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This trial comparing usual care with a care management program (patient education, action plans for exacerbations, and scheduled telephone calls with case managers) was stopped early when the data safety monitoring board noted more deaths in the intervention group. The study illustrates the importance of data safety monitoring in behavioral intervention studies.
The clinical course of patients with idiopathic pulmonary fibrosis varies, making predicting survival difficult. This study developed and validated 2 models to predict mortality by using variables readily available in clinical encounters (sex, age, FVC, and diffusion capacity). One model used continuous predictors and the other a simple point-scoring system. Each performed well in predicting survival. The models may be useful in identifying patients at heightened risk for death and in guiding care and clinical research.
Computed tomographic colonography (CTC) and optical colonoscopy require a laxative bowel preparation, which remains a barrier to colorectal cancer screening. A third screening method, laxative-free CTC, combines the use of low-fiber diet, oral contrast, and postprocessing software to electronically cleanse images. This study compared laxative-free CTC with optical colonoscopy in the same patients and found that laxative-free CTC performed well at detecting adenomas larger than 10 mm but not for smaller lesions.
People may be at greater risk for colorectal cancer if they have a first-degree relative who has an adenomatous polyp, but that risk is not well-understood. This systematic review found 2 studies that report an increased risk; however, study design problems affect the validity and generalizability of their results. It also found 10 studies that have been cited incorrectly as reporting an increased risk. Further research is needed to inform recommendations about screening for colorectal cancer in patients with a family history of adenomatous polyps.
Several strategies to prevent venous thromboembolism are available for patients undergoing major orthopedic surgery. This systematic review examined 22 trials that compared oral factor Xa inhibitors with low-molecular-weight heparin (LMWH) in adults undergoing hip or knee replacement. Reviewers found no important differences in mortality or pulmonary embolism between the 2 drugs. However, compared with LMWH, factor Xa inhibitors decreased the risk for symptomatic deep venous thrombosis (DVT). High, but not lower, doses of factor Xa inhibitors increased bleeding; lower doses reduced risk for symptomatic DVT without increasing bleeding.
The optimal duration of thromboprophylaxis after major orthopedic surgery is unclear. This systematic review identified 8 randomized trials that compared prolonged (≥21 days) with standard-duration (7 to 10 days) thromboprophylaxis after major orthopedic surgery in adults. Prolonged prophylaxis decreased the risk for venous thromboembolism, pulmonary embolism, and DVT but increased the risk for minor bleeding. Most data were for hip replacement surgery; applicability of these findings to knee replacement and hip fracture surgery is unclear.
Randomized, controlled trials are relatively rare in health services research, and institutional review boards (IRBs) may lack experience in reviewing them. The authors compared the outcomes of review of the same proposal for a multisite, minimal-risk trial. They assessed the variability in IRB reviews and the effect of review determinations on site participation, budget, and timeline and found that complying with IRB requirements required substantial resources and threatened the study's internal and external validity.
This Update summarizes studies published in 2011 that the authors consider highly relevant to the practice of pulmonary and critical care medicine.
Prophylactic antiviral therapy can prevent hepatitis B virus (HBV) reactivation; however, HBV testing before immunosuppressive therapy is recommended but often not done because of lack of awareness, uncertainty regarding who should be screened, and cost. This commentary advocates collaboration between multidisciplinary medical specialists and public health experts to promote recommendations for prevention.
Two articles in this issue raise ethical concerns about the conduct and monitoring of clinical trials. Fan and colleagues report a trial of a behavioral intervention strategy for patients with chronic obstructive pulmonary disease that was stopped early because of excess deaths in the intervention group. Petersen and colleagues illustrate how IRB requirements can be time-consuming and can adversely affect a trial's internal and external validity. The editorialist discusses these studies and the importance of ethical safeguards in clinical trials.
In this issue, 2 reviews assess the effect of type and duration of thromboprophylaxis in patients undergoing major orthopedic surgery. Neumann and colleagues compared the efficacy and safety of thromboprophylaxis using oral direct factor Xa inhibitors or LMWH. Sobieraj and colleagues compared outcomes of prolonged versus standard-duration thromboprophylaxis after major orthopedic surgery. The editorialists discuss the findings and identify the remaining questions that future studies should address.