What do the data show about the influence of payment on participant

perceptions and behaviors?

Scott D. Halpern, M.D., Ph.D. Associate Professor of Medicine, Epidemiology, and Medical Ethics & Health Policy

Director, Fostering Improvement in End-of-Life Decision Science (FIELDS) program

Deputy Director, Center for Health Incentives and Behavioral Economics (CHIBE)

1. Payment may be an undue inducement

2. Payment may be an unjust inducement

3. Payment may dissuade participant disclosure of contraindications

Conceptually coherent concerns that rest on empirically testable facts

Halpern SD. Amer J Med Sci 2011

Experimental survey studies refute these concerns (and suggest ethical virtues of payment)

Centers for Disease Control and Prevention. Cigarette Smoking Among Adults and Trends in Smoking Cessation -- United States, 2008. MMWR 2009;58(44):1227-32.

142 hypertensive patients recruited from clinics

6 failed quiz 126 Patients

10 refused to participate due to time

Trial description & knowledge assessment

Vary payment offered ($100, $1000, $2000)

Vary risk (10%, 20%, 30% chance of side effects, e.g. vomitting)

Assess participation across 9 trials administered in random sequence

Halpern SD, et al. Arch Intern Med 2004; 164:801-3.

Model of Undue Inducement

Risk

% Willing to Participate

$0

$$$

$$$

Main Effect of Payment = Rational Tradeoff

Payment x Risk Interaction = “Blunted” risk evaluation (i.e., an undue inducement)

Incentives for RCTs: Undue inducement?

Payment: p = 0.001

Payment-by-risk interaction: p = 0.12

Halpern SD, et al. Arch Intern Med 2004; 164:801-3.

Undue inducement (kidneys)?

Payment (family): p = 0.31

Payment (waitlist): p < 0.001

Payment-by-risk interaction: p = 0.87

Halpern SD, et al. Ann Intern Med 2010; 152:358-65.

Model of Unjust Inducement

Payment offered

% Willing to Participate

Low-income

High-income

Payment x income interaction → lower-income patients preferentially influenced by money

Low-income

$0

Income:

p = 0.70

Payment-by-income interaction:

p = 0.09

Incentives for RCTs: Unjust inducement?

Halpern SD, et al. Arch Intern Med 2004; 164:801-3.

Unjust inducement (kidneys)?

Income:

p = 0.016

Payment-by-income interaction:

p = 0.49

Halpern SD, et al. Ann Intern Med 2010; 152:358-65.

Neglecting to inform about

adverse effects?

Bentley JP, Thacker PG. J Med Ethics 2004; 30: 293-8.

Are higher payments associated with different judgments of riskiness?

Are higher payments associated with the amount of time/effort spent seeking info about risk?

stimulation or (2) blood draws; and offered different payments ($25, $100, $1000)

Riskiness ratings

$25: 2 (0 – 4) $1000: 3 (1 – 5)

p < 0.05

Cryder et al. Soc Sci Med 2010; 70: 455-64

Higher incentives are associated with greater information seeking

Cryder et al. Soc Sci Med 2010; 70: 455-64

R01 CA197332 7/01/15 – 6/30/20

15000

1st consent: Study about attitudes toward research

Demographics; Economic Well-Being; Research attitudes questionnaire (all patients)

Randomization

Randomization

Patients identified as eligible for RTOG 1308. Patients shown video about trial.

Legend

Primary outcome Secondary outcomes Study processes and parent RCT outcomes

Clinical Outcomes

Assess risk perception and therapeutic misconception

Decision to sign 2nd consent form to enroll in parent RCT (RTOG 1308)

Review (but do not sign) 2nd consent Time spent reviewing 2nd consent form

Assess understanding of basic trial elements (all participants) and perceptions of coercion ($400 and $1200 arms)

Debriefing about incentives study and payment equalization

IMRT PBT

$1,200 $400 $0

Semi-structured interviews of patients who do not sign 2nd consent (selected equally among 3 incentive arms) [HOLD]

Outcomes & Recruitment Goals

• Primary Outcome: – Rate of consent to participate in the parent RCT

• Secondary Outcomes: – Patients’ research attitudes, motivations to participate or not, attention to

study details and risks, perceptions of research risks, therapeutic misconceptions, understanding of trial design, and health care system distrust.

• Target n= 576 – powered to rule out undue/unjust inducements • 44 months of recruitment • 3 incentive amounts: $0, 400, 1,200