In the News
for the Week of 10-26-10
- Hormone therapy associated with increased invasive breast cancer
- Guidelines updated for patient selection for cardiac computed tomography
- MKSAP Quiz: confusion, fever, and flank pain
- Hospitalizations for diabetes increase, especially among younger women
- Weekly home INR testing comparable to monthly clinic testing
- Drug company information might influence prescribing habits
- Warnings added to prostate cancer drugs
- Talk about health care reform with CMS Administrator Don Berwick
- PQRI incentive payments now being sent
- Are you enrolled in PECOS?
- AAIM offers textbook for internal medicine education programs
From the College
Cartoon caption contest
- Vote for your favorite entry
Physician editor: Darren Taichman, FACP
Hormone therapy associated with increased invasive breast cancer
Hormone therapy not only increases the risk of breast cancer but its potential to spread to the lymph nodes and possibly also women’s risk of dying from the disease, according to a new analysis of the Women’s Health Initiative.
In the WHI trial, more than 16,000 postmenopausal women were randomized to receive either combined conjugated equine estrogens (0.625 mg/day) and medroxyprogesterone acetate (2.5 mg/day) or placebo. This new analysis was based on follow up data collected for a mean of 11 years. Follow up information was obtained from 83% of the surviving participants of the trial. The results were published in the Oct. 20 Journal of the American Medical Association.
Among participants providing follow up data, use of estrogen plus progestin was associated with a significantly higher risk of invasive breast cancer (385 cases vs. 293 cases; hazard ratio [HR], 1.25; P=0.004). The cancers in the active and placebo groups were similar in histology and grade, but women who took the active pills were more likely to have lymph-node involvement in their cancer (81 cases [23.7%] vs. 43 [16.2%]; HR, 1.78; P=0.03). These findings differ from previous observational studies which have found hormone use to be associated with breast cancers with more favorable characteristics, possibly because observational trials are confounded by the tendency of hormone users to have more mammograms, the study authors said.
The analysis also found that the group taking hormones had more deaths directly attributed to breast cancer (25 deaths vs. 12 deaths; HR, 1.96; 95% confidence interval [CI], 1.00-4.04; P=0.049) and more deaths from all causes after breast cancer diagnosis (51 deaths vs. 31 deaths, HR, 1.57; CI, 1.01-2.48; P=0.045). The actual mortality rate from breast cancer likely lies somewhere between these two statistics, the study authors noted, but the all-cause deaths may also reflect the problematic effect of hormones on lung cancer growth and spread.
The confidence intervals and P values for the mortality risks indicate that the difference between groups was not very significant, an accompanying editorial said. However, the direction of the statistical curves suggests that longer follow up could reveal that the damaging effects of hormone therapy have actually been underestimated, the editorialist speculated. He urged caution in the use of hormone therapy, even when using briefer courses of the drugs than the WHI included.
Currently, a safe interval for combined hormone therapy use cannot be reliably defined, the study authors also concluded. Given the scientific uncertainty, patients cannot be informed enough about the risks and benefits to make a valid decision, the editorialist said. He called for additional randomized trials of lower doses and shorter durations of hormone therapy..
Guidelines updated for patient selection for cardiac computed tomography
A new report provides new and expanded criteria to help clinicians optimally select patients who could benefit from cardiac computed tomography (CCT) and inform payers about appropriate clinical scenarios for its use.
The new criteria, issued by the American College of Cardiology and the Society of Cardiovascular Computed Tomography, assessed the appropriateness of CCT imaging for 93 different clinical scenarios—an increase from 39 in the 2006 report—scoring each to determine if the use of CCT imaging was appropriate, inappropriate or uncertain for a given situation.
According to the new guidelines, CCT angiography is considered appropriate for diagnosis and risk assessment in patients with symptoms of possible heart disease who have a low to intermediate risk of a heart problem, or uncertainty regarding their diagnosis after other tests are performed. Testing in high-risk patients, routine repeat testing and general screening in patients with no symptoms or other clinical scenarios are generally not considered appropriate.
The original appropriate use criteria for CCT were issued in 2006 when this technology was still relatively new. The updated criteria also broadened the number of patients and applications of non-contrast CT for calcium scanning. According to the appropriateness ratings, calcium scanning is considered appropriate among patients without heart symptoms who have an intermediate risk of heart disease or selected patients with low risk (particularly women or younger men) who have a family history of heart problems.
The guidelines’ clinical scenarios include acute and chronic chest pain, testing in symptomatic and asymptomatic patients, heart failure, preoperative risk assessment before both cardiac and noncardiac surgery, and evaluation of cardiac structure and function, among others. Of the clinical scenarios evaluated, cardiac CT was deemed appropriate in 37%, and the remainder were considered either inappropriate uses or uncertain.
Groups endorsing the criteria include the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, the American College of Radiology and the Society for Cardiovascular Magnetic Resonance.
Full text of this report will be published in the November 23, 2010, issue of the Journal of the American College of Cardiology and available on the organization's Web site. It will also be co-published in Circulation and the Journal of Cardiovascular Computed Tomography.
MKSAP Quiz: confusion, fever and flank pain
A 71-year-old woman is brought to the emergency department from a nursing home because of confusion, fever and flank pain. Her temperature is 38.5 °C (101.3 °F), blood pressure is 82/48 mm Hg, pulse rate is 123/min, and respiration rate is 27/min. Mucous membranes are dry, and there is costovertebral angle tenderness, poor skin turgor, and no edema. Hemoglobin concentration is 10.5 g/dL (105 g/L), leukocyte count is 15,600/µL (15.6 × 109/L); urinalysis reveals 50 to 100 leukocytes/hpf and many bacteria/hpf. The patient has an anion gap metabolic acidosis. A central venous catheter is placed, and antibiotic therapy is started.
Which of the following additional interventions is most likely to improve survival for this patient?
A) Aggressive fluid resuscitation
B) Hemodynamic monitoring with a pulmonary artery catheter
C) Maintaining hemoglobin concentration above 12 g/dL (120 g/L)
D) Maintaining Pco2 below 50 mm Hg (6.65 kPa)
Click here or scroll to the bottom of the page for the answer and critique.
Hospitalizations for diabetes increase, especially among younger women
The number of hospitalizations with a primary or secondary diagnosis of diabetes increased dramatically between 1993 and 2006, especially among younger people, a new study found.
Researchers gathered their statistics from hospital discharges included in the Nationwide Inpatient Sample and the results were published online by the Journal of Women’s Health. Over the 14-year period, diabetes hospitalizations increased 65.3% overall. The largest increase in discharges of 102% was among patients 30-39 years old. Younger women saw greater increases than younger men, with diabetes hospitalizations increasing 63% in 20- to 29-year-old women and 118% in 30- to 39-year-olds (compared to 46% and 85% respectively in men). At age 50, the trend flipped, with more men over age 50 being hospitalized for diabetes than women. During this same time period, overall hospitalization rates for adults declined, the study authors noted.
The analysis also looked at the primary diagnoses associated with these hospitalizations. Excluding pregnancy-related hospitalizations, diabetes with complications was the top diagnosis in all age groups, but psychiatric disorders also accounted for a substantial proportion of younger patients’ hospitalizations. Affective disorders were the second most common diagnosis in women 20-39, while schizophrenia was the fifth biggest among young men. Younger age and female gender have been associated with increased risk of depression in diabetics, and atypical neuroleptics have been associated with incident diabetes, the study authors noted.
Overall, the increases found by the study may reflect increasing diabetes prevalence in the adult population, the authors said. The differences between men and women may be related to previous findings that women diabetics receive less preventive care and aggressive medical management. However, the study was limited by several potential confounding factors, including increasing awareness of type 2 diabetes during the time period (which could lead to more diagnoses recorded in hospital records) and the change in 1997 to defining diabetes as a fasting blood glucose of 126 mg/dL or higher, instead of 140 mg/dL or higher.
Still, the statistics indicate that the cost burden of diabetes hospitalizations will continue to escalate as these patients age, the authors concluded. They recommended more focus on diabetes prevention and research to assess whether the growth in hospitalizations has resulted from increasing prevalence of diabetes or an increasing burden of comorbid disease.
Weekly home INR testing comparable to monthly clinic testing
Weekly home testing of international normalized ratio (INR) offers similar efficacy to monthly, high-quality tests in a clinic for preventing strokes and other major events, as well as modest improvements in patient satisfaction, quality of life and time within the therapeutic range, reports a study.
The Veterans Affairs Cooperative Studies Program conducted The Home INR Study (THINRS) and reported results in the Oct. 21 New England Journal of Medicine.
The prospective, randomized, nonblinded trial assigned 2,922 patients taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices. Data were collected at 28 VA medical centers with anticoagulation clinics that met guidelines defined by the Managing Anticoagulation Services Trial and were treating at least 400 patients.
Patients were followed for 2.0 to 4.75 years, for a total of 8,730 patient-years of follow up. Time to the first primary event was not significantly longer in the self-testing group (hazard ratio, 0.88; 95% confidence interval [CI], 0.75 to 1.04; P=0.14). Clinical outcomes were similar, except that the self-testing group reported more minor bleeding episodes. Also, the self-testing group had a 3.8% improvement in the percentage of time during which the INR was within the target range (95% CI, 2.7-5.0; P<0.001).
At two years, patient satisfaction with anticoagulation, as measured by the DASS (scores range from 25 to 225, with lower scores indicating better satisfaction) was greater in the self-testing group (−2.4 points; 95% CI, −3.9 to −1.0; P=0.002). The self-testing group also saw a cumulative gain in the Health Utilities Index Mark 3 (difference, 0.155 points; 95% CI, 0.111 to 0.198; P<0.001). Costs were higher in the self-testing group (difference, $1,249; 95% CI, -$1,205 to $3,703; P=0.32).
A limitation to the results is that the study criteria—a controlled setting, patients screened for competence and compliance with screening test manufacturers' guidelines—probably differ from real-life use.
Study authors wrote, "In light of the poor record of usual care and the value of anticoagulation in preventing major events, we recommend that self-testing be considered for patients whose access to high-quality anticoagulation care is limited by disability, geographic distance, or other factors, if the alternative would be to withhold a highly effective treatment."
Drug company information might influence prescribing habits
Information from drug companies influences doctors' decisions, and not necessarily positively, according to a meta-analysis.
Researchers reviewed studies of prescribing physicians who were exposed to sales visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software and participation in sponsored clinical trials. The outcomes measured were quality, quantity and cost of physicians’ prescribing.
The meta-analysis included randomized controlled trials, time series analyses, before-after studies, cohort studies, case-control studies, ecological studies and cross-sectional studies. Studies were included if they both measured exposure to any type of information directly provided by pharmaceutical companies and physicians' prescribing. Studies were excluded if they looked at the indirect information, such as continuing medical education courses funded by unrestricted grants, or if they were case series, case reports, abstracts, news items and short reports.
Results were published Oct. 19 at PLoS Medicine.
Of the studies, 38 showed that exposure to drug company information resulted in more frequent prescriptions, while 13 did not. Among the many analyses of potentially influential factors:
- Of studies of pharmaceutical sales representative visits, 17 found an association with increased prescribing of the promoted drug. None found less frequent prescribing. Of the remaining 11, six had mixed results.
- Of the four studies that measured journal advertisements and included statistical tests, one found that journal advertisements had a more pronounced effect on market share for the advertised drug than did positive scientific information published in medical journals.
- Of eight studies of pharmaceutical company-sponsored meetings, five found positive associations with prescribing frequency and three did not.
- Of three studies of mailed promotional material, one found an association with increased prescribing and two did not.
- A single study that examined the effect of advertising in clinical practice software found no association with prescribing frequency for six medications and less prescribing of one medication.
- Several studies combined the outcome measures for various exposures to pharmaceutical company information or measured overall promotional investment, a proxy for the amount of exposure to information from pharmaceutical companies. Three studies found that total promotional investment was positively associated with prescribing frequency. Two studies found both positive results and no association. One study did not detect an association.
While the limitations of the original studies and of the nature of meta-analysis itself limit the researchers conclusions, researchers found some evidence of increased costs and decreased quality of prescribing. They did not find evidence of net improvements in the quality of prescribing associated with exposure to information from pharmaceutical companies. In the absence of such evidence, researchers wrote, "We recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies unless evidence of net benefit emerges."
Warnings added to prostate cancer drugs
New warnings will be added to the labels of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer, the FDA announced last week.
The warnings will alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications, based on an FDA analysis which found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke and sudden death.
GnRH agnoists are marketed under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. Several generic products are also available.
Talk about health care reform with CMS Administrator Don Berwick
Don Berwick, MD, administrator for the Centers for Medicare and Medicaid Services, will hold a conference call to talk about CMS' role in health care reform on Oct. 29. The free call, at 2:30 p.m. EST, is sponsored by ACP, the American College of Cardiology, American Medical Women's Association, the Committee of Interns and Residents, the Society of General Internal Medicine and Doctors for America. Registration is available online..
PQRI incentive payments now being sent
Medicare began distributing incentive payments for the 2009 Physician Quality Reporting Initiative program last week. All payments are scheduled to be distributed by Nov. 12.
The feedback reports for the 2009 program will be available online the second week of November at the Physician and Other Health Care Professionals Quality Reporting Portal. You must be registered through the CMS security system known as Individuals Authorized Access to the CMS Computer Services (IACS) to use the portal.
Realizing that many physicians have had great difficulty registering for the IACS system, CMS also enables physicians to call their Medicare contractor to request their feedback report. The phone number for each contractor Provider Contact Centers is available online. The contractor will ask you to provide an e-mail address and you will then receive your report within 30 days. You can also ask the contractor status and amount of your PQRI incentive payment.
There is still time to begin your participation in the 2010 CMS Physician Quality Reporting Initiative (PQRI) and potentially qualify to receive incentive payments equal to 2% of total Medicare Part B allowed charges. The current 6-month reporting period began on July 1, 2010. The claims-based or registry-based reporting options are available.
There is no sign-up or registration needed for the program, but there are a few advance steps that you can take before you begin PQRI reporting. Details about how to participate in PQRI are available at http://www.cms.hhs.gov/PQRI/ on the CMS website..
Are you enrolled in PECOS?
In order to receive incentive payments from the Medicare EHR incentive program that begins in 2011, physicians must have an enrollment record in the Provider Enrollment, Chain and Ownership System (PECOS).
It is possible to bill and receive payments from Medicare without being in the system, so if you plan on participating in the EHR incentive program, you may want to take a moment to verify your PECOS enrollment. Information about how to check your enrollment is online. Another inducement to be sure your enrollment information is in PECOS is that the ability of individuals, such as specialist colleagues, and entities to which you refer beneficiaries to get paid for services, tests, and items could be jeopardized in the near future if you are not in the system.
More information about the EHR incentive program can be found on the CMS website.
AAIM offers textbook for internal medicine education programs
The Alliance for Academic Internal Medicine is offering The Toolkit Series: A Textbook for Internal Medicine Education Programs for internal medicine residency and fellowship education.
The series is a valuable resource for tackling common problems encountered by faculty and staff in undergraduate and graduate medical education. Released in July 2010, the 10th edition includes more than 50 chapters—six new and 25 updated—written by expert faculty and staff in departments of internal medicine.
Available for $75, each book includes a disc with all the content in PDF format. Shipping is free. The complete table of contents and two sample chapters are available for download.
From the College.
ACP's John Tooker, MACP, blogs at KevinMD
John Tooker, MACP, ACP's Associate Executive Vice President, continues his monthly column at KevinMD.com, one of the Web's most influential medical blogs. This month's column considers professional civility—or the lack thereof—in the ongoing health care reform debate..
Nominate candidates for upcoming ACP council elections
The Council of Young Physicians (CYP), the Council of Associates (COA), and the Council of Student Members (CSM) are currently seeking candidates to fill all vacant seats for 2011-2012.
Each Council meets once a year in Philadelphia and several times via conference call and webinars and is responsible for contributing to the development of programming and products, creating internal medicine workshops, and advocating for their respective constituencies on Capitol Hill. CYP candidates must be Members or Fellows of the College who are within 16 years of graduating from medical school as of May 1, 2011; COA candidates must be Associate Members of the College; and CSM candidates must be current Medical Student Members.
Cartoon caption contest.
Vote for your favorite entry
ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite captions to determine the winner.
Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Monday, Nov. 1, with the winner announced in the Nov. 2 issue..
MKSAP answer and critique
The correct answer is A) Aggressive fluid resuscitation. This item is available to MKSAP 15 subscribers as item 99 in the Pulmonology and Critical Care Medicine module.
The patient has severe sepsis presumptively from pyelonephritis. Aggressive fluid resuscitation with resolution of lactic acidosis within 6 hours would have a beneficial effect on this patient’s survival. Resuscitation of the circulation should target a central venous oxygen saturation (Scvo2) or mixed venous oxygen saturation (Svo2) of at least 70%. Other reasonable goals include a central venous pressure of 8 to 12 mm Hg, a mean arterial pressure of at least 65 mm Hg, and a urine output of at least 0.5 mL/kg/h. In patients such as the one presented, this often translates into administration of 5 to 6 L of fluid. Timing of resuscitation matters to survival. In a landmark study by Rivers and colleagues, early goal-directed therapy that included interventions within the first 6 hours to maintain a Scvo2 of greater than 70% and to resolve lactic acidosis resulted in higher survival rates than more delayed resuscitation attempts. Over the first 72 hours, patients in the control arm received the same quantity of fluid for resuscitation, but they had a significantly higher likelihood of dying by discharge or at 60 days.
Crystalloid is given much more frequently than colloid, and there are no data to support routinely using colloid in lieu of crystalloid. Blood transfusion may be part of resuscitation for anemic patients in shock, but maintaining hemoglobin levels above 12 g/dL (120 g/L) is not supported by evidence. In stable patients who are not in shock, a transfusion threshold of 7 g/dL (70 g/L) is an acceptable conservative approach. There are no data to support that maintaining a lower Pco2 or using a pulmonary artery catheter would help to increase survival in this patient.
- In patients with severe sepsis, early goal-directed therapy within the first 6 hours to maintain a central venous or mixed venous oxygen saturation of greater than 70% and to resolve lactic acidosis improves survival compared with more delayed resuscitation attempts.
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A 56-year-old woman is evaluated in the emergency department for sudden onset of a severe generalized headache that began 36 hours ago and has not responded to over-the-counter medications. Following laboratory studies and a CT scan, what is the most appropriate next diagnostic test?
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