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The quality items to be assessed are allocation concealment, blinding, intention to treat analysis, and completeness of follow-up.
More large trials were well conducted than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data.
Data extraction: Data were extracted by two reviewers on the language of publication, use of randomization, blinding, intention to treat analysis, study sample size and statistical significance.
Large trials showed significantly better reporting quality than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data.
The following methodological features were collected: blinding, intention to treat analysis or not and number of participants who completed follow-up.
Similar(55)
We assessed the bias risk in respect to generation of the allocation sequence, allocation concealment, blinding, intention-to-treat analysis, drop-outs, reporting of outcome measures, economic bias, and academic bias.
The quality items assessed were the allocation concealment, blinding, intention-to-treat analysis, and completeness of follow-up.
The following methodological features were collected: simple or double blinding, intention-to-treat-analysis or not, number of participants who completed the follow-up.
Methodological quality at the level of the study was assessed by two independent reviewers who rated sequence generation, allocation concealment, blinding, intention-to-treat analyses, and attrition.
A double-plus sign was assigned to studies that adequately fit all the criteria of randomisation, concealment, blinding, intention-to-treat analysis and predefined outcomes.
However, in that study, the small trials were not statistically different from those of large trials in terms of blinding, intention-to-treat analysis, thus, the small-study effects cannot be fully explained by methodological quality.
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