Comparing methods to identify general internal medicine clinic patients with chronic heart failure.

OBJECTIVES: Identification of patients with left ventricular systolic dysfunction is the first step in identifying which patients may benefit from clinical practice guidelines. The purpose of this study was to develop and validate a computerized tool using clinical information that is commonly available to identify patients with left ventricular systolic dysfunction (LVSD). METHODS: We performed a cross-sectional study of patients seen in a Department of Veterans Affairs General Internal Medicine Clinic who had echocardiography or radionuclide ventriculography performed as part of their clinical care. RESULTS: We identified 2246 subjects who had at least one cardiac imaging study. A total of 778 (34.6%) subjects met study criteria for LVSD. Subjects with LVSD were slightly older than subjects without LVSD (70 years vs 68 years, P =.00002) but were similar with regard to sex and race. Subjects with LVSD were more likely to have prescriptions for angiotensin-converting enzyme (ACE) inhibitors, carvedilol, digoxin, loop diuretics, hydralazine, nitrates, and angiotensin II receptor antagonists. Of the variables included in the final predictive model, ACE inhibitors, loop diuretics, and digoxin exerted the greatest predictive power. Discriminant analysis demonstrated that models containing pharmacy information were consistently more accurate (75% accurate [65% sensitivity, 81% specificity]) than those models that contained only International Classification of Diseases, 9th revision (ICD-9), codes, including ICD-9 codes for congestive heart failure (72% accurate [80% sensitivity, 68% specificity]). CONCLUSIONS: We demonstrated that an automated, computer-driven algorithm identifying LVSD permits simple, rapid, and timely identification of patients with congestive heart failure by use of only routinely collected data. Future research is needed to develop accurate electronic identification of heart failure and other common chronic conditions.

Regional variations in health status.

CONTEXT: Knowledge about variations in the health status of patients seeking primary care in different parts of the United States is limited. OBJECTIVE: To examine regional variations in the physical and mental health of patients receiving primary care in the largest integrated health care system in the United States which is operated by the Department of Veteran Affairs (VA). STUDY DESIGN AND SETTING: We performed a mailed, cross sectional survey of 54,844 patients who were enrolled in seven VA General Internal Medicine clinics. RESULTS: Among the 30,690 patients who returned an initial set of screening questionnaires, the prevalence of common chronic conditions varied by as much as 60% among the seven clinics. Moreover, patients' general health (measured by the SF-36) also varied significantly in a pattern that mirrored the observed differences in the prevalence of chronic conditions. After adjustment for important comorbid illnesses and sociodemographic factors, geographic site accounted for a small percentage of the explained variance in patient assessed health status. CONCLUSIONS: The substantial differences in the health of patients enrolled in different VA primary clinics have important implications for the evaluation of clinical performance and health outcomes. Most of these differences can be attributed to sociodemographic and comorbid factors.

Transforming self-rated health and the SF-36 scales to include death and improve interpretability.

BACKGROUND: Most measures of health-related quality of life are undefined for people who die. Longitudinal analyses are often limited to a healthier cohort (survivors) that cannot be identified prospectively, and that may have had little change in health. OBJECTIVE: To develop and evaluate methods to transform a single self-rated health item (excellent to poor; EVGGFP) and the physical component score of the SF-36 (PCS) to new variables that include a defensible value for death. METHODS: Using longitudinal data from two large studies of older adults, health variables were transformed to the probability of being healthy in the future, conditional on the current observed value; death then has the value of 0. For EVGGFP, the new transformations were compared with some that were published earlier, based on different data. For the PCS, how well three different transformations, based on different definitions of being healthy, discriminated among groups of patients, and detected change in time were assessed. RESULTS: The new transformation for EVGGFP was similar to that published previously. Coding the 5 categories as 95, 90, 80, 30, and 15, and coding dead as 0 is recommended. The three transformations of the PCS detected group differences and change at least as well as the standard PCS. CONCLUSION: These easily interpretable transformed variables permit keeping persons who die in the analyses. Using the transformed variables for longitudinal analyses of health when deaths occur, either for secondary or primary analysis, is recommended. This approach can be applied to other measures of health.

The relationship between alcohol screening questionnaires and mortality among male veteran outpatients.

OBJECTIVE: This study evaluated whether responses to alcohol screening questionnaires predicted mortality in a Department of Veterans Affairs (VA) primary care population. METHOD: This study involved 5,703 male outpatients (mean age = 64) who were enrolled in General Internal Medicine clinics at three Veterans Affairs (VA) medical centers and returned mailed questionnaires in 1993-94. The two questionnaires included the CAGE and Alcohol Use Disorders Identification Test (AUDIT) alcohol screening tests. Mortality was ascertained using the VA Beneficiary Identification and Record Locator System. Five-year crude and adjusted mortality rates were calculated for patients who screened positive and patients who screened negative on each alcohol screening test. RESULTS: The risk of mortality was increased among drinkers who scored > or = 8 on the full AUDIT (hazard ratio: 1.47; 95% confidence interval [CI]: 1.08-2.00) or the three AUDIT consumption questions (1.58; 1.11-2.27), after adjusting for age, smoking, sociodemographic characteristics and chronic illnesses. The risk of mortality was also increased among drinkers who reported drinking > or = 3 drinks daily (1.69; 1.28-2.22) or prior alcohol treatment (1.66; 1.27-2.17), in "fully adjusted" models. A positive CAGE score (> or = 2) was associated with significantly increased risk of mortality among drinkers in a model adjusted only for age and smoking (1.27; 1.02-1.58). Among nondrinkers, neither a positive CAGE score (> or = 2) nor report of prior alcohol treatment was associated with increased risk of mortality. CONCLUSIONS: VA outpatients who reported drinking during the previous year and who had a positive result on an alcohol screening test experienced higher mortality over the subsequent 5 years than did patients who screened negative.

Association between depression and worse disease-specific functional status in outpatients with coronary artery disease.

BACKGROUND: The objective of this study was to determine if depression is associated with worse disease-specific functional status in patients with coronary artery disease. The study was designed as a cross-sectional survey and 3-month longitudinal cohort. METHODS AND RESULTS: The study took place in outpatient clinics of 3 Veterans Administration hospitals. All 7282 enrollees were surveyed and 4560 (62.6%) returned baseline questionnaires, including a screening instrument for depression. Thirty-nine percent (n = 1793) reported evidence of coronary artery disease and 1282 patients (71.5%) returned the Seattle Angina Questionnaire; 1025 patients (80%) completed a subsequent 3-month series of instruments. Main outcome measures used were the Seattle Angina Questionnaire, a valid, reliable, and responsive disease-specific functional status measure for patients with coronary disease, and the Mental Health Inventory, a mental health screening instrument from the Short Form-36. Mental Health Inventory evidence of depression was associated with significantly worse disease-specific functional status. Depressed patients had more physical limitation (mean difference in Seattle Angina Questionnaire score = 16.9, P <.001), more frequent angina (mean difference in Seattle Angina Questionnaire score = 9.5, P <.001), less satisfaction with their treatment for coronary artery disease (mean difference in Seattle Angina Questionnaire score = 9.9, P <.001), and lower perceived quality of life (mean difference in Seattle Angina Questionnaire score = 16.3, P <.001) than nondepressed patients. Frequency of depressive symptoms demonstrated an inverse relation with cardiac-specific functional status and when patients' depression status changed over time, so did their cardiac-specific health status. CONCLUSIONS: Depression is associated with significantly more physical limitation, more frequent angina, less treatment satisfaction, and lower perceived quality of life in outpatients with coronary artery disease.

Management of negative symptoms among patients with schizophrenia attending multiple-family groups.

OBJECTIVE: Outcomes for negative symptoms over a one-year period were examined in two groups of patients, one receiving psychoeducational multiple-family group treatment and one receiving standard care. METHODS: A total of 63 outpatients, ages 18 to 45 years, with DSM-IV diagnoses of schizophrenic disorders were randomly assigned to standard care or multiple-family group psychoeducation treatment at a large mental health center in Spokane, Washington. Treatment assignment was stratified by whether patients were taking typical or atypical antipsychotic medications. Negative symptom status was monitored monthly for one year by raters blind to group assignment and measured as a composite of five symptoms using the Modified Scale for the Assessment of Negative Symptoms. RESULTS: When the analysis controlled for baseline negative symptoms, participants in the multiple-family group experienced significantly reduced negative symptoms compared with those receiving standard care. Taking atypical antipsychotic medication or having a diagnosis of substance abuse was not associated with the severity of negative symptoms. An additional analysis of the five individual negative symptoms indicated small but consistent group differences on all dimensions except inattention. Negative symptoms were significantly correlated with relapse to acute illness but not with outpatient or inpatient service use. CONCLUSIONS: The study demonstrated that a psychoeducational multiple-family group intervention was more effective than standard care in managing negative symptoms over a 12-month period. The results are particularly relevant because negative symptoms are associated with relapse, poor social and occupational functioning, cognitive impairment, and lower subjective quality of life.

The AUDIT alcohol consumption questions: reliability, validity, and responsiveness to change in older male primary care patients.

OBJECTIVES: To determine the reliability, validity, and responsiveness to change of AUDIT (Alcohol Use Disorders Identification Test) questions 1 to 3 about alcohol consumption in a primary care setting. PATIENTS: Randomly selected, male general medical patients (n = 441) from three VA Medical Centers, who had 5 or more drinks containing alcohol in the past year and were willing to be interviewed about their health habits. MEASURES: Three self-administered AUDIT consumption questions were compared with a telephone-administered version of the trilevel World Health Organization interview about alcohol consumption. RESULTS: Of 393 eligible patients, 264 (67%) completed interviews. Test-retest reliability--Correlations between baseline and repeat measures 3 months later for four dimensions of consumption according to the AUDIT, ranged from 0.65 to 0.85, among patients who indicated they had not changed their drinking (Kendall's Tau-b). Criterion validity--Correlations between AUDIT and interview for four dimensions of alcohol consumption ranged from 0.47 to 0.66 (Kendall's Tau-b). Discriminative validity--The AUDIT questions were specific (90 to 93%), but only moderately sensitive (54 to 79%), for corresponding criteria for heavy drinking. Responsiveness to change--The AUDIT consumption questions had a Guyatt responsiveness statistic of 1.04 for detecting a change of 7 drinks/week, suggesting excellent responsiveness to change. CONCLUSIONS: AUDIT questions 1 to 3 demonstrate moderate to good validity, but excellent reliability and responsiveness to change. Although they often underestimate heavy alcohol consumption according to interview, they performed adequately to be used as a proxy measure of consumption in a clinical trial of heavy drinkers in this population.

The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test.

OBJECTIVE: To evaluate the 3 alcohol consumption questions from the Alcohol Use Disorders Identification Test (AUDIT-C) as a brief screening test for heavy drinking and/or active alcohol abuse or dependence. METHODS: Patients from 3 Veterans Affairs general medical clinics were mailed questionnaires. A random, weighted sample of Health History Questionnaire respondents, who had 5 or more drinks over the past year, were eligible for telephone interviews (N = 447). Heavy drinkers were oversampled 2:1. Patients were excluded if they could not be contacted by telephone, were too ill for interviews, or were female (n = 54). Areas under receiver operating characteristic curves (AUROCs) were used to compare mailed alcohol screening questionnaires (AUDIT-C and full AUDIT) with 3 comparison standards based on telephone interviews: (1) past year heavy drinking (>14 drinks/week or > or =5 drinks/ occasion); (2) active alcohol abuse or dependence according to the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition, criteria; and (3) either. RESULTS: Of 393 eligible patients, 243 (62%) completed AUDIT-C and interviews. For detecting heavy drinking, AUDIT-C had a higher AUROC than the full AUDIT (0.891 vs 0.881; P = .03). Although the full AUDIT performed better than AUDIT-C for detecting active alcohol abuse or dependence (0.811 vs 0.786; P<.001), the 2 questionnaires performed similarly for detecting heavy drinking and/or active abuse or dependence (0.880 vs 0.881). CONCLUSIONS: Three questions about alcohol consumption (AUDIT-C) appear to be a practical, valid primary care screening test for heavy drinking and/or active alcohol abuse or dependence.

Screening for problem drinking: comparison of CAGE and AUDIT. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test.

OBJECTIVE: To compare self-administered versions of three questionnaires for detecting heavy and problem drinking: the CAGE, the Alcohol Use Disorders Identification Test (AUDIT), and an augmented version of the CAGE. DESIGN: Cross-sectional surveys. SETTING: Three Department of Veterans Affairs general medical clinics. PATIENTS: Random sample of consenting male outpatients who consumed at least 5 drinks over the past year ("drinkers"). Heavy drinkers were oversampled. MEASUREMENTS: An augmented version of the CAGE was included in a questionnaire mailed to all patients. The AUDIT was subsequently mailed to "drinkers." Comparison standards, based on the tri-level World Health Organization alcohol consumption interview and the Diagnostic Interview Schedule, included heavy drinking (> 14 drinks per week typically or > or = 5 drinks per day at least monthly) and active DSM-IIIR alcohol abuse or dependence (positive diagnosis and at least one alcohol-related symptom in the past year). Areas under receiver operating characteristic curves (AUROCs) were used to compare screening questionnaires. MAIN RESULTS: Of 393 eligible patients, 261 (66%) returned the AUDIT and completed interviews. For detection of active alcohol abuse or dependence, the CAGE augmented with three more questions (AUROC 0.871) performed better than either the CAGE alone or AUDIT (AUROCs 0.820 and 0.777, respectively). For identification of heavy-drinking patients, however, the AUDIT performed best (AUROC 0.870). To identify both heavy drinking and active alcohol abuse or dependence, the augmented CAGE and AUDIT both performed well, but the AUDIT was superior (AUROC 0.861). CONCLUSIONS: For identification of patients with heavy drinking or active alcohol abuse or dependence, the self-administered AUDIT was superior to the CAGE in this population.

Screening for problem drinking : Comparison of CAGE and AUDIT.

OBJECTIVE: To compare self-administered versions of three questionnaires for detecting heavy and problem drinking: the CAGE, the Alcohol Use Disorders Identification Test (AUDIT), and an augmented version of the CAGE. DESIGN: Cross-sectional surveys. SETTING: Three Department of Veterans Affairs general medical clinics. PATIENTS: Random sample of consenting male outpatients who consumed at least 5 drinks over the past year ("drinkers"). Heavy drinkers were oversampled. MEASUREMENTS: An augmented version of the CAGE was included in a questionnaire mailed to all patients. The AUDIT was subsequently mailed to "drinkers." Comparison standards, based on the tri-level World Health Organization alcohol consumption interview and the Diagnostic Interview Schedule, included heavy drinking (>14 drinks per week typically or >/=5 drinks per day at least monthly) and active DSM-IIIR alcohol abuse or dependence (positive diagnosis and at least one alcohol-related symptom in the past year). Areas under receiver operating characteristic curves (AUROCs) were used to compare screening questionnaires. MAIN RESULTS: Of 393 eligible patients, 261 (66%) returned the AUDIT and completed interviews. For detection of active alcohol abuse or dependence, the CAGE augmented with three more questions (AUROC 0.871) performed better than either the CAGE alone or AUDIT (AUROCs 0.820 and 0.777, respectively). For identification of heavy-drinking patients, however, the AUDIT performed best (AUROC 0.870). To identify both heavy drinking and active alcohol abuse or dependence, the augmented CAGE and AUDIT both performed well, but the AUDIT was superior (AUROC 0.861). CONCLUSIONS: For identification of patients with heavy drinking or active alcohol abuse or dependence, the self-administered AUDIT was superior to the CAGE in this population.

A new self-administered questionnaire to monitor health-related quality of life in patients with COPD. Ambulatory Care Quality Improvement Project (ACQUIP) Investigators.

STUDY OBJECTIVE: To develop and validate a brief, computer-scannable, self-administered questionnaire to monitor health-related quality of life in patients with COPD. The Seattle Obstructive Lung Disease Questionnaire (SOLQ) consists of 29 items measuring four health dimensions: physical function, emotional function, coping skills, and treatment satisfaction. METHODS: A series of studies was performed to assess reliability, validity, and responsiveness. Internal consistency was measured using a cross-sectional survey of 203 COPD patients. Reproducibility was tested over a 4-month interval among 97 patients with self-reported stable conditions. To assess construct validity, SOLQ scales were correlated with corresponding Chronic Respiratory Disease Questionnaire (CRDQ) scales, the COPD Self-Efficacy Scale (CSES), percent predicted FEV1, and 6-min walk test. Treatment satisfaction scores of 920 subjects were correlated with a general measure of patient satisfaction. Baseline and follow-up scores of subjects were compared to assess treatment responsiveness. RESULTS: SOLQ scales were reliable (Cronbach's alpha 0.79 to 0.93, and intraclass correlation coefficients 0.64 to 0.87). Change in SOLQ scores correlated with corresponding CRDQ scales: dyspnea, r=0.42; emotional burden, r=0.49; mastery, r=0.36. Coping skills correlated highly with CSES, r=0.93. Treatment satisfaction correlation was r=0.54. Significant changes occurred in all three scales postintervention. CONCLUSION: The SOLQ is a reliable, valid, and responsive measure of physical and emotional function, coping skills, and treatment satisfaction. Brief, self-administered, and computer scannable, it is useful in monitoring long-term outcomes among large groups of COPD patients.

The risk for and severity of bleeding complications in elderly patients treated with warfarin. The National Consortium of Anticoagulation Clinics.

OBJECTIVE: To determine whether increasing age is associated with an increased risk for bleeding during warfarin treatment. DESIGN: Combined retrospective and prospective cohort studies. SETTING: 6 anticoagulation clinics. PATIENTS: 2376 patients receiving warfarin for various indications. MEASUREMENTS: Bleeding events categorized as minor (resulting in no costs or consequences), serious (requiring testing or treatment), life-threatening, or fatal. RESULTS: 812 first bleeding events (4 fatal, 33 life-threatening, 222 serious, and 553 minor) occurred during 3702 patient-years. Age was inversely related to the mean warfarin dose and dose-adjusted prothrombin time ratio. The unadjusted incidence of minor bleeding complications did not vary according to age group: 18.0 per 100 patient-years for patients younger than 50 years of age, 21.5 for patients 50 to 59 years of age, 24.0 for patients 60 to 69 years of age; 23.5 for patients 70 to 79 years of age, and 16.3 for patient 80 years of age and older. The unadjusted incidence of serious bleeding complications also did not vary according to age group: 9.3 per 100 patient-years for patients younger than 50 years of age, 7.1 for patients 50 to 59 years of age, 6.6 for patients 60 to 69 years of age, 5.1 for patients 70 to 79 years of age, and 4.4 for patients 80 years of age and older. The unadjusted incidence of life-threatening or fatal complications combined was significantly higher among the oldest patients: 0.75 per 100 patient-years for patients younger than 50 years of age, 0.97 for patients 50 to 59 years of age, 1.10 for patients 60 to 69 years of age, 0.68 for patients 70 to 79 years of age, and 3.38 for patients 80 years of age and older. Patients 80 years of age and older had a relative risk of 4.5 (95% CI, 1.3 to 15.6) compared with patients younger than 50 years of age. After adjustment for the intensity of anticoagulation therapy and the deviation in the prothrombin time ratio using Cox and Poisson regression, age was not generally associated with the occurrence of bleeding; relative risk estimates ranged from 0.99 to 1.03 per year of age (lower-bound 95% CI, 0.97 to 1.01; upper-bound 95% CI, 1.00 to 1.09). The single exception was life-threatening and fatal complications in patients 80 years of age or older (relative risk, 4.6 [CI, 1.2 to 18.1]). CONCLUSIONS: Age did not appear to be an important determinant of risk for bleeding in patients receiving warfarin, with the possible exception of age 80 years or older. The intensity of anticoagulation therapy and the deviation in the prothrombin time ratio were much stronger predictors of risk for bleeding.

Management and prognosis of life-threatening bleeding during warfarin therapy. National Consortium of Anticoagulation Clinics.

BACKGROUND: The incidence of explicity defined life-threatening bleeding during warfarin sodium therapy is largely unknown, as are the prognosis for and treatment of patients who have such bleeding. In addition, the location of the source of the life-threatening bleeding and the risk factors associated with life-threatening bleeding are not well-defined. OBJECTIVES: To determine the incidence of explicitly defined life-threatening bleeding during warfarin therapy, to identify the site of bleeding, to determine the risk factors for life-threatening bleeding, and to determine the risk of subsequent bleeding among patients receiving warfarin therapy. METHODS: A cross-sectional prevalence study was conducted and data were combined with those obtained during prospective observation of a dynamic cohort of patients followed up in 2 university-affiliated and 3 Veterans Administration anticoagulation clinics. RESULTS: For this study, 1999 patients were followed up for 3865 patient-years; 32 patients (11 women, 21 men, mean age of 60 years) met criteria for life-threatening bleeding, an incidence of 0.83 events/100 patient-years (95% confidence interval, 0.54-1.12). The most common indication for warfarin was to prevent thromboembolism because the patient had a mechanical heart valve (17/32 patients, 53%). The gastrointestinal tract was the definite or likely site of bleeding in 21 (66%) of the 32 patients. The prothrombin time ratio was longer than 2.0 or the international normalized ratio was longer than 4.5 in 16 (55%) of the 29 patients in whom a coagulation time was measured. Fourteen (44%) of the 32 patients had a history of peptic ulcer disease or gastrointestinal bleeding. Warfarin was restarted in 26 (81%) of the 32 patients. Twenty-five of 26 patients were followed up for a median of 30 months (range, 5-143 months); 14 (56%) of the 25 patients had a subsequent bleeding event, with 8 (57%) of the 14 having 1 or more additional life-threatening bleeding events (1 fatal) after a median of 11.5 months (range, 0.5-22 months). CONCLUSIONS: We conclude that in this cohort: (1) the incidence of life-threatening bleeding was rare, (2) the gastrointestinal tract was the site of bleeding in two thirds of the patients who experienced life-threatening bleeding, (3) most patients who experienced life-threatening bleeding had multiple risk factors for bleeding, including excessive anticoagulation, and (4) the risk of subsequent bleeding was extremely high among the patients who continued to receive warfarin therapy.

A comprehensive system for quality improvement in ambulatory care: assessing the quality of diabetes care.

A comprehensive state-of-the-art system for quality improvement in ambulatory care has been designed to test (1) whether patients at 8 intervention sites demonstrate improved health status and satisfaction with their care as compared to patients at 8 control sites and (2) the extent to which timely patient self-reported data influences provider practice patterns. During the study pilot period, several investigators developed, tested and analyzed disease-specific questionnaires for 7 common chronic conditions. An advanced automated information system was designed to link hospital computer information and patient questionnaire data in order to provide timely communication between patients and providers about important health problems. This report briefly describes the 3-year quality of ambulatory care clinical trial and details the development and pilot testing of the disease specific questionnaire for diabetes. Reliability testing showed correlations were higher for fixed events such as foot ulcers than for subjective judgments such as satisfaction with providers. Responsiveness testing indicated that this questionnaire could measure behavior and care modifications in patients 6 months following an outpatient education course, compared to the baseline pre-education values. Diabetes severity information has been collected from self-administered questionnaires and laboratory data to assist providers in assessing the patients' likelihood of 4-year mortality. It is anticipated that the rapid identification of important patient issues will assist patients and clinicians in mutually addressing and resolving health care problems, thereby improving the quality of outpatient care.

Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.

OBJECTIVES: This study sought to establish the validity, reproducibility and responsiveness of the Seattle Angina Questionnaire, a 19-item self-administered questionnaire measuring five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. BACKGROUND: Assessing the functional status of patients is becoming increasingly important in both clinical research and quality assurance programs. No current functional status measure quantifies all of the important domains affected by coronary artery disease. METHODS: Cross-sectional or serial administration of the Seattle Angina Questionnaire was carried out in four groups of patients: 70 undergoing exercise treadmill testing, 58 undergoing coronary angioplasty, 160 with initially stable coronary artery disease and an additional 84 with coronary artery disease. Evidence of validity was sought by comparing the questionnaire's five scales with the duration of exercise treadmill tests, physician diagnoses, nitroglycerin refills and other validated instruments. Reproducibility and responsiveness were assessed by comparing serial responses over a 3-month interval. RESULTS: All five scales correlated significantly with other measures of diagnosis and patient function (r = 0.31 to 0.70, p < or = 0.001). Questionnaire responses of patients with stable coronary artery disease did not change over 3 months. The questionnaire was sensitive to both dramatic clinical change, as seen after successful coronary angioplasty, and to more subtle clinical change, as seen among outpatients with initially stable coronary artery disease. CONCLUSIONS: The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease. It is sensitive to clinical change and should be a valuable measure of outcome in cardiovascular research.

A computerized intervention to improve timing of outpatient follow-up: a multicenter randomized trial in patients treated with warfarin. National Consortium of Anticoagulation Clinics.

OBJECTIVE: To evaluate a computerized scheduling model that employs nonlinear optimization to recommend optimal follow-up intervals for patients taking warfarin. DESIGN: Randomized trial. SETTING: 5 anticoagulation clinics. PATIENTS/PARTICIPANTS: 620 patients expected to receive warfarin for > or = 6 weeks. INTERVENTIONS: Computer-generated recommendations for scheduling the next visit were presented to or withheld from practitioners. MEASUREMENTS AND MAIN RESULTS: The main outcome measures were the follow-up interval scheduled by the provider, the interval at which the patient actually returned to clinic, and the quality of anticoagulation control (computed as the absolute difference between the measured and target prothrombin times [PTRs] or international normalized ratios [INRs]). Follow-up intervals scheduled for the patients whose practitioners received computer-generated recommendations were significantly longer than those for control patients (mean, 4.4 vs 3.5 weeks, p < 0.001), despite the fact that the practitioners modified the suggested return interval by > 1 week on 40% of the visits. The interval at which the intervention group actually returned to clinic was also longer (mean, 4.4 vs 4.1 weeks, p < 0.05), even though the control patients tended to return at longer intervals than were scheduled by their practitioners. Control of anticoagulation was nearly the same among experimental and control patients. Life-threatening complications occurred in the care of three experimental patients and one control patient, while other serious complications occurred in the care of 16 experimental patients and 17 control patients. CONCLUSIONS: Recommendations based on nonlinear optimization prompted clinicians to schedule less frequent follow-up for patients taking warfarin, with no deterioration in anticoagulation control. This approach to scheduling can potentially reduce utilization while maintaining quality of care for patients who require long-term monitoring.

Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin Optimized Outpatient Follow-up Study Group.

OBJECTIVE: To define risk factors for complications that occur during warfarin therapy. DESIGN: Retrospective cohort study. SETTING: Five anticoagulation clinics. PATIENTS: Nine hundred twenty-eight consecutive patients receiving 1103 courses of warfarin. MAIN OUTCOME MEASURES: Hemorrhagic and thromboembolic complications. RESULTS: In 1950 patient-years of follow-up, there were 1332 bleeding events (4 were classified as fatal, 31 as life-threatening, 226 as serious, and 1071 as minor). The cumulative incidence of fatal bleeding was 1% at 1 year and 2% at 3 years. The cumulative incidences of first episodes of life-threatening and serious bleeding at 1, 2, 4, and 8 years were 1%, 2%, 5%, and 9% and 12%, 20%, 28%, and 40%, respectively. Of 156 patients who had a serious or life-threatening hemorrhage, 32% suffered a recurrence, typically within 1 year. Independent predictors of a first episode of serious bleeding included a mean prothrombin time ratio (PTR) of 2.0 or more during the course of treatment (relative risk, 3.0; 95% CI, 1.9 to 4.7); recent initiation of warfarin therapy (relative risk during the first 3 months compared with the rest of the first year, the second year, and anytime thereafter, 1.9 [CI, 1.3 to 3.0], 3.0 [CI, 1.8 to 4.8], and 5.9 [CI, 3.8 to 9.3], respectively); variability of the PTR over time (relative risk for the highest compared with the lowest tertile, 1.6 [CI, 1.2 to 2.7]); and the presence of 3 or more comorbid conditions (RR, 1.4 [CI, 1.1 to 2.5]). Age, reason for anticoagulation, use of interfering drugs, and hypertension were not associated with risk for bleeding. The risk for a thromboembolic complication at a PTR of less than 1.3 was 3.6 (CI, 2.1 to 6.4) times higher than at a PTR of 1.3 to 1.5. CONCLUSIONS: The incidence of warfarin-associated bleeding may be reduced by attending to modifiable risk factors (that is, highly variable PTRs and values greater than 2.0), frequent monitoring early in treatment, and careful patient selection. Older age, in and of itself, is not a risk factor.

A model for planning optimal follow-up for outpatients on warfarin anticoagulation. Warfarin Optimal Outpatient Follow-up Study Group.

Patients taking warfarin for long-term anticoagulation require frequent clinic visits to monitor the prothrombin time ratio (PTR), a measure of blood clotting. A dynamic stochastic model using nonlinear optimization was developed to select follow-up visit intervals that minimize the overall costs of patient care. Assuming that fluctuations in a patient's PTR behave as a random diffusion process, future PTR fluctuations are unknown, except as revealed by past PTRs. To determine the incidence and costs of complications in relation to PTR, the authors reviewed the charts of 216 patients who had 719 patient-years of follow-up with 695 trivial, significant, life-threatening, or fatal complications. They modeled the relationship between costs of complications and deviation of the PTR from the therapeutic target as a fourth-order convex polynomial. The model is used to compute the interval to the next follow-up visit to minimize accumulated potential costs. Variables in the optimization are the cost of a monitoring visit and the expected costs of complications. The latter are derived from the current PTR, the variability of the patient's past PTR values, the number of past PTRs available, and the target PTR for the patient. No attempt is made to predict the level of the next PTR or suggest adjustments in the warfarin dose. Shorter follow-up is recommended for patients who have histories of large fluctuations in past PTRs and for patients with few prior PTR determinations. As visits accumulate, the patient's degree of variability can be estimated more accurately and visit intervals adjusted accordingly. The scheduling method balances costs to the health care system of monitoring each patient against the expected costs of complications. This approach has the potential to reduce the number of monitoring visits necessary for safe management of anticoagulated patients with stable PTRs and to improve control among unstable patients.

Identification and characterization of a target antigen of a monoclonal antibody directed against Eimeria tenella merozoites.

Monoclonal antibodies (Mab) were produced against Eimeria tenella merozoites. A single Mab, LPMC-61, was selected because of its ability to bind to merozoites by indirect immunofluorescence assay (IFA) and to inhibit in vitro sporozoite development. Mab LPMC-61 reacts with an approx. 10-12-kDa merozoite polypeptide in reduced SDS-PAGE, but with an approx. 80-kDa protein in non-reduced SDS-PAGE. The monoclonal recognizes similarly sized polypeptides in E. tenella sporozoites, oocysts and schizonts. A partial cDNA (LPMC-61f) encoding the LPMC-61 antigen was identified from an E. tenella sporozoite cDNA library in bacteriophage lambda gt11. In addition to Mab LPMC-61, the recombinant beta-galactosidase/LPMC-61f fusion protein is recognized by hyperimmune rabbit anti-E. tenella sporozoite serum, rabbit anti-E. tenella merozoite serum, and E. tenella-infected and immune chicken sera. DNA sequencing of LPMC-61f cDNA showed that the putative protein has an unusual tandem, non-perfect repeated sequence, with glutamine comprising about 48% of the predicted amino acids. A hydropathicity plot of the predicted amino acid sequence shows a central hydrophilic region, consisting of the repeated sequences, surrounded by hydrophobic regions on both sides. Since the merozoite stage of avian Eimeria has been implicated in the induction of a protective immune response in chickens, LPMC-61 may be an important immunogen for use as a vaccine against E. tenella.

Digital arthrodesis: an alternate method for correction of hammer toe deformity.

A technique of internal wire fixation in end-to-end digital arthrodesis is illustrated and described for correction of hammer toe deformity. A clinical study involving 25 patients and 62 digital fusions are evaluated. All patients interviewed considered their hammer toe surgery successful in eliminating their chief complaint. All patients examined showed solid fusion of the arthrodesed digit. This procedure offers an effective means for digital fusion in correction of the hammer toe deformity. It is easily performed and presents few complications.