Abstract

Our objectives were to identify characteristics of response shift studies using patient-reported outcomes (PROMs) that explain variability in (1) the detection and (2) the magnitude of response shift effects. We conducted a systematic review of quantitative studies published before June 2023. First, two-level multivariable logistic regression models (effect- and sample-levels) were used to explain variability in the probability of finding a response shift effect. Second, variability in effect sizes (standardized mean differences) was investigated with 3-level meta-regression models (participant-, effect- and sample-levels). Explanatory variables identified via the purposeful selection methodology included response shift method and type, and population-, study design-, PROM- and study-quality characteristics. First, logistic regression analysis of 5597 effects from 206 samples in 171 studies identified variables explaining 41.5% of the effect-level variance, while no variables explained sample-level variance. The average probability of response shift detection is 0.20 (95% CI: 0.17-0.28). Variation in detection was predominantly explained by response shift methods and type (recalibration vs. reprioritization/reconceptualization). Second, effect sizes were analyzed for 769 effects from 114 samples and 96 studies based on the then-test and structural equation modeling methods. Meta-regression analysis identified variables explaining 11.6% of the effect-level variance and 26.4% of the sample-level variance, with an average effect size of 0.30 (95% CI: 0.26-0.34). Response shift detection is influenced by study design and methods. Insights into the variables explaining response shift effects can be used to interpret results of other comparable studies using PROMs and inform the design of future response shift studies.

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