Comparing Maximum-Acceptable Risk Estimates from 2 Preference-Elicitation Methods: A Discrete-Choice Experiment and a Threshold-Technique Exercise

Author(s)

Sutphin J1, Wallace M2, Yang JC1, Corriere MA3, Secemsky EA4, Johnson R1, Gonzalez JM5, Tarver ME6, Saha A6, Gebben D6, Chen AL6, Farb A6, Malone M6, Babalola O6, Rorer E6, Buckley D6, Capanna K6, Reed S1
1Duke Clinical Research Institute, Durham, NC, USA, 2Duke Clinical Research Institute, Madison, WI, USA, 3University of Michigan, Ann Arbor, MI, USA, 4Beth Israel Deaconess Medical Center, Boston, MA, USA, 5Duke University, Durham, NC, USA, 6U.S. Food and Drug Administration, Silver Spring, MD, USA

Presentation Documents

OBJECTIVES:

A stated-preference study aimed to quantify patients’ benefit-risk preferences for alternative devices used in revascularization procedures for peripheral arterial disease (PAD). A main objective was testing whether parallel discrete-choice experiment (DCE) and threshold-technique (TT) data would yield similar maximum acceptable risk (MAR) estimates.

METHODS:

Eight DCE questions offered patients a choice between 2 device options for a revascularization procedure for PAD. Four probabilistic attributes included the chance of a repeat revascularization procedure at 2 years (10% or 30%) and 5 years (30%, 40%, or 50%) and mortality risk at 2 (2% or 5%) and 5 years (8%, 10%, 16%, 20%). The key metric of interest was the maximum 5-year mortality risk patients would accept in excess of 8%, for a device that could reduce the risk of another procedure by 2 years from 30% to 10%, and by 5 years from 40% to 30%. The TT offered patients a fixed level of improvement with 5-year mortality risk starting at 8% and increasing by 2 percentage points up to 20%. DCE and TT order was randomized. DCE data were analyzed with mixed-logit models and TT with interval regressions. MARs were calculated for the sample and each patient. Participants were recruited from seven U.S. medical centers.

RESULTS:

Among those who saw the DCE first (n=136), the mean MAR was 13.26% [95% CI: 12.20, 14.31]. Among those who saw the TT first (n=134), the mean MAR was 14.00% [12.22, 14.78]. Sensitivity analysis of MARs to order shown and risk presentation were similar [DCE: 11.94-13.71, TT: 12.84-14.14]. At the individual level, discordance between DCE and TT ranged from 0 to 12 percentage-points with a mean difference of 2.5.

CONCLUSIONS:

DCE and TT preference methods yielded similar mean MAR estimates at the sample level. However, concordance at the individual level varied widely.

Conference/Value in Health Info

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)

Code

PCR106

Topic

Patient-Centered Research

Topic Subcategory

Stated Preference & Patient Satisfaction

Disease

Medical Devices

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