Measuring the Preferences of Patients With Type II Diabetes Using Best-worst Scaling and Discrete Choice Experiment

NCT ID: NCT02637622

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-02-28

Brief Summary

In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives.

First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR).

Second, address methodological gaps pertaining to the use of stated-preference methods in studying preferences in PCOR. These include identifying the best methods for designing a preference study and strategies for analyzing variation in preferences. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods.

Third, demonstrate good practices for applying stated-preference methods by studying the preferences of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups.

Clinical Significance:

This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the preferences of patients and stakeholders and directing health care.

Detailed Description

This study will apply the principles of CBPR to involve patients and stakeholders associated with a local community board and a national diabetes advisory board in key decisions in the project. During year 1, the investigators will utilize mixed methods to develop, pretest, and pilot the survey instruments to assess the preferences of patients with type II diabetes. In year 2, the investigators plan further engagement to finalize the survey instruments, and will implement a nationally representative, racially/ethnically diverse sample of patients with type II diabetes. Based on further consultation, the investigators will conduct statistical analysis, including stratified analyses and segmentation of patients with similar preferences. In year 3, mixed methods will be applied to assess beliefs of patients and other consumers about the relevance of this work and its generalizability to other PCOR topics. Finally, lay language reports will be developed to highlight patient and stakeholder engagement and the application of stated-preference methods to the study of the preferences of patients with type II diabetes.

Conditions

Type II Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Best-Worst Scaling (Case 2)

Preference measured by best-worst scaling (case 2)

Best-Worst Scaling (Case 2)

Intervention Type: OTHER

Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.

Discrete Choice Experiment

Preference measured by discrete choice experiment

Discrete Choice Experiment

Intervention Type: OTHER

Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.

Interventions

Best-Worst Scaling (Case 2)

Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.

Intervention Type: OTHER

Discrete Choice Experiment

Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participate in the GfK's KnowledgePanel
• Self-reported Type II diabetes diagnosis

Exclusion Criteria

• Does not have Type II diabetes diagnosis
• Unable to communicate in English or Spanish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Bridges, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

PCORI 90056532 PF

Identifier Type: -

Identifier Source: org_study_id