Center for Informing Health Decisions (CIHD)Quantifying the Patient Voice
Traditional models of medical care assume that physicians are the best judge of what is best for patients. While some patients are comfortable with this assumption, many increasingly expect to share decision-making responsibility with their healthcare providers. The growing and influential patient-centeredness movement emphasizes the critical role patients' concerns, values, and preferences must play in regulatory, coverage and treatment decisions. As part of the DCRI's continuing commitment to patient-centered, evidence-based medicine, researchers are translating patients' concerns and preferences into quantitative scientific evidence.
CIHD: A Powerful Approach to Quantitative Stated-Preference Research
How much risk are patients willing to accept in return for improvements in treatment outcomes? How much improvement in outcomes do patients require for given treatment-related risks? How much symptom-free time is equivalent to time living with symptoms of different severity? While much can be learned from listening to patients' accounts of their personal health challenges, scientific quantification of patient concerns and preferences is necessary to have a significant impact on how treatment development decisions are made, how potential new treatments are evaluated by regulatory agencies, and how existing treatments are used. In response to this need, the DCRI has established the Center for Informing Health Decisions (CIHD).
CIHD includes internationally recognized leaders in developing and applying stated-preference methods. These methods, also known as conjoint analysis, include discrete-choice experiments (DCE), best-worst scaling (BWS), and contingent valuation (CV). Direct access to leading clinical key opinion leaders at Duke University provides critical insights into what patients are saying to their healthcare providers and what healthcare providers are saying to their patients about therapeutic alternatives. Understanding such conversations is essential to developing state-of-the-science survey instruments to quantify patients' willingness to accept tradeoffs between treatment benefits and risks.
CIHD's highly experienced interdisciplinary team of researchers contribute to the successful design, implementation, and analysis of such surveys. CIHD's outstanding record in effective communication through publications in top medical journals ensures that the results of these studies will have a lasting influence.
Stated-preference research is relevant across the therapeutic spectrum. Currently, the CIHD group is conducting research projects in the following conditions:
- Blood Cancers
- Breast Cancer
- Food Allergies
- Heart Failure
- Knee Replacement
- Mental Illness
- Organ Transplantation
- Ovarian Cancer
- Sickle Cell Disease
- Thyroid Cancer
BuildING Regulatory Relationships
As part of FDA’s Patient Preference Initiative, CIHD faculty led the first FDA-sponsored study to quantify patients’ risk tolerance for the benefits of new medical technologies. This study served as the basis for the first FDA guidance on the submission of patient preference information to support regulatory reviews and product labeling at the Center for Devices and Radiological Health (CDRH). The faculty are active in a number of continuing initiatives to promote greater regulatory and industry commitments to the consideration of patient preferences throughout product-development lifecycles.
The work done by DCRI investigators played a significant role in the decision of the FDA to accept this type of scientific evidence in its regulatory reviews. We continue to build on our reputation for scientifically valid, policy-relevant research to promote greater acceptance and use of patient-preference data in regulatory decision making.
View our listing of select published papers over the last 10 years that represent best-practice applications and methods development, including recent highlights:
- Something Is Better Than Nothing: The Value of Active Intervention in Stated Preferences for Treatments to Delay Onset of Alzheimer's Disease Symptoms - September 2019
- Patient preferences for attributes of primary surgical debulking versus neoadjuvant chemotherapy for treatment of newly diagnosed ovarian cancer - August 2019
- Comparing the Noncomparable: The Need for Equivalence Measures That Make Sense in Health-Economic Evaluations - June, 2019
CIHD Contributes to FDA Decision
The DCRI surveyed patients to quantify the benefits and harms of esketamine, a drug recently approved to treat individuals with treatment-resistant depression. A patient preference survey designed and conducted by the CIHD group was presented to the FDA prior to its recent approval of a treatment for patients with treatment-resistant depression.
Lead the Way with CIHD
The faculty of CIHD have extensive experience in stated-preference research and are leaders in their respective fields of study. They are experts in designing patient and physician surveys to assess a wide variety of outcomes, such as patient preference, quality of life, burden of illness, patient satisfaction, willingness-to-pay, risk tolerance, medication adherence, and time tradeoff. CIHD senior faculty include:
Shelby D. Reed, PhD, CIHD director, professor in medicine at the Duke University School of Medicine, faculty member in the DCRI, and an affiliate member of the Duke Cancer Institute. Reed has a strong background in health economics and health services research and an extensive professional network both inside and outside Duke University.
F. Reed Johnson, PhD, senior research scholar at the DCRI. An internationally recognized thought leader, Johnson is one of the most highly published experts in the field of health applications of stated-preference research.
Juan Marcos Gonzalez, PhD, recently joined the DCRI as an assistant professor in medicine. Dr. Gonzalez has led industry-sponsored, health-preference research studies for nearly 9 years. He is an internationally recognized expert in designing stated-preference survey instruments and advanced analysis of stated-preference data from discrete-choice experiments, contingent valuation, and other preference-elicitation methods.