Abstract
The EARLYSTIM Study compared deep brain stimulation (DBS) with best medical treatment (BMT) over 2-years, showing a between-group difference of 8.0 from baseline in favor of DBS in health-related quality of life (HRQoL), measured with the PDQ-39 SI (summary index). This study obtained complementary information about the importance of the change in HRQoL as measured by the PDQ-39, using anchor-based (Patient Global Impression of Change, PGIC) and distribution-based techniques (magnitude of change, effect size, thresholds, distribution of benefit) applied to the EARLYSTIM study data. Anchor-based techniques showed a difference follow-up–baseline for patients who reported “minimal improvement” of -5.8 [-9.9, -1.6] (mean [95%CI]) in the DBS group vs -2.9 [-9.0, 3.1] in the BMT group. As the vast majority (80.8%) of DBS patients reported “much or very much improvement”, this difference was explored for the latter group and amounted to -8.7 for the DBS group and -6.5 in the BMT group. Distribution-based techniques that analyzed the relative change and treatment effect size showed a moderate benefit of the DBS on the HRQoL, whereas a slight worsening was observed in the BMT group. The change in the DBS group (-7.8) was higher than the MIC (Minimally Important Change) estimated value (-5.8 by the anchor; -6.3 by triangulation of thresholds), but not in the BMT (0.2 vs. -3.0 to -5.4, respectively). Almost 90% of the patients in the DBS group declared some improvement (58.3% and 56.7% beyond the estimated MIC), which was significantly different from the BMT group whose proportions were 32.0% and 30.3%, respectively. The number needed to treat to improve ≥1 MIC by DBS vs BMT was 3.8. Change in depression, disability and pain influenced the improvement of the DBS group. DBS improved HRQoL in a high proportion of patients to a significant and moderate degree, at 2 years follow-up.
Highlights
Parkinson’s disease (PD) is a neurodegenerative disorder, second in prevalence after Alzheimer disease in population greater than 60 years, and the global burden of Parkinson’s disease has more than doubled with aging of the population and longer disease duration [1]
Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) were assessed, and health-related quality of life (HRQoL) was evaluated with MOS Short Form 36 items (SF-36), and Parkinson’s Disease Questionnaire-39 items (PDQ-39) Summary Index (PDQ-39 SI)
At 24-month follow-up, 120 patients remained in the deep brain stimulation (DBS) arm, with a PDQ-39 SI score of 22.40±1.41 (-7.8±1.2; p
Summary
Parkinson’s disease (PD) is a neurodegenerative disorder, second in prevalence after Alzheimer disease in population greater than 60 years, and the global burden of Parkinson’s disease has more than doubled with aging of the population and longer disease duration [1]. Progression of the disease over time bears progressive disability, physical and mental complications (e.g., dyskinesia, dementia), psychosocial malfunction, and potential personal financial loss. All these factors can impact on and severely deteriorate the patients’ health-related quality of life (HRQoL) [2,3,4,5,6]. The main components of the construct HRQoL are: Physical symptoms, Mental symptoms (mood and cognition), Functional ability, and Social functioning [8, 9] Derived from traditions such as the health and social indicators, and designed and validated through psychometric theories, HRQoL measures are available. Measures used for HRQoL assessment in PD have been reviewed by an ad hoc Movement Disorder Society Task Force [12]
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