In the News
for the Week of 7-20-10
- Physicians don’t always report impaired or incompetent colleagues
- ASCO guidelines recommend aromatase inhibitors
- MKSAP Quiz: Preoperative evaluation
- Intensive control of glucose, cholesterol reduces retinopathy
- Albumin-creatinine ratio in morning urine is most predictive
From the College
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, FACP
Physicians don’t always report impaired or incompetent colleagues
Most physicians agree they have an ethical obligation to report impaired or incompetent colleagues, but many don't always do so, according to a new study.
Researchers performed a survey of 2,938 physicians practicing in the fields of anesthesiology, cardiology, family practice, general surgery, internal medicine, pediatrics and psychiatry. The response rate was 64.4%. Respondents were asked whether they agreed or disagreed that physicians should always report impaired or incompetent colleagues. They were also asked whether they were prepared to deal with such colleagues and whether they had been aware of and subsequently reported an impaired or incompetent colleague in the past three years. Those who reported knowing of an impaired or incompetent colleague were asked if they had ever not reported unprofessional behavior for certain reasons, such as believing someone else was handling the problem or that the physician in question would be too harshly disciplined as a result of the reporting. The survey results appear in the July 14 Journal of the American Medical Association.
Overall, 1,120 physicians (64%) agreed that the tenets of their profession obligated them to report impaired or incompetent colleagues. Still, only 69% (n=1,208) were prepared to deal with impaired colleagues and 64% (n=1,126) were prepared to deal with incompetent colleagues. Of the 309 physicians (17%) who personally knew an incompetent colleague, 67% (n=204) said that they had reported him or her. Physicians who were underrepresented minorities, who did not graduate from a U.S. medical school and who lived in an area where malpractice claim numbers were high were less likely to report, while those working in hospitals or medical schools rather than group or small practices were more likely to report. Physicians were most likely to cite a belief that "someone else was taking care of the problem" as the reason for failing to report. Other common reasons included believing that reporting would have no effect and fearing that it would lead to retribution.
The study results may have been affected by nonresponse bias, and physicians may have been wrong about their colleagues' job performance. However, the authors concluded that based on their survey results, self-regulation does not guarantee accurate reporting of impaired or incompetent physicians. External regulation by such bodies as professional societies should be strengthened, they suggested, and reporting systems must guarantee reporting physicians’ anonymity and provide feedback once the reported problem is addressed.
The author of an accompanying editorial pointed out that the study results could alternatively be viewed more positively, since most physicians did agree that they had an obligation to report impaired or incompetent colleagues. He also noted that "today there are multiple complementary methods, developed by the profession, to monitor competence and detect impairment," such as performance measurement, CME requirements, and maintenance of certification programs. The editorialist agreed that some physicians do not report colleagues when they should, and that the existing reporting system should be improved. However, he wrote, the current study "is also a reminder that physicians are always seeking to perfect the complex web of interactive processes used for quality assurance in medicine.".
ASCO guidelines recommend aromatase inhibitors
New guidelines from the American Society of Clinical Oncology (ASCO) recommend that postmenopausal women with hormone receptor-positive breast cancer take an aromatase inhibitor to reduce the risk of recurrence.
An expert panel revised existing ASCO guidelines based on a systematic review of the literature (including 12 major trials) on endocrine therapy for women with hormone-receptor positive disease. The experts concluded that most postmenopausal women with the disease should take an aromatase inhibitor (AI) at some point, either as the initial adjuvant therapy or after taking tamoxifen. The guideline recommends that the switch from tamoxifen to an AI be made after two to three years, but the experts noted that switching after five years is also supported by the evidence. AI therapy can be continued for up to five years.
The three different AIs that are currently available show no clinically important differences in effectiveness, the experts concluded. They also compared side effects of the AIs and tamoxifen, finding them to be mild overall, but noting that AIs may reduce the chances of blood clots and uterine cancer but increase the risk of osteoporosis and fractures compared to tamoxifen. Patients who are intolerant of one AI may be advised to switch to another AI or tamoxifen.
Women who are pre- or peri-menopausal should not take an AI, the experts said. For those women, the guidelines recommend five years of tamoxifen. For post-menopausal women, the choice of whether and when to incorporate AI therapy should be based on adverse event profiles and patient preferences, the guidelines said. No biomarkers have been proven effective at determining which treatment strategy is best.
The guidelines also called for additional research on improving adherence to therapy, the optimal time to switch from one therapy to another, the role of drug metabolism and pharmacogenetics, and markers of subtypes of hormone-receptor positive cancer than may respond better to certain therapies. The guidelines were published online July 12 by the Journal of Clinical Oncology. A press release is also online.
MKSAP Quiz: Preoperative evaluation
A 65-year-old woman comes for a preoperative evaluation before elective right knee arthroplasty. The patient has severe pain and disability due to osteoarthritis of the right knee. She had a myocardial infarction 4 months ago and required a percutaneous coronary intervention with placement of a paclitaxel drug-eluting stent in the left anterior descending coronary artery. The patient also has hypertension and type 2 diabetes mellitus. She currently has no chest pain or dyspnea but can only walk two blocks and climb one flight of stairs because of the osteoarthritis. Current medications are clopidogrel, metoprolol, atorvastatin, losartan, metformin, aspirin, acetaminophen and tramadol.
Vital signs are normal. Other than evidence of bony hypertrophy of the knees and a small effusion in the right knee, the remainder of the examination is unremarkable.
An electrocardiogram shows normal sinus rhythm; Q waves in leads II, III, and aVF; and left ventricular hypertrophy.
Which of the following is the best preoperative management?
A) Postpone surgery for 6 months after stent was placed
B) Postpone surgery for 12 months after stent was placed
C) Proceed with surgery; continue aspirin but temporarily stop the clopidogrel
D) Proceed with surgery; continue both aspirin and clopidogrel
E) Proceed with surgery; temporarily discontinue aspirin and clopidogrel
Click here or scroll to the bottom of the page for the answer and critique.
Intensive control of glucose, cholesterol reduces retinopathy
Intensive control of glycemia and dyslipidemia slowed progression of diabetic retinopathy, according to a new analysis from the ACCORD trial.
The subgroup analysis included 2,856 patients who were randomized to either intensive or standard control of glycemia (target hemoglobin A1c <6% or 7.0-7.9%), dyslipidemia (simvastatin plus either 160 mg daily fenofibrate or placebo) and blood pressure (target <120 or <140 mm Hg systolic). The effect of the intervention was measured after four years. Retinopathy was considered to have progressed if patients moved three or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale or needed laser photocoagulation or vitrectomy.
The intensive glycemic control was associated with a reduced progression to retinopathy—7.3% of patients in the intensive group compared to 10.4% in the standard treatment group (P=0.003). The use of fenofibrate also reduced progression (6.5% of those taking the drug vs. 10.2% of the placebo group, P=0.006). However, intensive blood pressure control did not significantly affect the odds of progressive retinopathy (10.4% vs. 8.8%, P=0.29).
The results confirm previous trials indicating that fenofibrate slows the progression of diabetic retinopathy, the study authors concluded. The study also showed that intensive glycemic control can have a positive effect on retinopathy, even in type 2 diabetics who are at high risk of cardiovascular disease. Previous research has shown an effect in type 1 diabetics and people newly diagnosed with type 2. The study appeared in the July 14 New England Journal of Medicine.
The lack of effect shown by tight blood pressure control may have related to the study’s relatively short follow-up and narrow range of blood pressures, speculated an accompanying editorial. The apparent effectiveness of fenofibrate is an exciting finding which could suggest the importance of the drug in treating diabetic retinopathy, and further research is needed to determine whether the results were due to an interaction between fenofibrate and simvastatin, the editorialist said..
Albumin-creatinine ratio in morning urine is most predictive
Using a first morning urine sample to measure albumin-creatinine ratio in patients with type 2 diabetes and renal disease offers the best predictor of renal events, according to a new study.
Researchers used data from the industry-funded RENAAL (Reduction In Endpoints in Non Insulin Dependent Diabetes Mellitus with the Angiotensin-II Antagonist Losartan) study to compare methods of measuring proteinuria in patients with type 2 diabetes and kidney disease. The four methods tested were urinary protein excretion from a 24-hour urine collection, urinary albumin excretion from a 24-hour urine collection, urinary albumin concentration from a first morning urine sample and albumin-creatinine ratio from a first morning urine sample. The study's primary outcome measure was time to doubling of serum creatinine concentration or time to end-stage renal disease. The results were published early online July 15 by the Journal of the American Society of Nephrology.
Seven hundred one patients with type 2 diabetes and nephropathy collected both a first morning urine sample and a 24-hour urine sample. Of these, 202 (28.8%) had a doubled serum creatinine concentration or developed end-stage renal disease during follow-up. Hazard ratios for renal outcome risk per SD increment in each measure were 3.16 (95% CI, 2.60 to 3.86) for urinary albumin excretion, 3.02 (95% CI, 2.53 to 3.62) for urinary protein excretion, 3.23 (95% CI, 2.67 to 3.91) for urinary albumin concentration and 4.36 (95% CI, 3.50 to 5.45) for albumin-creatinine ratio. The albumin-creatinine ratio had a significantly higher area under the receiver-operating curve than the other measures.
The authors cautioned that their results are not generalizable to patients without diabetes and nephropathy, but concluded that measuring albumin-creatinine ratio in first morning urine is the best way to predict progression of renal disease in this population. An accompanying editorial concurred, stating, “Given data from this study and the considerable patient effort required for a 24-hour urine collection, we agree with the authors that the first morning [albumin-creatinine ratio] is in general the logical choice for quantifying proteinuria in clinical practice.”
CMS defines meaningful use, ACP responds
Last week, the Centers for Medicare & Medicaid Services (CMS) issued final rules defining meaningful use of electronic health records, which physician practices and hospitals must meet in order to qualify for Medicare and Medicaid incentive payments.
Two companion final rules were announced. One regulation, issued by CMS, defines the minimum requirements that providers must meet through their use of certified EHR technology in order to qualify for the payments. The rule includes modifications that address concerns raised by stakeholders, according to a CMS press release. For example, as originally proposed the rule called on eligible professionals to meet 25 requirements (23 for hospitals) in their use of EHRs, but the final rule divides the requirements into a core group of requirements that must be met, plus an additional menu of procedures from which providers may choose. A summary overview of the requirements and a discussion of the rule by CMS leaders were published online by the New England Journal of Medicine.
The other rule, issued by the Office of the National Coordinator for Health Information Technology (ONC), identifies the standards and certification criteria for EHR technology, so providers may be assured that the systems they adopt are capable of performing the required functions.
ACP Executive Vice President and Chief Executive Officer John Tooker, MACP, responded to the rules’ release in a letter sent on Thursday to the administrators of CMS and ONC. Overall, ACP is pleased with the administration’s responses to the core issues regarding meaningful use and is supportive of the direction in which the rules move the health IT community. However, the College does have some remaining concerns, which College representatives intend to review with CMS and ONC.
Dr. Tooker said the rules are encouraging and lead ACP to believe that the remaining issues about which the College has concerns can be addressed through continued dialogue, clarification, and collaboration on future rule-making..
Start now to prepare for Version 5010
The first deadline for the transition of physician billing to Version 5010, the electronic transactions standards required by HIPAA, is fast approaching on Dec. 31.
By then practices must have completed internal testing of their ability to submit claims electronically in order to achieve Level I compliance. Practices must complete internal testing by the end of the year so that they are ready to move on to external testing with payers during 2011. Practices should check with their vendors about preparations to ensure that they are on track to complete the transition.
FDA panel divided on rosiglitazone
A panel that advises the FDA was divided last week in a vote on whether rosiglitazone (Avandia) should be removed from the market.
The panel has 33 members, 12 of whom voted that rosiglitazone should be withdrawn. Ten members voted that sale of the drug should be restricted and its warnings strengthened, while seven favored only strengthening the warnings and three voted for no changes, according the July 14 New York Times.
After reviewing large amounts of data, the advisory panel also found that there was sufficient evidence to be concerned that rosiglitazone increases the risk of heart attacks and strokes but insufficient evidence that it increases the risk of death, reported the July 15 Washington Post. The panel also recommended that the FDA approve a large head-to-head trial against pioglitazone (Actos)..
Coumadin samples recalled
Some sample packs of Coumadin (warfarin) have been recalled by the manufacturer because the active ingredient may be below or above therapeutic levels.
The voluntary recall by Bristol-Myers Squibb affects three lots of physician sample blister packs of Coumadin 1 mg tablets and five lots of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs. The following lot numbers are being recalled: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
According to a press release from the manufacturer, the recall is a precautionary measure based upon the company’s determination that some of the tablets, over time, may not meet specifications for isopropanol, which is used to maintain the active ingredient in a crystalline state..
Leflunomide gets new boxed warning
A boxed warning has been added to the label of leflunomide (Arava) highlighting the risk of severe liver injury in patients taking the drug, the FDA announced last week.
The FDA received reports of 49 cases of severe liver injury associated with the rheumatoid arthritis drug, including 14 cases of fatal liver failure, between August 2002 and May 2009. The greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury and patients with pre-existing liver disease, the FDA said. Therefore, the new warning recommends against giving the drug to patients with pre-existing liver disease or elevated liver enzymes (ALT greater than two times the upper limit of normal). Caution should be used in patients who are taking other drugs that can cause liver injury.
Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter. If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide, the drug should be stopped and cholestryamine washout begun, the FDA recommended.
From the College.
New ethics case study on MedscapeCME
A new case study in the ACP professionalism case studies series, “To Be or Not to Be: Should I Serve as an Expert Witness?” is now available on Medscape for CME credit. The study provides guidance for physicians participating as expert witnesses in legal cases.
The ACP Ethics Case Studies use hypothetical examples to elaborate on controversial or subtle aspects of issues not addressed in detail in ACP's Ethics Manual, the Physician Charter on Professionalism, and other ACP position statements. Other studies in the series, which was introduced on Medscape last September, focus on criteria for authorship and considerations for ending the patient-physician relationship.
Additional ethics resources, including the ACP Ethics Manual and the Physician Charter on Professionalism, are available online..
New online community launched to help with EHRs
The College partnered with Cientis Technologies to launch a new, free interactive website last week which will help medical practices compare, select, and implement electronic health records (EHRs).
AmericanEHR Partners brings together professional societies and health care professionals. The resulting collaboration provides credible information, tools, and expertise to support the optimal use of health information technology (health IT), and to improve the delivery of health care.
AmericanEHR Partners will help simplify EHR adoption by allowing healthcare professionals to:
- Evaluate readiness to adopt an EHR and provide a list of recommended resources to help overcome identified challenges;
- View comprehensive EHR user ratings on different solutions (ratings are based on surveys of physicians conducted through their professional societies);
- Sort EHR solutions based on medical subspecialty and desired functionality; and
- Provide side-by-side comparisons of EHR systems.
The site also provides educational content though newsletters, podcasts, webinars, blogs, and more. More information is online.
Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
E-mail all entries to firstname.lastname@example.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition.
MKSAP Answer and Critique
The correct answer is B) Postpone surgery for 12 months after stent was placed. This item is available to online to MKSAP 15 subscribers as item 95 in General Internal Medicine.
The American College of Cardiology/American Heart Association currently recommends that patients with recently placed paclitaxel or sirolimus drug-eluting stents continue uninterrupted dual antiplatelet therapy with aspirin and clopidogrel for at least 12 months, if possible, to minimize the possibility of in-stent thrombosis. Previous recommendations were dual antiplatelet therapy for at least 3 months for patients with sirolimus stents and 6 months for those with paclitaxel stents. The patient described here, whose stent was placed 4 months ago, should postpone surgery for an additional 8 months to reduce the risk of stent thrombosis. In patients who must undergo nonelective surgery, the risk of prematurely discontinuing one or both antiplatelet agents must be balanced against the risk of perioperative bleeding if these agents are continued.
- For patients with recently placed paclitaxel or sirolimus drug-eluting stents, dual antiplatelet therapy with aspirin and clopidogrel should be continued uninterrupted for at least 12 months, if possible, to minimize the possibility of stent thrombosis.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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