RESPONSE-SHIFT IN THE MEASUREMENT OF QUALITY OF LIFE IN MORBID OBESE PATIENTS AFTER STOMACH RESTRICTION SURGERY

Author(s)

van Mastrigt G, Joore M, van Dielen F, Greve J, University Hospital Maastricht, Maastricht, Netherlands

OBJECTIVES: Due to response shift (RS) the QoL scores over time may be biased. RS was investigated in morbid obese patients undergoing two types of stomach restriction surgery. METHODS: Study design was a randomised controlled trial (RCT) of VBG (open surgical procedure) versus LapBand-surgery (laparascopic surgical procedure) (N = 60), with a pre-test before surgery and post-tests 3 (T1) and 6 (T2) months after surgery. QoL was assessed using the EQ-5D Visual Analogue Scale (EQ-VAS).) RS was examined by a then-test: a retrospective pre-test obtained at the same time as the post-tests. RS was computed by subtracting the pre-test from the then-test score. Then-test change was computed by subtracting the then-test scores from post-test scores. Conventional change was computed by subtracting the pre-test score from the post-test score. Repeated-measures ANOVA was used to examine differences. RESULTS: Thirty-six patients (27 female, mean age 39 ± 8.7) underwent VBG and 24 patients (22 female, mean age 36 ± 7.8) underwent LapBand. EQ-VAS increased after surgery in both the LapBand-group (pre-test: 65 ± 16.9; T1: 78 ± 15.7; T2: 76 ± 18.8) and the VBG-group (pre-test: 60 ± 21.7; T1: 78 ± 16.8; T2: 80 ± 17.4) (p = 0.000, p = 0.000), but the conventional change was not different between the groups (p=.144). RS was larger in the VBG-group (T1: -17.5 ± 16.9; T2: -18.3 ± 22.8) than in the LapBand-group (T1: -9.38 ± 22.6; T2: -8.65 ± 21.0), but the between-group difference was not statistically significant (p = 0.798). Then-test change was statistically significantly different between the groups (p= 0.034). CONCLUSION: As a result of the between-group difference in RS the then-test change was, in contrast to the conventional change, statistically significantly different between the groups. Since RS was larger in the group with a larger treatment effect (VBG-group), RS may be not only be related to the direction, but also to the size of the treatment effect. This may have implications for the interpretation of QoL changes in RCTs.

Conference/Value in Health Info

2003-11, ISPOR Europe 2003, Barcelona, Spain

Value in Health, Vol. 6, No. 6 (November/December 2003)

Code

QL8

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders

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