Department of Statistics and Probability, College of Natural Science, Michigan State University, East Lansing, MI 48824, USA.
Evid Based Complement Alternat Med. 2011;2011:734517. doi: 10.1093/ecam/nep051. Epub 2011 Feb 14.
More than 80% of women with breast cancer are now reported to be using complementary and alternative medicine (CAM) therapies during conventional treatment. A randomized clinical trial (RCT) of reflexology with late stage breast cancer patients serves as the data source for this article. The purposes were to investigate: (i) reasons for refusal to participate in a RCT of reflexology; (ii) the differences between those who completed the baseline interview and those who dropped out before baseline; and (iii) the utility of the Palliative Prognostic Score (PPS) as a prognostic screening tool in minimizing early attrition (before baseline) from the trial. Eligible women (N = 400) approached at 12 cancer centers in the Midwest had advanced breast cancer, were on chemotherapy or hormonal therapy, and had a PPS of 11 or less. Comparisons of those who dropped out early (N = 33) to those who stayed in the trial (N = 240) were carried out using Wilcoxon rank, t-, chi-squared and Fisher's exact tests. The reasons of being "too sick" or "overwhelmed" were given by less than 12% of the women who refused to participate. There was a higher early dropout rate among black women compared to other (primarily white) women (P = .01). Cancer recurrence and metastasis, age, and the PPS were not predictive of early retention of women. Specialized techniques may be needed to ensure black women remain in the trial once consented. Women with advanced disease were likely to enter and remain in the trial despite deterioration in health.
超过 80%的乳腺癌女性在接受常规治疗的同时还会选择使用补充和替代医学（CAM）疗法。本文的数据来源于一项针对晚期乳腺癌患者进行反射疗法的随机临床试验（RCT）。研究目的在于：（i）调查拒绝参与反射疗法 RCT 的原因；（ii）完成基线访谈和在基线前退出的患者之间的差异；以及（iii）姑息预后评分（PPS）作为最小化试验早期退出（基线前）的预后筛选工具的效用。在中西部的 12 家癌症中心招募的符合条件的女性（N = 400）患有晚期乳腺癌，正在接受化疗或激素治疗，且 PPS 得分为 11 或更低。使用 Wilcoxon 秩和检验、t 检验、卡方检验和 Fisher 精确检验对早期退出（N = 33）的患者和留在试验中的患者（N = 240）进行了比较。不到 12%的拒绝参与的女性表示“病得太重”或“不堪重负”。与其他（主要为白人）女性相比，黑人女性的早期退出率更高（P =.01）。癌症复发和转移、年龄以及 PPS 均不能预测女性的早期保留率。一旦同意参与，可能需要特殊技术来确保黑人女性留在试验中。尽管健康状况恶化，晚期疾病女性仍有可能进入并留在试验中。
