Movement Disorders is a broad group of neurological disorders that cause abnormal movements such as increased / decreased or slow movements but can also cause involuntary movements. Movement disorders often pose challenges to diagnose and to treat. To raise awareness about this group of diseases, the “World Movement Disorders Day” is recognized annually on November 29th.
Parkinson’s disease (PD) is a movement disorder where clinical trials and scientific research have made significant progress and contribution to the lives of those who live with this disease. The current treatment options available may have an impact on how the symptoms of patients with PD fluctuate throughout the day.
At the Movement Disorder Society International Congress 2024 in Philadelphia, Signant presented our latest research on an electronic Diary for Parkinson's disease used to assess the functional status of Parkinson’s disease patients.
The most used common method used to track fluctuations in motor symptoms is the use of a patient diary. With the diary, patients can monitor daily symptoms and track their frequency and severity in specific time intervals, helping study teams to understand when the patient is in the “ON” state (defined as a “good” mobility due to the medication) or “OFF” state (“poor” mobility due to the lack of / poor response to medication).
Typically, diaries are provided in ‘pen-and-paper’ format. Paper diary completion poses questions of data integrity and quality as timely completion cannot be assured, recall over time may be inaccurate, and the fine motor skills required in its completion may be challenging at times.
The motor symptom diary in most common use was developed in a pen-and-paper format by Dr. Robert Hauser1 and has been shown to be a valid and reliable instrument in the assessment of Parkinson’s disease motor fluctuations2. It requires intensive use, with patients recording their motor status for each and every 30-min segment of the waking day when medication is thought to be providing motor fluctuation benefits, when such effects have worn off, and when dyskinesias are experienced. The diary is recommended for self-completion at home over 2–4-day intervals, periodically over a clinical trial treatment period.
Research has shown that true compliance in ‘pen-and-paper’ diaries is much lower than the diary entries themselves suggest, and that a “parking lot effect” is often observed - the behavior of completing missing entries in a paper diary just prior to a clinic visit (often in the parking lot)3. The 2009 FDA guidance4 on patient-reported outcomes expresses the importance of ensuring the timeliness of patient diary entries on data integrity and states, “If a patient diary or some other form of unsupervised data entry is used, we plan to review the clinical trial protocol to determine what steps are taken to ensure that patients make entries according to the clinical trial design and not, for example, just before a clinic visit when their reports will be collected, or at other times – such as just prior to a clinic appointment.”
The need for a more simple and more accurate way of capturing motor symptoms raises an opportunity to rethink the patient’s diary and to redesign them it as a digital tools.
Byrom and Muehlhausen5 provide a comprehensive appraisal of the benefits of electronic formats to collect patient-reported outcome measures (PROMs). In relation to the collection of motor symptoms in Parkinson’s disease studies, electronic screen-based formats deployed on smartphone or tablet computers offer the following advantages:
Signant Health developed an electronic version (tablet/smartphone) of the Hauser motor symptom diary, in collaboration with the diary’s author Dr. Robert Hauser, focusing on ease of use for PD patients.
Qualitative interviews in 10 PD patients aged 60 and over were conducted to understand the usability of the solution and guide iterative design decisions.
Patient interviews helped to establish eDiary design principles:
Patients with tremor and small joint issues indicated preference for:
Design principles established:
Electronic Hauser Diary – new version 2.0:
More recently, Signant Health have reviewed the design of version 1.0 of the Hauser diary with an aim to providing an enhanced user interface and better user experience. This has included the adoption of a different color scheme, more modern stylized objects, and a simplified interface such that ON/OFF options only appear once the time period has been selected.
Patient feedback:
Patient feedback on the eDiary design was overall positive. One patient concluded: “An eDiary would be my preferred method to use. The layout is nice and I like the bird alarm [completion reminder]. I might get a man bag to carry it”. Another patient stated: “The eDiary is definitely better than scribbling on a piece of paper. I can see myself using it”.
The Signant Health Electronic Hauser diary version 2.0 provides additional user interface enhancements and is in line with our earlier usability testing findings and industry design best practice.
References
[1] Hauser RA, Friedlander J, Zesiewicz TA et al. A home diary to assess functional status in patients with Parkinson's disease with motor fluctuations and dyskinesia. Clin Neuropharmacol. 2000; 23: 75-81.
[2] Hauser RA, Deckers F, Lehert P. Parkinson’s Disease Home Diary: Further Validation and Implications for Clinical Trials. Movement Disorders 2004; 19: 1409-1413.
[3] Stone AA, Shiffman S, Schwartz JE t al. Patient non-compliance with paper diaries. British Medical Journal 2002; 324: 1193-1194.
[4] Food and Drug Administration. Patient reported outcome measures: use in medical product development to support labelling claims. Washington DC. 2009 Dec.
[5] Byrom B, Muehlhausen W. Electronic Patient-Reported Outcome Measures: An Implementation Handbook for Clinical Research, Second Edition. ISBN-13: 979-8391769347.
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