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Hauser Motor Fluctuation Diary
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Supplemental - Highly Recommended: Parkinson's Disease (PD)
Recommendations for use: Indicated for studies assessing motor fluctuations.
Short Description of Instrument
To evaluate motor fluctuations by patients themselves in clinical trials, Hauser and colleagues have developed a diary in which the patient denotes his/her status (includes the categories asleep, OFF, ON without dyskinesia, ON with nontroublesome dyskinesia, and ON with troublesome dyskinesia) during preset intervals (normally half hour) over a 24-h period, and should be completed for each period at the end of that interval. The diary is applicable to surgical and non-surgical protocols or clinical management and places special emphasis on the differentiation of troublesome from non-troublesome dyskinesia.
Motor fluctuation diaries are designed for patients to assess their own health status without clinician bias, especially useful in understanding symptoms' temporal dynamics to evaluate the impact of their treatment.
Comments/Special Instructions
For PD patient diaries, subjects should receive training during screening from certified instructors with hands-on explanation of the process. At the end of the training session, patients are required to reach a certain degree (i.e., 80%) of diary concordance with a site rater. Therefore, the accuracy of this data is dependent on the patient being able to understand the definition of the various motor states and being able to correctly self-identify his/her status.
Electronic diaries have some advantages over paper diaries in that they can remind the patients to complete the diary entries on time, allow only one answer per entry and record the exact time and date were entered, increasing compliance and reliability of outcomes and reducing data entry errors. However, electronic diaries require more rigorous training and caregiver participation.
Scoring and Psychometric Properties
Scoring: Generally, patients are requested to complete home diaries for 2-3 consecutive days preceding baseline and scheduled visits. For results interpretation pre-visit diary recorded "OFF" times are averaged and compared to baseline.
Psychometric Properties: Coefficients of reliability as calculated by Cronbach's alpha were as follows: 2 days, r = 0.806; 3 days, r = 0.868; 4 days, r = 0.918; 5 days, r = 0.934; 6 days, r = 0.946. The standard error of measurement (SEM) was calculated to be 10.75%. The diary appears to be sufficiently simple and feasible. Test-retest reliability was good, and reliability increased with increasing number of diary days but compliance diminished beyond 3 days. Good on time (ONG = on time without dyskinesia or with nontroublesome dyskinesia) most strongly correlated with patients' perceived duration of a good response through the day and is an important outcome variable (Hauser et al., 2004).
Strengths: Patient diaries have gained wide acceptance as a primary endpoint for clinical development of therapeutics aiming to reduce treatment-related motor complications. Diaries are presently the best way of following an outpatient throughout a full day over the course of a study. There is evidence that a brief standardized training session can yield good agreement between patients and clinicians in categorizing parkinsonian motor fluctuation.
Weaknesses: Diaries have significant caveats including reduced compliance, recall biases, and diary fatigue. Delays in denoting motor status during an interval likely reduce the accuracy of the data. In addition, if a patient returns the diary with missing data, it cannot be recaptured. The compliance rate appears to fall when patients are requested to complete a greater number of consecutive days of diaries.
Key Reference:
Hauser RA, Friedlander J, Zesiewicz TA, Adler CH, Seeberger LC, O'Brien CF, Molho ES, Factor SA. A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol. 2000 Mar-Apr;23(2):75-81.
Additional References:
Antonini A, Martinez-Martin P, Chaudhuri RK, Merello M, Hauser R, Katzenschlager R, Odin P, Stacy M, Stocchi F, Poewe W, Rascol O, Sampaio C, Schrag A, Stebbins GT, Goetz CG. Wearing-off scales in Parkinson's disease: critique and recommendations. Mov Disord. 2011 Oct;26(12):2169-75.
Hauser RA, Deckers F, Lehert P. Parkinson's disease home diary: further validation and implications for clinical trials. Mov Disord. 2004 Dec;19(12):1409-13.
Papapetropoulos SS. Patient diaries as a clinical endpoint in Parkinson's disease clinical trials. CNS Neurosci Ther. 2012 May;18(5):380-7.
Document last updated August 2022