Journal watch: recent studies of note

Recent studies about treating COPD, avoiding gadolinium MRIs, and other topics.


New evidence for COPD treatments

Combination therapy for chronic obstructive pulmonary disease (COPD) shows significant benefits over monotherapy options but does not significantly affect mortality rates, a new study found.

In the randomized, double-blind trial, researchers treated 6,112 patients with salmeterol plus fluticasone propionate (combination therapy), placebo, salmeterol alone or fluticasone alone for a period of three years. The primary outcome was death from any cause, although the frequency of exacerbations, health status and spirometric values were also assessed. The study was published in the Feb. 22 New England Journal of Medicine.

All-cause mortality rates were 12.6% in the combination therapy group, 15.2% for placebo, 13.5% for salmeterol and 16.0% for fluticasone. Although combination therapy had the best results, the differences in mortality did not meet the study's standard for statistical significance. However, study authors did conclude that the combination regimen showed significant benefits in all other outcomes, including reducing the annual rate of exacerbations from 1.13 to 0.85.

One weakness of the study was that 40% or more of the enrolled subjects dropped out, noted an accompanying editorial. Patients in the placebo group may have left the study because their symptoms became intolerable, thus explaining why the trial failed to demonstrate the expected mortality rate in the placebo group.

Overall, the study indicates that monotherapy with corticosteroids should not be advocated for patients with COPD and that monotherapy with a long-acting bronchodilator appears to be safe, the editorial suggested. Caution in the use of combination therapy is urged because of the increased rate of pneumonia among all study patients receiving inhaled corticosteroids, a finding that requires further investigation, the editorial said.

Another recent study, released online last week by Annals of Internal Medicine, compared treatments in 449 Canadians with COPD. In the randomized, controlled trial, researchers tested tiotropium in combination with salmeterol, fluticasone-salmeterol or a placebo. The study found that the addition of fluticasone-salmeterol to tiotropium therapy did not statistically influence rates of COPD exacerbation but did improve lung function, quality of life, and hospitalization rates in patients with moderate to severe COPD. The article will be published in print in the April 17 issue of Annals.

Avoid gadolinium MRI in patients with kidney disease

MRI contrast agents containing gadolinium are potentially dangerous to people with advanced kidney disease and should be avoided in these patients except when medically necessary, according to a new recommendation from the CDC and a recent FDA advisory.

The CDC recently conducted an investigation of nephrogenic systemic fibrosis (also known as nephrogenic fibrosing dermopathy), a condition that is characterized by thickening and hardening of the skin and can lead to joint immobility and significant disability in affected persons. The investigation confirmed earlier studies finding an association of gadolinium exposure to development of NSF.

Another recent study found gadolinium levels in the tissue of patients with NSF that are 35- to 150-fold higher than the level of gadolinium retained in the bone of healthy volunteers with normal kidney function. Many academic medical centers, including Yale and Johns Hopkins, have recently drawn up guidelines regarding the use of gadolinium in patients with kidney disease.

The CDC study, published in the Feb. 23 Morbidity and Mortality Weekly Report, traced 33 NSF patients in St. Louis and found an association with gadolinium. As of Dec. 25, 2006, the FDA MedWatch system had received 90 reports of NSF possibly related to gadolinium-containing contrast agents. Clinicians should be aware of the potential for NSF and when possible avoid use of gadolinium-contrast agents in patients with advanced kidney disease, the CDC said.

Communication between hospitalists, primary care doctors poor, review finds

Primary care physicians often don't receive adequate patient information from hospitalists after discharge, a review in the Feb. 28 issue of the Journal of the American Medical Association found.

Researchers examined data from 55 observational studies published between 1970 and 2005. Only 3% of primary care doctors reported being involved in discussions about discharge, and 17% to 20% reported always being notified about discharges.

Discharge letters or summaries often didn't reach physicians-or didn't reach them in a timely manner-and frequently lacked important details. Approximately 11% of discharge letters and 25% of discharge summaries never reached primary care doctors. Only 12% to 34% of doctors had received a discharge summary at the first follow-up visit; after four weeks, 51% to 77% of doctors had received one.

In addition, 25% of discharge summaries failed to include the name of the hospitalist and 17.5% didn't include the main diagnosis. Other information left out included: test results pending at discharge (65%), patient or family counseling (90%-92%), diagnostic test results (38%), discharge medications (21%) and specific follow-up plans (14%).

Suggestions to improve information transfer between hospitalists and primary care doctors include:

  • Using subheadings in discharge summaries to highlight pertinent follow-up care information
  • Using information technology in hospitals to complete and issue discharge summaries
  • Giving each patient a copy of his or her discharge summary and telling the patient to bring it to his or her next follow-up visit.

Weaknesses of the review included a relative lack of high-quality investigations and the fact that most studies were conducted outside the U.S. in countries with a single-payer or national health system. Still, the authors said, the results are relevant and current given the rapid growth in hospitalists.

Intervention improves process of care, but not outcomes

A national initiative to improve care at community health centers improved the process of care for two out of three chronic conditions, but didn't improve intermediate clinical outcomes, a study in the March 1 issue of New England Journal of Medicine found.

Researchers studied 9,658 patients enrolled at 44 centers that participated in the Health Disparities Collaboratives, a quality improvement effort adopted by the Health Resources and Services Administration for 1,000 health centers nationally-and compared them to 20 centers that didn't participate. They studied patients' medical records a year before and after the intervention, and compared them to control centers.

Intervention centers saw a 21% increase in foot exams and a 16% increase in screening for glycated hemoglobin in patients with diabetes and a 14% increase in the use of anti-inflammatory medication for patients with asthma. There was no improvement, however, in quality of care for patients with hypertension, nor in any of the intermediate outcomes, which included urgent care of hospitalization for asthma, control of glycated hemoglobin levels for diabetes, and control of blood pressure for hypertension.

The study's focus on short-term outcomes may underestimate the true effect of quality improvement collaboratives, the authors said. As well, some of the improvements that were noticed may reflect better documentation as opposed to better care, they noted.