Skinner M, Chai-Adisaksopha C, Noone D, Curtis R, Frick N, Nichol M, O’Mahony B, Page D, Pastarnak A, Stonebraker J, Iorio A and the Patient Reported Outcomes Burdens and Experiences (PROBE) Study Investigator Group. Comparison of the Measurement Properties of the PROBE and EQ5D on Pain [Oral Presentation]. HTAi (2019).
Background
The Patient Reported Outcomes, Burdens and Experiences (PROBE) questionnaire has been developed for assessing patient reported outcomes in people living with hemophilia (PWH). The PROBE questionnaire consists of 29 questions involving the following domains: hemophilia-related problems, general health problems and health-related quality of life. The PROBE questionnaire contains 3 questions assessing pain (current use of pain medications, occurrence and interference of acute and chronic pain).
Objectives
This study aims to investigate the measurement properties of pain assessment of the PROBE questionnaire compared with the pain and discomfort domain of EQ5D-5L.
Methods
The participants of the PROBE study were recruited via national patient organizations from 21 countries. Participants who did not state status of hemophilia (having hemophilia or not) or those who did not report severity of disease were excluded from the analysis. Descriptive data were reported as a proportion and mean (standard deviation) as appropriate. We calculated the correlation coefficient between EQ5D-5L (pain domain) and the occurrence and inference of acute pain and chronic pain from the PROBE questionnaire. We investigated the discriminative property of the pain domain of the PROBE questionnaire and EQ5D-5L.
Results
A total of 1675 participants were included in the analysis (PWH 68.7%, 31.3% participants without bleeding disorders). Mean age was 37.5 years (SD 17.4). Data from the PROBE revealed that during the past 12 months, 60.5% and 51.1% of participants reported they have acute and chronic pain, respectively. 79.6% of participants reporting the use of pain medications. Acute pain occurred when walking (30.5%) followed by night time and weight bearing. Acute pain interfered with general activities the most (38.3%) followed by walking ability and mood. Chronic pain occurred when walking (38.9%), followed by stairclimbing and weight bearing. Chronic pain interfered with general activities the most (35.7%), followed by walking ability and mood. Table 1 shows the correlation coefficient of the counts of occurrence and inference of acute and chronic pain (PROBE) versus the pain domain of the EQ5D-5L. The correlations were moderate between acute pain (PROBE) and the pain domain on EQ5D-5L, whereas the correlations were strong between chronic pain (PROBE) and the pain domain on EQ5D-5L. When classifying participants to 4 groups (controls, mild-, moderate- and severe hemophilia), the discriminative property of PROBE (figure 1) and EQ5D-5L-pain (figure 2) was excellent. Both tools can differentiate participants with hemophilia (varied severity) and without hemophilia, ANOVA p-value<0.05.
Conclusions
The pain questions on the PROBE questionnaire are well correlated with the pain domain on EQ5D-5L. The discriminative property of both tools is found to be excellent to separate people with various severities of hemophilia as well as people without bleeding disorders. The strength of the pain domain on the PROBE questionnaire is that it provides more informative data on the use of pain medication, occurrence and interference of acute and chronic pain. Therefore, the PROBE questionnaire is a disease-specific patient reported outcome measure, which will provide more insightful information regarding pain status in PWH.
View Presentation: PROBE and EQ5D-5L on pain assessment
