| 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 |
| Cooke 2015 |
Low risk of bias |
Quote: "Randomization was 1:1:1 via a central telephone‐based service" and "Allocation was concealed from the participant and independent research midwife until the point of allocation". 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 “The weekly ranges of adherence for treatment use were 79% to 93% of participants for the olive oil group, 83% to 94% for the sunflower oil group and 100% for the no oil group.” |
Low risk of bias |
Adverse events collected for all participants. |
Low risk of bias |
Quote: " All measurements were taken by the investigator who remained blind to the treatment allocation. Changes in the skin were observed and recorded by the investigator at baseline and follow‐up (erythema, dryness and scaling, need for medical products/attention) between 48 h and 4 weeks." |
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 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 |
Adverse events prompted for at visits and an event recorded for 74/80=92.5%. |
Low risk of bias |
Outcome assessors were reporters who were aware of the allocation, but assessment of serious adverse events not likely to be influenced by knowledge of intervention received. |
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 domains. |
| Skjerven 2020 |
Low risk of bias |
Quote: “we used computer‐generated cluster randomisation based on 92 geographical living area blocks as well as eight 3‐month time blocks. All infants born in the same 3‐month period and belonging to the same postal code or city area were allocated to the same intervention group”. 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 IPD shows regular use of emollient (ceridal cream) (≥ 3 days a week averaged over intervention period) by only 1 control participant and 262/599 = 44% intervention arm. |
Low risk of bias |
Adverse events collected for all participants. |
Low risk of bias |
Outcome assessors were reporters who were aware of the allocation, but assessment of serious adverse events not likely to be influenced by knowledge of intervention received. |
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 domains. |
