Clinical trial NCT04359628: How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups?
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Disease
Heart Failure
Psoriasis
Fractures, Bone
Bipolar Disorder
Respiratory Failure
Knee Disease
Knee Injuries
Ankle Disease
Spinal Disease
Rheumatic Diseases
Osteoarthritis
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
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: Linkoeping University
name: Lund University
name: Ryhov County Hospital
name: Göteborg University
name: Umeå University
name: University of Melbourne
name: Office of Health Economics, London
First posted: 2020-04-24
Enrollment: 700000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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:

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at baseline/first visit registration
* Completed the PRO instrument, EQ-5D, at least at the baseline /first visit

Exclusion Criteria:

* Incomplete data on age, sex, or EQ-5D dimensions

Primary outcomes:
measure: Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
timeFrame: At baseline/ first visit
measure: Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
timeFrame: At 1-year follow-up
measure: EQ-VAS value
timeFrame: At baseline/ first visit
measure: EQ-VAS value
timeFrame: At 1-year follow-up
measure: EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
timeFrame: At baseline/ first visit
measure: EQ-5D index (for EQ-5D-3L and EQ-5D-5L)
timeFrame: At 1-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Registercentrum
Study officials:
References:
citation: 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.
citation: 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.