| 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.” |
Some concerns |
1115/1394 have outcome = 80% of randomised participants. Sensitivity analysis using the IPD data shows conclusions do not change if all missing are assumed to not have food allergy, RR=1.42, 95% CI 0.90 to 2.26, but when all missing are assumed to have food allergy RR=1.17, 95% CI 0.97 to 1.40 (Point estimate varies by ≥20% complete case estimate.) Missingness could have depended on outcome, but not likely as panel assessment based on skin prick testing and history incorporated. |
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. |
Some concerns |
Some concerns due to missing data (results varied in sensitivity analysis). Missingness could have depended on outcome, but not likely as panel assessment based on skin prick testing and history incorporated. Low risk of bias in all other domains. |
