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Quality of Life Research

, Volume 28, Issue 3, pp 593–607 | Cite as

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

  • Claudia RutherfordEmail author
  • Madeleine T. King
  • Phyllis Butow
  • France Legare
  • Anne Lyddiatt
  • Intissar Souli
  • Orlando Rincones
  • Dawn Stacey
Article

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.

Keywords

Quality of life Patient decision aids Shared decision making Randomized controlled trials Cochrane, systematic review 

Notes

Acknowledgements

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

Funding

None.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

11136_2018_2045_MOESM1_ESM.docx (27 kb)
Supplementary material 1 (DOCX 27 KB)

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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Quality of Life Office, Psycho-Oncology Co-Operative Research Group, School of PsychologyUniversity of SydneySydneyAustralia
  2. 2.Central Clinical School, Sydney Medical SchoolUniversity of SydneySydneyAustralia
  3. 3.Université Laval Primary Care Research Centre (CERSSPL-UL)Quebec CityCanada
  4. 4.Health ConsumerIngersollCanada
  5. 5.School of NursingUniversity of OttawaOttawaCanada
  6. 6.Ottawa Hospital Research InstituteOttawaCanada
  7. 7.Centre for Oncology Education and Research Translation (CONCERT)Ingham Institute for Applied Medical Research & University of New South WalesSydneyAustralia

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