NCT04008680

Changes in Reliability When Assessing Multiple Patient-Reported Outcome Measures

Collection of Remotely Administered Multiple Patient-Reported Outcome Measures (CRAM-PROMs) in Orthopaedic Trauma: Assessment of the Impact of Quantity on Quality

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates how reliability of patient reported outcomes can be affected with questionnaire burden and and the number of questionnaires given to study participants.

Detailed description

The primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. We will assess the internal consistency of the EuroQuol Five Dimension - Five Level (EQ-5D-5L) Health Survey questionnaire as more questionnaires are applied. The secondary objective is to evaluate how the number of questionnaires and the time it takes to complete them impact patient's preferences and values. We will measure the time taken by each participant to complete the EQ-5D-5L questionnaire to evaluate if it changes meaningfully as the number of questionnaires given to participants' increases. Additionally, we will assess patient preferences and values by asking how well the remotely collected PROMs reflect their health status, and how this changes relative to the number of questionnaires administered. Our hypothesis is that there is a progressive decline in psychometric properties in the EQ-5D-5L, both in reliability and validity, as we increase the number of questionnaires given to participants. We also hypothesize that the time to complete the ED-5D-5L will increase as the number of questionnaires given to participants' increases, and that there is a threshold at which the patient feels there are no additional value to completing additional remote PROMS to adequately reflect their health status.

Conditions

• PROM

Interventions

Type	Name	Description
OTHER	EQ-5D-5L survey internal consistency	To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-07-31
• Completion: 2022-12-31
• First posted: 2019-07-05
• Last updated: 2021-07-28

Locations

1 site across 1 country: Canada