In the News
for the Week of 11-17-09
- USPSTF changes stance on breast cancer screening age, self-exams and form of mammography
- Best way to get details on physician errors: Ask them
- MKSAP Quiz: abdominal pain after Roux-en-Y surgery
- Many women report persistent pain years after breast cancer surgery
- Erythropoiesis-stimulating agents don't reduce transfusions, may raise VTE risk
- Alternate-day fasting may help weight loss in obese adults, study finds
- Class 1 recall issued for aortic catheter
- Liposyn II and III and Propofol Injectable Emulsion recalled
- Genzyme Corp. medications may contain foreign particles
- Romidepsin approved for CTCL
- FDA investigates external biphasic defibrillators
- PQRI feedback reports now available
From ACP Hospitalist
- Second annual 'Top Docs' issue now online
From the College
- College seeks member input for online clinical content organization
- Chapter awardees, new Fellows noted
Cartoon caption contest
- Vote for your favorite entry
Physician editor: Darren Taichman, FACP
USPSTF changes stance on breast cancer screening age, self-exams and form of mammography
The U.S. Preventive Services Task Force (USPSTF) changed its breast cancer screening recommendations, including:
- not routinely screening women ages 40-49, biennially screening women ages 50-74, and screening ages 75 and beyond based on general health;
- discouraging teaching breast self-exams; and
- not recommending one form of mammography over another.
The USPSTF recommended against routinely screening women in their 40s, who should instead talk to their doctor about the best time to start regular, biennial screening mammography. Randomized controlled trials and statistical models suggest that when screening is started at age 40, about 60% more false-positive results occur per 1,000 screening exams, while averting few deaths. The USPSTF did not provide specific recommendations for women in their 40s at high risk for breast cancer because there was not enough evidence.
The USPSTF also suggests biennial screening intervals for woman ages 50-74. Randomized controlled trials, population studies, community studies and six statistical models consistently showed that biennial screens maximize benefits and minimize harms. For example, the six statistical models show that biennial screening in women ages 50-69 averts 70% to 90% of breast cancer deaths attainable with screening. Annual mammography averts two deaths per 1,000 women screened.
There is insufficient evidence from randomized controlled trials to determine the screening benefits and harms for women aged 75 or older because cardiovascular deaths become more prominent. Screening beyond 75 years should be based on general health.
The Task Force recommends against teaching breast self-examination, as adequate evidence suggests that teaching self-examination does not reduce breast cancer mortality and there is moderate certainty that the harms outweigh the benefits. Sensitivity ranges from 12% to 41%, lower than clinical breast exams and mammography, and it is age-dependent. While anxiety was not a concern, evidence suggests that more imaging and biopsies were done for women who did self-exams than for control subjects.
The USPSTF did not recommend one form of mammography over another. According to its recommendation, the current evidence is insufficient to assess additional benefits and harms of digital mammography, film mammography or magnetic resonance imaging..
Best way to get details on physician errors: Ask them
Physician self-reporting may be a valuable, yet underused, source of information on the reasons underlying common diagnostic errors, a national survey suggests.
Researchers administered a six-question survey asking physicians at 22 U.S. institutions to report three cases of diagnostic errors and their perceived causes, seriousness and frequency. Of 583 cases reported, 28% were rated as major, 41% as moderate and 31% as insignificant. Pulmonary embolism and drug reactions or overdose were the most common missed or delayed diagnoses (each with 4.5% of the total), followed by lung cancer (3.9%), colorectal cancer (3.3%), acute coronary syndrome (3.1%), breast cancer (3.1%) and stroke (2.6%). The study was sponsored by the Agency for Healthcare Research and Quality and was published in the Nov. 9 Archives of Internal Medicine.
Physicians surveyed readily reported on errors and shared their experiences, the authors noted, suggesting that tapping into physicians’ clinical experience might uncover many errors that are missed by existing surveillance and reporting systems. The survey gave physicians a venue to share their experiences anonymously in a blame-free setting, they added.
Beyond raising awareness, asking physicians to report on errors has several advantages, the authors said. These include:
- forcing physicians to reflect on past cases and learn from what went wrong,
- revealing patterns in diagnostic errors, such as inadequate follow-up of abnormal imaging studies,
- looking beyond individual diagnoses to generic factors that cut across disease areas,
- highlighting how cognitive and system errors overlap, and
- bringing hidden errors to light in order to encourage institutions to make improvements aimed at minimizing errors.
MKSAP Quiz: abdominal pain after Roux-en-Y surgery
A 32-year-old woman has episodes of abdominal pain that have been occurring every 1 to 2 weeks for the past month. The pain is primarily in the epigastrium and right upper abdominal quadrant and is worse after eating. The patient also has nausea but does not have fever, chills or vomiting. She underwent Roux-en-Y gastric bypass surgery approximately nine months ago for morbid obesity and has lost approximately 15.8 kg (35 lb) since that time. Medical history includes hypertension and hyperlipidemia, both of which have improved postoperatively.
On physical examination, vital signs are normal. Abdominal examination shows only a well-healed midline surgical scar without tenderness to palpation.
Which of the following is the most likely cause of this patient's symptoms?
A) Anastomotic leak
B) Anastomotic stricture
C) Fatty liver
E) Kidney stones
Click here or scroll to the bottom of the page for the answer and critique.
Many women report persistent pain years after breast cancer surgery
Almost half of women who undergo surgery for breast cancer, especially younger women, suffer persistent pain for up to three years following treatment, a study reported.
Researchers conducted a questionnaire study of 3,754 Danish women age 18 to 70 years who received surgery and adjuvant therapy for breast cancer. A total of 47% of the women reported pain ranging from light to severe and 58% reported sensory disturbances one to three years after surgery. Younger age and axillary lymph node dissection were associated with chronic pain and sensory disturbances. The results were published in the Nov. 11 Journal of the American Medical Association.
Age less than 40 was the most important predictor of persistent pain and sensory disturbances, the authors noted. Univariate analyses showed a strong association between chemotherapy and reports of pain and sensory disturbances, but multivariate analyses did not. This indicated that the association between pain and chemotherapy could be related to age, because younger women are more likely to receive chemotherapy, the authors said. The breast area was the most frequently reported site of pain.
The findings have the potential to help physicians identify patients at highest risk for postsurgical pain and initiate therapy early, said an accompanying editorial. Management of these patients also calls for a team-based approach including evaluation by surgeons, oncologists, pain management specialists, social workers and others involved in the patient’s care, the editorial concluded.
Read more about primary care physician's role in managing breast cancer survivors in ACP Internist..
Erythropoiesis-stimulating agents don't reduce transfusions, may raise VTE risk
The steady increase in use of erythropoiesis-stimulating agents (ESAs) since their approval in 1991 has not led to fewer blood transfusions during chemotherapy, and the drugs can raise the risk of venous thromboembolism, a recent study reported.
Researchers analyzed a Medicare database of over 56,000 patients age 65 and older who were diagnosed with and received chemotherapy for colon, non-small-cell lung, or breast cancer or diffuse large B-cell lymphoma between 1991 and 2002. The proportion of patients who received erythropoietin and darbepoietin increased from 4.8% in 1991 to 45.9% in 2002, but the annual rate of blood transfusions remained constant. Venous thromboembolism (VTE) developed in 14.3% of patients who received ESAs compared with 9.8% of patients who did not, although the agents did not affect mortality. The study appears in the Nov. 10 Journal of the National Cancer Institute.
ESAs were associated with reduced blood transfusions in clinical trials leading up to their approval in 1991, the authors noted, but patients who received at least one transfusion remained constant over the 10-year study period. The findings also support other recent reports that these agents put elderly patients with cancer at increased risk of developing VTE.
The study highlights the limitations of the FDA drug evaluation process, the authors commented. The initial approval of these agents was based on short-term data from two randomized trials, but, as is the case with many medications approved for cancer, the long-term risks were not evaluated prior to approval.
Post-marketing studies of new drugs have the potential to address this problem, the authors continued, noting that their analysis found that the association with VTE risk could have been detected as soon as four years after approval. The authors noted the public policy implications of their findings, as ESAs are the single largest Medicare Part B drug expenditure, reaching $10 billion in 2006.
Alternate-day fasting may help weight loss in obese adults
Alternate-day fasting may be a viable weight loss strategy in obese adults, according to a recent study.
Researchers from the University of Illinois conducted a 10-week trial to determine whether alternate-day fasting (ADF) under controlled and self-regulated conditions would be effective for weight loss and would improve markers of coronary artery disease (CAD) risk in obese adults. Twenty nondiabetic adults between 35 and 65 years of age with a body mass index between 30 and 39.9 kg/m2 were included. The trial took place in three consecutive phases: a two-week control phase, a four-week weight loss/ADF controlled food intake phase, and a four-week weight loss/ADF self-selected food intake phase. Results appear in the current American Journal of Clinical Nutrition.
During the control phase, patients maintained a stable body weight and made no changes to their exercise and diet routines. During the weight loss/ADF controlled food intake phase, patients consumed calorie-restricted meals consisting of 25% of their baseline energy needs on "fast" days and consumed food as needed on alternate days. Calorie-restricted meals were prepared at the University of Illinois research center and were part of a three-day rotating menu. On nonfast days, patients were told to keep fat intake to less than 30% of their energy needs. The weight loss/ADF self-selected food intake phase was similar to the previous phase, except that patients were not provided with food and instead met weekly with a registered dietitian for advice on adhering to the ADF regimen.
Twenty patients were included in the study, and 16 (four men and 12 women) completed the 10-week trial. Two patients withdrew because of time constraints, and two withdrew because they couldn’t adhere to the ADF regimen. Good adherence to the diet was observed during the ADF controlled food intake phase and the ADF self-selected food intake phase (86% and 89%, respectively). Rate of weight loss was maintained during both phases (0.67 ± 0.1 kg/wk vs. 0.68 ± 0.1 kg/wk). After eight weeks of dieting, body weight had decreased by 5.6 ± 1.0 kg, or approximately 6%, and percentage of body fat had decreased from 45% ± 2% to 42% ± 2%. In addition, HDL cholesterol remained unchanged while total cholesterol, LDL cholesterol and triacylglycerol concentrations decreased by 21% ± 4%, 25% ± 10% and 32% ± 6%, respectively. Systolic blood pressure also decreased from 124 ± 5 mm Hg to 116 ± 3 mm Hg.
The authors acknowledged that their study was small and uncontrolled and noted that two participants withdrew because they couldn’t follow the ADF protocol. However, they pointed out that the observed weight loss was significant and was similar during both the controlled and self-selected ADF periods, indicating that participants were able to follow the diet even when preparing their own food at home. The authors concluded that ADF may be an effective diet for obese individuals because it facilitates weight loss and improves markers of CAD risk. Future studies, they wrote, should examine the effectiveness of ADF without a dietitian’s advice, as well as whether long-term adherence to ADF is sustainable.
Class 1 recall issued for aortic catheter
The FDA last week announced a class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, because the balloon catheters may spontaneously rupture during surgery, an FDA alert said.
This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009. The catheter is used to block off the aorta, monitor aortic pressure and deliver solution to stop the heart during cardiopulmonary bypass procedures..
Liposyn II and III and Propofol Injectable Emulsion recalled
Dozens of lots of Liposyn II and III and Propofol Injectable Emulsion have been recalled because some may contain particulate matter that impedes blood flow, an FDA alert said.
The recall comprises 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July and October of 2009.
The particulate matter has been traced to stainless steel equipment used in the manufacturing process, the alert said. The contaminants could potentially act as emboli and impede blood flow, which could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death, it said..
Genzyme Corp. medications may contain foreign particles
The FDA said last week that five medications for rare diseases made by Genzyme Corporation may be contaminated by foreign particles, including stainless steel fragments, non-latex rubber and fiber-like material, according to a notice.
The affected medications include all of the following products with lot numbers that start with “A” (e.g., Lot A12345): imiglucerase (Cerezyme), an IV infusion for Gaucher disease; agalsidase beta (Fabrazyme), an IV infusion for Fabry disease, alglucosidase alpha (Myozyme), an IV infusion for Pompe disease; laronidase (Aldurazyme), an IV infusion for Mucoploysaccharidosis Type I; and thyrotropin alpha (Thyrogen), an intramuscular injection used as an adjunctive diagnostic tool and treatment for thyroid cancer.
The foreign particles could potentially cause “serious adverse events” in patients, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions, the notice said. Less serious reactions could include local pain, swelling and inflammation. No adverse events have been reported. The contaminants are thought to be found in less than 1% of the products, based on product lots assessed thus far.
Laronidase is supplied as a liquid solution, while the other four products are supplied as lyophilized powders requiring reconstitution before administration. To reduce the risk of administering a contaminated product, health care professionals should:
- Visually inspect the powder in the vial for the presence of particles before reconstitution;
- Visually inspect the reconstituted powder (in solution) and the laronidase solution for the presence of particles;
- Not administer any product with visualized particles. The product should be returned to Genzyme Corporation (1-800-745-4447, option 2);
- Continue to use an in-line, low protein-binding 0.2 or 0.22 micrometer filter as recommended in the drug labeling. Note that at this time, the FDA has not determined whether using an in-line, low protein-binding 0.2 or 0.22 micrometer filter will remove all foreign particles or whether foreign particles might affect the integrity of the in-line filter.
- Observe for local or systemic infusion reactions after administration.
Romidepsin approved for CTCL
The FDA last week approved injectable romidepsin (Istodax) to treat patients with cutaneous T-cell lymphoma (CTCL).
Romidepsin, which interferes with cell replication, is meant to be used when CTCL gets worse or comes back after at least one other type of chemotherapy has been used, the FDA said in a news release.
The drug was evaluated based on two clinical studies with 167 patients. About 35% of patients in both trials experienced tumor responses, indicating a reduction of tumor size. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory and X-ray examinations. Responses lasted a median of 15 months in one study and 11 months in the other study, the release said.
Side effects of romidepsin may include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells. The drug may cause changes in an electrocardiogram (ECG), so periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Periodic blood tests should also be done to monitor electrolytes. Women shouldn’t become pregnant while taking the drug, as it may harm a fetus..
FDA investigates external biphasic defibrillators
The FDA is investigating energy levels in external biphasic defibrillators with shocks < 200 J due to 14 reports of the devices being ineffective, an FDA notice said.
In the 14 events, which occurred since 2006, a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well, the FDA said. The events involved multiple shocks from defibrillators from different manufacturers, the agency added, noting that the scientific literature doesn’t provide clarity on the question of optimal energy delivery.
The agency doesn’t recommend any changes to clinical practice at this time. It is seeking additional information in order to interpret the significance of these 14 events, and to determine whether FDA activities are advised. If you suspect a problem with a defibrillator, such as a situation where a patient received shocks from multiple devices, the problem should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-332-1088.
PQRI feedback reports now available
Feedback reports for the 2008 Physician Quality Reporting Initiative (PQRI) are now available through CMS. The feedback reports for those who were eligible for the 2007 re-run are also available.
Doctors can access feedback reports using either the group’s Tax Identification Number (TIN), or the National Provider Identifier (NPI) number. Via the TIN, reports can be accessed through the PQRI Portal. Information about accessing reports using an NPI number can be found on the CMS Web site.
The incentive payments for the 2008 PQRI program were mailed in October. Those expecting a 2007 re-run incentive payment should look for them in November.
From ACP Hospitalist.
Second annual 'Top Docs' issue now online
The issue also features the following:
Is it observation or inpatient? The question has perplexed hospital physicians for some time, but it’s recently acquired greater financial significance.
A deviant approach to hospital challenges. Positive deviance is a bottom-up, rather than top-down, approach to solving seemingly intractable problems in an institution or a community.
Success story: Homemade computer program improves glucose control. The Medical University of South Carolina Medical Center in Charleston, S.C., developed a nurse-driven Web-based insulin infusion protocol to manage blood glucose.
From the College.
College seeks member input for online clinical content organization
The College is asking for member input in an online activity to gain information on how members categorize and organize clinical multimedia content. The feedback will be used to help create a more logical way to access clinical multimedia on www.acponline.org. The clinical content card sort game is online..
Chapter awardees, new Fellows noted
The following 224 new Fellows were recommended by the Credentials Subcommittee and approved by the Board of Regents for election in November 2009.
Also, in recognition of their outstanding service, these exceptional individuals received chapter awards in July through October 2009.
Cartoon caption contest.
Vote for your favorite entry
ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner.
"I'm the new CAT scanner."
"And then Timmy says to me, 'Jump, girl. You can make it.'"
"Doc says my gait disturbance is caused by Barkinson's disease."
Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Nov. 23, with the winner announced in the Nov. 24 issue..
MKSAP answer and critique
The correct answer is D) Gallstones. This item is available online to MKSAP 14 subscribers in the Gastroenterology and Hepatology section, Item 23.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
This patient has gallstones as a complication of the weight loss associated with bariatric surgery. The number of operative procedures performed for treatment of morbid obesity has steadily increased over the past several years. The most common procedure is the Roux-en-Y gastric bypass. Recent studies have confirmed that these operations are effective in reducing morbidity associated with obesity-related complications, such as type 2 diabetes mellitus, hypertension, obstructive sleep apnea, and hyperlipidemia. Cholelithiasis develops in as many as 35% of patients who have had rapid weight loss following bariatric procedures, and more than 40% of these patients develop symptoms secondary to the gallstones.
Both anastomotic leak and anastomotic stricture are known complications of bariatric surgery. However, a leak usually develops early in the perioperative period and is associated with respiratory distress and tachycardia, and a stricture is generally associated with symptoms resembling mechanical obstruction, such as worsening early satiety and vomiting. Fatty liver can develop secondary to rapid weight loss, but the abdominal discomfort associated with this disorder is mild and persistent. Kidney stones are not a known complication of bariatric surgery.
- Bariatric surgery is effective for reducing morbidity associated with obesity-related disorders, such as type 2 diabetes mellitus, hypertension, obstructive sleep apnea, and hyperlipidemia.
- Development of gallstones is a common complication following bariatric surgery.
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A 30-year-old woman is evaluated for a 1-year history of fatigue, headaches, poor sleep, depression, intermittently blurred vision, and weakness when climbing stairs. She takes no medication.
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