Kappa scores were generally higher for internal reviewers, indicating higher reliability for internal reviewers. Internal reviewers identified 588 harms for 10,415 patient days (25.1 harms per 100 patient days), which occurred in 423 unique patients (18.1%). A majority (63.1%) of harms were considered preventable. Forty-one percent of harms were temporary and required intervention; 2.4% caused or contributed to a patient’s death.
There was no significant change over time in the rate of harms (regardless of reviewer type) even after adjusting for demographics.
This study is limited because it is based only in North Carolina hospitals. It was not powered to evaluate change in individual hospitals. There might have been unmeasurable improvements that were not accounted for by the trigger tool.
Bottom line: Despite a higher focus on patient safety, investigators did not find a decrease in the rate of harms. A majority of the harms were preventable. This study should not preclude efforts to continue to improve patient safety.
Citation: Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363(22):2124-2134.
Intensive Lifestyle Modification Improves Weight Loss in Severely Obese Individuals
Clinical question: Does the combination of diet modification and increased physical activity lead to weight loss and improve health risks in severely obese patients?
Background: Obesity is at epidemic proportions, but there are no evidence-based treatment guidelines for severe obesity.
Study design: Randomized, single-blind trial.
Setting: Community volunteers.
Synopsis: A total of 130 individuals with a body mass index (BMI) of ≥35 were randomized to receive lifestyle interventions consisting of diet and initial physical activity for 12 months, or diet for six months and delayed physical activity for the remainder of the year.
The initial-physical-activity group demonstrated greater weight loss at six months, but the overall weight loss did not differ between the two groups. At 12 months, the initial physical activity group lost 12.1 kg and the delayed-physical-activity group lost 9.87 kg. Both groups demonstrated significantly reduced blood pressure, reduced serum liver enzymes, and improved insulin resistance.
Candidates with a history of coronary artery disease, uncontrolled blood pressure, or diabetes were excluded. Participants were provided with prepackaged meal replacements for the first six months and received financial compensation for participation in the study.
This study is limited by the fact that a majority of the participants were female (85.1%). Providing meals to the participants also limits the application of this program to the general public.
Bottom line: The results of this study reflect the importance of diet and exercise on weight loss in obese individuals. However, adherence to the goals of the study required multiple individual and group meetings throughout the year, the provision of prepackaged meals, and some financial incentive for compliance.
Citation: Goodpaster GH, Delany JP, Otto AD, et al. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010;304 (16):1795-1802.
Transcatheter Aortic-Valve Implantation Is Superior to Standard Nonoperative Therapy for Symptomatic Aortic Stenosis
Clinical question: Is there a mortality benefit to transcatheter valve implantation over standard therapy in nonsurgical candidates with severe aortic stenosis (AS)?