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Annals of Internal Medicine | 2007

Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus

Shari Bolen; Leonard Feldman; Jason L. Vassy; Lisa M. Wilson; Hsin Chieh Yeh; Spyridon S Marinopoulos; Crystal Wiley; Elizabeth Selvin; Renee F Wilson; Eric B Bass; Frederick L. Brancati

The prevalence and morbidity associated with type 2 diabetes mellitus continue to increase in the United States and elsewhere (1, 2). Several studies of the treatment of type 2 diabetes suggest that improved glycemic control reduces microvascular risks (37). In contrast, the effects of treatment on macrovascular risk are more controversial (3, 4, 8, 9), and the comparative effects of oral diabetes agents on clinical outcomes are even less certain. As newer oral agents, such as thiazolidinediones and meglitinides, are increasingly marketed, clinicians and patients must decide whether they prefer these generally more costly medications over older agents, such as sulfonylureas and metformin. Systematic reviews and meta-analyses of oral diabetes agents have attempted to fill this gap (1019), but few have compared all agents with one another (18, 19). The few investigations that have compared all oral agents focused narrowly on individual outcomes, such as hemoglobin A1c level (18) or serum lipid levels (19). No systematic review has summarized all available head-to-head comparisons with regard to the full range of intermediate end points (including hemoglobin A1c level, lipid levels, and body weight) and other clinically important outcomes, such as adverse effects and macrovascular risks. Therefore, the Agency for Healthcare Research and Quality commissioned a systematic review to summarize the comparative benefits and harms of oral agents that are used to treat type 2 diabetes. Methods Data Sources and Selection We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from inception to January 2006 for original articles. We also searched these databases until November 2005 for systematic reviews. We reviewed reference lists of related reviews and original data articles, hand-searched recent issues of 15 medical journals, invited experts to provide additional citations, reviewed selected medications from the U.S. Food and Drug Administration (FDA) Web site, and reviewed unpublished data from several pharmaceutical companies and public registries of clinical trials. Our search strategy for the bibliographic databases combined terms for type 2 diabetes and oral diabetes agents and was limited to English-language articles and studies in adults. The search for systematic reviews was similar but included terms for study design as well. We selected studies that included original data on adults with type 2 diabetes and assessed benefits or harms of FDA-approved oral diabetes agents that were available in the United States as of January 2006. To facilitate head-to-head comparisons of drug classes, we included drugs not on the U.S. market if members of their class were in use and had not been banned (voglibose, gliclazide, and glibenclamide). We also included studies of combinations of therapies that are commonly used, such as combinations of metformin, second-generation sulfonylureas, and thiazolidinediones. We excluded studies that evaluated combinations of 3 oral diabetes agents, and we also excluded first-generation sulfonylureas, because few clinicians prescribe these medications. We sought studies that reported on major clinical outcomes (for example, all-cause mortality, cardiovascular morbidity and mortality, and microvascular outcomes) or any of the following intermediate end points or adverse events: hemoglobin A1c level, body weight, systolic and diastolic blood pressure, high-density lipoprotein (HDL) cholesterol level, low-density lipoprotein (LDL) cholesterol level, triglyceride level, hypoglycemia, gastrointestinal problems, congestive heart failure, edema or hypervolemia, lactic acidosis, elevated aminotransferase levels, liver failure, anemia, leukopenia, thrombocytopenia, allergic reactions requiring hospitalization or causing death, and other serious adverse events. For intermediate end points, we included only randomized, controlled trials, which were abundant. For major clinical end points and adverse events, we considered observational studies as well as trials, because fewer randomized trials assessed these end points. We excluded studies that followed patients for less than 3 months (the conventional threshold for determining effects on hemoglobin A1c) or had fewer than 40 patients. Figure 1 shows the search and selection process, and the full technical report (available at effectivehealthcare.ahrq.gov/repFiles/OralFullReport.pdf) provides a more detailed description of the study methods (20). Figure 1. Study flow diagram. Data Extraction and Quality Assessment One investigator used standardized forms to abstract data about study samples, interventions, designs, and outcomes, and a second investigator confirmed the abstracted data. Two investigators independently applied the Jadad scale to assess some aspects of the quality of randomized trials (21). We considered observational studies and nonrandomized trials to provide weaker evidence than randomized trials, and we did not use a standardized scoring system to assess their quality (22). We used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group definitions to grade the overall strength of the evidence as high, moderate, low, very low, or insufficient (23). Data Synthesis and Analysis We first performed a qualitative synthesis based on scientific rigor and type of end point. In general, we described the UKPDS (United Kingdom Prospective Diabetes Study) separately, because this large randomized, controlled trial differed from other trials in design, end points, and duration. When data were sufficient (that is, obtained from at least 2 randomized, controlled trials) and studies were relatively homogeneous in sample characteristics, study duration, and drug dose, we conducted meta-analyses for the following intermediate outcomes and adverse effects: hemoglobin A1c level, weight, systolic blood pressure, LDL cholesterol level, HDL cholesterol level, triglyceride level, and hypoglycemia. For trials with more than 1 dosing group, we chose the dose that was most comparable with other trials and most clinically relevant. We combined drugs into drug classes only when similar results were found across individual drugs. We could not perform formal meta-analyses for microvascular or macrovascular outcomes, mortality, and adverse events other than hypoglycemia because of methodological diversity among the trials or insufficient numbers of trials. We used a random-effects model with the DerSimonian and Laird formula to derive pooled estimates (posttreatment weighted mean differences for intermediate outcomes and posttreatment absolute risk differences for adverse events) (24). We tested for heterogeneity among the trials by using a chi-square test with set to 0.10 or less and an I 2 statistic greater than 50% (25). If heterogeneity was found, we conducted meta-regression analyses by using study-level characteristics of double-blinding, study duration, and dose ratio (calculated as the dose given in the study divided by the maximum approved dose of drug). The full report contains data on indirect comparisons, in which 2 interventions are compared through their relative effect against a common comparator (20). We tested for publication bias by using the tests of Begg and Mazumdar (26) and Egger and colleagues (27). All statistical analyses were done by using STATA Intercooled, version 8.0 (Stata, College Station, Texas). Role of the Funding Source The Agency for Healthcare Research and Quality suggested the initial questions and provided copyright release for this manuscript but did not participate in the literature search, data analysis, or interpretation of the results. Results Comparative Effectiveness of Oral Diabetes Agents in Reducing the Risk for Microvascular and Macrovascular Outcomes and Death We found no definitive evidence about the comparative effectiveness of oral diabetes agents on all-cause mortality, cardiovascular mortality or morbidity, peripheral arterial disease, neuropathy, retinopathy, or nephropathy (Table 1). For each head-to-head comparison on specific outcomes, the number of randomized trials (3 trials) and the absolute number of events were small (20). The few observational studies were limited in quantity, consistency, and adjustment for key confounders. Table 1. Evidence of the Comparative Effectiveness of Oral Diabetes Medications on Mortality, Microvascular and Macrovascular Outcomes, and Intermediate End Points Since our review, 2 high-profile comparative randomized trials with about 4 years of follow-up have been published, providing data on cardiovascular outcomes (28, 29). In ADOPT (A Diabetes Outcome Progression Trial) (28), the incidence of cardiovascular events was lower with glyburide than with rosiglitazone or metformin (1.8%, 3.4%, and 3.2%, respectively; P< 0.05). This effect was mainly driven by fewer congestive heart failure events and a lower rate of nonfatal myocardial infarction events in the glyburide group. Loss to follow-up was high (40%) and was disproportionate among the groups and therefore may account for some differences among groups. The interim analysis of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study reported that rosiglitazone plus metformin or a sulfonylurea compared with metformin plus a sulfonylurea had a hazard ratio of 1.08 (95% CI, 0.89 to 1.31) for the primary end point of hospitalization or death from cardiovascular disease (29). The hazard ratio was driven by more congestive heart failure in the rosiglitazone plus metformin or sulfonylurea group than in the control group of metformin plus sulfonylurea (absolute risk, 1.7% vs. 0.8%, respectively). In KaplanMeier curves, the risk for hospitalization or death from myocardial infarction was slightly lower in the control group than in the rosiglitazone group, but the difference was not statistically significant. A limitation of


JAMA Internal Medicine | 2008

Cardiovascular Outcomes in Trials of Oral Diabetes Medications: A Systematic Review

Elizabeth Selvin; Shari Bolen; Hsin Chieh Yeh; Crystal Wiley; Lisa M. Wilson; Spyridon S Marinopoulos; Leonard Feldman; Jason L. Vassy; Renee F Wilson; Eric B Bass; Frederick L. Brancati

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.


JAMA Internal Medicine | 2013

Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial.

Sanjay V. Desai; Leonard Feldman; Lorrel Brown; Rebecca Dezube; Hsin Chieh Yeh; Naresh M. Punjabi; Kia Afshar; Michael R. Grunwald; Colleen Harrington; Rakhi Naik; Joseph Cofrancesco

IMPORTANCE On July 1, 2011, the Accreditation Council for Graduate Medical Education implemented further restrictions of its 2003 regulations on duty hours and supervision. It remains unclear if the 2003 regulations improved trainee well-being or patient safety. OBJECTIVE To determine the effects of the 2011 Accreditation Council for Graduate Medical Education duty hour regulations compared with the 2003 regulations concerning sleep duration, trainee education, continuity of patient care, and perceived quality of care among internal medicine trainees. DESIGN AND SETTING Crossover study design in an academic research setting. PARTICIPANTS Medical house staff. INTERVENTION General medical teams were randomly assigned using a sealed-envelope draw to an experimental model or a control model. MAIN OUTCOME MEASURES We randomly assigned 4 medical house staff teams (43 interns) using a 3-month crossover design to a 2003-compliant model of every fourth night overnight call (control) with 30-hour duty limits or to one of two 2011-compliant models of every fifth night overnight call (Q5) or a night float schedule (NF), both with 16-hour duty limits. We measured sleep duration using actigraphy and used admission volumes, educational opportunities, the number of handoffs, and satisfaction surveys to assess trainee education, continuity of patient care, and perceived quality of care. RESULTS The study included 560 control, 420 Q5, and 140 NF days that interns worked and 834 hospital admissions. Compared with controls, interns on NF slept longer during the on call period (mean, 5.1 vs 8.3 hours; P = .003), and interns on Q5 slept longer during the postcall period (mean, 7.5 vs 10.2 hours; P = .05). However, both the Q5 and NF models increased handoffs, decreased availability for teaching conferences, and reduced intern presence during daytime work hours. Residents and nurses in both experimental models perceived reduced quality of care, so much so with NF that it was terminated early. CONCLUSIONS AND RELEVANCE Compared with a 2003-compliant model, two 2011 duty hour regulation-compliant models were associated with increased sleep duration during the on-call period and with deteriorations in educational opportunities, continuity of patient care, and perceived quality of care.


Annals of Internal Medicine | 2008

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

Rehan Qayyum; Shari Bolen; Nisa M. Maruthur; Leonard Feldman; Lisa M. Wilson; Spyridon S Marinopoulos; Padmini D Ranasinghe; Muhammed Amer; Eric B Bass

Context The relative effects of premixed insulin analogues, other insulin regimens, and noninsulin antidiabetic agents for adults with type 2 diabetes are unclear. Contribution This systematic review of comparative trials in adults with type 2 diabetes found that premixed insulin analogues and premixed human insulin provided similar glycemic control. Premixed analogues provided tighter glycemic control and caused more hypoglycemia than long-acting insulin analogues and noninsulin antidiabetic agents. Caution Evidence for effects on clinical outcomes was scant and inconclusive. Implication We need large, long-term trials that compare premixed insulin analogues with other agents to see whether improvements in glucose control lead to improved clinical outcomes. The Editors According to the National Health Interview Survey, 28% of patients with type 2 diabetes are using insulin, either alone (16%) or in combination with oral antidiabetic agents (12%) (1). In the management of type 2 diabetes, the role of premixed insulin analogues relative to other insulin regimens and noninsulin antidiabetic agents is unclear. Premixed insulin analogues are derived from rapid-acting insulin analogues and consist of a mixture of a rapid-acting insulin analogue and its intermediate-acting protaminated form. Premixed insulin analogues may be a better alternative than premixed human insulin preparations for patients who wish to have a near-physiologic insulin administration regimen but want to avoid multiple daily insulin injections. In addition, they may allow patients flexible meal times, because these preparations can be administered from 15 minutes before meals to immediately after a meal. Given the increasing prevalence of type 2 diabetes (2), the number of patients who use insulin for glycemic control (1), and the importance of glycemic control in decreasing mortality and morbidity (3), it is imperative to establish the weight of evidence for the safety and effectiveness of these relatively newer insulin preparations compared with traditional insulin preparations. Therefore, the Agency for Healthcare Research and Quality commissioned a systematic review of published studies on the comparative effectiveness and safety of all the premixed insulin analogues that are approved by the U.S. Food and Drug Administration and are available in the United States. Methods Data Sources We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and CINAHL from inception to February 2008. The complete search strategy is available at effectivehealthcare.ahrq.gov/. We also reviewed reference lists of included articles, recent issues of 13 medical journals, the U.S. Food and Drug Administration and European Medicines Agency Web sites for the premixed insulin analogues, unpublished data from premixed insulin analogue manufacturers (Eli Lilly and Company, Indianapolis, Indiana; Sanofi-Aventis, Bridgewater, New Jersey; and Novo Nordisk, Bagsvaerd, Denmark), and Web sites of public registries of clinical trials (ClinicalTrials.gov and ClinicalStudyResults.org). Study Selection We included studies that compared a premixed insulin analogue approved by the U.S. Food and Drug Administration as of February 2008 with any other drug for adults with type 2 diabetes and evaluated clinical outcomes (such as mortality), intermediate outcomes (such as hemoglobin A1c level), or adverse events (such as hypoglycemia). We included randomized, controlled trials (RCTs); controlled clinical trials; and observational studies with control groups, regardless of their duration or sample size. However, we used data from crossover studies only for intermediate outcomes and hypoglycemia. We excluded crossover trials from the quantitative evaluation of outcomes that were either progressive (for example, retinopathy) or irreversible (for example, death). For the evaluation of hemoglobin A1c, we included crossover trials with at least 12 weeks of follow-up before and after the crossover phase. We aimed to use within-individual comparisons from crossover trials if trials had reported data in such detail, but no study did so. Because all crossover studies reported results for each intervention and no trial reported a statistically significant carryover effect, we ignored the crossover design and used reported estimates as if they came from a parallel trial. We excluded nonEnglish-language articles, editorials, comments, letters, and abstracts. Data Extraction and Quality Assessment Two investigators independently reviewed the titles, abstracts, and full articles for inclusion and abstracted data by using standardized forms. We developed a study quality assessment tool based on the Jadad criteria (4), the Newcastle-Ottawa Scale (5), and questions from Agency for Healthcare Research and Qualitys guide for conducting comparative effectiveness reviews (6). We adapted the evidence grading scheme recommended by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group (7) to classify the strength of the body of evidence on each comparison as high, moderate, low, or insufficient. Data Synthesis and Analysis We conducted meta-analyses for outcomes when data were sufficient (2 trials). For intermediate outcomes (fasting glucose, postprandial glucose, and hemoglobin A1c levels) and the adverse outcome of weight gain, we recorded the mean difference between groups, along with its measure of dispersion. If this was not reported, we calculated the point estimate by using the mean difference from baseline for each group. If the mean difference from baseline was not reported, we calculated this from the baseline and final values for each group. If no measure of dispersion was reported for the between-group difference, we calculated it by using the sum of the variances for the mean difference from baseline for each group. If there were no measures of dispersion for the mean difference from baseline for each group, we calculated the variance by using the standard deviation of the baseline and final values, assuming a correlation between baseline and final values of 0.5. We pooled the results of the plasma and blood glucose levels from different studies because blood glucose measurements accurately reflect plasma glucose levels (8). For hypoglycemia, we used 2 strategies to synthesize data. If a trial reported the incidence of hypoglycemia, we calculated an odds ratio (OR) by using the incidence of hypoglycemia in each study group. If a trial did not report the incidence of hypoglycemia but reported event rates in episodes per patient per 30 days, we calculated the rate ratio by dividing the event rate in the premixed insulin analogue group by the event rate in the comparator group. If a trial reported the number of episodes in each group or reported an event rate in a form other than episodes per patient per 30 days, we converted this information into episodes per patient per 30 days. We pooled the results of individual studies by using a random-effects model. These analyses were conducted by using Comprehensive Meta-Analysis, version 2.2.046 (Biostat, Englewood, New Jersey). For clinical outcomes, we included all studies that reported any information about clinical events (all-cause mortality and cardiovascular mortality and morbidity). All analyses followed the intention-to-treat principle. We combined results from the premixed insulin analogue group of different trials, assuming that the results were similar enough between premixed insulin analogues. In the study with 3 groups and comparing a premixed insulin analogue with 2 different insulin preparations (9), we chose the most relevant comparison to include in the meta-analyses (premixed insulin analogue vs. long-acting insulin analogue). We calculated pooled ORs and 95% CIs by using a MantelHaenszel fixed-effects model (with a 0.1 continuity correction) in Stata Intercooled, version 9.2 (Stata, College Station, Texas) (10, 11). For analysis of clinical outcomes, we used a fixed-effects model because it is less biased with rare event data (12). For sensitivity analyses, we used 3 meta-analytic methods: the Peto method, the MantelHaenszel fixed-effects model (with 0.5 and 0.01 continuity corrections), and Bayesian analysis (13). Heterogeneity among the trials was tested by using a standard chi-square test, with a significance level of 0.10 or less. We also examined inconsistency among studies by using an I 2 statistic (14); a value greater than 50% represented substantial variability. For all outcomes, we conducted sensitivity analyses by omitting 1 study at a time. We assessed publication bias visually by examining the symmetry of funnel plots and statistically by using the Begg (15) and Egger (16) tests. Role of the Funding Source The Agency for Healthcare Research and Quality suggested the initial questions and provided copyright release for this manuscript but did not participate in the literature search, data analysis, or interpretation of the results. Results Study Characteristics The Appendix Figure shows the results of the literature search. We found 45 studies that reported at least 1 of the intermediate clinical outcomes or adverse events (Appendix Table). All studies except 2 (17, 18) were RCTs. In 1 study (17), patients were enrolled consecutively and followed prospectively, and in the other study (18), data were obtained from the medical record database of a large employer. Among the RCTs, 23 were parallel-group (9, 1940) and 20 were crossovers (4160). The median duration of follow-up in these trials was 16 weeks (range, 1 day to 2 years). Appendix Table. Characteristics of the Included Studies Appendix Figure. Study flow diagram. FDA = U.S. Food and Drug Administration. * The total may exceed the number in the corresponding box because articles could be excluded for more than 1 reason at this level. The trials enrolled a total of 14603 patients (median per trial, 93 patient


Journal of Hospital Medicine | 2012

Nurse‐pharmacist collaboration on medication reconciliation prevents potential harm

Leonard Feldman; Linda L. Costa; E. Robert Feroli; Terry S. Nelson; Stephanie S. Poe; Kevin D. Frick; Leigh E. Efird; Redonda G. Miller

BACKGROUND Medication reconciliation can prevent some adverse drug events (ADEs). Our prospective study explored whether an easily replicable nurse-pharmacist led medication reconciliation process could efficiently and inexpensively prevent potential ADEs. METHODS Nurses at a 1000 bed urban, tertiary care hospital developed the home medication list (HML) through patient interview. If a patient was not able to provide a written HML or recall medications, the nurses reviewed the electronic record along with other sources. The nurses then compared the HML to the patients active inpatient medications and judged whether the discrepancies were intentional or potentially unintentional. This was repeated at discharge as well. If the prescriber changed the order when contacted about a potential unintentional discrepancy, it was categorized as unintentional and rated on a 1-3 potential harm scale. RESULTS The study included 563 patients. HML information gathering averaged 29 minutes. Two hundred twenty-five patients (40%; 95% confidence interval [CI], 36%-44%) had at least 1 unintended discrepancy on admission or discharge. One hundred sixty-two of the 225 patients had an unintended discrepancy ranked 2 or 3 on the harm scale. It cost


Postgraduate Medical Journal | 2013

Residency schedule, burnout and patient care among first-year residents

Lauren Block; Albert W. Wu; Leonard Feldman; Hsin Chieh Yeh; Sanjay V. Desai

113.64 to find 1 potentially harmful discrepancy. Based on the 2008 cost of an ADE, preventing 1 discrepancy in every 290 patient encounters would offset the intervention costs. We potentially averted 81 ADEs for every 290 patients. CONCLUSION Potentially harmful medication discrepancies occurred frequently at both admission and discharge. A nurse-pharmacist collaboration allowed many discrepancies to be reconciled before causing harm. The collaboration was efficient and cost-effective, and the process potentially improves patient safety.


Journal of The American College of Radiology | 2013

Provider Cost Transparency Alone Has No Impact on Inpatient Imaging Utilization

Daniel J. Durand; Leonard Feldman; Jonathan S. Lewin; Daniel J. Brotman

Background The 2011 US Accreditation Council for Graduate Medical Education (ACGME) mandates reaffirm the need to design residency schedules to augment patient safety and minimise resident fatigue. Objectives To evaluate which elements of the residency schedule were associated with resident burnout and fatigue and whether resident burnout and fatigue were associated with lower perceived quality of patient care. Methods A cross-sectional survey of first-year medicine residents at three hospitals in May–June 2011 assessed residency schedule characteristics, including hours worked, adherence to 2003 work-hour regulations, burnout and fatigue, trainee-reported quality of care and medical errors. Results Response rate was 55/76 (72%). Forty-two of the 55 respondents (76%) met criteria for burnout and 28/55 (51%) for fatigue. After adjustment for age, gender and residency programme, an overnight call was associated with higher burnout and fatigue scores. Adherence to the 80 h working week, number of days off and leaving on time were not associated with burnout or fatigue. Residents with high burnout scores were more likely to report making errors due to excessive workload and fewer reported that the quality of care provided was satisfactory. Conclusions Burnout and fatigue were prevalent among residents in this study and associated with undesirable personal and perceived patient-care outcomes. Being on a rotation with at least 24 h of overnight call was associated with higher burnout and fatigue scores, but adherence to the 2003 ACGME work-hour requirements, including the 80 h working week, leaving on time at the end of shifts and number of days off in the previous month, was not. Residency schedule redesign should include efforts to reduce characteristics that are associated with burnout and fatigue.


Journal of Hospital Medicine | 2013

Do internal medicine interns practice etiquette‐based communication? A critical look at the inpatient encounter

Lauren Block; Lindsey Hutzler; Robert Habicht; Albert W. Wu; Sanjay V. Desai; Kathryn Novello Silva; Timothy Niessen; Nora Oliver; Leonard Feldman

PURPOSE The aim of this study was to determine whether presenting providers with cost information at the point of order entry significantly influences imaging utilization. METHODS Using data from fiscal year 2007, the 10 most frequently ordered imaging tests were identified. Five of these were randomly assigned to the active cost display group and 5 to the control group. During a 6-month baseline period from November 10, 2008, to May 9, 2009, no costs were displayed. During a seasonally matched intervention period from November 10, 2009, to May 9, 2010, costs were displayed only for tests in the active group. At the conclusion of the study, the radiology information system was queried to determine the number of orders executed for all tests during both periods. The main outcome measure was the mean relative utilization change between the control and intervention periods for the active group vs the control group. An additional measure was the correlation between test cost and utilization change in the active group vs the control group. RESULTS The mean utilization change was +2.8 ± 4.4% for the active group and -3.0 ± 5.5% for the control group, with no significant difference between the two groups (P = .10, Students t-test). There was also no significant difference in the correlation between test cost and utilization change for the active group vs the control group (P = .25, Fishers z-test). On the basis of the observed standard deviations, this study had 90% power to detect an 11.8% difference in mean relative utilization change between groups. CONCLUSIONS Provider cost transparency alone does not significantly influence inpatient imaging utilization.


Substance Abuse | 2016

Internal medicine resident knowledge, attitudes, and barriers to naloxone prescription in hospital and clinic settings.

J. Deanna Wilson; Natalie Spicyn; Pamela Matson; Anika A. H. Alvanzo; Leonard Feldman

Etiquette-based communication may improve the inpatient experience but is not universally practiced. We sought to determine the extent to which internal medicine interns practice behaviors that characterize etiquette-based medicine. Trained observers evaluated the use of 5 key communication strategies by internal medicine interns during inpatient clinical encounters: introducing ones self, explaining ones role in the patients care, touching the patient, asking open-ended questions, and sitting down with the patient. Participants at 1 site then completed a survey estimating how frequently they performed each of the observed behaviors. A convenience sample of 29 interns was observed on a total of 732 patient encounters. Overall, interns introduced themselves 40% of the time and explained their role 37% of the time. Interns touched patients on 65% of visits, asked open-ended questions on 75% of visits, and sat down with patients during 9% of visits. Interns at 1 site estimated introducing themselves and their role and sitting with patients significantly more frequently than was observed (80% vs 40%, P < 0.01; 80% vs 37%, P < 0.01; and 58% vs 9%, P < 0.01, respectively). Resident physicians introduced themselves to patients, explained their role, and sat down with patients infrequently during observed inpatient encounters. Residents surveyed tended to overestimate their own practice of etiquette-based medicine.


American Journal of Medical Quality | 2014

Focus on Transitions of Care Description and Evaluation of an Educational Intervention for Internal Medicine Residents

Hanan Aboumatar; Robert D. Allison; Leonard Feldman; Kevin Woods; Patricia Thomas; Charles M. Wiener

BACKGROUND The United States is facing an epidemic of opioid use and misuse leading to historically high rates of overdose. Community-based overdose education and naloxone distribution has effectively trained lay bystanders to recognize signs of overdose and administer naloxone for reversal. There has been a movement to encourage physicians to prescribe naloxone to all patients at risk of overdose; however, the rate of physician prescribing remains low. This study aims to describe resident knowledge of overdose risk assessment, naloxone prescribing practices, attitudes related to naloxone, and barriers to overdose prevention and naloxone prescription. METHODS The HOPE (Hospital-based Overdose Prevention and Education) Initiative is an educational campaign to teach internal medicine residents to assess overdose risk, provide risk reduction counseling, and prescribe naloxone. As part of a needs assessment, internal medicine residents at an academic medical center in Baltimore, Maryland, were surveyed in 2015. Data were collected anonymously using Qualtrics. RESULTS Ninety-seven residents participated. Residents were overwhelmingly aware of naloxone (80%) and endorsed a willingness to prescribe (90%). Yet despite a high proportion of residents reporting patients in their panels at increased overdose risk (79%), few had prescribed naloxone (15%). Residents were willing to discuss overdose prevention strategies, although only a minority reported doing so (47%). The most common barriers to naloxone prescribing were related to knowledge gaps in how to prescribe and how to assess risk of overdose and identify candidates for naloxone (52% reporting low confidence in ability to identify patients who are at risk). CONCLUSIONS Medicine residents are aware of naloxone and willing to prescribe it to at-risk patients. Due to decreased applied knowledge and limited self-efficacy, few residents have prescribed naloxone in the past. In order to improve rates of physician prescribing, initiatives must help physicians better assess risk of overdose and improve prescribing self-efficacy.

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Sanjay V. Desai

Johns Hopkins University School of Medicine

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Albert W. Wu

Johns Hopkins University

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Eric B Bass

Johns Hopkins University

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Lisa M. Wilson

Johns Hopkins University

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Shari Bolen

Johns Hopkins University School of Medicine

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Crystal Wiley

Johns Hopkins University

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Hsin Chieh Yeh

Johns Hopkins University School of Medicine

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