Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema

Figures & data

Table 1 RetTSQ subscales and scoring

No	RetTSQ question description	Subscale	Comments
1	Current satisfaction	Positive
2	Treatment working well	Positive
3	Side effects	Negative
4	Discomfort/pain	Negative
5	Unpleasant	Negative
6	Difficult	Negative	Scores from 0 to 6, being least favorable to high favorable.
7	Apprehensive	Negative	Possible total scores range from 0 to 78
8	Influence	Positive	Subscales: positive (7 items; possible positive scores range from 0 to 42) and negative (6 items; possible negative scores range from 0 to 36)
9	Safety	Positive
10	Time consuming	Negative
11	Information	Positive
12	Encourage others	Positive
13	Continue/repeat	Positive
14	Any other features

Abbreviation: RetTSQ, Retinopathy Treatment Satisfaction Questionnaire.

Table 2 Change in questionnaires from baseline to month 12

Questionnaire score change	Overall	Fixed	PRN	P-value
	Mean ± SD	Mean ± SD	Mean ± SD
RetDQoL	−3.01±2.37	−2.95±2.13	−3.16±2.62	0.794
NEI VFQ-25	3.39±14.2	6.68±14.7	0.09±13.0	0.056
RetTSQ	4.04±13.72	4.35±12.8	3.72±14.8	0.861

Note: Bold value denotes borderline significance.

Abbreviations: PRN, pro re nata; RetDQoL, Retinopathy-Dependent Quality of Life; NEI VFQ-25, National Eye Institute Visual Function Questionnaire-25; RetTSQ, Retinopathy Treatment Satisfaction Questionnaire; SD, standard deviation.

Table 3 RetDQoL score change between baseline and the exit visit in all domains

RetDQoL subscales	All patients	Fixed Ozurdex (dexamethasone intravitreal implant)	PRN dexamethasone intravitreal implant	P-value
	Mean ± SD	Mean ± SD	Mean ± SD
Present QoL	−0.06±1.17	0.06±1.42	−0.19±0.85	0.288
QoL without diabetes	−0.06±1.23	−0.15±1.43	0.02±0.99	0.661
Household tasks	−0.49±3.30	−0.60±3.78	−0.38±2.77	0.757
Personal affairs	0.00±3.31	−0.31±3.66	0.33±2.91	0.279
Shopping	−0.37±2.86	−0.22±3.16	−0.52±2.55	0.726
Feelings about the future	−0.13±3.13	−0.02±3.38	−0.23±2.88	0.875
Anger or regret	−0.43±3.27	−0.42±3.74	−0.43±2.74	0.997
Work	−0.70±2.48	−0.53±2.83	−0.92±2.07	0.798
Personal relationship	−0.49±3.16	−0.33±3.34	−0.60±3.06	0.425
Family life	−0.11±3.31	−0.49±3.42	0.47±3.17	0.359
Social life	−0.26±2.78	−0.38±2.90	−0.15±2.67	0.733
Do for others	−0.33±3.01	0.02±3.18	−0.68±2.81	0.202
Get out and about	−0.13±2.75	−0.17±2.91	−0.09±2.60	0.910
Holidays	0.07±3.18	0.30±3.81	−0.13±2.57	0.735
Finance	−0.13±2.56	−0.29±2.58	0.04±2.55	0.242
People’s reaction to me	−0.18±2.58	−0.10±2.86	−0.27±2.28	0.733
Physical appearance	−0.03±2.60	0.02±2.93	−0.09±2.24	0.597
Do physically	−0.32±2.63	−0.71±2.78	0.09±2.43	0.081
Leisure	0.02±2.64	−0.17±2.88	0.21±2.38	0.495
Self-confidence	−0.20±3.19	−0.42±3.23	0.02±3.16	0.235
Motivation	−0.42±2.88	−0.52±2.77	−0.32±3.02	0.925
Independence	−1.02±3.06	−1.44±3.58	−0.66±2.54	0.366
Mishaps	−0.21±2.90	−0.49±3.06	0.06±2.75	0.184
Time taken	−0.56±2.93	−0.81±3.02	−0.30±2.84	0.161
Care for my diabetes	0.22±3.39	−0.23±3.42	0.68±3.32	0.441
Enjoy nature	−0.08±2.53	−0.06±2.94	−0.11±2.06	0.747
Composite score	−3.01±2.37	−2.95±2.13	−3.16±2.62	0.794

Abbreviations: RetDQoL, Retinopathy-Dependent Quality of Life; PRN, pro re nata; QoL, quality of life; SD, standard deviation.

Table 4 NEI VFQ-25 score change between the exit visit and baseline

NEI VFQ-25 subscales	All patients	Fixed Ozurdex (dexamethasone intravitreal implant)	PRN dexamethasone intravitreal implant	P-value
	Mean ± SD	Mean ± SD	Mean ± SD
GV	1.89±17.3	1.67±16.9	2.13±17.8	0.917
NA	0.61±20.2	3.47±22.7	−2.31±17.0	0.362
DA	3.43±19.5	9.28±19.2	−2.17±18.3	0.008
VSMH	557±24.4	5.31±27.2	5.84±21.4	0.942
VSRD	0.27±27.2	−0.26±29.1	0.82±25.3	0.734
VSD	2.48±25.5	1.74±27.2	3.26±24.0	0.813
VSSF	3.23±19.9	6.25±21.1	0±18.3	0.142
D	1.25±16.2	0±4.6	1.92±14.8	0.949
CV	3.68±20.3	7.81±25.9	−0.53±11.0	0.045
OP	−1.33±19.7	2.60±19.3	−5.43±19.5	0.061
PV	0.79±27.5	4.69±27.1	−3.26±27.7	0.138
GH	−1.86±23.8	1.06±25.0	−4.79±22.5	0.917
Composite score (minus GH)	3.39±14.2	6.68±14.7	0.09±13.0	0.065

Note: Bold values denote statistical significance.

Abbreviations: NEI VFQ-25, National Eye Institute Visual Function Questionnaire-25; PRN, pro re nata; GV, general vision; NA, near activities; DA, distance activities; VSMH, vision-specific mental health; VSRD, vision-specific role difficulties; VSD, vision-specific dependency; VSSF, vision-specific social functioning; D, driving; CV, color vision; OP, ocular pain; PV, peripheral vision; GH, general health; SD, standard deviation.

Table 5 RetTSQ score change at the exit visit compared to baseline

RetTSQ subscales	PRN	Fixed	P-value
	Mean ± SD	Mean ± SD
Current satisfaction	0.32±1.4	0.21±1.2	0.525
Treatment working well	0.62±2.0	0.29±1.7	0.162
Side effects	0.15±2.3	0.77±2.2	0.140
Discomfort/pain	0.47±2.2	0.77±2.4	0.746
Unpleasant	−0.19±2.1	0.19±2.0	0.686
Difficult	0.30±1.9	0.38±2.0	0.873
Apprehensive	0.49±2.4	0.79±2.3	0.567
Influence	0.64±1.8	0.0±1.0	0.185
Safety	0.36±1.6	0.52±1.1	0.712
Time consuming	0.62±1.8	0.38±1.5	0.374
Information	−0.02±1.2	0.06±1.2	0.993
Encourage others	−0.04±1.6	0.12±1.0	0.529
Continue/repeat	0.02±1.8	−0.13±1.7	0.536
Overall score	3.72±14.8	4.35±12.8	0.861

Abbreviations: RetTSQ, Retinopathy Treatment Satisfaction Questionnaire; PRN, pro re nata; SD, standard deviation.

Table 6 Logistic regression analysis for factors affecting RetTSQ

Factors at the exit visit predicting change in RetTSQ	Category	Odds ratio (95% CI)	P-value
BCVA (ETDRS letters)	≥55 vs <552	3.55 (1.17–10.75)	0.03
CST (μm)	≥300 vs <300	0.28 (0.10–0.78)	0.04
Macular volume (mm^3)	<9.2 vs ≥9.2	3.13 (1.07–9.17)	0.02

Abbreviations: RetTSQ, Retinopathy Treatment Satisfaction Questionnaire; BCVA, best-corrected visual acuity; ETDRS, Early Treatment of Diabetic Retinopathy Study; CST, central subfield thickness.