Centre for Cardiovascular Science, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16?4TJ, UK.
Thrombosis Research Institute, Emmanuel Kaye Building, Manresa Road, London SW3?6LR, UK.
Eur Heart J Qual Care Clin Outcomes. 2018 Jan 1;4(1):27-35. doi: 10.1093/ehjqcco/qcx030.
Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result.
Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0 and 18 months (such that the total time of follow-up was 24 months; data collection December 2009 and October 2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between March 2010 and October 2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs. 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51-3.67] vs. 4.05 [95% CI 3.53-4.63]; P = 0.016).
Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment.
http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF (NCT01090362).
回顾性和前瞻性观察性研究旨在反映临床实践中的真实世界证据，但可能得出相互矛盾的结果。GARFIELD-AF 登记处包括这两种入组方法，并允许分析可能导致的患者特征和结局差异。
在 19 个国家，招募了诊断为房颤（AF）且至少有 1 个中风危险因素的患者，分别采用回顾性（n=5069）或前瞻性（n=5501）方法入组，然后进行前瞻性随访。回顾性入组队列包括至少 6 个月且在入组前 24 个月内确诊的持续性房颤患者，这些患者是通过回顾性方法识别的（从电子病历中收集基线和部分随访数据），然后在 0 至 18 个月之间进行前瞻性随访（因此总随访时间为 24 个月；数据收集时间为 2009 年 12 月至 2010 年 10 月）。在前瞻性入组队列中，新诊断为房颤（诊断后 6 周内）的患者于 2010 年 3 月至 2011 年 10 月期间招募，并在入组后随访 24 个月。在临床特征方面，包括房颤类型、卒中预防策略和事件发生率，两个队列之间存在差异。在回顾性确定的队列中，接受维生素 K 拮抗剂的患者比例（62.1% vs. 53.2%）更高，而接受非维生素 K 口服抗凝剂的患者比例（1.8% vs. 4.2%）更低。在前瞻性随访期间（从第一次研究访视开始至 1 年），每 100 人年的全因死亡率在回顾性队列中显著低于前瞻性队列（3.04[95%CI 2.51-3.67] vs. 4.05[95%CI 3.53-4.63]；P=0.016）。
评估房颤患者特征和结局的登记处数据的解释必须考虑到登记处设计的差异，以及回顾性入组带来的回忆偏倚和生存偏差的影响。
http://www.clinicaltrials.gov。GARFIELD-AF（NCT01090362）的独特标识符。
