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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Likert Scale | Priority elicitation survey using a Likert scale method. |
| |
| Best-Worst Scaling (Case 1) | Priority elicitation survey using a best-worst scaling method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Likert Scale | Other | Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Difficulty in Understanding and Answering the Survey Questions | Questions that asked respondents to evaluate whether it was easy to understand and answer the Likert scale or BWS tasks. | One-time survey |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with type II diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| John Bridges, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37733885 | Result | 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/ |
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638 respondents (34%) did not respond to the survey and 139 people among those who responded (11%) were excluded based on the screening questions.
The survey was conducted through GfK KnowledgePanel. Eligible members were invited by email to participate in the survey. All participants were required to be 18 years or older with self-reported physician-diagnosed type 2 diabetes and able to read English or Spanish. African Americans and Latinos were oversampled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Likert Scale | Priority elicitation survey using a Likert scale method. Likert Scale: Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. |
| FG001 | Best-Worst Scaling (Case 1) | Priority elicitation survey using a best-worst scaling method. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Respondents who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Likert Scale | Priority measured by Likert scale Likert Scale: Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. |
| BG001 | Best-Worst Scaling (Case 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Respondents who completed the survey. | Posted | Mean | 95% Confidence Interval | units on a scale | One-time survey |
|
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Adverse events not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Likert Scale | Priority measured by Likert scale Likert Scale: Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John FP Bridges | Johns Hopkins Bloomberg School of Public Health | 614-685-2543 | john.bridges@osumc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2014 | Dec 12, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. |
|
Priority measured by Best-Worse Scaling (BWS)
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
|
| Years of diagnosis | Mean | Standard Deviation | years |
|
| Self-reported health | Count of Participants | Participants |
|
| No. of hypoglycemic events in the past 6 months | Count of Participants | Participants |
|
| No. of HbA1c level measured in past 6 months | Count of Participants | Participants |
|
| Most recent HbA1c level | Count of Participants | Participants |
|
| Type of diabetes medicine used | Count of Participants | Participants |
|
| Complications | Count of Participants | Participants |
|
| Other chronic conditions | Count of Participants | Participants |
|
| OG001 |
| Best-Worst Scaling (Case 1) |
Priority measured by best-worst scaling 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. |
|
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| Secondary | Self-reported Difficulty in Understanding and Answering the Survey Questions | Questions that asked respondents to evaluate whether it was easy to understand and answer the Likert scale or BWS tasks. | Respondents who completed the survey. | Posted | Count of Participants | Participants | One-time survey |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Best-Worst Scaling (Case 1) | Priority measured by BWS 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Neither agree nor disagree |
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| Agree |
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| Strongly agree |
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| Refused |
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| I found it easy to answer all the questions |
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| My answers are consistent with my preferences |
|