• Keine Ergebnisse gefunden

Supplementary Table 1.

N/A
N/A
Protected

Academic year: 2022

Aktie "Supplementary Table 1."

Copied!
17
0
0

Wird geladen.... (Jetzt Volltext ansehen)

Volltext

(1)

Supplementary Table 1. Weight definitions for EQ-5D-5L dimensions and levels

EQ-5D-5L Dimension Weight

Mobility

Slight 0.058

Moderate 0.076

Severe 0.207

Unable 0.274

Self-care

Slight 0.050

Moderate 0.080

Severe 0.164

Unable 0.203

Usual activities

Slight 0.050

Moderate 0.063

Severe 0.162

Unable 0.184

Pain/discomfort

Slight 0.063

Moderate 0.084

Severe 0.276

Extreme 0.335

Anxiety/depression

Slight 0.078

Moderate 0.104

Severe 0.285

Extreme 0.289

‘No problem’ was weighted as 0

If the weight of any dimension was missing the utility index was not computed EQ-5D-5L, EuroQol five dimensions five levels

(2)

Supplementary Table 2. VFQ-25 questionnaire scoring Scoring key: recoding of items

Item numbers Original response

categorya Recoded value

1,3,4,15cb 1 100

2 75

3 50

4 25

5 0

2 1 100

2 80

3 60

4 40

5 20

6 0

5–14, 16, 16a, A3–A9c 1 100

2 75

3 50

4 25

5 0

6 d

17–25, A11a, A11b, A12, A13

1 0

2 25

3 50

4 75

5 100

A1, A2 0 to 10 0 to 100

VFQ sub-scales

Scale Number of items Items to be averaged (after recoding)

General health 2 1

General vision 2 2

Ocular pain 2 4, 19

Near activities 6 5, 6, 7, A3–A5

Distance activities 6 8, 9, 14, A6–A8

Vision specific

Social functioning 3 11, 13

Mental health 5 3, 21, 22, 25

Role difficulties 4 17, 18

Dependency 4 20, 23, 24

Driving 3 15c, 16, 16a

Color vision 1 12

Peripheral vision 1 10

aPrecoded response choices as printed in the questionnaire

bItem 15c has four response levels, but was expanded to five levels using item 15b. Note: If 15b=1, item 15c was recoded to ‘0’ and if 15b=2 or 3, item 15c was recoded to missing

(3)

c‘A’ indicates an optional item from the Appendix. If optional items are used, NEI-VFQ developers encourage users to use all items for a given sub-scale to enhance the comparability of sub-scale scores across studies

dResponse choice ‘6’ indicates a patient who does not perform the activity due to non–vision-related problems. If this choice is selected, the item is coded as “missing”

NEI, National Eye Institute; VFQ-25, Visual Function Questionnaire

(4)

Supplementary Table 3. WPAI-UV (Uveitis 2.0) questionnaire Question

Q1 Are you currently employed (working for pay, yes/no)?

Q2 During the past seven days, how many hours did you miss from work because of problems associated with your uveitis?

Q3 During the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?

Q4 During the past seven days, how many hours did you actually work?

Q5 During the past seven days, how much time did your uveitis affect your productivity while you were working? (0=uveitis had no effect on my work;

10=uveitis completely prevented me from working)

Q6 During the past seven days, how much did your uveitis affect your ability to do your regular daily activities, other than work at a job? (0=uveitis had no effect on my daily activities; 10=uveitis completely prevented me from doing my daily activities)

WPAI-UV, Work Productivity and Activity Impairment - Uveitis

(5)

Supplementary Table 4. Conversion table for visual acuity [1]

Ranges (ICD-9-CM) Decimal logMAR

(Near-) Normal vision

Normal vision 1.6

1.25 1.0 0.8

-0.2 -0.1 0 +0.1

Mild vision loss 0.63

0.5 0.4 0.32

0.2 0.3 0.4 0.5 Low vision

Moderate vision loss 0.25

0.20 0.16 0.125

0.6 0.7 0.8 0.9

Severe vision loss 0.10

0.08 0.063

0.05

+1.0 1.1 1.2 1.3

Profound vision loss 0.04

0.03 0.025

0.02

1.4 1.5 1.6 1.7 (Near-) blindness

Near-blindness 0.016

0.0125 0.01

1.8 1.9 +2.0

Blindness No light perception

ICD-9-CM, International Classification of Diseases, 9th revision, Clinical Modification; logMAR, logarithm of the minimum angle of resolution

(6)

Supplementary Table 5. List of participating sites

Institution (Hospital) City Country

Private practices Buenos Aires Argentina

Organización Médica de Investigación Buenos Aires Argentina Universidade Federal de São Paulo -

Departamento de Oftalmologia

São Paulo-SP Brazil

Hospital Oftalmológico de Sorocaba Sorocaba - SP Brazil Hospital São Geraldo (UFMG) Santa Efigênia - Belo

Horizonte

Brazil Hospital Universitário Cassiano Antônio de

Moraes (UFES)

Santa Cecilia, Vitória - ES

Brazil Berner Augenklinik am Lindenhofspital Bern Switzerland

Stadtspital Triemli Augenklinik Zürich Switzerland

Hospital del Salvador Santiago Chile

Clinica Oftalmologica del caribe Barranquilla Colombia Fundación Oftalmologica de Santander -

FOSCAL

Bucaramanga Colombia

Fundacion Valle del Lili Cali Colombia

Všeobecná fakultní nemocnice v Praze Prague Czech

Republic

Clinical Hospital Center Zagreb Zagreb Croatia

Clinical Hospital Center Osijek Osijek Croatia

Clinical Hospital Center Rijeka Rijeka Croatia

Galilee Medical Center Nahariya Israel

Rabin Medical Center Petah Tikva Israel

Hadassah Medical Center Jerusalem Israel

Kazakh Scientific-research institute of eye diseases

Almaty Kazakhstan

Bucharest Emergency University Hospital Bucharest Romania National Institute of infectious diseases - Prof.

Dr. Matei Bals

Bucharest Romania

St Andrew's County Clinical Emergency Hospital Constanta

Constanta Romania

St Spiridon County Clinical Emergency Hospital Iasi

Iasi Romania

SC Retina SRL Bucharest Romania

Clinical Centre of Serbia Belgrade Serbia

Clinical Centre Kragujevac Kragujevac Serbia

Clinical Centre Nis Nis Serbia

Oftalmologická ambulancia Národný ústav Vyšné Hágy

Vyšné Hágy Slovakia

Istanbul University Istanbul Faculty of Medicine Department of Ophthalmology

Istanbul Turkey

Ankara Ulucanlar Ophtalmology Education Ankara Turkey

(7)

and Research Hospital

Hacettepe University Department of Ophtalmology

Ankara Turkey

Ankara University İbn-i Sina Hospita Department of Ophtalmology

Ankara Turkey

Dokuz Eylül University Hospital Department of Ophtalmology

Izmir Turkey

Istanbul Cerrahpasa University, Faculty of Medicine, Department of Ophthalmology

Istanbul Turkey

Gazi University, School of Medicine, Department of Ophthalmology

Ankara Turkey

Ondokuz Mayis University Medical Faculty Hospital

Samsun Turkey

SBÜ Prof. Dr. N. Reşat Belger Beyoğlu Ophtalmology Education and Research Hospital

Istanbul Turkey

Izmir Katip Çelebi University Department of Ophtalmology

Izmir Turkey

Ege University Medical Faculty Izmir Turkey

Umraniye Education and Research Hospital Istanbul Turkey Filatov V.P. Institute of Eye Diseases and

Tissue Therapy

Odesa Ukraine

Regional Clinical Hospital-Center of

Emergency Medicine and Disaster Medicine

Kharkiv Ukraine

(8)

Supplementary Table 6. Summary of site characteristics in the EyeCOPE study

Site informationa

N=48 n (%)b Type of site

Academic center/university hospital 36 (76.6)

Other hospital 1 (2.1)

Outpatient clinic 2 (4.3)

Private practice 8 (17.0)

Other 0 (0.0)

Missing 1

Average number of all patients examined at site per year

<100 patients 0 (0.0)

100 to <1000 patients 7 (14.9)

1000 to <10 000 patients 13 (27.7)

≥10 000 patients 27 (57.4)

Missing 1

Average number of all type uveitis patients examined at site per year

<50 patients 4 (8.7)

50 to 99 patients 3 (6.5)

100 to 999 patients 24 (52.2)

≥1000 patients 15 (32.6)

Missing 2

Average number of NIIPPU patients examined at site per yearc

<50 patients 11 (23.4)

50 to 99 patients 11 (23.4)

100 to 999 patients 15 (31.9)

≥1000 patients 10 (21.3)

Missing 1

OCT machined

Any 44 (91.7)

Spectralis/Heidelberg engineering 19 (39.6)

Cirrus/Carl Zeiss Meditec 11 (22.9)

3D-OCT/TOPCON 5 (10.4)

Stratus/Carl Zeiss Meditec 1 (2.1)

Other 14 (29.2)

aSites with valid data

bPercentages calculated based on non-missing values

cPatients with valid data

dMultiple entries were possible

OCT, optical coherence tomography; 3D, three dimensional

(9)

Supplementary Table 7. Number of certified/specialized ophthalmologists per study site

N Missing Mean (SD)

Median (min, max) Number of certified ophthalmologists

per site

47 1 13.4

(13.7)

10.0 (0, 78) Number of ophthalmologists

specialized in uveitis per site

47 1 2.5 (2.2) 2.0 (1, 10)

max, maximum; min, minimum; SD, standard deviation

(10)

Supplementary Table 8. Healthcare resource utilization due to uveitis (MAS population with healthcare visit in the preceding 12 months)

Visits for uveitisa n (%)

Seen by healthcare professional N=531

Yes 522 (98.3)

No 9 (1.7)

Seen in the emergency room N=531

Yes 95 (17.9)

No 436 (82.1)

Admission to hospital N=531

Yes 117 (22.0)

No 414 (78.0)

aParticipants who had any visits for uveitis in the preceding 12 months MAS, main analysis set

(11)

Supplementary Table 9. Summary of healthcare visits due to uveitis (MAS patients with respective visit)

N Missin

g

Mean (SD)

Median (min, max) Number of visits to healthcare

professional per month

522 0 0.5 (0.4) 0.4 (0.1, 3.3)

Number of visits to emergency room per month

94 1 0.1 (0.2) 0.1 (0.1, 1.7)

Number of days in hospital per month

93 24 1.0 (0.8) 0.8 (0.1, 4.3) MAS, main analysis set; max, maximum; min, minimum; SD, standard deviation

(12)

Supplementary Table 10. Patient-reported quality of life and work productivity (MAS population)

N Missing Mean (SD)

Median (min, max) EQ-5D-5L

Utility index 553 12 0.8 (0.2) 0.9 (-0.1, 1.0)

Self-rated (global) health status 564 1 71.7 (19.0)

75.0 (0, 100) VFQ-25

General health 562 3 48.4

(24.5)

50.0 (0.0, 100.0)

General vision 563 2 66.7

(19.4)

60.0 (0.0, 100.0)

Ocular pain 565 0 72.1

(22.7)

75.0 (0.0, 100.0)

Near activities 565 0 73.5

(26.7)

83.3 (0.0, 100.0)

Distance activities 565 0 73.6

(26.3)

83.3 (0.0, 100.0)

Social functioning 565 0 82.7

(26.2)

100.0 (0.0, 100.0)

Mental health 565 0 63.8

(27.5)

68.8 (0.0, 100.0)

Role difficulties 563 2 64.0

(31.2)

75.0 (0.0, 100.0)

Dependency 563 2 77.9

(29.9)

91.7 (0.0, 100.0)

Driving 316 249 63.2

(36.0)

75.0 (0.0, 100.0)

Color vision 562 3 89.5

(22.3)

100.0 (0.0, 100.0)

Peripheral vision 564 1 75.7

(27.2)

75.0 (0.0, 100.0)

Overall composite score 565 0 73.3

(21.8)

80.1 (8.1, 100.0) WPAI-UV

Presenteeisma 293 15 24.7

(29.1)

10.0 (0.0, 100.0)

Absenteeisma 287 21 14.6

(29.6)

0.0 (0.0, 100.0) Total work productivity

impairmenta

277 31 31.0

(32.4)

20.0 (0.0, 100.0)

Total activity impairment 557 8 32.0

(31.5)

20.0 (0.0, 100.0)

(13)

aFor presenteeism, absenteeism and total work productivity impairment only employed MAS patients were considered

EQ-5D-5L, EuroQol five dimensions five levels questionnaire; MAS, main analysis set; max,

maximum; min, minimum; SD, standard deviation; VFQ-25, Visual Function Questionnaire; WPAI-UV, Work Productivity and Activity Impairment – Uveitis

(14)

Supplementary Table 11. Ethics Committees

Country International Ethics Committee/International Review Board Argentina Independent Committee on Ethics for Clinical Pharmacology Trials

Independent Ethics committee for Clinical Training Trials Foundation of Pharmacological and Drug Studies

Brazil National Commission on Ethics in Research Ophthalmological Hospital of Sorocaba/SP

Federal University of Espirito Santo, University Hospital Cassiano Antônio de Moraes DA

Federal Univeristy of Minas Gerais

Universidade Federal de São Paulo, Hospital São Paulo – Hospital Universitario DA

Chile Ethical-Scientific Committee, Eastern Metropolitan Health Service Colombia Research Ethics Committee, Ophthalmological Foundation of

Santander

Committee of Ethics and Clinical Research, Clinica Oftalmologica del Caribe

Ethics Committee in Biomedical Research Valle del Lili Foundation

Croatia Central Ethics Committee

Republic of Croatia Agency for Medicinal products and Medical Devices

Ethical Committee, Clinical Hospital Center Osijek Ethics Committee, Clinical Hospital Center Rijeka Drug Comission, Clinical Hospital Center Zagreb

Czech Republic Ethics Committee of the General University Hospital, Prague Israel Institutional Review Board/Helsinki Committee, Galilee Medical

Center

Institutional Review Board/Helsinki Committee, Rabin Medical Center

Institutional Review Board/Helsinki Committee, Hadassah University Medical Center

Kazakhstan The Central Ethics Committee of the Ministry of Health of the Republic of Kazakhstan

Romania National Committee for Bioethics of Medicine and Medical Devices, Academy of Medical Sciences of Romania

Serbia Ethics Committee, Clinical Centre of Niš Ethics Committee, Clinical Center Kragujevac Ethics Committee, Klinical Center Vojvodine Clinical Center of Serbia, Clinic for Eye Diseases

Slovakia Ethics Committee of the National Institute of Tuberculosis, Lung Diseases, and Thoracic Surgery, Vysne Hagy

Switzerland Cantonal Ethics Committee for Research, Health and Welfare Directorate of the Canton of Bern

Turkey Research Ethics Committee, Istanbul University, Fatih/Istanbul Ukraine Ethics Committee of Regional Clinial Hospital Center of Medical Aid

and Catastrophe Medicine, 13 Nezalezhnosti Ave Kharkiv 61058 Committee on Bioethics at Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of

(15)

Ukraine

Reference

1. Colenbrander A. Introduction to Visual Acuity Measurement. Available at:

https://www.precision-vision.com/wp-content/uploads/2020/01/VA-Man01312020.pdf.

Accessed June 17, 2020.

Referenzen

ÄHNLICHE DOKUMENTE

In studies of proposals submitted to ethics com- mittees (table 3) of trials funded by the National Institutes of Health [14], trials submitted to licens- ing authorities [15],

Der Beitrag ist unter mindestens drei Gesichtspunkten wichtig: Erstens gibt es genügend Gründe, eine Selbstregulation der Wissenschaftsgemeinschaft anzustreben; zweitens gibt es

The study by MCGINN and BOSACKI is important because they report on the responses of future researchers to a course in which they come face to face with a range of problematic

Beijing Chest Hospital Ethics Committee of Beijing Chest Hospital, Capital Medical University The 8 th Medical Center of Chinese PLA General Hospital Ethics Committee of Chinese

Table 1.Ethics infrastructure in Germany Institutions of PoliticiansBureaucratscontrol (all E7) Strong elements (mostly E6)Soft elementsStrong elementsSoft elementsStrong and

1 Ethics Committee of The First Affiliated Hospital, College of Medicine, Zhejiang University 2016 Lun Shen

Therefore, as a part of our work on conflict-resolution, security, and policy-making, Global Political Trends (GPoT) Center launched this Terrorism-Counter-Terrorism Statistics

Therefore, as a part of our work on conflict-resolution, security, and policy-making, Global Political Trends (GPoT) Center launches its Terrorism-Counter-Terrorism Statistics