No registrations found.
ID
Source
Health condition
EQ-5D-5L, EQ-5D, Orthopedic, Quality of life, proxy, self-completed, PROM, patient reported outcome measure, agreement
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the level of agreement for domain scores weighted kappa, and the interclass correlation coefficient (ICC) for the overall health state visual analogue scale (VAS) and utility scores.
Background summary
Rationale: There are two by proxy versions of the EQ-5D-5L questionnaire if the patient is not able to self complete the questionnaire. Currently there is no conclusive evidence which of these two by proxy versions reflects the self-completed EQ-5D-5L most accurately.
Objective: To compare the self-completed EQ-5D-5L questionnaire and its proxy versions in a population of adult orthopaedic patients at the outpatient clinic.
Study design: A randomised monocenter agreement study.
Study population: All orthopaedic patients of 18 years of older with no signs of cognitive impairment based on the judgement of the clinician, who are visiting the outpatient clinic with a relative.
Agreement study: The outcomes of the proxy-proxy and the proxy-patient version of the EQ-5D-5L questionnaire will be compared with the self-completed EQ-5D-5L questionnaire to estimate which by proxy version is superior.
Main study parameters/endpoints: The level of agreement between the outcomes of the self-completed EQ-5D-5L questionnaire and its proxy versions.
Study objective
The proxy-patient perspective outcome has a higher level of agreement with the outcome of the self-completed EQ-5D-5L, compared with the proxy-proxy perspective outcome in mentally healthy patients.
Study design
The EQ-5D-5L questionnaire will be assessed at the Orthopaedic outpatient clinic. The patient and proxy giver should independently complete the questionnaire, without helping each other.
Intervention
The EQ-5D-5L is a generic HRQoL measurement tool where respondents choose 1 of 5 descriptors in 5 domains of their health (mobility, personal care, usual activities, pain/discomfort, and anxiety/depression) followed by a Visual Analogue Scale (VAS) of their overall current health state.
Patients allocated to the proxy-proxy group A will receive the proxy A version of the EQ-5D-5L: The proxy giver is asked to rate the patient¡¯s health-related quality of life in their (the proxy¡¯s) opinion.
Patients allocated to the proxy-patient group B will receive the proxy B version of the EQ-5D-5L: The proxy giver is asked to rate how he/she (the proxy) thinks the patient would rate his/her own health-related quality of life if the patient were able to communicate it.
Inclusion criteria
- 18 years or older at time of visiting the orthopaedic outpatient clinic
- Compos mentis
- Dutch fluency and literacy
Exclusion criteria
- Signs of cognitive impairment
- Patients visiting the outpatient clinic without a relative / friend
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7310 |
| NTR-old | NTR7526 |
| Other | : WO 18.059 |