Dataset Information

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

ABSTRACT:

Background

Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.

Methods

Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario. Device scenarios offered an additional year of physical functioning equivalent to New York Heart Association class III or a year with improved (ie, class II) symptoms, or both, with 30-day mortality risks ranging from 0% to 15%, in-hospital complication risks ranging from 0% to 40%, and a remote adjustment device feature. Logit-based regression models fit participants' choices as a function of health outcomes, risks and remote adjustment.

Results

Latent-class analysis of 613 participants (mean age, 65; 49% female) revealed that two-thirds were best represented by a pro-device, more risk-tolerant class, accepting up to 9% (95% CI, 7%-11%) absolute risk of device-associated mortality for a one-year gain in improved functioning (New York Heart Association class II). Approximately 20% were best represented by a less risk-tolerant class, accepting a maximum device-associated mortality risk of 3% (95% CI, 1%-4%) for the same benefit. The remaining class had strong antidevice preferences, thus maximum-acceptable risk was not calculated.

Conclusions

Quantitative evidence on benefit-risk tradeoffs for implantable heart-failure device profiles may facilitate incorporating patients' views during product development, regulatory decision-making, and clinical practice.

SUBMITTER: Reed SD

PROVIDER: S-EPMC8763248 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

Reed Shelby D SD Yang Jui-Chen JC Rickert Timothy T Johnson F Reed FR Gonzalez Juan Marcos JM Mentz Robert J RJ Krucoff Mitchell W MW Vemulapalli Sreekanth S Adamson Philip B PB Gebben David J DJ Rincon-Gonzalez Liliana L Saha Anindita A Schaber Daniel D Stein Kenneth M KM Tarver Michelle E ME Bruhn-Ding Dean D

Circulation. Heart failure 20211223 1

<h4>Background</h4>Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.<h4>Methods</h4>Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomi ...[more]

PMID: 34937393

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Dataset Information

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

Background

Methods

Results

Conclusions

Publications

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

Similar Datasets

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