PATIENT REPORTED OUTCOMES (PROS) ARE SUBJECT TO INTERPRETATION ERRORS: PATIENTS’ UNDERSTANDING OF HOW TO REPORT PAIN SEVERITY OVER A PERIOD OF TIME

• Published in: Value in health Vol. 20; no. 5; p. A227
• Main Authors: Yamamoto, RT, 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 training; Clinical trials; Data quality; Efficacy; Medical errors; Pain; Patients; Severity; Variability
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: To determine if people understand a sample instruction from a PRO on pain severity. Patient reported outcomes (PROs) are often primary endpoints in clinical trials, serving to determine treatment safety and/or efficacy. In clinical trials for pain treatments, it is important to accurately determine pain severity to assess treatment efficacy. If data are unreliable, due to variability resulting from subject interpretation errors, results will be unreliable. METHODS: 485 people responded to an online survey. People were asked to select one of three answers to the following: "If you were participating in a clinical trial that asked you to report how severe your pain was on a daily basis, you should report." RESULTS: 436 people responded to the question. Significantiy more people (66.7%) chose the wrong answer (#22=22.6, P< 0.001); 42.7% (186 people) selected "Average the pain you had throughout the day and report the average," while 24.1% (105 people) selected "The pain level that you are experiencing when you record the pain rating" and 33.3% (145 people) of respondents answered correctly that they should report "The pain level at its worst point." Selecting only those who reported "pain" diagnoses, 61.8% (126 of 204 people) chose the wrong answer (#22=12.8, p=0.002). Results were similar for those who previously participated in clinical trials, even though 90.6% felt they understood a lot or completely understood what to do. CONCLUSIONS: These findings suggest that people often fail to understand instructions and concepts they are being asked to report on. When patients fail to interpret the PROs as intended and use various criteria when responding, variability is introduced impacting data quality. Failure to train subjects on instructions and concepts could lead to the erroneous assumption that data are reliable. Our findings support the need for custom training on PROs in clinical trials.