Ramos García Vanesa, Rivero-Santana Amado, Peñate-Castro Wenceslao, Álvarez-Pérez Yolanda, Del Mar Trujillo-Martín María, González-Pacheco Himar, Santos-Álvarez Anthea, Duarte-Díaz Andrea, Del Cura-González María Isabel, Perestelo-Pérez Lilisbeth
Evaluation Unit (SESCS), Canary Islands Health Service (SCS), Santa Cruz de Tenerife, Tenerife, Spain.
Canary Islands Health Research Institute Foundation (FIISC), Santa Cruz de Tenerife, Spain.
BMJ Health Care Inform. 2025 Jul 8;32(1):e101185. doi: 10.1136/bmjhci-2024-101185.
To evaluate the effectiveness of an online Patient Decision Aid (PtDA) for patients with Generalised Anxiety Disorder (GAD).
Randomised controlled trial comparing the PtDA to general information (fact sheet).
The study took place in 17 primary care centres in the Canary Islands (Spain).
Patients diagnosed with GAD and a score ≥8 in the GAD-7 questionnaire.
Patients were randomly allocated to the PtDA group (n=58) or the control group (n=61).
The primary outcome was decisional conflict at postintervention, assessed with the Decisional Conflict Scale (DCS). Secondary outcomes include knowledge about GAD and its treatments, concordance between informed preference and 3 month actual choice, decision quality and GAD symptoms.
There were no significant differences in decisional conflict at postintervention or 3 month follow-up in the intention-to-treat (ITT) or per-protocol sample (PPS). The PtDA significantly improved postintervention (MD=1.65, 95% CI: 0.84 to 2.46) and 3 month objective knowledge (MD=0.78, 95% CI: 0.02 to 1.55). In the PPS, anxiety symptoms at 3 months were significantly lower in the PtDA group (MD=-3.00, 95% CI: -5.69 to -0.30), but in the ITT sample, this difference did not reach significance (p=0.06). There were no significant differences in the rate of patients unsure about treatment preference at postintervention, nor on concordance or decision quality at follow-up.
The use of the PtDA led to improvements in knowledge at 3 months, but it did not result in a significant reduction of decisional conflict. These results must be interpreted with caution, given the methodological limitations of the study, mainly the high rate of dropouts. Further research is needed to confirm these results, the first published on the effectiveness of a PtDA for GAD patients.
NCT04364958.
评估在线患者决策辅助工具（PtDA）对广泛性焦虑症（GAD）患者的有效性。
将PtDA与一般信息（情况说明书）进行比较的随机对照试验。
该研究在西班牙加那利群岛的17个初级保健中心进行。
被诊断为GAD且在GAD-7问卷中得分≥8的患者。
患者被随机分配到PtDA组（n = 58）或对照组（n = 61）。
主要结局是干预后使用决策冲突量表（DCS）评估的决策冲突。次要结局包括关于GAD及其治疗的知识、知情偏好与3个月实际选择之间的一致性、决策质量和GAD症状。
在意向性分析（ITT）或符合方案样本（PPS）中，干预后或3个月随访时的决策冲突没有显著差异。PtDA显著改善了干预后（MD = 1.65，95%CI：0.84至2.46）和3个月时的客观知识（MD = 0.78，95%CI：0.02至1.55）。在PPS中，PtDA组3个月时的焦虑症状显著更低（MD = -3.00，95%CI：-5.69至-0.30），但在ITT样本中，这种差异未达到显著水平（p = 0.06）。干预后不确定治疗偏好的患者比例以及随访时的一致性或决策质量没有显著差异。
使用PtDA在3个月时提高了知识水平，但并未显著减少决策冲突。鉴于该研究的方法学局限性，主要是高失访率，这些结果必须谨慎解释。需要进一步研究来证实这些结果，这是首次发表的关于PtDA对GAD患者有效性的研究。
NCT04364958。
