Patient Preference Survey
OtherPatient preference survey on implantable cardiac pacemaker systems
NCT Number: NCT05327101
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
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Notify Me18 year and older
All sexes
Observational
Honor Health, Scottsdale, Arizona, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient preference survey on implantable cardiac pacemaker systems
Time frame: Baseline
Ranking of six pacemaker device features from most concerning (1) to least concerning (6)
Time frame: 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.
Time frame: Baseline
The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Abbott Medical Devices
Industry
Quantifying Patient Preferences for Leadless Pacemaker Devices
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