In the News
for the Week of 3-15-11
- U.S. and U.K. doctors differ on reporting conflicts, errors, impaired colleagues
- Lower blood pressure targets of unproven value in chronic kidney disease
- MKSAP Quiz: bleeding gums and petechiae
- Less microalbuminuria but more CV deaths with olmesartan
- Chlorthalidone appears better than hydrochlorothiazide for high-risk patients with hypertension
Transitions of care
- Low cognition at discharge may impede elderly patients' self-care
Models of care
- Joint guidelines released for recognition, accreditation of patient-centered medical homes
From the College
- ACP Annual Business Meeting to be held
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, FACP
U.S. and U.K. doctors differ on reporting conflicts, errors, impaired colleagues
Physicians in both the U.S. and the United Kingdom report differences between their professional values and their actual behavior, according to new survey results.
Researchers collected responses from about 1,900 American physicians in various specialties and about 1,100 physicians in the U.K. to a series of questions about their professional values. The results, published online March 7 in BMJ Quality and Safety, revealed differences in beliefs and practices between the two countries, as well as gaps between physicians' values and actions.
For example, nearly a fifth of doctors in both countries reported direct personal experience with an impaired or incompetent colleague in the past three years, but one-third of those respondents had not reported the colleague to authorities. U.K. physicians were far more likely (34% vs. 12%) to list fear of retribution as a reason for their failure to report—an issue that has been previously noted in British medicine, the study authors said. The U.S. physicians were more likely to respond to incompetence by not referring patients to the colleague, an option which is often less available to U.K. physicians.
The doctors also differed on their acceptance of conflicts of interest: 83% of U.S. doctors reported receiving samples or gifts from industry (compared to 73% of British doctors), 47% thought business ventures with patients were inappropriate (60% in the U.K.), and 9% had actually provided care for a person with whom they had a direct financial relationship (1% in the U.K.). A majority, but far from all, physicians in both countries felt that physicians should put patients' welfare above their own financial interests (79% in the U.S., 82% in the U.K.).
U.S. physicians were more strongly in favor of disclosing their own financial relationships with industry and benefits and risks of treatment to patients than their British peers (65% vs. 59% and 88% vs. 74%, respectively). However, they were less likely to believe in disclosing all significant medical errors to affected patients, which was perhaps related to the fact that they were more likely to report not having disclosed an error due to fear of being sued (64% vs. 70% and 21% vs. 13%, respectively).
The results indicate that physicians in both countries share a core of professional values, but that they have some differences resulting from the contexts in which they practice, study authors said. Given that both countries are currently working on major health care reform, physicians should advocate for creation of health care systems that encourage behavior congruent with physicians' professional values, they concluded..
Lower blood pressure targets of unproven value in chronic kidney disease
Blood pressure targets less than 130/80 mm Hg in adults with chronic kidney disease (CKD) do not improve clinical outcomes more than a target of 140/90 mm Hg, a new study found. However, lower targets may benefit patients with proteinuria greater than 300 to 1,000 mg/d.
Researchers reviewed randomized, controlled trials and observational follow-up reports comparing blood pressure targets in adults with non-dialysis-dependent CKD. Results were published early online March 15 by Annals of Internal Medicine. Trials were eligible if they included patients with CKD (defined as glomerular filtration rate [GFR] less than 60 mL/min per 1.73 m2, elevated urinary albumin level [>30 mg/d, or urinary albumin-creatinine ratio >0.03 g/g or dipstick-positive albuminuria], or elevated urinary protein level [>300 mg/d, or urinary protein-creatinine ratio >0.2 g/g]).
Three trials were included: the Modification of Diet in Renal Disease Study (MDRD), the African American Study of Kidney Disease and Hypertension Trial (AASK), and the Ramipril Efficacy in Nephropathy 2 study (REIN-2), with a total of 2,272 participants. After a mean two- to four-year follow-up, the main trial results did not show benefit for clinical outcomes.
A post-trial follow-up report from MDRD showed benefit of the lower target for kidney failure after about six years of follow-up. Subgroup analyses by baseline proteinuria levels in the MDRD and AASK trials (but not REIN-2) suggested benefit from the lower target in patients with proteinuria greater than 1,000 mg/d and urinary protein-creatinine ratio greater than 0.22 g/g, respectively. Treatment to a lower target required an average of 0.3 to 0.6 additional antihypertensive drugs per patient. A slightly higher rate of adverse events was suggested in the low target groups.
Although the point estimates in MDRD and AASK suggested that the low target might reduce kidney failure, the CIs around the estimates were wide and included the possibility of either important benefit or harm, the authors wrote. The only statistically significant result was in the MDRD Study follow-up, which showed a 23% reduction (95% CI, 18% to 43%) in the hazard for kidney failure in the group assigned to the lower target.
"We suggest that practitioners use discretion in patients with CKD and proteinuria and base the blood pressure target on individualized risk-benefit assessment and the patient’s tolerance and preferences," the authors wrote. "Treatment to a lower target may require greater vigilance to monitor for and avoid possible symptoms and adverse events from hypotension." A major limitation of the evidence base is that the trials excluded type 1 diabetes and included very few patients with diabetic kidney disease. In addition, trial durations may have been too short to detect differences for clinically important outcomes, such as death and kidney failure.
MKSAP Quiz: bleeding gums and petechiae
A 28-year-old woman has a 3-month history of easy bruising and bleeding gums. She feels otherwise well. Medical and family histories are unremarkable, and she takes no medications.
On physical examination, temperature is normal, blood pressure is 110/70 mm Hg, pulse rate is 64/min, and respiration rate is 14/min. Petechiae are present on the buccal mucosa and pretibial areas, and ecchymoses are noted on the upper thighs. There is no lymphadenopathy or splenomegaly.
|Hemoglobin||10.4 g/dL (104 g/L)|
|Leukocyte count||5200/µL (5.2 × 109/L)|
|Absolute neutrophil count||1200/µL (1.2 × 109/L) (normal >1500/µL [1.5 × 109/L])|
|Platelet count||18,000/µL (18 × 109/L)|
|Reticulocyte count||0.9% of erythrocytes|
|Direct antiglobulin (Coombs) test||Negative|
A peripheral blood smear shows no circulating blasts. The platelets are decreased and are not clumped, enlarged, or bizarre in appearance. Bone marrow examination shows hypoplastic marrow (<20% cellularity) with trilineage normoblastic maturation and normal iron stores. There are no findings suggesting an infiltrative disease and no increases in CD34 blasts or reticulin fibrosis.
Which of the following is the most likely diagnosis?
A) Acute myeloid leukemia
B) Aplastic anemia
C) Immune thrombocytopenic purpura
D) Myelodysplastic syndrome
Click here to see the answer and critique for this question.
Less microalbuminuria but more CV deaths with olmesartan
The angiotensin-receptor blocker (ARB) olmesartan delayed diabetic patients' development of microalbuminuria compared to placebo, a new trial found.
The manufacturer-sponsored, randomized trial assigned more than 4,000 patients with type 2 diabetes to either 40 mg of olmesartan per day or placebo for a median of 3.2 years. Patients also took other antihypertensive drugs (except angiotensin-converting enzyme inhibitors or ARBs) as needed to achieve a target blood pressure of less than 130/80 mm Hg. Overall, the target was achieved in more than 70% of patients. The results were published in the March 10 New England Journal of Medicine.
Blood pressure in the olmesartan group was lower than in the placebo group by 3.1/1.9 mm Hg. The intervention group also fared better on the study's primary outcome—time to microalbuminuria—with a 23% longer time to onset (P=0.01). Intervention patients also had lower overall rates of microalbuminuria (8.2% vs. 9.8%). The greatest benefits were seen in patients who had higher systolic blood pressure at baseline, better control of diabetes, lower renal function and a urinary albumin-to-creatinine ratio of more than 4. Other recent studies support the finding that higher baseline blood pressure is associated with more benefit from an ARB or angiotensin-converting enzyme inhibitor, the authors noted.
Secondary end points of the study included renal and cardiovascular events. The overall rate of these events was low (about 4%), but one concerning finding was the greater number of deaths from cardiovascular causes in the olmesartan group (15 patients vs. 3, P=0.01). The finding could be due to chance, study authors cautioned, but they also noted that a similar finding from another olmesartan trial (ORIENT) has led the FDA to initiate a review of the drug's safety. In the current study, the increase in cardiovascular deaths appeared to be due to differences in patients with preexisting coronary heart disease, and it was strongest among those with the highest or lowest blood pressures, consistent with the "J-curve effect."
The study's findings provide hope that it is possible to prevent progression to chronic kidney disease in type 2 diabetics, concluded an accompanying commentary. Physicians will likely be divided about what the results mean for use of olmesartan specifically, with some concluding that the benefits outweigh the possible risks of cardiovascular death and others preferring to prescribe one of the other ARBs that have not been associated with this risk, the commentary author wrote..
Chlorthalidone appears better than hydrochlorothiazide for high-risk patients with hypertension
Chlorthalidone appears to be superior to hydrochlorothiazide for hypertension treatment in high-risk patients, a new study reports.
Researchers at the University of Michigan performed a retrospective observational cohort study using data from the National Heart, Lung and Blood Institute's Multiple Risk Factor Intervention Trial (MRFIT). MRFIT examined primary cardiovascular prevention with chlorthalidone (CTD) or hydrochlorothiazide (HCTZ) in high-risk men (defined as those in the upper 15% of risk for death from coronary heart disease based on elevated cholesterol, elevated diastolic blood pressure and cigarette smoking). Cardiovascular and several laboratory values, including systolic blood pressure, cholesterol, and triglycerides, were measured yearly beginning at study enrollment in 1973. The current trial's primary objective was comparing cardiovascular end points in patients who took CTD and those who took HCTZ. The researchers also compared change in systolic blood pressure; total, low-density lipoprotein and high-density lipoprotein cholesterol; triglycerides; potassium; glucose; and uric acid. The study was published early online March 7 by Hypertension.
The MRFIT included 12,866 patients, of whom 2,392 were initially prescribed CTD and 4,049 were initially prescribed HCTZ. Median follow-up was six years. Seventy-five percent of patients who began the study on HCTZ and 76% of those who began the study on CTD either crossed over to the other drug group or stopped taking diuretics at some point during follow-up. After performing repeated-measures mixed modeling, adjusting each model for predictors of each variable, the authors found that cardiovascular event rates were statistically significantly lower in patients taking CTD or HCTZ (adjusted hazard ratios, 0.51 [95% CI, 0.43 to 0.61] and 0.65 [95% CI, 0.55 to 0.75]) than in those who took neither drug (P<0.0001 for both comparisons). Patients taking CTD had statistically significantly fewer cardiovascular events than those taking HCTZ (P=0.0016). Systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and potassium levels were statistically significantly lower over time in patients taking CTD than in those taking HCTZ, while uric acid levels were statistically significantly higher.
The authors speculated that CTD may work better than HCTZ because of greater potency and longer half-life, and because it may lead to greater reductions in systolic blood pressure. Limitations of the study include its observational design and potential unmeasured confounding, the authors acknowledged. They concluded that both CTD and HCTZ reduce cardiovascular events compared to no treatment in high-risk patients with hypertension, but that CTD is more effective although HCTZ is more commonly prescribed, and that randomized trials are needed for confirmation. The authors of an accompanying editorial agreed, writing that until data from such trials are available, "the totality of the evidence favors the use of chlorthalidone over HCTZ as the preferred diuretic in hypertension treatment."
Transitions of care.
Low cognition at discharge may impede elderly patients' self-care
It may be worthwhile to screen patients for low cognition at hospital discharge and to offer care instructions after—rather than at the time of—discharge for those who score poorly, a new study suggests.
To determine the frequency of low cognition at hospital discharge, researchers conducted face-to-face surveys at the time of discharge and one month later in the homes of 200 community-dwelling seniors. The subjects had been admitted for more than 24 hours to the acute medicine service of Northwestern Memorial Hospital in Chicago. Their mean age was 79.6 years (range, 70 to 100 years) and 58% were women. Patients had consented to their own procedures, did not have previously documented cognitive loss, and were not admitted for cognitive changes. Results appeared online March 4 in the Journal of General Internal Medicine.
Researchers applied the Mini-Mental Status Examination (MMSE), Backward Digit Span, and 15 Word Immediate and Delayed Recall Tests to evaluate cognition. Upon hospital discharge, 31.5% of subjects (n=60) had previously unrecognized low cognition. One month later, only 13.5% (n=27) had low cognition (P<0.001). Patients with low cognition had a mean score on the MMSE of 20.56 (range, 14 to 24) at discharge, which improved to a mean of 24.57 (range, 18 to 29) by one month (P<0.001). Orientation, task completion, registration, repetition, naming, reading, writing and calculation improved significantly. At discharge, only 54% of low-cognition subjects were able to correctly complete a three-step task of folding paper, placing it in their left hands, and handing the pieces to an interviewer. One month later, 98.4% were able to perform the task correctly.
According to assessment by the Backward Digit Span test, low cognition in working memory was present at discharge in 35.5% of the subjects, and declined to only 31.5% one month later (P=0.014). With the 15 Word Immediate and Delayed Recall Tests, 50% of subjects had low cognition and were not able to remember more than one word from the 15-word list after eight minutes. One month post-discharge, significant improvements were seen, but 34.5% of subjects still had trouble (P<0.001).
Transient cognitive impairment threatens the comprehension and fulfillment of discharge instructions for seniors, half of whom lived alone and 85% of whom managed their own medications in this study, the authors said. Screening for low cognition at discharge and educating caregivers to provide more attention to those who score poorly would help seniors transition back into their home environments, the authors wrote. "This tailoring of discharge interventions would decrease the costs to the hospital of initiating sweeping interventions to all discharged seniors," they wrote. "These seniors may also benefit from closer follow-up with their primary care physician to ensure that the discharge plan is being followed and to monitor the cognitive impairment."
Court rules physicians not subject to red flags rule
A federal appeals court has decided that physicians who bill after providing services to their patients should not be subject to the Federal Trade Commission’s red flags rule for creditors.
In December, Congress passed a clarification to the original rule to specifically define who should count as a creditor. The new court decision reinforces the clarification and further eliminates any confusion about who is subject to complying with the red flags rule.
More information about the recent court decision is available from the American Medical Association..
Medicare adjusts Faslodex claims edit
On Jan. 1, CMS implemented a Medically Unlikely Edit (MUE) for injectable drug Faslodex (fulvestrant, 25 mg), HCPCS code J9395.
The edit was set at 10 units of service, meaning that a physician could bill a maximum of 250 mg per day (the then-current FDA approved dosage), per patient. Shortly before the implementation date, the FDA increased the approved dosage to 500 mg. CMS was not able to update the amount of its edit to reflect the new FDA dosage in time for the January implementation. However, after the initial implementation, CMS went back and subsequently increased the edit to 20 units of service to allow a maximum of 500 mg to be billed per patient per day. The new edit is retroactive to Jan. 1.
Because of the lag time between the FDA increase and the edit adjustment, physicians may delay submission of their Faslodex claims until April 1. Alternatively, in this instance only, physicians may submit their claims prior to April 1 by reporting J9395 on two lines of a claim, utilizing modifier -59 with the modifier on only one claim line. The physician may report 10 units of service on each claim line.
If physicians have had their claims denied due to this MUE value, they may resubmit their claims or they may appeal them to their local claims processing contractor after April 1.
Models of care.
Joint guidelines released for recognition, accreditation of patient-centered medical homes
The American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American Osteopathic Association released joint guidelines last week on recognition and accreditation of patient-centered medical homes (PCMHs).
The organizations developed the 13 guidelines to describe important elements considered essential for effective PCMH recognition programs. According to the guidelines, all PCMH recognition or accreditation programs should:
- incorporate the Joint Principles of the PCMH, as developed by the four organizations in 2007;
- address the complete scope of primary care services;
- ensure the incorporation of patient- and family-centered care emphasizing engagement of patients, their families, and their caregivers;
- engage multiple stakeholders in the development and implementation of the program;
- align standards, elements, characteristics, and/or measures with meaningful use requirements;
- identify essential standards, elements, and characteristics;
- address the core concept of continuous improvement that is central to the PCMH model;
- allow for innovative ideas;
- acknowledge care coordination within the medical neighborhood;
- clearly identify PCMH recognition or accreditation requirements for training programs;
- ensure transparency in program structure and scoring;
- apply reasonable documentation/data collection requirements; and
- conduct evaluations of the program’s effectiveness and implement improvements over time.
The joint guidelines have been sent to the National Committee for Quality Assurance, the Accreditation Association for Ambulatory Health Care, The Joint Commission, and URAC, all of which have or plan to soon release programs related to PCMH recognition or accreditation.
ACP president J. Fred Ralston Jr., FACP, said in a press release, "The consideration of these joint guidelines for PCMH recognition programs will help ensure that recognized practices truly provide patient-centered care that is effectively integrated and of high quality."
The full text of the guidelines is available online.
From the College.
ACP Annual Business Meeting to be held
All Members, Fellows, Masters, Associates and Affiliates are encouraged to attend ACP's Annual Business Meeting during Internal Medicine 2011. Current College Officers will retire from office and incoming Officers, new Regents and Governors-Elect will be introduced.
The meeting will be held Saturday, April 9, 2011 at the San Diego Convention Center from 12:45 p.m. to 1:45 p.m., with J. Fred Ralston Jr., FACP, ACP President, presiding. Dennis R. Schaberg, MACP, will present the Annual Report of the Treasurer. A key feature of the meeting is the presentation of ACP's priorities for 2011-2012 by Executive Vice President and Chief Executive Officer Steven E. Weinberger, FACP. Members will have the opportunity to ask questions following Dr. Weinberger's presentation.
The full list of new Officers and Regents was announced in the March ACP Internist.
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) Aplastic anemia. This item is available to MKSAP 15 subscribers as item 46 in the Hematology and Oncology section.
This patient has aplastic anemia. Patients with this disorder have pancytopenia and a hypoplastic bone marrow (<20 cellularity) with normal maturation of all cell lines. Aplastic anemia is a fatal disorder in which myeloid progenitor cells and stem cells are severely diminished or absent in the bone marrow because of an intrinsic defect of the stem cells or immune-mediated stem cell destruction, which leads to transfusion-dependent anemia, thrombocytopenia, and severe neutropenia. In approximately 50% of cases of aplastic anemia, there is no obvious cause, whereas chemicals, drugs, viral infections, collagen vascular diseases, and thymoma can be implicated in the remaining cases. Interferon-activated T lymphocytes are implicated in autoimmune destruction of stem cells in a significant proportion of patients with the idiopathic or the acquired form of the disease; this fact explains why immunosuppressive therapy is effective in some patients. Initial management involves withdrawal of any potentially causative agents and a CT scan of the chest to rule out an associated thymoma.
Patients with acute myeloid leukemia may have pancytopenia, but bone marrow examination shows infiltration with CD34 blasts, and circulating myeloblasts are likely to be present on the peripheral blood smear.
Patients with immune thrombocytopenic purpura (ITP) have petechiae and ecchymoses but do not have a decreased leukocyte count. Although patients with ITP and an associated autoimmune hemolytic anemia may have a low hemoglobin level, this patient’s direct antiglobulin (Coombs) test was negative, and she had a low reticulocyte count. In addition, her bone marrow did not show the increased number of megakaryocytes characteristic of ITP. Finally, some patients with ITP may have anemia secondary to bleeding; however, this patient does not have a clinical history of bleeding, and her iron stores are normal, suggesting that hemorrhage is not the cause of her anemia.
Although pancytopenia may be present in patients with a myelodysplastic syndrome, bone marrow examination typically shows hypercellular marrow. In addition, the diagnosis of a myelodysplastic syndrome requires the presence of dysplasia in at least two cell lines, which is not present in this patient.
- Patients with aplastic anemia have pancytopenia, a low reticulocyte count, and hypoplastic bone marrow.
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Copyright 2011 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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