Reply to Comment on: The Most Bothersome Aspects of off Periods Reported by Individuals with Parkinson's Disease

We thank Mantese and Reider1 for their insightful comments regarding the use of the Wearing Off Questionnaires (WOQs). Our manuscript2 did not examine the sensitivity of WOQs as screening tools for detection of wearing off (WO). Rather, we assessed whether the WOQs capture what bothers Parkinson's disease (PD) patients most about OFF periods. In almost half of patients, they did not.2 Our results indicate that the WOQs do not capture the full experience of OFF periods. These results do not, however, speak to the use of the WOQs as screening tools for detecting WO. As Mantese and Reider1 point out, the sensitivity of the WOQs for detection of WO is high, and symptom burden as detected by the WOQ correlates with quality of life (QOL). To illustrate this, we present additional data. As part of our study,2 at the very end of the questionnaire (after participants responded to the question about most bothersome aspects of OFF periods), they were then administered the 19-item-WOQ (WOQ19). A subset of this cohort also completed at the same study visit, via their participation in the parent Fox Insight study,3 the Parkinson's Disease Questionnaire 8-item (PDQ8), a PD-specific measure of QOL.4 This study was performed in accordance with Declaration of Helsinki and is approved by New England IRB. Online informed consent was obtained from each participant. Characteristics of the 533 subjects who completed both the WOQ19 and PDQ8 were: mean age 66.9 (SD, 8.20) yr, 97.4% Caucasian, 5.5% Hispanic, 53.1% male, and mean disease duration 6.13 (SD, 5.69) yr. As described,2 participants had to endorse OFF periods to be included in this study. Participants reported an average of 3 hr of OFF time per day,2 and mean number of symptoms endorsed on the WOQ19 was 9. Mean number of symptoms that occurred and were medication-responsive symptoms (MRS) was 4.82 (SD, 3.56). 79.92% endorsed ≥2 MRS on the WOQ19. In the sample as a whole, mean PDQ8 summary index (PDQ8-SI) score was 22.14 (SD, 15.43). Supportive of the assertions made by Mantese and Reider,1 mean PDQ8-SI was significantly higher (worse) in those endorsing ≥2 MRS on the WOQ19 versus those who did not (mean, 23.52 vs 16.68, respectively, P < 0.0001). There was a moderate correlation between number of MRS and PDQ8-SI (Spearman's rho = 0.376, P < 0.001). In a linear regression model, the relationship between PDQ8-SI (outcome) and number of MRS on the WOQ19 remained significant when age and disease duration were included as covariates (number of MRS β = 1.53, 95% CI = 1.18–1.87, P < 0.001; model adjusted-R2, 18.76%). These findings reinforce the potential use of the WOQs as screening tools to detect WO symptoms that affect QOL. The WOQs and many other movement disorders patient-reported questionnaires have been, and will continue to be, integral research and clinical tools. However, our work indicates they do not capture the full patient experience, and additional work will be needed to refine questionnaires and/or develop new ones that capture the patient voice and experience and what matters most to patients.5 This work occurred as part of The Michael J Fox Foundation's Parkinson's Disease Education Consortium 2018 (PDEC 2018) project. The Parkinson's Disease Education Program Consortium is sponsored by the following industry partners: ACADIA Pharmaceuticals, Adamas Pharmaceuticals, Intec Pharma, Lundbeck Inc., and Sunovion Pharmaceuticals. The Fox Insight Study (FI) is funded by The Michael J. Fox Foundation for Parkinson's Research. We would like to thank the Parkinson's community for participating in this study to make this research possible. (1) Research Project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript Preparation: A. Writing of the first draft, B. Review and Critique; L.M.C.: 1A, 1B, 1C, 2A, 2B, 2C, 3A B.E.: 2A, 2B, 3A S.M.: 2C, 3B C.K.: 1A, 1B, 1C, 3B C.M.: 1A, 1B, 1C, 2A, 2B, 2C, 3A This study was performed in accordance with Declaration of Helsinki and is approved by New England IRB. Online informed consent was obtained from each participant. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. Funding Sources and Conflicts of Interest: This work was funded by the Michael J Fox Foundation for Parkinson's Disease Research. The authors declare that there are no conflicts of interest relevant to this work. Financial Disclosures for the Previous 12 Months: Lana M Chahine receives research support from the Michael J Fox Foundation (MJFF), receives research support from the UPMC Competitive Medical Research Fund, is study site investigator for a study sponsored by Biogen, is a site sub-investigator for a study sponsored by Voyager, received payment from Elsevier (for book authorship), and receives royalties from Wolters Kluwel (for book authorship). Briana Edison has no financial disclosures. Sneha Mantri receives research support from the Michael J Fox Foundation, is a paid consultant to the Michael J Fox Foundation, is a paid consultant to Cerevel Therapeutics, is a study site investigator for a study sponsored by Neuraly Rho, and is a study site sub-investigator for a study sponsored by Biogen. Catherine Kopil is an employee of the Michael J Fox Foundation. Connie Marras was a paid consultant for Acorda Therapeutics, on the advisory board of Denali therapeutics, received honoraria for teaching from EMD Serono, a steering committee member for Michael J Fox Foundation Grants, Canadian Institutes of Health Research, Parkinson's Foundation (US), National Institutes of Health (US), International Parkinson and Movement Disorders Society, and is in contracted with Gray Matter Technologies.

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