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Is quality of life a suitable measure of patient decision aid effectiveness? Sub-analysis of a Cochrane systematic review

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Abstract

Purpose

Patient decision-aids (PtDAs) help patients make informed treatment decisions incorporating their values. Health-related quality of life (HRQOL) is sometimes an outcome of PtDA effectiveness trials, but its suitability for this purpose is unclear. We sought to provide insights into this question by critically appraising how randomized controlled trials (RCTs) evaluating PtDA effectiveness measure and report HRQOL.

Methods

We conducted a sub-analysis of RCTs included in the 2017 Cochrane review of PtDAs. Trials assessing HRQOL at baseline and post-PtDA, and comparing PtDA with comparison groups were included. Two reviewers independently extracted data and assessed study quality. Analysis was descriptive.

Results

Of 105 RCTs, 11 were eligible for inclusion. Patients randomized to PtDAs did not report better HRQOL than those randomized to usual care. While all 11 RCTs adequately described baseline sample characteristics and reported HRQOL results for study groups, few stated a priori HRQOL expectations or hypotheses (36%); made a link between HRQOL and the decision (18%); provided a rationale or justification for HRQOL assessment (18%); provided reason for choice of HRQOL assessment time-points (9%); or adjusted p-values for multiple HRQOL domains and time-points (0%).

Discussion

PtDAs did not conclusively impact HRQOL. If this holds generally, then HRQOL is an uninformative endpoint for PtDA effectiveness trials. When planning trials of PtDAs, investigators considering HRQOL endpoints should consider whether and why their PtDA is likely to affect HRQOL in their context, and if so, which specific aspect(s) of HRQOL and at which time-point(s), and ensure HRQOL is assessed accordingly.

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Acknowledgements

We thank the authors of the Cochrane review of decision aids for people facing health screening and treatment decisions.

Funding

None.

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Authors and Affiliations

  1. Quality of Life Office, Psycho-Oncology Co-Operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O’Brien Lifehouse C39Z, Sydney, NSW, 2006, Australia

    Claudia Rutherford, Madeleine T. King & Phyllis Butow

  2. Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia

    Madeleine T. King

  3. Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec City, Canada

    France Legare

  4. Health Consumer, Ingersoll, ON, Canada

    Anne Lyddiatt

  5. School of Nursing, University of Ottawa, Ottawa, Canada

    Intissar Souli & Dawn Stacey

  6. Ottawa Hospital Research Institute, Ottawa, Canada

    Intissar Souli & Dawn Stacey

  7. Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research & University of New South Wales, Sydney, Australia

    Orlando Rincones

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  1. Claudia Rutherford
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Correspondence to Claudia Rutherford.

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Rutherford, C., King, M.T., Butow, P. et al. Is quality of life a suitable measure of patient decision aid effectiveness? Sub-analysis of a Cochrane systematic review. Qual Life Res 28, 593–607 (2019). https://doi.org/10.1007/s11136-018-2045-7

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