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Modifying the quality-adjusted life year calculation to account for meaningful change in health-related quality of life: insights from a pragmatic clinical trial

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Abstract

Background

We propose a modified quality-adjusted life year (QALY) calculation that aims to be consistent with guidance for interpreting change in patient-reported outcomes. This calculation incorporates the minimally important difference (MID) in generic preference-based health-related quality of life (HRQL) change scores to reflect what might be considered meaningful HRQL improvement/deterioration. In doing so, we review common issues in QALY calculations such as adjustment for baseline scores and standardizing for between-group differences.

Methods

Using EQ-5D-5L outcome data from the Alberta TEAMCare-Primary Care Network trial in the management of depression for patients with type 2 diabetes (n = 98), this study compared results from different QALY calculation methods to investigate the impact of (i) adjusting for baseline HRQL score, (ii) standardizing between-group differences at baseline, and (iii) adjusting for ‘meaningful’ HRQL changes. The following QALY calculation methods are examined: area under curve (QALY-AUC), change from baseline (QALY-CFB), regression modelling (QALY-R), and incorporating an MID for HRQL changes from baseline (QALY-MID).

Results

The incremental QALY-AUC estimate favoured the Collaborative Care group (0.031) while the incremental QALY-CFB (−0.028) estimate favoured Enhanced Care. Adjusting for meaningful HRQL changes resulted in a crude incremental QALY-MID of −0.023; however, after adjusting for between-group differences at baseline, QALY-R and adjusted incremental QALY-MID estimates were −0.007 and −0.001, respectively. In addition, recursive regression analyses showed that very low baseline HRQL scores impact incremental QALY estimates.

Conclusions

Uncertainty in incremental QALY estimates reflects uncertainty in the value of small within-individual change as well as the impact of small differences between groups at baseline. Applying a responder-definition approach yielded crude and adjusted QALY-MID estimates that were more in favour of Collaborative Care than QALY-CFB and QALY-R estimates, respectively, suggesting that ambiguous small changes in HRQL scores have the potential to influence QALY outcomes used in economic or non-economic applications.

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Data availability

The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study.

Code availability

The R code used to conduct the analyses in this study is available from the corresponding author on reasonable request.

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Funding

Financial support for this study was provided in part by a grant from Alberta Innovates awarded to NSM as a Graduate Studentship. The funding agreement ensured the author’s independence in designing the study, interpreting the data, writing, and publishing the study.

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Authors and Affiliations

  1. 2-040 Li Ka Shing Centre for Health Research Innovation, School of Public Health, University of Alberta, Edmonton, AB, T6G 2E1, Canada

    Nathan S. McClure, Mike Paulden, Arto Ohinmaa & Jeffrey A. Johnson

  2. Alberta PROMs and EQ-5D Research and Support Unit (APERSU), University of Alberta, Edmonton, AB, Canada

    Nathan S. McClure, Arto Ohinmaa & Jeffrey A. Johnson

Authors
  1. Nathan S. McClure
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  2. Mike Paulden
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Contributions

NSM and JAJ conceived the study. JAJ was the investigator for the Alberta TEAMCare-PCN trial. MP and AO contributed to the study design. Material preparation, data collection and analysis were performed by NSM. The first draft of the manuscript was written by NSM and all authors commented on later versions of the manuscript. All authors reviewed and approved the final manuscript.

Corresponding author

Correspondence to Jeffrey A. Johnson.

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Conflicts of interest

JAJ and AO are members of the EuroQol Group. The views expressed by the authors in this paper do not necessarily reflect the views of the EuroQol Group. Other authors declare that they have no conflict of interest.

Ethics approval

This study followed requirements outlined in the Canadian Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans. Ethics approval for the study was granted from the Health Research Ethics Board (HREB #Pro00087637) at the University of Alberta.

Consent to participate

Informed consent was obtained from all individual participants included in the TEAMCare-PCN trial.

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Not applicable.

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McClure, N.S., Paulden, M., Ohinmaa, A. et al. Modifying the quality-adjusted life year calculation to account for meaningful change in health-related quality of life: insights from a pragmatic clinical trial. Eur J Health Econ 22, 1441–1451 (2021). https://doi.org/10.1007/s10198-021-01324-x

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