Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice
Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice
复制标题
DOI：
10.1093/fampra/cmh402
复制
发表时间：
2004-08-01
期刊：
影响因子：
2.2
通讯作者：
Russell, I
中科院分区：
文献类型：
--
作者：
Edwards, A;Elwyn, G;Russell, I
背景从伦理学的角度来看，越来越多的专家和患者之间的共同决策（SDM）被提倡。关于这些方法对健康或其他基于患者的结果的影响，一些数据正在积累。这些影响往往在研究之间有很大差异。我们的目的是评估SDM中培训全科医生的效果，以及在全科实践中使用简单的风险沟通辅助工具对患者结局的影响。进行了一项交叉分组随机试验，20个最近合格的全科医生在城市和农村的一般做法在Gwent，南威尔士州的参与。共有747名已知患有房颤、前列腺炎、月经过多或绝经症状的患者被邀请参加咨询，以审查其病情或治疗。基线后，参与的医生被随机接受培训（i）SDM技能;或（ii）使用简单的风险沟通辅助工具，使用模拟患者。然后为最终研究阶段提供替代培训。患者被随机分配到基线或干预1（SDM或风险沟通辅助工具）或干预2阶段的咨询。随机选择一半的咨询发生在“研究诊所”，以评估与通常的手术时间相比，更多的咨询时间的影响。在退出咨询和1个月随访时评估基于患者的结局。这些是：COMRADE工具（主要测量;风险沟通和决策信心子量表）和一系列次要测量（焦虑、患者支持、坚持所选治疗的意图、决策满意度、决策支持和SF-12健康状况测量）。以结局评分为因变量，以随访时间（即每例患者退出或1个月后）、患者和医生水平为解释变量进行多水平建模。未发现由于培训干预导致的基于患者的结局发生统计学显著变化：风险沟通培训后COMRADE风险沟通评分增加0.7 [95%置信区间（CI）-0.92至2.32]，（95% CI -0.89至2.35）; COMRADE的沟通满意度得分提高了1.0（95% CI -1.1至3.1），SDM培训后下降0.6（95% CI 2.7至-1.5）。与常规手术时间相比，在研究诊所（当有更多时间可用时）就诊的患者中，患者对决策的信心（增加2.1，95% CI 0.7-3.5，P < 0.01）和坚持所选治疗的期望（增加0.7，95% CI 0.04-1.36，P < 0.05）显著更高。大多数结局在退出和1个月后恶化。干预效果之间无交互作用。患者可以更多地参与治疗决策，并且可以更详细地解释治疗方案的风险和益处，而不会对基于患者的结局产生不利影响。SDM和风险沟通可以从价值观和伦理原则中提倡，即使没有证据表明健康收益或改善患者的结果，但也必须考虑到提高这些专业技能所需的资源。这些数据还表明了额外咨询时间的好处。
Background. Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies.Objective. Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes.Methods. A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables.Results. No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects.Conclusion. Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time.