Optimal frequency for measuring health care resource utilization in Parkinson's disease using participant recall: The FS-TOO resource utilization substudy

Abstract

Objective The aim of this substudy was to determine the agreement between 2 approaches for measuring health care resource utilization (eg, number of hospital visits, number of primary care physician visits) in trial participants with Parkinson’s disease (PD). Methods A substudy of the 1-year multicenter futility trial of GPI-1485 and coenzyme Q10 (FS-TOO) was performed to assess health care resource utilization agreement by measuring participant utilization recall after 12 months versus measuring participant utilization recall at regular 3-month intervals. Trial participants were selected from patients in the National Institutes of Health-sponsored FS-TOO multicenter study. Persons aged ≥30 years with confirmed PD diagnosis within the previous 5 years were eligible for inclusion in the substudy. Participants were also required to have at least 2 of 3 cardinal manifestations of PD (tremor, rigidity, and bradykinesia). Participants were excluded from the study if they had presence of atypical Parkinson’s syndromes due to drugs, metabolic identified neurogenetic disorders, encephalitis, or other degenerative diseases. Agreement was determined using Lin’s concordance and Cohen’s kappa statistics. Results Between March and July of 2004, a total of 424 potential subjects were identified and evaluated for trial eligibility. Of these, 213 subjects (139 men, 74 women; mean [SD] age, 61.5 [10.3] years) met entry criteria and were included in the study. Trial participants were randomized equally to 1 of 3 groups. The 3 groups had similar baseline characteristics in terms of demographic data (age, race, sex, employment status, and annual income), total Unified Parkinson Disease Rating Scale (UPDRS) score, and UPDRS subscores. In this substudy, 141 participants had a true baseline visit, indicating a clinical baseline date, and 182 participants completed the Baseline Resource Utilization Form within 3 months of the true baseline visit. The comparison of concordance between the summed information over 3-month recalls and the 12-month recall from baseline was derived from these 182 participants. The level of agreement between the 2 approaches was high, ranging from 64.4% to 95.1%. Where disagreement was identified, the more frequent measurement approach (every 3 months) led to higher estimates, ranging from 20.4% to 77.4%. Conclusion The results of this trial indicate internal consistency with the self-reported measures of health care resource utilization, suggesting that these simple measures might provide reliable information about units of health care resource utilization in the context of clinical trials for PD.

Quantifying Downstream Healthcare Utilization in Studies of Genomic Testing

“…We classified services as having occurred based on family report although respondent recall is often biased or incomplete, 43,44 particularly for minor services received over longer time horizons. 45,46 Patient-and provider-reported services were not always verified, and the scope of care received by newborns outside of the BCH and Partners HealthCare systems was unclear. Data were collected from a single trial in metro Boston and may not generalize well to other studies and settings.…”

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial

“…Additional quality-of-life metrics are the Patient Global Impression of Change [ 94 ] and the European Quality of Life Five Dimension Five Level Scale (EuroQoL-5D-5 L) [ 95 ]. Patient-reported utilization of health care services such as hospitalizations, emergency room visits, and visits to primary care doctors [ 96 ] will also be compared between the control and intervention arms.…”