Patient Controlled Analgesia (PCA) is a common method of post-surgical pain management. The extent to which this method is optimal in terms of overall convenience, ease of use, and effectiveness of managing pain from a patient’s perspective has not been determined. OBJECTIVES: To develop a questionnaire to measure “ease-of-care” outcomes from the perspective of patients who use PCA delivery systems for post-operative pain management. METHODS: We conducted qualitative interviews among a convenience sample of 15 patients who had undergone hip or lower abdominal surgery and who received intravenous (IV) PCA for their post-operative pain at Thomas Jefferson University Medical Center during June 2003. A content analysis approach was used to identify domains of relevance and generate an item pool. Content validation of the draft “ease of care” questionnaire was performed by subjects who participated in the initial interviews. Subjects were asked to rate the relevancy of each item on a scale of zero (not at all relevant) to four (highly relevant). Each item was assessed for clarity and relevance, and revised as appropriate. Cognitive debriefing interviews to evaluate patient experiences completing the instrument were conducted with a separate sample of 10 patients from the same institution who completed the questionnaire approximately 36-48 hours post-surgery. RESULTS: The final Patient Ease-of-Care Questionnaire consists of 28 items and covers seven aspects associated with acute care pain management systems: control/self-efficacy, device function, mobility, quality of pain control, confidence, knowledge/understanding, and satisfaction. All items are scored on a 6-point Likert scale. CONCLUSION: We developed an instrument to capture “ease-of -care” outcomes among patients who use PCA delivery systems for the management of their acute pain. The instrument is currently being used in clinical trials comparing two PCA delivery systems. Psychometric properties of the instrument are currently being evaluated.