RESPOND TO STROKE SYMPTOMS. G. Kefalas 1 , S. Hazelett 1 , K. Hua 2 , K.R. Allen 1 , G.C. Wickstrom 3 ; 1 Summa Health System, Akron, OHIO; 2 Northeastern Ohio Universities College of Medicine, Rootstown, OHIO; 3 Summa Health System, Akron, OH PURPOSE: Lack of knowledge of stroke signs and symptoms is prevalent, even among stroke survivors. This lack of knowledge can translate into a delay in seeking treatment at the onset of stroke symptoms. Such delays limit the effectiveness of current treatments for stroke. It is assumed that the education stroke survivors receive on an acute stroke unit is sufficient to ensure that they will recognize and properly respond to stroke symptoms after discharge. This assumption has not been tested. METHODS: This study examined stroke survivors' knowledge of stroke symptoms and their anticipated response to these symptoms at the time of discharge from an acute stroke unit and after either a 3 month post-discharge comprehensive team management intervention or usual post-discharge care. This was a secondary analysis of data from a randomized controlled pilot study measuring the overall impact of the post-discharge intervention and included 96 patients discharged from an acute stroke unit. The investigator-generated``stroke knowledge test'' assessed 1) how patients would respond to specific stroke symptoms (i.e., call 911, call their Dr, call a friend, take care of themselves), 2) whether they could correctly label varied symptoms as stroke-related, and 3) if they would call 911 if they knew they were having a stroke. RESULTS: Overall, the percentage of correct responses declined over three months in the control group but increased in the intervention group. At three months 91% of intervention patients and 85% of controls recognized numbness in an extremity as a stroke symptom, and, of these, significantly more intervention patients (p = 0.02) reportedly would have called 911 if they experienced such numbness. Likewise, 100% of intervention and 97% of control patients recognized sudden speech difficulties as a stroke symptom at three months, but significantly more intervention patients would have called 911 if they experienced these speech difficulties (p = 0.002). Lastly, 94% of intervention patients and 88% of controls recognized sudden onset of dizziness as a stroke symptom at three months, but significantly more intervention patients (p = 0.005) would have called 911 if they experienced such dizziness. When asked at three months what they would do first if they knew they were having a stroke, 86% of intervention patients and 74% of controls said they would call 911. CONCLUSION: This study showed that stroke education incorporated in a comprehensive post-discharge intervention improves post-discharge knowledge of stroke symptoms compared to education on the stroke unit alone, and, in as much as self-reported anticipated behavior correlates with actual performance, results in more patients calling 911 at the onset of stroke symptoms. These results suggest that in-hospital education alone may not be as effective as that combined with education delivered in an outpatient setting. They also suggest that the emphasis of educational efforts should be on the appropriate response to stroke symptoms, not just on stroke symptom recognition. PURPOSE: In the PURSUIT trial, eptifibitide was found to reduce the risk of acute myocardial infarction (AMI) and mortality (composite) from 15.7% to 14.2% (relative risk reduction [RRR] = 9.6 percent) in patients presenting with non-ST elevation acute cardiac ischemia (ACI). A published cost-effectiveness analysis, based only on the more favorable United States (US) results of the trial, found that the cost-effectiveness ratio for eptifibitide for this indication was $16,491 per year of life saved. We sought to estimate the cost-effectiveness of eptifibitide based on the results of the entire trial and the expected risk of AMI/death in a community based-sample of patients. METHODS: Using logistic regression equations to predict patient-specific risks of AMI and death and assuming a constant RRR of 9.6 percent for AMI and death, we estimated the costeffectiveness of routine use of eptifibitide across a population of 2,780 consecutive patients with non-ST elevation ACI who were admitted to hospital, but were not treated with eptifibitide. RESULTS: Predictions were obtained on 2,766 (99.5 %) of patients who met inclusion criteria. Of these patients, 2.0 percent died at 30 days and 12.2 percent had the composite outcome of AMI or death. Given these overall risks and a constant RRR, the average cost per year of life saved in our sample was estimated to be $41,832 per year of life saved. Moreover, adjusting each patient's risk of AMI and death using individual patient characteristics, only 6 percent of patients were at sufficiently high-risk to warrant therapy under a threshold of $20,000 per year of life saved. More than half of admitted patients were at such low risk for a bad outcome, even without therapy, that the marginal cost-effectiveness in these patients was greater than $50,000 per year of life saved. According to our analysis, one in twenty admitted patients were at insufficient risk to warrant therapy even under a threshold of $100,000. CONCLUSION: Given a constant RRR, use of eptifibitide is economically attractive in highrisk patients, but less attractive in low risk patients. Strategies to risk stratify patients to optimize clinical and economic outcomes should be considered. PURPOSE: It has been demonstrated that primary angioplasty (PTCA) in high-PTCA-volume hospitals is more effective in reducing mortality in reperfusion-eligible patients with acute myocardial infarction (AMI) than thrombolytic therapy. However, the benefits of PTCA disappear completely at low-volume hospitals. These findings support the strategy of bypassing low-volume community hospitals to deliver reperfusion-eligible patients with AMI to highvolume cardiac centers. However, bypassing community hospitals, or transferring patients from their emergency departments, causes delays that may nullify the expected benefits of PTCA. Moreover, immediate thrombolytic therapy leads to excellent outcomes in most patients. Thus, it is not clear which patients might benefit from PTCA, in the face of additional transportrelated delay. METHODS: We used the results of ten published trials and meta-regression techniques to assess the relationship between the treatment benefit of PTCA (in terms of the reduction in mortality rate in a trial) and procedure-related time delay (i.e. the difference between the median``door-toneedle'' time with thrombolytic therapy and the median``door-to-balloon'' time with PTCA in a trial). The magnitude and statistical significance of the relationship was estimated using weighted least squared regression, weighting each trial by the inverse of the variance of its log odds ratio. We also assessed the relationship between treatment benefit and mortality risk (using the mortality rate in the control group treated with thrombolytic therapy as a measure of baseline risk). RESULTS: A statistically significant trend demonstrates that the treatment effect of PTCA decreases across trials as procedure-related delay increases (p = 0.014). The regression line crosses the x-axis at 48 minutes, suggesting that, where the median procedure-related delay is greater than about three quarters of an hour, PTCA may be no more effective than thrombolytic therapy and may be harmful, even at the high volume centers represented in these trials. Additionally, all trials in which the baseline mortality risk of the patients was moderate to high (reflected by a mortality rate in the thrombolytic treatment arm of greater than 5 percent), showed treatment benefit, while four out of five trials with low mortality risks demonstrated no benefit for PTCA, and potential harm. CONCLUSION: Our meta-regression suggests that high-risk patient populations get substantially greater benefit from PTCA than low risk patients with AMI. It also suggests that the benefits of PTCA, on average, are nullified where the procedure-related delay is about 45 minutes or more. How this``time interval to mortality equivalence'' varies with a patient's mortality risk, and with the time elapsed from symptom onset, requires modeling on individual patient data. PURPOSE: Studies suggest that health status influences patient satisfaction, but little work has examined the influence of general physical functioning versus disease severity health status measures on satisfaction. Using data from a survey of diabetic patients, our objectives were to examine 1) the association between health status and patient satisfaction using two different health status measures and 2) whether the associations differed with different dimensions of satisfaction. METHODS: We surveyed 2000 patients receiving diabetes care across four Veterans Integrated Service Networks in fiscal years 1998 and 1999. Diabetes severity was measured using diabetes-related components of the Total Illness Burden Index (TIBI), a measure of diabetes complications and co-morbidities. Physical health status was measured by the Physical Function Index (PFI10) from the Short Form 36. Using satisfaction with overall quality as the dependent variable, we constructed two separate multiple linear regression models that examined the association between physical health status (PFI10 or TIBI) and overall satisfaction, controlling for gender, race, income, education, age, number of primary care visits, and presence of mental health diagnosis. We re-ran these models using a scale of satisfaction with patient-provider communication as the dependent variable. RESULTS: 70% of eligible patients responded to the survey (n=1314). These patients reported low levels of physical function (PFI10 mean(SD) = 46.5(30.2)), and high levels of diabetes severity (TIBI mean(SD) = 40.5(18.8)). Overall, these patients were moderately satisfied, with 65% percent reporting excellent or very good quality of care. Lower levels of physical functioning were associated with less satisfaction (p < .01), but generic physical health status explained less than 1% of the variation in satisfaction (model r-squared =.03). In contrast, diabetes-related severity and co-morbidities were more strongly associated with lower levels of satisfaction (p < .001), with the TIBI explaining 4% of satisfaction variation (model r-squared =.05). Results were similar when we examined satisfaction with patient-provider communication. CONCLUSION: In this diabetes population, diabetes-related disease severity and comorbidities explained a greater portion of the variance in satisfaction than did a measure of physical functioning. Adjusting only for general physical function in studies comparing satisfaction among individual providers or organizations may not be sufficient if patients of these providers have similar physical functioning but differing degrees of disease severity. PURPOSE: Although attention to substance abuse is considered important in the care of the homeless, published data do not indicate whether homelessness carries a worse prognosis following detoxification. We studied the association between housing status and substance abuse relapse following detoxification (detox). METHODS: Subjects underwent inpatient detox for alcohol, cocaine or heroin from 6/97 to 3/ 99. Baseline interviews assessed substance use, homelessness during the 6 months prior to detox, and demographic, health and psychosocial variables. Six months later, subjects reported recurrent substance use (relapse) and post-detox treatment history. Survival analysis (proportional hazards regression) was used to assess the association between homelessness, other clinically relevant predictors, and tune to relapse follow4ng detox. We specified a single interaction term, homelessness with Inpatient Sobriety Stabilization Program (ISSP) exposure. ISSP's are voluntary, short-term transitional sobriety-oriented facilities, often called``holding programs.'' RESULTS: Of 254 subjects (54% of 470) available at 6 months, 72% reported relapse, occurring a median of 31 days after detox. Forty-nine percent of subjects had reported 1 homeless night before detox. Follow-up rates did not significantly differ between homeless and nonhomeless subjects. There was no difference in time to relapse for subjects stratified by housing status or by varying durations of homelessness. Controlling for demographic and psychosocial variables, subjects with full-time employment were at significantly lower risk of relapse ISSP-(Hazard Ratio=0.71, 95% CI .50 ± .98). There was no main effect for homelessness (p=.19) but there was a significant interaction between homelessness and ISSP exposure (p=.04). The Table shows the proportion relapsed at 6 months, broken down by housing status and ISSP exposure, and helps to demonstrate the interaction. Homeless persons who used ISSP's had the lowest relapse risk. In Navajo women, a population at high-risk for type 2 diabetes mellitus, depot medroxyprogesterone (DMPA) is a common contraceptive due to its ease of administration. However, recent evidence suggests that DMPA contraception may lead to weight gain and independently decrease insulin sensitivity. The objective of this study was to determine if DMPA was associated with development of diabetes in Navajo women. METHODS: We conducted a clinic-based case-control study. Eligible subjects were Navajo women aged 18 ± 50 years who had seen a healthcare provider at a Navajo Area Indian Health Service clinic at least once in 1998. Diabetic cases (n = 284) and non-diabetic controls (n = 570) were matched by age. Medical records were reviewed to determine contraception use before the diagnosis date of diabetes in each case and its matched controls. RESULTS: DMPA users were more likely to develop diabetes than patients who had used combination estrogen-progesterone oral contraception only (OR 3.8, 95% CI [1.8 ± 7.9]). The greater odds persisted after adjustment for body mass index (BMI) (OR 3.6, 95% CI [1.6 ± 7.9]). When DMPA use of 3 months vs. 4 ± 11 months vs. 12 or more months was compared, risk of diabetes was associated with longer use(p = 0.02). Longer DMPA use was also associated with greater BMI; each additional month of use was associated with a 0.12 kg/m2 greater BMI (95% CI 0.001 ± 0.24). CONCLUSION: DMPA contraception was associated with greater risk of diabetes compared to combination oral contraception, and risk was greater with longer use and persisted after adjustment for body mass index. Additional research is needed to confirm these results and elucidate the mechanism, but DMPA may have this previously unrecognized side effect that could influence choice of contraceptive method, especially in women at high risk for diabetes mellitus. PURPOSE: Diabetes mellitus affects an increasingly younger population. Although over 10 million women in the United States use oral contraceptives (OCs), the association between diabetes and current OC use in young adult women is unclear. We studied the associations between 1)current OC use and 2)glucose levels, insulin levels, and diabetes in young adult women. METHODS: Female participants (n=2,787) in the Coronary Artery Risk Development in Young Adults study (CARDIA), a multi-center, prospective observational study of African-Americans and whites, were aged 18 ± 30 years at enrollment. OC use, fasting glucose, fasting insulin levels, and diabetes diagnosis were assessed at study examination years 0, 7, and 10. Current OC use was defined as OC use at each time of examination; non-use (the reference group) was defined as combined past OC use and never use at each examination. Using generalized estimating equations, we analyzed the cross-sectional associations between 1)current OC use and 2)fasting glucose, fasting insulin, and presence of diabetes.