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Table 2 Characteristics of Included Studies

From: Evaluating patient-reported outcome measures (PROMs) for clinical trials and clinical practice in adult patients with uveitis or scleritis: a systematic review

First authorYear

Instrument and year of development

Domains/scales of QoL

Items

Uveitis relevant items, n

Country

Patients,

N

Patient characteristics

Completion time

Uveitis

 

Barry 2014 [25]

3 PROMS:

BD&MSQ

Qol BCR

Qol Meds

BD&MSQ 8 (lights, vision, skin, body pain, breathless, mood, sleep, hair loss)

QoL BCR 4 (mood/ relationship, daily activities, family relations, feeling unwell)

QoL Meds 3 (mood/ relationships, vision, low mood)

BD&MSQ 21

QoL BCR: 20

QoL Meds: 12

BD&MSQ:7

QoL BCR:3

QoL Meds: 4

UK, national patient group

2 patients for initial content; 8 for instrument development; 150 for validation plus 33 healthy controls

Birdshot chorioretinopathy patients (n = 152)

Mean age 53.1 (SD 9.6) years, 73.0% female

Not reported

Wu 1996 [26]

CMV Retinitis (no formal instrument name), 1992

Visual symptoms (5 items); visual function (7 items); global vision (2 items), impact of treatment (4 items)

18

14

USA, 7 sites

18 to develop item content; 26 to develop and validate instrument

CMV retinitis patients with AIDS (n = 26). Mean age 38.5 (SD 5.9) years, 96% male, 88% White

5 min

Martin 2001 [27]

CMV Retinitis (no formal instrument name, Wu 1996)

VALIDATION STUDY

This study included 4 scales with 16 items from Wu et al. 1996: Visual symptoms (5 items), visual function (7 items), global vision (2 items); impact of treatment (2 items)

16

14

USA, 12 sites, 1992–1995

279 patients recruited in the CRRT trial

CMV retinitis patients (n = 279). Mean age 38.6 years, 91.8% male, 60.6% White

Not reported

Mangione 2001 [29]

NEI VFQ-25

9 subscales:

General health (1 item), general vision (1 item), near vision (3 items), distance vision (3 items), ocular pain (2 items), colour vision (1 item), peripheral vision (1 item), driving (3 items); and VISION-SPECIFIC social functioning (2 items), mental health (4 items), dependency (3 items), and role limitations (2 items)

26

25

USA

Data from n = 262 pilot study and n = 597 field test who completed an earlier 51-item instrument, for validation

N = 262 of which n = 21 CMV retinitis. Mean age 61 years, 54% female, 81% White

N = 597 of which n = 37 CMV retinitis. Mean age 64 years, 59% female, 63% White

Aimed to be 5 min, but not reported

Naik 2013 [30, 31]

Normative comparison [32]

NEI-VFQ-25 for uveitis

VALIDATION STUDY

General health 1 plus 25-items as above (Mangione 2001)

26

25

18 countries, 46 sites

N = 224 HURON RCT patients compared to NEI VFQ data from n = 122 [29]

Patients (n = 224) including 188 with intermediate, and 44 with posterior uveitis. Mean age 44.6 (SD 14.3) years, 63.4% female, 60.3% White

Not reported

Patel [28]

KSQ

5 modules: general health status, lung, skin, eye and medication

29

7 in eye module, with 10 General Health Status forming unidimensional set

UK

Content: 23 (including 7 with ocular sarcoidosis)

Development and validation: 207 patients

100% sarcoidosis, n = 45/207 with ocular involvement

Mean 10 (SD 8) minutes

Scleritis

 

No studies

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