Prescription Opioid Use and the Risk of Injury among Elderly Americans

描述（由申请人提供）：给疼痛的老年人开阿片类药物处方涉及疼痛控制和不利的负面健康后果之间的潜在权衡，其中一个可能是伤害。缺乏良好的数据来指导临床判断阿片类药物使用者致命和非致命伤害的绝对和相对风险。拟议的前瞻性队列研究将使用大型卫生保健数据集和药物流行病学方法来生成有关使用处方阿片类药物的美国老年人受伤风险的新的临床相关信息。研究人群包括1994-2005年在宾夕法尼亚州和新泽西州领取处方药福利的中低收入美国老年人。该研究将比较1)服用阿片类药物的老年人与未服用阿片类药物的老年人的特定伤害率，以及2)阿片类药物使用者受伤风险的变化。结果将包括由跌倒、机动车碰撞、意外过量用药和自杀企图造成的致命和非致命伤害。基本表格将描述研究人群、粗转归率以及阿片类药物使用与损伤转归之间调整后的关联。阿片类药物治疗开始后损伤的时变性质将通过绘制阿片类药物使用者中选择损伤事件率的Kaplan-Meier曲线作为连续阿片类药物使用时间的函数来呈现。使用随时间变化的Cox比例风险回归模型，根据基线患者特征进行调整，评估不同剂量、作用时间和使用时间的相对损伤风险。相互作用术语将确定加剧与阿片类药物使用相关的伤害风险的因素。需要探讨的因素包括患者特征、特定制剂和阿片类药物的使用，根据明确的处方指南出现问题。这项提议的工作很重要，因为伤害、伤害死亡和阿片类药物使用在美国老年人中很常见。例如，2004年，美国老年人因受伤到急诊科就诊近300万次，其中180万次是因为跌倒（25%需要住院治疗）。这些伤害的未知部分发生在5%使用处方阿片类药物的社区居住老年人中。拟议研究的结果将与治疗老年疼痛患者的临床医生和公共卫生从业人员相关，因为阿片类药物导致的相对伤害风险即使小幅增加，每年也可能造成数千人受伤。由于许多美国老年人受益于阿片类药物，因此无效发现或风险集中的发现（例如，在某些但不是其他特定制剂中）也将具有临床相关性。

DESCRIPTION (provided by applicant): Prescribing opioids to older persons in pain involves potential trade-offs between pain control and untoward negative health consequences, one of which may be injuries. Good data to guide clinical judgment about the absolute and relative risk of fatal and non-fatal injuries among opioid users are lacking. The proposed prospective cohort study will use a large health care data set and pharmacoepidemiologic methods to generate new, clinically relevant information about the risk of injury among elderly Americans using prescription opioids. The study population consist of low-moderate income elderly Americans who received prescription drug benefits through the states of Pennsylvania and New Jersey, 1994-2005. The study will compare 1) the rate of selected injuries among elderly persons taking opioids to those not, and 2) variation in the risk of injury among opioid users. Outcomes will include fatal and non-fatal injuries resulting from falls, motor vehicle collisions, unintentional overdoses, and suicide attempts. Basic tables will describe the study population, crude outcome rates, and adjusted associations between opioid use and injury outcomes. The time-varying nature of injuries after initiation of opioid treatment will be rendered by plotting Kaplan-Meier curves for event rates of select injuries among opioid users as a function of the duration of continuous opioid use. The relative risk of injuries by potency, duration of action, and duration of use will be estimated using Cox proportional hazard regression models with time-varying exposure, adjusting for baseline patient characteristics. Interaction terms will identify factors that exacerbate the risk of injury associated with opioid use. Factors to be explored include patient characteristics, specific preparations, and opioid use that appears problematic based on explicit prescribing guidelines. The proposed work is important because injury, injury deaths, and opioid use are common among elderly Americans. In 2004, for example, older Americans made nearly three million visits to emergency departments for injuries, 1.8 million resulted from falls (25% required hospitalization). An unknown fraction of these injuries occurred among the 5% of community dwelling elderly who use prescription opioids. Results from the proposed study will be relevant to clinicians treating elderly patients in pain and to public health practitioners, since even small increases in the relative risk of injury attributable to opioids could amount to thousands of injuries each year. Since many older Americans benefit from opioids, a null finding or a finding that risk is concentrated (e.g., in some but not other specific preparations) would also be clinically relevant.