Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling

Completed

Conditions: Type II Diabetes

Interventions: Other: Best-Worst Scaling (Case 1)
Other: Likert Scale

Registration Number: NCT02637609

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1103

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Best-Worst Scaling (Case 1)	Best-Worst Scaling (Case 1)	Priority elicitation survey using a best-worst scaling method.
Likert Scale	Likert Scale	Priority elicitation survey using a Likert scale method.

Primary Outcome Measures

Name	Time	Method
Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management	One-time survey	Average Likert score or best-worst score that measures the impact of each factor on diabetes self-management. Positive scores indicate facilitators for diabetes self-management while negative scores indicate barriers. The magnitude of the score suggests the degree of the impact. Both scales are on a +1--1 scale. Positive 1 would be the largest possible facilitator and a negative 1 would be the largest possible barrier.

Secondary Outcome Measures

Name	Time	Method
Self-reported Difficulty in Understanding and Answering the Survey Questions	One-time survey	Questions that asked respondents to evaluate whether it was easy to understand and answer the Likert scale or BWS tasks.