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Biomedical subjects

Stephan D Fihn

Publications and source records attributed to Stephan D Fihn.

At least 55 records · Page 3Linked to original sources

Prevalence and determinants of vaginal flora alterations in postmenopausal women.

The vaginal ecology of 463 community-dwelling postmenopausal women was characterized. Vaginal lactobacilli were present in 62% of the women and were significantly more prevalent among women receiving hormone replacement therapy during the previous year. Vaginal Escherichia coli and enterococci were each present in 39% of women and were significantly more frequent in women with a history of urinary tract infection. Heavy growth of lactobacilli was associated with a lower frequency of vaginal colonization with E. coli. Thus, postmenopausal women have a relative depletion of vaginal lactobacilli and an increase in vaginal E. coli compared with premenopausal women.

Aged↗

Anginal symptoms consistently predict total mortality among outpatients with coronary artery disease.

BACKGROUND: Age, race, education, and diabetes have been associated with differences in anginal symptoms, treatments, and outcomes among outpatients with coronary artery disease (CAD), but there is little data on whether such characteristics affect relationships between anginal symptoms and mortality. METHODS: Using a prospective cohort design, we examined associations of anginal symptoms, as assessed by the Seattle Angina Questionnaire, with total mortality among 8908 outpatients with CAD to investigate whether this relationship is influenced by patient demographic or clinical characteristics. Potential effect modification was primarily assessed for age, race, education, and diabetes, and secondarily assessed for smoking, prevalent congestive heart failure (CHF), myocardial infarction, and coronary revascularization. RESULTS: Over 2 years mean follow-up, there were 896 deaths. After adjustment for potential confounders, persons reporting greater physical limitation due to angina had higher mortality: 27% higher with mild limitation (hazard ratio [HR] 1.27, 95% CI 0.98-1.64), 61% higher with moderate limitation (HR 1.61, 95% CI 1.27-2.05), and 2.5-fold higher with the greatest limitation (HR 2.55, 95% CI 1.97-3.30), compared with little or no limitation (P for trend <.001). Anginal instability was also independently predictive of mortality. There was little evidence that these relationships varied by age, race, education, diabetes, smoking, or presence of CHF, prior myocardial infarction, or prior coronary revascularization (P for each interaction >.28). Anginal symptoms predicted higher mortality risk comparable to a decade of age difference, presence of diabetes, or presence of CHF. CONCLUSIONS: Among outpatients with CAD, self-reported anginal symptoms consistently predict mortality irrespective of differences in age, race, education, or clinical comorbidities.

Age Factors↗

Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care.

OBJECTIVE: To compare collaborative care for treatment of depression in primary care with consult-liaison (CL) care. In collaborative care, a mental health team provided a treatment plan to the primary care provider, telephoned patients to support adherence to the plan, reviewed treatment results, and suggested modifications to the provider. In CL care, study clinicians informed the primary care provider of the diagnosis and facilitated referrals to psychiatry residents practicing in the primary care clinic. DESIGN: Patients were randomly assigned to treatment model by clinic firm. SETTING: VA primary care clinic. PARTICIPANTS: One hundred sixty-eight collaborative care and 186 CL patients who met criteria for major depression and/or dysthymia. MEASUREMENTS: Hopkins Symptom Checklist (SCL-20), Short Form (SF)-36, Sheehan Disability Scale. MAIN RESULTS: Collaborative care produced greater improvement than CL in depressive symptomatology from baseline to 3 months (SCL-20 change scores), but at 9 months there was no significant difference. The intervention increased the proportion of patients receiving prescriptions and cognitive behavioral therapy. Collaborative care produced significantly greater improvement on the Sheehan at 3 months. A greater proportion of collaborative care patients exhibited an improvement in SF-36 Mental Component Score of 5 points or more from baseline to 9 months. CONCLUSIONS: Collaborative care resulted in more rapid improvement in depression symptomatology, and a more rapid and sustained improvement in mental health status compared to the more standard model. Mounting evidence indicates that collaboration between primary care providers and mental health specialists can improve depression treatment and supports the necessary changes in clinic structure and incentives.

Adult↗

Clinically important changes in health-related quality of life for patients with chronic obstructive pulmonary disease: an expert consensus panel report.

OBJECTIVE: Without clinical input on what constitutes a significant change, health-related quality of life (HRQoL) measures are less likely to be adopted by clinicians for use in daily practice. Although standards can be determined empirically by within-person change studies based on patient self-reports, these anchor-based methods incorporate only the patients' perspectives of important HRQoL change, and do not reflect an informed clinical evaluation. The objective of this study was to establish clinically important difference standards from the physician's perspective for use of 2 HRQoL measures among patients with chronic obstructive pulmonary disease (COPD). DESIGN: We assembled a 9-person expert panel of North American physicians familiar with the use of the Chronic Respiratory Questionnaire (CRQ), a disease-specific HRQoL measure, or the generic Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, Version 2.0) among patients with COPD. RESULTS: Using 2 rounds of the Delphi process, 1 in-person meeting, and an iterative improvement process for circulating and correcting the final report, the expert panel established small, moderate, and large clinically important change levels for the CRQ and SF-36. CONCLUSIONS: For this expert physician panel, levels for detecting clinically important differences on the CRQ were equal to or slightly higher than previous studies based on patient-reported differences. Clinically important differences on the SF-36, Version 2.0, were noticeably larger than previous estimates based on cross-sectional differences between clinically defined patient groups.

Health Status Indicators↗

Accounting for deaths in longitudinal studies using the SF-36: the performance of the Physical Component Scale of the Short Form 36-item health survey and the PCTD.

BACKGROUND: Commonly used measures such as the Physical Component Scale of the Short Form 36-item health survey (PCS) are undefined at death, limiting longitudinal analyses to survivors, a healthier cohort that cannot be identified prospectively, and that might have had little change in health. One proposed approach is to transform the PCS into the Physical Component Transformed, with Deaths included (PCTD), which is the probability of being healthy 1 year later and for which deaths logically have a value of zero. Data missing for other reasons than death have not been considered. OBJECTIVE: To examine the performance of the PCTD, to determine the influence of including deaths, the additional effects of imputing missing values and adjusting for covariates, and the calibration of the PCTD in different populations. METHODS: We imputed missing values of the PCTD, calling the new variable the PCTDI. We compared the distributions of the PCS, PCTD, and PCTDI cross-sectionally and over time. In 3 different populations, we determined whether the PCTD accurately predicted the probability of being healthy 1 year later. RESULTS: The patients who died did not have extreme values on the PCTD. The experience of the cohort was best described by the PCTDI. The calibration of the PCTD was surprisingly good in all the populations examined. Results were similar for the physical function index. CONCLUSION: The PCTDI is an improvement over the PCS, in which patients who had died have no influence, and over the PCTD, where they might have too much influence. We recommend the PCTDI for longitudinal analyses of physical health when deaths occur, for primary or secondary analysis.

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Comparison of control and stability of oral anticoagulant therapy using acenocoumarol versus phenprocoumon.

Variability in the control of oral anticoagulant therapy has been associated with a heightened risk of complications. We compared control of anticoagulation between two commonly used coumarins, phenprocoumon and acenocoumarol, and among anticoagulation clinics. All qualifying patients were managed at six regional anticoagulation clinics in the Netherlands. This retrospective cohort study compiled data during a three-year period from a computerised dosing and management system. Anticoagulation control was expressed as the percent of time within the therapeutic range and stability expressed as the time-weighted variance in the international normalised ratio (INR). Data were available for 22,178 patients of whom 72% were treated with acenocoumarol. INRs of patients who received phenprocoumon were within the therapeutic range 50% of the time compared with 43% for acenocoumarol (OR 1.32, 95% CI 1.24-1.41). Moreover, patients on phenprocoumon required 15% fewer monitoring visits and had more stable INR values. These observations were consistent for all six clinics. There were also sizable differences between the clinics with respect to control and stability of anticoagulation that were stable from year-to-year and were unrelated to the drug used. With its longer half-life of three to five days, phenprocoumon produces more stable anticoagulation than acenocoumarol and should generally be the drug of choice when these are the available choices. The differences observed among clinics suggest that certain clinics employ policies and practices resulting in better control of anticoagulation.

Acenocoumarol↗

Risk of mortality and heart failure exacerbations associated with inhaled beta-adrenoceptor agonists among patients with known left ventricular systolic dysfunction.

OBJECTIVES: Recent studies suggest that myocardial beta(2)-adrenoceptors may be important in chronic heart failure. We sought to determine if use of selective beta(2)-agonists was associated with hospitalization for heart failure and all-cause mortality. METHODS: We studied a cohort of patients with left ventricular systolic dysfunction (LVSD). The outcome was the first hospitalization with a primary diagnosis of chronic heart failure or death from any cause. The exposure was the average number of beta-agonist canisters filled per month in the 90 days prior to and 15 days after enrollment. RESULTS: Among 1,529 subjects, the relative risk (RR) of chronic heart failure hospital admission associated with inhaled beta-agonists followed a dose-response relationship: RR for one canister per month, 1.4 (95% confidence interval [CI], 0.9 to 2.0), RR for two canisters per month, 1.7 (95% CI, 1.2 to 2.5), and RR for three canisters per month, 2.1 (95% CI, 1.4 to 3.1). The RR of death demonstrated a similar finding: RR for one canister per month, 0.9 (95% CI, 0.5 to 1.5), RR for two canisters per month, 1.3 (95% CI, 0.9 to 2.1), and RR for three canisters per month, 2.0 (95% CI, 1.3 to 3.1). Adjusting for potential confounding factors did not affect the estimates. CONCLUSION: Among subjects with LVSD, inhaled beta-agonists were associated with an increased risk of heart failure hospitalization, and all-cause mortality. Clinicians should carefully consider the etiology of dyspnea when prescribing beta-agonists to patients with LVSD.

Administration, Inhalation↗

Health status predicts long-term outcome in outpatients with coronary disease.

BACKGROUND: Although patient-reported health status measures have been used as end points in clinical trials, they are rarely used in other settings. Demonstrating that they independently predict mortality and hospitalizations among outpatients with coronary disease could emphasize their clinical value. METHODS AND RESULTS: This study evaluated the prognostic utility of the Seattle Angina Questionnaire (SAQ), a disease-specific health status measure for patients with coronary artery disease. Patients were enrolled in a prospective cohort study from 6 Veterans Affairs General Internal Medicine Clinics. All patients reporting coronary artery disease who completed a SAQ and had 1 year of follow-up were analyzed (n=5558). SAQ predictor variables were the physical limitation, angina stability, angina frequency, and quality-of-life scores. The primary outcome was 1-year all-cause mortality, and a secondary outcome was hospitalization for acute coronary syndrome (ACS). Lower SAQ scores were associated with increased risks of mortality and ACS admissions. Prognostic models controlling for demographic and clinical characteristics demonstrated significant independent mortality risk with lower SAQ physical limitation scores; odds ratios for mild, moderate, and severe limitation were 1.5, 2.0, and 4.0 versus minimal limitation (P<0.001). Odds ratios for mild, moderate, and severe angina frequency were 0.8, 1.2, and 1.6 (P=0.078). The odds ratios for ACS admission among those with mild, moderate, and severe angina frequency were 1.4, 2.0, and 2.2, respectively (P=0.016). CONCLUSIONS: SAQ scores are independently associated with 1-year mortality and ACS among outpatients with coronary disease and may serve a valuable role in the risk stratification of such patients.

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Validation of case-mix measures derived from self-reports of diagnoses and health.

Self-reported chronic diseases and health status are associated with resource use. However, few data exist regarding their ability to predict mortality or hospitalizations. We sought to determine whether self-reported chronic medical conditions and the SF-36 could be used individually or in combination to assess co-morbidity in the outpatient setting. The study was designed as a prospective cohort study. Patients were enrolled in the primary care clinics at seven Veterans Affairs (VA) medical centers participating in the Ambulatory Care Quality Improvement Project (ACQUIP). 10,947 patients, > or = 50 years of age, enrolled in general internal medicine clinics who returned both a baseline health inventory checklist and the baseline SF-36 who were followed for a mean of 722.5 (+/-84.3) days. The primary outcome was all-cause mortality, with a secondary outcome of hospitalization within the VA system. Using a Cox proportional hazards model in a development set of 5,469 patients, a co-morbidity index [Seattle Index of Co-morbidity (SIC)] was constructed using information about age, smoking status and seven of 25 self-reported medical conditions that were associated with increased mortality. In the validation set of 5,478 patients, the SIC was predictive of both mortality and hospitalizations within the VA system. A separate model was constructed in which only age and the PCS and MCS scores of the SF-36 were entered to predict mortality. The SF-36 component scores and the SIC had comparable discriminatory ability (AUC for discrimination of death within 2 y 0.71 for both models). When combined, the SIC and SF-36 together had improved discrimination for mortality (AUC = 0.74, p-value for difference in AUC < 0.005). A new outpatient co-morbidity score developed using self-identified chronic medical conditions on a baseline health inventory checklist was predictive of 2-y mortality and hospitalization within the VA system in general internal medicine patients.

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Therapeutic quality control of oral anticoagulant therapy comparing the short-acting acenocoumarol and the long-acting phenprocoumon.

To investigate whether the different pharmacokinetics of acenocoumarol (t(1/2) = 11 h) and phenprocoumon (t(1/2) = 140 h) result in a different quality of anticoagulation, we studied patients from the Leiden anticoagulation clinic treated between 1998 and 1999 for more than 16 weeks. Two hundred and twenty-eight pairs were closely matched for indication for oral anticoagulant therapy (OAT), age, sex and date of start of treatment. Four hundred and fifty six patients with 7245 International Normalized Ratio (INR) checks yielded 230 patient-years. Quality of OAT calculated over the whole treatment period was higher with phenprocoumon as expressed by the number of INR checks in the therapeutic range (phenprocoumon: 42.7%, acenocoumarol: 36.5%, difference: 6.1%, CI(95) of the difference: 3.0-9.3%) and by time in range (phenprocoumon: 46.6%, acenocoumarol: 41.6%, difference: 5.0%, CI(95) of the difference: 1.3-8.6%). After the initial 6 weeks of OAT, the differences became more pronounced (difference: 6.1%, CI(95): 1.8-10.4%). The incidence of severe bleeding complications was similar (phenprocoumon: 0.04/patient/year vs acenocoumarol: 0.03/patient/year) with a slight excess of minor bleeds with phenprocoumon (0.19/patient/year vs 0.06/patient/year). We conclude that phenprocoumon leads to a better quality of OAT than acenocoumarol. As there is no difference in major bleeding complications and only a small difference in minor bleeding complications, phenprocoumon is preferable to acenocoumarol for prolonged OAT.

Acenocoumarol↗

Benefits of an "angina clinic" for patients with coronary artery disease: a demonstration of health status measures as markers of health care quality.

OBJECTIVE: Our purpose was to determine the efficacy of health status measurement in quantifying improvements in quality of care provided by an "angina clinic." STUDY DESIGN: In a pretest-posttest, nonequivalent control group design in the outpatient clinics of a Veterans Affairs Medical Center, 535 patients with coronary disease were followed up, without intervention, for 3 months and were defined as the "usual-care" group. Concurrently, a clinical trial that optimized the antianginal medications of 100 patients with chronic, stable coronary disease was conducted and defined as the "angina clinic" group. The 3-month change in scores for the Seattle Angina Questionnaire, a valid, reliable, and responsive disease-specific health status measure for patients with coronary disease, was used as the main outcome measure. RESULTS: After baseline differences between groups were controlled, the "angina clinic" conferred substantial improvement on patient symptom control (3-month benefit in angina frequency +9.4, P <.001; in angina stability +14.7, P <.001), treatment satisfaction (+8.6, P <.001), quality of life (+6.8, P <.001), and physical limitations resulting from coronary disease (+3.6, P =.047). Only the changes in physical limitation were not clinically significant. CONCLUSION: Disease-specific health status measures can provide valuable insights into the quality of care associated with innovations in health care delivery. These results suggest that patients in a clinical trial optimizing antianginal medications had greater improvements in symptom control, treatment satisfaction, and quality of life compared with similar patients receiving "usual care" in a general medicine clinic.

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Association between inhaled beta-agonists and the risk of unstable angina and myocardial infarction.

BACKGROUND: beta-Adrenoceptor agonists (beta-agonists) are commonly used to treat obstructive lung diseases, and preliminary studies have suggested they are associated with an increased risk of adverse cardiovascular outcomes. We further examined the association between acute coronary syndromes and inhaled beta-agonist therapy. METHODS: We performed a nested, case-control study using data that were collected as part of a larger, ongoing, prospective study of quality improvement in the primary care clinics of seven Veterans Administration Medical Centers. We identified 630 patients with unstable angina or acute myocardial infarction hospitalized between 1996 and 1999. We frequency matched these case patients to 10,486 control subjects according to clinic location, and randomly assigned each an "index date." The computerized pharmacy database at each center was used to ascertain beta-agonist use. Cardiovascular risk factors were assessed from mailed questionnaires and electronic medical records, which included inpatient and outpatient diagnoses, medications, and laboratory results. RESULTS: In comparison with patients who had not filled a beta-agonist prescription during the 90 days prior to their index date, patients who had filled a beta-agonist prescription had an increased risk of experiencing an acute coronary syndrome. The increased risk of an acute coronary syndrome persisted after adjusting for age and cardiovascular risk factors, including hypertension, diabetes, and smoking history. Moreover, there was a dose-response relationship with an adjusted odds ratio (OR) of 1.38 for one to two metered-dose inhaler (MDI) canisters (95% confidence interval [CI], 0.86 to 2.23), an OR of 1.57 for three to five MDI canisters (95% CI, 1.01 to 2.46), and an OR of 1.93 for six or more MDI canisters (95% CI, 1.23 to 3.03). After stratifying for receipt of a beta-blocker prescription, the adjusted OR in subjects who did not receive a beta-blocker was 1.55 for one to two MDI canisters (95% CI, 0.60 to 3.99), an OR of 4.07 for three to five canisters (95% CI, 2.17 to 7.64), and an OR of 3.83 for six or more canisters (95% CI, 2.02 to 7.29). Subjects who had received both beta-blockers and beta-agonists had no increase in risk in acute coronary syndromes unless they had filled six or more beta-agonist MDI canisters. CONCLUSIONS: A prescription for inhaled beta-agonists may increase the risk of myocardial infarction and unstable angina in patients with COPD.

Administration, Inhalation↗