譯文（字數 6847）：

實施大型保險系統隨機有效性測試

作者：Niteesh K. Choudhry,  William H. Shrank 

背景

需要確定如何最好地安排健康保險和提供醫療服務是比較效益研究中心優先事項。研究旨在評估這些問題在大型保險制度經常進行。我們試圖描述進行在這種情況下試驗時所面臨的挑戰。

方法

使用心肌梗死后免費接收事件和經濟評價（MI FREEE）試驗作為一個例子，我們描述進行大型保險制度試驗的方法和實際挑戰。

結果

我們遇到的六大關鍵挑戰，同時進行MI FREEE試驗，即需要獲得計劃發起人同意進行試驗，計劃發起人的渴望擁有他們所有的受益人收到同樣的干預，基于聲明的識別方法不準確而產生的影響索賠落后于潛在的符合條件的患者按時入學，病人不愿參加保險為基礎的干預和知情同意的潛在需求，在現實世界輸送系統的頻繁推出新cointerventions，而高利率的損失來后續因保險“客戶流失。”我們描述了用于克服這些挑戰的方法。

外文原文（字符數 21960）：

Implementing randomized effectiveness trials in large insurance systems

Niteesh K. Choudhry, , William H. Shrank 

Abstract

Background

The need to identify how best to structure health insurance and to deliver health care services is a central priority for comparative effectiveness research. Studies designed to evaluate these issues are frequently conducted in large insurance systems. We sought to describe the challenges faced when conducting trials in this context.

Methods

Using the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial as an example, we describe the methodological and practical challenges of conducting trials in large insurance systems.

Results

We encountered six key challenges while conducting MI FREEE trial, namely the need to obtain plan sponsor permission to experiment, the desire of plan sponsors to have all of their beneficiaries receive the same intervention, the inaccuracy of claims-based identification methods and the impact of claims lag on the timely enrollment of potentially eligible patients, the reluctance of patients to participate in insurance-based interventions and the potential need for informed consent, the frequent introduction of new cointerventions in real-world delivery systems, and the high rates of loss to follow-up because of insurance “churn.” We describe the approaches we used to overcome these challenges.