Comparative Effectiveness of Prophylaxis in Cataract Surgery

描述(申请人提供)：白内障手术可恢复视力，是最常见的手术之一。由于这些原因，白内障手术程序和治疗的有效性、安全性、成本和可获得性是非常重要的。由于预防感染的证据基础有限，外科医生的做法千差万别。我们建议进行一项回溯性的比较有效性研究，该研究将利用297名为Kaiser Permanente的660万加州成员提供护理的白内障外科医生的实践差异。这项研究将检验Kaiser Permanente外科医生在预防措施上的明显差异是否会导致感染风险的差异。最近的初步数据显示，71%的外科医生在手术前常规使用患者滴眼液，26%的外科医生在术前等待区使用护士滴眼液，13%的外科医生使用结膜下注射，30%的外科医生使用房内注射，58%的外科医生在术中使用滴眼液。几乎所有人都在术后使用眼药水，但在选择药剂方面有所不同。这项研究将使用这些变体 评估预防策略的相对有效性和增量有效性。这项研究将使用2005-2011年间进行的46万例白内障手术的电子医疗记录数据，其中350例发生感染。我们将验证1000名患者的眼内炎诊断和手术并发症(全部350例眼内炎患者加上700例非眼内炎患者的随机样本)。这项研究将使用工具变量来做出有效的推断，每个预防程序将被单独评估，而其他预防程序保持不变。我们提出的快速、低成本的研究是为未来研究发展知识库的重要一步。我们将使用这些数据来充分阐明随机对照试验的基本原理，包括信息差距、优先顺序和可行性，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同意过程的单位、资格和人口子集、研究臂的数量、对比、测量系统、方案遵守和研究权力相关的设计权衡。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，尤其是在治疗前一天，在任何手术并发症发生之前进行预防。如果医疗保险收费服务计划中的实践差异水平与Kaiser Permanente的情况相同，那么每年额外的感染人数可能高达2000人。如果这项研究证明可以取消术前抗生素管理，我们计算出每个病例仅在药品成本方面就可能节省约70美元，总计每年为联邦医疗保险节省1.27亿美元。如果进一步证明术中和术后给药可以改用老一代抗生素，每个病例将额外节省约60美元，每年为联邦医疗保险节省的总金额为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.