Stacey Dawn, Légaré France, Col Nananda F, Bennett Carol L, Barry Michael J, Eden Karen B, Holmes-Rovner Margaret, Llewellyn-Thomas Hilary, Lyddiatt Anne, Thomson Richard, Trevena Lyndal, Wu Julie H C
School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada.
Cochrane Database Syst Rev. 2014 Jan 28(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty.
To assess the effects of decision aids for people facing treatment or screening decisions.
For this update, we searched from 2009 to June 2012 in MEDLINE; CENTRAL; EMBASE; PsycINFO; and grey literature. Cumulatively, we have searched each database since its start date including CINAHL (to September 2008).
We included published randomized controlled trials of decision aids, which are interventions designed to support patients' decision making by making explicit the decision, providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies of participants making hypothetical decisions.
Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were:A) 'choice made' attributes;B) 'decision-making process' attributes.Secondary outcomes were behavioral, health, and health-system effects. We pooled results using mean differences (MD) and relative risks (RR), applying a random-effects model.
This update includes 33 new studies for a total of 115 studies involving 34,444 participants. For risk of bias, selective outcome reporting and blinding of participants and personnel were mostly rated as unclear due to inadequate reporting. Based on 7 items, 8 of 115 studies had high risk of bias for 1 or 2 items each.Of 115 included studies, 88 (76.5%) used at least one of the IPDAS effectiveness criteria: A) 'choice made' attributes criteria: knowledge scores (76 studies); accurate risk perceptions (25 studies); and informed value-based choice (20 studies); and B) 'decision-making process' attributes criteria: feeling informed (34 studies) and feeling clear about values (29 studies).A) Criteria involving 'choice made' attributes:Compared to usual care, decision aids increased knowledge (MD 13.34 out of 100; 95% confidence interval (CI) 11.17 to 15.51; n = 42). When more detailed decision aids were compared to simple decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). Exposure to a decision aid with explicit values clarification resulted in a higher proportion of patients choosing an option congruent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).B) Criteria involving 'decision-making process' attributes:Decision aids compared to usual care interventions resulted in:a) lower decisional conflict related to feeling uninformed (MD -7.26 of 100; 95% CI -9.73 to -4.78; n = 22) and feeling unclear about personal values (MD -6.09; 95% CI -8.50 to -3.67; n = 18);b) reduced proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); andc) reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18).Decision aids appeared to have a positive effect on patient-practitioner communication in all nine studies that measured this outcome. For satisfaction with the decision (n = 20), decision-making process (n = 17), and/or preparation for decision making (n = 3), those exposed to a decision aid were either more satisfied, or there was no difference between the decision aid versus comparison interventions. No studies evaluated decision-making process attributes for helping patients to recognize that a decision needs to be made, or understanding that values affect the choice.C) Secondary outcomes Exposure to decision aids compared to usual care reduced the number of people of choosing major elective invasive surgery in favour of more conservative options (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care reduced the number of people choosing to have prostate-specific antigen screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, fewer people chose menopausal hormone therapy (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable.The effect of decision aids on length of consultation varied from 8 minutes shorter to 23 minutes longer (median 2.55 minutes longer) with 2 studies indicating statistically-significantly longer, 1 study shorter, and 6 studies reporting no difference in consultation length. Groups of patients receiving decision aids do not appear to differ from comparison groups in terms of anxiety (n = 30), general health outcomes (n = 11), and condition-specific health outcomes (n = 11). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.
AUTHORS' CONCLUSIONS: There is high-quality evidence that decision aids compared to usual care improve people's knowledge regarding options, and reduce their decisional conflict related to feeling uninformed and unclear about their personal values. There is moderate-quality evidence that decision aids compared to usual care stimulate people to take a more active role in decision making, and improve accurate risk perceptions when probabilities are included in decision aids, compared to not being included. There is low-quality evidence that decision aids improve congruence between the chosen option and the patient's values.New for this updated review is further evidence indicating more informed, values-based choices, and improved patient-practitioner communication. There is a variable effect of decision aids on length of consultation. Consistent with findings from the previous review, decision aids have a variable effect on choices. They reduce the number of people choosing discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, cost-effectiveness, use with lower literacy populations, and level of detail needed in decision aids need further evaluation. Little is known about the degree of detail that decision aids need in order to have a positive effect on attributes of the choice made, or the decision-making process.
决策辅助工具旨在帮助人们参与决策，这些决策通常涉及在科学存在不确定性的情况下权衡治疗方案的利弊。
评估决策辅助工具对面临治疗或筛查决策的人群的影响。
本次更新中，我们检索了2009年至2012年6月期间的MEDLINE、CENTRAL、EMBASE、PsycINFO以及灰色文献。累计而言，自各数据库起始日期起我们均进行了检索，包括CINAHL（截至2008年9月）。
我们纳入已发表的决策辅助工具随机对照试验，这些干预措施旨在通过明确决策、提供治疗或筛查选项及其相关结果的信息来支持患者决策，与常规护理和/或替代干预措施进行比较。我们排除了参与者进行假设性决策的研究。
两位综述作者独立筛选纳入的文献引用、提取数据并评估偏倚风险。基于国际患者决策辅助工具标准（IPDAS）的主要结局为：A）“做出的选择”属性；B）“决策过程”属性。次要结局为行为、健康和卫生系统方面的影响。我们使用均数差（MD）和相对危险度（RR）汇总结果，应用随机效应模型。
本次更新纳入33项新研究，共计115项研究，涉及34444名参与者。关于偏倚风险，由于报告不充分，选择性结局报告以及参与者和研究人员的盲法大多被评为不清楚。基于7项指标，115项研究中有8项因1项或2项指标存在高偏倚风险。在115项纳入研究中，88项（76.5%）至少使用了一项IPDAS有效性标准：A）“做出的选择”属性标准：知识得分（76项研究）；准确的风险认知（25项研究）；以及基于价值观的明智选择（20项研究）；B）“决策过程”属性标准：感觉信息充分（34项研究）和感觉价值观清晰（29项研究）。A）涉及“做出的选择”属性的标准：与常规护理相比（MD为100分制中的13.34分；95%置信区间（CI）为11.17至15.51；n = 42）。当将更详细的决策辅助工具与简单决策辅助工具进行比较时，知识方面的相对改善具有统计学意义（MD为100分制中的5.52分；95% CI为3.90至7.15；n = 19）。接触包含明确概率的决策辅助工具会使具有准确风险认知的人群比例更高（RR为1.82；95% CI为1.52至2.16；n = 19）。接触具有明确价值观澄清的决策辅助工具会使选择与自身价值观相符选项的患者比例更高（RR为1.51；95% CI为1.17至1.96；n = 13）。B）涉及“决策过程”属性的标准：与常规护理干预相比，决策辅助工具导致：a）与感觉信息不充分相关的决策冲突降低（MD为100分制中的 -7.26分；95% CI为 -9.73至 -4.78；n = 22）以及与个人价值观不清晰相关的决策冲突降低（MD为 -6.09；95% CI为 -8.50至 -3.67；n = 18）；b）决策中被动人群的比例降低（RR为0.66；95% CI为0.53至0.81；n = 14）；c）干预后仍未做出决定的人群比例降低（RR为0.59；95% CI为0.47至0.72；n = 18）。在所有9项测量此结局的研究中，决策辅助工具似乎对医患沟通有积极影响。对于对决策的满意度（n = 20）、决策过程（n = 17）和/或决策准备情况（n = 3），接触决策辅助工具的人群要么更满意，要么决策辅助工具与对照干预措施之间没有差异。没有研究评估决策辅助工具在帮助患者认识到需要做出决策或理解价值观影响选择方面的决策过程属性。C）次要结局与常规护理相比，接触决策辅助工具减少了选择大型择期侵入性手术而倾向于更保守选项的人数（RR为0.79；95% CI为0.68至0.93；n = 15）。与常规护理相比，接触决策辅助工具减少了选择前列腺特异性抗原筛查的人数（RR为0.87；95% CI为0.77至0.98；n = 9）。当使用详细决策辅助工具与简单决策辅助工具进行比较时，选择更年期激素治疗的人数减少（RR为0.73；95% CI为0.55至0.98；n = 3）。对于其他决策，对选择的影响各不相同。决策辅助工具对咨询时长的影响从缩短8分钟到延长23分钟不等（中位数延长2.55分钟），2项研究表明咨询时长在统计学上显著更长，1项研究表明更短，6项研究报告咨询时长无差异。接受决策辅助工具的患者组在焦虑（n = 30）、总体健康结局（n = 11）和特定疾病健康结局（n = 11）方面与对照组似乎没有差异。决策辅助工具对其他结局（对决策的依从性、成本/资源使用）的影响尚无定论。
有高质量证据表明，与常规护理相比，决策辅助工具可提高人们对选项的了解，并减少与感觉信息不充分和个人价值观不清晰相关的决策冲突。有中等质量证据表明，与常规护理相比，决策辅助工具能促使人们在决策中发挥更积极的作用，并且与未包含概率信息的决策辅助工具相比，当决策辅助工具包含概率信息时能改善准确的风险认知。有低质量证据表明决策辅助工具可提高所选选项与患者价值观之间的一致性。本次更新综述的新发现是，有进一步证据表明基于价值观的选择更明智，且医患沟通得到改善。决策辅助工具对咨询时长的影响各不相同。与之前综述的结果一致，决策辅助工具对选择的影响各不相同。它们减少了选择选择性手术的人数，且对健康结局或满意度没有明显不良影响。对所选选项的依从性、成本效益、在低识字率人群中的使用以及决策辅助工具所需的详细程度的影响需要进一步评估。关于决策辅助工具为对做出的选择属性或决策过程产生积极影响所需的详细程度知之甚少。
