In the News
for the Week of 11-9-10
- Expert consensus says PPIs, antiplatelets can be used together
- Reimbursement cuts improved evidence-based use of prostate drugs
- MKSAP Quiz: managing risk factors
- DHA doesn’t slow decline in mild to moderate Alzheimer’s
- Study details comprehensive models to decrease care fragmentation in older adults
- Commercial drivers should stay off the road for a year after TIA or stroke
- Grassroots initiative helps promote primary care
From the College
- AMA sponsors ‘Heal that Claim’ month
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, FACP
Expert consensus says PPIs, antiplatelets can be used together
Proton-pump inhibitors (PPIs) and antiplatelet drugs can be used together in cardiovascular disease patients who are at high risk of upper gastrointestinal (GI) bleeds, according to an expert consensus document drafted by three medical societies.
New recommendations include the following:
- PPIs are recommended for patients with a history of upper GI bleeding, or for those with multiple risk factors such as a history of peptic ulcers, advanced age, Helicobacter pylori infection, or the use of antiplatelets, steroids or nonsteroidal anti-inflammatory drugs.
- PPIs are not recommended to reduce upper GI bleeding in low-risk patients, and those who are less likely to benefit from prophylaxis.
- Future studies are required to assess the impact of PPIs and antiplatelets among high-risk cardiac patients who poorly metabolize antiplatelet drugs.
The document will be released by the American College of Cardiology (ACC), the American College of Gastroenterology (ACG), and the American Heart Association (AHA) in their respective journals and on their websites, a press release said.
The three organizations recommended concomitant PPI and antiplatelet use in a 2008 document. But subsequent research suggested PPIs possibly lessened the efficacy of antiplatelet drugs. However, the consensus group noted, much of the published data used platelet function tests as surrogate markers of cardiovascular risk. The clinical significance of laboratory test results has not been substantiated in large patient studies using clinically relevant endpoints, such as heart attacks or strokes.
The only published randomized controlled trial specifically designed to assess the clinical occurrence of GI bleeding, heart attacks and strokes associated with the prescription of clopidogrel alone versus clopidogrel with a PPI found no significant difference in cardiac events. Recent publication of a randomized trial (COGENT) of 3,761 patients with cardiovascular disease demonstrated a 56% decrease in GI bleeding..
Reimbursement cuts improved evidence-based use of prostate drugs
Medicare reimbursement cuts were associated with reduced use of androgen-deprivation therapy (ADT) for prostate cancer, particularly among men for whom the benefits of such therapy were unclear.
Researchers identified from the Surveillance, Epidemiology, and End Results Medicare database 54,925 men who received a diagnosis of incident prostate cancer from 2003 through 2005. Of this group, 43.2% received ADT within six months after diagnosis. Results appeared in the Nov. 4 issue of the New England Journal of Medicine.
Researchers divided the men into groups according to the strength of the indication for ADT use, defined as:
- inappropriate for men with localized cancers of a low-to-moderate grade (T1 or T2, for whom a survival benefit of such therapy was improbable),
- appropriate as adjuvant therapy with radiation therapy for men with locally advanced cancers (T3 or T4, for whom a survival benefit was established), and
- discretionary for men receiving either primary or adjuvant therapy for localized but high-grade tumors.
In the 1990s, Medicare reimbursed gonadotropin-releasing hormone (GnRH) agonists based on 95% of the average wholesale price. But the Government Accountability Office found that physicians typically bought them at an average of 82% of the average wholesale price, and that profits could make up 40% of urologists' revenues. Medicare reduced reimbursement for ADT moderately in 2004 and substantially in 2005.
Reimbursement for a monthly dose of GnRH agonists fell from $356 in 2003 to $311 in 2004 to $176 in 2005. While there was no decline in the appropriate-use group, the rate of use in the inappropriate group fell from 39.0% in the fourth quarter of 2003 to 30.3% in the first quarter of 2004. The rate reached a plateau of 22.4% by the end of 2005. In the discretionary-use subgroups, use was highest through 2003, gradually declined in 2004 and markedly dropped in 2005.
Authors wrote, "... [R]eductions in reimbursement may influence the delivery of care in a potentially beneficial way, with even the modest changes in 2004 associated with a substantial decrease in the use of inappropriate therapy. The corollary is that reimbursement policies should be carefully considered to avoid providing incentives for care for which no clear benefit has been established. The extreme profitability of the use of GnRH during the 1990s probably contributed to the rapid growth in the use of ADT for indications that were not evidence based."
MKSAP Quiz: managing risk factors
A 59-year-old woman with a history of coronary artery disease comes for a routine physical examination. She is asymptomatic. One year ago, she underwent placement of a drug-eluting stent in the right coronary artery. She also has hypertension and dyslipidemia. Average home blood pressure measurement is 125/80 mm Hg. Medications are clopidogrel, metoprolol, simvastatin, and low-dose aspirin.
On physical examination, vital signs are normal except for a blood pressure of 135/82 mm Hg in both arms. BMI is 32. The remainder of the physical examination is normal.
|Glucose (fasting)||98 mg/dL (5.4 mmol/L)|
|Total cholesterol||190 mg/dL (4.9 mmol/L)|
|High-density lipoprotein cholesterol||45 mg/dL (1.2 mmol/L)|
|Low-density lipoprotein cholesterol||100 mg/dL (2.6 mmol/L)|
|Triglycerides||225 mg/dL (2.5 mmol/L)|
|Serum creatinine||1.4 mg/dL (123.8 µmol/L)|
Which of the following diagnostic studies should be performed next in this patient?
A) 24-hour urine collection for protein
B) Kidney ultrasonography
C) Spot urine albumin-creatinine ratio
D) No further studies at this time
Click here or scroll to the bottom of the page for the answer and critique.
DHA doesn’t slow decline in mild to moderate Alzheimer’s
DHA supplements did not affect rates of cognitive and functional decline compared with placebo in adults who had mild to moderate Alzheimer’s disease, according to a new study.
Researchers from the Alzheimer’s Disease Cooperative Study, a consortium funded by the National Institute on Aging, conducted a randomized, double-blind, placebo-controlled trial at 51 U.S. clinical research centers to determine whether DHA supplements would slow decline in patients with Alzheimer’s disease. The study was conducted between November 2007 and May 2009. Eligible patients had a Mini-Mental State Examination (MMSE) score between 14 and 26, were medically stable, were currently consuming 200 mg of DHA per day or less, and were not taking supplements of DHA or omega-3 fatty acids. The study had two co-primary outcome measures over 18 months: rate of change on both the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog) and the Clinical Dementia Rating (CDR) sum of boxes. Brain atrophy rate was also measured by volumetric MRI in a subpopulation of 102 patients, 53 in the DHA group and 49 in the placebo group. The study results were published in the Nov. 3 Journal of the American Medical Association.
Four hundred two patients were randomly assigned to receive algal DHA, 2 g/d, or identical-appearing placebo. Two hundred ninety-five patients completed the trial while still taking study medication, 171 in the DHA group and 124 in the placebo group. ADAS-cog score was not affected by DHA supplementation (mean increase over 18 months, 7.98 points [95% CI, 2.44 to 3.30 points] in the DHA group vs. 8.27 points [95% CI, 6.72 to 9.82 points] in the placebo group; P=0.41), nor was the CDR sum of boxes score (mean increase over 18 months, 2.87 points [95% CI, 2.44 to 3.30 points] vs. 2.93 points [95% CI, 2.44 to 3.42]; P=0.68). In patients who underwent volumetric MRI, brain atrophy did not differ by study group.
The authors concluded that cognitive and functional decline did not slow in patients with mild to moderate Alzheimer’s disease who took DHA supplements. The study had a high dropout rate (28% in the DHA group and 24% in the placebo group), which the authors attributed to participants’ belief that the study drug was not helping them, suggesting that future studies try to “temper the expectations of participants or run the risk of a dropout rate that may limit the ability to generalize study results,” they wrote.
Future studies should also test whether DHA supplementation could have more of an effect if offered earlier, for example in patients with mild cognitive impairment, the authors said. Finally, they noted that in an exploratory analysis of their data, a benefit was seen on the ADAS-cog and MMSE in DHA participants who were APOE ε4-negative, but cautioned that these results would need to be confirmed in a randomized, controlled trial..
Study details comprehensive models to decrease care fragmentation in older adults
Three existing comprehensive care models have the most potential to decrease care fragmentation and improve quality of life in older U.S. adults, a new study reports.
Two researchers performed a literature search of trials that examined the performance of comprehensive primary care models in improving care of older U.S. adults with several chronic conditions. Models were evaluated by how well they addressed the following four factors, determined by expert consensus: comprehensive assessment of patients’ physical, mental and social conditions; evidence-based care planning and monitoring that considers patients’ health needs and care preferences; formal and informal promotion of patients’ and caregivers’ engagement in care; and communication and coordination of all professionals caring for patients, especially during care transitions. The study results were published in the Nov. 3 Journal of the American Medical Association.
The authors concluded that the Geriatric Resources for Assessment and Care of Elders (GRACE) model, Guided Care, and the Program of All-inclusive Care for the Elderly (PACE) address all four of the predetermined processes and help to improve outcomes of primary care while maintaining or decreasing costs. All three of these models utilize team-based primary care that offers patients comprehensive care, implementation of a care plan over time, proactive monitoring and care coordination, especially at care transitions.
While GRACE and Guided Care are overseen by patients’ existing primary care physicians, PACE patients’ care is transferred to PACE staff physicians (some of whom are community-based). PACE involves the most frequent contact, with one to five days a week, versus GRACE and Guided Care’s monthly visits. Services provided by GRACE and Guided Care, which were established in 2002 and 2006, respectively, are not currently reimbursed by Medicare, Medicaid or private insurance, so these programs are limited to areas with regional pilots or medical home/advanced primary care demonstrations. In PACE, which was established in 1990, each site is considered a managed care plan and receives capitated payments from Medicare and Medicaid.
The authors noted that more research is needed to determine how to identify patients who will benefit from a comprehensive primary care model, how access to such models can be improved, and how such care can be adequately reimbursed. An accompanying editorial examined existing barriers to providing comprehensive care to older U.S. adults and concluded that development of cost-effective care models needs to be expedited. “To move ahead, CMS should establish explicit goals for reforms and ensure that there are robust data from which to draw clear conclusions about current and alternative program success,” the editorialists concluded.
Commercial drivers should stay off the road for a year after TIA or stroke
Patients who have had a transient ischemic attack (TIA) or stroke should not drive a commercial vehicle for at least the next year, determined a panel of experts advising the U.S. Department of Transportation.
The three-member panel conducted a systematic review on stroke and TIA survivors’ risk for recurrent attacks and motor vehicle crashes. They found strong evidence that people who have had a TIA are at increased risk for stroke. Specifically, their pooled analysis found a 65-fold increased risk for stroke one month after TIA, which decreased to 16-fold at six months, and 6-fold at one year. Less evidence was available regarding the motor vehicle crash risk of stroke survivors. Because the studies on this topic were small and of low-to-moderate quality, the experts concluded that the current evidence only suggests that drivers who had a stroke are at increased, but unspecified, risk for a crash.
There is moderate evidence to suggest that neuropsychological testing can predict poststroke patients’ driving performance, the experts concluded. In particular, the dot cancellation test, road sign recognition test and “what else is in the square” test were found to be significant outcome predictors in multiple studies.
Based on their review of the evidence, the panel concluded that patients who have suffered a TIA or minor stroke should not drive a commercial vehicle for at least one year, even if they are taking medication to prevent a stroke. After a year, individuals who want to drive commercially should undergo a thorough physical and mental evaluation by a neurologist or other physician knowledgeable on the topic.
The evaluation process should include an on-road driving evaluation, because it remains the gold standard for certification, the experts said. If the drivers pass the examination, they should be recertified on annual basis and any recurrence of stroke or TIA will result in permanent disqualification. The panel’s conclusions were published by Stroke on Oct. 28.
Grassroots initiative helps promote primary care
Grassroots efforts at Harvard Medical School helped lead to the launch of a new center for primary care education, research and delivery, the school recently announced.
The Center for Primary Care was made possible by a $30 million anonymous gift and is the culmination of successful grassroots efforts of students, residents, faculty and clinicians at Harvard who advocated for a reshaping of primary care opportunities at the school. That community went on to form the nonprofit Primary Care Progress, which is building a national grassroots network of advocates who share an interest in developing innovative approaches to care delivery and training. Primary Care Progress pairs medical students with clinical innovators to work together on improving practice, develops local speakers bureaus and encourages clinicians, trainees and patients to share their primary care successes with others via its blog.
From the College.
College Fellows elected to Institute of Medicine
Nine College Fellows have been elected to membership in the Institute of Medicine of the National Academy of Sciences (IOM).
John Z. Ayanian, FACP; Nancy Berliner, FACP; Jack A. Elias, FACP; Charis Eng, FACP; Joseph Fins, FACP; Robert S. Galvin, FACP; J. Marc Overhage, FACP; Jeremy Sugarman, FACP; and George E. Thibault, FACP, were among those honored at the IOM's 40th annual meeting, the organization recently announced. The IOM recognizes those who have shown outstanding professional achievement and commitment to service and have contributed to the advancement of the medical sciences, health care, and public health. Elected members contribute to the IOM's work by serving on IOM committees, boards and other activities..
New ACP EVP/CEO speaks to members via the Web
ACP's EVP and CEO, Steven Weinberger, FACP, addresses ACP members through a video message where he outlines his priorities for the College and discusses some opportunities and challenges. The message is available online.
AMA sponsors ‘Heal that Claim’ month
For the month of November, the American Medical Association is sponsoring a “Heal the Claims Process” campaign with the goal of reducing the cost of submitting claims for physician practices from as much as 14% of total collections to just 1%.
The program encourages physicians to do their part to ensure an efficient claims process by implementing practice efficiencies and submitting timely and accurate claims. The AMA website has additional information about the campaign, including resources to help practices with the claims submission process and a request for physicians to pledge to take part.
ACP supports the "Heal that Claim" campaign and also wants to know when insurers are not doing their part and are inappropriately denying or holding up claims. The College is working to address these issues with payers. Physicians having difficulties with claims can contact Tenita Richards at email@example.com or 202-261-4574.
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 C) Spot urine albumin-creatinine ratio. This item is available to MKSAP 15 subscribers as item 40 in the Nephrology module.
The most appropriate study for this patient is a spot urine albumin-creatinine ratio. This patient has risk factors for chronic kidney disease (CKD), including coronary artery disease, hyperlipidemia, and hypertension. The National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) clinical practice guidelines recommend that patients at risk for CKD undergo screening with urinalysis, serum creatinine measurement, and estimation of the glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease (MDRD) study equation in order to classify the stage of CKD. This equation is most accurate for estimating the GFR in patients with an estimated GFR below 60 mL/min/1.73 m2. Measurement of the albumin- or protein-creatinine ratio using a first morning void urine sample would help to determine the protein- or albumin-creatinine ratio, which would be sufficient to document proteinuria.
Although rarely clinically indicated, a 24-hour urine collection for creatinine clearance is recommended to estimate the GFR in patients with a normal or near-normal GFR. However, mathematical equations to estimate the GFR generally are preferred over 24-hour urine collection, which is cumbersome and often inaccurate.
Kidney ultrasonography is recommended in patients with CKD to evaluate for structural abnormalities. However, performing this study would be premature until a diagnosis of CKD is established.
- Patients with risk factors for chronic kidney disease should undergo screening with urinalysis, serum creatinine measurement, first morning void random urine protein- or albumin-creatinine ratio, and estimation of the glomerular filtration rate (GFR) using the Modification of Diet in Renal Disease (MDRD) study equation when the estimated GFR is below 60 mL/min/1.73 m2.
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A 53-year-old woman is evaluated for a 3-month history of swelling of the face, hands, and feet. She has untreated hepatitis C virus infection. She takes lithium for bipolar disorder. She has no additional symptoms. After a physical exam, lab results and kidney biopsy, what is the most likely cause of this patient's nephrotic syndrome?
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