Table 7.
Grading of the confidence in the evidence for symptomatic food allergy and timing of introduction of eggf
| Certainty assessment | Characteristics | No of subjects | Effect in the LoE | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line of evidence and initial rating | No studies | Design | RoB | Inconsistency | Generalisability | Imprecision | Magnitude | Dose response | Other | Comparator, population | Early CF | Late CF | Age | Analysis | Early | Late | Relative | Certainty in the LoE | Certainty across LoE |
|
1 (main‐A) ++++ |
1 | RCT | ↔ | o | ↓ | ↓ | ↑ | ↑ | ↓a |
EBF, EU, gen pop |
3–4 m | 6 m | 1 or 3 y | FAS | 21/569 (3.7%) | 32/596 (5.4%) |
RR 0.69 (0.40–1.18) |
+++ | ++ to +++ g |
| PP | 3/214 (1.4%) | 29/525 (5.5%) |
RR 0.25 (0.08–0.82) |
||||||||||||||||
|
2 (main‐B) ++++ |
1 | RCT | ↔ | o | ↓↓ | ↓↓ | ↑ | o | ↔ |
CF, EU, gen pop |
4–6 m | No egg | 1 y | FAS | 3/142 (2.1%) | 1/156 (0.6%) |
RR 3.3 (0.35–31.3) |
+ d | |
|
3 (main‐C) +++ |
1 | PC | ↔ | o | ↓↓ | ↓ | ↔ | o | ↔ |
CF, SG, gen pop |
< 6 m | > 6 m | 2 y | n/a |
0/19 (0%) |
6/777 (0.8%) |
n/a | + e | |
|
4 (main‐D) ++++ |
3 | RCT | ↔ | ↔ | ↓↓ | ↔ | ↔ | ↔ | ↔ |
CF, AU, at‐risk |
4–6 m | > 8–10 m | 1 y | FAS |
48/542 (8.9%) |
70/536 (13.1%) |
RR 0.69 (0.51–0.93) |
++ | |
|
4 (S‐A) + |
1 | CS | ↔ | o | ↓ | ↔ | ↔ | o | ↑b |
CF, AU, at‐risk |
4–6 m | 7–12 m | 1 y | n/a | 27/485 (5.6%) | 147/1663 (8.8%) |
OR 0.61 c (0.40‐0.93) |
+ | + |
|
4 (S‐B) + |
1 | CS | ↔ | o | ↓ | ↔ | ↔ | o | ↑b |
CF, AU, gen pop |
4–6 m | 7–12 m | 1 y | n/a | n/a | n/a | n/a | + | |
AU: Australia; CS: cross‐sectional; CF: complementary food; EBF: exclusively breastfed; FAS: full analysis set; gen pop: general population LoE: line of evidence; m: months; n/a: not applicable; OR: odds ratio; PP: per‐protocol analysis; RCT: randomised controlled trial; RR: risk ratio; SG: Singapore; y: year(s); ↓: downgrade; ↑: upgrade; ↔: no concern/impact; o: not evaluable.
Because of inconsistency between FAS and PP analysis.
Significant p‐for‐trend across different age categories of introduction of egg.
Unadjusted (calculated based on the raw data of events per group).
This line of evidence is not considered to be inconsistent with the findings in the lines of evidence 1 and 3, as differential findings could be explained. In addition, the study was underpowered. Therefore, this line of evidence was not considered in the grading of the confidence of the evidence.
The study in this line of evidence was most likely underpowered and therefore this line of evidence was not considered in the grading of the confidence of the evidence.
Results for sensitisation were consistent with the results on symptomatic food allergy within each of the RCTs in the general population and could not be interpreted for two additional studies (Gabet et al., 2016; Tran et al., 2017) in the general population in the absence of results on symptomatic food allergy in these studies. Also, the results on sensitisation of the meta‐analysis on the three RCTs considered in the line of evidence 4 in at‐risk populations cannot be interpreted. Therefore, the studies on sensitisation were not used in the grading of the confidence in the evidence.
Derived as a range from the certainty in the lines of evidence 4 (++) and 1 (+++).