Clinical trial NCT02637609: Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling
Official title: Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes
Keywords: conjoint analysis
stated-preference methods
patient centered outcome research (PCOR)
community-based participatory research (CBPR)
patient priority
diabetes
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-12-22
Enrollment: 1103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type II diabetes.

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 priorities in PCOR. These include identifying the best methods for identifying patient priorities and strategies for analyzing variation in priorities. 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 priorities 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 priorities 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 priorities 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 priorities. 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 priorities of patients with type II diabetes.

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

Primary outcomes:
measure: Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management
timeFrame: One-time survey
Secondary outcomes:
measure: Self-reported Difficulty in Understanding and Answering the Survey Questions
timeFrame: One-time survey
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: John Bridges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bridges JFP, Janssen EM, Zhou M, Bone L, Segal JB, Purnell T, Longo DR, Wu A. Comparing Different Ways of Asking People with Type 2 Diabetes about Their Care Priorities and Preferences [Internet]. Washington (DC): Patient-Centered Outcomes Research Institute (PCORI); 2019 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK594947/