Cardiovascular Disease
Conditions
Brief summary
The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.
Detailed description
The Million Veteran Program - Return of Actionable Results (MVP-ROAR) Study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. MVP participants with a medically actionable variant in their MVP chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. First, a non-randomized pilot trial will be conducted among 10 eligible MVP participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling. Three hypotheses will be tested: Hypothesis 1 (LDL-C change): LDL-C reduction after 6 months will be greater in the Immediate Results arm compared to the Delayed Results arm (primary outcome) Hypothesis 2 (LDL-C target): The proportion of participants meeting clinically significant LDL-C targets (\<100mg/dL for primary prevention and \<70 mg/dL for secondary prevention) at 6 months will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome) Hypothesis 3 (Pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome)
Interventions
GENETICResult disclosure
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Living enrollee in MVP * Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data
Exclusion criteria
* Previously underwent genetic testing for the condition of interest * Is incarcerated * Is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C Change | 6 months | Change in LDL-C after 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C Target | 6 months | The number of participants meeting clinically significant LDL-C targets (\< 100mg/dL for primary prevention and \<70 mg/dL for secondary prevention) at 6 months. |
| Pharmacotherapy | 6 months | The number of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | 6 months | Medication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ). |
| Cascade Testing | 6 months | The number of first-degree relatives having undergone genetic testing at 6 months. |
| Smoking Status | 6-month | 6-month smoking status |
| Lifestyle Behaviors | 6 months | The number of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses. |
| Quality of Life (Veterans RAND Survey) | 6 months | Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores (Physical Component Score and a Mental Component Score) ranging from 0-100, with a higher score indicating better health. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on February 27, 2020. 459 MVP participants with a suspected FH-associated variant were recruited and assessed for eligibility.
Pre-assignment details
347 participants were excluded from randomization due to: not meeting inclusion criteria, unable to contact, declined to participate, lost to follow up, withdrew, or deceased.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Results Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization. | 55 |
| Delayed Results Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization. | 57 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
| Overall Study | Did not complete testing | 3 | 13 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Delayed Results | Total | Immediate Results |
|---|---|---|---|
| Age, Continuous | 65.2 Years STANDARD_DEVIATION 12.6 | 65.9 Years STANDARD_DEVIATION 13.3 | 66.7 Years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 101 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| LDL-C | 104.7 mg/dL | 109.5 mg/dL | 114.4 mg/dL |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 31 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 33 Participants | 72 Participants | 39 Participants |
| Sex: Female, Male Female | 7 Participants | 18 Participants | 11 Participants |
| Sex: Female, Male Male | 50 Participants | 94 Participants | 44 Participants |
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
LDL-C Change
Change in LDL-C after 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Results | LDL-C Change | -8.0 mg/dL | Standard Deviation 32.3 |
| Delayed Results | LDL-C Change | 2.4 mg/dL | Standard Deviation 28.9 |
Secondary
LDL-C Target
The number of participants meeting clinically significant LDL-C targets (\< 100mg/dL for primary prevention and \<70 mg/dL for secondary prevention) at 6 months.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Results | LDL-C Target | 15 Participants |
| Delayed Results | LDL-C Target | 14 Participants |
Secondary
Pharmacotherapy
The number of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Results | Pharmacotherapy | 11 Participants |
| Delayed Results | Pharmacotherapy | 5 Participants |
Other Pre-specified
Cascade Testing
The number of first-degree relatives having undergone genetic testing at 6 months.
Time frame: 6 months
Population: Only the participants in the immediate results arm completed this survey measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Results | Cascade Testing | 3 Participants |
| Delayed Results | Cascade Testing | 0 Participants |
Other Pre-specified
Lifestyle Behaviors
The number of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.
Time frame: 6 months
Population: Survey responses fully or partially missing from some participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Results | Lifestyle Behaviors | 6-month physical activity | YES, I have been for MORE than 6 months | 30 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month physical activity | YES, I have, but for less than 6 months | 3 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month physical activity | NO, but I intend to in the next 30 days | 4 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month physical activity | NO, but I intend to in the next 6 months | 6 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month physical activity | NO, and I do NOT intend to in the next 6 months | 7 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month saturated fat consumption | YES, I have been for MORE than 6 months | 23 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month saturated fat consumption | YES, I have, but for less than 6 months | 2 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, but I intend to in the next 30 days | 1 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, but I intend to in the next 6 months | 3 Participants |
| Immediate Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, and I do NOT intend to in the next 6 months | 19 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, but I intend to in the next 30 days | 3 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month physical activity | YES, I have been for MORE than 6 months | 27 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month saturated fat consumption | YES, I have been for MORE than 6 months | 28 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month physical activity | YES, I have, but for less than 6 months | 4 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, and I do NOT intend to in the next 6 months | 13 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month physical activity | NO, but I intend to in the next 30 days | 6 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month saturated fat consumption | YES, I have, but for less than 6 months | 0 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month physical activity | NO, but I intend to in the next 6 months | 1 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month saturated fat consumption | NO, but I intend to in the next 6 months | 0 Participants |
| Delayed Results | Lifestyle Behaviors | 6-month physical activity | NO, and I do NOT intend to in the next 6 months | 6 Participants |
Other Pre-specified
Medication Adherence
Medication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ).
Time frame: 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Neither agree nor disagree | 1 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Strongly agree | 8 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Strongly agree | 2 Participants |
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Agree | 6 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Disagree | 24 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Strongly agree | 6 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Strongly disagree | 10 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Disagree | 12 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Neither agree nor disagree | 8 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Agree | 20 Participants |
| Immediate Results | Medication Adherence | Medicines do more harm than good | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Disagree | 10 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Strongly agree | 1 Participants |
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Strongly agree | 0 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Agree | 6 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Strongly disagree | 3 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Disagree | 33 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Neither agree nor disagree | 4 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Strongly disagree | 6 Participants |
| Immediate Results | Medication Adherence | Most medicines are addictive | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Neither agree nor disagree | 11 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Strongly agree | 1 Participants |
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Agree | 3 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Agree | 0 Participants |
| Immediate Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Disagree | 34 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Strongly disagree | 1 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Strongly disagree | 14 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Strongly agree | 7 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Neither agree nor disagree | 1 Participants |
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Disagree | 30 Participants |
| Immediate Results | Medication Adherence | All medicines are poisons | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Agree | 22 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Strongly agree | 2 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Agree | 24 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Agree | 11 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Disagree | 12 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Disagree | 14 Participants |
| Immediate Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Strongly disagree | 16 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Strongly disagree | 7 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Strongly disagree | 3 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Neither agree nor disagree | 16 Participants |
| Immediate Results | Medication Adherence | Doctors use too many medications | Neither agree nor disagree | 5 Participants |
| Immediate Results | Medication Adherence | Natural remedies are safer than medicines | Did not respond/ Missing | 5 Participants |
| Immediate Results | Medication Adherence | Doctors place too much trust in medicines | Neither agree nor disagree | 6 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Strongly disagree | 6 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Neither agree nor disagree | 1 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Strongly agree | 6 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Agree | 14 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Disagree | 18 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Strongly disagree | 0 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Neither agree nor disagree | 7 Participants |
| Delayed Results | Medication Adherence | Doctors use too many medications | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Strongly agree | 0 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Agree | 0 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Disagree | 32 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Strongly disagree | 10 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Neither agree nor disagree | 3 Participants |
| Delayed Results | Medication Adherence | People who take medicines should stop their treatment every now and then | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Strongly agree | 2 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Disagree | 15 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Strongly disagree | 1 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Neither agree nor disagree | 9 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Strongly agree | 3 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Agree | 17 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Disagree | 15 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Strongly disagree | 0 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Neither agree nor disagree | 10 Participants |
| Delayed Results | Medication Adherence | Doctors place too much trust in medicines | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Strongly agree | 1 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Agree | 3 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Disagree | 25 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Strongly disagree | 9 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Neither agree nor disagree | 7 Participants |
| Delayed Results | Medication Adherence | Medicines do more harm than good | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Strongly agree | 1 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Agree | 5 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Disagree | 32 Participants |
| Delayed Results | Medication Adherence | Most medicines are addictive | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Strongly agree | 0 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Agree | 0 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Disagree | 28 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Strongly disagree | 16 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Neither agree nor disagree | 1 Participants |
| Delayed Results | Medication Adherence | All medicines are poisons | Did not respond/ Missing | 12 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Strongly agree | 2 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Agree | 5 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Disagree | 20 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Strongly disagree | 3 Participants |
| Delayed Results | Medication Adherence | Natural remedies are safer than medicines | Neither agree nor disagree | 15 Participants |
| Delayed Results | Medication Adherence | If doctors have more time with patients they would prescribe fewer medicines | Agree | 18 Participants |
Other Pre-specified
Quality of Life (Veterans RAND Survey)
Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores (Physical Component Score and a Mental Component Score) ranging from 0-100, with a higher score indicating better health.
Time frame: 6 months
Population: Survey responses fully or partially missing from some participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Results | Quality of Life (Veterans RAND Survey) | Physical component: baseline | 38.32 score on a scale | Standard Deviation 11.05 |
| Immediate Results | Quality of Life (Veterans RAND Survey) | Physical component: change | 0.78 score on a scale | Standard Deviation 4.45 |
| Immediate Results | Quality of Life (Veterans RAND Survey) | Mental component: change | -0.403 score on a scale | Standard Deviation 6.29 |
| Immediate Results | Quality of Life (Veterans RAND Survey) | Mental component: baseline | 47.78 score on a scale | Standard Deviation 13.98 |
| Immediate Results | Quality of Life (Veterans RAND Survey) | Physical component: 6-month | 39.10 score on a scale | Standard Deviation 11.44 |
| Immediate Results | Quality of Life (Veterans RAND Survey) | Mental component: 6-month | 47.38 score on a scale | Standard Deviation 14.29 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Mental component: change | 0.31 score on a scale | Standard Deviation 4.66 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Mental component: 6-month | 49.99 score on a scale | Standard Deviation 12.98 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Physical component: baseline | 39.08 score on a scale | Standard Deviation 14.47 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Physical component: 6-month | 40.58 score on a scale | Standard Deviation 14.14 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Physical component: change | 1.5 score on a scale | Standard Deviation 4.83 |
| Delayed Results | Quality of Life (Veterans RAND Survey) | Mental component: baseline | 49.69 score on a scale | Standard Deviation 12.98 |
Other Pre-specified
Smoking Status
6-month smoking status
Time frame: 6-month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate Results | Smoking Status | Quit > 6 months | 30 Participants |
| Immediate Results | Smoking Status | Never smoked | 15 Participants |
| Immediate Results | Smoking Status | Current smoker | 4 Participants |
| Immediate Results | Smoking Status | Quit within 6 months | 1 Participants |
| Delayed Results | Smoking Status | Current smoker | 3 Participants |
| Delayed Results | Smoking Status | Never smoked | 23 Participants |
| Delayed Results | Smoking Status | Quit within 6 months | 2 Participants |
| Delayed Results | Smoking Status | Quit > 6 months | 16 Participants |