Academic Unit of Primary Medical Care, Northern General Hospital, University of Sheffield, Sheffield, UK.
BMJ Open. 2012 Nov 5;2(6). doi: 10.1136/bmjopen-2012-001469. Print 2012.
To determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT).
A cluster RCT.
49 general practices in UK randomised into intervention (n=25) and control (n=24).
General practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy.
currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and anlaysis.
Brief training of clinicians and use of PDA with patients in single consultation.
Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).
Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.
Intervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of 'hypo', 'weight gain', 'complications'; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups.
Use of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice. ISRCTN TRIALS REGISTER NUMBER: 14842077.
通过一项集群随机对照试验（RCT）来确定患者决策辅助工具（PDA）在改善糖尿病患者治疗选择方面的决策质量和血糖控制的有效性。
集群 RCT。
英国 49 家普通诊所，随机分为干预组（n=25）和对照组（n=24）。
普通诊所入选标准：>4 名医疗合作伙伴；列表大小>7000；以及糖尿病登记册，其患者人数占实践人群的>1%。对 191 家诊所进行了资格评估，49 家诊所被随机分配并完成了研究。患者 2 型糖尿病患者（T2DM）服用至少两种口服降糖药物，最大耐受剂量，糖化血红蛋白（HbA1c）>7.4%（IFCC HbA1c>57 mmol/mol）或在之前的 6 个月内建议添加或考虑改用胰岛素治疗。
目前正在使用胰岛素治疗；阅读或理解英语有困难；难以理解研究的目的；视力或认知障碍或精神疾病。共有 182 人接受了资格评估，175 人随机分为 95 名干预组和 80 名对照组，167 人完成了分析。
对临床医生进行简短培训，并在单次就诊中使用 PDA 与患者一起使用。
决策质量（决策冲突评分、知识、现实期望和自主性）和血糖控制（糖化血红蛋白，HbA1c）。
对胰岛素治疗和糖尿病并发症的风险和益处的知识和现实期望。
干预组：总决策冲突评分较低（17.4 对 25.2，p<0.001）；知识更好（51.6% 对 28.8%，p<0.001）；现实期望（低血糖、体重增加、并发症的风险；81.0% 对 5.2%、70.5% 对 5.3%、26.3% 对 5.0%，p<0.001）；决策更加自主（64.1% 对 42.9%，p=0.012）。两组之间的血糖控制没有显著差异。
在普通诊所中，使用 PANDAs 决策辅助工具可降低决策冲突，提高知识水平，增强糖尿病患者在治疗选择方面的现实期望和自主性。
ISRCTN 临床试验注册号：14842077。
