Predictive tool to prevent overdose in patients treated with prescription opioids

问题：在过去二十年中，与阿片类药物有关的意外过量已成为美国主要的公共卫生威胁。处方类阿片使用者发病和死亡的原因越来越普遍，但这是可以预防的，部分原因是用于治疗急性和慢性疼痛的类阿片镇痛药处方大幅扩大。在过去五年中，15%的美国人至少服用过一种阿片类药物。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他们的家庭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增加了两倍多，从1999年的4030人增加到2014年的18893人。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：Venebio阿片类药物顾问（VOA）是一种临床决策支持系统（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）中收集的基于证据的临床数据，准确识别有过量或严重阿片类药物引起的呼吸抑制（OIRD）风险的个体。美国之音将通过嵌入电子病历系统的独立计算机应用程序传送，或者通过安全的互联网连接将其放置在远程服务器上。VOA将自动从电子病历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呈现给医疗保健提供者，从而实现基于证据的指导和教育，针对个体患者的特定风险因素概况进行个性化。识别个体经历处方阿片类药物相关毒性或阿片类药物过量风险升高的能力将使卫生保健提供者和患者了解个体风险水平。方法：我们提出的II期研究的总体目标是首先改进和验证用于创建现有的Venebio阿片顾问算法的临床内容，然后将这些改进的信息与额外的循证指导和教育内容合并到临床决策支持系统中，最后在VOA的前瞻性试点研究中验证该CDSS在现实世界的临床疼痛管理设置。

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.