Comparative Effectiveness of Prophylaxis in Cataract Surgery

描述（由申请人提供）：白内障手术恢复视力，是最常见的手术之一。由于这些原因，白内障手术程序和疗法的有效性、安全性、成本和可及性是非常重要的。由于感染预防的证据基础有限，外科医生的做法是高度可变的。我们建议进行一项回顾性比较有效性研究，该研究将利用为660万加州Kaiser Permanente成员提供护理的297名白内障外科医生的实践差异。该研究将检查Kaiser Permanente外科医生之间预防措施的差异是否导致感染风险的差异。最近的初步数据表明，71%的外科医生在手术前一天常规使用患者滴眼液，26%在术前保持区域使用护士滴眼液，13%结膜下注射，30%前房内注射和58%术中滴眼液。几乎所有的手术后滴眼液，但在药物的选择上有差异。本研究将使用这些变量 评估预防策略的相对和增量有效性。 该研究将使用2005年至2011年期间进行的460，000例白内障手术的电子病历中记录的数据，其中发生了350例感染。我们将验证1000例患者的眼内炎诊断和手术并发症（所有350例眼内炎病例加上700例非病例的随机样本）。本研究将使用工具变量进行有效推断，并将单独评价每种预防性程序，同时保持其他预防性程序不变。我们提出的快速，低成本的研究是为未来研究开发知识库的重要一步。我们将使用这些数据充分阐明随机对照试验的基本原理，包括信息差距、优先事项和可行性，并建立外科医生和药剂师的支持。此外，我们将阐明与随机化和知情同意过程、合格性和人群子集、研究组数量、对比、测量系统、方案依从性和研究把握度相关的设计权衡。此外，比较有效性研究很有可能在几个关键问题上立即为临床决策提供信息，特别是在治疗前一天，在任何手术并发症发生之前进行预防。如果医疗保险按服务收费项目的实践水平与凯撒医疗机构的相似，那么每年的感染人数可能高达2,000人。如果研究表明可以取消术前抗生素管理，我们计算出每个病例仅药物费用就可节省约70美元，每年可为Medicare节省1.27亿美元。如果它进一步证明术中和术后管理可以转换为老一代抗生素，则每个病例的额外节省将达到约60美元，每年为医疗保险节省2.36亿美元。

DESCRIPTION (provided by applicant): Cataract surgery restores sight and is one of the most common surgeries performed. For these reasons, the effectiveness, safety, cost, and accessibility of cataract surgery procedures and therapies are highly significant. Because the evidence base for infection prophylaxis is limited, surgeon practices are highly variable. We propose to conduct a retrospective comparative effectiveness study that will leverage variation in practice among the 297 cataract surgeons providing care to 6.6 million California members of Kaiser Permanente. The study will examine whether the variation in prophylaxis evident among Kaiser Permanente surgeons resulted in differences in infection risk. Recent preliminary data indicate that 71% of surgeons routinely use patient- instilled eye drops before the day of surgery, 26% nurse-instilled eye drops in the pre-op holding area, 13% subconjunctival injection, 30% intracameral injection, and 58% intra-operative eye drops. Nearly all use post- operative eye drops, but there is variation in choice of agent. The study will use these variations to estimate the comparative and incremental effectiveness of prophylactic strategies. The study will use data recorded into the electronic medical record from 460,000 cataract surgeries performed during 2005-2011, of which 350 infections occurred. We will validate the endophthalmitis diagnosis and surgical complications for 1000 patients (all 350 endophthalmitis cases plus a random sample of 700 non- cases). The study will use instrumental variables to make valid inferences, and each prophylactic procedure will be evaluated individually, while holding constant other prophylactic procedures. The rapid, low-cost study we propose is an essential step to developing the knowledge base for future research. We will use the data to fully articulate the rationale for a randomized controlled trial, including information gaps, priorities, and feasibility, and to build surgeon and pharmacist support. In addition, we will elucidate design trade-offs linked to the unit of randomization and consent process, eligibility and population subsets, the number of study arms, contrasts, the measurement system, protocol adherence, and study power. In addition, the comparative-effectiveness study has a high likelihood of immediately informing clinical decision-making on several key issues, most particularly, prophylaxis before the day of therapy, before any surgical complication could occur. If the level of practice variation in the Medicare fee-for-service program mirrors Kaiser Permanente's, then the excess number of infections could be as large as 2,000 annually. If the study demonstrates that pre-operative antibiotic administrations can be eliminated, we calculate potential savings of ~$70 per case in drug costs alone, totaling $127 million annual savings to Medicare. If it further demonstrates that intra- and post- operative administrations can be switched to the older-generation antibiotics, additional savings would amount to ~$60 per case for a total annual savings to Medicare of $236 million annually.