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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700,000
- 试验地点
- 1
- 主要终点
- Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at baseline/first visit registration
- •Completed the PRO instrument, EQ-5D, at least at the baseline /first visit
排除标准
- •Incomplete data on age, sex, or EQ-5D dimensions
研究组 & 干预措施
BOA
Patients with osteoarthritis registered in the Better BOA register
干预措施: BOA
Swedankle
Patients who underwent ankle replacement, fusion or osteotomies and registered in the Swedish ankle registry
干预措施: Swedankle
xBase
Patients with cruciate ligament injuries who received surgical treatment and were registered in the Anterior Cruciate Ligament Register
干预措施: xBase
SFR
Patients who received treatment in the Swedish Fracture Register
干预措施: SFR
SHAR
Patients who underwent hip replacement therapy and registered in the Swedish Hip Arthroplasty Register
干预措施: SHAR
SKAR
Patients with knee osteoarthritis and other diagnoses who underwent knee replacement or osteotomies and were registered in the Swedish Knee Arthroplasty Register
干预措施: SKAR
Bipolär
Patients with Bipolar disorder receiving treatment and were registered in the Swedish National Register for Bipolar Disorder
干预措施: Bipolär
Swedevox
Patients with respiratory failure receiving technical respiratory assistance and were registered in the Swedish National Registry for Respiratory Failure
干预措施: Swedevox
PsoReg
Patients receiving systemic treatment for psoriasis and were registered in the Swedish Registry for Systematic Psoriasis Treatment
干预措施: PsoReg
SRQ
Patients with rheumatic disease receiving medical treatment and rehabilitation and were registered in the Swedish Rheumatology Quality Register
干预措施: SRQ
SwedeHF
Patients who received treatments of different types in the Swedish Heart Failure Registry
干预措施: SwedeHF
Swespine
Patients with spinal stenosis, disc hernia and related diagnoses receiving surgical spine treatment and were registered in the Swedish Spine Register
干预措施: Swespine
Population health survey
Data of members of the general population who answered population surveys using the EQ-5D-3L instrument
干预措施: Population health survey
结局指标
主要结局
Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Ola Rolfson
Professor
Vastra Gotaland Region