An interventional study of EQ-5D-5L survey internal consistency in PROM, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Hamilton Health Sciences Corporation · Not applicable, Interventional, and Other
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.
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.
Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Participants will be assigned to complete only the EQ-5D-5L questionnaire.
Other: EQ-5D-5L survey internal consistency
Participants will be assigned to complete the General Anxiety Disorder-7 (GAD-7) questionnaire first, followed by the EQ-5D-5L questionnaire.
Other: EQ-5D-5L survey internal consistency
Participants will be assigned to complete the Pain Catastrophizing Scale (PCS) questionnaire first, followed by the GAD-7, and lastly the EQ-5D-5L questionnaire.
Other: EQ-5D-5L survey internal consistency
Participants will be assigned to complete the Brief Pain Inventory (BPI) questionnaire first, followed by the PCS secondly, the GAD-7 third, and lastly the EQ-5D-5L questionnaire.
Other: EQ-5D-5L survey internal consistency
To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
Reliability and validity of the EQ-5D-5L
The questionnaire selected to analyze reliability in our population is the EQ-5D-5L.This well-known, generic, patient-reported health questionnaire is frequently used in musculoskeletal research and has shown to have a good internal consistency. We will compute the Cronbach's alpha coefficient for the EQ-5D-5L questionnaire. We will contrast these results to analyze if there is any difference in the values obtained from the answers of the EQ-5D-5L questionnaire between the four groups.
Time frame: Day 1
Time to completion
Time to complete the questionnaire. We will collect data (through electronic software) on time to completion of the EQ-5D-5L questionnaire. We hypothesize that as patients are asked to complete more surveys, patients will fatigue as the research burden increases and take longer to complete the surveys. Data will be collected in minutes, and the mean time to completion will be compared across groups through analysis of variance tests.
Time frame: Day 1
Plan to share: No — Undecided. Data collected (Internal consistency, demographics etc will be shared previous agreement)
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation