Andrew L. Avins

Case-Finding Instruments for Depression: Two Questions Are as Good as Many

ObjectiveTo determine the validity of a two-question case-finding instrument for depression as compared with six previously validated instruments.DesignThe test characteristics of a two-question case-fidning instrument that asks about depressed mood and anhedonia were compared with six common case-finding instruments, using the Quick Diagnostic Interview Schedule as a criterion standard for the diagnosis of major depression.SettingUrgent care clinic at the San Francisco Department of Veterans Affairs Medical Center.ParticipantsFive hundred thirty-six consecutive adult patients without mania or schizophrenia.Measurements and main resultsMeasurements were two questions from the Primary Care Evaluation of Mental Disorders patient questionnaire, both the long and short forms of the Center for Epidemiologic Studies Depression Scale, both the long and short forms of the Beck Depression Inventory, the Symptom-Driven Diagnostic System for Primary Care, the Medical Outcomes Study depression measure, and the Quick Diagnostic Interview Schedule. The prevalence of depression, as determined by the standardized interview, was 18% (97 of 536). Overall, the case-finding instruments had sensitivities of 89% to 96% and specificities of 51% to 72% for diagnosing major depression. A positive response to the two-item instrument had a sensitivity of 96% (95% confidence interval [CI], 90–99%) and a specificity of 57% (95% CI 53–62%). Areas under the receiver operating characteristic curves were similar for all of the instruments, with a range of 0.82 to 0.89.ConclusionsThe two-question case-finding instrument is a useful measure for detecting depression in primary care. It has similar test characteristics to other case-finding instruments and is less time-consuming.

Update on AUA Guideline on the Management of Benign Prostatic Hyperplasia

PURPOSE To revise the 2003 version of the American Urological Associations (AUA) Guideline on the management of benign prostatic hyperplasia (BPH). MATERIALS AND METHODS From MEDLINE® searches of English language publications (January 1999 through February 2008) using relevant MeSH terms, articles concerning the management of the index patient, a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms (LUTS) were identified. Qualitative analysis of the evidence was performed. Selected studies were stratified by design, comparator, follow-up interval, and intensity of intervention, and meta-analyses (quantitative synthesis) of outcomes of randomized controlled trials were planned. Guideline statements were drafted by an appointed expert Panel based on the evidence. RESULTS The studies varied as to patient selection; randomization; blinding mechanism; run-in periods; patient demographics, comorbidities, prostate characteristics and symptoms; drug doses; other intervention characteristics; comparators; rigor and intervals of follow-up; trial duration and timing; suspected lack of applicability to current US practice; and techniques of outcomes measurement. These variations affected the quality of the evidence reviewed making formal meta-analysis impractical or futile. Instead, the Panel and extractors reviewed the data in a systematic fashion and without statistical rigor. Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases. Guideline statements concerning pharmacotherapies, watchful waiting, surgical options and minimally invasive procedures were either updated or newly drafted, peer reviewed and approved by AUA Board of Directors. CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms. The management of LUTS/BPH continues to evolve.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

BACKGROUND Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. METHODS A total of 638 adults with chronic mechanical low back pain were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland-Morris Disability Questionnaire score; range, 0-23) and symptom bothersomeness (0-10 scale). Outcomes were assessed at baseline and after 8, 26, and 52 weeks. RESULTS At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P < .001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs 39%; P < .001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P < .001). After 1 year, participants in the treatment groups were more likely than those receiving usual care to experience clinically meaningful improvements in dysfunction (59% to 65% vs 50%, respectively; P = .02) but not in symptoms (P > .05). CONCLUSIONS Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupunctures purported mechanisms of action. It remains unclear whether acupuncture or our simulated method of acupuncture provide physiologically important stimulation or represent placebo or nonspecific effects.

Systematic Literature Review of Imaging Features of Spinal Degeneration in Asymptomatic Populations

This meta-analysis of the literature reveals that imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, increasing with age. Many imaging-based degenerative features are likely part of normal aging and unassociated with pain. BACKGROUND AND PURPOSE: Degenerative changes are commonly found in spine imaging but often occur in pain-free individuals as well as those with back pain. We sought to estimate the prevalence, by age, of common degenerative spine conditions by performing a systematic review studying the prevalence of spine degeneration on imaging in asymptomatic individuals. MATERIALS AND METHODS: We performed a systematic review of articles reporting the prevalence of imaging findings (CT or MR imaging) in asymptomatic individuals from published English literature through April 2014. Two reviewers evaluated each manuscript. We selected age groupings by decade (20, 30, 40, 50, 60, 70, 80 years), determining age-specific prevalence estimates. For each imaging finding, we fit a generalized linear mixed-effects model for the age-specific prevalence estimate clustering in the study, adjusting for the midpoint of the reported age interval. RESULTS: Thirty-three articles reporting imaging findings for 3110 asymptomatic individuals met our study inclusion criteria. The prevalence of disk degeneration in asymptomatic individuals increased from 37% of 20-year-old individuals to 96% of 80-year-old individuals. Disk bulge prevalence increased from 30% of those 20 years of age to 84% of those 80 years of age. Disk protrusion prevalence increased from 29% of those 20 years of age to 43% of those 80 years of age. The prevalence of annular fissure increased from 19% of those 20 years of age to 29% of those 80 years of age. CONCLUSIONS: Imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, increasing with age. Many imaging-based degenerative features are likely part of normal aging and unassociated with pain. These imaging findings must be interpreted in the context of the patients clinical condition.

Bundle-Branch Block and In-Hospital Mortality in Acute Myocardial Infarction

Complete left or right bundle-branch block (BBB) on electrocardiography at presentation has been reported to occur in 1% to 15% of patients with acute myocardial infarction, and it has been associated with increased risk for short- and long-term death [1-19]. Left BBB is considered an important predictor of poor outcome in patients with myocardial infarction [20, 21], but the effect of right BBB is less well-understood and has received relatively little attention [22-24]. Previous studies have reported a wide range of mortality rates in patients with acute myocardial infarction and left BBB (19% to 65%) [4, 6, 8-1012-15, 19] or right BBB (11% to 77%) [3-58, 9, 11-1315-17, 19]. However, although some studies suggest that left or right BBB is an independent predictor of in-hospital death in patients with acute myocardial infarction [11, 12, 19], others have found either no effect [9] or an effect dependent on age [25] or location of infarction [16, 17]. Previous studies had small numbers of patients with BBB [1, 2, 4, 5, 9-19, 25]; were done in the prethrombolytic era [1, 2, 4-68, 10, 13-18, 25]; did not compare both left and right BBB in the same population [11, 16, 17]; or did not assess the association of BBB with adverse outcomes after adjustment for potential confounding by differences in clinical characteristics, location of infarction, and treatment [1-19, 25]. To address these problems, we studied 297 832 patients with acute myocardial infarction to estimate the prevalence of left and right BBB, compare the clinical characteristics of and treatments received by patients, and assess the association of left and right BBB with in-hospital death. Methods Data Source and Study Sample The National Registry of Myocardial Infarction (NRMI) 2 is a voluntary, prospective, observational registry that includes patients with acute myocardial infarction from all 50 states who were admitted to participating U.S. hospitals. The data set for our analysis included 510 044 patients from 1571 hospitals enrolled between 1 June 1994 and 30 April 1997. A trained registry coordinator at each participating hospital retrospectively reviewed charts and recorded information on individual patients onto standardized case report forms. Completed forms were processed by an independent central data collection center. Extensive electronic data checks were done; errors in the forms were resolved before patient data were included in the database [26]. We analyzed 297 832 patients who were at least 18 years of age and were admitted to participating hospitals with confirmed acute myocardial infarction, which was defined on the basis of typical symptoms and signs accompanied by 1) a total creatine kinase level or creatine kinase-MB fraction at least twice the upper limit of normal; 2) electrocardiographic evidence of acute myocardial infarction; 3) other enzymatic, scintigraphic, echocardiographic, or autopsy evidence indicating myocardial infarction; or, if the preceding three variables were unavailable, 4) a principal discharge diagnosis of acute myocardial infarction (code 410, International Classification of Diseases, 9th Revision, Clinical Modification). The diagnosis of myocardial infarction was not independently validated. Patients who were transferred to or out of a participating hospital (n = 212 212) were excluded from the cohort to ensure that data on demographic characteristics, clinical presentation, myocardial infarction care, and in-hospital death were more complete. Measurements The main predictor variable was the presence of left or right BBB on the first 12-lead electrocardiogram, which was ascertained from responses on case report forms describing initial electrocardiography results. Diagnosis of left or right BBB was not independently validated. Information on the timing of onset (new or old) or persistence of BBB was not collected. Data on the presence of left anterior or posterior fascicular block were unavailable. The small proportion of patients identified with both left and right BBB (0.1%; n = 410) was categorized as having left BBB for the purpose of our analysis. Our results were not significantly affected by the inclusion or exclusion of these patients, and we therefore included them in all analyses. Other predictor variables included age, sex, ethnicity (white, black, or other/unknown), cardiovascular history (previous myocardial infarction, angina, congestive heart failure, stroke, percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft surgery [CABG]), known cardiac risk factors (diabetes mellitus, hypertension, current cigarette smoking, family history of coronary heart disease, or hypercholesterolemia), chest pain at admission, interval between symptom onset and arrival at the hospital, body weight, systolic and diastolic blood pressure at admission, heart rate at admission, Killip class, and location of infarction. If more than one infarction location was noted, patients were hierarchically assigned to the category with the worst prognosis: anterior, which could include any other specified category; right ventricular involvement, which could include any other specified category except anterior; inferior, which could include any other specified category except anterior and right ventricular involvement; and other/unknown, which included all remaining categories other than anterior, right ventricular involvement, and inferior and also included patients with unspecified location of infarction and patients with nondiagnostic electrocardiograms. The main outcome variable was in-hospital death. Secondary clinical outcome variables were in-hospital cardiovascular events other than death: development of congestive heart failure, hypotension requiring treatment, cardiogenic shock, recurrent ischemia or angina, second- or third-degree heart block, and cardiac arrest. Process-measure outcome variables included use of intravenous thrombolytic therapy, location at which thrombolytic therapy was initiated (emergency department, intensive care or cardiac care unit, or catheterization laboratory/other), time from symptom onset to initiation of thrombolytic therapy, time from arrival at the hospital to initiation of thrombolytic therapy, reason for not using thrombolytic therapy (advanced age, nondiagnostic electrocardiogram, duration of symptoms, other contraindications, or other/reason not specified), use of primary PTCA, use of initial reperfusion strategies other than PTCA (immediate CABG or intracoronary thrombolytic therapy), medical therapies given within the first 24 hours (aspirin, -blockers, heparin, nitroglycerin, angiotensin-converting enzyme [ACE] inhibitors, or calcium-channel blockers), elective PTCA, elective CABG, and pacemaker insertion. Statistical Analysis Demographic and clinical characteristics of, treatments received by, and outcomes for patients with left, right, or no BBB were compared by using the Student t-test or the Wilcoxon rank-sum test for continuous variables and the chi-square test for proportions. All pairwise comparisons were made. All analyses were planned a priori and were treated with equal importance. Only P values of 0.001 or less were considered statistically significant, and any significant differences were assessed for clinical importance. No additional adjustments were made for multiple comparisons [27]. We used logistic regression models to evaluate the independent association of left BBB and right BBB with in-hospital death; patients with no BBB and no ST-segment elevation served as the reference group. In model 1, we adjusted for 1) differences in baseline demographic and clinical variables previously shown to affect risk for in-hospital death in patients with acute myocardial infarction and 2) any other variables associated with in-hospital death on bivariate analyses with a P value less than 0.01. In model 2, we included all of the variables from model 1 and added treatment variables previously shown to be related to in-hospital death, including time-dependent use of intravenous thrombolytic therapy or primary PTCA (<6 hours, 6 to 12 hours, or >12 hours from symptom onset); use of aspirin, -blockers, or ACE inhibitors within the first 24 hours; and in-hospital CABG. On the basis of an a priori hypothesis, we also tested for an interaction between left or right BBB and the presence of chest pain at presentation. Only a minimal interaction was found between left BBB and chest pain on stratified analyses; therefore, results of models without interaction terms are presented. All analyses were done by using SAS statistical software, version 6.12 (SAS Institute, Inc., Cary, North Carolina). Role of the Funding Source Two of the authors are employees of Genentech, Inc. (South San Francisco, California). One of the authors is a consultant for Genentech, Inc., and is on the NRMI Advisory Board. The funding source sponsored the development of NRMI 2 and provided funding for data analysis. The funding source works in conjunction with an independent NRMI Advisory Board made up of nationally recognized experts in cardiology and emergency medicine. The final version of the manuscript was reviewed by a member of the NRMI Advisory Board. Results Prevalence of Bundle-Branch Block and Patient Characteristics The prevalence of right BBB on the first 12-lead electrocardiogram was 6.2% (95% CI, 6.1% to 6.3%); the prevalence of left BBB was 6.7% (CI, 6.6% to 6.8%) (Table 1). Table 1. Characteristics of 297 832 Patients with Acute Myocardial Infarction with and without Bundle-Branch Block at Presentation in the National Registry of Myocardial Infarction 2 (1 June 1994-30 April 1997)* Compared with patients with no BBB, patients with right or left BBB were more likely to be older; to be white; and to have a history of infarction, angina, congestive heart failure, CABG, stroke, diabetes mellitus, and hypertension. The proportion of female patients was greater among pat

Brief Communication: Better Ways To Question Patients about Adverse Medical Events: A Randomized, Controlled Trial

Context Investigators use diverse methods to assess the adverse events experienced by study participants. Contribution During a 1-month placebo run-in period of a clinical trial, this single-blind substudy randomly assigned 214 men with benign prostatic hyperplasia to 3 groups to test different methods of asking about recent medical problems. Men who completed a checklist about 53 common side effects reported many more problems than participants in the 2 groups that were given different formats of open-ended questions. For example, 77% of the checklist group reported 1 or more medical problems, compared with 13% and 14% of the open-ended groups. Implications Varying the assessment method can cause large differences in reported rates of adverse events. The Editors Currently, there is no standard method for identifying adverse events that occur during a clinical trial. Although regulatory agencies (such as the U.S. Food and Drug Administration) require that studies of new drugs report adverse events in a standard way, they do not specify a standard method for ascertaining these data (1). Consequently, how individual studies identify adverse events varies considerably. For example, early studies of nonsteroidal anti-inflammatory druginduced gastric ulcers reported much lower frequencies of ulcers than more recent studies, mostly because researchers have recently made greater efforts to detect this side effect (2). The implications of this lack of consistent ascertainment methods are substantial; comparisons of rates of reported side effects from 2 or more drugs may not be valid if the methods of collecting adverse events differ. This could impair the ability of patients and physicians to compare the riskbenefit profile of drugs. We therefore conducted a randomized, controlled trial to determine whether different methods of identifying adverse events in a clinical trial would lead to different estimates of the frequency of these events. Methods Study Design The study protocol and all procedures were approved by the Committee on Human Research at the University of California, San Francisco. The study, which took place between April 2002 and April 2005, was a randomized, single-blind, controlled trial that assigned patients to 3 groups to test self-administered methods of assessing medical problems that they experienced while taking a placebo for 1 month. Participants We recruited participants from a larger study that was examining the safety and efficacy of the herb saw palmetto for treatment of benign prostatic hyperplasia (3). The trial, known as the STEP (Saw Palmetto Treatment for Enlarged Prostates) study, required that participants be 50 years of age or older, have moderate to severe symptoms of benign prostatic hyperplasia, and have no serious comorbid illness. All participants in the study gave informed consent; were told that they would be taking placebo at some point during the study; and were assigned to a single-blind, 1-month placebo run-in period. Randomization and Intervention After taking the placebo (referred to as the study medication) for 1 month, patients were randomly assigned to 3 methods of collecting adverse events. All patients were given 1 of 3 self-administered paper forms. The form given to the first group asked an open-ended question: Did you have any significant medical problem since the last study visit? The form given to the second group asked an open-ended question that was more defined: Since the last study visit, have you limited your usual daily activities for more than 1 day because of a medical problem? A checklist accompanied the form given to the third group, which asked a more pointed question: Since the last visit, have you experienced any of the following (checklist attached)? The checklist contained 53 symptoms, grouped by anatomical region. Two of the authors developed the checklist after conducting an unpublished review of checklists that were used in earlier clinical trials performed at the same institution. The checklist did not ask patients to rate the frequency or severity of symptoms and did not ask patients to make a judgment about whether their medical problem was caused by the study medication. Patients in the open-ended question groups who answered yes were asked to identify their medical problem, which was recorded by a study assistant on the same checklist used in the third group. Outcomes and Analysis The primary outcome measure was the difference in the proportion of patients reporting 1 or more adverse events in each group. All patients in the STEP study were included in the current study; therefore, the sample size was not calculated on the basis of the needs of this study. Participants were randomly assigned to the 3 groups in equal proportions by using a computer-generated, random allocation sequence that was prepared before the study began. Study personnel were blinded to the allocation sequence but were aware of group assignments after they were made. Patients were not informed of their group assignment. Persons performing the data analysis were blinded to group assignment. Baseline characteristics of the 3 intervention groups were compared by using analysis of variance for continuous variables and chi-square tests for categorical variables. We also used chi-square tests to compare the number and specific type of adverse events that occurred among groups. All analyses were performed by using Stata, version 8.0 (Stata Corp., College Station, Texas). Role of the Funding Sources The funding organizations had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript. Results We randomly assigned 214 patients to 1 of 3 methods of collecting data on adverse effects. Patients were predominantly healthy, well-educated white men (mean age, 63 years) who were taking a mean of 2.5 medications (Table 1). Baseline characteristics of the patients were similar among the 3 groups. All patients completed the study and the outcome assessment (Figure). Table 1. Baseline Characteristics of Study Participants Figure. Flow diagram showing the distribution of participants at each stage of the study. The group that was assigned to a checklist method reported a significantly greater number of adverse events (238 events) than the first and second groups, which were asked open-ended questions (11 and 14 adverse events, respectively; P< 0.001) (Table 2). A much higher percentage of patients in the checklist group reported 1 or more adverse events (77%) compared with the patients asked each of the 2 different open-ended questions (14% for the first group and 13% for the second group; P< 0.001). For each of the 10 most commonly reported adverse events (Table 2), participants in the checklist group reported a greater number of adverse events (P< 0.001). No serious adverse events occurred during the study period. Table 2. 10 Most Frequently Reported Adverse Events Discussion In this randomized, controlled trial, we found that a checklist method of identifying adverse events dramatically increased the number of reported events compared with 2 types of open-ended questions. Although this finding is intuitive, the magnitude of effect has important implications both for the conduct of clinical trials and for assessment of the riskbenefit profile of drugs and other interventions. It is common practice for physicians and patients to select drugs and other interventions on the basis of their reported rate of side effects. However, if different drugs used for the same indication are examined in clinical trials that use different methods of identifying adverse events, then it is not valid to compare the reported rate of side effects. For example, the reported rates of sexual side effects from selective serotonin reuptake inhibitors range from 2% to 73%; much of this difference is probably attributable to different methods of adverse event collection (4). Similarly, a recent systematic review found that published trials of pharmacologic treatments for rheumatoid arthritis were much more likely to report data on harm than trials of nonpharmacologic treatment (5), highlighting the difficulty of comparing the safety of different treatments for the same condition. The 3 self-administered questions that we used to assess the frequency of adverse events in this study were, by design, limited in scope. The self-administered forms did not ask patients to describe the timing, severity, or frequency of their medical problems, nor did they ask participants or investigators to make a judgment of causality. Other techniques to assess adverse events, such as changes in vital signs, laboratory tests, physical examinations, or more detailed searches for expected adverse events, were not included. The purpose of this simplified approach was to isolate and contrast 3 different initial screening methods of identifying medical problems occurring among participants in a clinical trial. Because all patients in the current study were taking placebo, probably none of the reported adverse events were true side effects of the study medication but were merely symptoms that commonly occur in adults. For example, a previous survey of university students and hospital staff found that 81% of respondents reported some symptom within the past 3 days when prompted by a checklist (6). This highlights the problem that most study participants are likely to have a high prevalence of symptoms that are unrelated to a study drug or intervention, and a checklist method is therefore likely to have very low specificity for detecting true side effects. The wording of the 3 self-administered questions that we used in this study asked about 3 different thresholds of medical problems. One question asked participants if they experienced a significant medical problem, one asked if they limited their usual daily activities fo

Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature: a case report and systematic review of the literature.

AbstractBACKGROUND:Ginkgo biloba (ginkgo) is a herbal remedy used by over 2% of the adult population in the United States. Several review articles have suggested that ginkgo may increase the risk of bleeding. OBJECTIVE: To report a case of bleeding associated with using ginkgo, to systematically review the literature for similar case reports, and to evaluate whether using ginkgo is causally related to bleeding. DATA SOURCES: We searched MEDLINE, EMBASE, IBIDS, and the Cochrane Collaboration Database from 1966 to October 2004 with no language restrictions. REVIEW METHODS: Published case reports of bleeding events in persons using ginkgo were selected. Two reviewers independently abstracted a standard set of information to assess whether ginkgo caused the bleeding event. RESULTS: Fifteen published case reports described a temporal association between using ginkgo and a bleeding event. Most cases involved serious medical conditions, including 8 episodes of intracranial bleeding. However, 13 of the case reports identified other risk factors for bleeding. Only 6 reports clearly described that ginkgo was stopped and that bleeding did not recur. Bleeding times, measured in 3 reports, were elevated when patients were taking ginkgo. CONCLUSION: A structured assessment of published case reports suggests a possible causal association between using ginkgo and bleeding events. Given the widespread use of this herb and the serious nature of the reported events, further studies are needed. Patients using ginkgo, particularly those with known bleeding risks, should be counseled about a possible increase in bleeding risk.

Spontaneous bleeding associated with Ginkgo biloba

AbstractBACKGROUND:Ginkgo biloba (ginkgo) is a herbal remedy used by over 2% of the adult population in the United States. Several review articles have suggested that ginkgo may increase the risk of bleeding. OBJECTIVE: To report a case of bleeding associated with using ginkgo, to systematically review the literature for similar case reports, and to evaluate whether using ginkgo is causally related to bleeding. DATA SOURCES: We searched MEDLINE, EMBASE, IBIDS, and the Cochrane Collaboration Database from 1966 to October 2004 with no language restrictions. REVIEW METHODS: Published case reports of bleeding events in persons using ginkgo were selected. Two reviewers independently abstracted a standard set of information to assess whether ginkgo caused the bleeding event. RESULTS: Fifteen published case reports described a temporal association between using ginkgo and a bleeding event. Most cases involved serious medical conditions, including 8 episodes of intracranial bleeding. However, 13 of the case reports identified other risk factors for bleeding. Only 6 reports clearly described that ginkgo was stopped and that bleeding did not recur. Bleeding times, measured in 3 reports, were elevated when patients were taking ginkgo. CONCLUSION: A structured assessment of published case reports suggests a possible causal association between using ginkgo and bleeding events. Given the widespread use of this herb and the serious nature of the reported events, further studies are needed. Patients using ginkgo, particularly those with known bleeding risks, should be counseled about a possible increase in bleeding risk.

Do ratings on the american board of internal medicine resident evaluation form detect differences in clinical competence

AbstractObjective: To determine whether raters using the American Board of Internal Medicine (ABIM) Resident Evaluation Form can detect differences among residents in clinical competence. Design: Cross-sectional study. Setting: Inpatient general medicine service in a university-affiliated public hospital. Participants: University-based internal medicine (UCIM) residents (ABIM certifying examination pass rate, 91%; mean score, 95th percentile), community hospital-based internal medicine (CHIM) residents (ABIM examination pass rate, 68%; mean score, 42nd percentile), and residents from three university-based non-internal medicine (UC non-IM) programs all assigned to the same inpatient general medicine service over a three-year period. Four hundred eighty-nine evaluations of 110 postgraduate-year-one residents were analyzed. Measurements and main results: Mean ratings for the UCIM residents were significantly higher than those for the CHIM or UC non-IM residents (analysis of variance [ANOVA], p<0.05). Variance was smallest for the UCIM residents (F test, p<0.01), and only the UCIM residents’ mean scores were in the “superior” range (7–9) in all evaluated categories. The mean ratings for the CHIM residents while at the university-affiliated hospital were not significantly different from the ratings of the same residents at their home hospital. The ratings for the CHIM residents at either site were significantly lower than those for the UCIM residents in all categories (ANOVA, p<0.05). Factor analysis revealed a single factor accounting for 76% of the variance among the ratings with all dimensions loading high on that factor (0.75–0.95), providing evidence for a “halo” effect. Mean interrater agreement over all variables was 0.87, indicating good consistency among raters. Conclusions: Ratings on the ABIM Resident Evaluation Form detect global differences among residents in clinical competence in the expected direction based on type of training program and performance on the ABIM certification examination, but fail to differentiate among the nine evaluated dimensions of clinical care. This rating method may be valid for assessing overall clinical performance, but is less useful for providing feedback in specific areas to individual residents.

Cardiovascular risk reductions associated with aggressive lifestyle modification and cardiac rehabilitation

BACKGROUND Patients who have been treated for coronary heart disease can enroll in traditional cardiac rehabilitation, the Ornish Program, or no rehabilitation at all. No study has compared the impact of each on cardiovascular disease risk (CVD) factors. METHODS The current study compared CVD risk changes in post coronary artery bypass graft or percutaneous coronary intervention procedure patients who participated in the Ornish Heart Disease Reversing Program, a traditional cardiac rehabilitation, and a control group that received no formal cardiac risk-reduction program. This was a longitudinal, observational study of 84 patients receiving CVD standard of care who elected to participate in 1 of the 3 study groups. Assessments of CVD risk factors and anginal severity were obtained at baseline, 3 months, and 6 months. RESULTS Ornish program participants had significantly greater reductions in anginal frequency, body weight, body mass index, systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, glucose, dietary fat, and increases in complex carbohydrates than were documented in the rehabilitation or control groups. The control group experienced the greatest reduction in anginal pain severity, but also had significantly higher systolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol. CONCLUSIONS These findings suggest that CVD patients who choose to participate in the Ornish program can experience greater improvements in CVD risks than patients who choose to participate in traditional cardiac rehabilitation or no formal program.