Wilda D Rosmolen1, Nadine K Y N Phoa1, Phytia T Nieuwkerk2, Roos E Pouw1, Bas L A M Weusten3, Raf Bisschops4, Erik J Schoon5, Mirjam A G Sprangers2, Jacques J G H M Bergman1. 1. Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 2. Department of Medical Psychology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 3. Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands. 4. Department of Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium. 5. Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.
Abstract
BACKGROUND AND AIMS: A previous multicenter randomized trial demonstrated that radiofrequency ablation (RFA) significantly reduced the risk of neoplastic progression compared with surveillance (1.5% vs 26.5%) in patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD). In the same population, this study aimed to compare the quality of life (QOL) and illness perception (IP) among patients treated with RFA and patients kept under surveillance. METHODS:From June 2007 to June 2011, patients with BE and LGD were randomly assigned to RFA or surveillance. QOL and IP were assessed at baseline, 2, 9, 14, 26, and 38 months. Standardized questionnaires were used (SF-36, EORTC QLQ-C30, EORTC QLQ-OES18, and the brief Illness Perception Questionnaire [IPQ]). RESULTS: Forty-seven patients in the ablation group and 49 patients in the surveillance group completed the questionnaires (median follow-up, 36 months). Marginal differences were observed in the SF-36 and the EORTC-QLQ-C30. Based on the EORTC-QLQ-OES18, the ablation group reported more diarrhea (7.8 vs 4.0; P = .018), whereas the surveillance group reported more reflux (15.1 vs 9.0; P < .001) and more problems with speaking (4.3 vs 2.2; P = .019). The IPQ showed that patients in the ablation group perceived their disease lasted for a shorter period of time (P < .001), experienced fewer symptoms (P < .001), had fewer concerns about their condition (P < .001), and tended to be less emotionally affected by their condition (P = .012) than patients in the surveillance group. As a result, patients who underwent ablation experienced their condition as less threatening compared with patients in the surveillance group (P < .001). CONCLUSION:Patients treated with ablation for BE with LGD reported a QOL comparable with that of patients undergoing endoscopic surveillance; however, the patients in the ablation group had fewer concerns and a less-threatening view of their condition. (Clinical trial registration number [www.trialregister.nl]: NTR1198; 25-1-2008.).
RCT Entities:
BACKGROUND AND AIMS: A previous multicenter randomized trial demonstrated that radiofrequency ablation (RFA) significantly reduced the risk of neoplastic progression compared with surveillance (1.5% vs 26.5%) in patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD). In the same population, this study aimed to compare the quality of life (QOL) and illness perception (IP) among patients treated with RFA and patients kept under surveillance. METHODS: From June 2007 to June 2011, patients with BE and LGD were randomly assigned to RFA or surveillance. QOL and IP were assessed at baseline, 2, 9, 14, 26, and 38 months. Standardized questionnaires were used (SF-36, EORTC QLQ-C30, EORTC QLQ-OES18, and the brief Illness Perception Questionnaire [IPQ]). RESULTS: Forty-seven patients in the ablation group and 49 patients in the surveillance group completed the questionnaires (median follow-up, 36 months). Marginal differences were observed in the SF-36 and the EORTC-QLQ-C30. Based on the EORTC-QLQ-OES18, the ablation group reported more diarrhea (7.8 vs 4.0; P = .018), whereas the surveillance group reported more reflux (15.1 vs 9.0; P < .001) and more problems with speaking (4.3 vs 2.2; P = .019). The IPQ showed that patients in the ablation group perceived their disease lasted for a shorter period of time (P < .001), experienced fewer symptoms (P < .001), had fewer concerns about their condition (P < .001), and tended to be less emotionally affected by their condition (P = .012) than patients in the surveillance group. As a result, patients who underwent ablation experienced their condition as less threatening compared with patients in the surveillance group (P < .001). CONCLUSION:Patients treated with ablation for BE with LGD reported a QOL comparable with that of patients undergoing endoscopic surveillance; however, the patients in the ablation group had fewer concerns and a less-threatening view of their condition. (Clinical trial registration number [www.trialregister.nl]: NTR1198; 25-1-2008.).
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