Bradycardia, Cardiac Pacemaker Artificial, Cardiac Rhythm Disorder
Conditions
Brief summary
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
Detailed description
The purpose of this study is to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers. The preference study is designed to elicit patient preferences for risks and features that vary between a dual chamber leadless pacemaker system and a dual chamber transvenous pacemaker system, to quantify their relative importance.
Interventions
Patient preference survey on implantable cardiac pacemaker systems
Sponsors
Study design
Eligibility
Inclusion criteria
* Able to read and speak English to consent to participate in the survey * Willing and able to use a tablet or computer to complete the survey * Scheduled to undergo evaluation for a de novo cardiac pacemaker at the study site (patient may or may not have a known indication for a pacemaker at the time)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Baseline | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker non-removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. |
| Probability of Choosing Specified Pacemakers - All 3 Profiles | Baseline | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable, leadless pacemaker non-removable, or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. |
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Baseline | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or leadless pacemaker non-removable. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. |
| Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Baseline | Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another. |
| Mean Rankings for Pacemaker Device Features | Baseline | Ranking of six pacemaker device features from most concerning (1) to least concerning (6) |
| Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Baseline | The preference weights for the RPL model. Effect-coded parameters generate log-odds preference weights representing the relative strength of preference for each attribute level versus the mean effect across levels normalized at zero. A higher weight indicates a more preferred level while a lower weight indicates a less preferred level. |
| Maximum-acceptable Risks of a Complication | Baseline | Maximum-acceptable risk (MAR) of a complication was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represents risk level patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. |
| Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Baseline | The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity. |
| Maximum-acceptable Risks of an Infection | Baseline | Maximum-acceptable risk (MAR) of an infection was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represent the risk that patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Discrete Choice Experiment Questions Answered | Baseline | Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions. |
| Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Baseline | Respondent characteristics can be associated with class membership probabilities to profile the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval. |
| Constrained 2-class Latent-class Model Preference Weights | Baseline | Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from Aveir™ DR IDE trial study sites. One-hundred seventeen patients were recruited and completed the survey instrument.
Participants by arm
| Arm | Count |
|---|---|
| Patient Preferences Survey Patients were recruited from Aveir™ DR IDE trial study sites. To minimize selection bias, patients meeting specified criteria and agreeing to participate were asked to complete the patient-preference survey before being approached about their potential interest in enrolling in the IDE trial. Thus, they completed the patient-preference survey before they received information about dual-chamber pacemakers from the site physician and/or the Aveir™ DR IDE study and before they received a pacemaker if they ultimately received one. | 117 |
| Total | 117 |
Baseline characteristics
| Characteristic | Patient Preferences Survey |
|---|---|
| Age, Customized | 67.3 years STANDARD_DEVIATION 14.6 |
| BMI | 28.1 kg/m^2 STANDARD_DEVIATION 5.6 |
| Employment Disabled | 11 Participants |
| Employment Employed with hourly pay | 13 Participants |
| Employment Employed with salary | 18 Participants |
| Employment Homemaker | 4 Participants |
| Employment Not working and NOT looking for a job | 1 Participants |
| Employment Not working but looking for a job | 1 Participants |
| Employment Other | 0 Participants |
| Employment Retired | 68 Participants |
| Employment Self-employed | 9 Participants |
| Employment Student | 1 Participants |
| Employment Unable to work or on disability | 1 Participants |
| Employment Volunteer work | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Health Insurance I do not have health insurance | 2 participants |
| Health Insurance Medicaid | 7 participants |
| Health Insurance Medicare alone | 27 participants |
| Health Insurance Medicare and supplemental insurance | 53 participants |
| Health Insurance Other | 1 participants |
| Health Insurance Through a state or federal insurance exchange | 11 participants |
| Health Insurance Through my (or another person's) employer or union | 26 participants |
| Health Insurance Veterans affairs | 6 participants |
| Height | 67.8 inches STANDARD_DEVIATION 4.5 |
| Highest Level of Education 4-year college degree (such as BA, BS) | 26 Participants |
| Highest Level of Education Associate's degree or 2-year college degree | 16 Participants |
| Highest Level of Education Graduate or professional degree (such as MBA, MS, MA, MD, PhD) | 15 Participants |
| Highest Level of Education High school or equivalent (such as GED) | 19 Participants |
| Highest Level of Education Less than high school | 4 Participants |
| Highest Level of Education Missing | 2 Participants |
| Highest Level of Education Some college but no degree | 22 Participants |
| Highest Level of Education Some graduate school but no degree | 3 Participants |
| Highest Level of Education Some high school | 3 Participants |
| Highest Level of Education Technical school | 7 Participants |
| Marital Status Divorced or separated | 19 Participants |
| Marital Status Married/living as married | 81 Participants |
| Marital Status Other | 1 Participants |
| Marital Status Single/never married | 7 Participants |
| Marital Status Widowed/surviving partner | 9 Participants |
| Race American Indian or Alaska Native | 1 Participants |
| Race Asian | 3 Participants |
| Race Black or African American | 4 Participants |
| Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race Other | 1 Participants |
| Race White | 110 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 68 Participants |
| Weight | 184.9 pounds STANDARD_DEVIATION 43.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Maximum-acceptable Risks of a Complication
Maximum-acceptable risk (MAR) of a complication was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represents risk level patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in leadless class willing to accept MAR for removable leadless rather than transvenous | 13.4 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in transvenous class willing to accept MAR for removable leadless rather than transvenous | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in leadless class willing to accept MAR for transvenous rather than removable leadless | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in transvenous class willing to accept MAR for transvenous rather than removable leadless | 7.6 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless | 14.5 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in leadless class willing to accept MAR for removable rather than nonremovable leadless | 5.1 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Patients in transvenous class willing to accept MAR for removable rather than nonremovable leadless | 6.3 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Transvenous class patients willing to accept MAR for 10 yrs since government approval rather than 2 | 0.7 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Leadless class patients willing to accept MAR for 10 yrs since government approval rather than 2 | 6.8 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Leadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 2 | 6.7 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of a Complication | Leadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort | 2.0 percentage of maximum-acceptable risk |
Maximum-acceptable Risks of an Infection
Maximum-acceptable risk (MAR) of an infection was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represent the risk that patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in leadless class willing to accept MAR for removable leadless rather than transvenous | 16.8 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in transvenous class willing to accept MAR for removable leadless rather than transvenous | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in leadless class willing to accept MAR for transvenous rather than removable leadless | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in transvenous class willing to accept MAR for transvenous rather than removable leadless | 8.9 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless | 0 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless | 17.8 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in leadless class willing to accept MAR for removable rather than nonremovable leadless | 4.7 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Patients in transvenous class willing to accept MAR for removable rather than nonremovable leadless | 6.6 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Transvenous class patients willing to accept MAR for 10 yrs since government approval rather than 2 | 0.8 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Leadless class patients willing to accept MAR for 10 yrs since government approval rather than 2 | 7.6 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Leadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 2 | 7.5 percentage of maximum-acceptable risk |
| Patient Preferences Survey | Maximum-acceptable Risks of an Infection | Leadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort | 1.9 percentage of maximum-acceptable risk |
Mean Rankings for Pacemaker Device Features
Ranking of six pacemaker device features from most concerning (1) to least concerning (6)
Time frame: Baseline
Population: Each respondent was asked to rank the six features (insertion procedure, pacemaker type, pacemaker location, no heavy lifting, scar on chest, and lump on chest) from most concerning (1) to least concerning (6). The table reports the mean ranking for each device feature evaluated on a scale from 1-6. The number of respondents is 90 because 27 respondents skipped the ranking questions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | Insertion procedure | 2.3 score on a scale | Standard Deviation 1.3 |
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | Pacemaker type | 2.6 score on a scale | Standard Deviation 1.2 |
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | Pacemaker location | 2.2 score on a scale | Standard Deviation 1 |
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | No heavy lifting for 6 weeks | 4.7 score on a scale | Standard Deviation 1.5 |
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | Scar on chest | 5.1 score on a scale | Standard Deviation 1 |
| Patient Preferences Survey | Mean Rankings for Pacemaker Device Features | Lump on chest | 4.1 score on a scale | Standard Deviation 1.4 |
Probability of Choosing Specified Pacemakers - All 3 Profiles
Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable, leadless pacemaker non-removable, or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability leadless class to choose profile: leadless pacemaker removable | 41.7 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability transvenous class to choose profile: leadless pacemaker removable | 8.0 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability leadless class to choose profile: leadless pacemaker non-removable | 27.4 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability transvenous class to choose profile: leadless pacemaker non-removable | 4.5 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability leadless class to choose profile: pacemaker with leads | 30.9 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - All 3 Profiles | Probability transvenous class to choose profile: pacemaker with leads | 87.5 percentage of probability |
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads
Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker non-removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Probability leadless class to choose profile: leadless pacemaker non-removable | 46.9 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Probability transvenous class to choose profile: leadless pacemaker non-removable | 4.9 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Probability leadless class to choose profile: pacemaker with leads | 53.1 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads | Probability transvenous class to choose profile: pacemaker with leads | 95.1 percentage of probability |
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable
Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or leadless pacemaker non-removable. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Probability leadless class to choose profile: leadless pacemaker removable | 60.4 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Probability transvenous class to choose profile: leadless pacemaker removable | 64.0 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Probability leadless class to choose profile: leadless pacemaker non-removable | 39.6 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable | Probability transvenous class to choose profile: leadless pacemaker non-removable | 36 percentage of probability |
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads
Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Probability leadless class to choose profile: leadless pacemaker removable | 57.4 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Probability transvenous class to choose profile: leadless pacemaker removable | 8.4 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Probability leadless class to choose profile: pacemaker with leads | 42.6 percentage of probability |
| Patient Preferences Survey | Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads | Probability transvenous class to choose profile: pacemaker with leads | 91.6 percentage of probability |
Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)
The preference weights for the RPL model. Effect-coded parameters generate log-odds preference weights representing the relative strength of preference for each attribute level versus the mean effect across levels normalized at zero. A higher weight indicates a more preferred level while a lower weight indicates a less preferred level.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Pacemaker type - Leadless, removable | 0.340 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Pacemaker type - Leadless, non-removable | -0.310 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Pacemaker type - Transvenous | -0.030 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Battery life - 15 years | 0.454 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Battery life - 12 years | 0.253 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Battery life - 8 years | -0.235 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Battery life - 5 years | -0.473 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Time since regulatory approval - 10 years | 0.212 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Time since regulatory approval - 2 years | -0.212 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Discomfort for 6 months - No discomfort | 0.099 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Discomfort for 6 months - Discomfort | -0.099 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of Complication - 1% | 0.957 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of Complication - 5% | 0.396 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of Complication - 10% | -0.390 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of Complication - 20% | -0.963 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of infection - 1% | 0.961 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of infection - 5% | 0.408 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of infection - 10% | -0.132 preference weights |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) | Risk of infection - 20% | -1.237 preference weights |
Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations
The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Pacemaker type - Leadless, removable | 0.490 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Pacemaker type - Leadless, non-removable | 1.411 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Pacemaker type - Transvenous | 0.921 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Battery life - 15 years | 0.562 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Battery life - 12 years | 0.420 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Battery life - 8 years | 0.242 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Battery life - 5 years | 0.741 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Time since regulatory approval - 10 years | 0.345 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Time since regulatory approval - 2 years | 0.345 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Discomfort for 6 months - No discomfort | 0.121 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Discomfort for 6 months - Discomfort | 0.121 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of Complication - 1% | 0.606 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of Complication - 5% | 0.346 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of Complication - 10% | 0.838 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of Complication - 20% | 1.790 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of infection - 1% | 0.683 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of infection - 5% | 0.293 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of infection - 10% | 0.077 standard deviation |
| Patient Preferences Survey | Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations | Risk of infection - 20% | 1.052 standard deviation |
Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class
Respondent characteristics can be associated with class membership probabilities to profile the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Male | 1.15 odds ratio |
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Age, per 1-year increase | 0.99 odds ratio |
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | BMI, per unit increase | 1.05 odds ratio |
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Major surgery requiring hospitalization in the last 5 years | 1.55 odds ratio |
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Sedentary lifestyle with light activity | 2.73 odds ratio |
| Patient Preferences Survey | Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class | Interaction of lifestyle and BMI | 0.98 odds ratio |
Constrained 2-class Latent-class Model Preference Weights
Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Preferences Survey | Constrained 2-class Latent-class Model Preference Weights | Leadless Class | 50.5 percentage of participants |
| Patient Preferences Survey | Constrained 2-class Latent-class Model Preference Weights | Transvenous class | 49.6 percentage of participants |
Number of Discrete Choice Experiment Questions Answered
Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Preferences Survey | Number of Discrete Choice Experiment Questions Answered | 8 questions | 41 Participants |
| Patient Preferences Survey | Number of Discrete Choice Experiment Questions Answered | 12 questions | 76 Participants |