Ellis P M, Butow P N, Tattersall M H N
Medical Oncologist Hamilton Regional Cancer Center, Hamilton, Ontario, Canada.
Ann Oncol. 2002 Sep;13(9):1414-23. doi: 10.1093/annonc/mdf255.
To evaluate the impact of an educational booklet on women's knowledge of and willingness to participate in a randomized clinical trial of treatment for breast cancer.
Women undergoing surgery for newly diagnosed early stage breast cancer were randomized to receive, or not, an information booklet explaining the need for and manner in which randomized trials are conducted.
Eighty-three women with newly diagnosed early stage breast cancer completed a questionnaire assessing attitudes to random clinical trials (RCTs) and were randomized to receive usual information treatment options provided from their oncologist, or the educational booklet in addition to usual information from their oncologist (42 usual information, 41 booklet). Fewer women who received the clinical trials booklet (40% versus 47%) would consider participating in the hypothetical clinical trial (P = 0.6). Mean knowledge scores increased for both groups; moreover, women who did not receive the booklet showed similar improvements to women who received the booklet [mean difference 0.09, 95% confidence interval (CI) -0.66 to 0.83]. In a multivariate analysis women who would consider participating in the clinical trial were more anxious [odds ratio (OR) 5.9, P = 0.02] had involved lymph nodes (OR 5.8, P = 0.02) and were less influenced by negative aspects of clinical trials (OR 7.7, P = 0.0001). After adjustment for these variables women who received the educational booklet were significantly less likely to consider trial participation (OR 0.22, P = 0.05).
Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs. Women appear to be more influenced by their perception of risk than understanding. This finding has ethical implications for communication of information about RCTs.
评估一本教育手册对女性乳腺癌治疗随机临床试验知识及参与意愿的影响。
对新诊断为早期乳腺癌且即将接受手术的女性进行随机分组，一组接受，另一组不接受一本解释随机试验必要性及开展方式的信息手册。
83例新诊断为早期乳腺癌的女性完成了一份评估对随机临床试验（RCT）态度的问卷，并被随机分配接受肿瘤学家提供的常规信息治疗选项，或除肿瘤学家提供的常规信息外还接受教育手册（42例接受常规信息，41例接受手册）。接受临床试验手册的女性中考虑参与假设临床试验的比例更低（40%对47%）（P = 0.6）。两组的平均知识得分均有所提高；此外，未接受手册的女性与接受手册的女性表现出相似的改善[平均差异0.09，95%置信区间（CI）-0.66至0.83]。在多变量分析中，考虑参与临床试验的女性更焦虑[比值比（OR）5.9，P = 0.02]、有淋巴结受累（OR 5.8，P = 0.02）且受临床试验负面因素的影响较小（OR 7.7，P = 0.0001）。在对这些变量进行调整后，接受教育手册的女性考虑参与试验的可能性显著降低（OR 0.22，P = 0.05）。
以这种方式对女性进行临床试验教育似乎对改善RCT的招募效果不佳。女性似乎更多地受到其对风险的认知而非理解的影响。这一发现对RCT信息的交流具有伦理意义。
