Wisconsin Spine Outcome Study-Pilot: preliminary data.

ABSTRACT

OBJECT Given the pragmatic difficulties in developing randomized controlled trials in patients with disorders of the spine, the Wisconsin Spine Outcome Group has adopted the use of a prospective registry design to perform comparative effectiveness research on treatments for degenerative lumbar disorders. The goal of the Wisconsin Spine Outcome Study-Pilot (WISPOS-P) was to establish a Web-based, Health Insurance Portability and Accountability Act-compliant registry and to implement a patient registration paradigm that demonstrates at least 80% compliance in collecting pre- and posttreatment data in patients with lumbar disorders, regardless of the treatment they receive. The primary outcome measures were the percentage of patients with lumbar spine disorders who completed a Web-based survey preappointment, and at 1 and 3 months postappointment; the percentage of patients receiving a physician-assigned diagnosis in the registry; and the success of electronic data transition from the Web-based interface to a locally controlled registry. METHODS: The WISPOS-P uses a prospective, diagnosis-based registry design. A universally accessible and secure Internet-based data management platform was created that accrues self-entered patient data on validated disability indices, including the visual analog pain scale, Oswestry Disability Index (ODI), and the 36-Item Short Form Health Survey questionnaire. Data were obtained on patients, preappointment and at 1 and 3 months postappointment, regardless of the treatment rendered. A physician-entered diagnosis was assigned to each patient for data stratification. RESULTS: One hundred patients were invited into the WISPOS-P; 90 patients participated, and 10 withdrew for various reasons. Eighty-eight of 90 patients were assigned a diagnosis by the evaluating physician. Preliminary and qualitative assessment of the data shows that the major difference between patients who withdrew from the study and those who participated was the number of days between study invitation and clinic appointment (median 11 vs 20.5 days, respectively). In evaluating patients by mode of survey completion, the 2 largest groups were those who completed their intake forms electronically before their clinic appointment and those who used the paper format. The median age of patients electronically completing this survey was 14.34 years younger than those using the paper format. A significantly higher proportion of patients who completed their forms electronically had listed an email address. The 3 major diagnoses were disc disease (32 patients), stenosis (24 patients), and nonsurgical pain of spinal origin (14 patients). Patients with stenosis were older than those in the other 2 groups. Patients with nonsurgical pain of spinal origin had lower ODI scores compared with the other 2 groups. CONCLUSIONS: A diagnosis-based registry design is effective in collecting pretreatment data for patients with lumbar disorders. When stratified by diagnosis, comparative effectiveness analyses can be performed to identify optimum treatments for lumbar disorders given individual patient characteristics. The WISPOS-P has established a mechanism and proof of principle for the participation of patients in an outcomes registry.