Predictive tool to prevent overdose in patients treated with prescription opioids

问题：在过去的20年里，与阿片类药物相关的无意过量已经成为美国的一个主要公共健康威胁。在处方阿片类药物使用者中，这一日益常见但可预防的致病和死亡原因部分是由于阿片类止痛药处方的大幅扩大，以管理急性和慢性疼痛状况。在过去五年的任何一年里，15%的美国人口至少开了一张阿片类药物处方。2012年，美国开出了2.59亿张阿片类药物处方--足够每个美国成年人在家里的药柜里放一瓶阿片类止痛药。2013年，近200万12岁及以上的美国人滥用或依赖阿片类止痛药。阿片类药物中毒或过量死亡人数从1999年的4030人增加到2014年的18893人，增加了三倍多。2009年，美国处方阿片类药物过量的总成本超过200亿美元。这是一个严重且迅速增长的问题。解决方案：威尼斯生物阿片顾问(VOA)是一个临床决策支持系统(CDSS)，基于VG现有的正在申请专利的风险指数算法，通过利用从患者电子病历(EMR)中收集的循证临床数据准确识别过量或严重阿片类药物所致呼吸抑制(OIRD)的风险。美国之音将通过独立的计算机应用程序提供，嵌入电子病历系统，或者位于可通过安全互联网连接访问的远程服务器上。美国之音将自动从EMR中提取患者的相关临床数据，评估患者阿片类药物过量的风险，并将患者的风险评分直接提供给医疗保健提供者--使基于证据的指导和教育能够根据个别患者的特定风险因素档案进行个性化。能够识别经历处方阿片类药物相关毒性或阿片类药物过量的风险较高的个人，将使卫生保健提供者和患者都了解个人的风险水平。方法：我们提议的第二阶段研究的首要目标是首先提炼和验证用于创建现有Venbio阿片类药物Advisor算法的临床内容，然后将这些精炼信息与额外的循证指导和教育内容一起纳入临床决策支持系统，最后在现实世界临床疼痛管理环境中VOA的前瞻性试点研究中验证这一CDSS。

Problem: Over the last two decades, unintentional opioid-related overdose has emerged as a major public health threat in the United States. This increasingly common, yet preventable, cause of morbidity and death among users of prescription opioids is partially due to a substantial expansion in the prescription of opioid analgesics to manage acute and chronic pain conditions. Within any given year during the past five, 15% of the U.S. population filled at least one opioid prescription. In 2012, 259 million opioid prescriptions were written in the U.S. – enough for every American adult to have one bottle of opioid painkillers in their home medicine cabinet. In 2013, nearly two million Americans aged 12 or older either abused or were dependent on opioid painkillers. Opioid poisoning or overdose deaths have more than quadrupled from 4,030 in 1999 to 18,893 in 2014. Total prescription opioid overdose costs in the U.S. were more than $20 billion in 2009.This is a significant and rapidly growing problem. Solution: Venebio Opioid Advisor (VOA) is a clinical decision support system (CDSS) based on VG’s existing, patent-pending, risk-index algorithm that accurately identifies individuals at risk for overdose or serious opioid-induced respiratory depression (OIRD) by utilizing evidence-based clinical data gathered from patient electronic medical records (EMRs) as opioids are being prescribed. VOA will be delivered via a stand-alone computer application, embedded in an EMR system, or alternatively located on a remote server accessible through a secure Internet connection. VOA will extract a patient’s relevant clinical data automatically from the EMR, assess the patient’s risk for opioid overdose, and present the patient’s risk score directly to the health care provider – enabling evidence-based guidance and education that is personalized to the individual patient's specific risk factor profile. The ability to identify individuals at elevated risk of experiencing prescription opioid-related toxicity or opioid overdose will provide awareness of the individual risk level to both the health care provider and the patient. Methods: The overarching objective of our proposed Phase II research is first to refine and validate the clinical content used to create the existing Venebio Opioid Advisor algorithm, then to incorporate this refined information, along with the additional, evidence-based guidance and educational content, into a clinical decision support system, and finally to validate this CDSS during a prospective pilot study of VOA in the real-world clinical pain management setting.