American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News for the Week of 4-10-07

News highlights

  • Cardiovascular risk from hormone use varies with age
  • Mammograms not improved by computer-aided detection
  • Major depression overdiagnosed in as many as 1 in 4 patients

Clinical news

  • ACP Journal Club: Inhaled insulin provides better glycemic control than oral hypoglycemic agents but not as good as injected insulin
  • Statins reduce sepsis in kidney disease patients
  • Adding chemotherapy to tamoxifen increases breast cancer survival

CMS news

  • New quality reporting measures released
  • Deadline for NPI numbers extended

Cost of care

  • Many doctors don’t consider patient costs when prescribing tests

College news

  • ACP endorses new rules to electronically verify insurance information
  • Former Regent honored by Drexel University

News highlights

Cardiovascular risk from hormone use varies with age

Women who initiate hormone therapy soon after menopause may have a slightly reduced risk of coronary heart disease, while those who start hormones later face an increased CHD risk, according to a new analysis of data from the Women’s Health Initiative study.

The differences in risk did not meet the researchers’ standards for statistical significance, but did provide some confirmation for critics of the WHI, who felt that the original study results overstated the risks of hormone therapy. Critics had argued that women in the study were older than typical hormone users, noted the April 4 Washington Post. The new analysis was published in the April 4 Journal of the American Medical Association.

The randomized controlled trials of the WHI assigned more than 27,000 postmenopausal women to estrogen, estrogen-progestin or placebo. According to the new analysis, women on either hormone who were less than 10 years from menopause had a 24% reduced risk of CHD, but women who were 10-19 years post-menopause had a 10% increased risk. The analysis also found a reduced risk for CHD and a lower mortality rate among women 50 to 59 years old who took hormones. However, the analysis confirmed prior findings that hormones caused women of all ages to have an increased risk for stroke and breast cancer.

For women and their clinicians who are considering hormones in the first few years after menopause, the finding of low or absent excess risk of CHD for women close to menopause may be reassuring, study authors said. The results are consistent with current recommendations that hormone therapy be used in the short-term for relief of menopause symptoms, but not in the longer term for prevention of cardiovascular disease, the authors concluded.

The Journal of the American Medical Association is online.

The Washington Post is online.

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Mammograms not improved by computer-aided detection

The use of a computer reduces, instead of improving, the accuracy of screening mammography interpretation, according to a new study. Using data from 222,135 mammograms, researchers compared the performance of mammography facilities that used computer-aided detection (CAD) to those that did not.

At facilities that began using CAD, the study compared cancer detection before and after the implementation of the computer systems. Results found that CAD did not significantly change the cancer-detection rate and resulted in a significantly increased number of false positives. Diagnostic specificity decreased from 90.2% before implementation to 87.2% after. Comparison to the control group—facilities not using CAD—also found that the computers led to significantly lower overall accuracy. The study was published in the April 5 New England Journal of Medicine.

Based on the results, study authors concluded that CAD is associated with reduced accuracy in screening mammograms, and that the increased rate of biopsy (which went up almost 20% in the CAD group) is not clearly associated with improved detection of invasive breast cancer. According to an accompanying editorial, one possible flaw in the study is the failure to account for the time it takes for mammographers to adjust to CAD. The adjustment time to correctly distinguish false positives marked by the computer has been estimated at weeks to years, the editorial said.

The study’s findings will not end the use of CAD, due in part to financial incentives from Medicare, but the results do constitute a setback for the technology, the editorial author noted. The next step in this area of research should be larger, controlled studies of CAD that assess mortality as well as cancer diagnosis, the editorial concluded.

The New England Journal of Medicine article and editorial are online.

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Major depression overdiagnosed in as many as 1 in 4 patients

About a quarter of people diagnosed with major depression may instead be dealing normally with a difficult event, like job loss, divorce or a natural disaster, a new study suggests.

The DSM-IV defines major depression by the presence of at least five symptoms—including sadness and lack of interest—for at least two weeks. It makes exceptions for grieving a loved one’s death, saying it’s normal to have depression-like symptoms for up to two months, but doesn’t do so for other kinds of loss, like a job, home or money.

Researchers analyzed 8,098 people aged 15 to 54 years from the National Comorbidity Survey, identifying persons who met major depressive disorder (MDD) criteria and whose MDD episodes were triggered by either bereavement or other loss. They found depression episodes triggered by bereavement or other loss were not significantly different in 8 of 9 symptom groups, including sleep problems, lack of energy or feelings of worthlessness. The bereaved group was more likely to think about death, however.

If further research confirms the findings, the DSM-IV should be revised to give equal attention to bereavement and non-bereavement triggers of sadness, the authors said. While it’s estimated that 15% of Americans are depressed at some point in their lives, revised criteria would lower that number to 11.3%, they said.

Limitations of the study are the fact that its age range excludes the elderly, a major group affected by bereavement and other loss, as well as depression. Also, information on episode-triggering events was self-reported, and survey respondents may have misremembered the timing or other details of a triggering event, the authors said.

The Archives of General Psychiatry is online.

The New York Times is online.

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Clinical news

ACP Journal Club: Inhaled insulin provides better glycemic control than oral hypoglycemic agents but not as good as injected insulin

A new review found that inhaled insulin provides better glycemic control for diabetes patients than oral hypoglycemic agents, but it is not as effective as subcutaneous insulin (SC).

In a meta-analysis, researchers analyzed 16 randomized controlled trials of greater than 12 weeks duration which were published as full, peer-reviewed, English-language articles. Selected studies compared inhaled insulin with SC insulin or oral hypoglycemic agents in non-pregnant adult patients with type 1 or 2 diabetes. Mean age range of the 4,023 patients was 29 to 60 years; 58% were men.

Results showed that inhaled insulin didn’t reduce HbA1c level as much as SC in patients with type 1 and type 2 diabetes, but did reduce it more than oral agents in patients with type 2 diabetes. The proportion of patients who achieved HbA1c levels <7% or had at least one episode of severe hypoglycemia did not differ between inhaled and SC insulin, but was higher with inhaled insulin than with oral agents. Risks for adverse pulmonary outcomes were greatest with inhaled insulin. The study is abstracted in the March/April ACP Journal Club.

Though patients tend to prefer inhaled insulin and it may provide better short-term diabetes control than suboptimum use of oral agents, prescribers should still exercise caution, given the short-term evidence of worse pulmonary function and symptoms and the unknown long term risks, said Journal Club reviewer Zubin Punthakee, MD, of McMaster University, Ontario, Canada. Further, current delivery devices are cumbersome.

Peer ratings for this review: Internists and Primary Care Physicians: 6/7 stars. Emergency Medicine: 6/7 stars. Pulmonologists: 6/7 stars. Allergists and Immunologists: 4/7 stars.

ACP Journal Club is online.

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Statins reduce sepsis in kidney disease patients

Statins may reduce the risk of hospitalization for sepsis in patients with chronic kidney disease, according to a study in the April 4 Journal of the American Medical Association.

Within a prospective, observational study of 1,041 dialysis patients (14% of whom took statins), researchers tracked 303 hospitalizations for sepsis. The rate of sepsis-related hospitalization for patients on statins was 41 per 1,000 patient-years, compared to 110 per 1,000 for patients not receiving statins. After adjusting for demographic characteristics, dialysis modality, comorbidities and laboratory values, statin users showed a 62% lower risk of hospitalization for sepsis.

Several mechanisms may explain the observed protective effects of statins, said study authors. The known immunomodulatory properties of the drugs may regulate the immune response to infections, minimizing the risk of clinical sepsis in patients with infections. Statins may also have direct antimicrobial effects, as previous studies of statins’ effect on HIV, salmonella and yeast growth have shown, the authors noted.

Although limited by its observational design, this study is the first research to show that a medication administered long-term could have a strong and significant effect on sepsis rates among patients with chronic kidney disease. A randomized trial is warranted, given the high rates of sepsis and sepsis-related mortality in these patients, the authors concluded.

The Journal of the American Medical Association is online.

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Adding chemotherapy to tamoxifen increases breast cancer survival

Women with early-stage breast cancer are more likely to survive if they have chemotherapy with tamoxifen instead of taking tamoxifen alone, but adding ovarian-suppression treatment to tamoxifen provides no benefit, new studies show.

In the first study, 1,991 patients aged 26-81 were randomly assigned to chemotherapy or no chemotherapy. All were receiving 5 years tamoxifen treatment, and some were receiving ovarian ablation or suppression. Chemotherapy improved relapse-free survival (298 relapse events with chemotherapy vs. 332 events without, HR=0.86, CI=.73 to 1.01) and overall survival (243 deaths with chemotherapy vs. 282 without, HR=0.83, 95% CI=.70 to .99). Chemotherapy was most beneficial to women under 50, particularly premenopausal women who were not receiving ovarian ablation or suppression.

In the second study, 2,144 women were randomized to receive ovarian ablation or suppression, or not. All had a background of 5 years of tamoxifen treatment with or without chemotherapy. Overall, no benefit was seen for relapse-free survival (290 relapses in the ovarian ablation/suppression group vs. 306 in the control group, HR= 0.95, 95% CI=.81 to 1.12) or overall survival (215 deaths in the ovarian ablation/suppression group vs. 230 control group, HR=.94, 95% CI=.78 to 1.13). For women younger than 40 who didn’t receive chemotherapy, there was a trend toward benefit from the treatment, but it wasn’t statistically significant (survival HR=0.55, 95% CI=0.17 to 1.85).

A major weakness of the studies, which sprang from the same trial and were published in the April 4 Journal of the National Cancer Institute, is that more than 40% of patients didn’t have tumor estrogen receptor levels measured. “(This) limits the ability to perform the subset analyses that could prove most interesting,” said Kathleen Pritchard, MD, Toronto Sunnybrook Regional Cancer Centre, in an editorial. “Nonetheless, these studies confirm the role of CMF or equivalent chemotherapy in women receiving 5 years of tamoxifen with or without ovarian ablation or suppression, and suggest that further investigation of ovarian ablation or suppression added to tamoxifen or to chemotherapy is worthwhile,” Dr. Pritchard said.

The first and second studies are online in the Journal of the National Cancer Institute.

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CMS news

New quality reporting measures released

CMS has announced the quality measures that physicians will use to participate in and receive incentives under the 2007 Physician Quality Reporting Initiative (PQRI).

The PQRI is a new pay-for-reporting program from Medicare that will begin on July 1 and run through Dec. 31. The program was established under federal law in December 2006 and the CMS has spent the first few months of 2007 designing the details of the program.

Under the PQRI, CMS will pay physicians for reporting on specified quality measures. Internists will need to successfully report on three of 74 different quality measures to receive a 1.5% bonus to their Medicare payments. The new, detailed specifications contain descriptions of the different measures, instructions for reporting and clinical recommendation statements for each measure.

The specifications have been posted in advance of the program's start date to help physicians identify the measures that apply to their practices and prepare for submission of quality data. CMS also said that it expects a small number of additional specification changes, which may expand the applicability of the measures to additional eligible professionals.

The measure specifications are online.

Additional CMS information on the PQRI is online.

Information from ACP on the PQRI is online.

ACP members can gain access by registering online.

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Deadline for NPI numbers extended

Health plans and providers that are not ready to use National Provider Identifier (NPI) numbers may take a little extra time to convert their systems, the Centers for Medicare & Medicaid Services (CMS) announced last week. CMS had previously set a deadline of May 23 for implementation of the new numbers.

Under a new contingency guideline, the agency will not enforce penalties as long as health plans are making a good-faith effort to convert to the new system. Insurers can continue to use older provider identification numbers for up to year in order to ensure the smooth flow of payments. The deadline was extended after it became apparent that many covered entities would not be able to fully comply with the NPI standard by the deadline, CMS officials said.

The NPI is a number that will be used by all payers to identify health care providers, eliminating the current need for multiple identifiers for the same provider. CMS encourages health care providers that have not yet obtained NPIs to do so immediately, and to use their NPIs in HIPAA transactions as soon as possible. Applying for an NPI is fast, easy and free, CMS officials said. Apply for an NPI number online.

The CMS press release is online.

The January ACP Observer has more information on NPI numbers.

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Cost of care

Many doctors don’t consider patient costs when prescribing tests

Nearly half of physicians don’t consider patients’ out-of-pocket costs when deciding which diagnostic tests to recommend, though most do consider costs when prescribing drugs, a new study found.

Based on surveys returned by 6,628 practicing doctors, the study found 51.2% consider insured patients’ out-of-pocket costs for co-payments and deductibles when deciding which tests to recommend, and 40.2% consider these costs when choosing between inpatient and outpatient settings if a choice is available. But 78% take costs into account when prescribing generic vs. brand-name drugs, according to the study published in the April 9 Archives of Internal Medicine.

Primary care doctors were more likely than specialists to consider patients’ costs in prescribing drugs (85% vs. 75%), care settings (54% vs. 43%) and diagnostic tests (46% vs. 30%). Doctors who provide charity care, as well as those in solo or two-person practices, were more likely to consider patient costs when choosing tests or care settings, while those working in large groups or HMOs were more likely to consider costs when prescribing drugs.

Previous research has shown physicians’ decisions affect how 90% of every health care dollar is spent, the authors noted. “Because physicians consider patient costs less frequently in making decisions about more expensive services, it’s likely that increased patient cost sharing will be limited as an effective cost-control tool,” said Hoangmai Pham, MD, MPH, the study’s lead author.

The Archives of Internal Medicine is online.

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College news

ACP endorses new rules to electronically verify insurance information

ACP has endorsed new rules released by the Council for Affordable Quality Health Care (CAQH) Committee on Operating Rules for Information Exchange to standardize the electronic exchange of patient insurance information.

Last week CAQH announced that nearly 20 health organizations are now using the new CORE rules to exchange patient administrative data voluntarily. The rules were first released in September 2006.

CAQH launched the CORE in January 2005 to simplify eligibility and benefits data transactions, promote better health plan/provider interoperability and improve provider access to administrative information. The new rules allow health care providers and hospitals to access eligibility and benefits information required to verify patient health insurance coverage in a matter of seconds.

CAQH’s announcement is online.

More information on CORE is online.

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Former Regent honored by Drexel University

Risa J. Lavizzo-Mourey, MACP, has been selected to receive the 2007 Woman One Award from the Institute for Women's Health and Leadership at Drexel University College of Medicine. The award is presented annually to a woman who, by the influence of her actions and the excellence of her example, inspires women of all ages to reach for the highest standards of health and human behavior.

Dr. Lavizzo-Mourey is a former College Regent and president and CEO of the Robert Wood Johnson Foundation. In addition to her position at the foundation, Dr. Lavizzo-Mourey has worked in academic medicine as an independent researcher as well as helping formulate government health policies. She will receive the award at a ceremony in Philadelphia on April 23.

More information about the award is online.

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A 46-year-old woman is evaluated before undergoing a dental cleaning procedure involving deep scaling. She has a history of mitral valve prolapse without regurgitation and also had methicillin-resistant Staphylococcus aureus (MRSA) aortic valve endocarditis 10 years ago treated successfully with antibiotics. The patient notes an allergy to penicillin characterized by hypotension, hives, and wheezing. The remainder of the history is noncontributory. Following a physical and cardiopulmonary examination, what is the most appropriate prophylactic regimen for this patient before her dental procedure?

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