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A home diary to assess functional status in patients with Parkinson's disease
with motor fluctuations and dyskinesia.

In clinical trials for patients with Parkinson's disease (PD) with motor
fluctuations, efficacy is generally ascribed to an intervention if motor
function is significantly improved or if off-time is significantly reduced.

However, we have argued that patients might not be improved if off-time is
reduced only to the extent that unwanted dyskinesia is increased.

Therefore, a home diary should include an assessment of dyskinesia to
provide an accurate reflection of clinical status over a period of time.

We undertook two studies to develop a home diary to assess functional
status in patients with PD with motor fluctuations and dyskinesia.

In both studies, patients concurrently completed a test and a reference diary.

In Study I, we evaluated the impact of different severities of dyskinesia
on patient-defined functional status.

There were 1,149 evaluable half-hour time periods from 24 patients;
94.3% of off-time was considered "bad" time and
90.2% of on-time without dyskinesia,
72.6% of on-time with mild dyskinesia,
43.0% of on-time with moderate dyskinesia, and
15.2% of on-time with severe dyskinesia was considered "good" time.

In Study II, we evaluated a new home diary designed to separate dyskinesia
that had a negative impact on patient-defined functional status from
dyskinesia that did not.

There were 816 evaluable time periods from 17 patients;
84.9% of off-time and
89.9% of on-time with troublesome dyskinesia was considered "bad" time while
85.5% of on-time without dyskinesia and
93.8% of on-time with nontroublesome dyskinesia was considered "good" time.

With this diary (Diary II), the effect of an intervention can be expressed
as the change in off-time and the change in on-time with troublesome
dyskinesia ("bad" time).

The sum can be used as an outcome variable and compared to baseline or
across groups.

In evaluating the efficacy of an intervention, assessment of change in
off-time and change in on-time with troublesome dyskinesia provides a more
accurate reflection of clinical response than change in off-time alone.


Clin Neuropharmacol 2000 Mar-Apr;23(2):75-81
Hauser RA, Friedlander J, Zesiewicz TA, Adler CH,
Seeberger LC, O'Brien CF, Molho ES, Factor SA
Department of Neurology, University of South Florida, Tampa, USA.
PMID: 10803796, UI: 20260941

http://www.ncbi.nlm.nih.gov/PubMed/

janet paterson, an akinetic rigid subtype parkie
53 now / 44 dx cd / 43 onset cd / 41 dx pd / 37 onset pd
TEL: 613 256 8340 SMAIL: PO Box 171 Almonte Ontario K0A 1A0 Canada
EMAIL: [log in to unmask] URL: http://www.geocities.com/janet313/