Karagiannis Thomas, Liakos Aris, Branda Megan E, Athanasiadou Eleni, Mainou Maria, Boura Panagiota, Goulis Dimitrios G, LeBlanc Annie, Montori Victor M, Tsapas Apostolos
Clinical Research and Evidence-Based Medicine Unit, Aristotle University Thessaloniki, Thessaloniki, Greece.
Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.
BMJ Open. 2016 Nov 14;6(11):e012185. doi: 10.1136/bmjopen-2016-012185.
To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece.
Open-label cluster randomised controlled trial.
Primary and secondary care practices across Greece.
5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients).
Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care.
The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24 weeks.
Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms -6.9, 95% CI -21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI -15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy.
The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making.
NCT01861756. Pre-results.
评估希腊2型糖尿病患者使用糖尿病药物选择决策辅助工具的疗效。
开放标签整群随机对照试验。
希腊各地的初级和二级医疗保健机构。
5个地点分配到决策辅助工具组（n = 101例患者），4个地点为对照组（n = 103例患者）。
干预组的临床医生和患者使用基于在选择降糖药物时均认为重要的结果的决策辅助工具。对照组患者接受常规护理。
主要观察指标为初次临床接触后患者的决策舒适度水平。次要观察指标包括患者对2型糖尿病和药物的知识、患者和临床医生的满意度。在24周时评估降糖药物的依从性和糖化血红蛋白的变化。
两组患者在总体决策舒适度及其子量表方面得分相似（常规护理组与决策辅助工具组的平均差异为 -6.9，95%可信区间为 -21.5至7.7）。两组患者的知识水平都较高（平均差异为2.3%，95%可信区间为 -15.7%至20.4%）。两组患者和临床医生对决策过程的满意度相同。两组在药物依从性和血糖控制方面未发现显著差异。临床医生认为决策辅助工具有用，并报告说将其纳入日常工作很容易。
该决策辅助工具在希腊的临床环境中得到实施并获得积极反馈，符合当前指南所认可的以患者为中心的方法。然而，就患者结局而言，该试验结果不精确。需要进一步研究以调查患者与临床医生之间的互动，以阐明使用决策辅助工具与实施共同决策之间的关联。
NCT01861756。预结果。
