Abstract

Bariatric surgery is considered an effective treatment for individuals with severe and complex obesity. Besides reducing weight and improving obesity related comorbidities such as diabetes, bariatric surgery could improve patients’ health-related quality of life. However, the frequently used instrument to measure quality of life, the EQ-5D has not been validated for use in bariatric surgery, which is a major limitation to its use in this clinical context. Our study undertook a psychometric validation of the 5 level EQ-5D (EQ-5D-5L) using clinical trial data to measure health-related quality of life in patients with severe and complex obesity undergoing bariatric surgery. Health-related quality of life was assessed at baseline (before randomisation) and six months later in 189 patients in a randomised controlled trial of bariatric surgery. Patients completed two generic health-related quality of life instruments, the EQ-5D-5L and SF-12, which were used together for the validation using data from all patients in the trial as the trial is ongoing. Psychometric analyses included construct and criterion validity and responsiveness to change. Of the 189 validation patients, 141 (75%) were female, the median age was 49 years old (range 23–70 years) and body mass index ranged from 33–70 kg/m2. For construct validity, there were significant improvements in the distribution of responses in all EQ-5D dimensions between baseline and 6 months after randomisation. For criterion validity, the highest degree of correlation was between the EQ-5D pain/discomfort and SF-12 bodily pain domain. For responsiveness the EQ-5D and SF-12 showed statistically significant improvements in health-related quality of life between baseline and 6 months after randomisation. The EQ-5D-5L is a valid generic measure for measuring health-related quality of life in bariatric surgery patients.

Highlights

  • Obesity refers to a body mass index (BMI) of greater than or equal to 30 kg/m2 and increases the risk of morbidity and mortality from obesity-associated diseases and conditions including type 2 diabetes, osteoarthritis and cardiac disease [1, 2]

  • health related quality of life (HRQOL) data from the patients recruited earliest into the (Roux-en-Y gastric bypass and adjustable gastric band surgery) were used for the validation analyses

  • Psychometric validation of the EQ-5D-5L for bariatric surgery correlated with the Short Form-12 (SF-12), confirming criterion validity

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Summary

Introduction

Obesity refers to a body mass index (BMI) of greater than or equal to 30 kg/m2 and increases the risk of morbidity and mortality from obesity-associated diseases and conditions including type 2 diabetes, osteoarthritis and cardiac disease [1, 2]. For severe and complex obesity, bariatric surgery is considered an effective treatment option and recommended by national bodies such as the National Institute for Health and Care Excellence (NICE) [3]. The most common types of bariatric surgery are laparoscopic Roux-en-Y gastric bypass, adjustable gastric band surgery and laparoscopic sleeve gastrectomy, with each having its respective benefits and risks. A gastric Band is an inflatable silicone device, which is placed around the top portion of the stomach to create a smaller stomach pouch, and weight loss is more gradual than with a Bypass. Short term surgical risks of an adjustable gastric band are low [5], but longer term complications include band erosion, migration or infection which may require revision surgery or band removal [4, 6]. Complications include sleeve leakage resulting in a fistula and prolonged hospital stay, blood clots, infections, nausea and vomiting [7]

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