| Sequence generation |
We outlined the methods used to generate the allocation sequence in sufficient detail, to assess whether it should have produced comparable groups, using quotations wherever possible. We added a comment, such as 'probably done' or 'probably not done', to supplement any ambiguous quotation. We assigned each included study to one of the following categories.
Low risk of bias, which indicates an adequate randomisation method (for example, coin toss or table of random numbers) High risk of bias, which indicates that an inadequate randomisation method (for example, case file number, date of birth or alternate numbers) Unclear risk of bias, which indicates uncertainty about the appropriateness of the randomisation method
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| Allocation concealment |
We described the methods used to conceal the allocation sequence in sufficient detail to determine whether intervention allocation could have been foreseen in advance of, or during, recruitment and assigned the included studies to one of the following criteria.
Low risk of bias, which indicates adequate allocation concealment (for example, pre‐numbered or coded identical containers administered serially to participants) High risk of bias, which indicates inadequate allocation concealment (for example, alternate assignment) Unclear risk of bias, which indicates uncertainty about the adequacy of allocation concealment (for example, the authors did not describe the allocation methods)
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| Blinding of participants and personnel |
As this review is addressing parent‐mediated interventions, it was not possible (or highly unlikely) that participants who received the intervention (the caregivers) and the personnel who deliver the intervention (that is, the clinicians) will have been blinded to the type of intervention received. Nonetheless, we described the methods used, if any, to blind study participants and personnel from knowledge of which intervention was received for each included study. We assessed the risk of bias that resulted from any lack of blinding on a case‐by‐case basis, using the categories listed below.
Low risk of bias, which indicates that participants and personnel were blinded, or we judged that the lack of blinding was unlikely to have affected results High risk of bias, which indicates that some participants or key study personnel were not blinded, and the lack of blinding was likely to introduce bias; or blinding of key study participants and personnel was attempted, but it was likely that the blinding could have been broken Unclear risk of bias, which indicates that insufficient information was provided to permit a judgement of low or high risk of bias
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| Blinding of outcome assessment |
For each included study, we described the methods used, if any, to blind outcome assessor(s) from knowledge of which intervention a participant received. Assessment was made for each main outcome (for example, outcome measures at 6 and 12 months postintervention). We graded this domain as follows.
Low risk of bias, which indicates that blinding of participants and key study personnel was ensured, and it is unlikely that the blinding could have been broken High risk of bias, which indicates no blinding or incomplete blinding, and the outcome or outcome measurement was likely to be influenced by lack of blinding Unclear risk of bias, which indicates that the study did not address this outcome
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| Incomplete outcome data |
We described the completeness of outcome data for each main outcome, including attrition and exclusions from the analysis. We reported the numbers in each intervention group (compared with total randomised participants); the reason(s) for attrition/exclusion, where provided; and any re‐inclusions in analyses performed by the review authors. We graded this domain as follows.
Low risk of bias, which indicates no missing outcome data; reasons for missing outcome data were unlikely to be related to the true outcome; or missing outcome data were balanced across groups High risk of bias, which indicates that the reason for the missing outcome data was likely to be related to the true outcome Unclear risk of bias, which indicates that insufficient information was provided to permit a judgement of low or high risk of bias
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| Selective outcome reporting |
We assessed the possibility of selective outcome reporting by the study authors by checking whether any of the stated outcomes were not reported at the end of the study. We assessed this by checking the trial protocol, if available from a trial registry or from the study authors, and by looking for potential inconsistencies of reporting in the final study paper, such as inconsistencies between the Methods and Results sections. We assigned each included study to one of the following categories.
Low risk of bias, which indicates that the studies reported all pre‐specified outcomes High risk of bias, which indicates that selective reporting of outcomes was evident in the study Unclear risk of bias, which indicates uncertainty about whether selective reporting bias was avoided
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| Other potential sources of bias |
We described any additional problems that may have put a study at risk of bias. We graded this domain as follows.
Low risk of bias, which indicates that the study was free from other sources of bias High risk of bias, which indicates that there was at least 1 important risk of bias (for example, baseline imbalance, early stopping, or cointervention such as participants receiving additional treatment outside of the study protocol of parent‐mediated intervention) Unclear risk of bias, which indicates that insufficient information was provided to permit a judgement of low or high risk of bias
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