Clinical Pharmacy and Pharmacology, University Medical Center Groningen, PO Box 30.001, Groningen, Netherlands University of Groningen, University Medical Center Groningen, Groningen, Netherlands
University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
BMJ. 2014 Sep 25;349:g5651. doi: 10.1136/bmj.g5651.
To assess the effects of a patient oriented decision aid for prioritising treatment goals in diabetes compared with usual care on patient empowerment and treatment decisions.
Pragmatic randomised controlled trial.
18 general practices in the north of the Netherlands.
344 patients with type 2 diabetes aged ≤ 65 years at the time of diagnosis and managed in primary care between April 2011 and August 2012: 225 were allocated to the intervention group and 119 to the usual care group.
The intervention comprised a decision aid for people with diabetes, with individually tailored risk information and treatment options for multiple risk factors. The aid was intended to empower patients to prioritise between clinical domains and to support treatment decisions. It was offered to participants before a regular diabetes check-up and to their healthcare provider during the consultation. Four different formats of the decision aid were included for additional explorative analyses.
The primary outcome was the effects on patient empowerment for setting and achieving goals. The secondary outcomes were changes in the prescribing of drugs to regulate glucose, blood pressure, lipids, and albuminuria. Data were collected through structured questionnaires and automated data extraction from electronic health records during six months before and after the intervention.
Of all intervention participants, 103 (46%) reported to have received the basic elements of the intervention. For the primary outcome analysis, 199 intervention and 107 control patients with sufficient baseline and follow-up data could be included. The mean empowerment score increased 0.1 on a 5 point scale in the overall intervention group, which was not significantly different from that of the control group (mean difference after adjusting for baseline 0.039, 95% confidence interval -0.056 to 0.134). Lipid regulating drug treatment was intensified in 25% of intervention and 12% of control participants with increased cholesterol levels, which did not reach significance when the intervention was compared with the usual care group (odds ratio 2.54, 95% confidence interval 0.89 to 7.23). Prespecified explorative analyses showed that this effect was significant for the printed version of the decision aid in comparison to usual care (3.90, 1.29 to 11.80). No relevant or significant changes were seen for other treatments.
We found no evidence that the patient oriented treatment decision aid improves patient empowerment by an important amount. The aid was not used to its full extent in a substantial number of participants.
Dutch trial register NTR1942.
评估以患者为导向的决策辅助工具与常规护理相比，在糖尿病患者的治疗目标优先排序方面对患者赋权和治疗决策的影响。
实用随机对照试验。
荷兰北部的 18 家全科诊所。
2011 年 4 月至 2012 年 8 月期间在初级保健中管理的≤65 岁的 2 型糖尿病新诊断患者 344 名：225 名被分配到干预组，119 名被分配到常规护理组。
干预措施包括为糖尿病患者提供决策辅助工具，具有个性化的风险信息和多种风险因素的治疗选择。该辅助工具旨在使患者能够在临床领域之间进行优先级排序，并支持治疗决策。它在定期糖尿病检查前提供给参与者，并在咨询期间提供给他们的医疗保健提供者。为了进行额外的探索性分析，纳入了该决策辅助工具的四种不同格式。
主要结果是对设定和实现目标的患者赋权的影响。次要结果是调节血糖、血压、血脂和白蛋白尿的药物处方的变化。在干预前和干预后六个月期间，通过结构化问卷和电子健康记录中的自动数据提取收集数据。
在所有干预参与者中，有 103 名（46%）报告已接受了干预的基本内容。在主要结局分析中，纳入了 199 名干预组和 107 名对照患者，这些患者有足够的基线和随访数据。总体干预组的赋权评分平均增加了 0.1 分（在 5 分制上），与对照组无显著差异（调整基线后的平均差异 0.039，95%置信区间 -0.056 至 0.134）。胆固醇水平升高的 25%的干预组和 12%的对照组参与者接受了强化血脂调节药物治疗，但与常规护理组相比，这并未达到显著水平（比值比 2.54，95%置信区间 0.89 至 7.23）。预设定的探索性分析表明，与常规护理相比，该决策辅助工具的印刷版本在这方面具有显著效果（3.90，1.29 至 11.80）。其他治疗未见相关或显著变化。
我们没有发现以患者为导向的治疗决策辅助工具能显著提高患者赋权的证据。在很大一部分参与者中，该辅助工具并未得到充分利用。
荷兰试验注册 NTR1942。
