使用决策辅助工具能否改善人工心脏瓣膜选择中的决策制定？一项多中心随机试验。
Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial.
作者信息
Korteland Nelleke M, Ahmed Yunus, Koolbergen David R, Brouwer Marjan, de Heer Frederiek, Kluin Jolanda, Bruggemans Eline F, Klautz Robert J M, Stiggelbout Anne M, Bucx Jeroen J J, Roos-Hesselink Jolien W, Polak Peter, Markou Thanasie, van den Broek Inge, Ligthart Rene, Bogers Ad J J C, Takkenberg Johanna J M
机构信息
From the Department of Cardio-Thoracic Surgery (N.M.K., A.J.J.C.B., J.J.M.T.) and Department of Cardiology (J.W.R.-H.), Erasmus MC, Rotterdam, The Netherlands; Department of Cardio-Thoracic Surgery, Academic Medical Center, University of Amsterdam, The Netherlands (Y.A., D.R.K., F.d.H, J.K.); Department of Cardio-Thoracic Surgery, University Medical Center Utrecht, The Netherlands (M.B.); Department of Cardio-Thoracic Surgery (E.F.B., R.J.M.K.) and Department of Medical Decision Making (A.M.S.), Leiden University Medical Center, The Netherlands; Department of Cardiology, Diakonessenhuis, Utrecht, The Netherlands (J.J.J.B.); Department of Cardiology, St. Anna Hospital, Geldrop, The Netherlands (P.P.); Department of Cardio-Thoracic Surgery, Isala Klinieken, Zwolle, The Netherlands (T.M.); and Patient Organisation De Hart&Vaatgroep, The Hague, The Netherlands (I.v.d.B., R.L.).
出版信息
Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2). doi: 10.1161/CIRCOUTCOMES.116.003178. Epub 2017 Feb 22.
BACKGROUND
A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection.
METHODS AND RESULTS
In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%; =0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17; =0.046) and had a better knowledge of prosthetic valves (85% versus 68%; =0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9; =0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50; =0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups.
CONCLUSIONS
A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being.
CLINICAL TRIAL REGISTRATION
http://www.trialregister.nl. Unique identifier: NTR4350.
背景
最近开发了一种荷兰在线患者决策辅助工具，以支持人工心脏瓣膜的选择。进行了一项多中心随机对照试验，以评估使用该患者决策辅助工具是否能优化人工心脏瓣膜选择中的共同决策。
方法与结果
在一项5中心随机对照试验中，患者被分配接受标准术前护理（对照组）或额外使用患者决策辅助工具（干预组）。纳入计划接受择期单纯或联合主动脉瓣和二尖瓣置换术的具有法律行为能力的成年患者。主要结局是术前决策冲突（决策冲突量表）；次要结局包括患者知识、参与瓣膜选择情况、焦虑和抑郁、（特定瓣膜的）生活质量以及遗憾感。在306例符合条件的患者中，155例被随机分组（78例对照组和77例干预组）。两组术前决策冲突无差异（34%对33%；P=0.834）。干预组患者感觉信息更充分（决策冲突量表信息子量表中位数：8对17；P=0.046），对人工瓣膜的了解更好（85%对68%；P=0.004）。干预组患者焦虑和抑郁程度更低（医院焦虑抑郁量表中位数评分：6对9；P=0.015），心理健康状况更好（简短健康调查问卷平均评分：54对50；P=0.032）。术后3个月，两组特定瓣膜的生活质量和遗憾感无差异。
结论
支持人工心脏瓣膜选择中共同决策的患者决策辅助工具不会降低决策冲突。它确实能使患者知识更丰富、信息更充分、焦虑和抑郁程度更低，心理健康状况更好。
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