Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568029
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Construct Validity and Responsiveness of EQ-5D-3L in Patients With Rheumatic Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the construct validity convergent and known-groups and responsiveness of EQ-5D-3L in patients with rheumatoid arthritis polyarthritis psoriatic arthritis and ankylosing spondylitis The study is based on retrospective registry data from the Swedish Rheumatology Registry SRQ
Detailed Description:
Background
Patient-reported outcome measures PROMs are used to measure how patients themselves experience their health and health related quality of life HRQoL Sveriges kommuner och regioner 2023 One of the most commonly used PROMs is EQ-5D which is a generic instrument used to measure value and compare health across symptoms and diagnoses Devlin and Brooks 2017 When choosing a PROM to follow-up care from the patient perspective and to assess HRQoL in patients with rheumatic disease it is important to know that the instrument is valid and responsive An instrument with low validity and responsiveness might not capture and describe patients health and changes in their health accurately The aim of the study is therefore to investigate the validity and responsiveness of EQ-5D-3L The research questions are 1 What is the construct validity of EQ-5D-3L in patients with rheumatic disease 2 What is the responsiveness of EQ-5D-3L in patients with rheumatic disease
Methodology
Study design and data collection
This study will assess the construct validity and responsiveness of EQ-5D-3L among patients with rheumatoid arthritis RA polyarthritis psoriatic arthritis PsA and ankylosing spondylitis AS based on retrospective registry data The design of the study will follow the established guidelines from COSMIN on how to assess validity and responsiveness of PROMs Mokkink Prinsen et al 2019
Construct validity refers to the degree to which an instrument measures the constructs it intends to measure Fayers and Machin 2007 Construct validity will be assessed in two ways convergent validity and known-groups validity Convergent validity refers to how well the instrument under study EQ-5D-3L and EQ VAS correlates with other outcome measures Fayers and Machin 2007 Known-groups validity refers to how well the instrument can find differences between groups known to differ Responsiveness refers to the ability of the instrument to capture change over time in the construct that is measured Mokkink Terwee et al 2010
Historical registry data from the Swedish Rheumatology Register SRQ will be used to assess the construct validity and responsiveness of EQ-5D-3L and EQ VAS Data on EQ-5D-3L has been collected since 2008 Ernstsson Janssen et al 2020 and the study will include data from 2008 until the time of data extraction The analyses will be conducted independently for the different patient groups
Ethical approval has been granted for the project 2023-04394-01
Outcome measures
EQ-5D-3L and EQ VAS see text about intervention DAS28 DAPSA BASDAI ASDAS The Health Assessment Questionnaire Disability Index HAQ-DI the Bath Ankylosing Spondylitis Functional Index BASFI VAS questions pain fatigue and global score
Convergent validity EQ-5D-3L
Convergent validity will be assessed by testing hypotheses regarding the expected direction and magnitude of correlation between the EQ-5D-3L and the other outcome measures see hypotheses in document Study Protocol and Statistical Analysis Plan Constructs that are considered to be related are expected to have at least a moderate correlation and constructs that are considered to be similar are expected to have a strong correlation Prinsen Mokkink et al 2018
Known-groups validity EQ-5D-3L
In the assessment of known-groups validity patients will be divided into groups for which there is an expected difference in HRQoL see hypotheses in document Study Protocol and Statistical Analysis Plan The groups represent patients with different levels of disease activity or functional ability
Responsiveness EQ-5D-3L
Responsiveness will be assessed in two ways One way is by assessing the relationship between individual changes in EQ-5D-3L index value and dimensions over time with changes in other outcome measures over the same time period see hypotheses in document Study Protocol and Statistical Analysis Plan The second way is to assess whether EQ-5D-3L can discriminate between patients who have improved over time and those that have not based on changes in disease activity or functional ability The relationship between changes in the EQ-5D-3L and changes in other outcome measures will be assessed by analysing the correlation between the changes in the variables between the two first measurements of each individual during the first year after diagnosis see hypotheses in document Study Protocol and Statistical Analysis Plan
To assess whether EQ-5D-3L can discriminate between patients who have improved and those that have not the area under the receiver operating curve ROC curve AUC will be calculated Patients will be considered to have improved based on results from the measures of disease activity DAS28 DAPSA ASDAS or BASDAI and functional ability BASFI and HAQ-DI using criteria for what is defined as a response from previous studies see hypotheses in document Study Protocol and Statistical Analysis Plan
Convergent validity EQ VAS
Convergent validity of EQ VAS will be assessed with the same analyses used for EQ-5D-3L see the section about convergent validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Known-groups validity EQ VAS
Known-groups validity of EQ VAS will be assessed for the same groups as the EQ-5D-3L index see section about Known-groups validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Responsiveness EQ VAS
Responsiveness of EQ VAS will be assessed with the same analyses used for EQ-5D-3L see the section about responsiveness EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Patient-reported outcome measures PROMs are used to measure how patients themselves experience their health and health related quality of life HRQoL Sveriges kommuner och regioner 2023 One of the most commonly used PROMs is EQ-5D which is a generic instrument used to measure value and compare health across symptoms and diagnoses Devlin and Brooks 2017 When choosing a PROM to follow-up care from the patient perspective and to assess HRQoL in patients with rheumatic disease it is important to know that the instrument is valid and responsive An instrument with low validity and responsiveness might not capture and describe patients health and changes in their health accurately The aim of the study is therefore to investigate the validity and responsiveness of EQ-5D-3L The research questions are 1 What is the construct validity of EQ-5D-3L in patients with rheumatic disease 2 What is the responsiveness of EQ-5D-3L in patients with rheumatic disease
Methodology
Study design and data collection
This study will assess the construct validity and responsiveness of EQ-5D-3L among patients with rheumatoid arthritis RA polyarthritis psoriatic arthritis PsA and ankylosing spondylitis AS based on retrospective registry data The design of the study will follow the established guidelines from COSMIN on how to assess validity and responsiveness of PROMs Mokkink Prinsen et al 2019
Construct validity refers to the degree to which an instrument measures the constructs it intends to measure Fayers and Machin 2007 Construct validity will be assessed in two ways convergent validity and known-groups validity Convergent validity refers to how well the instrument under study EQ-5D-3L and EQ VAS correlates with other outcome measures Fayers and Machin 2007 Known-groups validity refers to how well the instrument can find differences between groups known to differ Responsiveness refers to the ability of the instrument to capture change over time in the construct that is measured Mokkink Terwee et al 2010
Historical registry data from the Swedish Rheumatology Register SRQ will be used to assess the construct validity and responsiveness of EQ-5D-3L and EQ VAS Data on EQ-5D-3L has been collected since 2008 Ernstsson Janssen et al 2020 and the study will include data from 2008 until the time of data extraction The analyses will be conducted independently for the different patient groups
Ethical approval has been granted for the project 2023-04394-01
Outcome measures
EQ-5D-3L and EQ VAS see text about intervention DAS28 DAPSA BASDAI ASDAS The Health Assessment Questionnaire Disability Index HAQ-DI the Bath Ankylosing Spondylitis Functional Index BASFI VAS questions pain fatigue and global score
Convergent validity EQ-5D-3L
Convergent validity will be assessed by testing hypotheses regarding the expected direction and magnitude of correlation between the EQ-5D-3L and the other outcome measures see hypotheses in document Study Protocol and Statistical Analysis Plan Constructs that are considered to be related are expected to have at least a moderate correlation and constructs that are considered to be similar are expected to have a strong correlation Prinsen Mokkink et al 2018
Known-groups validity EQ-5D-3L
In the assessment of known-groups validity patients will be divided into groups for which there is an expected difference in HRQoL see hypotheses in document Study Protocol and Statistical Analysis Plan The groups represent patients with different levels of disease activity or functional ability
Responsiveness EQ-5D-3L
Responsiveness will be assessed in two ways One way is by assessing the relationship between individual changes in EQ-5D-3L index value and dimensions over time with changes in other outcome measures over the same time period see hypotheses in document Study Protocol and Statistical Analysis Plan The second way is to assess whether EQ-5D-3L can discriminate between patients who have improved over time and those that have not based on changes in disease activity or functional ability The relationship between changes in the EQ-5D-3L and changes in other outcome measures will be assessed by analysing the correlation between the changes in the variables between the two first measurements of each individual during the first year after diagnosis see hypotheses in document Study Protocol and Statistical Analysis Plan
To assess whether EQ-5D-3L can discriminate between patients who have improved and those that have not the area under the receiver operating curve ROC curve AUC will be calculated Patients will be considered to have improved based on results from the measures of disease activity DAS28 DAPSA ASDAS or BASDAI and functional ability BASFI and HAQ-DI using criteria for what is defined as a response from previous studies see hypotheses in document Study Protocol and Statistical Analysis Plan
Convergent validity EQ VAS
Convergent validity of EQ VAS will be assessed with the same analyses used for EQ-5D-3L see the section about convergent validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Known-groups validity EQ VAS
Known-groups validity of EQ VAS will be assessed for the same groups as the EQ-5D-3L index see section about Known-groups validity EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Responsiveness EQ VAS
Responsiveness of EQ VAS will be assessed with the same analyses used for EQ-5D-3L see the section about responsiveness EQ-5D-3L and hypotheses in document Study Protocol and Statistical Analysis Plan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None