Type II Diabetes
Conditions
Keywords
conjoint analysis, stated-preference methods, patient centered outcome research (PCOR), community-based participatory research (CBPR), patient priority, diabetes
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.
Interventions
OTHERLikert Scale
Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.
OTHERBest-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.
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins Bloomberg School of Public Health
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
638 respondents (34%) did not respond to the survey and 139 people among those who responded (11%) were excluded based on the screening questions.
Participants by arm
| Arm | Count |
|---|---|
| Likert Scale Priority measured by Likert scale
Likert Scale: Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management. | 549 |
| Best-Worst Scaling (Case 1) 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. | 554 |
| Total | 1,103 |
Baseline characteristics
| Characteristic | Total | Best-Worst Scaling (Case 1) | Likert Scale |
|---|---|---|---|
| Age, Continuous | 61.93 years | 61.57 years | 62.29 years |
| Complications No | 640 Participants | 324 Participants | 316 Participants |
| Complications Yes | 463 Participants | 230 Participants | 233 Participants |
| Education Bachelor's degree or higher | 321 Participants | 168 Participants | 153 Participants |
| Education High school | 362 Participants | 173 Participants | 189 Participants |
| Education Less than high school | 82 Participants | 38 Participants | 44 Participants |
| Education Some college | 338 Participants | 175 Participants | 163 Participants |
| Income $25,000 - $49,999 | 308 Participants | 152 Participants | 156 Participants |
| Income $50,000 - $74,999 | 222 Participants | 116 Participants | 106 Participants |
| Income $75,000 and above | 300 Participants | 145 Participants | 155 Participants |
| Income Less than $25,000 | 273 Participants | 141 Participants | 132 Participants |
| Most recent HbA1c level Don't know | 183 Participants | 100 Participants | 83 Participants |
| Most recent HbA1c level Over 7.0% but under 8.0% | 297 Participants | 148 Participants | 149 Participants |
| Most recent HbA1c level Over 8.0% but under 9.0% | 105 Participants | 53 Participants | 52 Participants |
| Most recent HbA1c level Over 9.0% | 58 Participants | 35 Participants | 23 Participants |
| Most recent HbA1c level Under 7.0% | 460 Participants | 218 Participants | 242 Participants |
| No. of HbA1c level measured in past 6 months 1 time | 492 Participants | 249 Participants | 243 Participants |
| No. of HbA1c level measured in past 6 months Don't know | 32 Participants | 13 Participants | 19 Participants |
| No. of HbA1c level measured in past 6 months More than 2 times | 507 Participants | 250 Participants | 257 Participants |
| No. of HbA1c level measured in past 6 months None | 72 Participants | 42 Participants | 30 Participants |
| No. of hypoglycemic events in the past 6 months 1 time | 160 Participants | 80 Participants | 80 Participants |
| No. of hypoglycemic events in the past 6 months 2-5 times | 278 Participants | 131 Participants | 147 Participants |
| No. of hypoglycemic events in the past 6 months More than 5 times | 94 Participants | 51 Participants | 43 Participants |
| No. of hypoglycemic events in the past 6 months None | 571 Participants | 292 Participants | 279 Participants |
| Other chronic conditions No | 182 Participants | 84 Participants | 98 Participants |
| Other chronic conditions Yes | 921 Participants | 470 Participants | 451 Participants |
| Race/Ethnicity, Customized 2+ Races, Non-Hispanic | 15 Participants | 8 Participants | 7 Participants |
| Race/Ethnicity, Customized Black, Non-Hispanic | 254 Participants | 128 Participants | 126 Participants |
| Race/Ethnicity, Customized Hispanic | 236 Participants | 119 Participants | 117 Participants |
| Race/Ethnicity, Customized Other, Non-Hispanic | 23 Participants | 11 Participants | 12 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 575 Participants | 288 Participants | 287 Participants |
| Region of Enrollment United States | 1103 Participants | 554 Participants | 549 Participants |
| Self-reported health Excellent | 60 Participants | 25 Participants | 35 Participants |
| Self-reported health Fair | 209 Participants | 121 Participants | 88 Participants |
| Self-reported health Good | 465 Participants | 238 Participants | 227 Participants |
| Self-reported health Poor | 53 Participants | 24 Participants | 29 Participants |
| Self-reported health Very good | 316 Participants | 146 Participants | 170 Participants |
| Sex: Female, Male Female | 553 Participants | 290 Participants | 263 Participants |
| Sex: Female, Male Male | 550 Participants | 264 Participants | 286 Participants |
| Type of diabetes medicine used No prescription medicine | 99 Participants | 47 Participants | 52 Participants |
| Type of diabetes medicine used Only injections/shots | 90 Participants | 42 Participants | 48 Participants |
| Type of diabetes medicine used Only pills | 666 Participants | 333 Participants | 333 Participants |
| Type of diabetes medicine used Pills and injections/shots | 246 Participants | 131 Participants | 115 Participants |
| Type of diabetes medicine used Refused | 2 Participants | 1 Participants | 1 Participants |
| Years of diagnosis | 11.35 years STANDARD_DEVIATION 8.03 | 11.17 years STANDARD_DEVIATION 7.99 | 11.54 years STANDARD_DEVIATION 8.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: One-time survey
Population: Respondents who completed the survey.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Support from others | 0.359 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Physical environment | 0.287 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Access to healthy food | 0.439 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | My ability to pay | 0.207 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Staying motivated | 0.344 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Local events | 0.087 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | My own knowledge | 0.500 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Work commitments | 0.082 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Family commitments | 0.293 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Other health conditions | 0.067 units on a scale |
| Likert Scale | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Healthcare providers | 0.505 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Other health conditions | -0.281 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Healthcare providers | 0.327 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | My own knowledge | 0.369 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Access to healthy food | 0.211 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Support from others | 0.058 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Staying motivated | 0.019 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Family commitments | 0.002 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Physical environment | -0.079 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | My ability to pay | -0.166 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Local events | -0.236 units on a scale |
| Best-Worst Scaling (Case 1) | Priority Scores for Potential Barriers and Facilitators for Diabetes Self-management | Work commitments | -0.217 units on a scale |
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.
Time frame: One-time survey
Population: Respondents who completed the survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Strongly disagree | 10 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Disagree | 23 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Neither agree nor disagree | 73 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Agree | 316 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Strongly agree | 122 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Refused | 5 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Strongly disagree | 9 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Disagree | 33 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Neither agree nor disagree | 71 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Agree | 317 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Strongly agree | 113 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Refused | 6 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Strongly disagree | 6 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Disagree | 8 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Neither agree nor disagree | 61 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Agree | 338 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Strongly agree | 130 Participants |
| Likert Scale | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Refused | 6 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Disagree | 13 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Strongly disagree | 26 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Agree | 196 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Disagree | 90 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Refused | 0 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Neither agree nor disagree | 141 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Strongly agree | 66 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Agree | 224 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Neither agree nor disagree | 130 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Strongly agree | 71 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Refused | 1 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to understand the questions | Refused | 2 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Strongly agree | 99 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Strongly disagree | 34 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Strongly disagree | 6 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Disagree | 97 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | My answers are consistent with my preferences | Agree | 306 Participants |
| Best-Worst Scaling (Case 1) | Self-reported Difficulty in Understanding and Answering the Survey Questions | I found it easy to answer all the questions | Neither agree nor disagree | 160 Participants |