Claudia Rutherford1, Madeleine T King2,3, Phyllis Butow2, France Legare4, Anne Lyddiatt5, Intissar Souli6,7, Orlando Rincones8, Dawn Stacey6,7. 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@sydney.edu.au. 2. 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. 3. Central Clinical School, Sydney Medical School, University of Sydney, Sydney, NSW, 2006, Australia. 4. Université Laval Primary Care Research Centre (CERSSPL-UL), Quebec City, Canada. 5. Health Consumer, Ingersoll, ON, Canada. 6. School of Nursing, University of Ottawa, Ottawa, Canada. 7. Ottawa Hospital Research Institute, Ottawa, Canada. 8. Centre for Oncology Education and Research Translation (CONCERT), Ingham Institute for Applied Medical Research & University of New South Wales, Sydney, Australia.
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.
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.
Entities:
Keywords:
Cochrane, systematic review; Patient decision aids; Quality of life; Randomized controlled trials; Shared decision making
Authors: Mina K Chung; Angela Fagerlin; Paul J Wang; Tinuola B Ajayi; Larry A Allen; Tina Baykaner; Emelia J Benjamin; Megan Branda; Kerri L Cavanaugh; Lin Y Chen; George H Crossley; Rebecca K Delaney; Lee L Eckhardt; Kathleen L Grady; Ian G Hargraves; Mellanie True Hills; Matthew M Kalscheur; Daniel B Kramer; Marleen Kunneman; Rachel Lampert; Aisha T Langford; Krystina B Lewis; Ying Lu; John M Mandrola; Kathryn Martinez; Daniel D Matlock; Sarah R McCarthy; Victor M Montori; Peter A Noseworthy; Kate M Orland; Elissa Ozanne; Rod Passman; Krishna Pundi; Dan M Roden; Elizabeth V Saarel; Monika M Schmidt; Samuel F Sears; Dawn Stacey; Randall S Stafford; Benjamin A Steinberg; Sojin Youn Wass; Jennifer M Wright Journal: Circ Arrhythm Electrophysiol Date: 2021-12-06
Authors: Catherine Yu; Dorothy Choi; Brigida A Bruno; Kevin E Thorpe; Sharon E Straus; Paul Cantarutti; Karen Chu; Paul Frydrych; Amy Hoang-Kim; Noah Ivers; David Kaplan; Fok-Han Leung; John Maxted; Jeremy Rezmovitz; Joanna Sale; Sumeet Sodhi-Helou; Dawn Stacey; Deanna Telner Journal: J Med Internet Res Date: 2020-09-30 Impact factor: 5.428