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Table 3 GRADE Summary of Findings of Supplemental Inositol Compared to Placebo for Retinopathy of Prematurity

From: The efficacy and safety of inositol supplementation in preterm infants to prevent retinopathy of prematurity: a systematic review and meta-analysis

Outcomes

No. of Cases per 1000 Infants

RR (95% CI)

Participants, No.

Studies No.

Quality of Evidenceb

Assumed Risk of Placeboa

Corresponding Risk of Supplemental Inositol (95% CI)

Severe ROP

110

54 (19–145)

0.49 (0.18–1.32)

898

5

Low c, d

Mortality

155

194 (127–294)

1.25 (0.82–1.90)

1177

6

Low c, e

All stage of ROP

472

463 (411–524)

0.98 (0.87–1.11)

889

4

Moderate e

BPD

436

414 (314–545)

0.95 (0.72–1.25)

1099

6

Low c, e

Suspected or proven NEC

88

75 (51–109)

0.85 (0.58–1.24)

1189

6

Moderate e

Surgical NEC

37

28 (9–88)

0.76 (0.24–2.38)

834

3

Moderate c

All stage of IVH

392

302 (231–392)

0.77 (0.59–1.00)

429

3

Moderate f

Severe IVH (grade III/IV)

174

118 (78.3–180)

0.68 (0.45–1.03)

1179

6

Low c, e

Late-onset sepsis

194

236 (188–299)

1.22 (0.97–1.54)

1141

5

Low c, f

Seizure

26

27 (11–66)

1.02 (0.41–2.56)

833

3

High

Hearing impairment

107

146 (93–247)

1.36 (0.87–2.31)

605

3

High

  1. aThe basis for the assumed risk (e.g. the median control group risk across studies) is provided. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
  2. bThe GRADE Working Group grades of evidence are as follows: high quality (further research is very unlikely to change our confidence in the estimate of effect), moderate quality (further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate), low quality (further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate), and very low quality (we are very uncertain about the estimate)
  3. cHeterogeneity is highly significant between included trials and hard to be explained
  4. dOne trial has high risk of bias and one has unclear risk of bias
  5. eTwo trials have high risk of bias and one has unclear risk of bias
  6. fTwo trials have high risk of bias