How Does Patients' Overall Assessment of Their Health Vary Across and Within Different Disease Groups?

NCT04359628 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 700000

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER
  • Linkoeping University

    collaborator OTHER_GOV
  • Lund University

    collaborator OTHER
  • Ryhov County Hospital

    collaborator OTHER
  • Göteborg University

    collaborator OTHER
  • Umeå University

    collaborator OTHER
  • University of Melbourne

    collaborator OTHER
  • Office of Health Economics, London

    collaborator UNKNOWN
  • Vastra Gotaland Region

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04359628 on ClinicalTrials.gov