Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Feasibility of handheld cardiac ultrasound performed by general practitioners supported by automatic interpretation of left ventricular function. |
Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the general practitioners and successfully automatically interpreted |
Feasibility will be tested on day 0 (time of study inclusion) |
|
Other |
Feasibility of handheld cardiac ultrasound performed by general practitioners with expert support by telemedicine |
Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the general practitioners and successfully interpreted by experts utilizing a near real-time telemedicine approach. |
Feasibility will be tested on day 0 (time of study inclusion) |
|
Other |
Reliability of handheld cardiac ultrasound performed by general practitioners |
Reliability, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the operator. |
Reliability will be tested on day 0 (time of study inclusion) |
|
Other |
Reliability of handheld cardiac ultrasound performed by general practitioners supported by automatic interpretation of left ventricular function. |
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation of left ventricular function by the algorithms included in the handheld ultrasound device compared to Reference imaging by specialists in cardiology |
Reliability will be tested on day 0 (time of study inclusion) |
|
Other |
Reliability of handheld cardiac ultrasound performed by general practitioners with expert support by telemedicine |
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology |
Reliability will be tested on day 0 (time of study inclusion) |
|
Other |
Feasibility of handheld cardiac ultrasound performed by nurses supported by automatic interpretation of left ventricular function. |
Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses and successfully automatically interpreted |
Feasibility will be tested on day 0 (time of study inclusion) |
|
Other |
Feasibility of handheld cardiac ultrasound performed by nurses with expert support by telemedicine |
Feasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the algorithms included in the handheld ultrasound device. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses and successfully interpreted by experts utilizing a near real-time telemedicine approach. |
Feasibility will be tested on day 0 (time of study inclusion) |
|
Other |
Reliability of handheld cardiac ultrasound performed by nurses supported by automatic interpretation of left ventricular function. |
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation of left ventricular function by the algorithms included in the handheld ultrasound device compared to Reference imaging by specialists in cardiology |
Reliability will be tested on day 0 (time of study inclusion) |
|
Other |
Reliability of handheld cardiac ultrasound performed by nurses with expert support by telemedicine |
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology |
Reliability will be tested on day 0 (time of study inclusion) |
|
Other |
Time use of handheld cardiac ultrasound performed by inexperienced users with expert support by telemedicine |
Time used for the sum of recording of cardiac ultrasound examination, telemedicine transfer of recordings and telemedicine interpretation by experts. |
Time consumption will be tested on day 0 (time of study inclusion) |
|
Other |
Quality of cardiac ultrasound performed by general practitioners |
Evaluation of the quality of recordings of cardiac ultrasound obtained by the general practitioners as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist. |
Quality will be tested on day 0 (time of study inclusion) |
|
Other |
Quality of cardiac ultrasound performed by nurses |
Evaluation of the quality of recordings of cardiac ultrasound obtained by the nurses as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist. |
Quality will be tested on day 0 (time of study inclusion) |
|
Other |
Evaluation of different methods for cardiac ultrasound user support |
User evaluation of the usability assessed by the system usability scale. |
Usability of methods of support will be tested on day 0 (time of study inclusion) |
|
Other |
Health care related cost of diagnostic handheld ultrasound algorithms in patients with suspected heart failure examinations supported by telemedicine |
Health care related cost will be evaluated by the costs related to the diagnostic algorithms in patients with suspected heart failure |
Health care related cost will be tested on day 0 (time of study inclusion) |
|
Primary |
Clinical influence of diagnostic ultrasound examinations supported by telemedicine |
Clinical influence will be evaluated by the proportion of patients correct evaluated to have or not to have heart failure by the use of handheld ultrasound |
Clinical influence will be tested on day 0 (time of study inclusion) |
|
Secondary |
Feasibility of handheld cardiac ultrasound performed by general practitioners |
ReliabiFeasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the operator. |
Feasibility will be tested on day 0 (time of study inclusion) |
|