Mullan Rebecca J, Montori Victor M, Shah Nilay D, Christianson Teresa J H, Bryant Sandra C, Guyatt Gordon H, Perestelo-Perez Lilisbeth I, Stroebel Robert J, Yawn Barbara P, Yapuncich Victor, Breslin Maggie A, Pencille Laurie, Smith Steven A
Knowledge and Encounter Research Unit, Mayo Center for Translational Science Activities, Mayo Clinic, Rochester, MN 55905, USA.
Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus.
We conducted a pilot, cluster randomized trial of Diabetes Medication Choice, a decision aid that describes 5 antihyperglycemic drugs, their treatment burden (adverse effects, administration, and self-monitoring demands), and impact on hemoglobin A(1c) (HbA(1c)) levels. Twenty-one clinicians were randomized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet. We used surveys and video analysis to assess postvisit decisional outcomes, and medical and pharmacy records to assess 6-month medication adherence and HbA(1c) levels.
Compared with usual care patients (n = 37), patients receiving the decision aid (n = 48) found the tool more helpful (clustered-adjusted mean difference [AMD] in a 7-point scale, 0.38; 95% confidence interval [CI], 0.04-0.72); had improved knowledge (AMD, 1.10 of 10 questions; 95% CI, 0.11-2.09); and had more involvement in making decisions about diabetes medications (AMD, 21.8 of 100; 95% CI, 13.0-30.5). At 6-month follow-up, both groups had nearly perfect medication use (median, 100% of days covered), with better adherence (AMD, 9% more days covered; 95% CI, 4%-14%) and persistence (AMD, 12 more days covered; 95% CI, 3-21 days) in the usual care group, and no significant impact on HbA(1c) levels (AMD, 0.01; 95% CI, -0.49 to 0.50).
An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA(1c) levels. Trial Registration clinicaltrials.gov Identifier: NCT00388050.
患者参与降糖药物的选择可提高2型糖尿病患者的依从性并优化血糖控制。
我们开展了一项关于糖尿病药物选择的试点整群随机试验，这是一种决策辅助工具，描述了5种降糖药物、它们的治疗负担（不良反应、给药方式及自我监测要求）以及对糖化血红蛋白（HbA1c）水平的影响。21名临床医生被随机分配在临床诊疗过程中使用该决策辅助工具，19名临床医生提供常规护理并发放一份教育手册。我们通过调查和视频分析评估就诊后的决策结果，通过医疗和药房记录评估6个月的药物依从性和HbA1c水平。
与接受常规护理的患者（n = 37）相比，使用决策辅助工具的患者（n = 48）认为该工具更有帮助（在7分制量表中的整群调整均值差[AMD]为0.38；95%置信区间[CI]为0.04 - 0.72）；知识有所提高（10道题目的AMD为1.10；95% CI为0.11 - 2.09）；并且在糖尿病药物决策方面的参与度更高（100分中的AMD为21.8；95% CI为13.0 - 30.5）。在6个月的随访中，两组的药物使用情况几乎都达到完美（中位数为覆盖天数的100%），常规护理组的依从性更好（AMD为多覆盖9%的天数；95% CI为4% - 14%）且持续性更佳（AMD为多覆盖12天；95% CI为3 - 21天），但对HbA1c水平无显著影响（AMD为0.01；95% CI为 - 0.49至0.50）。
一种创新的决策辅助工具有效地让2型糖尿病患者参与到药物决策中，但未提高依从性或HbA1c水平。试验注册 clinicaltrials.gov标识符：NCT00388050。
