Department of Health Services Research, Care and Public Health Research Institute (CAPHRI), Maastricht University, 6200 MD, Maastricht, The Netherlands.
Department of Internal Medicine, VieCuri Medical Center, 5912 BL Venlo, The Netherlands.
J Bone Miner Res. 2024 Oct 29;39(11):1584-1595. doi: 10.1093/jbmr/zjae161.
Shared decision-making (SDM) aims to improve patients' experiences with care, treatment adherence, and health outcomes. However, the effectiveness of SDM in patients with a recent fracture who require anti-osteoporosis medication (AOM) is unclear. The objective of this study was to assess the effectiveness of a multicomponent adherence intervention (MCAI) including a patient decision aid (PDA) and motivational interviewing at Fracture Liaison Services (FLS) on multiple outcomes compared with usual care (UC). This pre-post superiority study included patients with a recent fracture attending FLS and with AOM treatment indication. The primary outcome was 1-year AOM persistence measured by pharmacy records. Secondary outcomes included treatment initiation, AOM adherence (measured by medication possession ratio [MPR]), decision quality (SDM process; 0-100, best), and decisional conflict (0-100, highest conflict), subsequent fractures, and mortality. Outcomes were tested in MCAI and UC groups at the first FLS visit and 4 and 12 months afterwards. Multiple imputation and uni- and multivariable analyses were performed. Post hoc analyses assessed the role of health literacy level. In total, 245 patients (MCAI: n = 136, UC: n = 109) were included. AOM persistence was 80.4% in the MCAI and 76.7% in the UC group (p=.626). SDM process scores were significantly better in MCAI (60.4 vs 55.1; p = .003). AOM initiation (97.8% vs 97.5%), MPR (90.9% vs 88.3%, p=.582), and decisional conflict (21.7 vs 23.0; p = .314) did not differ between groups. Results did not change importantly after adjustment. Stratified analyses by health literacy showed a better effect on MPR and SDM in those with adequate health literacy. This study showed no significant effect on AOM persistence; however, it demonstrated a significant positive effect of MCAI on SDM process in FLS attendees. (Netherlands Trial Registry, Trial NL7236 [NTR7435]; version 1.0; 26-11-2020 https://onderzoekmetmensen.nl/nl/trial/22858).
目的：
旨在改善患者就医体验、治疗依从性和健康结局。然而，在需要抗骨质疏松药物（AOM）治疗的近期骨折患者中，SDM 的效果尚不清楚。本研究旨在评估骨折联络服务（FLS）中包含患者决策辅助工具（PDA）和动机性访谈的多组分依从性干预（MCAI）与常规护理（UC）相比，在多种结局上的效果。
方法：
该研究为前后对照的优势研究，纳入近期骨折就诊于 FLS 且有 AOM 治疗指征的患者。主要结局为通过药房记录测量的 1 年 AOM 持续用药率。次要结局包括治疗起始、AOM 依从性（用药比例比[MPR]测量）、决策质量（SDM 过程；0-100，最佳）和决策冲突（0-100，最高冲突）、后续骨折和死亡率。在 FLS 就诊时和之后 4 个月及 12 个月，分别在 MCAI 组和 UC 组中检测这些结局。采用多重插补和单变量及多变量分析。事后分析评估了健康素养水平的作用。
结果：
共纳入 245 例患者（MCAI 组：n=136，UC 组：n=109）。MCAI 组和 UC 组的 AOM 持续用药率分别为 80.4%和 76.7%（p=0.626）。MCAI 组的 SDM 过程评分显著更高（60.4 比 55.1；p=0.003）。AOM 起始（97.8%比 97.5%）、MPR（90.9%比 88.3%，p=0.582）和决策冲突（21.7 比 23.0；p=0.314）在两组间无差异。调整后结果无重要变化。按健康素养分层分析显示，MCAI 对有足够健康素养的患者的 MPR 和 SDM 有更好的效果。
结论：
本研究未显示 AOM 持续用药率有显著影响，但表明 FLS 就诊者中 MCAI 对 SDM 过程有显著的积极影响。
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