| 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 |
Skin infections were prompted for at all visits. |
Some concerns |
Skin infections were reported by parents on the 3, 6 and 12 month questionnaires. 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. |
| 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 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 |
Adverse events prompted for at visits and an event recorded for 74/80=92.5%. |
Some concerns |
Adverse events prompted for at visits (week 6, month 6 and month 12). 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. |
| McClanahan 2019 |
Low risk of bias |
Quote: "Randomization was completed via a computer‐generated randomization list issued by a statistician with block sizes of 10 and concealed from the recruitment coordinator until randomization." 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.: "At 2, 6 and 12 months, the intervention group had 87%, 72.4% and 66.7% high adherence, respectively, vs. 45.2%, 45.8% and 45.5% in the control group, respectively." The control group rates are high but similar to those reported in another study by the same group (e.g. up to ~75 % in Rendell et al. 2011). |
Low risk of bias |
Adverse events self‐recalled by all participants and prompted for at visits. |
Some concerns |
Adverse events self‐recalled by all participants and prompted for at visits (2, 6 and 12mo) and telephone follow‐up calls (18 and 24 mo). Outcome assessors were reporters who were aware of the allocation (parents). |
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. |
| Simpson 2014 |
Low risk of bias |
Quote: "Infants were randomized at a 1:1 ratio using random block sizes to either the intervention or control group with a central, Web‐based, computer generated, Internet randomization service." 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 “Eight (13.3%) parents in the control group reported using emollients in a way that mirrored the intervention (ie, regular generalized application of emollient for reasons other than the treatment of cradle cap, nappy rash, or eczema).” The IPD shows regular use of emollient (≥ 3 days a week) by 50/55 intervention individuals and only 3/53 control participants with eczema outcome recorded). |
Low risk of bias |
Skin infections were prompted for at all patient visits. |
Some concerns |
Skin infections were prompted for at 10days, 6 weeks, 12 weeks, 18 weeks and 24 weeks. 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. |
| 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. |
Some concerns |
Quote: "Adverse events were recorded in weekly electronic diaries up to week 26, in electronic questionnaires every 3 months, and in specific forms by personnel at the discretion of the study personnell." 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. |
