BACKGROUND: The long-term consequences of an awareness episode vary. Some patients do not have any long-term disability, whereas others develop psychological problems that may be severe and persistent. In this study, we compared the incidence of posttraumatic stress disorder (PTSD) in patients with and without confirmed awareness who were randomized in the B-Aware Trial. METHODS: We used a matched cohort design, aiming to follow up the 13 patients with confirmed awareness. Each surviving awareness patient was matched with 4 controls for age, sex, surgery type, date of surgery, and hospital. A face-to-face interview was conducted with each awareness patient and matched controls using the Clinician Administered Posttraumatic Stress Disorder Scale. RESULTS: Data collection for this study occurred between June 2006 and March 2007, with a median follow-up time of 5.3 yr (range, 4.3-5.7 yr). Six of the 13 confirmed awareness patients had died. Five of the 7 confirmed awareness patients (71%) and 3 of the 25 controls (12%) fulfilled the criteria for PTSD at the time of the interview (adjusted odds ratio = 13.3 [95% confidence interval: 1.4-650]; P = 0.02). The median onset time of symptoms was 14 days (range, 7-243 days) after surgery, and the median duration of symptoms was 4.7 yr (range, 4.4-5.6 yr). CONCLUSIONS: PTSD was common and persistent in the confirmed awareness patients of the B-Aware Trial. Strategies to prevent awareness in patients under general anesthesia are justified.
RCT Entities:
BACKGROUND: The long-term consequences of an awareness episode vary. Some patients do not have any long-term disability, whereas others develop psychological problems that may be severe and persistent. In this study, we compared the incidence of posttraumatic stress disorder (PTSD) in patients with and without confirmed awareness who were randomized in the B-Aware Trial. METHODS: We used a matched cohort design, aiming to follow up the 13 patients with confirmed awareness. Each surviving awareness patient was matched with 4 controls for age, sex, surgery type, date of surgery, and hospital. A face-to-face interview was conducted with each awareness patient and matched controls using the Clinician Administered Posttraumatic Stress Disorder Scale. RESULTS: Data collection for this study occurred between June 2006 and March 2007, with a median follow-up time of 5.3 yr (range, 4.3-5.7 yr). Six of the 13 confirmed awareness patients had died. Five of the 7 confirmed awareness patients (71%) and 3 of the 25 controls (12%) fulfilled the criteria for PTSD at the time of the interview (adjusted odds ratio = 13.3 [95% confidence interval: 1.4-650]; P = 0.02). The median onset time of symptoms was 14 days (range, 7-243 days) after surgery, and the median duration of symptoms was 4.7 yr (range, 4.4-5.6 yr). CONCLUSIONS:PTSD was common and persistent in the confirmed awareness patients of the B-Aware Trial. Strategies to prevent awareness in patients under general anesthesia are justified.
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