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

NCT02637609 | Completed Results

• 1 other identifier: PCORI 90056532
• Study Type: observational
• Target: 1,103
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes

Keywords

conjoint analysis; stated-preference methods; patient centered outcome research (PCOR); community-based participatory research (CBPR); patient priority; diabetes

Outcome Measures

Primary Outcomes (1)

• Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management

  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.

  One-time survey

Secondary Outcomes (1)

• Self-reported Difficulty in Understanding and Answering the Survey Questions

  One-time survey

Study Arms (2)

Likert Scale

Priority elicitation survey using a Likert scale method.

Other: Likert Scale

Best-Worst Scaling (Case 1)

Priority elicitation survey using a best-worst scaling method.

Other: Best-Worst Scaling (Case 1)

Interventions

Likert Scale OTHER

Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.

Likert Scale

Best-Worst Scaling (Case 1) OTHER

Respondents receive questions asking them to choose the best and worst factors that affect their diabetes self-management among a list of barriers and facilitators.

Best-Worst Scaling (Case 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with type II diabetes.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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/

  PMID: 37733885 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: John FP Bridges
• Organization: Johns Hopkins Bloomberg School of Public Health

john.bridges@osumc.edu

614-685-2543

Study Officials

• John Bridges, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 22, 2015
• Study Start: July 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2024-12

Locations

US (1)