帮助2型糖尿病患者做出治疗决策：他汀类药物选择随机试验。

Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial.

作者信息

Weymiller Audrey J, Montori Victor M, Jones Lesley A, Gafni Amiram, Guyatt Gordon H, Bryant Sandra C, Christianson Teresa J H, Mullan Rebecca J, Smith Steven A

机构信息

Knowledge and Encounter Research Unit, Division of Diabetes, Endocrinology, and Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.

出版信息

Arch Intern Med. 2007 May 28;167(10):1076-82. doi: 10.1001/archinte.167.10.1076.

DOI:10.1001/archinte.167.10.1076

PMID:17533211

Abstract

BACKGROUND

Poor quality of information transfer about the benefits and risks of statin drug use may result in patients not making informed decisions that they can act on in a timely fashion.

METHODS

The effect of a decision aid about statin drugs on treatment decision making in 98 patients with diabetes was determined in a cluster randomized trial of decision aid vs control pamphlet, with concealed allocation, blinding of participants to study goals, and adherence to the intention-to-treat principle. Twenty-one endocrinologists conducted specialty outpatient metabolic consultations. Patients in the intervention group received Statin Choice, a tailored decision aid that presents the estimated 10-year cardiovascular risk, the absolute risk reduction with use of statin drugs, and the disadvantages of using statin drugs. Patients in the control group received the institution's pamphlet about cholesterol management. We measured acceptability, knowledge about options and cardiovascular risk, and decisional conflict immediately after the visit, and adherence to pill taking was measured 3 months later.

RESULTS

Patients favored using the decision aid (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.2-6.9); patients who received the decision aid (n = 52) knew more (difference, 2.4 of 9 points; 95% CI, 1.5-3.3), had better estimated cardiovascular risk (OR, 22.4; 95% CI, 5.9-85.6) and potential absolute risk reduction with statin drugs (OR, 6.7; 95% CI, 2.2-19.7), and had less decisional conflict (difference, -10.6; 95% CI, -15.4 to -5.9 on a 100-point scale) than did patients in the control group (n = 46). Of 33 patients in the intervention group taking statin drugs at 3 months, 2 reported missing 1 dose or more in the last week compared with 6 of 29 patients in the control group taking statin drugs (OR, 3.4; 95% CI, 1.5-7.5).

CONCLUSIONS

A decision aid enhanced decision making about statin drugs and may have favorably affected drug adherence.

摘要

背景

关于他汀类药物使用的益处和风险的信息传递质量不佳，可能导致患者无法做出能及时付诸行动的明智决策。

方法

在一项决策辅助工具与对照手册的整群随机试验中，确定了一种关于他汀类药物的决策辅助工具对98例糖尿病患者治疗决策的影响，试验采用隐蔽分配、参与者对研究目标不知情以及遵循意向性分析原则。21名内分泌科医生进行专科门诊代谢咨询。干预组患者接受“他汀选择”，这是一种量身定制的决策辅助工具，呈现估计的10年心血管风险、使用他汀类药物的绝对风险降低以及使用他汀类药物的弊端。对照组患者接受该机构关于胆固醇管理的手册。我们在就诊后立即测量可接受性、对治疗选择和心血管风险的了解以及决策冲突，并在3个月后测量服药依从性。

结果

患者倾向于使用决策辅助工具（比值比[OR]，2.8；95%置信区间[CI]，1.2 - 6.9）；接受决策辅助工具的患者（n = 52）了解更多（差异为9分制中的2.4分；95% CI，1.5 - 3.3），对心血管风险的估计更好（OR，22.4；95% CI，5.9 - 85.6），对他汀类药物潜在绝对风险降低的估计更好（OR，6.7；95% CI，2.2 - 19.7），并且与对照组患者（n = 46）相比，决策冲突更少（差异为 - 10.6；95% CI， - 15.4至 - 5.9，满分100分）。干预组33例在3个月时服用他汀类药物的患者中，2例报告在过去一周漏服一剂或更多剂量，而对照组29例服用他汀类药物患者中有6例（OR，3.4；95% CI，1.5 - 7.5）。