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

NCT04359628 | Unknown

• 1 other identifier: 1185-18/2019-00812
• Study Type: observational
• Target: 700,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)

  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)

  At baseline/ first visit

• Problems reported on the EQ-5D dimensions (EQ-5D-3L and EQ-5D-5L)

  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)

  At 1-year follow-up

• EQ-VAS value

  It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

  At baseline/ first visit

• EQ-VAS value

  It describes an overall assessment by respondent of their health, ranging on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

  At 1-year follow-up

• EQ-5D index (for EQ-5D-3L and EQ-5D-5L)

  An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.

  At baseline/ first visit

• EQ-5D index (for EQ-5D-3L and EQ-5D-5L)

  An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.

  At 1-year follow-up

Study Arms (13)

BOA

Patients with osteoarthritis registered in the Better BOA register

Swedankle

Patients who underwent ankle replacement, fusion or osteotomies and registered in the Swedish ankle registry

xBase

Patients with cruciate ligament injuries who received surgical treatment and were registered in the Anterior Cruciate Ligament Register

SFR

Patients who received treatment in the Swedish Fracture Register

SHAR

Patients who underwent hip replacement therapy and registered in the Swedish Hip Arthroplasty Register

SKAR

Patients with knee osteoarthritis and other diagnoses who underwent knee replacement or osteotomies and were registered in the Swedish Knee Arthroplasty Register

Bipolär

Patients with Bipolar disorder receiving treatment and were registered in the Swedish National Register for Bipolar Disorder

Swedevox

Patients with respiratory failure receiving technical respiratory assistance and were registered in the Swedish National Registry for Respiratory Failure

PsoReg

Patients receiving systemic treatment for psoriasis and were registered in the Swedish Registry for Systematic Psoriasis Treatment

SRQ

Patients with rheumatic disease receiving medical treatment and rehabilitation and were registered in the Swedish Rheumatology Quality Register

SwedeHF

Patients who received treatments of different types in the Swedish Heart Failure Registry

Swespine

Patients with spinal stenosis, disc hernia and related diagnoses receiving surgical spine treatment and were registered in the Swedish Spine Register

Population health survey

Data of members of the general population who answered population surveys using the EQ-5D-3L instrument

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Karolinska Institutet: collaborator
• Linkoeping University: collaborator
• Lund University: collaborator
• Ryhov County Hospital: collaborator
• Göteborg University: collaborator
• Umeå University: collaborator
• University of Melbourne: collaborator
• Office of Health Economics, London: collaborator

Study Sites (1)

Registercentrum

Gothenburg, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 34992101 DERIVED

• 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.

  PMID: 34448726 DERIVED

MeSH Terms

Conditions

Heart Failure; Psoriasis; Fractures, Bone; Bipolar Disorder; Respiratory Insufficiency; Knee Injuries; Spinal Diseases; Rheumatic Diseases; Osteoarthritis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Leg Injuries; Bone Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Joint Diseases

Central Study Contacts

Ola Rolfson, MD, PhD

CONTACT

0 31-343 0852; ola.rolfson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 24, 2020
• Study Start: January 1, 2002
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)