The EQ-5D-5L is a valid approach to measure health related quality of life in patients undergoing bariatric surgery

Jilles M Fermont, Jane M Blazeby, Chris A Rogers, Sarah Wordsworth, By-Band-Sleeve Study Management Group, Jilles M Fermont, Jane M Blazeby, Chris A Rogers, Sarah Wordsworth, By-Band-Sleeve Study Management Group

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.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1
a-d. Boxplots health realated quality of life scores at baseline and 6 months after randomisation including change scores (with quartiles and extreme scores) (n = 189). VAS, Visual Analogue Scale; PHC, Physical Health Composite score; MHC, Mental Health Composite score.

References

    1. Malnick SDH, Knobler H. The medical complications of obesity. Qjm. 2006;99(9):565–79. doi:
    1. Dixon JB. The effect of obesity on health outcomes. Molecular and cellular endocrinology. 2010;316(2):104–8. doi:
    1. National Institute for Health and Care Excellence. Obesity: The Prevention, Identification, Assessment and Management of Overweight and Obesity in Adults and Children. In: National Clinical Guideline Centre, editor. London2014.
    1. Tice JA, Karliner L, Walsh J, Petersen AJ, Feldman MD. Gastric banding or bypass? A systematic review comparing the two most popular bariatric procedures. Am J Med. 2008;121(10):885–93. doi:
    1. Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. The New England journal of medicine. 2009;361(5):445–54. doi:
    1. Puzziferri N, Nakonezny PA, Livingston EH, Carmody TJ, Provost DA, Rush AJ. Variations of weight loss following gastric bypass and gastric band. Ann Surg. 2008;248(2):233–42. doi:
    1. National Obesity Observatory. Bariatric surgery for obesity NHS, 2010. Available from:
    1. Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. The American journal of medicine. 2009;122(3):248–56.e5. doi:
    1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. Jama. 2004;292(14):1724–37. doi:
    1. Dixon JB, Dixon ME, O'Brien PE. Quality of life after lap-band placement: influence of time, weight loss, and comorbidities. Obes Res. 2001;9(11):713–21. doi:
    1. Colquitt JL, Picot J, Loveman E, Clegg AJ. Surgery for obesity. Cochrane database of systematic reviews. 2009;(2):CD003641 doi:
    1. Pontiroli AE, Morabito A. Long-term prevention of mortality in morbid obesity through bariatric surgery. a systematic review and meta-analysis of trials performed with gastric banding and gastric bypass. Ann Surg. 2011;253(3):484–7. doi:
    1. Zhao Y, Encinosa W. Bariatric Surgery Utilization and Outcomes in 1998 and 2004: Statistical Brief #23. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD) 2006.
    1. Kendrick ML, Dakin GF. Surgical approaches to obesity. Mayo Clin Proc. 2006;81(10 Suppl):S18–24.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Annals of Medicine. 2001;33(5):337–43. doi:
    1. van Agt HM, Essink-Bot ML, Krabbe PF, Bonsel GJ. Test-retest reliability of health state valuations collected with the EuroQol questionnaire. Social science & medicine. 1994;39(11):1537–44.
    1. Rogers C, Welbourn R, Byrne J, Donovan J, Reeves B, Wordsworth S, et al. The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase. Trials. 2014;15(1):53.
    1. Rogers C, Reeves B, Byrne J, Donovan J, Mazza G, Paramasivan S, et al. Adaptation of the By-Band randomized controlled trial to By-Band-Sleeve to include a new intervention and to maintain relevance of the study to practice. British Journal of Surgery. 2017. Epub In Press.
    1. The By-Band-Sleeve Study. HTA—09/127/53: Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial (The By-Band-Sleeve Study) Bristol [cited 2016]. Available from: .
    1. EMGO+. Questionnaires: selecting, translating and validating. Institute for health and Care Research, 2010 Contract No.: HB Nr.: 1.1B-08.
    1. Wee CC, Davis RB, Hamel MB. Comparing the SF-12 and SF-36 health status questionnaires in patients with and without obesity. Health Qual Life Outcomes. 2008;6:11 doi:
    1. Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11(3):193–205.
    1. Sprangers MA, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. 1998;7(4):291–300.
    1. Sach TH, Barton GR, Doherty M, Muir KR, Jenkinson C, Avery AJ. The relationship between body mass index and health-related quality of life: comparing the EQ-5D, EuroQol VAS and SF-6 D. International journal of obesity (2005). 2007;31(1):189–96.
    1. Korhonen PE, Seppala T, Jarvenpaa S, Kautiainen H. Body mass index and health-related quality of life in apparently healthy individuals. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. 2013. doi:
    1. Jia H, Lubetkin EI. The impact of obesity on health-related quality-of-life in the general adult US population. J Public Health (Oxf). 2005;27(2):156–64.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences: Elsevier Science; 2013.
    1. Devlin N, Shah K, Feng Y, Mulhern B, van Hout B. Valuing health-related quality of life: an EQ-5D-5L value set for England. 2016.
    1. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Medical care. 1989;27(3 Suppl):S178–89.
    1. Brazier J, Deverill M, Green C, Harper R, Booth A. A review of the use of health status measures in economic evaluation. Health technology assessment. 1999;3(9):i–iv, 1–164.
    1. Deyo RA, Diehr P, Patrick DL. Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Control Clin Trials. 1991;12(4 Suppl):142S–58S.
    1. Lau DC, Douketis JD, Morrison KM, Hramiak IM, Sharma AM, Ur E, et al. 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children [summary]. Cmaj. 2007;176(8):S1–13. doi:
    1. U.S. Department of Health and Human Services. The Practical Guide Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Bethesda, Maryland: National Insitutes of Health. National Heart, Lung, and Blood Institute. North American Association for the Study of Obesity, 2000 Contract No.: NIH Publication Number 00–4084.
    1. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014;129(25 Suppl 2):S102–38. doi:
    1. Lavie CJ, McAuley PA, Church TS, Milani RV, Blair SN. Obesity and cardiovascular diseases: implications regarding fitness, fatness, and severity in the obesity paradox. J Am Coll Cardiol. 2014;63(14):1345–54. doi:
    1. Warkentin LM, Majumdar SR, Johnson JA, Agborsangaya CB, Rueda-Clausen CF, Sharma AM, et al. Weight loss required by the severely obese to achieve clinically important differences in health-related quality of life: two-year prospective cohort study. BMC Medicine. 2014;12 doi:
    1. van Mastrigt GA, van Dielen FM, Severens JL, Voss GB, Greve JW. One-year cost-effectiveness of surgical treatment of morbid obesity: vertical banded gastroplasty versus Lap-Band. Obesity surgery. 2006;16(1):75–84. doi:
    1. Date RS, Walton SJ, Ryan N, Rahman SN, Henley NC. Is selection bias toward super obese patients in the rationing of metabolic surgery justified?-A pilot study from the United Kingdom. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery. 2013.
    1. Ribaric G, Buchwald JN, d'Orsay G, Daoud F, French Hlth Technology A. 3-Year Real-World Outcomes with the Swedish Adjustable Gastric Band (TM) in France. Obes Surg. 2013;23(2):184–96. doi:
    1. Mar J, Karlsson J, Arrospide A, Mar B, Martinez de Aragon G, Martinez-Blazquez C. Two-year changes in generic and obesity-specific quality of life after gastric bypass. Eat Weight Disord. 2013;18(3):305–10. doi:
    1. Coulman KD, Abdelrahman T, Owen-Smith A, Andrews RC, Welbourn R, Blazeby JM. Patient-reported outcomes in bariatric surgery: a systematic review of standards of reporting. Obesity reviews: an official journal of the International Association for the Study of Obesity. 2013. doi:
    1. Nowels D, McGloin J, Westfall JM, Holcomb S. Validation of the EQ-5D quality of life instrument in patients after myocardial infarction. Qual Life Res. 2005;14(1):95–105.
    1. Bushnell DM, Martin ML, Ricci J-F, Bracco A. Performance of the EQ-5D in patients with irritable bowel syndrome. Value Health. 2006;9(2):90–7. doi:
    1. De Smedt D, Clays E, Annemans L, De Bacquer D. EQ-5D versus SF-12 in coronary patients: are they interchangeable? Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2014;17(1):84–9. doi:
    1. Dawes AJ, Maggard-Gibbons M, Maher AR, et al. Mental health conditions among patients seeking and undergoing bariatric surgery: A meta-analysis. JAMA. 2016;315(2):150–63. doi:
    1. Mulhern B, Mukuria C, Barkham M, Knapp M, Byford S, Soeteman D, et al. Using generic preference-based measures in mental health: psychometric validity of the EQ-5D and SF-6D. Brit J Psychiat. 2014;205(3):236–43. doi:

Source: PubMed

3
Abonnere