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Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

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.

SUBMITTER: Martinez-Martin P

PROVIDER: S-EPMC7442251 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

Martinez-Martin Pablo P Deuschl Guenther G Tonder Lisa L Schnitzler Alfons A Houeto Jean-Luc JL Timmermann Lars L Rau Joern J Schade-Brittinger Carmen C Stoker Valerie V Vidailhet Marie M Krack Paul P

PloS one 20200821 8

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 ...[more]

PMID: 32822437

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Project description:Background:Parkinson's disease impacts health-related quality of life (HRQoL), however no studies inquired on predictors of HRQoL changes after rehabilitation. This study assessed the relationship between mobility domain of HRQoL measured by Parkinson's Disease Questionnaires-39 (PDQ-39) and clinical-demographic characteristics and developed a model predicting changes after rehabilitation. Methods:Subjects with Parkinson's disease underwent rehabilitation treatment and completed the following predictors: 10-m walking test (10MWT), Timed Up and Go (TUG), Berg Balance scale (BBS), Activities-specific Balance Confidence scales (ABC), Freezing of Gait (FOGQ) and PDQ-39. Two general linear models were calculated to predict the relationship between HRQoL at baseline and to predict HRQoL changes after rehabilitation. Results:Forty-two subjects (age 74.9?±?7.3?years, Hoehn&Yahr 2.8?±?0.6) completed the baseline evaluation. The first model (multiple R2?=?0.59, F?=?5.86, P?<?0.001) showed that ABC (B?=?-?0.51, CI?=?-?0.86 to 0.15, R2?=?0.41, P?=?0.005) and FOGQ (B?=?2.38, CI?=?1.03 to 3.73, R2?=?0.07, P?=?0.001) were statistically significant predictors of mobility aspect of HRQoL at baseline. Thirty seven subjects completed the rehabilitation sessions, data were entered in the second model (multiple R2?=?0.40, F?=?4.24, P?<?0.004) showing that gender (B?=?-?5.12, CI?=?-?9.86 to -?0.39, R2?=?0.23, P?=?0.034), Hoehn&Yahr (B?=?10.93, CI?=?+?3.27 to +?18.61, R2?=?0.22, P?=?0.006) and PDQ-39 mobility at baseline (B?=?-?0.38, CI?=?-?0.63 to -?0.14, R2?=?0.55, P?=?0.002) were statistically significant predictors of changes of the mobility aspect of HRQoL. Conclusions:Balance confidence and Freezing of Gait are associated with the mobility aspect of HRQoL. Changes in mobility domain of HRQoL (as assessed by PDQ-39) are likely to be greater in males, in people at higher stages of the disease and in people with more severe limitation in mobility domain of HRQoL (as assessed by PDQ-39) before rehabilitation. Results might be different when considering different outcomes or different measures for the same outcome (performance mobility test instead of self-report questionnaires). Further investigations are needed to better understand other components of HRQoL in addition to mobility. Trial registration:NCT02713971 registered March 8, 2016.

Project description:BackgroundCurrent evidence on chronic conditions favors promotion of health behaviors as a mean to positively impact health outcomes. In Parkinson's disease, performing health behaviors is indicated as a means to fight the long-lasting burden of the disease. Understanding actual engagement in health behaviors and patient activation and their association to function and health-related quality of life is therefore important. Our objectives were, among people with Parkinson's disease: (1) to characterize health behaviors including utilization of rehabilitative treatments, physical activity, and patient activation levels, and (2) to test the associations between these health behaviors and health outcomes.MethodsA cross-sectional study of 88 people with Parkinson's disease (age 66.84 ± 8.8) was conducted. Participants answered questionnaires measuring health behaviors including utilization of health professions treatments, physical activity, patient activation, and health outcomes consisting of function and health-related quality of life. Linear regression models were conducted to test associations between measured health behaviors, function and health-related quality of life.ResultsParticipants rarely engage in rehabilitative treatments, but showed high levels of patient activation. Controlled by demographics and disease severity, physical activity and patient activation were associated with function (b = 0.41, p < .001; b = 0.2, p = .02, respectively) and physical activity but not patient activation, which was associated with health-related quality of life (b = 0.19, p = .03). There was also interaction effects of physical activity and non-motor symptoms, and physical activity and motor symptoms on health-related quality of life (b = 0.19, p = .02 and b = - 0.22, p = .01, respectively).ConclusionsIn respect to their potential health-related benefits for people with Parkinson's disease, health professionals' treatments are underutilized. Findings supported the importance of health behaviors for maintaining function and health-related quality of life among people with Parkinson's disease. They also show a differential contribution of motor and non-motor symptoms to the association between physical activity and quality of life. It is suggested that policy makers encourage opportunities for physical activity tailored for people with Parkinson's disease and adopt a proactive stance towards enhancing awareness and use of rehabilitation services. Trial registration NCT05211700, ClinicalTrials.gov ID: NCT05211700 first release 12/30/2021, https://classic.Clinicaltrialsgov/ct2/show/NCT05211700.

Dataset Information

Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

Publications

Interpretation of health-related quality of life outcomes in Parkinson's disease from the EARLYSTIM Study.

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