Stacey Dawn, Bennett Carol L, Barry Michael J, Col Nananda F, Eden Karen B, Holmes-Rovner Margaret, Llewellyn-Thomas Hilary, Lyddiatt Anne, Légaré France, Thomson Richard
School of Nursing, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada.
Cochrane Database Syst Rev. 2011 Oct 5(10):CD001431. doi: 10.1002/14651858.CD001431.pub3.
Decision aids prepare people to participate in decisions that involve weighing benefits, harms, and scientific uncertainty.
To evaluate the effectiveness of decision aids for people facing treatment or screening decisions.
For this update, we searched from January 2006 to December 2009 in MEDLINE (Ovid); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, issue 4 2009); CINAHL (Ovid) (to September 2008 only); EMBASE (Ovid); PsycINFO (Ovid); and grey literature. Cumulatively, we have searched each database since its start date.
We included published randomised controlled trials (RCTs) of decision aids, which are interventions designed to support patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to usual care and/or alternative interventions. We excluded studies in which participants were not making an active treatment or screening decision.
Two review authors independently screened abstracts for inclusion, extracted data, and assessed potential risk of bias. The primary outcomes, based on the International Patient Decision Aid Standards, were:A) decision attributes;B) decision making process attributes.Secondary outcomes were behavioral, health, and health system effects. We pooled results of RCTs using mean differences (MD) and relative risks (RR), applying a random effects model.
Of 34,316 unique citations, 86 studies involving 20,209 participants met the eligibility criteria and were included. Thirty-one of these studies are new in this update. Twenty-nine trials are ongoing. There was variability in potential risk of bias across studies. The two criteria that were most problematic were lack of blinding and the potential for selective outcome reporting, given that most of the earlier trials were not registered.Of 86 included studies, 63 (73%) used at least one measure that mapped onto an IPDAS effectiveness criterion: A) criteria involving decision attributes: knowledge scores (51 studies); accurate risk perceptions (16 studies); and informed value-based choice (12 studies); and B) criteria involving decision process attributes: feeling informed (30 studies) and feeling clear about values (18 studies).A) Criteria involving decision attributes:Decision aids performed better than usual care interventions by increasing knowledge (MD 13.77 out of 100; 95% confidence interval (CI) 11.40 to 16.15; n = 26). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 4.97 out of 100; 95% CI 3.22 to 6.72; n = 15). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.74; 95% CI 1.46 to 2.08; n = 14). The effect was stronger when probabilities were expressed in numbers (RR 1.93; 95% CI 1.58 to 2.37; n = 11) rather than words (RR 1.27; 95% CI 1.09 to 1.48; n = 3). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.25; 95% CI 1.03 to 1.52; n = 8).B) Criteria involving decision process attributes:Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed (MD -6.43 of 100; 95% CI -9.16 to -3.70; n = 17); b) lower decisional conflict related to feeling unclear about personal values (MD -4.81; 95% CI -7.23 to -2.40; n = 14); c) reduced the proportions of people who were passive in decision making (RR 0.61; 95% CI 0.49 to 0.77; n = 11); and d) reduced proportions of people who remained undecided post-intervention (RR 0.57; 95% CI 0.44 to 0.74; n = 9). Decision aids appear to have a positive effect on patient-practitioner communication in the four studies that measured this outcome. For satisfaction with the decision (n = 12) and/or the decision making process (n = 12), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There were no studies evaluating the decision process attributes relating to helping patients to recognize that a decision needs to be made or understand that values affect the choice.C) Secondary outcomesExposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favour of conservative options (RR 0.80; 95% CI 0.64 to 1.00; n = 11). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.85; 95% CI 0.74 to 0.98; n = 7). When detailed compared to simple decision aids were used, there was reduced choice of menopausal hormones (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 to +23 minutes (median 2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 20), and general health outcomes (n = 7), and condition specific health outcomes (n = 9). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.
AUTHORS' CONCLUSIONS: New for this updated review is evidence that: decision aids with explicit values clarification exercises improve informed values-based choices; decision aids appear to have a positive effect on patient-practitioner communication; and decision aids have a variable effect on length of consultation.Consistent with findings from the previous review, which had included studies up to 2006: decision aids increase people's involvement, and improve knowledge and realistic perception of outcomes; however, the size of the effect varies across studies. Decision aids have a variable effect on choices. They reduce the choice of discretionary surgery and have no apparent adverse effects on health outcomes or satisfaction. The effects on adherence with the chosen option, patient-practitioner communication, cost-effectiveness, and use with developing and/or lower literacy populations need further evaluation. Little is known about the degree of detail that decision aids need in order to have positive effects on attributes of the decision or decision-making process.
决策辅助工具帮助人们参与涉及权衡利弊和科学不确定性的决策。
评估决策辅助工具对面临治疗或筛查决策人群的有效性。
本次更新中,我们检索了2006年1月至2009年12月期间的MEDLINE(Ovid)、Cochrane对照试验中心注册库(CENTRAL,Cochrane图书馆,2009年第4期)、CINAHL(Ovid)(仅检索至2008年9月)、EMBASE(Ovid)、PsycINFO(Ovid)以及灰色文献。自各数据库起始日期以来,我们累计对每个数据库都进行了检索。
我们纳入已发表的决策辅助工具随机对照试验(RCT),这些干预措施旨在通过提供治疗或筛查选项及其相关结果的信息,支持患者决策,与常规护理和/或替代干预措施进行比较。我们排除了参与者未进行积极治疗或筛查决策的研究。
两位综述作者独立筛选摘要以确定是否纳入,提取数据,并评估潜在的偏倚风险。基于国际患者决策辅助工具标准,主要结局为:A)决策属性;B)决策过程属性。次要结局为行为、健康和卫生系统影响。我们使用均值差(MD)和相对风险(RR)汇总RCT结果,应用随机效应模型。
在34316条独特的文献引用中,86项研究涉及20209名参与者,符合纳入标准并被纳入。其中31项研究是本次更新中的新增研究。29项试验正在进行中。各研究的潜在偏倚风险存在差异。最成问题的两个标准是缺乏盲法和选择性报告结局的可能性,因为大多数早期试验未进行注册。在86项纳入研究中,63项(73%)至少使用了一项符合国际患者决策辅助工具标准有效性标准的测量方法:A)涉及决策属性的标准:知识得分(51项研究);准确的风险认知(16项研究);基于价值的明智选择(12项研究);B)涉及决策过程属性的标准:感觉信息充分(30项研究)和感觉价值观清晰(18项研究)。A)涉及决策属性的标准:决策辅助工具通过增加知识(满分100分中MD为13.77;95%置信区间(CI)为11.40至16.15;n = 26),比常规护理干预表现更好。当将更详细的决策辅助工具与更简单的决策辅助工具进行比较时,知识的相对改善具有显著性(满分100分中MD为4.97;95%CI为3.22至6.72;n = 15)。接触具有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1.74;95%CI为1.46至2.08;n = 14)。当概率用数字表示时(RR为1.