Background
Methods
Design
Objectives
Site and patient selection
Data collection
Site Questionnaire | Enrollment | Demographics | Information on AF | Medical treatment Prior to enrollment | Diagnostic Procedures | Acute Treatment of AF | Discharge | Follow-up at 60 days |
---|---|---|---|---|---|---|---|---|
Center characteristics (type, size, units) | Demographics (age, gender, ethnicity) | Anthropometrics (ht, wt, bp) | Current episode (symptoms, type, time of onset, triggers) | ATT, rate control, other (type, indication, dose) | Laboratory measures (Hg, K, sCr, PG, INR-T) | AA/Rate control (type, dose), | Basics (vital status, date, time, destination) | Contact information (mode, date) |
Specialties at site (clinics, physicians, number and availability, procedures available) | Admission information (date, time, site, reason) | Medical history (CVD, CHF, details thereof) | History of AF (date, frequency, nature, treatment) | ECG (rhythm, rate, PR & QT interval, QRS duration, LVH) | PCV & ECV (labs before, after, type, dose/joules & number of shocks route, worked?, time to SR, SR after) | Rhythm at discharge; LoS by unit | Basics (vital status, current rhyuthm) | |
Most frequent and most preferred approach to cardioversion | ECG information (date, time, results) | History of risk factors (family hx of disease, DM, smoking, htn, hyperlipidemia) | TTE (LA size, LVEDD, LV-EF, LVH) | Catheter ablation (type, technique, location, status), pacemaker, ICD implantation (type, indication) | Complications and AEs experienced (specified, date) | Recurrence and rehospitalization since discharge (date, LoS, documentation, CV info., reason) | ||
Other comorbidities | TEE (findings) | Surgery (time, date, location, technique) | Discharge medications (type, dose, indication) | Complications and AEs experienced (specified, date) | ||||
Chest X-Ray, Stress test, Holter ECG, MRI, CT exam | Discharge medications (type, dose, indication) |
Study organization
Data management
Statistical considerations
Results
Total | AUS | BR | FR | DEU | ITL | NL | POL | ESP | SWE | UK | |
---|---|---|---|---|---|---|---|---|---|---|---|
Number of sites
| 175 | 8 | 10 | 27 | 22 | 10 | 6 | 15 | 49 | 14 | 14 |
% (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | |
Hospitals, n
|
175
|
8
|
10
|
27
|
22
|
10
|
6
|
15
|
49
|
14
|
14
|
Academic/Teaching
| 70.5 (122/173) | 100 (8/8) | 70.0 (7/10) | 40.0 (10/25) | 95.5 (21/22) | 20.0 (2/10)- | 66.6 (4/6) | 80.0 (12/15) | 81.6 (40/49) | 42.9 (6/14)- | 85.7 (12/14) |
Non-academic
| 29.5 (51/173) | - | 30.0 (3/10) | 60.0 (15/25) | 4.5 (1/22) | 80.0 (8/10) | 33.3 (2/6) | 20.0 (3/15) | 18.4 (9/49) | 57.1 (8/14) | 14.3 (2/14) |
median (IQR) | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | median, IQR | |
n* | n | n | n | n | n | n | n | n | n | n | |
Total number of beds in hospital
| 510 (350–880) | 632 (493.5-750) | 307 (239–520) | 500 (350–1133) | 803 (389–1000) | 233 (120–450) | 798 (550–994) | 400 (200–726) | 580 (400–918) | 450 (92–605) | 620 (500–1000) |
n = 171 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of beds in Cardiology department
| 38.5 (20–65) | 30(17.5-39) | 27 (12–70) | 57 (40–80) | 81 (70–100) | 18 (15–30) | 53 (24–60) | 46(37–80) | 30 (18–40) | 22 (11–36) | 32 (20–80) |
n = 172 | n = 8 | n = 10 | n = 24 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of beds in CCU/ICU
| 14 (8–25) | 25 (13–43.5) | 29 (14–37) | 12 (8–15.5) | 20 (12–30) | 6 (0–10) | 20 (12–27) | 10 (7–21) | 15 (11–30) | 8 (4–14) | 10 (8–18) |
n = 172 | n = 8 | n = 10 | n = 24 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of beds in EP
| 0 (0–9) | 0 | 2 (0–6) | 11 (0–19) | 11 (0–30) | 0 (0–3) | 6 (0–16) | 2 (0–10) | 0 (0–3) | 0 (0–0) | 0 (0–6) |
n = 172 | n = 8 | n = 10 | n = 24 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of beds in Cardiac surgery dept. | 0 (0–25) | 17 (10.5-25) | 10 (0–24) | 15 (0–35) | 11 (0–50) | 0 (0–16) | 31 (0–34) | 10 (0–30) | 0 (0–18) | 0 (0–0) | 0 (0–28) |
n = 171 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of Cardiologists
| 11 (7–20) | 12 (10.5-16) | 45 (35–237) | 10 (7–20) | 9 (6–11) | 16 (5–20) | 17 (9–26) | 12 (9–20) | 12 (9–20) | 10 (3–22) | 6 (4–9) |
n = 171 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of Electrophysiologists
| 2 (1–4) | 3 (1–4) | 5 (2–5) | 3 (2–4) | 2 (1–3) | 4 (1–4) | 4 (0–4) | 4 (1–5) | 4 (1–5) | 1 (0–3) | 1 (0–2) |
n = 171 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
Number of Cardiac surgeons
| 2 (0–6) | 4 (2.5-5.5) | 14 (6–33) | 3 (0–4) | 3 (0–8) | 0 (0–11) | 6 (0–7) | 2 (0–6) | 2 (0–6) | 0 (0–0) | 0 (0–6) |
n = 171 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 49 | n = 14 | n = 14 | |
% (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | |
Anticoagulation clinics
| 65.9 (114/173) | 25.0 (2/8) | 90.0 (9/10) | 20.0 (5/25) | 36.4 (8/22) | 80.0 (8/10) | 50.0 (3/6) | 53.3 (8/15) | 95.9 (47/49) | 78.6 (11/14) | 92.9 (13/14) |
Heart failure clinics
| 75.1 (130/173) | 87.5 (7/8) | 90.0 (9/10) | 36.0 (9/25) | 63.6 (14/22) | 100 (10/10) | 100 (6/6) | 60.0 (9/15) | 87.8 (43/49) | 85.7 (12/14) | 78.6 (11/14) |
Hypertension clinics
| 60.1 (104/173) | 75.0 (6/8) | 90.0 (9/10) | 24.0 (6/25) | 45.4 (10/22) | 70.0 (7/10) | 33.3 (2/6) | 60.0 (9/15) | 89.8 (44/49) | 42.9 (6/14) | 35.7 (5/14) |
TEE in center
| 94.8 (164/173) | 100 (8/8) | 100 (10/10) | 100 (25/25) | 100 (22/22) | 90.0 (9/10) | 100 (6/6) | 93.3 (14/15) | 91.8 (45/49) | 78.6 (11/14) | 100 (14/14) |
Catheter Ablation
| 66.5 (115/173) | 75.0 (6/8) | 100 (10/10) | 84.0 (21/25) | 81.8 (18/22) | 60.0 (6/10) | 66.7 (4/6) | 80.0 (12/15) | 59.2 (29/49) | 21.4 (3/14) | 42.9 (6/14) |
Pacemaker implantation
| 93.1 (161/173) | 100 (8/8) | 100 (10/10) | 100 (25/25) | 100 (22/22) | 70.0 (7/10) | 100 (6/6) | 93.3 (14/15) | 93.9 (46/49) | 71.4 (10/14) | 92.9 (13/14) |
Defibrillator implantation
| 80.9 (140/173) | 100 (8/8) | 100 (10/10) | 84.0 (21/25) | 100 (22/22) | 70.0 (7/10) | 66.7 (4/6) | 93.3 (14/15) | 73.5 (36/49) | 57.1 (8/14) | 71.4 (10/14) |
Surgical Therapy for AF
| 49.7 (86/173) | 87.5 (7/8) | 90.0 (9/10) | 60.0 (15/25) | 50.0 (11/22) | 50.0 (5/10) | 66.7 (4/6) | 46.7 (7/15) | 40.8 (20/49) | 14.3 (2/14) | 42.9 (6/14) |
Total | AUS | BR | FR | DEU | ITL | NL | POL | ESP | SWE | UK | |
---|---|---|---|---|---|---|---|---|---|---|---|
% (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | % (n/N) | |
Frequency “wait-and-see” approach
| |||||||||||
never
| 17.9 (31/173) | 12.5 (1/8) | 20.0 (2/10) | 12.0 (3/25) | 4.6 (1/22) | 0 | 0 | 20.0 (3/15) | 34.7 (17/49) | 0 | 28.6 (4/14) |
sometimes
| 69.4 (120/173) | 75.0 (6/8) | 50.0 (5/10) | 60.0 (15/25) | 90.9 (20/22) | 80.0 (8/10) | 100 (6/6) | 66.7 (10/15) | 59.2 (29/49) | 92.9 (13/14) | 57.1 (8/14) |
frequent
| 12.7 (22/173) | 12.5 (1/8) | 30.0 (3/10) | 28.0 (7/25) | 4.6 (1/22) | 20.0 (2/10) | 0 | 13.3 (2/15) | 6.1 (3/49) | 7.1 (1/14) | 14.3 (2/14) |
Frequency PCV
| |||||||||||
never
| 0.6 (1/173) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7.1 (1/14) | 0 |
sometimes
| 37.6 (65/173) | 50.0 (4/8) | 20.0 (2/10) | 32.0 (8/25) | 68.2 (15/22) | 40.0 (4/10) | 50.0 (3/6) | 20.0 (3/15) | 14.3 (7/49) | 85.7 (12/14) | 50.0 (7/14) |
frequent
| 61.8 (107/173) | 50.0 (4/8) | 80.0 (8/10) | 68.0 (17/25) | 31.8 (7/22) | 60.0 (6/10) | 50.0 (3/6) | 80.0 (12/15) | 85.7 (42/49) | 7.1 (1/14) | 50.0 (7/14) |
Frequency ECV
| |||||||||||
never
| 0.6 (1/172) | 0 | 0 | 0 | 0 | 10.0 (1/10) | 0 | 0 | 0 | 0 | 0 |
sometimes
| 32.6 (56/172) | 25.0 (2/8) | 30.0 (3/10) | 16.7 (4/24) | 0 | 70.0 (7/10) | 0 | 6.7 (1/15) | 67.4 (33/49) | 14.3 (2/14) | 28.6 (4/14) |
frequent
| 66.9 (115/172) | 75.0 (6/8) | 70.0 (7/10) | 83.3 (20/24) | 100 (22/22) | 20.0 (2/10) | 100 (6/6) | 93.3 (14/15) | 32.6 (16/49) | 85.7 (12/14) | 71.4 (10/14) |
Preferred drugs for PCV* | |||||||||||
Amiodarone
| 85.7 (150/175) | 100 (8/8) | 100 (10/10) | 81.5 (22/27) | 90.9 (20/22) | 60.0 (6/10) | 83.3 (5/6) | 93.3 (14/15) | 85.7 (42/49) | 64.3 (9/14) | 100 (14/14) |
Beta-blocker
| 23.4 (41/175) | 12.5 (1/8) | 40.0 (4/10) | 0 | 40.9 (9/22) | 10.0 (1/10) | 16.7 (1/6) | 53.3 (8/15) | 12.2 (6/49) | 28.6 (4/14) | 50.0 (7/14) |
Dronedarone
| 8.6 (15/175) | 0 | 0 | 0 | 45.5 (10/22) | 0 | 0 | 0 | 0 | 21.4 (3/14) | 14.3 (2/14) |
Flecainide
| 60.6 (106/175) | 75.0 (6/8) | 0 | 33.3 (9/27) | 81.8 (18/22) | 60.0 (6/10) | 100 (6/6) | 0 | 91.8 (45/49) | 35.7 (5/14) | 78.6 (11/14) |
Propafenone
| 26.9 (47/175) | 0 | 70.0 (7/10) | 3.7 (1/27) | 27.3 (6/22) | 80.0 (8/10) | 0 | 80.0 (12/15) | 20.4 (10/49) | 7.1 (1/14) | 14.3 (2/14) |
Sotalol
| 12.0 (21/175) | 75.0 (6/8) | 20.0 (2/10) | 0 | 0 | 10.0 (1/10) | 33.3 (2/6) | 26.7 (4/15) | 2.0 (1/49) | 7.1 (1/14) | 28.6 (4/14) |
Verapamil
| 6.3 (11/175) | 12.5 (1/8) | 10.0 (1/10) | 0 | 0 | 10.0 (1/10) | 0 | 13.3 (2/15) | 8.2 (4/49) | 0 | 14.3 (2/14) |
Other† | 5.1 (9/175) | 0 | 0 | 0 | 0 | 10.0 (1/10) | 33.3 (2/6) | 0 | 6.1 (3/49) | 14.3 (2/14) | 7.1 (1/14) |
Preferred type of ECV
| |||||||||||
Mono
| 5.8 (10/173) | 0 | 10.0 (1/10) | 12.0 (3/25) | 4.6 (1/22) | 10.0 (1/10) | 0 | 0 | 6.1 (3/49) | 7.1 (1/14) | 0 |
Biphasic
| 94.2 (163/173) | 100 (8/8) | 90.0 (9/10) | 88.0 (22/25) | 95.5 (21/22) | 90.0 (9/10) | 100 (6/6) | 100 (15/15) | 93.9 (46/49) | 92.9 (13/14) | 100 (14/14) |
Preferred heart rate target with rate control: | |||||||||||
≤ 80 beats per minute
| 72.5 (124/171) | 100 (8/8) | 40.0 (4/10) | 87.5 (21/24) | 95.5 (21/22) | 90.0 (9/10) | 66.7 (4/6) | 86.7 (13/15) | 55.1 (27/49) | 57.1 (8/14) | 69.2 (9/13) |
≤ 110 beats per minute‡ | 25.1 (43/171) | 0 | 60.0 (6/10) | 12.5 (3/24) | 4.5 (1/22) | 10.0 (1//10) | 33.3 (2/6) | 13.3 (2/15) | 36.7 (18/49) | 42.9 (6/14) | 30.8 (4/13) |
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
|
median, IQR
| |
n§ |
n
|
n
|
n
|
n
|
n
|
n
|
n
|
n
|
n
|
n
| |
No. ECVs/year
| 100 (50–200) | 105 (90–200.5) | 30 (9–70) | 120 (85–200) | 300 (150–500) | 85 (15–200) | 225 (115–300) | 70 (40–120) | 50 (24–126.5) | 225 (80–280) | 111(100–168) |
n = 170 | n = 8 | n = 10 | n = 23 | n = 22 | n = 10 | n = 6 | n = 15 | n = 48 | n = 14 | n = 14 | |
No. PCVs/
year
| 100 (37.5-200) | 102 (32.5-185) | 50 (20–80) | 150 (30–200) | 60 (25–100) | 175 (100–250) | 108 (50–200) | 150 (40–250) | 121 (98–300) | 15 (4–30) | 68 (30–140) |
n = 168 | n = 8 | n = 9 | n = 22 | n = 21 | n = 10 | n = 6 | n = 15 | n = 48 | n = 14 | n = 14 | |
Number of ablation procedures (among those performing ablations) | 156 (53–300) | 46 (35–179) | 64 (20–180) | 300 (112–450) | 300 (155–400) | 210 (120–480) | 440 (279–669) | 105 (53–171) | 125 (40–188) | 250 (120–856) | 35 (19–88) |
n = 112 | n = 6 | n = 10 | n = 19 | n = 18 | n = 6 | n = 4 | n = 12 | n = 29 | n = 3 | n = 5 |
Discussion
Conclusion
Appendix
-
Australia
-
Royal Adelaide Hospital, SA
-
Royal Perth Hospital, WA
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Alfred Hospital, VIC
-
Monash Medical Centre, VIC
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Geelong Hospital, VIC
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Princess Alexandra, QLD
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Liverpool, NSW
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Canberra Hospital, ACT
-
-
Brazil
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Research Ethics Committee of the Institute of Cardiovascular Diseases (Comitê de Ética em Pesquisa do Instituto de Moléstias Cardiovasculares)
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Research Ethics Committee of the HCPA (Comitê de Ética e Pesquisa do HCPA)
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Research Ethics Committee of the University of São Paulo UNIFESP / EPM (Comitê de Ética em Pesquisa da Universidade de São Paulo UNIFESP/EPM)
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Research Ethics Committee of the Albert Einstein Israeli Hospital (Comitê de Ética em Pesquisa do Hospital Israelita Albert Eisntein)
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Ethics Committee for Analysis of Research Projects HCFMUSP (Comissão de Ética para Análise de Projetos de Pesquisa do HCFMUSP (CAPPesq))
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Research Ethics Committee of PUC-PR (Comitê de Ética em Pesquisa da PUC-PR)
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Ethics Committee in Research / Faculty of Medical Sciences / UNICAMP (Comitê de Ética em Pesquisa / Faculdade de Ciências Médicas / UNICAMP)
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Research Ethics Committee of the Institute of Cardiology of the Federal District (Comitê de Ética em Pesquisa do Instituto de Cardiologia do Distrito Federal)
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Ethics Committee on Human Research of the Oswaldo Cruz German Hospital (Comitê de Ética em Pesquisa em Seres Humanos do Hospital Alemão Oswaldo Cruz)
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Research Ethics Committee - CEPesq Syrian-Lebanese Hospital (Comitê de Ética em Pesquisa – CEPesq Hospital Sírio Libanês)
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France
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French Consultative Committee on Health Research Data Processing (Comité Consultatif sur le Traitement de l'Information en Matière de Recherche dans le Domaine de la Santé)
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French Data Protection Authority (Commission nationale de l'informatique et des libertés)
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-
Germany
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Ethics Committee of the Bavarian Medical Association (Ethik-Kommission der Bayerischen-Landesärztekammer)
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Italy
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Ethics Committee of Azienda Ospedaliera Sant'Andrea
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Ethics Committee of Azienda Ospedaliera Riuniti di Bergamo
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Ethics Committee of Azienda ULSS 12 Veneziana
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Ethics Committee of Azienda USL di Pescara
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Ethics Committee of Azienda Provinciale Servizi Santitari APSS
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Ethics Committee of ASL RM/B
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Ethics Committee of CEAS – Azienda Sanitarie dell'Umbria
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Ethics Committee of Centro Cardiologico S.P.A. Fondazione Monzino IRCS
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Ethics Committee of ASL 3 Genovese Ospedale Villa Scassi
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Ethics Committee of Ospedale di Scilla
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Netherlands
-
No IRB/ethics committee approval necessary since the study was not viewed as a study in human with an intensive change in treatment; the following sites participated
-
Academic Hospital Maastrich, Maastrichtt
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Isala Klinieken Zwolle, Zwolle
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Vie CurieMedical centre Nord Limburg, Venlo
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St Antonus hospital, Nieuwegein
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Universital Medical Centre Groningen, Groningen
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Refaja Hospital, Stadskanaal
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-
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Poland
-
According to Polish law, no approvals are required for epidemiological surveys; however, the following were notified about the study:
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Bioethics Commission at the Lower Silesian Chamber of Physicians and Dentists (Komisja Bioetyczna przy Dolnośląskiej Izbie Lekarskiej)
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Committee on Bioethics at the Medical University of Warsaw (Komisja Bioetyczna przy Warszawskim Uniwersytecie Medycznym)
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Bioethics Commission (Komisja Bioetyczna)
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Bioethics Committee of the Medical University of Silesia (Komisja Bioetyczna Śląskiego Uniwersytetu Medycznego)
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Ethics Committee and Oversight research on Humans and Animals CSKMSWiA (Komisja Etyki i Nadzoru nad Badaniami nad Ludźmi i Zwierzętami CSKMSWiA)
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Bioethics Committee of the Medical University (Komisja Bioetyczna Uniwersytetu Medycznego)
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Bioethics Committee at the University of Medical Sciences (Komisja Bioetyczna przy Akademii Medycznej im)
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Bioethics Commission at the Lower Silesian Chamber of Physicians and Dentists (Komisja Bioetyczna przy Dolnośląskiej Izbie Lekarskiej)
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Bioethics Commission at the Regional Medical Chamber in Warsaw (Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Warszawie)
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Bioethics Commission at the Institute of Cardiology (Komisja Bioetyczna przy Instytucie Kardiologii)
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Bioethics Committee of the Medical University of Silesia (Komisja Bioetyczna Śląskiego Uniwersytetu Medycznego)
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Bioethics Committee of Pomeranian Medical University (Komisja Bioetyczna Pomorskiej Akademii Medycznej)
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Bioethics Commission Medical University of Warsaw (Komisja Bioetyczna Warszawski Uniwersytet Medyczny)
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Bioethics Committee for Research on Humans Medical University (Komisja Bioetyki ds. badań na ludziach Uniwersytetu Medycznego w Łodzi)
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Spain
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Hospital Universitario La Princesa de Madrid
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Hospital del Mar
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Hospital Universitario de Bellvitge
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Hospital Universitario Vall d'Hebrón
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Hospital Regional Universitario Carlos Haya
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Hospital Universitario Virgen de las Nieves
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Hospital Ntra. Sra. del Prado
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Hospital Universitario Río Ortega
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Hospital Universitario Clínic de Barcelona
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Hospital Universitario 12 de Octubre
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Hospital Universitario Fundación Alcorcón
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Hospital Universitario de Getafe
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Hospital Universitario Puerta de Hierro Majadahonda
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Hospital Universitario Ramón y Cajal
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Hospital de Crucez
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Hospital General Universitario de Alicante
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Hospital Universitario La Fe
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Galicia
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Área 9
-
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Sweden
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Regional Ethical Review Board (Regionala Etikprövningsnämnden), Lund
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-
UK
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Tayside Committee on Medical Research Ethics B, East of Scotland Research Ethics Service
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