regression models controlled for site and patient factors, with propensity matching used to adjust for differences in POAF versus no-POAF patients' risk profiles. RESULTS: Using the existing CABG trial database, 2,096 patient records were analyzed, including POAF patients (n = 549) versus no-POAF patients (n = 1,547). For the index CABG hospitalization, POAF patients had longer postoperative length of stay (+3.9 days) and higher discharge costs (+$13,993) than no-POAF patients. At 1 year, POAF patients had more than twice the adjusted odds of dying (p < 0.01), with higher 1-year total cumulative costs. This 1-year cost difference (+$15,593) was largely attributable to hospital-based costs during the index surgery hospitalization. There was no difference in 1-year HRQoL scores (or HRQoL score changes) between POAF patients and no-POAF patients. CONCLUSIONS: Compared with no-POAF patients, POAF patients had higher discharge and 1-year costs along with higher 1-year mortality rates, but no differences were observed in 1-year HRQoL scores. Additional research appears warranted to improve the longer-term survival rates for POAF CABG patients, targeting future POAF-specific postdischarge interventions.

Long-term mortality rates (>8-year) improve as compared to the general and obese population following bariatric surgery.

INTRODUCTION: Sparse data are available on long-term patient mortality following bariatric surgery as compared to the general population. The purpose of this study was to assess long-term mortality rates and identify risk factors for all-cause mortality following bariatric surgery. METHODS: New York State (NYS) Planning and Research Cooperative System (SPARCS) longitudinal administrative data were used to identify 7,862 adult patients who underwent a primary laparoscopic bariatric surgery from 1999 to 2005. The Social Security Death Index database identified >30-day mortalities. Risk factors for mortality were screened using a univariate Cox proportional hazard (PH) model and analyzed using a multiple PH model. Based on age, gender, and race/ethnicity, actuarial projections for NYS mortality rates obtained from Centers of Disease Control were compared to the actual post-bariatric surgery mortality rates observed. RESULTS: The mean bariatric mortality rate was 2.5 % with 8-14 years of follow-up. Mean time to death ranged from 4 to 6 year and did not differ by operation (p = 0.073). From 1999 to 2010, the actuarial mortality rate predicted for the general NYS population was 2.1 % versus the observed 1.5 % for the bariatric surgery population (p = 0.005). Extrapolating to 2013, demonstrated the actuarial mortality predictions at 3.1 % versus the bariatric surgery patients' observed morality rate of 2.5 % (p = 0.01). Risk factors associated with an earlier time to death included: age, male gender, Medicare/Medicaid insurance, congestive heart failure, rheumatoid arthritis, pulmonary circulation disorders, and diabetes. No procedure-specific or perioperative complication impact for time-to-death was found. CONCLUSION: Long-term mortality rate of patients undergoing bariatric surgery significantly improves as compared to the general population regardless of bariatric operation performed. Additionally, perioperative complications do not increase long-term mortality risk. This study did identify specific patient risk factors for long-term mortality. Special attention and consideration should be given to these "at risk" patient sub-populations.

Comparing off-pump and on-pump clinical outcomes and costs for diabetic cardiac surgery patients.

BACKGROUND: Observational studies have documented an off-pump over on-pump advantage for high-risk patients, including diabetic patients. Randomized trials have not confirmed this advantage. The VA Randomization On Versus Off Bypass (ROOBY) trial randomly assigned 2,203 coronary artery bypass graft surgery (CABG) patients at 18 sites to either on-pump (n=1,099) or off-pump (n=1,104) procedures. An a priori ROOBY aim was to evaluate treatment impact on diabetic patients. METHODS: Actively treated diabetic patients (n=835, receiving oral hypoglycemic or insulin medications) received off-pump CABG (n=402) or on-pump CABG (n=433). The primary ROOBY trial endpoints were a short-term composite (30-day operative death or major complications) and a 1-year composite (death, nonfatal acute myocardial infarction, or repeat revascularization). Secondary ROOBY endpoints included 1-year all-cause death, 1-year graft patency, 1-year changes from baseline in neurocognitive status and health-related quality of life, and costs. RESULTS: Diabetic patients' risk factors at baseline were balanced across treatments. For diabetic patients, the primary short-term composite outcome rate showed a worse trend for off-pump (8.0%) than on-pump (3.9%, p=0.013), with no difference in the 1-year primary composite outcome or 1-year death rate. One-year patency was 83.1% off-pump versus 88.4% on-pump (p=0.004). No differences were found in neurocognitive, health-related quality of life, discharge cost, and 1-year cumulative cost. CONCLUSIONS: Concordant with the ROOBY trial's overall findings, off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients. The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG, with no other significant outcome or cost differences.

On-pump versus off-pump coronary artery bypass surgery: cost-effectiveness analysis alongside a multisite trial.

BACKGROUND: Questions have been raised about the costs and outcomes for patients receiving on-pump and off-pump coronary artery bypass graft surgery. As part of the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) multisite trial, a cost-effectiveness analysis was performed to compare on-pump versus off-pump patients' quality-adjusted life-years and costs at 1 year. METHODS: One-year outcomes and costs (standardized to 2010 dollars) were estimated in multivariate regression models, controlling for site and baseline patient factors. The 1-year incremental cost-effectiveness analysis ratio with 95% confidence intervals was calculated using bootstrapping. RESULTS: Eighteen centers randomly assigned 2,203 participants to on-pump (n=1,099) versus off-pump (n=1,104) coronary artery bypass graft surgery. Both groups' quality of life improved significantly after surgery (p<0.01) compared with baseline, but no differences were found between treatment groups. Adjusted cost of the index coronary artery bypass graft surgery hospitalization was $36,046 on-pump and $36,536 off-pump (p=0.16). At 1 year, on-pump adjusted cost was $56,023 versus $59,623 off-pump (p=0.046). Off-pump-to-on-pump conversions after first distal anastomosis (4.8%) had significantly higher 1-year costs. Excluding conversions, there were no significant differences between treatments for index hospitalization or 1-year total costs. CONCLUSIONS: At 1 year, off-pump coronary artery bypass graft surgery was more expensive than on-pump when late off-pump-to-on-pump conversions were included. Excluding late conversions, there was no difference in quality-adjusted life-years or costs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00032630; http://clinicaltrials.gov/ct2/show/NCT00032630.

Report from a quality assurance program on patients undergoing the MILD procedure.

OBJECTIVES: To characterize trends in pain and functional outcomes and identify risk factors in patients with lumbar spinal stenosis (LSS) and neurogenic claudication undergoing the "Minimally Invasive Lumbar Decompression" (MILD) procedure. DESIGN: Retrospective observational cohort study. SETTING: Academic multidisciplinary pain center at Stony Brook Medicine. SUBJECTS: Patients undergoing the MILD procedure from October 2010 to November 2012. METHODS: De-identified perioperative, pain and function related data for 50 patients undergoing MILD were extracted from the Center for Pain Management's quality assessment database. Data included numerical rating scale (NRS), symptom severity and physical function (Zurich Claudication Questionnaire), functional status (Oswestry Disability Index [ODI]), pain interference scores (National Institutes of Health Patient-Reported Outcomes Measurement Information System [PROMIS]), and patients' self-reported low back and lower extremity pain distribution. RESULTS: No MILD patient incurred procedure-related complications. Average NRS scores decreased postoperatively and 64.3% of patients reported less pain at 3 months. Clinically meaningful functional ODI improvements of at least 20% from baseline were present in 25% of the patients at 6 months. Preliminary analysis of changes in PROMIS scores at 3 months revealed that pre-MILD "severe" lumbar canal stenosis may be associated with high risk of "no improvement." No such impact was observed for NRS or ODI outcomes. CONCLUSION: Overall, pain is reduced and functional status improved in LSS patients following the MILD procedure at 3 and 6 months. Given the small sample size, it is not yet possible to identify patient subgroups at risk for "no improvement." Continued follow-up of longer-term outcomes appears warranted to develop evidence-based patient selection criteria.

Clinical science training at the University of Colorado: a measurement of trainee satisfaction.

BACKGROUND: Clinical science (CLSC) research education differs from basic science education in that many CLSC programs have an added goal of creating successful academicians. CLSC programs have expanded curricula that include teaching career development techniques, such as manuscript and grant writing, and helping young investigators establish successful mentor-mentee relationships. METHODS: A group of K30 CLSC training program students coordinated a pilot survey to determine if the CLSC training programs at the University of Colorado were meeting the needs of the participants in both didactic courses and in other aspects of academic medicine, including research. The small group survey was conducted as part of a clinical outcomes assessment course. Opportunities for improvement in the CLSC training programs were explored based on the results. RESULTS: Of 117 CLSC training program participants surveyed, 56% responded. Overall, there was a positive improvement found for the didactic CLSC research constructs. Participants also reported success in manuscript publication and grant writing applications. The CLSC program, however, was not successful in coordinating faculty mentor support for student research projects for 78% of respondents. Once a mentoring relationship was established, students were satisfied with the mentoring they received. CONCLUSION: In general, CLSC trainees were satisfied that the K30 clinical research curriculum was meeting their needs. Many of the trainees were successful in developing academic skills during the program. Establishing a mentor relationship was the missing ingredient within the K30 CLSC training program. This may be an important component that should be considered when developing programs to create the next generation of clinician-scientists.

Updated evaluation of the cost-effectiveness of lung volume reduction surgery.

BACKGROUND: The National Emphysema Treatment Trial, a randomized clinical trial of lung volume reduction surgery (LVRS) vs medical therapy for severe emphysema, included a prospective economic analysis. We present an updated analysis of cost-effectiveness with 1-year additional follow-up data. METHODS: Following pulmonary rehabilitation, 1,218 patients at 17 medical centers were randomized to receive LVRS or continued medical treatment. The cost-effectiveness of LVRS vs medical therapy was calculated over the duration of the trial (January 1998 to December 2003) and estimated at 10 years using modeling based on observed trends in survival, cost, and quality of life. RESULTS: The cost-effectiveness of LVRS vs medical therapy was $140,000 per quality-adjusted life-year (QALY) gained (95% confidence interval, $40,155 to $239,359) at 5 years, and was projected to be $54,000 per QALY gained at 10 years. In subgroup analysis, the cost-effectiveness of LVRS in patients with upper-lobe emphysema and low exercise capacity was $77,000 per QALY gained at 5 years, and was projected to be $48,000 per QALY at 10 years. Compared to the initial results, the updated results are similar for the overall cohort but vary substantially for the subgroups. CONCLUSIONS: LVRS is costly relative to other health-care programs during the time horizon when costs and outcomes are known. The extended follow-up period offers more certainty regarding the long-term value and economic impact of this procedure.

A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial.

BACKGROUND: Since the late 1960s, coronary artery bypass graft (CABG-only) procedures were traditionally performed using a heart-lung machine on an arrested heart (on-pump). Over the past decade, an increasing number CABG-only procedures were performed on a beating heart (off-pump). Advocates of the off-pump approach expect to reduce many of the adverse side effects related to using the heart-lung machine, while advocates for the on-pump procedure raise concerns related to graft patency rates and long-term event-free survival for the off-pump technique. PURPOSE: The U.S. Department of Veteran Affairs (VA) Cooperative Studies Program funded a randomized, multicenter clinical trial comparing the clinical and resource-related outcomes following on-pump versus off-pump techniques for veterans undergoing a non-emergent CABG-only procedure. The planning committee was faced with several critically important challenges to assure feasibility of study costs and required sample size; generalizability to non-VA surgical practices; and comparability of clinically meaningful results. These challenges are discussed. METHODS: This study is a prospective, randomized, multicenter, single blinded (patient) clinical trial that compares on-pump and off-pump techniques for veterans requiring non-emergent CABG-only procedures. There will be 2200 patients randomized at 17 VA Medical Centers when the five-year recruitment period ends on 15 April 2007. There are two primary objectives: a short-term objective to assess the immediate impact of the two techniques on 30-day mortality/morbidity and a long-term objective to assess one-year mortality/morbidity. Major secondary outcomes are one-year graft patency rates and change in neuropsychological assessments from baseline to one year. All patients are assessed at 30 days post-surgery or discharge from the hospital, whichever is latest, and at one-year post-surgery. RESULTS: During planning, several key issues had to be decided. These included 1) choosing primary objectives: a short-term (30-day) and a long-term (one-year) objective were chosen; 2) choosing primary outcome measures: composite measures were selected to ensure sufficient end-points; 3) standardization of surgical techniques: minimal standardization required but guidelines and continuing discussions on both techniques provided; 4) establishing criteria for surgeons and residents for participation: surgeons required to have completed 20 off-pump procedures prior to doing study procedures and residents, in presence of study surgeon, capable of doing either procedure; 5) identifying metrics of cognitive dysfunction sensitive to treatment: a neuropshychologist hired who centrally monitors cognitive functioning testing; and 6) blinding participants of surgical procedure: attempt to blind participants. LIMITATIONS: Areas of concern are whether all surgeons sufficiently experienced on the off-pump procedure, should residents have been allowed to do study surgeries, should techniques have been standardized more and were the best neurocognitive tests selected. CONCLUSION: The study design presented allows for a balanced and fair assessment of the on-pump and off-pump CABG procedures across a diversity of clinical outcomes and resource use metrics. Its results have the potential to influence clinical cardiac surgical practice in the future.

Mortality after cardiac bypass surgery: prediction from administrative versus clinical data.

BACKGROUND: Risk-adjusted outcome rates frequently are used to make inferences about hospital quality of care. We calculated risk-adjusted mortality rates in veterans undergoing isolated coronary artery bypass surgery (CABS) from administrative data and from chart-based clinical data and compared the assessment of hospital high and low outlier status for mortality that results from these 2 data sources. STUDY POPULATION: We studied veterans who underwent CABS in 43 VA hospitals between October 1, 1993, and March 30, 1996 (n=15,288). METHODS: To evaluate administrative data, we entered 6 groups of International Classification of Diseases (ICD)-9-CM codes for comorbid diagnoses from the VA Patient Treatment File (PTF) into a logistic regression model predicting postoperative mortality. We also evaluated counts of comorbid ICD-9-CM codes within each group, along with 3 common principal diagnoses, weekend admission or surgery, major procedures associated with CABS, and demographic variables. Data from the VA Continuous Improvement in Cardiac Surgery Program (CICSP) were used to create a separate clinical model predicting postoperative mortality. For each hospital, an observed-to-expected (O/E) ratio of mortality was calculated from (1) the PTF model and (2) the CICSP model. We defined outlier status as an O/E ratio outside of 1.0 (based on the hospital's 90% confidence interval). To improve the statistical and predictive power of the PTF model, selected clinical variables from CICSP were added to it and outlier status reassessed. RESULTS: Significant predictors of postoperative mortality in the PTF model included 1 group of comorbid ICD-9-CM codes, intraortic balloon pump insertion before CABS, angioplasty on the day of or before CABS, weekend surgery, and a principal diagnosis of other forms of ischemic heart disease. The model's c-index was 0.698. As expected, the CICSP model's predictive power was significantly greater than that of the administrative model (c=0.761). The addition of just 2 CICSP variables to the PTF model improved its predictive power (c=0.741). This model identified 5 of 6 high mortality outliers identified by the CICSP model. Additional CICSP variables were statistically significant predictors but did not improve the assessment of high outlier status. CONCLUSIONS: Models using administrative data to predict postoperative mortality can be improved with the addition of a very small number of clinical variables. Limited clinical improvements of administrative data may make it suitable for use in quality improvement efforts.

Relationship between processes of care and coronary bypass operative mortality and morbidity.

BACKGROUND: Information is limited regarding the effects of processes of care on cardiac surgical outcomes. Correspondingly, many recommended cardiac surgical processes of care are derived from animal experiments or clinical judgment. This report from the VA Cooperative Study in Health Services, "Processes, Structures, and Outcomes of Cardiac Surgery," focuses on the relationships between 3 process groups (preoperative evaluation, intraoperative care, and supervision by senior physicians) and a composite outcome, perioperative mortality and morbidity. METHODS: Data on 734 risk, process, and structure variables were collected prospectively on 3,988 patients who underwent coronary artery bypass grafting at 14 VA medical centers between 1992 and 1996. Data reduction was accomplished by examining data completeness and variation across sites and surgeon, using previously published data and clinical judgment. We then applied multivariable logistic regression to the 39 remaining processes of care to determine which were related to the composite outcome after adjusting for 17 patient-related risk factors and controlling for intraoperative complications. RESULTS: Our first analysis showed several measures of operative duration, the use of inotropic agents, transesophageal echo, lowest systemic temperature, and hemoconcentration/ultrafiltration, to be powerful predictors of the composite outcome. Because the use of inotropic agents and operative duration may be related to an intermediate outcome (eg, intraoperative complications), we performed a second analysis omitting these processes. The use of intraoperative transesophageal echo and hemoconcentration/ultrafiltration remained significantly associated with an increased risk of an event (odds ratios 1.60 and 1.36, respectively). CONCLUSIONS: Our results viewed in the context of past studies suggest the possibility that inotropic use, TEE, and hemoconcentration/ultrafiltration may have adverse effects on operative outcome. Further evaluation of these processes of care using observational data, as well as randomized trials when feasible, would be of interest.