USING STATED RISK-BENEFIT TRADEOFF PREFERENCES TO IDENTIFY POTENTIAL THERAPEUTIC RISK-MANAGEMENT PROBLEMS

Author(s)

Johnson FR, Andrews EB

Presentation Documents

OBJECTIVES: Off-label use and adherence problems can occur when there are systematic differences between physicians’ and patients’ perceptions and regulators’ explicit or implicit judgments regarding relative risks and benefits. The objective of this study is to quantify subjective risk-benefit tradeoffs to inform risk-management decision making. METHODS: Stated-Preference (SP) methods, such as conjoint analysis elicit patient and physician assessments of hypothetical risk-benefit tradeoffs provide a necessary common utility metric for comparing risks to benefits. We administered a web-enabled SP survey to a convenience sample of health-care professionals registered for a major epidemiology conference (N=444). The instrument required subjects to complete 6 tradeoff tasks involving paired hypothetical pain medications relative to a constant, standard-treatment option. Background risks were set to approximate mean male population myocardial infarction (MI) risks. Efficacy, MI risks, and costs were varied according to a D-optimal statistical design. RESULTS: Part-worth utility weights were estimated using conditional logit analysis. All parameters were statistically significant at the 0.01 level or better. "Somewhat-controlled" and "well-controlled" efficacy were significantly different (p = 0.005), but there was no significant difference between "well-controlled" and "fully-controlled" efficacy levels. Maximum acceptable risk (MAR) is the increase in risk that exactly offsets the increase in utility from improved pain control. Mean MAR for an increase in efficacy from somewhat-controlled to well-controlled is 0.0385, or about 15 times background risk. The corresponding mean estimate for maximum acceptable cost or willingness to pay (WTP) is $1465 per month. CONCLUSIONS: A convenience sample of health care professionals provided theoretically consistent, well-structured risk-benefit stated preferences for pain-control therapy. Both MAR and WTP estimates indicate strong preferences for pain control. However, maximum acceptable risk is much larger than typical regulatory standards. Such differences between patient and regulatory risk-benefit tradeoffs signal potential problems for adherence, off-label use, and other impediments to effective risk management.

Conference/Value in Health Info

2004-10, ISPOR Europe 2004, Hamburg, Germany

Value in Health, Vol. 7, No. 6 (November/December 2004)

Code

MC7

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Systemic Disorders/Conditions

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