ERRORS IN PATIENT REPORTED OUTCOMES (PROS): PATIENTS’ UNDERSTANDING OF HOW TO RECORD A HEADACHE DAY

• Published in: Value in health Vol. 20; no. 5; p. A59
• Main Authors: Dias, N, Zhao, L, Durand, EM, Gary, ST, Tuller, JM, Dallabrida, SM
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01-05-2017
• Subjects: Answers; Clinical outcomes; Clinical research; Clinical trials; Data quality; Headache; Headaches; Measurement; Quality of life; Severity; Variability
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: Patient-reported outcomes (PROs) collected as endpoints in clinical trials often require patients to report symptom severity, frequency, or the impact of symptoms on quality of life. It is generally accepted that variability in PROs should be reduced to ensure data quality, however, assessment variability due to the subject's interpretation of measurement parameters may be overlooked. METHODS: We collected data from 485 individuals who were asked to respond to the following scenario, "If you were participating in a clinical trial that asked you to report how many days you had a headache in a week, and you had a headache from 8:00 pm Sunday night to 8:00 am Monday morning, does it count as 1 or 2 days with a headache?". In addition, demographic data, as well as whether patients have ever participated in clinical trials, were also collected. RESULTS: Among the total participants, 434 people responded to this question. A strong majority of responders (76.5%, n = 332) answered the question incorrectly. Only 23.5% (102 patients) answered the question correctly ("2 days. I had a headache on Sunday and Monday"). Of those that answered incorrectly, 27.1% (n= 90) felt that there was not enough information to answer the question. Interestingly, among this majority of 332 patients (76.5%) who chose incorrect answers, 94 (28.3%) also reported that they have participated in a clinical trial at some point. CONCLUSIONS: These findings suggest that without standardized training, patients have a wide-range of interpretations and would report highly variable data during a clinical trial. FDA guidance states that "the headache diary should be shown to be well defined and reliable for the target population." Therefore, custom training including specific guidance on headache diary completion and understanding of trial expectation would be highly beneficial in improving clinical trial data quality while complying with the FDA's recommendations.