OBJECTIVES: Parkinson's Disease (PD) is a chronic neurological disease with disabling motor symptoms such as tremor and rigidity, which may occur intermittently. The DIREQT trial is an open label randomised trial designed to study the effects of Duodopa (intra-intestinal administration of l-DOPA) compared to conventional oral therapy of PD. DIREQT has three phases: 1) two weeks pre-study phase; and 2) two weeks of Duodopa followed by two weeks of conventional therapy - or vice versa; C: 6 months follow-up with conventional therapy or Duodopa depending on patient preferences. Since PD symptoms fluctuate from hour to hour, standard methods for evaluating quality of life are less suitable. The aim of this paper is to describe a novel method for assessing outcome in PD. METHODS: The Clinitrac system consists of a handheld computer (PDA) with a mobile telephone. The PDA is pre-programmed with PD questionnaires (UPDRS, PSAA, PDQ-39) and generic quality of life (QoL) instruments (TTO, 15D). Patients receive notification to fill in the forms through the PDA at 8 AM, noon, 4 PM and 8PM. Entries are automatically transmitted to a central database via the mobile phone. If the patient does not respond within 15 minutes, the data will be reported missing and later entry is not allowed. The principal investigator and a research nurse have access to the database, supervise the data collection and may contact patients with high missing rates. RESULTS: During the period August 2002 through November 2002 in total 12 patients have been included in the study. All were able to use the PDA in spite of severe PD symptoms. The rate of compliance with scheduled data entries varied between 77% and 97%. CONCLUSION: Clinitrac seems to offer a system that is acceptable to the patient for repeated QoL measurements during one single day. Compliance with the scheduled data entries is excellent, but validity of entries has not yet been established.