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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 janet paterson 53 now / 44 dx cd / 43 onset cd / 41 dx pd / 37 onset pd tel: 613 256 8340 url: "http://www.geocities.com/janet313/" email: [log in to unmask] smail: POBox 171 Almonte Ontario K0A 1A0 Canada