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

NCT02637622 | Completed Results

• 1 other identifier: PCORI 90056532 PF
• 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 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.

Conditions

Type II Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Patient Medication Preference as Estimated by a Choice Model

  Preference estimate for each medicine attribute level from a conditional logit regression analysis. For each arm, there were six attributes of the medication, with 3 levels each. Within each attribute the parameter estimates for each of the levels sum to 0. If a parameter estimate for a level is above (below) 0 then the parameter is higher (lower) than average for that medication attribute.

  One-time survey

• Weight Respondents Assign to Medication Attribute (Relative Attribute Importance) Assessed by a Choice Model

  Relative attribute importance (RAI) for each attribute in each arm measures the overall importance of that attribute. It is estimated by subtracting the lowest parameter estimate from the highest parameter estimate within each attribute. The RAI was then re-scaled on a 0 to 10 scale with 0 demonstrating no importance and 10 reflecting the most important attribute in each arm.

  One-time survey

Secondary Outcomes (1)

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

  One-time survey

Study Arms (2)

Best-Worst Scaling (Case 2)

Preference measured by best-worst scaling (case 2)

Other: Best-Worst Scaling (Case 2)

Discrete Choice Experiment

Preference measured by discrete choice experiment

Other: Discrete Choice Experiment

Interventions

Best-Worst Scaling (Case 2) OTHER

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

Best-Worst Scaling (Case 2)

Discrete Choice Experiment OTHER

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

Discrete Choice Experiment

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Preference; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

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: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-10

Locations

US (1)