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. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2

Risk of bias for analysis 1.40 Adverse event: slippage accidents.

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 Slippage accidents were prompted for at all visits. Some concerns Slippage incidents and 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
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 arise 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.
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 AE's were prompted for at all patient visits, including accidents. Some concerns AE's were prompted for at all follow‐ups (10days, 6 weeks, 12 weeks, 18 weeks and 24 weeks), including accidents. 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.