| Chalmers 2020 |
Low risk of bias |
Quote: "The randomisation schedule was created by the CTU using computer‐generated pseudo‐random code with permuted blocks of randomly varying size. The sequence was known only to the programmer until database lock." Baseline variables by treatment group do not suggest a problem with randomisation, characteristics well balanced (IPD available) |
Low risk of bias |
Not possible to blind participants’ carers, but there is no evidence that deviations arised because of the trial context. The control group rates of skin care application were consistent with other trials and observational studies (e.g. up to 75 % in Rendell et al. 2011). Quote: “Of families in the emollient group with complete questionnaire data on adherence at each time point, 466 (88%) of 532 had satisfactory adherence at 3 months, 427 (82%) of 519 at 6 months, and 375 (74%) of 506 at 12 months.” “No emollient was supplied to the control group, but self‐directed use of emollients at least three times per week to most of the body (contamination) occurred in 18% (82 of 457) at 3 months, 17% (62 of 372) at 6 months, and 15% (49 of 324) at 12 months” |
High risk of bias |
996/1394 have outcome =71% of randomised participants. Sensitivity analysis using the IPD data shows conclusions do not change significantly if all missing are assumed to not have food allergy, RR=2.46, 95% CI 0.96 to 6.30. But conclusions vary when all missing are assumed to have food allergy RR=1.09, 95% CI 0.93 to 1.28. The overall proportion of missing data is similar in the two treatment groups. However there is a difference between treatment groups in the proportion of participants who underwent oral food challenge. Of those invited to oral food challenge due to suspected food allergy, only 39 of 133 (29%) in the intervention group and 21 of 125 (17%) in the control group underwent oral food challenge. This suggests that missingness is likely to have depended on the outcome. |
Low risk of bias |
Quote: "Research nurses doing skin examinations, skin prick testing, food challenges, or making food allergy decisions, and the statistician, were masked to treatment allocation during the study." |
Low risk of bias |
Full trial dataset provided by investigators and IPD meta‐analysis SAP followed. |
High risk of bias |
High risk of bias due to missing data (29% and results varied in sensitivity analysis) which could have depended on the outcome, but low risk of bias in all other domains. |
