University of Melbourne, Melbourne, Australia. l.busija @ deakin.edu.au
Cerebrovasc Dis. 2013;35(5):483-91. doi: 10.1159/000350724. Epub 2013 May 31.
Stroke is one of the most disabling neurological conditions. Clinical research is vital for expanding knowledge of treatment effectiveness among stroke patients. However, evidence begins to accumulate that stroke patients who take part in research represent only a small proportion of all stroke patients. Research participants may also differ from the broader patient population in ways that could potentially distort treatment effects reported in therapeutic trials. The aims of this study were to estimate the proportion of stroke patients who take part in clinical research studies and to compare demographic and clinical profiles of research participants and non-participants.
5,235 consecutive patients admitted to the Stroke Care Unit of the Royal Melbourne Hospital, Melbourne, Australia, for stroke or transient ischaemic attack between January 2004 and December 2011 were studied. The study used cross-sectional design. Information was collected on patients' demographic and socio-economic characteristics, risk factors, and comorbidities. Associations between research participation and patient characteristics were initially assessed using χ(2) or Mann-Whitney tests, followed by a multivariable logistic regression analysis. The logistic regression analysis was carried out using generalised estimating equations approach, to account for patient readmissions during the study period.
558 Stroke Care Unit patients (10.7%) took part in at least one of the 33 clinical research studies during the study period. Transfer from another hospital (OR = 0.35, 95% CI 0.22-0.55), worse premorbid function (OR = 0.61, 95% CI 0.54-0.70), being single (OR = 0.61, 95% CI 0.44-0.84) or widowed (OR = 0.77, 95% CI 0.60-0.99), non-English language (OR = 0.67, 95% CI 0.53-0.85), high socio-economic status (OR = 0.74, 95% CI 0.59-0.93), residence outside Melbourne (OR = 0.75, 95% CI 0.60-0.95), weekend admission (OR = 0.78, 95% CI 0.64-0.94), and a history of atrial fibrillation (OR = 0.79, 95% CI 0.63-0.99) were associated with lower odds of research participation. A history of hypertension (OR = 1.50, 95% CI 1.08-2.07) and current smoking (OR = 1.23, 95% CI 1.01-1.50) on the other hand were associated with higher odds of research participation.
The results of this study indicate that stroke patients who take part in clinical research do not represent 'typical' patient admitted to a stroke unit. The imbalance of prognostic factors between stroke participants and non-participants has serious implications for interpretation of research findings reported in stroke literature. This study provides insights into clinical, demographic, and socio-economic characteristics of stroke patients that could potentially be targeted to enhance generalizability of stroke research studies. Given the imbalance of prognostic factors between research participants and non-participants, future studies need to examine differences in stroke outcomes of these groups of patients.
中风是最具致残性的神经疾病之一。临床研究对于扩大中风患者治疗效果的知识至关重要。然而，有证据表明，参与研究的中风患者仅占所有中风患者的一小部分。研究参与者也可能在可能潜在扭曲治疗效果的报告的方式上与更广泛的患者群体有所不同。本研究的目的是估计参与临床研究的中风患者的比例，并比较研究参与者和非参与者的人口统计学和临床特征。
2004 年 1 月至 2011 年 12 月期间，连续 5235 名中风患者入住澳大利亚墨尔本皇家医院中风护理病房进行中风或短暂性脑缺血发作，采用横断面设计。收集患者的人口统计学和社会经济特征、风险因素和合并症的信息。使用卡方或曼-惠特尼检验评估研究参与和患者特征之间的关联，然后进行多变量逻辑回归分析。逻辑回归分析使用广义估计方程方法进行，以考虑研究期间患者的再入院情况。
在研究期间，有 558 名中风护理病房患者（10.7%）参加了至少一项 33 项临床研究之一。从另一家医院转院（OR=0.35，95%CI 0.22-0.55）、病前功能较差（OR=0.61，95%CI 0.54-0.70）、单身（OR=0.61，95%CI 0.44-0.84）或丧偶（OR=0.77，95%CI 0.60-0.99）、非英语语言（OR=0.67，95%CI 0.53-0.85）、高社会经济地位（OR=0.74，95%CI 0.59-0.93）、居住在墨尔本以外（OR=0.75，95%CI 0.60-0.95）、周末入院（OR=0.78，95%CI 0.64-0.94）和房颤史（OR=0.79，95%CI 0.63-0.99）与较低的研究参与率相关。另一方面，高血压史（OR=1.50，95%CI 1.08-2.07）和当前吸烟（OR=1.23，95%CI 1.01-1.50）与较高的研究参与率相关。
本研究结果表明，参与临床研究的中风患者并不代表入住中风病房的“典型”患者。研究参与者和非参与者之间的预后因素不平衡对中风文献中报告的研究结果的解释有严重影响。本研究提供了中风患者的临床、人口统计学和社会经济特征的见解，这些特征可能会针对增强中风研究的普遍性。鉴于研究参与者和非参与者之间的预后因素不平衡，未来的研究需要检查这些患者群体的中风结局差异。
