Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02637609|
Recruitment Status : Unknown
Verified October 2015 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was: Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
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.
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.
|Condition or disease||Intervention/treatment|
|Type II Diabetes||Other: Likert Scale Other: Best-Worst Scaling (Case 1)|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Priority elicitation survey using a Likert scale method.
Other: Likert Scale
Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.
Best-Worst Scaling (Case 1)
Priority elicitation survey using a best-worst scaling method.
Other: Best-Worst Scaling (Case 1)
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.
- Measuring patients' priorities for barriers and facilitators for diabetes self-management using Likert scale [ Time Frame: The outcome will be evaluated during a one-time survey conducted one year after the start of the study. ]The investigators will measure patients' view on the barriers and facilitators for diabetes self-management using a survey with the traditional Likert scale method.
- Measuring patients' priorities for barriers and facilitators for diabetes self-management using Best-Worst Scaling [ Time Frame: The outcome will be evaluated during a one-time survey conducted one year after the start of the study. ]The investigators will measure patients' view on the barriers and facilitators for diabetes self-management using a survey with the best-worst scaling (case 1) method.
- Self-reported difficulty in understanding and answering the survey questions [ Time Frame: The outcome will be evaluated during the surveys conducted one year after the start of the study. ]The survey will ask the respondents to evaluate whether it is easy to understand and answer the questions using Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637609
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||John Bridges, PhD||Johns Hopkins University|