Rule Britannia
Rule Britannia
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统治不列颠尼亚
作者：
J. Javitt
这项由约翰斯顿和同事们进行的研究，题为《试点国家电子白内障手术调查》，发表在本月的版本上，其标题是谦逊的，但其含义是革命性的。据我所知，这项工作首次证明了将整个地区或国家的手术结果汇集到在线数据库中的潜力，以便了解如何最好地照顾病人。在过去的几十年里，眼科研究人员（就像一般的临床研究人员一样）已经从轶事病例报告和系列转移到各种方法来收集数据，以代表将得出推论的人群。这些方法包括随机前瞻性研究，广泛的结果分析，横断面研究和索赔数据分析。我一直是所有这些方法的研究者，并努力解决每种方法的优点和相当大的缺点。约翰斯顿和他的同事们所描述的技术，如果广泛而有效地实施，有可能将所有这些技术联合收割机结合起来并使之黯然失色。显然，随机前瞻性试验被认为最有可能回答特定的临床问题，通常是关于治疗优效性。然而，它们遭受与性能相关的最高费用。此外，几乎不可能进行一项临床试验，其中受试者及其疾病水平代表基础人群。同样，对于外科临床试验，参与的外科医生通常是经过严格挑选的人群。一些有用的临床见解可以通过“结果研究”获得，自从我和同事们在眼科文献中发表了第一篇使用该名称的研究以来，这个术语在十年中越来越多地被滥用。按照最初的预期，这一概念是对在足够广泛的人群样本中获得的临床结果进行采样，以代表社区实践中通常获得的结果。在我们的工作背景下，我们从国家名单中随机选择外科医生，根据他们的手术量分层，并在他们的实践中对连续患者进行抽样研究。近年来，“结果研究”一词被错误地应用于一个或几个机构的病例系列，这些机构试图使他们的工作看起来像是对患者方便样本的分析。然而，即使在最好的情况下，使用我们在1990年采用的手动技术收集的数据本质上也不如通过实时系统（如约翰斯顿的系统）收集的数据可靠，在该系统中，为患者护理和临床研究收集的数据是同一个数据。为了获得尽可能广泛的国家样本，以了解手术并发症（如眼内炎、视网膜脱离和类似罕见事件）发生率的“真相”，我过去曾参与分析美国、丹麦和其他地方的管理数据集。这些研究提供了有趣的调查结果和基准数据。然而，没有人认为管理数据的编码非常准确。人们只希望在数百万人的样本中，编码中的错误在案例和控制中是等同的。当我们被要求重新研究一项基于索赔数据的分析时，情况就是如此，该分析显示了Nd：YAG囊切开术与随后的视网膜脱离之间的相关性。最初的发现被认为是如此具有煽动性，以至于委托进行了一项重复研究，这次有资金从白内障外科医生和视网膜外科医生那里获得原始信息。正如我们所料，编码是不完美的。一些被编码为白内障手术的患者没有，一些被编码为视网膜脱离的患者没有，还有一些被编码为术后病程不复杂的患者确实出现了并发症。尽管如此，正如我们所料，编码错误同样发生在美国华盛顿
The study by Johnston and colleagues, entitled Pilot National Electronic Cataract Surgery Survey, published in this month’s edition is as unassuming in its title as it is revolutionary in its implications. To the best of my knowledge, this work represents the first demonstration of potential for pooling the surgical results from an entire region or country in an on-line database in order to learn how best to care for patients. Over the past several decades, ophthalmologic researchers (as have clinical researchers in general) have shifted from anecdotal case reports and series to various methodologies for gathering data in a manner that represents the population of people about whom inferences will be drawn. Those methodologies include randomized prospective studies, broad outcomes analyses, crosssectional studies, and claims data analysis. I have been an investigator in all of those methodologies and have grappled with the advantages and considerable disadvantages of each. The technology described by Johnston and colleagues, if implemented broadly and efficiently has the potential to both combine and eclipse all of these technologies. Clearly, randomized prospective trials are viewed as having the best potential to answer specific clinical questions, generally with regard to treatment superiority. However, they suffer from the highest expense associated with performance. Moreover, it is nearly impossible to conduct a clinical trial in which subjects and their level of illness are representative of those in the underlying population. Similarly, for surgical clinical trials, the surgeons who participate are frequently a highly selected crowd. Some useful clinical insights can be obtained by ‘outcome studies,’ a term that has been increasingly abused in the decade since colleagues and I published the first studies in the ophthalmologic literature to use that appellation. As originally intended, the notion was to sample the clinical results obtained in a sufficiently broad sample of the population as to be representative of the results typically obtained in community practice. In the context of our work, we randomly selected surgeons from national lists, stratified by their surgical volume and sampled sequential patients within their practices for study. In recent years, the term ‘outcomes study’ has been erroneously applied to case series from one or a few institutions that are attempting to make their work appear as something other than the analysis of a convenience sample of patients. Even under the best of circumstances, however, data collected using the manual techniques we employed in 1990 are inherently less reliable than those collected through a real-time system such as Johnston’s where the data collected for patient care and for clinical research are one and the same. In an attempt to gain the broadest possible national sample in order to learn the ‘truth’ about rates of complications of surgery, such as endophthalmitis, retinal detachment, and similar rare events, I have in the past been associated with analyses of administrative data sets in the United States, Denmark, and elsewhere. These studies provided interesting findings and benchmark data. However, nobody assumes that the administrative data are coded with perfect accuracy. One only hopes that errors in coding are equivalent in cases and controls for a sample of several million people. Such was the case, when we were challenged to restudy a claims-data-based analysis that showed a correlation between Nd:YAG capsulotomy and subsequent retinal detachment. The original finding was considered so inflammatory that a repeat study was commissioned, this time with funds to obtain primary information from both the cataract surgeon and the retinal surgeon. As we expected, the coding was imperfect. Some patients coded as having had cataract surgery had not, some patients coded as having had retinal detachments did not have them, and some patients coded as having had an uncomplicated postoperative course had, indeed suffered complications. Nevertheless, as we expected, the coding errors were equally Washington, DC, USA