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Barbara C Tilley

Publications and source records attributed to Barbara C Tilley.

At least 19 recordsLinked to original sources
PubMed2007

Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Process, format, and clinimetric testing plan.

This article presents the revision process, major innovations, and clinimetric testing program for the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (UPDRS), known as the MDS-UPDRS. The UPDRS is the most widely used scale for the clinical study of Parkinson's disease (PD). The MDS previously organized a critique of the UPDRS, which cited many strengths, but recommended revision of the scale to accommodate new advances and to resolve problematic areas. An MDS-UPDRS committee prepared the revision using the recommendations of the published critique of the scale. Subcommittees developed new material that was reviewed by the entire committee. A 1-day face-to-face committee meeting was organized to resolve areas of debate and to arrive at a working draft ready for clinimetric testing. The MDS-UPDRS retains the UPDRS structure of four parts with a total summed score, but the parts have been modified to provide a section that integrates nonmotor elements of PD: I, Nonmotor Experiences of Daily Living; II, Motor Experiences of Daily Living; III, Motor Examination; and IV, Motor Complications. All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Several questions in Part I and all of Part II are written as a patient/caregiver questionnaire, so that the total rater time should remain approximately 30 minutes. Detailed instructions for testing and data acquisition accompany the MDS-UPDRS in order to increase uniform usage. Multiple language editions are planned. A three-part clinimetric program will provide testing of reliability, validity, and responsiveness to interventions. Although the MDS-UPDRS will not be published until it has successfully passed clinimetric testing, explanation of the process, key changes, and clinimetric programs allow clinicians and researchers to understand and participate in the revision process.

Disability Evaluation↗
PubMed2006

Association of serial biochemical markers with acute ischemic stroke: the National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator Stroke Study.

BACKGROUND AND PURPOSE: Biochemical markers of acute neuronal injury may aid in the diagnosis and management of acute ischemic stroke. Serum samples from the National Institute for Neurological Disorders and Stroke (NINDS) recombinant tissue plasminogen activator Stroke Study were analyzed for the presence of 4 biochemical markers of neuronal, glial, and endothelial cell injury. These biochemical markers, myelin basic protein (MBP), neuron-specific enolase (NSE), S100beta, and soluble thrombomodulin, were studied for an association with initial stroke severity, infarct volume, and functional outcome. METHODS: In the original NINDS study, serum samples were drawn from all patients on presentation to the Emergency Department and at approximately 2 and 24 hours after initiation of study therapy. In this analysis, stored serum samples were available for 359 patients; 107 patients had samples for all 3 time points. Serum marker concentrations were measured by ELISA techniques. We examined the relation between serum concentrations of each marker and the degree of baseline neurological deficit, functional outcome, and infarct size on computed tomography at 24 hours and the effect of fibrinolytic therapy. RESULTS: Higher 24-hour peak concentrations of MBP, NSE, and S100beta were associated with higher National Institutes of Health Stroke Scale baseline scores (r=0.186, P<0.0001; r=0.117, P=0.032; and r=0.263, P<0.0001, respectively). Higher peak concentrations of MBP and S100beta (r=0.209, P<0.0001; r=0.239, P<0.0001) were associated with larger computed tomography lesion volumes. Patients with favorable outcomes had smaller changes in MBP and S100beta (P<0.05) concentrations in the first 24 hours. Soluble thrombomodulin was not associated with any severity or outcome measure. CONCLUSIONS: This study corroborates previous work demonstrating correlations of MBP, NSE, and S100beta with clinical and radiographic features in acute stroke. Despite significantly better outcomes in the tissue plasminogen activator-treated group, we found no difference in the early release of the 4 biomarkers between treatment groups. Further study will define the role of biomarkers in acute stroke management and prognostication.

Acute Disease↗
PubMed2006

Hemostatic activation and outcome after recombinant tissue plasminogen activator therapy for acute ischemic stroke.

BACKGROUND AND PURPOSE: Early thrombolytic therapy with intravenous recombinant tissue plasminogen activator (rtPA) improves clinical outcome in acute ischemic stroke (AIS), but impaired endogenous fibrinolysis, thrombin generation, and vascular injury may hamper the efficacy of thrombolysis. We investigated in an exploratory, post hoc analysis the relationship between hemostatic markers and clinical outcomes among patients included in the National Institute of Neurological Disorders and Stroke (NINDS) rtPA Stroke Study. METHODS: Tissue plasminogen activator (tPA) antigen, thrombin-antithrombin complex (TAT), soluble thrombomodulin, and fibrinogen levels were measured in patients with AIS included in the NINDS rtPA Stroke Study from plasma samples collected at baseline, at 2 hours after treatment, and after 24 hours. RESULTS: TAT and tPA antigen levels peaked at 2 hours selectively in the rtPA treatment group, whereas fibrinogen levels dropped at 2 hours and remained low after 24 hours (P<0.0001 for interaction effects between time and treatment). At 24 hours, higher levels of tPA antigen were associated with a lower chance of favorable outcome (odds ratio [OR]=0.34; 95% CI, 0.14 to 0.82) selectively in the rtPA group, and higher levels of TAT (OR=1.72; 95% CI, 1.26 to 2.34) in the entire cohort and of thrombomodulin selectively in the rtPA group (OR=4.45; 95% CI, 1.26 to 15.67) were associated with higher 3-month mortality. CONCLUSIONS: Hemostatic activation after AIS appears to be independently associated with clinical outcome in patients treated with rtPA. However, because we have tested for multiple associations, some may have been identified by chance alone and require further confirmatory studies. On the basis of this exploratory analysis, there is a rationale to investigate the safety and efficacy of protocols in which rtPA is complemented by agents that are antithrombotic and enhance fibrinolysis.

Acute Disease↗
PubMed2006

Lessons from adult stroke trials.

Before designing epidemiologic, genetic, or treatment trials in pediatric stroke, we should learn from adult trials which preceded. Adult trialists state that there is a need for improved animal models to mimic human disease. Dose-response curves with blinded outcome measures would improve preclinical data. Functional and histologic outcome measures would improve the animal model. In regard to human Phase 2 medication trials, safety, delivery, end points, and surrogate markers are necessary. The detection of biologic activity can be defined in Phase 2B trials. For Phase 3 trials, the experiment needs to be simple with global outcome measures as end points. New statistical designs such as futility analysis may improve and streamline trials in both adults and children. Clinical trials are a long process, and care needs to be incorporated at every step. Why is there a propensity of failed studies for acute ischemic stroke in adults? The reasons include (a) the animal model fails us, (b) the Phase 2 trials are ineffective in defining dose, and (c) the Phase 3 trials are poorly done. Because clinical trials, more often than not, fail to give positive (effective treatment) results, it seems reasonable to attempt to learn from others' past experiences before initiating pediatric stroke trials.

Adult↗
PubMed2006

Racial variation in clinical and immunological manifestations of systemic sclerosis.

OBJECTIVE: To clarify which racial differences in disease manifestations can be attributed to differences in other factors such as gender, education, disease classification, and disease duration. METHODS: The study included white and black patients with systemic sclerosis (SSc) treated at a university hospital rheumatology clinic between November 1997 and April 2003. Demographic, clinical, and immunological measurements were obtained on each subject. Using multivariable statistical techniques we assessed differences in disease manifestations between white and black patients after adjusting for gender and classification and duration of disease. RESULTS: Two hundred sixty-three patients (199 whites, 64 blacks) were enrolled in the study. Blacks experienced an earlier age at disease onset than whites and were significantly more likely to have diffuse disease, digital ulcers, digital pitting, impaired lung function, and anti-RNP, and anti-Ro antibodies. Whites were significantly more likely to have anti-centromere antibodies. CONCLUSION: After adjusting for gender, disease classification, and disease duration, whites and blacks with SSc differ in some clinical and immunological manifestations of disease. Whether these differences can be attributed to genetic or environmental factors remains unknown.

Adult↗
PubMed2005

Applying a phase II futility study design to therapeutic stroke trials.

BACKGROUND AND PURPOSE: Most large, randomized phase III efficacy trials of therapeutic agents in ischemic stroke have failed to find treatment benefit. We determined whether some phase III studies could have been avoided if preceded by smaller single-arm phase II studies to evaluate the futility of proceeding to phase III. METHODS: To provide examples of the application of phase II methodology, we obtained primary outcome data for the active treatment group of 6 phase III ischemic stroke therapy trials. For each study, we estimated the sample size number required for a multistage single-arm study using parameters specified in the original study. We evaluated outcome data for the first number of subjects in the phase III study treatment arm ordered by enrollment dates. We compared the proportion of favorable outcomes to prespecified stopping criteria derived from a single-arm phase II futility design. If the observed proportion of favorable outcomes was less than the stopping criterion, we declared the treatment not sufficiently effective to warrant further evaluation in phase III. RESULTS: We identified 3 trials as futile in phase II; none of 3 showed treatment efficacy in phase III. In the 3 remaining phase II trials in which we did not show futility, one showed efficacy in phase III. CONCLUSIONS: Single-arm phase II futility studies have been underused in stroke research, but provide a strategy for discarding treatments likely to be ineffective in phase III trials.

Clinical Trials as Topic↗
PubMed2005

A responsive outcome for Parkinson's disease neuroprotection futility studies.

Futility studies are designed to test new treatments over a short period in a small number of subjects to determine if those treatments are worthy of larger and longer term studies, or if they should be abandoned. An appropriate outcome measure for a neuroprotection futility study in Parkinson's disease (sensitive to tracking disease progression in the short-term) has not been determined. Data sets from three clinical trials were used to compare Parkinson's disease outcome measures. Total Unified Parkinson's Disease Rating Scale (UPDRS; Mentation + Activities of Daily Living + Motor) change and Motor plus Activities of Daily Living UPDRS change, measured in untreated patients, required the smallest sample sizes of all the outcome measures explored. Other outcomes (UPDRS Motor, UPDRS Activities of Daily Living, and time to need levodopa) required somewhat larger sample sizes. Futility designs in Parkinson's disease are feasible in terms of short duration and small sample size requirements, and this design is being applied in two ongoing Parkinson's disease studies to select agents for future larger and longer term neuroprotection studies.

Clinical Trials as Topic↗
PubMed2005

The impact of imbalances in baseline stroke severity on outcome in the National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator Stroke Study.

STUDY OBJECTIVE: The National Institute of Neurological Disorders and Stroke (NINDS) Recombinant Tissue Plasminogen Activator (rtPA) Stroke Study demonstrated a clinically meaningful and statistically significant benefit of tissue plasminogen activator (tPA). Adjusting for the baseline National Institutes of Health (NIH) Stroke Scale, the benefit of tPA remained. However, other authors suggest that an imbalance in baseline stroke severity between the tPA and placebo groups confounded the results. Another issue that has been raised concerns a possible increase in early mortality for individuals given tPA. In post hoc subgroup analysis, we describe the effect of tPA across a spectrum of time from stroke onset to treatment and stroke severity subgroups. Stroke severity was based on the NIH Stroke Scale. We also compare early mortality (2-week and 30-day) in the tPA and placebo groups. METHODS: Using combined data from the 2 NINDS rtPA Stroke Study trials, we performed post hoc subgroup analyses of 3-month favorable outcome (defined by the NIH Stroke Scale, Barthel, Rankin, and Glasgow Outcome Scales). We categorized patients from the trials into onset to treatment (0 to 90 minutes, 91 to 180 minutes) by NIH Stroke Scale (< or =5, 6 to 20, >20) subgroups. Analyses were adjusted for all variables previously shown to be associated with favorable outcome at 3 months. We also compared early mortality within onset-to-treatment subgroups. RESULTS: For all the 12 specified onset-to-treatment-NIH Stroke Scale subgroups, the adjusted odds ratio for a favorable 3-month outcome was greater than 1.0 and favored tPA. We detected no difference in mortality between patients treated with rtPA and those treated with placebo by 2 weeks posttreatment (rtPA=9%, placebo=13%; P =.49) or by 30 days (rtPA=11%, placebo=16%; P =.30). CONCLUSION: These are descriptive post hoc subgroup analyses. Using cut points defined in previous critiques of the NINDS trials, these analyses give results consistent with previous NINDS Study Group reports. Baseline NIH Stroke Scale imbalance does not account for the better outcome of rtPA-treated patients.

Brain Ischemia↗
PubMed2005

Quasi-likelihood estimation for relative risk regression models.

For a prospective randomized clinical trial with two groups, the relative risk can be used as a measure of treatment effect and is directly interpretable as the ratio of success probabilities in the new treatment group versus the placebo group. For a prospective study with many covariates and a binary outcome (success or failure), relative risk regression may be of interest. If we model the log of the success probability as a linear function of covariates, the regression coefficients are log-relative risks. However, using such a log-linear model with a Bernoulli likelihood can lead to convergence problems in the Newton-Raphson algorithm. This is likely to occur when the success probabilities are close to one. A constrained likelihood method proposed by Wacholder (1986, American Journal of Epidemiology 123, 174-184), also has convergence problems. We propose a quasi-likelihood method of moments technique in which we naively assume the Bernoulli outcome is Poisson, with the mean (success probability) following a log-linear model. We use the Poisson maximum likelihood equations to estimate the regression coefficients without constraints. Using method of moment ideas, one can show that the estimates using the Poisson likelihood will be consistent and asymptotically normal. We apply these methods to a double-blinded randomized trial in primary biliary cirrhosis of the liver (Markus et al., 1989, New England Journal of Medicine 320, 1709-1713).

Antibiotics, Antineoplastic↗
PubMed2005

Adjusting O'Brien's test to control type I error for the generalized nonparametric Behrens-Fisher problem.

O'Brien (1984, Biometrics 40, 1079-1087) introduced a simple nonparametric test procedure for testing whether multiple outcomes in one treatment group have consistently larger values than outcomes in the other treatment group. We first explore the theoretical properties of O'Brien's test. We then extend it to the general nonparametric Behrens-Fisher hypothesis problem when no assumption is made regarding the shape of the distributions. We provide conditions when O'Brien's test controls its error probability asymptotically and when it fails. We also provide adjusted tests when the conditions do not hold. Throughout this article, we do not assume that all outcomes are continuous. Simulations are performed to compare the adjusted tests to O'Brien's test. The difference is also illustrated using data from a Parkinson's disease clinical trial.

Algorithms↗
PubMed2005

Non-linearity of Parkinson's disease progression: implications for sample size calculations in clinical trials.

BACKGROUND: Estimation of sample size for long-term studies of neuroprotection in Parkinson's disease requires information on expected clinical decline. Values may be obtained by analyzing existing long-term data sets or by prediction models of clinical decline applied to available data from shorter-term trials. The most commonly used measure to track clinical decline is the Unified Parkinson's Disease Rating Scale (UPDRS) but this measure is also affected by symptomatic therapy. Models can help better understand behavior of the UPDRS after initiation of symptomatic therapy when scores will improve and eventually start deteriorating again. PURPOSE: To understand how UPDRS scores progress after initiation of symptomatic therapy and how this progression impacts sample size calculations. METHODS: We developed a non-linear model of UPDRS after introduction of symptomatic therapy. The model is specified as a non-linear mixed effects model and is applied to three different data sets from clinical trials. The model is then used to produce estimates for the change in UPDRS and its associated variance for a period of up to five years of follow-up. The estimates produced by the model serve as the basis for sample-size calculations for different lengths of follow-up (one through five years) and for different values of clinically meaningful change in UPDRS. RESULTS: Despite differences in the short-term benefit of the dopaminergic drugs, after a period of approximately six months UPDRS scores progress linearly at an estimated rate of approximately three points a year. The sample size that is required for a clinical trial where the baseline coincides with initiation of symptomatic therapy is very large. On the other hand, if baseline is set at six months after initiation of symptomatic therapy then the sample size required decreases with length of follow-up. LIMITATIONS: Model specification and estimation is based on a set of simplifying assumptions regarding the progression of individual level UPDRS scores. CONCLUSIONS: Sample size calculations based on these estimates indicate a substantial reduction in sample size if patients are required to be on symptomatic treatment for a period of time before being randomized to a neuroprotective trial.

Antiparkinson Agents↗
PubMed2005

Nonprescribed antimicrobial drugs in Latino community, South Carolina.

We investigated in a sample of Latinos the practices of antimicrobial drug importation and use of nonprescribed antimicrobial drugs. In interviews conducted with 219 adults, we assessed health beliefs and past and present behaviors consistent with acquiring antimicrobial drugs without a prescription in the United States. Many (30.6%) believed that antimicrobial drugs should be available in the United States without a prescription. Furthermore, 16.4% had transported nonprescribed antimicrobial drugs into the United States, and 19.2% had acquired antimicrobial agents in the United States without a prescription. A stepwise logistic regression analysis showed that the best predictors of having acquired nonprescribed antimicrobial drugs in the United States were beliefs and behavior consistent with limited regulations on such drugs. Many persons within the Latino community self-medicate with antimicrobial drugs obtained without a prescription both inside and outside the United States, which adds to the reservoir of antimicrobial drugs in the United States.

Adult↗
PubMed2005

Correlates of depression, including overall and gastrointestinal functional status, among patients with systemic sclerosis.

OBJECTIVE: Patients with systemic sclerosis (SSc) may develop psychological problems in addition to physiologic symptoms. We investigated whether demographic and clinical factors are associated with comorbid depression. METHODS: From a university hospital's rheumatology clinic, 72 SSc patients who completed 3 questionnaires [Center for Epidemiologic Studies Depression (CES-D) scale, an abbreviated version of a functional status instrument, the Scleroderma Health Assessment Questionnaire (SHAQ), and the Gastrointestinal Quality of Life Index (GIQLI)] during an examination were recruited into the study. Correlations among scores on the 3 questionnaires [including upper and lower gastrointestinal (GI) tract subscales of the GIQLI] were calculated, and associations between CES-D scores and a variety of demographic and clinical characteristics were examined using stepwise linear regression. RESULTS: Higher CES-D scores (i.e., more depression symptoms) were significantly correlated with upper (r = -0.48, p < 0.0001) and lower (r = -0.41, p < 0.001) GI tract dysfunction and worse overall functional status (r = 0.51, p < 0.0001). Stepwise regression indicated that higher levels of depression were independently associated with lower levels of education (p < 0.01), worse upper GI tract functioning (p = 0.019), worse functional status (p = 0.34), current corticosteroid use (p = 0.061), and cardiac involvement (p = 0.086). CONCLUSION: Decreased functional status and abnormal GI functioning are significantly correlated with depression among patients with SSc. Other demographic and clinical indicators are also associated with depression.

Cross-Sectional Studies↗
PubMed2005

Demographic and clinical factors associated with in-hospital death among patients with systemic sclerosis.

OBJECTIVE: To examine demographic and clinical predictors of in-hospital death of patients with systemic sclerosis (SSc) and determine to what extent apparent racial differences may be attributed to socioeconomic factors. METHODS: Data were obtained on all hospitalizations in South Carolina for patients who were ever hospitalized between 1996 and 2000 with a diagnosis of SSc. Multiple logistic regression was used to examine predictors of in-hospital death among whites, blacks, and other patients. RESULTS: Proportions of in-hospital deaths among blacks (23.0%) and others (27.7%) were higher than among whites (15.6%), a finding that remained after adjustment for other sociodemographic and clinical factors (black/white odds ratio: 1.70, 95% confidence interval: 1.01-2.86; other/white OR 2.06, 95% CI 1.04-4.09). Other factors associated with in-hospital death included transfer status, emergency admission, length of stay, number of hospitalizations during the time period, and presence of congestive heart failure (OR 1.79; 95% CI 1.06-3.03) or hypertension (OR 0.41; 95% CI 0.23-0.71). CONCLUSION: Black and other non-white patients with SSc appear to experience an elevated risk of death during their hospital stays. Further research is necessary to understand the reasons for these disparities.

Adult↗
PubMed2004

Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.

BACKGROUND: Quick administration of intravenous recombinant tissue plasminogen activator (rt-PA) after stroke improved outcomes in previous trials. We aimed to analyse combined data for individual patients to confirm the importance of rapid treatment. METHODS: We pooled common data elements from six randomised placebo-controlled trials of intravenous rt-PA. Using multivariable logistic regression we assessed the relation of the interval from stroke onset to start of treatment (OTT) on favourable 3-month outcome and on the occurrence of clinically relevant parenchymal haemorrhage. FINDINGS: Treatment was started within 360 min of onset of stroke in 2775 patients randomly allocated to rt-PA or placebo. Median age was 68 years, median baseline National Institute of Health Stroke Scale (NIHSS) 11, and median OTT 243 min. Odds of a favourable 3-month outcome increased as OTT decreased (p=0.005). Odds were 2.8 (95% CI 1.8-4.5) for 0-90 min, 1.6 (1.1-2.2) for 91-180 min, 1.4 (1.1-1.9) for 181-270 min, and 1.2 (0.9-1.5) for 271-360 min in favour of the rt-PA group. The hazard ratio for death adjusted for baseline NIHSS was not different from 1.0 for the 0-90, 91-180, and 181-270 min intervals; for 271-360 min it was 1.45 (1.02-2.07). Haemorrhage was seen in 82 (5.9%) rt-PA patients and 15 (1.1%) controls (p<0.0001). Haemorrhage was not associated with OTT but was with rt-PA treatment (p=0.0001) and age (p=0.0002). INTERPRETATION: The sooner that rt-PA is given to stroke patients, the greater the benefit, especially if started within 90 min. Our results suggest a potential benefit beyond 3 h, but this potential might come with some risks.

Aged↗
PubMed2004

Antiphospholipid antibodies and subsequent thrombo-occlusive events in patients with ischemic stroke.

CONTEXT: The presence of antiphospholipid antibodies (aPL) has been associated with vascular occlusive events. However, the role of aPL in predicting ischemic events, particularly recurrent ischemic stroke, is controversial. OBJECTIVE: To evaluate the effect of baseline aPL positivity (ie, positivity for anticardiolipin antibodies [aCL], lupus anticoagulant antibodies [LA], or both) on subsequent thrombo-occlusive events, including recurrent stroke. DESIGN, SETTING, AND PARTICIPANTS: The Antiphospholipid Antibodies and Stroke Study (APASS), a prospective cohort study within the Warfarin vs Aspirin Recurrent Stroke Study (WARSS), a randomized double-blind trial (N = 2206) conducted at multiple US clinical sites from June 1993 through June 2000 and comparing adjusted-dose warfarin (target international normalized ratio, 1.4-2.8) and aspirin (325 mg/d) for prevention of recurrent stroke or death. APASS participants were 1770 (80%) WARSS participants who consented to enroll in the APASS, with usable baseline blood samples drawn prior to randomization to the WARSS and analyzed for aPL status within 90 days of index stroke by a central independent laboratory. Quality assurance was performed on approximately 10% of samples by a second independent laboratory. MAIN OUTCOME MEASURE: Two-year rate of the composite end point of death from any cause, ischemic stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism, and other systemic thrombo-occlusive events. The primary analysis assessed the outcome associated with aPL positivity within each WARSS treatment group separately, after risk-factor adjustment (since these aPL-positive vs aPL-negative comparisons were not randomized). RESULTS: Of the 1770 APASS patients, 720 (41%) were classified as aPL-positive and 1050 (59%) as aPL-negative. There was no increased risk of thrombo-occlusive events associated with baseline aPL status in patients treated with either warfarin (relative risk [RR], 0.99; 95% confidence interval [CI], 0.75-1.31; P =.94), or aspirin (RR, 0.94; 95% CI, 0.70-1.28; P =.71). The overall event rate was 22.2% among aPL-positive and 21.8% among aPL-negative patients. There was no treatment x aPL interaction (P =.91). Patients with baseline positivity for both LA and aCL antibodies tended to have a higher event rate (31.7%) than did patients who tested negative for both antibodies (24.0%) (unadjusted RR, 1.36; 95% CI, 0.97-1.92; P =.07). Classification and regression tree analyses did not identify a specific LA test or aCL isotype or titer that was associated with increased risk of thrombo-occlusive event. CONCLUSIONS: The presence of aPL (either LA or aCL) among patients with ischemic stroke does not predict either increased risk for subsequent vascular occlusive events over 2 years or a differential response to aspirin or warfarin therapy. Routine screening for aPL in patients with ischemic stroke does not appear warranted.

Aged↗
PubMed2004

An assessment of racial differences in clinical practices for hypertension at primary care sites for medically underserved patients.

Ethnic disparities in hypertension-related outcomes may relate to differences in medical care. This study assessed primary care sites serving low-income patients to determine if differences in process and treatment indicators might contribute to disparities in outcomes. Eight sites were enrolled with 100,000 patients, collectively. Trained nurses abstracted a random sample of medical records for diagnoses, laboratory data, medications, and demographic variables. Data were obtained on 1250 white and 2786 African-American adults. African Americans were more likely (p<0.01) to be hypertensive (44% vs. 23%) and diabetic (16% vs. 8%) than whites. African Americans were more likely to have serum creatinine, potassium, lipid, and glycosylated hemoglobin values recorded in the medical record than whites (p<0.01). African-American hypertensives were more likely (p<0.05) than white hypertensives to receive calcium channel blockers, angiotensin-converting enzyme inhibitors, diuretics, and combination therapy. Thus, there appeared to be little difference in the level of care between the two groups. Based on the sites examined, ethnic variations in important process and treatment indicators do not explain racial differences in cardiovascular and renal outcomes.

Adolescent↗