The ALS Patient Care Database - Goals, design, and early results

Objective: The ALS Patient Care Database was created to improve the quality of care for patients with ALS by 1) providing neurologists with data to ev aluate and improve their practices, 2) publishing data on temporal trends i n the care of patients with ALS, and 3) developing hypotheses to be tested during formal clinical trials. Background: Substantial variations exist in managing ALS, but there has been no North American database to measure outc omes in ALS until now. Methods: This observational database is open to all neurologists practicing in North America, who are encouraged to enroll both incident and prevalent ALS patients. Longitudinal data are collected ai; i ntervals of 3 to 6 months by using standard data collection instruments. Fo rms are submitted to a central data coordinating center, which mails quarte rly reports to participating neurologists. Results: Beginning in September 1996 through November 30, 1998, 1,857 patients were enrolled at 83 clinical sites. On enrollment, patients had a mean age of 58.6 years +/- 12.9 (SD) years (range, 20.1 to 95.1 years), 92% were white, and 61% were men. The me an interval between onset of symptoms and diagnosis was 1.2 +/- 1.6 years ( range, 0 to 31.9 years). Riluzole was the most frequently used disease-spec ific therapy (48%). Physical therapy was the most common nonpharmacologic i ntervention (45%). The primary caregiver was generally the spouse (77%). Ad vance directives were in place at the time of death for 70% of 213 enrolled patients who were reported to have died. Conclusions: The ALS Patient Care Database appears to provide valuable data on physician practices and patie nt-focused outcomes in ALS.