Health and wellness among incoming resident physicians: A multi-domain survey.

INTRODUCTION: Burnout and depression are well-described in medical students and physicians and can lead to adverse personal and patient outcomes; however, their time course and risk factors remain understudied. Here, we measured multiple domains of mental and physical health and wellness and assessed gender differences among incoming physician trainees beginning residency at an academic medical center. METHODS: Using a cross-sectional study design, all incoming trainees (i.e. housestaff) at Johns Hopkins Hospital received a questionnaire assessing depression, burnout, sleep, exercise, and alcohol consumption, among other domains. Standardized instruments were utilized for questionnaire development. Tests of significance were two-tailed. RESULTS: 196 of 229 incoming housestaff (86%) completed the survey, and 49% were female. A history of depression was reported in 8%, and 5.4% met criteria for at least moderate depression by Patient Health Questionnaire (PHQ-9). Females were more likely to report a history of depression than males (13% vs. 3%, p=0.02) but had similar PHQ-9 scores. Four percent of participants reported feeling they were in the wrong profession. Goal and mean sleep were 7 and 6.7 hours/night, respectively. Forty-seven percent reported exercising once/week or not at all. While mean reported weekly alcohol consumption was three drinks, participants reported consuming ≥5 drinks in one sitting on average 1.6 times in the prior 6 months, and 4% used alcohol to sleep. CONCLUSIONS: Incoming housestaff reported generally favorable mental and physical health at the beginning of residency training. However, exercise rates were low, and ill-suited alcohol consumption was noted, though infrequent. The few areas of possible improvement were largely similar between males and females. Wellness interventions might capitalize on the relatively high morale and health at the completion of medical school by helping to promote healthy habits, including regular exercise and avoidance of excess alcohol consumption, throughout future training and practice.

Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations.

BACKGROUND: Given the increase in medications for type 2 diabetes mellitus, clinicians and patients need information about their effectiveness and safety to make informed choices. PURPOSE: To summarize the benefits and harms of metformin, second-generation sulfonylureas, thiazolidinediones, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 receptor agonists, as monotherapy and in combination, to treat adults with type 2 diabetes. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception through April 2010 for English-language observational studies and trials. The MEDLINE search was updated to December 2010 for long-term clinical outcomes. STUDY SELECTION: Two reviewers independently screened reports and identified 140 trials and 26 observational studies of head-to-head comparisons of monotherapy or combination therapy that reported intermediate or long-term clinical outcomes or harms. DATA EXTRACTION: Two reviewers following standardized protocols serially extracted data, assessed applicability, and independently evaluated study quality. DATA SYNTHESIS: Evidence on long-term clinical outcomes (all-cause mortality, cardiovascular disease, nephropathy, and neuropathy) was of low strength or insufficient. Most medications decreased the hemoglobin A(1c) level by about 1 percentage point and most 2-drug combinations produced similar reductions. Metformin was more efficacious than the DPP-4 inhibitors, and compared with thiazolidinediones or sulfonylureas, the mean differences in body weight were about -2.5 kg. Metformin decreased low-density lipoprotein cholesterol levels compared with pioglitazone, sulfonylureas, and DPP-4 inhibitors. Sulfonylureas had a 4-fold higher risk for mild or moderate hypoglycemia than metformin alone and, in combination with metformin, had more than a 5-fold increased risk compared with metformin plus thiazolidinediones. Thiazolidinediones increased risk for congestive heart failure compared with sulfonylureas and increased risk for bone fractures compared with metformin. Diarrhea occurred more often with metformin than with thiazolidinediones. LIMITATIONS: Only English-language publications were reviewed. Some studies may have selectively reported outcomes. Many studies were small, were of short duration, and had limited ability to assess clinically important harms and benefits. CONCLUSION: Evidence supports metformin as a first-line agent to treat type 2 diabetes. Most 2-drug combinations similarly reduce hemoglobin A(1c) levels, but some increased risk for hypoglycemia and other adverse events. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

The science of continuing medical education: terms, tools, and gaps: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.

BACKGROUND: By its synthesis of a selected portion of the continuing medical education (CME) literature, the evidence-based practice center (EPC) review discovered several major issues in primary study design and in the systematic review process of CME studies. Through this process, the review speaks to the need for clarity in designing, reporting and synthesizing CME trials and provides an opportunity to advance the research agenda in this field. METHODS: The evidence-based guideline (EBG) committee reviewed the methods section of the EPC report and these guidelines in detail, commenting on the search and review process and on the nature of the primary literature and the definitions used within it, comparing these to other published standardized measures. RESULTS: Although the EBG committee noted much strength in the EPC review, limitations of the primary literature and the review methodology were identified and defined. These strengths and limitations hold implications for further research in this area. CONCLUSIONS: Noting these limitations and in order to move the field forward, the EBG committee proposes a standard nomenclature of terms in common use in CME; a more rigorous process of searching, distilling, and synthesizing the primary literature in this area; and a common format on which to base the development and description of future trials of CME interventions.

Methods and definition of terms: effectiveness of continuing medical education: American College of Chest Physicians Evidence-Based Educational Guidelines.

BACKGROUND: A core mission of the American College of Chest Physicians (ACCP) is the education of its members, including continuing medical education (CME). The question of what evidence supports the effectiveness of CME activities became central to the ACCP's Educational Resources Division and its education committee. METHODS: An application for consideration as a topic for an evidenced-based guideline was submitted to the ACCP Health and Science Policy Committee in 2004. The application was approved contingent on acceptance by the Agency for Healthcare Research and Quality (AHRQ) as a topic for an evidence-based review to be awarded to an AHRQ evidence-based practice center (EPC). The topic was accepted by AHRQ, with a collaborative revision developed by AHRQ and ACCP of the focused questions submitted in the nomination. The AHRQ awarded the evidence review to The Johns Hopkins University EPC (Baltimore, MD). An expert writing panel was assembled comprising methodologists from the EPC, and recommendations were developed from the EPC evidence review and graded using the ACCP system of categorizing the strength of each recommendation and the quality of evidence. CONCLUSIONS: This section describes the processes used to develop these guidelines, including identifying, evaluating, and synthesizing the evidence; assessing the strength of evidence; and grading each recommendation.

Factors associated with intensification of oral diabetes medications in primary care provider-patient dyads: a cohort study.

OBJECTIVE: Although suboptimal glycemic control is known to be common in diabetic adults, few studies have evaluated factors at the level of the physician-patient encounter. Our objective was to identify novel visit-based factors associated with intensification of oral diabetes medications in diabetic adults. RESEARCH DESIGN AND METHODS: We conducted a nonconcurrent prospective cohort study of 121 patients with type 2 diabetes and hyperglycemia (A1C > or =8%) enrolled in an academically affiliated managed-care program. Over a 24-month interval (1999-2001), we identified 574 hyperglycemic visits. We measured treatment intensification and factors associated with intensification at each visit. RESULTS: Provider-patient dyads intensified oral diabetes treatment in only 128 (22%) of 574 hyperglycemic visits. As expected, worse glycemia was an important predictor of intensification. Treatment was more likely to be intensified for patients with visits that were "routine" (odds ratio [OR] 2.55 [95% CI 1.49-4.38]), for patients taking two or more oral diabetes drugs (2.82 [1.74-4.56]), or for patients with longer intervals between visits (OR per 30 days 1.05 [1.00-1.10]). In contrast, patients with less recent A1C measurements (OR >30 days before the visit 0.53 [0.34-0.85]), patients with a higher number of prior visits (OR per prior visit 0.94 [0.88-1.00]), and African American patients (0.59 [0.35-1.00]) were less likely to have treatment intensified. CONCLUSIONS: Failure to intensify oral diabetes treatment is common in diabetes care. Quality improvement measures in type 2 diabetes should focus on overcoming inertia, improving continuity of care, and reducing racial disparities.

Cardiovascular outcomes in trials of oral diabetes medications: a systematic review.

BACKGROUND: A wide variety of oral diabetes medications are currently available for the treatment of type 2 diabetes mellitus, but it is unclear how these agents compare with respect to long-term cardiovascular risk. Our objective was to systematically examine the peer-reviewed literature on the cardiovascular risk associated with oral agents (second-generation sulfonylureas, biguanides, thiazolidinediones, and meglitinides) for treating adults with type 2 diabetes. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials, from inception through January 19, 2006. Forty publications of controlled trials that reported information on cardiovascular events (primarily myocardial infarction and stroke) met our inclusion criteria. Using standardized protocols, 2 reviewers serially abstracted data from each article. Trials were first described qualitatively. For comparisons with 4 or more independent trials, results were pooled quantitatively using the Mantel-Haenszel method. Results are presented as odds ratios (ORs) and corresponding 95% confidence intervals (CIs). RESULTS: Treatment with metformin hydrochloride was associated with a decreased risk of cardiovascular mortality (pooled OR, 0.74; 95% CI, 0.62-0.89) compared with any other oral diabetes agent or placebo; the results for cardiovascular morbidity and all-cause mortality were similar but not statistically significant. No other significant associations of oral diabetes agents with fatal or nonfatal cardiovascular disease or all-cause mortality were observed. When compared with any other agent or placebo, rosiglitazone was the only diabetes agent associated with an increased risk of cardiovascular morbidity or mortality, but this result was not statistically significant (OR, 1.68; 95% CI, 0.92-3.06). CONCLUSIONS: Meta-analysis suggested that, compared with other oral diabetes agents and placebo, metformin was moderately protective and rosiglitazone possibly harmful, but lack of power prohibited firmer conclusions. Larger, long-term studies taken to hard end points and better reporting of cardiovascular events in short-term studies will be required to draw firm conclusions about major clinical benefits and risks related to oral diabetes agents.

Missed opportunities in diabetes management: a longitudinal assessment of factors associated with sub-optimal quality.

BACKGROUND: In diabetic adults, tight control of risk factors reduces complications. OBJECTIVE: To determine whether failure to make visits, monitor risk factors, or intensify therapy affects control of blood pressure, glucose, and lipids. DESIGN: A non-concurrent, prospective study of data from electronic files and standardized abstraction of hard-copy medical records for the period 1/1/1999-12/31/2001. PARTICIPANTS: Three hundred eighty-three adults with diabetes managed in an academically affiliated managed care program. MEASUREMENTS: Main exposure variable: Intensification of therapy or failure to intensify, reckoned on a quarterly basis. MAIN OUTCOME MEASURE: Hemoglobin A1c (A1c), systolic blood pressure (SBP), and LDL-cholesterol at the end of the interval. RESULTS: In this visit-adherent cohort, control of glycemia and lipids showed improvement over 24 months, but many patients did not achieve targets. Only those with the worst blood pressure control (SBP >or=160 mmHg) showed any improvement over 2 years. Failure to intensify treatment in patients who kept visits was the single strongest predictor of sub-optimal control. Compared to their counterparts with no failures of intensification, patients with failures in >or=3 quarters showed markedly worse control of blood glucose (A1c 1.4% higher: 95% CI: 0.7, 2.1); hypertension (SBP 22.2 mmHg higher: 95% CI: 16.6, 27.9) and LDL cholesterol (LDL 43.7 mg/dl higher: 95% CI: 24.1, 63.3). These relationships were strong, graded, and independent of socio-demographic factors, baseline risk factor values, and co-morbidities. CONCLUSIONS: Failure to intensify therapy leads to suboptimal control, even with adequate visits and monitoring. Interventions designed to promote appropriate intensification should enhance diabetes care in primary practice.

Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes.

BACKGROUND: Evidence comparing premixed insulin analogues (a mixture of rapid-acting and intermediate-acting insulin analogues) with other antidiabetic agents is urgently required to guide appropriate therapy. PURPOSE: To summarize the English-language literature on the effectiveness and safety of premixed insulin analogues compared with other antidiabetic agents in adults with type 2 diabetes. DATA SOURCES: The authors searched MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to February 2008 and sought unpublished data from the U.S. Food and Drug Administration, European Medicines Agency, and industry. STUDY SELECTION: Studies with control groups that compared premixed insulin analogues with another antidiabetic medication in adults with type 2 diabetes. DATA EXTRACTION: 2 reviewers using standardized protocols performed serial abstraction. DATA SYNTHESIS: Evidence from clinical trials was inconclusive for clinical outcomes, such as mortality. Therefore, the review focused on intermediate outcomes. Premixed insulin analogues were similar to premixed human insulin in decreasing fasting glucose levels, hemoglobin A(1c) levels, and the incidence of hypoglycemia but were more effective in decreasing postprandial glucose levels (mean difference, -1.1 mmol/L; 95% CI, -1.4 to -0.7 mmol/L [-19.2 mg/dL; 95% CI, -25.9 to -12.5 mg/dL]). Compared with long-acting insulin analogues, premixed insulin analogues were superior in decreasing postprandial glucose levels (mean difference, -1.5 mmol/L; CI, -1.9 to -1.2 mmol/L [-27.9 mg/dL; CI, -34.3 to -21.5 mg/dL]) and hemoglobin A(1c) levels (mean difference, -0.39% [CI, -0.50% to -0.28%]) but were inferior in decreasing fasting glucose levels (mean difference, 0.7 mmol/L; CI, 0.3 to 1.0 mmol/L [12.0 mg/dL; CI, 6.0 to 18.1 mg/dL]) and were associated with a higher incidence of hypoglycemia. Compared with noninsulin antidiabetic agents, premixed insulin analogues were more effective in decreasing fasting glucose levels (mean difference, -1.1 mmol/L; CI, -1.7 to -0.6 mmol/L [-20.5 mg/dL; CI, -29.9 to -11.2 mg/dL]), postprandial glucose levels (mean difference, -2.1 mmol/L; CI, -3.4 to -0.8 mmol/L [-37.4 mg/dL; CI, -61.0 to -13.7 mg/dL]), and hemoglobin A(1c) levels (mean difference, -0.49% [CI, -0.86% to -0.12%]) but were associated with a higher incidence of hypoglycemia. LIMITATIONS: The literature search was restricted to studies published in English. Data on clinical outcomes were limited. The small number of studies for each comparison limited assessment of between-study heterogeneity. CONCLUSION: Premixed insulin analogues provide glycemic control similar to that of premixed human insulin and may provide tighter glycemic control than long-acting insulin analogues and noninsulin antidiabetic agents.

The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients.

OBJECTIVE: (1) To determine chronic illness costs for large cohort of primary care patients, (2) to develop prospective model predicting total costs over one year, using demographic and clinical information including widely used comorbidity index. STUDY DESIGN AND SETTING: Data including diagnostic, medication, and resource utilization were obtained for 5,861 patients from practice-based computer system over a 1-year period beginning December 1, 1993, for retrospective analysis. Hospital cost data were obtained from hospital cost accounting system. RESULTS: Average annual per patient cost was $2,655. Older patients and those with Medicare or Medicaid had higher costs. Hospital costs were $1,558, accounting for 58.7% of total costs. In the predictive model, individuals with higher comorbidity incurred exponentially higher annual costs, from $4,317 with comorbidity score of two, to $5,986 with score of three, to $13,326 with scores greater than seven. To use an adapted comorbidity index to predict total yearly costs, four conditions should be added to the index: hypertension, depression, and use of warfarin with a weight of one, skin ulcers/cellulitis, a weight of two. CONCLUSION: The adapted comorbidity index can be used to predict resource utilization. Predictive models may help to identify targets for reducing high costs, by prospectively identifying those at high risk.

The reported validity and reliability of methods for evaluating continuing medical education: a systematic review.

PURPOSE: To appraise the reported validity and reliability of evaluation methods used in high-quality trials of continuing medical education (CME). METHOD: The authors conducted a systematic review (1981 to February 2006) by hand-searching key journals and searching electronic databases. Eligible articles studied CME effectiveness using randomized controlled trials or historic/concurrent comparison designs, were conducted in the United States or Canada, were written in English, and involved at least 15 physicians. Sequential double review was conducted for data abstraction, using a traditional approach to validity and reliability. RESULTS: Of 136 eligible articles, 47 (34.6%) reported the validity or reliability of at least one evaluation method, for a total of 62 methods; 31 methods were drawn from previous sources. The most common targeted outcome was practice behavior (21 methods). Validity was reported for 31 evaluation methods, including content (16), concurrent criterion (8), predictive criterion (1), and construct (5) validity. Reliability was reported for 44 evaluation methods, including internal consistency (20), interrater (16), intrarater (2), equivalence (4), and test-retest (5) reliability. When reported, statistical tests yielded modest evidence of validity and reliability. Translated to the contemporary classification approach, our data indicate that reporting about internal structure validity exceeded reporting about other categories of validity evidence. CONCLUSIONS: The evidence for CME effectiveness is limited by weaknesses in the reported validity and reliability of evaluation methods. Educators should devote more attention to the development and reporting of high-quality CME evaluation methods and to emerging guidelines for establishing the validity of CME evaluation methods.

Failure to intensify antihypertensive treatment by primary care providers: a cohort study in adults with diabetes mellitus and hypertension.

BACKGROUND: Although tight blood pressure control is crucial in reducing vascular complications of diabetes, primary care providers often fail to appropriately intensify antihypertensive medications. OBJECTIVE: To identify novel visit-based factors associated with intensification of antihypertensive medications in adults with diabetes. DESIGN: Non-concurrent prospective cohort study. PATIENTS: A total of 254 patients with type 2 diabetes and hypertension enrolled in an academically affiliated managed care program. Over a 24-month interval (1999-2001), we identified 1,374 visits at which blood pressure was suboptimally controlled (systolic BP >/= 140 mmHg or diastolic BP >/= 90 mmHg). MEASUREMENTS AND MAIN RESULTS: Intensification of antihypertensive medications at each visit was the primary outcome. Primary care providers intensified antihypertensive treatment in only 176 (13%) of 1,374 visits at which blood pressure was elevated. As expected, higher mean systolic and mean diastolic blood pressures were important predictors of intensification. Treatment was also more likely to be intensified at visits that were "routine" odds ratio (OR) 2.08; 95% Confidence Interval [95% CI] 1.36-3.18), or that paired patients with their usual primary care provider (OR 1.84; 95% CI 1.11-3.06). In contrast, several factors were associated with failure to intensify treatment, including capillary glucose >150 mg/dL (OR 0.54; 95% CI 0.31-0.94) and the presence of coronary heart disease (OR 0.61; 95% CI 0.38-0.95). Co-management by a cardiologist accounted partly for this failure (OR 0.65; 95% CI 0.41-1.03). CONCLUSIONS: Failure to appropriately intensify antihypertensive treatment is common in diabetes care. Clinical distractions and shortcomings in continuity and coordination of care are possible targets for improvement.

Effectiveness of continuing medical education.

OBJECTIVES: Despite the broad range of continuing medical education (CME) offerings aimed at educating practicing physicians through the provision of up-to-date clinical information, physicians commonly overuse, under-use, and misuse therapeutic and diagnostic interventions. It has been suggested that the ineffective nature of CME either accounts for the discrepancy between evidence and practice or at a minimum contributes to this gap. Understanding what CME tools and techniques are most effective in disseminating and retaining medical knowledge is critical to improving CME and thus diminishing the gap between evidence and practice. The purpose of this review was to comprehensively and systematically synthesize evidence regarding the effectiveness of CME and differing instructional designs in terms of knowledge, attitudes, skills, practice behavior, and clinical practice outcomes. REVIEW METHODS: We formulated specific questions with input from external experts and representatives of the Agency for Healthcare Research and Quality (AHRQ) and the American College of Chest Physicians (ACCP) which nominated this topic. We systematically searched the literature using specific eligibility criteria, hand searching of selected journals, and electronic databases including: MEDLINE, EMBASE, the Cochrane Database of Systematic Reviews, The Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Abstracts of Reviews of Effects (DARE), PsycINFO, and the Educational Resource Information Center (ERIC). Two independent reviewers conducted title scans, abstract reviews, and then full article reviews to identify eligible articles. Each eligible article underwent double review for data abstraction and assessment of study quality. RESULTS: Of the 68,000 citations identified by literature searching, 136 articles and 9 systematic reviews ultimately met our eligibility criteria. The overall quality of the literature was low and consequently firm conclusions were not possible. Despite this, the literature overall supported the concept that CME was effective, at least to some degree, in achieving and maintaining the objectives studied, including knowledge (22 of 28 studies), attitudes (22 of 26), skills (12 of 15), practice behavior (61 of 105), and clinical practice outcomes (14 of 33). Common themes included that live media was more effective than print, multimedia was more effective than single media interventions, and multiple exposures were more effective than a single exposure. The number of articles that addressed internal and/or external characteristics of CME activities was too small and the studies too heterogeneous to determine if any of these are crucial for CME success. Evidence was limited on the reliability and validity of the tools that have been used to assess CME effectiveness. Based on previous reviews, the evidence indicates that simulation methods in medical education are effective in the dissemination of psychomotor and procedural skills. CONCLUSIONS: Despite the low quality of the evidence, CME appears to be effective at the acquisition and retention of knowledge, attitudes, skills, behaviors and clinical outcomes. More research is needed to determine with any degree of certainty which types of media, techniques, and exposure volumes as well as what internal and external audience characteristics are associated with improvements in outcomes.

End-digit preference and the quality of blood pressure monitoring in diabetic adults.

OBJECTIVE: Although tight blood pressure (BP) control is proven to reduce diabetes-related cardiovascular risk, it has been difficult to achieve in practice, perhaps in part because of low-quality monitoring data. We hypothesized that low-quality BP data, reflected in end-digit preference (EDP), remains common in primary care of diabetic adults. RESEARCH DESIGN AND METHODS: Data were abstracted from the charts of 404 adults with type 2 diabetes seen at 16 academically affiliated clinics from 1999 to 2001. End-digits of systolic and diastolic BPs taken with nonautomated sphygmomanometers were extracted, and prevalence of EDP for zero was calculated. Associations between EDP and selected patient characteristics were determined using multiple logistic regressions. RESULTS: EDP was highly prevalent in the BP measurements taken by nonphysicians (4,333 BPs; 50% of systolic, 50% of diastolic readings ended in zero; P < 0.001) and physicians (1,347 BPs; 69% of systolic, 64% of diastolic readings ended in zero; P < 0.001). In multivariate analysis, nonphysicians showed greater EDP for systolic BP in older patients (odds ratio [OR] 1.07 per 5 years) and women (OR 1.36 vs. men) and for diastolic BP in African-Americans (OR 1.25 vs. whites; all P < 0.05); physicians showed greater EDP for diastolic BP in less obese patients (OR 0.97 per 5 kg/m2 increment in BMI; P = 0.02). CONCLUSIONS: Low-quality BP measurement is common in primary care of diabetic adults. Procedural and technological improvements to BP measurement deserve attention as part of an overall strategy to tighten BP control and reduce cardiovascular risk.

Impact of gene expression profiling tests on breast cancer outcomes.

OBJECTIVES: To assess the evidence that three marketed gene expression-based assays improve prognostic accuracy, treatment choice, and health outcomes in women diagnosed with early stage breast cancer. REVIEW METHODS: We evaluated the evidence for three gene expression assays on the market; Oncotype DX, MammaPrint and the Breast Cancer Profiling (BCP or H/I ratio) test, and for gene expression signatures underlying the assays. We sought evidence on: analytic performance of tests, clinical validity (i.e., prognostic accuracy and discrimination), clinical utility (i.e., prediction of treatment benefit), harms, impact on clinical decision making and health care costs. RESULTS: Few papers were found on the analytic validity of the Oncotype DX and MammaPrint tests, but these showed reasonable within-laboratory replicability. Pre-analytic issues related to sample storage and preparation may play a larger role than within-laboratory variation. For clinical validity, studies differed according to whether they examined the actual test that is currently being offered to patients or the underlying gene signature. Almost all of the Oncotype DX evidence was for the marketed test, the strongest validation study being from one arm of a randomized controlled trial (NSABP-14) with a clinically homogeneous population. This study showed that the test, added in a clinically meaningful manner to standard prognostic indices. The MammaPrint signature and test itself was examined in studies with clinically heterogeneous populations (e.g., mix of ER positivity and tamoxifen treatment) and showed a clinically relevant separation of patients into risk categories, but it was not clear exactly how many predictions would be shifted across decision thresholds if this were used in combination with traditional indices. The BCP test itself was examined in one study, and the signature was tested in a variety of formulations in several studies. One randomized controlled trial provided high quality retrospective evidence of the clinical utility of Oncotype DX to predict chemotherapy treatment benefit, but evidence for clinical utility was not found for MammaPrint or the H/I ratio. Three decision analyses examined the cost-effectiveness of breast cancer gene expression assays, and overall were inconclusive. CONCLUSIONS: Oncotype DX is furthest along the validation pathway, with strong retrospective evidence that it predicts distant spread and chemotherapy benefit to a clinically relevant extent over standard predictors, in a well-defined clinical subgroup with clear treatment implications. The evidence for clinical implications of using MammaPrint was not as clear as with Oncotype DX, and the ability to predict chemotherapy benefit does not yet exist. The H/I ratio test requires further validation. For all tests, the relationship of predicted to observed risk in different populations still needs further study, as does their incremental contribution, optimal implementation, and relevance to patients on current therapies.

Current evidence for the use of emerging radiologic technologies for disease screening.

Recent technologic advances in the field of radiology have resulted in the availability of several new tests with potential applications for disease screening. Presently, these tests are being marketed directly to patients as noninvasive means to provide peace of mind that they are disease free. Such assurance is appealing to many individuals, and some are willing to spend up to 1500 dollars to choose from a menu of available diagnostic options. Given that a physician's referral is unnecessary, many healthcare providers are unaware that such testing has taken place until their patients present to them with abnormal test results. In this review, we examine the evidence supporting the use of electron beam computed tomography for coronary artery disease screening, spiral computed tomography of the chest for lung cancer screening, computed tomographic colonography for colon cancer screening, and total-body computed tomography for general screening. Although some of these modalities show promise for the future, there is insufficient evidence to support the use of any of these testing methods for secondary prevention. The potential for harm associated with false-positive test results, false-negative test results, undue anxiety, and radiation exposure exists but requires further study to quantify actual risk.