Hip DiseaseSWEQRNCT04359628
How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups?
An observational study of Hip Disease and Heart Failure, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
EQ-5D is one of the most commonly employed patient-reported outcome (PRO) measures. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using 'values' obtained from healthy members of the general public. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Disease, Heart Failure, Psoriasis
- How many people
- 700,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2002to Sep 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population includes patients who received medical, surgical and/or other related treatments and were registered in one of the 12 National Quality Registries (NQRs) in Sweden.
Who may be able to join
- Age 18 years or older at baseline/first visit registration
- Completed the PRO instrument, EQ-5D, at least at the baseline /first visit
Who cannot join
- Incomplete data on age, sex, or EQ-5D dimensions
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Registercentrum
Gothenburg
Ola Rolfson, MD, PhD
About this study
Official title: How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups? A Study Protocol to Study Health-related Quality of Life Using the EQ-5D in the Swedish National Quality Registers
EQ-5D is one of the most commonly employed patient-reported outcome (PRO) measures. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using 'values' obtained from healthy members of the general public. However an alternative - which remains to be studied in detail - is the potential to use patients' self-reported overall health on the visual analogue scale as a means of capturing experience-based values. The overall aim of this project is to increase knowledge on the potential applicability of EQ VAS as a health state valuation method through assessment of its variability across and within patient groups and compared with that of the general population in Sweden.
Data on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and from the general population will be analysed. Longitudinal studies of PROs among different patient groups will be conducted at baseline/first visit and 1-year follow-up. Descriptive analyses comparing EQ-5D health states and observed self-assessed EQ VAS within and across registers will be performed. Comparisons of the change in health state and observed EQ VAS values over one year will also be made. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each NQR. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off (TTO) value sets obtained from the general population. This research project will provide information on the variation among different patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. Knowledge on the relative importance of different dimensions of the EQ-5D to different patient groups as well as the general population will be gained in this project. The possibility of getting value sets based on patients' self-reported EQ VAS values and their comparison with value sets from experience-based general population studies will be discussed.
Read the detailed description
Research questions:
- How do EQ-5D health states and self-assessed EQ VAS values vary across and within patient groups, and over follow-up stages, and in comparison to the general population data?
- To what extent do EQ-5D health states predict EQ VAS values, and how do the resulting experience-based patient value sets differ when estimated from patients' data at baseline and 1-year follow-up and how do the EQ VAS values predicted for EQ-5D health states differ between different patient groups?
- How do these patient value sets modelled using data from the registers compare with the Swedish VAS and TTO experience-based EQ-5D value sets obtained from the general population?
- How do value sets for EQ-5D-3L, predicted from EQ VAS differ from value sets predicted for the EQ-5D-5L, predicted from its EQ VAS?
Data: In this project 12 National Quality Registries holding records of PROs, on the EQ-5D instrument, records of approximately 700,000 patients will be included. Clinical data (age, sex, BMI, diagnosis (es) and interventions) and PROs data (EQ-5D-3L and condition-specific) will be retrieved from the registries. Data from cross-sectional population surveys in Sweden will be included for comparison; a total of approximately 45,000 records used in developing the Swedish TTO and VAS value sets.
The quality registries to be part of the study include;
- Better management of patients with osteoarthritis (BOA)
- The Swedish Ankle Registry (Swedankle)
- The Swedish Fracture Register (SFR)
- The Swedish Heart Failure Registry (SwedHF)
- The Swedish Hip Arthroplasty Register (SHAR)
- The Swedish Knee Arthroplasty Register (SKAR)
- The Swedish National Anterior Cruciate Ligament Register (XBase)
- The Swedish National Quality Register for Bipolar Disorder (BipoläR)
- The Swedish National Registry for Respiratory Failure (Swedevox)
- The Swedish Registry for Systematic Psoriasis Treatment (PsoReg)
- The Swedish Rheumatology Quality Register (SRQ)
- The Swedish Spine Register (Swespine)
Data analysis: Records of patients in the registries with baseline and follow-up data on PROs will be included for the different analyses to be conducted. The analyses will focus on the three main data components coming from the EQ-5D instrument. Data collected by the EQ-5D descriptive system on the five dimensions; the EQ-VAS score and EQ-5D index resulting from transforming the EQ-5D health profile into a single index using value sets. Hence, analyses looking into how the EQ-5D profile varies within and across patient groups and how it varies over time will form one component of the analyses to be conducted. Similarly, the pattern of EQ-VAS scores across patient groups and follow-ups will be analysed. Similar comparisons of EQ-5D index within and across patient groups, based on current Swedish value sets and patient VAS value sets to be elicited from the dataset, will be performed.
- Conditions
- Hip Disease, Heart Failure, Psoriasis, Fractures, Bone, Bipolar Disorder, Respiratory Failure
- Keywords
- health-related quality of life, quality register, EQ-5D, patient-reported outcomes, patient-reported outcome measures, comorbidity, EQ VAS, experience-based values, health state valuation, hypothetical values, patient values
- Medical subject headings
- Heart Failure, Psoriasis, Fractures, Bone, Bipolar Disorder, Respiratory Insufficiency, Knee Injuries, Spinal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BOA | Patients with osteoarthritis registered in the Better BOA register | |
| Swedankle | Patients who underwent ankle replacement, fusion or osteotomies and registered in the Swedish ankle registry | |
| xBase | Patients with cruciate ligament injuries who received surgical treatment and were registered in the Anterior Cruciate Ligament Register | |
| SFR | Patients who received treatment in the Swedish Fracture Register | |
| SHAR | Patients who underwent hip replacement therapy and registered in the Swedish Hip Arthroplasty Register | |
| SKAR | Patients with knee osteoarthritis and other diagnoses who underwent knee replacement or osteotomies and were registered in the Swedish Knee Arthroplasty Register | |
| Bipolär | Patients with Bipolar disorder receiving treatment and were registered in the Swedish National Register for Bipolar Disorder | |
| Swedevox | Patients with respiratory failure receiving technical respiratory assistance and were registered in the Swedish National Registry for Respiratory Failure | |
| PsoReg | Patients receiving systemic treatment for psoriasis and were registered in the Swedish Registry for Systematic Psoriasis Treatment | |
| SRQ | Patients with rheumatic disease receiving medical treatment and rehabilitation and were registered in the Swedish Rheumatology Quality Register | |
| SwedeHF | Patients who received treatments of different types in the Swedish Heart Failure Registry | |
| Swespine | Patients with spinal stenosis, disc hernia and related diagnoses receiving surgical spine treatment and were registered in the Swedish Spine Register | |
| Population health survey | Data of members of the general population who answered population surveys using the EQ-5D-3L instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
These describe the proportions of levels of problems reported in each of the EQ-5D-3L or EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Measured: At baseline/ first visit
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
These describe the proportions of levels of problems reported in each of the EQ-5D-3L or EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Measured: At 1-year follow-up
EQ-VAS value
It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: At baseline/ first visit
EQ-VAS value
It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: At 1-year follow-up
EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Measured: At baseline/ first visit
EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Measured: At 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startJan 2002
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Linkoeping University, Lund University, Ryhov County Hospital, Göteborg University, Umeå University, University of Melbourne, Office of Health Economics, London
- Responsible party
- Principal investigator, Ola Rolfson, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359628
- Sponsor's protocol ID
- 1185-18/2019-00812
- Acronym
- SWEQR
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teni FS, Rolfson O, Devlin N, Parkin D, Naucler E, Burstrom K; Swedish Quality Register (SWEQR) Study Group. Longitudinal study of patients' health-related quality of life using EQ-5D-3L in 11 Swedish National Quality Registers. BMJ Open. 2022 Jan 6;12(1):e048176. doi: 10.1136/bmjopen-2020-048176.
PubMed 34992101Teni FS, Rolfson O, Devlin N, Parkin D, Naucler E, Burstrom K; Swedish Quality Register (SWEQR) Study Group. Variations in Patients' Overall Assessment of Their Health Across and Within Disease Groups Using the EQ-5D Questionnaire: Protocol for a Longitudinal Study in the Swedish National Quality Registers. JMIR Res Protoc. 2021 Aug 27;10(8):e27669. doi: 10.2196/27669.
PubMed 34448726
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups? A Study Protocol to Study Health-related Quality of Life Using the EQ-5D in the Swedish National Quality Registers
- ClinicalTrials.gov ID
- NCT04359628
- Acronym / sponsor ID
- SWEQR / 1185-18/2019-00812
- Conditions
- Hip Disease, Heart Failure, Psoriasis, Fractures, Bone, Bipolar Disorder, Respiratory Failure
- Keywords
- health-related quality of life, quality register, EQ-5D, patient-reported outcomes, patient-reported outcome measures, comorbidity, EQ VAS, experience-based values
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Karolinska Institutet, Linkoeping University, Lund University, Ryhov County Hospital, Göteborg University, Umeå University, University of Melbourne, Office of Health Economics, London
- Study start
- Jan 2002 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EQ-5D is one of the most commonly employed patient-reported outcome (PRO) measures. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using 'values' obtained from healthy members of the general public. However an alternative - which remains to be studied in detail - is the potential to use patients' self-reported overall health on the visual analogue scale as a means of capturing experience-based values. The overall aim of this project is to increase knowledge on the potential applicability of EQ VAS as a health state valuation method through assessment of its variability across and within patient groups and compared with that of the general population in Sweden.
Data on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and from the general population will be analysed. Longitudinal studies of PROs among different patient groups will be conducted at baseline/first visit and 1-year follow-up. Descriptive analyses comparing EQ-5D health states and observed self-assessed EQ VAS within and across registers will be performed. Comparisons of the change in health state and observed EQ VAS values over one year will also be made. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each NQR. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off (TTO) value sets obtained from the general population. This research project will provide information on the variation among different patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. Knowledge on the relative importance of different dimensions of the EQ-5D to different patient groups as well as the general population will be gained in this project. The possibility of getting value sets based on patients' self-reported EQ VAS values and their comparison with value sets from experience-based general population studies will be discussed.
Detailed description
Research questions:
- How do EQ-5D health states and self-assessed EQ VAS values vary across and within patient groups, and over follow-up stages, and in comparison to the general population data?
- To what extent do EQ-5D health states predict EQ VAS values, and how do the resulting experience-based patient value sets differ when estimated from patients' data at baseline and 1-year follow-up and how do the EQ VAS values predicted for EQ-5D health states differ between different patient groups?
- How do these patient value sets modelled using data from the registers compare with the Swedish VAS and TTO experience-based EQ-5D value sets obtained from the general population?
- How do value sets for EQ-5D-3L, predicted from EQ VAS differ from value sets predicted for the EQ-5D-5L, predicted from its EQ VAS?
Data: In this project 12 National Quality Registries holding records of PROs, on the EQ-5D instrument, records of approximately 700,000 patients will be included. Clinical data (age, sex, BMI, diagnosis (es) and interventions) and PROs data (EQ-5D-3L and condition-specific) will be retrieved from the registries. Data from cross-sectional population surveys in Sweden will be included for comparison; a total of approximately 45,000 records used in developing the Swedish TTO and VAS value sets.
The quality registries to be part of the study include;
- Better management of patients with osteoarthritis (BOA)
- The Swedish Ankle Registry (Swedankle)
- The Swedish Fracture Register (SFR)
- The Swedish Heart Failure Registry (SwedHF)
- The Swedish Hip Arthroplasty Register (SHAR)
- The Swedish Knee Arthroplasty Register (SKAR)
- The Swedish National Anterior Cruciate Ligament Register (XBase)
- The Swedish National Quality Register for Bipolar Disorder (BipoläR)
- The Swedish National Registry for Respiratory Failure (Swedevox)
- The Swedish Registry for Systematic Psoriasis Treatment (PsoReg)
- The Swedish Rheumatology Quality Register (SRQ)
- The Swedish Spine Register (Swespine)
Data analysis: Records of patients in the registries with baseline and follow-up data on PROs will be included for the different analyses to be conducted. The analyses will focus on the three main data components coming from the EQ-5D instrument. Data collected by the EQ-5D descriptive system on the five dimensions; the EQ-VAS score and EQ-5D index resulting from transforming the EQ-5D health profile into a single index using value sets. Hence, analyses looking into how the EQ-5D profile varies within and across patient groups and how it varies over time will form one component of the analyses to be conducted. Similarly, the pattern of EQ-VAS scores across patient groups and follow-ups will be analysed. Similar comparisons of EQ-5D index within and across patient groups, based on current Swedish value sets and patient VAS value sets to be elicited from the dataset, will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| BOA | – | –Patients with osteoarthritis registered in the Better BOA register |
| Swedankle | – | –Patients who underwent ankle replacement, fusion or osteotomies and registered in the Swedish ankle registry |
| xBase | – | –Patients with cruciate ligament injuries who received surgical treatment and were registered in the Anterior Cruciate Ligament Register |
| SFR | – | –Patients who received treatment in the Swedish Fracture Register |
| SHAR | – | –Patients who underwent hip replacement therapy and registered in the Swedish Hip Arthroplasty Register |
| SKAR | – | –Patients with knee osteoarthritis and other diagnoses who underwent knee replacement or osteotomies and were registered in the Swedish Knee Arthroplasty Register |
| Bipolär | – | –Patients with Bipolar disorder receiving treatment and were registered in the Swedish National Register for Bipolar Disorder |
| Swedevox | – | –Patients with respiratory failure receiving technical respiratory assistance and were registered in the Swedish National Registry for Respiratory Failure |
| PsoReg | – | –Patients receiving systemic treatment for psoriasis and were registered in the Swedish Registry for Systematic Psoriasis Treatment |
| SRQ | – | –Patients with rheumatic disease receiving medical treatment and rehabilitation and were registered in the Swedish Rheumatology Quality Register |
| SwedeHF | – | –Patients who received treatments of different types in the Swedish Heart Failure Registry |
| Swespine | – | –Patients with spinal stenosis, disc hernia and related diagnoses receiving surgical spine treatment and were registered in the Swedish Spine Register |
| Population health survey | – | –Data of members of the general population who answered population surveys using the EQ-5D-3L instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients who received medical, surgical and/or other related treatments and were registered in one of the 12 National Quality Registries (NQRs) in Sweden.
Key inclusion criteria (2 listed)
- Age 18 years or older at baseline/first visit registration
- Completed the PRO instrument, EQ-5D, at least at the baseline /first visit
Key exclusion criteria (1 listed)
- Incomplete data on age, sex, or EQ-5D dimensions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
Time frame: At baseline/ first visit
These describe the proportions of levels of problems reported in each of the EQ-5D-3L or EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
Time frame: At 1-year follow-up
These describe the proportions of levels of problems reported in each of the EQ-5D-3L or EQ-5D-5L dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
EQ-VAS value
Time frame: At baseline/ first visit
It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
EQ-VAS value
Time frame: At 1-year follow-up
It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
Time frame: At baseline/ first visit
An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
Time frame: At 1-year follow-up
An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 34992101Teni FS, Rolfson O, Devlin N, Parkin D, Naucler E, Burstrom K; Swedish Quality Register (SWEQR) Study Group. Longitudinal study of patients' health-related quality of life using EQ-5D-3L in 11 Swedish National Quality Registers. BMJ Open. 2022 Jan 6;12(1):e048176. doi: 10.1136/bmjopen-2020-048176.
- Derived from this study: PubMed 34448726Teni FS, Rolfson O, Devlin N, Parkin D, Naucler E, Burstrom K; Swedish Quality Register (SWEQR) Study Group. Variations in Patients' Overall Assessment of Their Health Across and Within Disease Groups Using the EQ-5D Questionnaire: Protocol for a Longitudinal Study in the Swedish National Quality Registers. JMIR Res Protoc. 2021 Aug 27;10(8):e27669. doi: 10.2196/27669.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease and Heart Failure, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola Rolfson, MD, PhD (0 31-343 0852, ola.rolfson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L) (time frame: At baseline/ first visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.