基于决策辅助工具与常规护理的前列腺癌筛查决策：一项随机临床试验。
Decision making in prostate cancer screening using decision aids vs usual care: a randomized clinical trial.
出版信息
JAMA Intern Med. 2013 Oct 14;173(18):1704-12. doi: 10.1001/jamainternmed.2013.9253.
IMPORTANCE
The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.
OBJECTIVE
To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.
DESIGN, SETTING, AND PARTICIPANTS: A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.
INTERVENTION
Random assignment to print-based decision aid (n = 628), web-based interactive decision aid (n = 625), or usual care (UC) (n = 626).
MAIN OUTCOMES AND MEASURES
Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.
RESULTS
Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d = 0.33) and print vs UC (d = 0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P = .009) and significantly more web (P = .001) and print (P = .03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P = .06) and web participants (50.4%; P = .10) were not significant. Screening rates at 13 months did not differ significantly among groups.
CONCLUSIONS AND RELEVANCE
Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00196807.
重要性
前列腺癌（PCa）筛查的相互矛盾的建议以及向公众传达的有关筛查效果的混杂信息，使得帮助男性做出明智决策至关重要。
目的
评估两种决策辅助工具在帮助男性做出明智的 PCa 筛查决策方面的有效性。
设计、地点和参与者：2007 年至 2011 年期间，我们从 3 个地点招募了年龄在 45 至 70 岁的不同种族的男性门诊患者，通过电话进行基线、1 个月和 13 个月的访谈。我们进行了意向治疗的单变量分析以及多变量线性和逻辑回归分析，根据基线结果进行了调整。
干预措施
随机分配至基于印刷的决策辅助工具（n=628）、基于网络的交互式决策辅助工具（n=625）或常规护理（UC）（n=626）。
主要结局和措施
前列腺癌知识、决策冲突、决策满意度以及参与者是否进行了 PCa 筛查。
结果
在 4794 名符合条件的男性中，有 1893 名被随机分配。在每次随访评估中，单变量和多变量分析表明，与 UC 相比，两种决策辅助工具均显著提高了 PCa 知识，并降低了决策冲突（均 P<0.001）。在 1 个月时，网络组与 UC 相比，知识的标准化均数差（Cohen’s d）为 0.74，印刷组与 UC 相比为 0.73。网络组与 UC 相比（d=0.33）和印刷组与 UC 相比（d=0.36），决策冲突明显降低。在 13 个月时，这些差异较小，但仍然显著。在 1 个月时，与 UC 相比，印刷组（60.4%）比网络组（52.2%；P=0.009）和网络组（P=0.001）和印刷组（P=0.03）报告高满意度的参与者明显更多。在 13 个月时，与 UC 相比（49.8%；P=0.06）和网络组（50.4%；P=0.10）相比，印刷组报告高满意度的比例差异不显著。13 个月时，各组之间的筛查率无显著差异。
结论和相关性
两种决策辅助工具都提高了参与者对 PCa 筛查的知情决策，最长可持续至 13 个月，但并未影响实际筛查率。这些决策辅助工具的传播可能是一种有价值的公共卫生工具。
试验注册
clinicaltrials.gov 标识符：NCT00196807。
Zotero 插件