Sampling bias in an internet treatment trial for depression.
Sampling bias in an internet treatment trial for depression.
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DOI：
10.1038/tp.2012.100
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发表时间：
2012-10-23
影响因子：
6.8
通讯作者：
Glozier N
中科院分区：
文献类型：
--
作者：
Donkin L;Hickie IB;Christensen H;Naismith SL;Neal B;Cockayne NL;Glozier N
网络心理干预是有效的，可以减少传统的访问障碍。没有研究评估这些试验中是否存在任何可能限制这些试验结果转化为现实世界应用的抽样偏倚。我们从一项基于社区的健康队列研究中确定了7999名潜在合格的试验参与者，并邀请他们参加一项针对抑郁症患者的在线认知行为治疗计划的随机对照试验。我们比较了那些同意接受试验纳入评估的人与不同意的人在健康研究中获得的人口统计学，临床和行为指标。然后评估任何潜在的偏倚因素与试验参与者中抑郁结局的相关性，以评估抽样偏倚的存在。在探索的35个健康调查变量中，只有4个与同意女性性行为的可能性较高独立相关（比值比（OR）1.11，95%置信区间（CI）1.05-1.19），在家讲英语（OR 1.48，95% CI 1.15-1.90）高等教育（OR 1.67，95% CI 1.46-1.92）和既往诊断为抑郁症（OR 1.37，95% CI 1.22-1.55）。多变量模型解释有限的方差（C-统计0.6）在解释参与。这四个因素与主要试验结局指标或干预组的任何差异性影响均无显著相关性，这表明在合格的试验参与者中，很少有因素与同意参与相关。没有迹象表明这种自我选择会使试验结果产生偏差，或者会限制其推广性和向公众或临床环境的转化。
Internet psychological interventions are efficacious and may reduce traditional access barriers. No studies have evaluated whether any sampling bias exists in these trials that may limit the translation of the results of these trials into real-world application. We identified 7999 potentially eligible trial participants from a community-based health cohort study and invited them to participate in a randomized controlled trial of an online cognitive behavioural therapy programme for people with depression. We compared those who consented to being assessed for trial inclusion with nonconsenters on demographic, clinical and behavioural indicators captured in the health study. Any potentially biasing factors were then assessed for their association with depression outcome among trial participants to evaluate the existence of sampling bias. Of the 35 health survey variables explored, only 4 were independently associated with higher likelihood of consenting—female sex (odds ratio (OR) 1.11, 95% confidence interval (CI) 1.05–1.19), speaking English at home (OR 1.48, 95% CI 1.15–1.90) higher education (OR 1.67, 95% CI 1.46–1.92) and a prior diagnosis of depression (OR 1.37, 95% CI 1.22–1.55). The multivariate model accounted for limited variance (C-statistic 0.6) in explaining participation. These four factors were not significantly associated with either the primary trial outcome measure or any differential impact by intervention arm. This demonstrates that, among eligible trial participants, few factors were associated with the consent to participate. There was no indication that such self-selection biased the trial results or would limit the generalizability and translation into a public or clinical setting.
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