Gross C P, Steiner C A, Bass E B, Powe N R
Primary Care Section, Yale University School of Medicine, New Haven, Conn 06520, USA.
JAMA. 2000 Dec 13;284(22):2886-93. doi: 10.1001/jama.284.22.2886.
Little is known about how clinical practice is affected by disseminating results of clinical trials prior to publication in peer-reviewed journals.
To determine whether prepublication release of carotid endarterectomy (CEA) trial results via National Institutes of Health Clinical Alerts was associated with prompt changes in patient care that were consistent with the new medical evidence.
DESIGN, SETTING, AND PATIENTS: Longitudinal data series analysis using acute care hospital discharge data from the Healthcare Cost and Utilization Project for patients who had CEA performed in acute care hospitals in 7 states (New York, California, Pennsylvania, Florida, Colorado, Illinois, and Wisconsin). The trials were the North American Symptomatic Carotid Endarterectomy Trial (NASCET clinical alert released February 1991) and the Asymptomatic Carotid Atherosclerosis Study (ACAS clinical alert released September 1994).
Carotid endarterectomy rate during each month from 1989 (2 years before the NASCET clinical alert) to 1996 (2 years after the ACAS clinical alert), adjusted for age and sex. Because both trials were limited to patients 80 years or younger in hospitals with low mortality, we also stratified CEA rates by patient age and hospital mortality rate.
From 1989 through 1996, 272849 CEAs were performed in the acute care hospitals in these 7 states, with the annual number increasing from 22300 to 51 495. Afterthe NASCET clinical alert, the adjusted CEA rate increased 3.4% per month (95% confidence interval [CI], 1.6%-5.3%) during the following 6 months and then increased 0.5% per month (95% CI, 0.2%-0.8%; P<.04) after journal publication of the NASCET study. After the ACAS clinical alert, the CEA rate increased 7.3 % per month (95% CI, 6.0%-8.5%) during the following 7 months and then decreased by 0.44% per month (95% CI, -0.86% to -0.0002%; P<.04) after journal publication of the ACAS study. After the ACAS clinical alert, the CEA rate increased more in patients aged 80 years or older than in younger patients; whereas, after journal publication of ACAS, the CEA rate decreased more rapidly in the older population. The overall proportion of CEAs performed in low-mortality hospitals did not change substantially after release of the clinical alerts or after journal publication.
In this study, prepublication dissemination of CEA trial results with clinical alerts was associated with prompt and substantial changes in medical practice, but the observed changes suggest that the results were extrapolated to patients and settings not directly supported by the trials.
在同行评审期刊发表之前传播临床试验结果对临床实践有何影响，目前所知甚少。
确定通过美国国立卫生研究院临床警报预先发布颈动脉内膜切除术（CEA）试验结果是否与根据新医学证据迅速改变患者护理有关。
设计、设置和患者：使用医疗保健成本和利用项目中7个州（纽约、加利福尼亚、宾夕法尼亚、佛罗里达、科罗拉多、伊利诺伊和威斯康星）急性护理医院的急性护理医院出院数据进行纵向数据系列分析。试验包括北美症状性颈动脉内膜切除术试验（1991年2月发布NASCET临床警报）和无症状颈动脉粥样硬化研究（1994年9月发布ACAS临床警报）。
1989年（NASCET临床警报前2年）至1996年（ACAS临床警报后2年）每月的颈动脉内膜切除术率，根据年龄和性别进行调整。由于两项试验都仅限于80岁及以下、死亡率低的医院患者，我们还按患者年龄和医院死亡率对CEA率进行了分层。
1989年至1996年，这7个州的急性护理医院共进行了272849例CEA手术，每年的手术数量从22300例增加到51495例。NASCET临床警报发布后，在接下来的6个月中，调整后的CEA率每月增加3.4%（95%置信区间[CI]，1.6%-5.3%），然后在NASCET研究发表于期刊后每月增加0.5%（95%CI，0.2%-0.8%；P<.04）。ACAS临床警报发布后，在接下来的7个月中，CEA率每月增加7.3%（95%CI，6.0%-8.5%），然后在ACAS研究发表于期刊后每月下降0.44%（95%CI，-0.86%至-0.0002%；P<.04）。ACAS临床警报发布后，80岁及以上患者的CEA率比年轻患者增加得更多；而在ACAS发表于期刊后，老年人群中的CEA率下降得更快。临床警报发布后或期刊发表后，低死亡率医院进行的CEA总体比例没有实质性变化。
在本研究中，通过临床警报预先发布CEA试验结果与医疗实践的迅速而重大的变化有关，但观察到的变化表明，结果被外推到了试验未直接支持的患者和环境中。
