Neslusan C A, Hylan T R, Dunn R L, Donoghue J
The MEDSTAT Group, Washington, DC, USA.
Value Health. 1999 Nov-Dec;2(6):435-45. doi: 10.1046/j.1524-4733.1999.26002.x.
Criticism has been made of observational studies in clinical practice because of their failure to control for unobserved factors that correlate with both initial treatment selection and observed outcomes.
A two-stage statistical model was applied to data obtained from a large general practitioner medical records database (DIN-LINK) to estimate the effect of initial antidepressant selection on the duration of antidepressant therapy and on the likelihood of being prescribed an average daily dose above the minimum recommended dose. The statistical model controlled for unobserved factors correlated with initial treatment selection and the observed outcomes as well as for observed confounders.
Unobserved factors correlated with treatment selection were not a statistically significant determinant of the number of days of antidepressant therapy. However, unobserved factors correlated with treatment selection were a statistically significant determinant of the likelihood of receiving an average dose during therapy greater than the minimum recommended. After controlling for relevant confounders, those patients who began treatment with sertraline as opposed to fluoxetine had fewer days of antidepressant therapy and were more likely to receive average doses greater than the minimum recommended during therapy.
Unobserved factors correlated with treatment selection can impact outcomes in observational studies and should be tested and controlled for whenever possible.
临床实践中的观察性研究受到批评,因为它们未能控制与初始治疗选择和观察到的结果均相关的未观察因素。
将两阶段统计模型应用于从大型全科医生医疗记录数据库(DIN-LINK)获得的数据,以估计初始抗抑郁药选择对抗抑郁治疗持续时间以及开具高于最低推荐剂量的平均日剂量可能性的影响。该统计模型控制了与初始治疗选择和观察到的结果相关的未观察因素以及观察到的混杂因素。
与治疗选择相关的未观察因素不是抗抑郁治疗天数的统计学显著决定因素。然而,与治疗选择相关的未观察因素是治疗期间接受高于最低推荐平均剂量可能性的统计学显著决定因素。在控制了相关混杂因素后,与使用氟西汀开始治疗的患者相比,使用舍曲林开始治疗的患者抗抑郁治疗天数更少,并且在治疗期间更有可能接受高于最低推荐的平均剂量。
与治疗选择相关的未观察因素可影响观察性研究的结果,应尽可能进行检验和控制。