Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II
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PurposeOsteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient’s estimated risk of fracture using the FRAX calculator is unknown.MethodsPatient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.ResultsWe enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and pConclusionSupporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.Trial Registrationclinical trials.gov NCT00949611
研究目的：骨质疏松症选择决策辅助工具（Osteoporosis Choice）可促使患者与临床医师就骨质疏松症治疗开展共同决策。目前，该工具相较于仅向临床医师提供基于FRAX计算器（FRAX calculator）估算的患者骨折风险这一常规诊疗方案的实际疗效尚未明确。 研究方法：本研究为个体患者水平的随机三臂试验，纳入年龄50岁以上、患有骨量减少或骨质疏松症且符合双膦酸盐类药物治疗指征的女性，通过对比使用Osteoporosis Choice、仅采用FRAX风险评估以及常规护理三种干预方式，考察其对患者知识水平、决策冲突程度、决策参与度、启动治疗意愿及双膦酸盐治疗依从性的影响。 研究结果：本研究共纳入3个试验组的79名女性。由于仅采用FRAX风险评估与常规护理的结局指标相似，故将两组合并进行分析。相较于合并组，使用Osteoporosis Choice可提升患者知识评分（中位数评分6 vs 4，p=0.01），并改善患者对骨折风险及双膦酸盐类药物风险降低作用的认知（p=0.01及p）。 研究结论：相较于提供或不提供FRAX结果作为临床决策支持的常规护理方案，在临床接诊过程中应用Osteoporosis Choice决策辅助工具，可有效优化骨质疏松症的治疗决策流程。 试验注册：临床试验注册编号为clinical trials.gov NCT00949611
