Table 2 Characteristics of included studies.

From: Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis

First author, year

Instrument name(s)

Domains/scales of QoL

Items

Optic neuritis relevant itemsa, n

Country

Patients, N

Patient characteristic

Completion time

Mangione, 2001 [42]

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 none had optic neuritis or optic nerve involving eye disease. Mean age 61 years, 54% female, 81% White.

Aimed to be 5 minutes, but not reported

Raphael, 2006 [41]

10-item NEI VFQ-25 Neuro-Ophthalmic supplement VALIDATION STUDY

In addition to NEI VFQ-25, 3 extra domains, vision function (6 items), visual functioning in daily life (2 items) and lid/eye appearance (2)

26 + 10

25 + 8

USA

215

Included n = 47 MS patients with acute optic neuritis.

Not reported

Cella, 1996 [5]

Functional Assessment of Multiple Sclerosis (FAMS)

The final 59 items comprising the six subscales: mobility (7 items), symptoms (7 items), emotional well-being (7 items); general contentment (7 items); thinking/fatigue (9 items), family/social well-being (7 items); unscored (15 items)

59

2, pain and headache

USA, two sites

20 MS patients with varying symptoms for item generation; 433 MS patients for development validation (377 from mail survey and 69 from clinical visit)

MS patients (n = 433) Average age 44.9 years (22–86); 70% women; 73% married and 90% white;

mean education of

14 years (7–29 years). One-third of the patients

were on disability.

Relapsing-remitting disease (n = 194) and

those with progressive disease (n = 174)

Not reported

MSQLI, 1997 [44]

IVIS

5 items. Difficulty: reading personal notes; printed letters; reading dials; watching TV; identifying house numbers street signs.

5

5

Not reported

Not reported

Not reported

2–3 minutes

Cole,

2000 [43]

National Eye Institute

Visual Function

Questionnaire (NEI–VFQ)

VALIDATION STUDY in ON

51 items comprising of 14 subscales: overall health, overall vision, difficulty with near vision, difficulty with distance vision, limitations in social functioning, role limitations due to vision, dependency due to vision, mental health symptoms due to vision, future expectations for vision, driving difficulties, limitations with peripheral and colour vision, and pain or discomfort in or around eyes.

51

51

California, USA

244 MS patients

All patients with acute

unilateral optic neuritis and no indication of a causal systemic

disease other than MS were enrolled. Average age 40 (+/− 7); 215 (79%) were female and 215 (88%)

were white.

Not reported

  1. abased on our clinical judgement of whether questions look relevant to optic neuritis.