McCullagh S, Feinstein A
Neuropsychiatry Program, Sunnybrook and Women's College Hospital, 2075 Bayview Avenue, Toronto, Ontario, Canada M4N 3M5.
J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):39-43. doi: 10.1136/jnnp.74.1.39.
Research concerning the natural history after mild traumatic brain injury (TBI) faces a number of methodological challenges, including those related to subject recruitment. The aim of this study was to determine whether subjects who agree to participate in longitudinal research differ from those who do not. The presence of identifiable, selective factors operating during recruitment may be an important source of systematic bias. In Canada, given the presence of universal healthcare coverage, this issue can be examined using population based, administrative databases to obtain information about a cohort that was approached for study enrollment, regardless of whether they ultimately agreed to participate.
A sample of 626 consecutive patients with mild TBI was invited to enroll in TBI outcome research. Those who agreed to participate (n=272) were compared with those who refused (n=354) on demographic, past health, and injury related variables. Thereafter, using encrypted health card data, the two groups were contrasted with respect to pre-injury and post-injury healthcare utilisation.
No premorbid differences between the groups emerged. However, all early indices of TBI severity were significantly worse for the participants group (p<0.001). Consistent with these findings, healthcare utilisation rates were no different before injury, but were significantly increased after injury for the participants (p<0.001), even beyond the period of study enrollment (p<0.001). Differences remained even after controlling for those with significant non-TBI injuries.
Premorbid factors did not predict whether patients comply with, or refuse study participation. However, the participants group was biased toward those with more significant injuries, which translated into higher rates of healthcare utilisation after injury. These results strike a cautionary note, given the apparent systematic bias influencing enrollment in longitudinal studies of mild TBI.
关于轻度创伤性脑损伤(TBI)后自然史的研究面临诸多方法学挑战,包括与受试者招募相关的挑战。本研究的目的是确定同意参与纵向研究的受试者与不同意的受试者是否存在差异。招募过程中存在的可识别的选择性因素可能是系统偏差的重要来源。在加拿大,鉴于全民医保覆盖的情况,可以利用基于人群的行政数据库来研究这一问题,以获取有关被邀请参加研究的队列的信息,无论他们最终是否同意参与。
邀请626例连续的轻度TBI患者参与TBI结局研究。将同意参与的患者(n = 272)与拒绝参与的患者(n = 354)在人口统计学、既往健康状况和损伤相关变量方面进行比较。此后,使用加密的健康卡数据,对比两组在伤前和伤后的医疗保健利用情况。
两组在病前无差异。然而,参与者组的所有TBI严重程度早期指标均明显更差(p < 0.001)。与这些发现一致,伤前医疗保健利用率无差异,但参与者伤后的利用率显著增加(p < 0.001),甚至在研究入组期之后仍显著增加(p < 0.001)。即使在控制了有严重非TBI损伤的患者后,差异仍然存在。
病前因素无法预测患者是否会遵守或拒绝参与研究。然而,参与者组偏向于损伤更严重的患者,这导致伤后医疗保健利用率更高。鉴于明显的系统偏差影响轻度TBI纵向研究的入组情况,这些结果值得警示。