| 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 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 |
1210/1394 = 87% have outcome. Sensitivity analysis using the IPD reveals conclusions do not change significantly if everyone missing is assumed to not have eczema, RR=0.93, 95% 0.76 to 1.15, or if all assumed to have eczema, RR=0.99, 95% CI 0.86 to 1.15. |
Low risk of bias |
UK working party criteria and blinded assessor used. 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 data set provided by investigators and IPD meta‐analysis SAP followed. |
Low risk of bias |
Low risk of bias in all 5 domains. |
| Dissanayake 2019 |
Low risk of bias |
Randomisation performed using minimization at a central location. 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. Quote: “we did not prohibit the application of moisturizers in the no‐intervention group. As this could mask the effect of the moisturizer used as an intervention, we looked at the effect of any emollient (irrespective of the formal intervention assigned) on the development of AD. We did not observe any difference in incidence between children who received any type of emollient vs. those who did not (data not shown).” “Approximately 80% of the parents/guardians in the emollient groups reported that they applied the emollient at least twice a day. Adjusting for emollient application rate did not lead to a significant difference in the rate of AD development among the groups. The effect of emollient application was also investigated in all babies who received emollient (groups 1 and 3) versus those who did not (groups 2 and 4), but this too did not show any difference in the incidence of AD.” |
Low risk of bias |
455/549=83% have outcome. Sensitivity analysis using the IPD shows conclusions do not change significantly if all individuals missing eczema outcome are assumed to not have eczema (RR 1.24 95% CI[0.84, 1.83]) or they do have eczema (RR 1.00 95% CI[0.79, 1.27]). |
Low risk of bias |
UK working party criteria and blinded assessor used. Quote: "AD diagnosis was further confirmed blindly." |
Low risk of bias |
Full trial dataset provided by investigators and IPD meta‐analysis SAP followed. |
Low risk of bias |
Low risk of bias in all 5 domains. |
| Lowe 2018a |
Low risk of bias |
Quote from trial protocol: "A computer generated random allocation list in blocks of variable length (4‐12) will be used. This list will be held by The RCH Pharmacy Department, which will be independent from the participant recruitment or testing. At all times, the allocation list will be concealed from the study coordinator and the other study investigators, who will manage participant recruitment." 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. The IPD shows regular use of emollient (≥ 3 days a week) by 11/36 (31%) control participants and 30/38 (79%) with eczema outcome recorded). |
Low risk of bias |
74/80 = 93% have outcome. Sensitivity analysis using the IPD reveals conclusions do not change significantly if everyone missing is assumed to not have eczema, RR=0.61 [0.26 to 1.40] or if all assumed to have eczema, RR=0.67 [0.34 to 1.33]. |
Low risk of bias |
UK working party criteria and blinded assessor used. |
Low risk of bias |
Full trial dataset provided by investigators and IPD meta‐analysis SAP followed. |
Low risk of bias |
Low risk of bias for all 5 domains. |
