Stakeholder Engagement in a Patient-Reported Outcomes (PRO) Measure Implementation: A Report from the SAFTINet Practice-based Research Network (PBRN).

PURPOSE: Patient-reported outcome (PRO) measures offer value for clinicians and researchers, although priorities and value propositions can conflict. PRO implementation in clinical practice may benefit from stakeholder engagement methods to align research and clinical practice stakeholder perspectives. The objective is to demonstrate the use of stakeholder engagement in PRO implementation. METHOD: Engaged stakeholders represented researchers and clinical practice representatives from the SAFTINet practice-based research network (PBRN). A stakeholder engagement process involving iterative analysis, deliberation, and decision making guided implementation of a medication adherence PRO measure (the Medication Adherence Survey [MAS]) for patients with hypertension and/or hyperlipidemia. RESULTS: Over 9 months, 40 of 45 practices (89%) implemented the MAS, collecting 3,247 surveys (mean = 72, median = 30, range: 0 - 416). Facilitators included: an electronic health record (EHR) with readily modifiable templates; existing staff, tools and workflows in which the MAS could be integrated (e.g., health risk appraisals, hypertension-specific visits, care coordinators); and engaged leadership and quality improvement teams. CONCLUSION: Stakeholder engagement appeared useful for promoting PRO measure implementation in clinical practice, in a way that met the needs of both researchers and clinical practice stakeholders. Limitations of this approach and opportunities for improving the PRO data collection infrastructure in PBRNs are discussed.

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.

Identification of risk factors for increased cost, charges, and length of stay for cardiac patients.

BACKGROUND: In this study we explored different risk model options to provide clinicians with predictions for resource utilization. The hypotheses were that predictors of mortality are not predictive of resource consumption, and that there is a correlation between cost estimates derived using a cost-to-charge ratio or a product-line costing approach. METHODS: From March 1992 to June 1995, 2,481 University of Colorado Hospital patients admitted for ischemic heart disease were classified by diagnosis-related group code as having undergone or experienced coronary bypass procedures (CBP), percutaneous cardiovascular procedures (PCVP), acute myocardial infarction (AMI), and other cardiac-related discharges (Other). For each diagnosis-related group, Cox proportional hazards models were developed to determine predictors of cost, charges, and length of stay. RESULTS: The diagnosis groups differed in the clinical factors that predicted resource use. As the two costing methods were highly correlated, either approach may be used to assess relative resource consumption provided costs are reconciled to audited financial statements. CONCLUSIONS: To develop valid prediction models for costs of care, the clinical risk factors that are traditionally used to predict risk-adjusted mortality may need to be expanded.

Mild renal failure is associated with adverse outcome after cardiac valve surgery.

The present study was performed to ascertain whether the presence of mild renal failure (defined as a serum creatinine concentration of 1. 5 to 3.0 mg/dL) is an independent risk factor for adverse outcome after cardiac valve surgery. An extensive set of preoperative and postoperative data was collected in 834 prospectively evaluated patients undergoing cardiac valve surgery at 14 Veterans Affairs Medical Centers. Univariate and multivariable analyses were performed to determine whether an independent association of mild renal dysfunction with adverse outcomes was present. Patients with mild renal failure had significantly greater 30-day mortality rates (P = 0.001; 16% versus 6%) and frequency of postoperative bleeding (P = 0.023; 16% versus 8%), respiratory complications (P = 0.02, 29% versus 16%), and cardiac complications (P = 0.002; 18% versus 7%) than patients with normal renal function (serum creatinine <1.5 mg/dL) when controlling for multiple other variables. The presence of a serum creatinine concentration of 1.5 to 3.0 mg/dL is significantly and independently associated with adverse outcomes after cardiac valve surgery.

Stroke in cardiac surgical patients: determinants and outcome.

BACKGROUND: Despite improving outcomes in cardiac surgical patients, stroke continues to remain a major complication. Few prospective studies are available on postoperative stroke. The present study was conducted to elucidate the incidence and predictors of stroke in a large group of cardiac surgical patients. METHODS AND RESULTS: Prospective data collected on 4,941 patients undergoing cardiac surgery were subjected to univariate and logistic regression analyses (98.4% men; 72% older than 60 years; 9.1% with history of prior stroke; 80.4% underwent isolated coronary artery bypass grafting). Stroke predictors include history of stroke and hypertension, older age, systolic hypertension, bronchodilator and diuretic use, high serum creatinine, surgical priority, great vessel repair, use of inotropic agents after cardiopulmonary bypass, and total cardiopulmonary bypass time (p < 0.05 for all comparisons). Median intensive care unit and hospital stays were longer, and hospital mortality and 6-month mortality were higher for patients with stroke (p < 0.001). CONCLUSIONS: Stroke after cardiac surgical procedures is a morbid event. Identification of predictors and development of strategies to modify these factors should lead to a lower incidence of stroke.

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.

Renal failure predisposes patients to adverse outcome after coronary artery bypass surgery. VA Cooperative Study #5.

BACKGROUND: More than 600,000 coronary artery bypass graft (CABG) procedures are done annually in the United States. Some data indicate that 10 to 20% of patients who are undergoing a CABG procedure have a serum creatinine of more than 1.5 mg/dl. There are few data on the impact of a mild increase in serum creatinine concentration on CABG outcome. METHODS: We analyzed a Veterans Affairs database obtained prospectively from 1992 through 1996 at 14 of 43 centers performing heart surgery. We compared the outcome after CABG in patients with a baseline serum creatinine of less than 1.5 mg/dl (median 1.1 mg/dl, N = 3271) to patients with a baseline serum creatinine of 1.5 to 3.0 mg/dl (median 1.7, N = 631). RESULTS: Univariate analysis revealed that patients with a serum creatinine of 1.5 to 3.0 mg/dl had a higher 30-day mortality (7% vs. 3%, P < 0.001) requirement for prolonged mechanical ventilation (15% vs. 8%, P = 0.001), stroke (7% vs. 2%, P < 0.001), renal failure requiring dialysis at discharge (3% vs. 1%, P < 0.001), and bleeding complications (8% vs. 3%, P < 0.001) than patients with a baseline serum creatinine of less than 1.5 mg/dl. Multiple logistic regression analyses found that patients with a baseline serum creatinine of less than 1.5 mg/dl had significantly lower (P < 0.02) 30-day mortality and postoperative bleeding and ventilatory complications than patients with a serum creatinine of 1.5 to 3.0 mg/dl when controlling for all other variables. CONCLUSION: These results demonstrate that mild renal failure is an independent risk factor for adverse outcome after CABG.

Early extubation following cardiac surgery in a veterans population.

BACKGROUND: Early tracheal extubation is an important component of the "fast track" cardiac surgery pathway. Factors associated with time to extubation in the Department of Veterans Affairs (DVA) population are unknown. The authors determined associations of preoperative risk and intraoperative clinical process variables with time to extubation in this population. METHODS: Three hundred four consecutive patients undergoing coronary artery bypass graft, valve surgery, or both on a fast track clinical pathway between October 1, 1993 and September 30, 1995 at a university-affiliated DVA medical center were studied retrospectively. After univariate screening of a battery of preoperative risk and intraoperative clinical process variables, stepwise logistic regression was used to determine associations with tracheal extubation < or = 10 h (early) or > 10 h (late) after surgery. Postoperative lengths of stay, complications, and 30-day and 6-month mortality rates were compared between the two groups. RESULTS: One hundred forty-six patients (48.3%) were extubated early; one patient required emergent reintubation (0.7%). Of the preoperative risk variables considered, only age (odds ratio, 1.80 per 10-yr increment) and preoperative intraaortic balloon pump (odds ratio, 7.88) were multivariately associated with time to extubation (model R) ("late" association is indicated by an odds ratio >1.00; "early" association is indicated by an odds ratio <1.00). Entry of these risk variables into a second regression model, followed by univariately significant intraoperative clinical process variables, yielded the following associations (model R-P): age (odds ratio, 1.86 per 10-yr increment), sufentanil dose (odds ratio, 1.54 per 1-microg/kg increment), major inotrope use (odds ratio, 5.73), platelet transfusion (odds ratio, 10.03), use of an arterial graft (odds ratio, 0.32), and fentanyl dose (odds ratio, 1.45 per 10-microg/kg increment). Time of arrival in the intensive care unit after surgery was also significant (odds ratio, 1.42 per 1-h increment). Intraoperative clinical process variables added significantly to model performance (P < 0.001 by the likelihood ratio test). CONCLUSIONS: In this population, early tracheal extubation was accomplished in 48% of patients. Intraoperative clinical process variables are important factors to be considered in the timing of postoperative extubation after fast track cardiac surgery.

Independent association between acute renal failure and mortality following cardiac surgery.

PURPOSE: To determine whether there is an independent association of acute renal failure requiring dialysis with operative mortality after cardiac surgery. PATIENTS AND METHODS: The 42,773 patients who underwent coronary artery bypass or valvular heart surgery at 43 Department of Veterans Affairs Medical Centers between 1987 and 1994 were evaluated to determine the association between acute renal failure sufficient to require dialysis and operative mortality, with and without adjustment for comorbidity and postoperative complications. Crude and adjusted odds ratios (OR) and 95% confidence intervals (95% CI) were derived from logistic regression analysis. RESULTS: Acute renal failure occurred in 460 (1.1%) patients. Overall operative mortality was 63.7% in these patients, compared with 4.3% in patients without this complication. The unadjusted OR for death was 39 (95% CI 32 to 48). After adjustment for comorbid factors related to the development of acute renal failure (surgery type, baseline renal function, preoperative intraaortic balloon pump, prior heart surgery, NYHA class IV status, peripheral vascular disease, pulmonary rales, left ventricular ejection fraction below 35%, chronic obstructive pulmonary disease, systolic blood pressure, and the cross-product of systolic blood pressure and surgery type), the OR was 27 (95% CI 22 to 34). Further adjustment was made for seven postoperative complications (low cardiac output, cardiac arrest, perioperative myocardial infarction, prolonged mechanical ventilation, reoperation for bleeding or repeat cardiopulmonary bypass, stroke or coma, and mediastinitis), that were independently associated with operative mortality. The OR adjusted for comorbidity and postoperative complications associated with acute renal failure was 7.9 (95% CI 6 to 10). CONCLUSIONS: Acute renal failure was independently associated with early mortality following cardiac surgery, even after adjustment for comorbidity and postoperative complications. Interventions to prevent or improve treatment of this condition are urgently needed.

Time series monitors of outcomes. A new dimension for measuring quality of care.

OBJECTIVES: Despite the popularity of risk-adjusted outcomes as quality of health care indicators, their instability with time and their inability to provide reliable comparisons of small volume providers have raised questions about the feasibility and credibility of using these measures. In this article the authors describe a new analytic strategy to address these problems by examining risk-adjusted mortality with time, "Time Series Monitors of Outcome" (TSMO), and its application to cardiac surgery performed throughout the Department of Veterans Affairs between April 1987 and September 1992. METHODS: Expected operative mortality for 24,029 patients undergoing coronary artery bypass surgery at all 43 centers performing this procedure was estimated using a logistic regression model to adjust for patient-specific risk factors. The ratio of observed-to-expected operative mortality was calculated for each hospital for each of the 11 6-month periods. Poisson regression models were used to identify high and low outlier hospitals based on significant deviation from the 5.5 year overall mean and/or the individual hospital's trend of observed-to-expected ratios with time. RESULTS: This method identified four high and one low outlier hospitals based on significant deviations from the overall mean and three upward and seven downward trending outlier hospitals based on significant deviations in trend with time. A significant downward trend in observed-to-expected ratios of 4% per year also was observed for all coronary artery bypass graft procedures performed throughout the Department of Veterans Affairs during the last 5.5 year period. CONCLUSIONS: Time Series Monitors of Outcome should help reduce misclassification of outliers due to random variation in outcomes as well as provide more reliable comparative information from which to evaluate provider performance.

Atrial fibrillation after cardiac surgery: a major morbid event?

OBJECTIVE: The purpose of the study was to investigate the incidence, predictors, morbidity, and mortality associated with postoperative atrial fibrillation (AF) and its impact on intensive care unit (ICU) and postoperative hospital stay in patients undergoing cardiac surgery in the Department of Veterans Affairs (VA). SUMMARY BACKGROUND DATA: Postoperative AF after open cardiac surgery is rather common. The etiology of this arrhythmia and factors responsible for its genesis are unclear, and its impact on postoperative surgical outcomes remains controversial. The purpose of this special substudy was to elucidate the incidence of postoperative AF and the factors associated with its development, as well as the impact of AF on surgical outcome. METHODS: The study population consisted of 3855 patients who underwent open cardiac surgery between September 1993 and December 1996 at 14 VA Medical Centers. Three hundred twenty-nine additional patients were excluded because of lack of complete data or presence of AF before surgery, and 3794 (98.4%) were male with a mean age of 63.7+/-9.6 years. Operations included coronary artery bypass grafting (CABG) (3126, 81%), CABG + AVR (aortic valve replacement) (228, 5.9%), CABG + MVR (mitral valve replacement) (35, 0.9%), AVR (231, 6%), MVR (41, 1.06%), CABG + others (95, 2.46%), and others (99, 2.5%). The incidence of postoperative AF was 29.6%. Multivariate logistic regression analysis of factors found significant on univariate analysis showed the following predictors of postoperative AF: preoperative patient risk predictors: advancing age (odds ratio [OR] 1.61, 95% confidence interval [CI] 1.48-1.75, p < 0.001), chronic obstructive pulmonary disease (OR 1.37, 95% CI 1.12-1.66, p < 0.001), use of digoxin within 2 weeks before surgery (OR 1.37, 95% CI 1.10-1.70, p < 0.003), low resting pulse rate <80 (OR 1.26, 95% CI 1.06-1.51, p < 0.009), high resting systolic blood pressure >120 (OR 1.19, 95% CI 1.02-1.40, p < 0.026), intraoperative process of care predictors: cardiac venting via right superior pulmonary vein (OR 1.42, 95% CI 1.21-1.67, p < 0.0001), mitral valve repair (OR 2.86, 95% CI 1.72-4.73, p < 0.0001) and replacement (OR 2.33, 95% CI 1.55-3.55, p < 0.0001), no use of topical ice slush (OR 1.29, 95% CI 1.10-1.49, p < 0.0009), and use of inotropic agents for greater than 30 minutes after termination of cardiopulmonary bypass (OR 1.36, 95% CI 1.16-1.59, p < 0.0001). Postoperative median ICU stay (3.6 days AF vs. 2 days no AF, p < 0.001) and hospital stay (10 days AF vs. 7 days no AF, p < 0.001) were higher in AF. Morbid events, hospital mortality, and 6-month mortality were significantly higher in AF (p < 0.001): ICU readmission 13% AF vs. 3.9% no AF, perioperative myocardial infarction 7.41 % AF vs. 3.36% no AF, persistent congestive heart failure 4.57% AF vs. 1.4% no AF, reintubation 10.59% AF vs. 2.47% no AF, stroke 5.26% AF vs. 2.44% no AF, hospital mortality 5.95% AF vs. 2.95% no AF, 6-month mortality 9.36% AF vs. 4.17% no AF. CONCLUSIONS: Atrial fibrillation after cardiac surgery occurs in approximately one third of patients and is associated with an increase in adverse events in all measurable outcomes of care and increases the use of hospital resources and, therefore, the cost of care. Strategies to reduce the incidence of AF after cardiac surgery should favorably affect surgical outcomes and reduce utilization of resources and thus lower cost of care.

Fast-track cardiac surgery in a Department of Veterans Affairs patient population.

BACKGROUND: "Fast-track" (FT) cardiac surgery is popular in the private and university sectors. This study was designed to examine its safety and efficacy in the Department of Veterans Affairs elderly, male patient population, a population with multiple comorbid risk factors, often decreased social functioning, and impaired support systems. METHODS: Time to extubation, hospital length of stay, perioperative morbidity, and mortality were studied in two consecutive cohorts undergoing cardiac operations requiring cardiopulmonary bypass before (pre-FT: n = 255, January 1992 to September 1993) and after (FT: n = 304, October 1993 to October 1995) institution of an FT protocol at a university-affiliated teaching Department of Veterans Affairs medical center. Preoperative risk factors, including a Department of Veterans Affairs risk-adjusted estimate of operative mortality, and perioperative surgical and anesthetic processes of care were evaluated. RESULTS: The mean Department of Veterans Affairs risk estimate of perioperative mortality was not different between the pre-FT and FT cohorts (3.5% versus 3.7%, p = 0.13). In the FT cohort, median time to extubation decreased significantly (19.2 versus 10.2 hours; p < 0.001) along with median surgical intensive care unit stay (96 versus 49 hours; p < 0.001) and total postoperative length of stay (222 versus 167 hours; p < 0.001). Median postoperative day of hospital discharge decreased from day 10 to 7 (p < 0.001). One patient (0.3%) required emergent reintubation directly related to early extubation. Reintubation for medical reasons was unchanged between pre-FT and FT groups (6.3% versus 5.0%; p = 0.48). Postoperative morbidity was similar between groups except for nosocomial pneumonia, the rate of which decreased significantly in the FT cohort (14.7% versus 7.3%; p < 0.005). Thirty-day (3.9% versus 4.6%; p = 0.69) and 6-month mortality (6.7% versus 6.9%; p = 0.91) were unchanged. CONCLUSIONS: An FT cardiac surgery protocol has been instituted in a university-affiliated teaching Department of Veterans Affairs medical center, with decreased length of stay and no significant increase in postoperative morbidity, 30-day mortality, or 6-month mortality. It was associated with a lower rate of nosocomial pneumonia, a finding that must be validated in a prospective study.

Preoperative renal risk stratification.

BACKGROUND: After cardiac surgery, acute renal failure (ARF) requiring dialysis develops in 1% to 5% of patients and is strongly associated with perioperative morbidity and mortality. Prior studies have attempted to identify predictors of ARF but have had insufficient power to perform multivariable analyses or to develop risk stratification algorithms. METHODS AND RESULTS: We conducted a prospective cohort study of 43 642 patients who underwent coronary artery bypass or valvular heart surgery in 43 Department of Veterans Affairs medical centers between April 1987 and March 1994. Logistic regression analysis was used to identify independent predictors of ARF requiring dialysis. A risk stratification algorithm derived from recursive partitioning was constructed and was validated on an independent sample of 3795 patients operated on between April and December 1994. The overall risk of ARF requiring dialysis was 1.1%. Thirty-day mortality in patients with ARF was 63.7%, compared with 4.3% in patients without ARF. Ten clinical variables related to baseline cardiovascular disease and renal function were independently associated with the risk of ARF. A risk stratification algorithm partitioned patients into low-risk (0.4%), medium-risk (0.9% to 2.8%), and high-risk (> or = 5.0%) groups on the basis of several of these factors and their interactions. CONCLUSIONS: The risk of ARF after cardiac surgery can be accurately quantified on the basis of readily available preoperative data. These findings may be used by physicians and surgeons to provide patients with improved risk estimates and to target high-risk subgroups for interventions aimed at reducing the risk and ameliorating the consequences of this serious complication.

Identification of preoperative variables needed for risk adjustment of short-term mortality after coronary artery bypass graft surgery. The Working Group Panel on the Cooperative CABG Database Project.

OBJECTIVES: The purpose of this consensus effort was to define and prioritize the importance of a set of clinical variables useful for monitoring and improving the short-term mortality of patients undergoing coronary artery bypass graft surgery (CABG). BACKGROUND: Despite widespread use of data bases to monitor the outcome of patients undergoing CABG, no consistent set of clinical variables has been defined for risk adjustment of observed outcomes for baseline differences in disease severity among patients. METHODS: Experts with a background in epidemiology, biostatistics and clinical care with an interest in assessing outcomes of CABG derived from previous work with professional societies, government or academic institutions volunteered to participate in this unsponsored consensus process. Two meetings of this ad hoc working group were required to define and prioritize clinical variables into core, level 1 or level 2 groupings to reflect their importance for relating to short-term mortality after CABG. Definitions of these 44 variables were simple and specific to enhance objectivity of the 7 core, 13 level 1 and 24 level 2 variables. Core and level 1 variables were evaluated using data from five existing data bases, and core variables only were examined in an additional two data bases to confirm the consensus opinion of the relative prognostic power of each variable. RESULTS: Multivariable logistic regression models of the seven core variables showed all to be predictive of bypass surgery mortality in some of the seven existing data sets. Variables relating to acuteness, age and previous operation proved to be the most important in all data sets tested. Variables describing coronary anatomy appeared to be least significant. Models including both the 7 core and 13 level 1 variables in five of the seven data sets showed the core variables to reflect 45% to 83% of the predictive information. However, some level 1 variables were stronger than some core variables in some data sets. CONCLUSIONS: A relatively small number of clinical variables provide a large amount of prognostic information in patients undergoing CABG.

Calculating risk and outcome: the Veterans Affairs database.

The methodology used by the Department of Veterans Affairs for data collection and analysis to derive observed/expected mortality ratios in cardiac surgical patients is reviewed. The Department of Veterans Affairs' use of univariate and multivariate analysis to develop risk ratios for individual risk factors is described. Its experience with tracking observed/expected mortality and morbidity associated with cardiac surgery and length of hospital stays is reviewed. Results of the Department of Veterans Affairs study of the relationship between hospital surgical volume and observed/expected ratios are reported. Feasible goals for the improvement of the predictive capability of database models and the limitations affecting model accuracy are discussed.

No continuous relationship between Veterans Affairs hospital coronary artery bypass grafting surgical volume and operative mortality.

BACKGROUND: The purpose of this study was to determine whether risk-adjusted coronary artery bypass grafting mortality rates are significantly related to coronary artery bypass grafting surgical procedure volume within the Department of Veterans Affairs hospital system. METHODS: From April 1987 to September 1992, expected mortality rates were calculated for 23,986 coronary artery bypass grafting procedures performed at 44 different Veterans Affairs hospitals. RESULTS: This study found a statistically significant relationship between annual hospital coronary artery bypass grafting volume and observed mortality rates (p < 0.02). However, no statistically significant relationship between coronary artery bypass grafting volume and risk-adjusted operative mortality was found (p = 0.10). Using analysis of variance on hospital-level data, hospitals with 100 or less cases per year have higher observed to expected mortality ratios than hospitals performing more than 100 cases per year (p = 0.03). Using Poisson regression models, however, a volume threshold could not be found. CONCLUSIONS: These findings are consistent with the current Veterans Affairs policy requirements to periodically review quality at low-volume hospitals.

Quality initiatives and the power of the database: what they are and how they run.

The criteria by which healthcare is judged or measured are quality, accessibility, and cost effectiveness. To evaluate these criteria it is important to have a database. There are many strengths and weakness to large databases. They can be used as an indicator of the level of performance or quality, for clinical decision making, and as a measurement of cost effectiveness. They can also be useful in the evaluation and development of treatment algorithms and critical pathways for patients with entry level disease. In addition, they can measure patient access to healthcare and the appropriateness of care. It is important for these databases to appropriately adjust for preoperative risk factors that may influence outcome. Outcome in most of the databases is measured by mortality, but morbidity, functional status, quality of life, cost of care, length of stay, return to work, and patient satisfaction are also important outcomes. Factors that can influence the quality of the outcome data are the methods by which the data are collected, standardization of definitions, the currentness of the database, adequate numbers of patients and outcomes, and appropriate analytic techniques. It is important to feed back the data to the healthcare providers in a timely enough fashion so that processes and structures of care can be modified to improve treatment and results. The reliability of the databases and the validity must be substantiated for the healthcare provider to have confidence in the database.(ABSTRACT TRUNCATED AT 250 WORDS)

The Processes, Structures, and Outcomes of Care in Cardiac Surgery study protocol.

Recently, a growing interest has arisen in defining and measuring health care outcomes. Although outcome measures may be used as potential quality-of-care screens, outcomes cannot indicate directly how care might be improved. Thus, the Processes, Structures, and Outcomes of Care in Cardiac Surgery (PSOCS) study was designed to investigate the linkages between the processes and structures of care with risk-adjusted outcomes for cardiac surgery care. Data are being collected on a comprehensive array of risk factors, processes, structures, and outcomes of care at 14 Veterans Affairs Medical Centers for this prospective, observational study. Approximately 6,000 cardiac surgery patients will be enrolled in this study over a 4.5-year period. Patient selection is based on a 6 workday rotating sampling frame with an oversampling of emergent patients. During the study, a register of all patients undergoing cardiac surgery at these centers is being maintained to assess the overall context of patient recruitment. The study will continue to enroll patients through December 1996. Major study end points extend beyond traditional measures of 30-day mortality and morbidity to encompass more innovative intermediate outcome measures, including changes in physical functional status and health-related quality of life.