DEVELOPING AND IMPLEMENTING PATIENT-RESOURCE USE DIARIES FOR A CLINICAL TRIAL ASSESSING SPINAL STENOSIS INTERVENTIONS IN THE ELDERLY

Author(s)

Bresnahan BW, Rundell S, Comstock B, Sullivan SD, Jarvik JG, Nguyen H, Bauer Z, Friedly JUniversity of Washington, Seattle , WA, USA

OBJECTIVES: To develop and implement patient-reported resource use questionnaires for assessing utilization and costs in elderly patients with lumbar spinal stenosis (SS), as part of an epidural steroid injection randomized clinical trial (RCT) in multiple integrated health systems. METHODS: We developed patient-completed diaries for a RCT in an elderly population with SS to capture medication use, time, and costs incurred by patients. Diary sections included: prescription opioid medications, non-opioid analgesics and over-the-counter (OTC) products, therapeutic services, time spent for SS care, and products purchased for back pain. We summarized demographics and commonly-reported opioid medications for currently-enrolled subjects.   RESULTS: We implemented resource use diaries in a RCT during baseline to week 3, weeks 4-6, weeks 24-26, and weeks 50-52. Overall, the diaries capture 12 weeks of data, distributed at key time points, during 12 months. The prescription opioid section and OTC section collect dose and daily medication use intensity. Later sections capture weekly visits, time, and purchases for back pain. We integrated the patient questionnaires into our overall electronic data management system, including prompts for sites to send participants diaries, collect diaries and enter the data on our RedCap™ electronic data capture system. To date, 100 RCT participants completed baseline diaries. The mean age was 69.6 years, 59% were females, and approximately 29% were from minority groups. The most commonly reported opioid medications were hydrocodone-acetaminophen and acetaminophen-codeine. CONCLUSIONS: It is important to capture the patient perspective in RCTs, particularly those with complex interactions among pain, functioning, medication use and economic endpoints. Electronic medical records are powerful tools to assess clinical and economic resource use, but still have limitations on collecting what patients spend and do to manage their pain condition. Logistical challenges and patient burden of completing questionnaires must be weighed against a more comprehensive economic evaluation and management of a high-priority condition.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PMS74

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Musculoskeletal Disorders, Systemic Disorders/Conditions

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