| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| 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.” |
Low risk of bias |
Outcome available for 1171/1394=84%. Sensitivity analysis using the IPD data shows conclusions do not change if all missing are assumed to assumed not to have reaction: RR = 1.24 [0.97 to 1.59] or if everyone missing is assumed to have reaction RR=1.20 [1.02 to 1.40]. |
Some concerns |
Outcome assessors were reporters who were aware of the allocation. |
Low risk of bias |
Full trial dataset provided by investigators and IPD meta‐analysis SAP followed. |
Some concerns |
Outcome assessors were reporters who were aware of the allocation. Low risk of bias for all other domains. |
| NCT03376243 |
Low risk of bias |
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. e.g. up to ~75 % in Rendell et al. 2011. The IPD shows daily use of emollient over intervention period by 7/27 (26%) control and 19/22 (86%) intervention participants with eczema outcomes recorded. |
Some concerns |
Data available for 41/54 = 76%. Zero events observed, therefore results differ in sensitivity analysis. Missingness could depend on outcome but not likely. |
Some concerns |
Outcome assessors were reporters who were aware of the allocation. |
Low risk of bias |
Full trial dataset provided by investigators and IPD meta‐analysis SAP followed. |
Some concerns |
Some concerns due to missing data (24%) and how outcome reporters (parents) were unblinded, but low risk of bias for other domains. |
