Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy.

AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. METHODS: Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman's correlation and the level of agreement was explored using Bland-Altman plots. RESULTS: Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. CONCLUSION: The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. TRIAL REGISTRATION: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011.

What Is the Optimal Time on a Low-Calorie Diet Prior to Laparoscopic Anti-reflux Surgery? A Prospective Case-Controlled Study.

INTRODUCTION: A very low-calorie diet (VLCD) or low-calorie diet (LCD) is often used prior to laparoscopic surgery to optimize access to the hiatus. Much debate exists in the literature regarding the required duration for a VLCD or LCD, and how to evaluate the presence of a fatty liver. The aim of our study was to determine the optimal amount of time on an LCD to achieve maximal liver volume reduction, and to assess the accuracy of the InBody 230® vs. bedside ultrasonography vs. magnetic resonance imaging (MRI) in the measurement of liver volume. METHODS: Seventeen consecutive patients undergoing laparoscopic anti-reflux surgery were recruited into the study. Each patient underwent body composition analysis with the InBody® 230, liver ultrasound, and liver MRI. Patients then began an LCD with a weekly ultrasound assessment until the day before surgery when they underwent repeat body composition analysis, liver ultrasound, and MRI. RESULTS: The mean age was 54 years (range 21, 74). Maximal liver volume loss was noted within 3 weeks for 88% of participants, with 47% achieving their maximal liver volume reduction after the first week of an LCD. The mean reduction in liver volume was 16%, 18.6%, and 19% for MRI, ultrasound, and body composition analysis, respectively. CONCLUSION: Close to 90% of patients require 3 weeks or less on an LCD to achieve maximal liver volume loss prior to laparoscopic anti-reflux surgery. Body composition analysis and bedside ultrasonography were both as accurate as the gold standard MRI in the assessment of liver volume.