Assessing risk of bias in randomized controlled trials of methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)

评估哌甲酯治疗儿童和青少年注意力缺陷多动障碍(ADHD)随机对照试验中的偏倚风险

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Abstract

To test how reliable the tool recommend by Cochrane Collaboration for assessing risk of bias systematic reviews of randomized clinical trials is in the context of methylphenidate for children and adolescents with attention deficit hyperactivity disorder. Confirmatory factor analysis was used to evaluate a unidimensional model for the 7 indicators, applied to 184 Randomized Clinical Trial (RCTs) within a 2015 Cochrane systematic review titled "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder." A unidimensional model resulted in excellent adequacy indices, but only 2 indicators had very high factor loadings and low measurement errors. In terms of content, the 7 indicators showed poor reliability (ω = 0.642); however, the set of indicators was precise in evaluating studies with a high amount of bias risk. The Cochrane model of risk of bias as it is, exhibited good fit indices but the majority of the items were not reliable to adequately capture risk of bias in the context of clinical trials of methylphenidate for ADHD.

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