How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups?
NCT ID: NCT04359628
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
700000 participants
OBSERVATIONAL
2002-01-31
2020-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quality of Life in Patients With Chronic Disease
NCT03925805
Healthy Older Adults Through Movement and Engagement
NCT07136168
Prevalence and Risk Factors for Common Diseases
NCT04091035
Cardiovascular Health Awareness Program (CHAP) in Subsidized Social Housing
NCT03549845
Improving Heart Health in Appalachia
NCT01884246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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?
2. 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?
3. 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?
4. 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;
1. Better management of patients with osteoarthritis (BOA)
2. The Swedish Ankle Registry (Swedankle)
3. The Swedish Fracture Register (SFR)
4. The Swedish Heart Failure Registry (SwedHF)
5. The Swedish Hip Arthroplasty Register (SHAR)
6. The Swedish Knee Arthroplasty Register (SKAR)
7. The Swedish National Anterior Cruciate Ligament Register (XBase)
8. The Swedish National Quality Register for Bipolar Disorder (BipoläR)
9. The Swedish National Registry for Respiratory Failure (Swedevox)
10. The Swedish Registry for Systematic Psoriasis Treatment (PsoReg)
11. The Swedish Rheumatology Quality Register (SRQ)
12. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BOA
Patients with osteoarthritis registered in the Better BOA register
No interventions assigned to this group
Swedankle
Patients who underwent ankle replacement, fusion or osteotomies and registered in the Swedish ankle registry
No interventions assigned to this group
xBase
Patients with cruciate ligament injuries who received surgical treatment and were registered in the Anterior Cruciate Ligament Register
No interventions assigned to this group
SFR
Patients who received treatment in the Swedish Fracture Register
No interventions assigned to this group
SHAR
Patients who underwent hip replacement therapy and registered in the Swedish Hip Arthroplasty Register
No interventions assigned to this group
SKAR
Patients with knee osteoarthritis and other diagnoses who underwent knee replacement or osteotomies and were registered in the Swedish Knee Arthroplasty Register
No interventions assigned to this group
Bipolär
Patients with Bipolar disorder receiving treatment and were registered in the Swedish National Register for Bipolar Disorder
No interventions assigned to this group
Swedevox
Patients with respiratory failure receiving technical respiratory assistance and were registered in the Swedish National Registry for Respiratory Failure
No interventions assigned to this group
PsoReg
Patients receiving systemic treatment for psoriasis and were registered in the Swedish Registry for Systematic Psoriasis Treatment
No interventions assigned to this group
SRQ
Patients with rheumatic disease receiving medical treatment and rehabilitation and were registered in the Swedish Rheumatology Quality Register
No interventions assigned to this group
SwedeHF
Patients who received treatments of different types in the Swedish Heart Failure Registry
No interventions assigned to this group
Swespine
Patients with spinal stenosis, disc hernia and related diagnoses receiving surgical spine treatment and were registered in the Swedish Spine Register
No interventions assigned to this group
Population health survey
Data of members of the general population who answered population surveys using the EQ-5D-3L instrument
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Completed the PRO instrument, EQ-5D, at least at the baseline /first visit
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska Institutet
OTHER
Linkoeping University
OTHER_GOV
Lund University
OTHER
Ryhov County Hospital
OTHER
Göteborg University
OTHER
Umeå University
OTHER
University of Melbourne
OTHER
Office of Health Economics, London
UNKNOWN
Vastra Gotaland Region
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ola Rolfson
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Registercentrum
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ola Rolfson, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Teni 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1185-18/2019-00812
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.