PDF(Pubmed)
Abstract：
BACKGROUND: A combination of self-reported questionnaire and administrative data could potentially enhance ascertainment of outcomes and alleviate the limitations of both in follow up studies. However, it is uncertain how access to only one of these data sources to assess outcomes impact study findings. Therefore, this study aimed to determine whether the study findings would be altered if the outcomes were assessed by different data sources alone or in combination.
METHODS: At 50-year follow-up of participants in a randomized trial, we assessed the effect of antenatal betamethasone exposure on the diagnosis of diabetes, pre-diabetes, hyperlipidemia, hypertension, mental health disorders, and asthma using a self-reported questionnaire, administrative data, a combination of both, or any data source, with or without adjudication by an expert panel of five clinicians. Differences between relative risks derived from each data source were calculated using the Bland-Altman approach.
RESULTS: There were 424 participants (46% of those eligible, aged 49 years, SD 1, 50% male). There were no differences in study outcomes between participants exposed to betamethasone and those exposed to placebo when the outcomes were assessed using different data sources. When compared to the study findings determined using adjudicated outcomes, the mean difference (limits of agreement) in relative risks derived from other data sources were: self-reported questionnaires 0.02 (-0.35 to 0.40), administrative data 0.06 (-0.32 to 0.44), both questionnaire and administrative data 0.01 (-0.41 to 0.43), and any data source, 0.01 (-0.08 to 0.10).
CONCLUSIONS: Utilizing a self-reported questionnaire, administrative data, both questionnaire and administrative data, or any of these sources for assessing study outcomes had no impact on the study findings compared with when study outcomes were assessed using adjudicated outcomes.
METHODS: At 50-year follow-up of participants in a randomized trial, we assessed the effect of antenatal betamethasone exposure on the diagnosis of diabetes, pre-diabetes, hyperlipidemia, hypertension, mental health disorders, and asthma using a self-reported questionnaire, administrative data, a combination of both, or any data source, with or without adjudication by an expert panel of five clinicians. Differences between relative risks derived from each data source were calculated using the Bland-Altman approach.
RESULTS: There were 424 participants (46% of those eligible, aged 49 years, SD 1, 50% male). There were no differences in study outcomes between participants exposed to betamethasone and those exposed to placebo when the outcomes were assessed using different data sources. When compared to the study findings determined using adjudicated outcomes, the mean difference (limits of agreement) in relative risks derived from other data sources were: self-reported questionnaires 0.02 (-0.35 to 0.40), administrative data 0.06 (-0.32 to 0.44), both questionnaire and administrative data 0.01 (-0.41 to 0.43), and any data source, 0.01 (-0.08 to 0.10).
CONCLUSIONS: Utilizing a self-reported questionnaire, administrative data, both questionnaire and administrative data, or any of these sources for assessing study outcomes had no impact on the study findings compared with when study outcomes were assessed using adjudicated outcomes.
摘要：
背景：自我报告的问卷和管理数据的组合可能会增强对结果的确定，并减轻两者在后续研究中的局限性。然而,尚不确定仅获取这些数据源之一来评估结果如何影响研究结果.因此,这项研究的目的是确定如果通过不同的数据来源单独或组合评估结局,研究结果是否会改变.
方法：对一项随机试验的参与者进行了50年的随访，我们评估了产前倍他米松暴露对糖尿病诊断的影响，糖尿病前期,高脂血症,高血压,精神健康障碍,使用自我报告的问卷和哮喘，行政数据，两者的结合，或任何数据源，有或没有由五名临床医生组成的专家小组裁决。使用Bland-Altman方法计算了从每个数据源得出的相对风险之间的差异。
结果：有424名参与者（46％的合格参与者，49岁,SD一1，50%男性）。当使用不同的数据源评估结果时，暴露于倍他米松的参与者和暴露于安慰剂的参与者之间的研究结果没有差异。与使用裁定结果确定的研究结果相比，从其他数据源得出的相对风险的平均差(协议限制)为:自我报告问卷0.02(-0.35至0.40)，行政数据0.06(-0.32至0.44)，问卷和行政数据0.01(-0.41至0.43)，和任何数据源，0.01（-0.08至0.10）。
结论：利用自我报告的问卷，行政数据，问卷调查和行政数据，与使用裁定结局评估研究结局时相比,这些用于评估研究结局的来源中的任何一个对研究结果均无影响.
方法：对一项随机试验的参与者进行了50年的随访，我们评估了产前倍他米松暴露对糖尿病诊断的影响，糖尿病前期,高脂血症,高血压,精神健康障碍,使用自我报告的问卷和哮喘，行政数据，两者的结合，或任何数据源，有或没有由五名临床医生组成的专家小组裁决。使用Bland-Altman方法计算了从每个数据源得出的相对风险之间的差异。
结果：有424名参与者（46％的合格参与者，49岁,SD一1，50%男性）。当使用不同的数据源评估结果时，暴露于倍他米松的参与者和暴露于安慰剂的参与者之间的研究结果没有差异。与使用裁定结果确定的研究结果相比，从其他数据源得出的相对风险的平均差(协议限制)为:自我报告问卷0.02(-0.35至0.40)，行政数据0.06(-0.32至0.44)，问卷和行政数据0.01(-0.41至0.43)，和任何数据源，0.01（-0.08至0.10）。
结论：利用自我报告的问卷，行政数据，问卷调查和行政数据，与使用裁定结局评估研究结局时相比,这些用于评估研究结局的来源中的任何一个对研究结果均无影响.
