Biomedical subjects

E John Orav

Publications and source records attributed to E John Orav.

At least 19 recordsLinked to original sources

PubMed2006

Estimates of prenatal abstinence from alcohol: a matter of perspective.

Abstinence from alcohol has been recommended for both pregnant and pre-conceptional women. The purpose of this study is to compare self and partner reports of abstinence from alcohol in a sample of 253 pregnant women who were T-ACE (Tolerance, Annoy, Cut-down, Eye-opener) alcohol screen positive. Dyads' reports of the women's abstinence from alcohol before, during, and after pregnancy were compared. Based on their own self-report, less than 20% of the pregnant women were abstinent in their first trimester and about half were abstinent for the rest of their pregnancy. Partners significantly over-estimated the women's abstinence from alcohol at all points except in the post-partum period when the dyad had the highest rate of agreement (85.4%). Reasons for the discrepancies in the self and partner reports of prenatal abstinence, and how partners might influence such behavior remain speculative, but identify areas for future research and prevention.

Adult↗

PubMed2006

Correlates of electronic health record adoption in office practices: a statewide survey.

OBJECTIVE: Despite emerging evidence that electronic health records (EHRs) can improve the efficiency and quality of medical care, most physicians in office practice in the United States do not currently use an EHR. We sought to measure the correlates of EHR adoption. DESIGN: Mailed survey to a stratified random sample of all medical practices in Massachusetts in 2005, with one physician per practice randomly selected for survey. MEASUREMENTS: EHR adoption rates. RESULTS: The response rate was 71% (1345/1884). Overall, while 45% of physicians were using an EHR, EHRs were present in only 23% of practices. In multivariate analysis, practice size was strongly correlated with EHR adoption; 52% of practices with 7 or more physicians had an EHR, as compared with 14% of solo practices (adjusted odds ratio, 3.66; 95% confidence interval, 2.28-5.87). Hospital-based practices (adjusted odds ratio, 2.44; 95% confidence interval, 1.53-3.91) and practices that teach medical students or residents (adjusted odds ratio, 2.30; 95% confidence interval, 1.60-3.31) were more likely to have an EHR. The most frequently cited barriers to adoption were start-up financial costs (84%), ongoing financial costs (82%), and loss of productivity (81%). CONCLUSIONS: While almost half of physicians in Massachusetts are using an EHR, fewer than one in four practices in Massachusetts have adopted EHRs. Adoption rates are lower in smaller practices, those not affiliated with hospitals, and those that do not teach medical students or residents. Interventions to expand EHR use must address both financial and non-financial barriers, especially among smaller practices.

Attitude to Computers↗

PubMed2006

Incidence, causes, and outcomes of dilated cardiomyopathy in children.

CONTEXT: Dilated cardiomyopathy (DCM) is the most common form of cardiomyopathy and cause of cardiac transplantation in children. However, the epidemiology and clinical course of DCM in children are not well established. OBJECTIVE: To provide a detailed description of the incidence, causes, outcomes, and related risk factors for DCM in children. DESIGN AND SETTING: Longitudinal study based on a population-based, prospective cohort of children diagnosed as having DCM since January 1, 1996, at 89 pediatric cardiac centers and a retrospectively collected cohort of patients seen primarily at large tertiary care centers in North America and who had diagnoses between January 1, 1990, and December 31, 1995, and were enrolled through February 2003. PARTICIPANTS: A total of 1426 children from the United States and Canada diagnosed as having DCM at younger than 18 years. Primary DCM was determined by strict echocardiographic and/or pathologic criteria. Patients with disease due to endocrine, immunologic, drug toxicity, and other causes were excluded. MAIN OUTCOME MEASURES: Annual incidence per 100,000 children; mortality; cardiac transplantation. RESULTS: The annual incidence of DCM in children younger than 18 years was 0.57 cases per 100,000 per year overall. The annual incidence was higher in boys than in girls (0.66 vs 0.47 cases per 100,000; P<.001), in blacks than in whites (0.98 vs 0.46 cases per 100,000; P<.001), and in infants (<1 year) than in children (4.40 vs 0.34 cases per 100,000; P<.001). The majority of children (66%) had idiopathic disease. The most common known causes were myocarditis (46%) and neuromuscular disease (26%). The 1- and 5-year rates of death or transplantation were 31% and 46%, respectively. Independent risk factors at DCM diagnosis for subsequent death or transplantation were older age, congestive heart failure, lower left ventricular fractional shortening Z score, and cause of DCM (P<.001 for all). CONCLUSIONS: In children, DCM is a diverse disorder with outcomes that depend largely on cause, age, and heart failure status at presentation. Race, sex, and age affect the incidence of disease. Most children do not have a known cause of DCM, which limits the potential for disease-specific therapies.

Adolescent↗

PubMed2006

Stages of change and prenatal alcohol use.

This study evaluated stage of change as a predictor of alcohol use in a sample of 301 pregnant women who were either in the precontemplation (62%) or in the action (38%) stage of change in their first trimester. Stage of change distinguished between different patterns of alcohol consumption before and after pregnancy. Those in the precontemplation stage drank more per episode and more often before pregnancy than those in the action stage. The precontemplation group also had a significantly greater quantity of alcohol after pregnancy. However, stage of change did not directly predict subsequent prenatal alcohol use. Previous alcohol use, age, and education were the most significant predictors of prenatal drinks per drinking day. Temptation to drink alcohol was the best predictor of prenatal drinking frequency after study enrollment. Women in both stages of change reduced the quantity and the frequency of their alcohol consumption while pregnant and achieved comparable rates of abstinence.

Adult↗

PubMed2006

Brief intervention for prenatal alcohol use: the role of drinking goal selection.

The behavioral problems and cognitive deficits resulting from even small amounts of prenatal alcohol exposure can be significant and enduring but completely preventable. The purpose of this study was to examine the impact of a prenatal drinking goal selected during a brief intervention for 115 pregnant women and their partners on subsequent consumption. Higher proportions of women having their first pregnancy chose abstinence as a goal over drinking reduction. Goal selection was highly predictive of subsequent drinking behavior. Interestingly, the participants who were abstinent at enrollment and who chose to remain abstinent had the highest rates of abstinence. In contrast, the women who chose cutting down on drinking were the least likely to drink less subsequently, despite recognizing more situations putting them at risk for drinking and identifying more alternatives to consumption. We conclude that goal choice in behavioral self-management of alcohol use by pregnant women is critical.

Adult↗

PubMed2006

Reliability of a structured assessment for nonclinicians to detect delirium among new admissions to postacute care.

OBJECTIVE: To evaluate the interrater reliability of a structured delirium assessment method for nonclinician interviewers in elderly patients newly admitted for postacute care. DESIGN: Prospective assessment using dyads of nonclinician raters. SETTING: Postacute (Medicare) units at 6 skilled nursing facilities. PARTICIPANTS: Forty elderly patients newly admitted for postacute care from medical or surgical units at acute care hospitals. MEASUREMENTS: Subjects underwent dual delirium assessments within 5 days of admission. The standardized delirium assessment included the Mini-Mental Status Exam and Digit Span to assess overall cognitive function, the Delirium Symptom Interview to elicit specific delirium symptoms, the Memorial Delirium Assessment Scale to measure the severity of delirium, and the Confusion Assessment Method (CAM) to make the diagnosis of delirium. A coding protocol that linked observations to specific coding was used to improve reliability. RESULTS: The structured delirium assessment process produced very high interobserver agreement for all instruments. Kappa for agreement on delirium diagnosis was 0.95. CONCLUSIONS: Nonclinician interviewers using a structured delirium assessment achieved reliability that rivaled or exceeded that of trained clinical assessors in other studies. Nonclinicians may offer an effective alternative for the assessment of delirium among postacute patients in skilled nursing facilities.

Aged↗

PubMed2006

Pacemaker implantation and quality of life in the Mode Selection Trial (MOST).

BACKGROUND: Dual-chamber pacemakers restore AV synchrony compared with ventricular pacemakers, but the effects on health-related quality of life (QOL) are uncertain. OBJECTIVES: The purpose of this study was to assess the effect of pacemaker implantation, clinical factors, and pacing mode on QOL. METHODS: The Mode Selection Trial (MOST) randomized 2,010 patients with sinus node dysfunction to rate-modulated right ventricular (VVIR) or dual-chamber (DDDR) pacing. A longitudinal analysis of serial QOL measures (Short Form-36 [SF-36], Specific Activity Scale, and time trade-off utility) was performed. In patients who crossed over from VVIR to DDDR because of severe pacemaker syndrome, the last known QOL prior to crossover was carried forward. RESULTS: Pacemaker implantation resulted in substantial improvement in almost all QOL measures. Subjects 75 years or older experienced significantly less improvement in functional status and physical component summary scores than did younger subjects. In longitudinal analyses of the effect of pacing mode on QOL, significant improvement in three SF-36 subscales was observed with DDDR pacing compared with VVIR pacing: role physical [62.8 points (95% confidence interval [CI] 60.2, 65.5) vs 56.4 (95% CI 53.7, 59.1)], role emotional [85.0 (95% CI 82.9, 87.0) vs 81.9 (95% CI 79.9, 84.0)], and vitality [51.8 (95% CI 50.3, 53.3) vs 49.3 (95% CI 47.8, 50.7)], but not in other SF-36 subscales, the Specific Activity Scale, or utilities. The gains in QOL were larger than the declines associated with 1 year of aging but smaller than those associated with heart failure. CONCLUSION: Pacemaker implantation improved health-related QOL. The mode selected was associated with much smaller, but significant, improvements in several domains, particularly role physical function.

Aged↗

PubMed2006

Effect of cholecalciferol plus calcium on falling in ambulatory older men and women: a 3-year randomized controlled trial.

BACKGROUND: A recent meta-analysis found that cholecalciferol (vitamin D) should reduce falls by more than 20%. However, little is known about whether supplemental cholecalciferol plus calcium citrate malate will lower the long-term risk of falling in men, active older individuals, and older individuals with higher 25-hydroxyvitamin D levels. METHODS: We studied the effect of 3-year supplementation with cholecalciferol-calcium on the risk of falling at least once in 199 men and 246 women 65 years or older and living at home. Individuals received 700 IU of cholecalciferol plus 500 mg of calcium citrate malate per day or placebo in a randomized double-blind manner. Subjects were classified as less physically active if physical activity was below the median level. Low 25-hydroxyvitamin D levels were classified as those below 32 ng/mL (<80 nmol/L). RESULTS: In 3 years, 55% of women and 45% of men reported at least 1 fall. Mean +/- SD baseline 25-hydroxyvitamin D levels were 26.6 +/- 12.7 ng/mL (66.4 +/- 31.7 nmol/L) in women and 33.2 +/- 14.2 ng/mL (82.9 +/- 34.9) in men. Cholecalciferol-calcium significantly reduced the odds of falling in women (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.30-0.97), but not in men (OR, 0.93; 95% CI, 0.50-1.72). Fall reduction was most pronounced in less active women (OR, 0.35; 95% CI, 0.15-0.81). Baseline 25-hydroxyvitamin D level did not modulate the treatment effect. CONCLUSIONS: Long-term dietary cholecalciferol-calcium supplementation reduces the odds of falling in ambulatory older women by 46%, and especially in less active women by 65%. Supplementation had a neutral effect in men independent of their physical activity level.

Accidental Falls↗

PubMed2006

Association between delirium resolution and functional recovery among newly admitted postacute facility patients.

BACKGROUND: Delirium is common among hospitalized elders and may persist for months. The adverse impact of delirium on independence may increasingly occur in the postacute care (PAC) setting. The purpose of this study is to examine the association between delirium resolution and functional recovery in skilled nursing facilities specializing in PAC. METHODS: Patients were screened for delirium on admission after an acute hospitalization at PAC facilities. Only patients with "Confusion Assessment Method"-defined delirium were enrolled. Delirium and activities of daily living were assessed prehospital, at PAC admission, and at four (2-week, and 1-, 3-, and 6-month) follow-up assessments to measure functional ability. Four distinct delirium resolution groups were created ranging from resolution within 2 weeks without recurrence to no resolution over 6 months. Repeated-measures analysis of covariance was used to determine if functional performance differed over time by delirium resolution status. RESULTS: Among the 393 PAC patients, functional recovery differed significantly (p <.0001) by delirium resolution status. Patients who resolved their delirium by 2 weeks without recurrence regained 100% of their prehospital functional level, whereas patients who never resolved their delirium retained less than 50% of their prehospital functional level. Patients with slower resolving delirium and recurrent delirium had intermediate functional outcomes. CONCLUSIONS: Resolution of delirium among PAC patients appears to be a prerequisite for functional recovery. Delirium resolution within 2 weeks without recurrence is associated with excellent functional recovery. Effective strategies to resolve delirium promptly and prevent its recurrence in the PAC setting will likely benefit patient rehabilitation and functional recovery.

Activities of Daily Living↗

PubMed2006

Distinctive patterns of medical care utilization in patients who somatize.

BACKGROUND: Somatizing patients have maladaptive and increased rates of medical care utilization. If there were a way of routinely identifying such patients, one that did not require intensive, case-by-case review, they could be targeted for specific interventions to improve their use of medical care. OBJECTIVE: We sought to identify patterns of medical care utilization that would distinguish somatizing and nonsomatizing medical outpatients with acceptable sensitivity and specificity. DESIGN: Subjects completed questionnaires assessing somatization and sociodemographic characteristics. Their medical care utilization was obtained for the 12 months preceding the index visit. We then used multivariable logistic regression and recursive partitioning to identify patients with a provisional diagnosis of somatoform disorder. These exploratory models used various patterns of medical care utilization and sociodemographic characteristics as the independent variables. SUBJECTS: We studied consecutive adults attending 2 primary care practices on randomly chosen days. MEASURES: The provisional diagnosis of a somatoform disorder was assessed with a 15-item self-report questionnaire. The number of primary care visits, specialty visits, mental health visits, emergency visits, and inpatient and outpatient costs were obtained for the 12 months preceding the index visit from our hospital's automated medical records, which also provided a rating of aggregate medical morbidity. Self-reported utilization outside our hospital system was obtained from a subsample of patients. RESULTS: Complete data were obtained on 1440 patients. Somatizing patients had more specialty care than primary care visits, higher outpatient than inpatient costs, and more emergency visits than nonsomatizing patients. A regression model containing 7 measures of utilization and 4 sociodemographic characteristics distinguished somatizing and nonsomatizing patients with a c-statistic = 0.73. Recursive partitioning identified 10 terminal nodes with a very high specificity (99%) but a very low sensitivity (15%). CONCLUSIONS: We identified 7 discrete patterns of medical care utilization that distinguished somatizing and nonsomatizing patients. However, they did so with only modest specificity and sensitivity. This algorithm might be used effectively as the first step in a 2-step screening procedure whose second step would entail more intensive screening or individual, case-by-case review to identify somatizing patients in primary care practice.

Adult↗

PubMed2006

Identifying risk drinking in expectant fathers.

BACKGROUND: Identification of risk drinking in expectant fathers may be helpful as an important part of efforts to minimize maternal alcohol use, and as an opportunity to inform them about a problematic practice during a critical developmental stage for the couple. The purpose of this study was to evaluate the T-ACE screening questionnaire, which asks about tolerance to alcohol, being annoyed by other's comments about drinking, attempts to cut down, and having a drink first thing in the morning ("eye-opener"), in the male partners of pregnant women who themselves were T-ACE positive. METHODS: Two hundred fifty-four male partners were asked to complete the T-ACE embedded in a health survey, the Alcohol Use Disorders Identification Test (AUDIT), and other questions about their alcohol use in the past 30 days when their pregnant partners had a median gestation of 11.5 weeks (T1). After delivery, male partners again completed the T-ACE and quantity-frequency questions (T2). The predictive ability of the T-ACE and AUDIT was compared, using risk drinking (>4 drinks/day or >14 drinks/week) as the criterion standard. RESULTS: A substantial minority of male partners had risk drinking, 31 percent at T1 and 25 percent at T2. Although the AUDIT was better than the T-ACE as an independent predictor of risk drinking, the latter was most accurate when the tolerance threshold exceeded 2 drinks, the same established for pregnant women. The sensitivity (T1= 84.6%, T2= 82.8%) and specificity (T1= 43.8%, T2= 51.1%) of the T-ACE at this threshold compared favorably with those of the AUDIT at the standard cut point of 8. CONCLUSIONS: The T-ACE may be a practical way for clinicians to identify risk drinking in both pregnant women and expectant fathers.

Adolescent↗

PubMed2006

Alcohol use by pregnant women: partners, knowledge, and other predictors.

OBJECTIVE: The impact of a couple's knowledge about healthy pregnancy habits involving alcohol and substance use was assessed in the context of other factors previously identified to predict prenatal alcohol consumption in a sample of 254 pregnant women and their male partners. METHOD: Couples were asked to assess independently a series of statements (true or false) describing the consequences of prenatal substance exposure, while also providing information about their own drinking. RESULTS: Although the couples demonstrated good knowledge of healthy habits during pregnancy, they did not agree when the element of chance was considered. Median household income was more highly predictive of a pregnant woman's knowledge score than her partner's score. In turn, the subject's knowledge of healthy pregnancy habits as manifested in the assessment score had only a weak relationship with prenatal alcohol consumption. Previous alcohol use by the pregnant woman was the strongest predictor of prenatal alcohol use. CONCLUSIONS: Because previous alcohol consumption use by the pregnant woman was the strongest predictor of prenatal alcohol use, the importance of its accurate identification is emphasized. Although pending further investigation, knowledge about healthy pregnancy behaviors may exert greater impact if it is shared by a pregnant woman and her partner.

Adult↗

PubMed2006

Factors associated with establishing a causal diagnosis for children with cardiomyopathy.

OBJECTIVE: The goal was to identify the clinical variables associated with establishing a cause of cardiomyopathy in children. METHODS: The Pediatric Cardiomyopathy Registry contains clinical and causal testing information for 916 children who were diagnosed as having cardiomyopathy in North America between 1990 and 1995. Children with a causal diagnosis were compared with those without with respect to several demographic, clinical, and causal testing variables. RESULTS: Cardiomyopathy was 1 of 4 types, hypertrophic (34.2%), dilated (53.8%), restrictive (3.2%), or other or mixed (8.9%). Only one third of cases had a known cause. Children with a known cause for hypertrophic cardiomyopathy were more likely to be female, to be relatively smaller, to present with congestive heart failure, and to have increased left ventricular posterior wall thickness without outflow tract obstruction. For dilated cardiomyopathy, a known cause was associated with older age, lower heart rate, smaller left ventricular dimensions, and greater shortening fraction. Family history of cardiomyopathy predicted a significantly higher rate of causal diagnoses for all cardiomyopathy types, whereas family histories of genetic syndromes and sudden death were also predictive of a cause for hypertrophic and dilated cardiomyopathies. For hypertrophic cardiomyopathy, only blood and urine testing was associated with a causal diagnosis, whereas both viral serologic testing or culture and endomyocardial biopsy were independent predictors of a causal diagnosis in dilated cardiomyopathy. CONCLUSIONS: Certain patient characteristics, family history, echocardiographic findings, laboratory testing, and biopsy were associated significantly with establishing a cause of pediatric cardiomyopathy. Early endomyocardial biopsy should be considered strongly for children with dilated cardiomyopathy, for definitive diagnosis of viral myocarditis. Although not widely used, skeletal muscle biopsy may yield a cause for some patients with hypertrophic cardiomyopathy and for patients suspected of having a mitochondrial disorder.

Biopsy↗

PubMed2005

Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials.

BACKGROUND: Binary angiographic and clinical restenosis rates can vary widely between clinical studies, even for the same stent, influenced heavily by case-mix covariates that differ among observational and randomized trials intended to assess a given stent system. We hypothesized that mean in-stent late loss might be a more stable estimator of restenosis propensity across such studies. METHODS AND RESULTS: In 46 trials of drug-eluting and bare-metal stenting, increasing mean late loss was associated with higher target lesion revascularization (TLR) rates (P<0.001). When the class of bare-metal stents was compared with the class of effective drug-eluting stents, late loss was more discriminating than TLR as measured by the high intraclass correlation coefficient (rho) (late loss, rho=0.71 versus TLR, rho=0.22; 95% CI of difference=0.33, 0.65). When the individual drug-eluting stents and bare-metal stents were compared, late loss was a better discriminator than TLR (0.68 versus 0.19; 95% CI of difference=0.24, 0.60). Greater adjustments of study covariates are needed to stabilize assessments of TLR compared with late loss because of greater influence of reference vessel diameter on TLR than on in-stent late loss. Optimization of late loss with the use of a novel method of standardization according to diabetes prevalence and mean lesion length resulted in minor adjustments in late loss (<0.08 mm for 90% of reported trials) and an ordered array of mean late loss values for the stent systems studied. CONCLUSIONS: Late loss is more reliable than restenosis rates for discriminating restenosis propensity between new drug-eluting stent platforms across studies and might be the optimum end point for evaluating drug-eluting stents in early, nonrandomized studies.

Blood Vessel Prosthesis Implantation↗

PubMed2005

Racial trends in the use of major procedures among the elderly.

BACKGROUND: Differences in the use of major procedures according to patients' race are well known. Whether national and local initiatives to reduce these differences have been successful is unknown. METHODS: We examined data for men and women enrolled in Medicare from 1992 through 2001 on annual age-standardized rates of receipt of nine surgical procedures previously shown to have disparities in the rates at which they were performed in black patients and in white patients. We also examined data according to hospital-referral region for three of the nine procedures: coronary-artery bypass grafting (CABG), carotid endarterectomy, and total hip replacement. RESULTS: Nationally, in 1992, the rates of receipt for all the procedures examined were higher among white patients than among black patients. The difference between the rates among whites and blacks increased significantly between 1992 and 2001 for five of the nine procedures, remained unchanged for three procedures, and narrowed significantly for one procedure. We examined rates of CABG, carotid endarterectomy, and total hip replacement in 158 hospital-referral regions (79 hospital-referral regions for black men and white men and 79 for black women and white women) with an adequate number of persons for each procedure. We found that in the early 1990s, whites had higher rates for these procedures than blacks in every hospital-referral region. By 2001, the difference between whites and blacks (both men and women) in the rates of these procedures narrowed significantly in 22 hospital-referral regions, widened significantly in 42, and were not significantly changed in the remaining hospital-referral regions. At the end of the study period, we found no hospital-referral region in which the difference in rates between whites and blacks was eliminated for men or women with regard to any of these three procedures. CONCLUSIONS: For the decade of the 1990s, we found no evidence, either nationally or locally, that efforts to eliminate racial disparities in the use of high-cost surgical procedures were successful.

Aged↗

PubMed2005

Care in U.S. hospitals--the Hospital Quality Alliance program.

BACKGROUND: The Hospital Quality Alliance (HQA) is the first initiative that routinely reports data on hospitals' performance nationally. Heretofore, such data have been unavailable. METHODS: We used data collected by the Centers for Medicare and Medicaid Services on 10 indicators of the quality of care for acute myocardial infarction, congestive heart failure, and pneumonia. The main outcome measures were hospitals' performance with respect to each indicator and summary scores for each clinical condition. Predictors of a high level of performance were determined with the use of multivariable linear regression. RESULTS: A total of 3558 hospitals reported data on at least one stable measure (defined as information obtained from discharge data from at least 25 patients) during the first half of 2004. Median performance scores (expressed as the percentage of patients who satisfied the criterion) were at least 90 percent for 5 of the 10 measures but lower for the other 5. Performance varied moderately among large hospital-referral regions, with the top-ranked regions scoring 12 percentage points (for acute myocardial infarction) to 23 percentage points (for pneumonia) higher than the bottom-ranked regions. A high quality of care for acute myocardial infarction predicted a high quality of care for congestive heart failure but was only marginally better than chance at predicting a high quality of care for pneumonia. Characteristics associated with small but significant increases in performance included being an academic hospital, being in the Northeast or Midwest, and being a not-for-profit hospital. CONCLUSIONS: Analysis of data from the new HQA national reporting system shows that performance varies among hospitals and across indicators. Given this variation and small differences based on hospitals' characteristics, performance reporting will probably need to include numerous clinical conditions from a broad range of hospitals.

Databases as Topic↗

PubMed2005

Late loss in lumen diameter and binary restenosis for drug-eluting stent comparison.

BACKGROUND: Published rates of coronary restenosis have fallen below 10% in drug-eluting stent trials. Early evaluations of new stents have used continuous end points that are presumed surrogates for restenosis, but the generalizability and power of such end points have not been examined systematically. METHODS AND RESULTS: We examined the relationship between incremental changes in observed late loss in lumen diameter and the probability of restenosis using reported late loss from 22 published trials of various types of stents (bare-metal, drug-eluting, and small-vessel stents). Next, the power of late loss differences was compared with that of corresponding binary restenosis rates. The relationship between mean late loss and its SD was linear and did not vary with stent type (drug-eluting or bare-metal) or vessel diameter. At all levels of late loss examined (0 to 1 mm), incremental changes were associated with increasing restenosis risk (with an increasing magnitude of effect at higher levels of late loss). The power to detect a treatment effect was greater for late loss than for binary angiographic restenosis (> or =32% relative increase in power, > or =24% absolute increase for late loss between 0.2 and 0.6 mm). CONCLUSIONS: Late loss is monotonically related to restenosis risk in published stent trials. It is a generalizable and powerful angiographic end point in early or small trials of new drug-eluting stents.

Clinical Trials as Topic↗

PubMed2005

A randomized trial of electronic clinical reminders to improve quality of care for diabetes and coronary artery disease.

OBJECTIVE: The aim of this study was to evaluate the impact of an integrated patient-specific electronic clinical reminder system on diabetes and coronary artery disease (CAD) care and to assess physician attitudes toward this reminder system. DESIGN: We enrolled 194 primary care physicians caring for 4549 patients with diabetes and 2199 patients with CAD at 20 ambulatory clinics. Clinics were randomized so that physicians received either evidence-based electronic reminders within their patients' electronic medical record or usual care. There were five reminders for diabetes care and four reminders for CAD care. MEASUREMENTS: The primary outcome was receipt of recommended care for diabetes and CAD. We created a summary outcome to assess the odds of increased compliance with overall diabetes care (based on five measures) and overall CAD care (based on four measures). We surveyed physicians to assess attitudes toward the reminder system. RESULTS: Baseline adherence rates to all quality measures were low. While electronic reminders increased the odds of recommended diabetes care (odds ratio [OR] 1.30, 95% confidence interval [CI] 1.01-1.67) and CAD (OR 1.25, 95% CI 1.01-1.55), the impact of individual reminders was variable. A total of three of nine reminders effectively increased rates of recommended care for diabetes or CAD. The majority of physicians (76%) thought that reminders improved quality of care. CONCLUSION: An integrated electronic reminder system resulted in variable improvement in care for diabetes and CAD. These improvements were often limited and quality gaps persist.

Algorithms↗