Heart Failure Clinical Trial
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.
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.
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