Health Fluctuations in Dementia and its Impact on the Assessment of Health-Related Quality of Life Using the EQ-5D-5L

Highlights•Previous studies predominately demonstrated fluctuations in symptom variability, especially cognitive impairment. Prospective studies that quantify health fluctuation and its impact on health-related quality of life assessments are lacking.•To our knowledge, our findings demonstrated, for the first time, that people living with dementia frequently experienced health fluctuations, on average, every second day. Health-state fluctuations were mainly triggered by problems with memory, mobility, concentration, sleep, pain, and usual activities. The documented health fluctuations affected the EQ-5D-5L assessment, causing a higher EQ-5D-5L utility variation and recall period nonadherence.•Health fluctuations affect patient-reported outcomes assessments and thus results of clinical and interventional trials in dementia. Further research is needed to evaluate if more extended recall periods or multiple assessments on consecutive days could capture recurrent health fluctuations more appropriately, resulting in a more accurate assessment of patient-reported outcomes in dementia.AbstractObjectivesTo quantify health fluctuations, identify affected health-related quality of life (HRQoL) dimensions, and evaluate if fluctuations affect the HRQoL instruments recall period adherence in people living with dementia (PlwD).MethodsCaregivers of PlwD completed a daily diary for 14 days, documenting if PlwD's health was better or worse than the day before and the affected HRQoL dimensions. Health fluctuation was categorized into low (0-4 fluctuations in 14 days), moderate (5-8), and high (9-14). Also, caregivers and PlwD completed the EQ-5D-5L (proxy- and self-reported) on days 1, 7, and 14. Subsequently, caregivers were interviewed to determine whether recurrent fluctuations were considered in the EQ-5D-5L assessment of today's health (recall period adherence).ResultsFluctuations were reported for 96% of PlwD, on average, for 7 of the 14 days. Dimensions most frequently triggering fluctuations included memory, mobility, concentration, sleep, pain, and usual activities. Fluctuations were associated with higher EQ-5D-5L health-states variation and nonadherence to the EQ-5D-5L recall period "today." PlwD with moderate to high fluctuation had the highest EQ-5D-5L utility change between day 1 and 14 (0.157 and 0.134) and recall period nonadherence (31% and 26%) compared with PlwD with low fluctuation (0.010; 17%). Recall period nonadherence was higher in PlwD with improved compared with those with deteriorated health in the diary (37% vs 9%).ConclusionsHealth fluctuations frequently occur in dementia and strongly affect HRQoL assessments. Further research is needed to evaluate if more extended recall periods and multiple, consecutive assessments could capture health fluctuations more appropriately in dementia.