Embargoed news for Annals of Internal Medicine

Trial of Comprehensive Care Management Program for COPD Cut Short Due to Excess Mortality

Self-monitoring and management of some chronic diseases can improve patient outcomes. Hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD) are associated with decreases in quality of life, lung function, and life expectancy, so researchers hypothesized that a self-management program could benefit patients. The authors enrolled 960 COPD patients in 20 Veterans Affairs hospital-based outpatient clinics in a randomized, controlled trial comparing a comprehensive care management program (CCMP) with guideline-based usual care. All patients had been hospitalized for COPD within the last year. The CCMP included individual and group education sessions, an action plan for identification and treatment of exacerbations, and scheduled telephone calls from a case manager. Patients in both groups were provided with a COPD information booklet and their physicians were given a copy of COPD guidelines and instructions to follow them. Researchers were to follow both groups to record the time to first hospitalization. However, a safety monitoring board stopped the trial before enrollment could be completed due to excess mortality among participants. Of the 209 patients enrolled in the CCMP group, 28 deaths occurred from all causes versus 10 in the usual care group. There were no differences seen in the number of hospitalizations or the time to initiation of treatment for an acute exacerbation of COPD. Researchers could not determine the cause of increased mortality or the reason that CCMP patients did not initiate treatment sooner. The author of an accompanying editorial cites several examples of clinical trials that were terminated early due to negative events. He stresses the importance of engaging an experienced data monitoring committee that can make wise, ethical judgments when evidence of harm arises in clinical trials. The authors of the CCMP study for COPD conclude that self-management may not be appropriate for COPD.

Colon cancer is the second most common cause of death from cancer. Screening saves lives because precancerous polyps can be removed during colonoscopy. However, the laxative bowel preparation is a strong deterrent to screening for many patients. Computer tomographic colonography (CTC or virtual colonoscopy) is an alternative to traditional colonoscopy, but a laxative is still required. A newer laxative-free CTC procedure utilizes a computer program to electronically "cleanse" the colon for radiologic evaluation. Researchers screened 605 patients with laxative-free CTC followed by traditional colonoscopy to assess the performance of laxative-free CTC at detecting adenomas of 6 mm or larger (the lesions most likely to become cancerous), and to see how well patients tolerate the procedure. Before CTC, patients adhered to a low-fiber diet and ingested a small dose of contrast material to thoroughly tag feces. After images were taken, computer software removed tagged feces from the colon images without altering the size or appearance of mucosal folds and polyps. The researchers found that laxative-free CTC accurately identified 91 percent of persons with adenomas 10 mm or larger. In addition, patients reported a much better experience than with traditional colonoscopy. Radiographic reporting was structured so that incidental extracolonic findings were limited to 5.5 percent (extracolonic findings have been reported as a limitation of virtural colonoscopy). According to the author, laxative-free CTC provides an alternative to patients who may not otherwise participate in colorectal cancer screening. However, this new technology will miss lesions smaller than 10 mm.

Colorectal cancer (CRC) screening guidelines recommend that average-risk persons begin screening at age 50. For those at higher risk, screening may begin earlier. Clear risk factors for CRC include polyposis syndrome, a family history of nonpolyposis colorectal cancer syndrome, and having a first-degree relative with CRC. Some studies have linked a family history of adenomatous polyps (adenomas) as an increased risk for colon cancer. Researchers reviewed published research to determine the validity of studies on this subject. Despite the stated objectives, only two of the 12 studies that met inclusion criteria actually were designed to determine if family history of adenomas increased risk for CRC. The other 10 studies more accurately assessed if patients with adenomas are more likely to have a family history of CRC. According to the study authors, this is an important distinction, as the data influence guidelines determining when screening should begin. The researchers suggest further studies with methodology specifically designed to determine if having a first-degree relative with one or more adenomas increases one's risk for CRC.