一项关于非甾体抗炎药风险认知共同决策的群组随机试验：主要结果与经验教训
A group-randomized trial of shared decision making for non-steroidal anti-inflammatory drug risk awareness: primary results and lessons learned.
作者信息
Miller Michael J, Allison Jeroan J, Cobaugh Daniel J, Ray Midge N, Saag Kenneth G
机构信息
Department of Pharmacy, Clinical and Administrative Sciences, College of Pharmacy, The University of Oklahoma Health Sciences Center, Tulsa, Oklahoma, USA.
出版信息
J Eval Clin Pract. 2014 Oct;20(5):638-48. doi: 10.1111/jep.12193. Epub 2014 Jun 11.
RATIONALE, AIMS AND OBJECTIVES: Frequent use and serious adverse effects related to non-steroidal anti-inflammatory drugs (NSAIDs) underscore the need to raise patient awareness about potential risks. Partial success of patient- or provider-based interventions has recently led to interest in combined approaches focusing on both patient and physician. This research tested a shared decision-making intervention for increasing patient-reported awareness of NSAID risk.
METHODS
A group randomized trial was performed in Alabama from 2005 to 2007. Intervention group doctor practices received continuing medical education (CME) about NSAIDs and patient activation tools promoting risk assessment and communication during visits. Comparison group doctor practices received only CME. Cross-sectional data were collected before and after the intervention. Generalized linear latent and mixed models with logistic link tested relationships among the intervention, study phase, intervention by study phase interaction and patient-reported awareness of risks with either prescription or over-the-counter (OTC) NSAIDs.
RESULTS
Three hundred and forty-seven patients at baseline and 355 patients at follow-up participated in this study. The intervention [adjusted odds ratio (AOR)=0.74, P=0.248], follow-up study phase (AOR=1.31, P=0.300) and intervention by study phase interaction (AOR=0.98, P=0.942) were not significantly associated with patient-reported awareness of any prescription NSAID risk. Follow-up study phase was associated with increased odds of reporting any OTC NSAID risk awareness (AOR=2.99, P<0.001), but the patient activation intervention and intervention by study phase interaction were not significantly associated with patient-reported awareness of any OTC NSAID risk (AOR=0.98, P=0.929; AOR=0.87, P=0.693, respectively).
CONCLUSIONS
Our point-of-care intervention encouraging shared decision making did not increase NSAID risk awareness.
原理、目的和目标：非甾体抗炎药（NSAIDs）的频繁使用及其严重不良反应凸显了提高患者对潜在风险认识的必要性。基于患者或医疗服务提供者的干预措施取得了部分成功，最近人们开始关注同时针对患者和医生的联合方法。本研究测试了一种共享决策干预措施，以提高患者报告的对NSAIDs风险的认识。
方法
2005年至2007年在阿拉巴马州进行了一项群组随机试验。干预组的医生诊所接受了关于NSAIDs的继续医学教育（CME）以及促进就诊期间风险评估和沟通的患者激活工具。对照组的医生诊所仅接受了CME。在干预前后收集横断面数据。采用具有逻辑链接的广义线性潜在和混合模型，测试干预、研究阶段、研究阶段交互作用下的干预与患者报告的使用处方或非处方（OTC）NSAIDs风险意识之间的关系。
结果
347名基线患者和355名随访患者参与了本研究。干预措施[调整优势比（AOR）=0.74，P=0.248]、随访研究阶段（AOR=1.31，P=0.300）以及研究阶段交互作用下的干预（AOR=0.98，P=0.942）与患者报告的任何处方NSAIDs风险意识均无显著关联。随访研究阶段与报告任何OTC NSAIDs风险意识的几率增加相关（AOR=2.99，P<0.001），但患者激活干预措施以及研究阶段交互作用下的干预与患者报告的任何OTC NSAIDs风险意识均无显著关联（分别为AOR=0.98，P=0.929；AOR=0.87，P=0.693）。
结论
我们鼓励共享决策的即时医疗干预措施并未提高对NSAIDs风险的认识。
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