School of Nursing, and Center for Bioethics and NewCourtlandCenter for Transitions and Health, University of Pennsylvania, Philadelphia, Pennsylvania 19106, United States.
Contemp Clin Trials. 2012 Jan;33(1):76-84. doi: 10.1016/j.cct.2011.09.005. Epub 2011 Sep 29.
Recruitment and retention of human participants in cancer clinical trials remains challenging for all investigators. Nurse Practitioners (NPs) are in a prime position to discuss, educate and refer patients to clinical trials as many NPs work in ethnically and geographically diverse primary care settings in the U.S., yet they remain an untapped resource. We examined NPs' general attitudes toward cancer clinical trial recommendations and assessed their willingness to recommend such trials
We randomly surveyed 455 primary care NPs in the state of Pennsylvania during 2008 with an adjusted response rate of 55.3%. Descriptive statistics were used to characterize NPs' demographic and practice characteristics, and logistic regression was used to assess the relative influence of the various attitudes and beliefs on the likelihood that the NP would bring up clinical trials as a treatment option.
NPs were more likely to bring up the topic of clinical trials with at least some patients if they were comfortable discussing treatment options with their cancer patients (OR=4.29, p=0.001), were comfortable discussing options of entering a clinical trial for treatment (OR=3.54, p=0.003), had adequate time during patients' visit to explain clinical trials (OR=3.40, p=0.008), and if they believed that patients in clinical trials were receiving the best medical treatment (OR=3.34, p=0.019). NPs who were comfortable discussing cancer clinical trials were almost 5 times more likely to think clinical trials were useful (OR=4.70; 95% CI=1.81-12.19; p=0.001). Nearly three-quarters (72.6%) of the entire responder sample reported three or more ethical concerns associated with clinical trials, including issues of randomization, informed consent, and patient burden.
NPs are willing to recommend clinical trials but need more education about the benefits and burdens of clinical trials, the associated ethical concerns, and evidence regarding the translatability of research to clinical practice to increase their knowledge and comfort level with discussing clinical trials.
对于所有研究者来说，招募和保留癌症临床试验的参与者仍然具有挑战性。护士从业者 (NPs) 处于讨论、教育和向临床试验转介患者的最佳位置，因为许多 NPs 在美国的种族和地理上多样化的初级保健环境中工作，但他们仍然是未被充分利用的资源。我们考察了 NPs 对癌症临床试验建议的总体态度，并评估了他们推荐此类试验的意愿。
我们在 2008 年期间随机调查了宾夕法尼亚州的 455 名初级保健 NPs，调整后的回应率为 55.3%。使用描述性统计来描述 NPs 的人口统计学和实践特征，并使用逻辑回归来评估各种态度和信念对 NPs 提出临床试验作为治疗选择的可能性的相对影响。
如果 NPs 与至少一些患者讨论癌症患者的治疗选择时感到舒适（OR=4.29，p=0.001），讨论参加临床试验治疗的选择时感到舒适（OR=3.54，p=0.003），在患者就诊期间有足够的时间解释临床试验（OR=3.40，p=0.008），并且他们相信参加临床试验的患者正在接受最佳医疗（OR=3.34，p=0.019），那么他们更有可能与至少一些患者讨论临床试验的话题。认为临床试验有用的 NPs 中，有近五分之四（OR=4.70；95%CI=1.81-12.19；p=0.001）认为临床试验有用。整个应答者样本中有近四分之三（72.6%）报告了与临床试验相关的三个或更多伦理问题，包括随机化、知情同意和患者负担问题。
NPs 愿意推荐临床试验，但需要更多关于临床试验的益处和负担、相关伦理问题以及研究向临床实践转化的证据的教育，以提高他们对讨论临床试验的了解和舒适度。
