Health-related quality of life in patients with lower limb amputation – an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry

Abstract

Purpose

To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA).

Methods

This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity.

Results

The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and −5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels.

Conclusion

The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.

Implications for rehabilitation

• The measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)

• The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measures

• The five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLA

• In the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities

Keywords:

• EQ-5D
• quality of life
• validity
• feasibility
• amputation
• registries

Acknowledgments

We would like to express our gratitude to all patients and personnel at the contributing units who provided data to the Amputation and Prosthetics Registry (SwedeAmp). The study was funded by Region Stockholm within a license agreement between Region Stockholm and the EuroQol Research Foundation. EH received a grant from VinnVård/FORTE (Vinnvård Improvement Science Fellow, dnr: 2015-01331). KH was funded by the Swedish state under the agreement between the Swedish government and the county councils, the ALF agreement [ALFGBG-76480]. MJ and GB were funded by the EuroQol Research Foundation. The views expressed by the authors in the publication do not necessarily reflect the views of the EuroQol Group. Some of the data in this study were summarized previously in a PhD thesis (“Making use of patient-reported outcome measures in health care: the case of EQ-5D in the Swedish national quality registries”, Karolinska Institutet, 2021).

Ethics approval

Registration in a Swedish national quality register is voluntary (with the possibility to opt-out). The patient has the right to receive information, to refuse registration, and to be removed from the register. Researchers are required to write a formal application regarding data extraction for research purposes, including approval from an ethical review board. The study was approved by an ethical review board and no written informed consent was required.

Disclosure statement

The study was funded by Region Stockholm within a research program that is part of a license agreement between Region Stockholm and the EuroQol Research Foundation. MJ is working on a freelance basis at the EuroQol Business Office and is a EuroQol member. GB is employed by the EuroQol Research Foundation and is a EuroQol member. OE and EH have received travel grants from the EuroQol Research Foundation. KH, SK, and NZ declare no conflict of interest.

Data availability statement

Access to data is restricted by Swedish law. General information about obtaining access to data is available from the corresponding author Olivia Ernstsson upon request.