Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to review the results of annual radiation doses received by interventional cardiologists and radiologists in France. The results of this study will allow the improvement of classification of interventional cardiology and radiology activities and procedures to help define radiation dose constraints for occupational exposure, according to the number and types of procedures performed. The study is based on the hypothesis that some specialties in interventional cardiology (cardiology or rythmology procedures) and in interventional radiology (vascular, neuroradiology, osteoarticular) and some types of procedures present greater exposure risks for interventional cardiologists and radiologists. It is expected that the annual radiation dose limits for workers can be exceeded if good practices for both patient and worker radiation protection are not applied. Also, dosimetry equipment used to detect radiation dose although provided to the workers are not systematically worn by the physician during the procedure . The study is likely to show that for an equivalent speciality and number of procedures per type of act, the correct use of collective and personal radiation protection equipment (préciser) will lower occupational radiation exposure of physician . Similarly, for an equivalent activity and number of procedures per type of act , a trained physician would have a lower occupational exposure than an untrained physician. The physician's radiation exposure should therefore increase with a greater number of procedures per type of procedure performed and as the radiation dose delivered to the patient increase. Finally, there would be a different correlation between patient's radiation dose and physician's exposure depending on specialty, procedures, modality, experience and availability and use of collective and personal radiation protection equipment.

Official Title
-----------------
Multicenter Retrospective Study of Passive Dosimeter Results for Interventional Cardiologists and Radiologists

Conditions
-----------------
Radiation Exposure

Intervention / Treatment
-----------------
* Other: Dosimetric monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician performing interventional cardiology or radiology procedures with a fixed C-arm system Physician systematically wearing at least one of the following personal dosimeters: whole body, extremities, lens. Exclusion Criteria: Physician who did not perform an interventional procedure during the observation period (2019-2021) For the primary endpoint by year, physician with more than 3 months of missing data (more than one 3-month period or more than 3 1-month periods)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiology: Coronary/Valvular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Cardiology: Rhythmology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Cardiology: Mixed<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Simple Vascular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Complex Vascular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Mixed Vascular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Simple Osteoarticular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Complex Osteoarticular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Mixed Osteoarticular<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Simple Neuroradiology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Complex Neuroradiology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Mixed Neuroradiology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Mixed<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Simple Oncology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Complex Oncology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|
| Radiology: Mixed Oncology<br> | Other: Dosimetric monitoring<br>* Dosimetric monitoring of workers Information retrieved from passive dosimeters results from the years 2019, 2020 and 2021<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2019 | 
| Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2020 | 
| Annual occupational radiation exposure levels for effective dose for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2021 | 
| Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2019 | 
| Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2020 | 
| Annual occupational radiation exposure levels for equivalent doses to the skin for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2021 | 
| Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2019 | 
| Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2020 | 
| Annual occupational radiation exposure levels for equivalent doses to the lens of the eye for interventional cardiologists and radiologists according to their specialty, activity and type of procedures performed | mSv | 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Availability and frequency of use for each passive dosimeter | Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Availability and frequency of use for each passive dosimeter | Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Availability and frequency of use for each passive dosimeter | Yes/no for each passive dosimeter (whole body, extremities, lens) 4 categories: worn systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| High and low radiation protection equipment availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| High radiation protection alone (ceiling suspension) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Low radiation protection alone (windscreen) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Radioprotective sterile fields (e.g. RADPAD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Arm support systems with a radioprotection (e.g. STARBOARD) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Lead apron or vests and skirts availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Leaded collars or thyroid protectors availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019, | 
| Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Leaded sleeves (handle) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019, 2020 and 2021 | 
| Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Leaded eye protection (glasses, over-glasses or visors) availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Gloves use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2019 | 
| Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2020 | 
| Leaded head caps availability and use by interventional physicians according to specialty, activity and type of procedures performed | Yes/no; classed as used systematically (100% of the time), often (> 50% of the time), infrequently (<50% of the time) or never (not worn) according to specialty, activity and type of procedures performed | 2021 | 
| Patient radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2019, | 
| Patient radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2020 | 
| Patient radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2021 | 
| Worker radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2019 | 
| Worker radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2020 | 
| Worker radiation protection training status according to specialty, activity and type of procedures performed | Up-to-date/needs renewing/never completed | 2021 | 
| Physician exposure according to total number of procedures | mSv: Information taken from Dosimetry Archiving and Communication System | 2019 | 
| Physician exposure according to total number of procedures | mSv: Information taken from Dosimetry Archiving and Communication System | 2020 | 
| Physician exposure according to total number of procedures | mSv: Information taken from Dosimetry Archiving and Communication System | 2021 | 
| Physician exposure according to number of procedures by type of specialty | mSv: Information taken from Dosimetry Archiving and Communication System | 2019 | 
| Physician exposure according to number of procedures by type of specialty | mSv: Information taken from Dosimetry Archiving and Communication System | 2020 | 
| Physician exposure according to number of procedures by type of specialty | mSv: Information taken from Dosimetry Archiving and Communication System | 2021 | 
| Physician exposure according to number of procedures by modality | mSv: Information taken from Dosimetry Archiving and Communication System | 2219 | 
| Physician exposure according to number of procedures by modality | mSv: Information taken from Dosimetry Archiving and Communication System | 2020 | 
| Physician exposure according to number of procedures by modality | mSv: Information taken from Dosimetry Archiving and Communication System | 2021 | 
| Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | Gy.cm² | 2019 | 
| Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | Gy.cm² | 2020 | 
| Relationships between the whole body, extremity and lens radiation exposures and the Dose Area Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | Gy.cm² | 2021 | 
| Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy | 2019 | 
| Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy | 2020 | 
| Relationships between whole body, extremity and lens exposures and the Air Kerma at the interventional reference point patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy | 2021 | 
| Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy.cm | 2019 | 
| Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy.cm | 2020 | 
| Relationships between the physician's whole body, extremity and lens exposures and the Dose Length Product patient dosimetric indicator per physician (dosimetric indicators) according to specialty, activity and type of procedures performed | mGy.cm | 2021 |