Kurt Anita, Kincaid Hope M, Curtis Charity, Semler Lauren, Meyers Matthew, Johnson Melanie, Careyva Beth A, Stello Brian, Friel Timothy J, Knouse Mark C, Smulian John C, Jacoby Jeanne L
Lehigh Valley Health Network, Department of Emergency Medicine Research, Allentown, Pennsylvania.
Lehigh Valley Health Network, Network Office of Research and Innovation, Allentown, Pennsylvania.
West J Emerg Med. 2017 Aug;18(5):846-855. doi: 10.5811/westjem.2017.5.33827. Epub 2017 Jul 17.
This study investigated factors that influence emergency medicine (EM) patients' decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties.
A survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants' responses.
A total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient's gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285-2.389}], ID [OR:3.281, 95% CI{2.293-4.695}], and OB/GYN [OR:2.408, 95% CI{1.741-3.330}]). EM's rankings of "how well the research was explained" and whether "the knowledge learned would benefit others" as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated "risk of unknown side effects" as their strongest barrier. Regardless of the patients' race, "time commitment" was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218-2.136}], ID [OR:1.340, 95% CI{1.006-1.784}], or OB/GYN [OR:1.901, 95% CI{1.431-2.526}]). Among the six resources assessed that help patients decide whether to participate in a clinical trial, only one scored statistically significantly different for EM (p<0.001). EM patients ranked "having all material provided in my own language" as the most helpful resource.
There are significant differences between EM patients and those of other specialties in the factors that influence their participation in clinical trials. Providing material in the patient's own language, explaining the study well, and elucidating how their participation might benefit others in the future may help to improve enrollment in EM-based clinical trials.
本研究调查了影响急诊医学（EM）患者参与临床试验决策的因素，以及这些因素的影响是否与其他医学专科不同。
在急诊医学、家庭医学（FM）、传染病（ID）和妇产科（OB/GYN）门诊候诊区进行了一项调查。纳入标准包括年龄在18岁及以上、调查当天的现患患者以及能够在无协助的情况下完成调查的患者。我们使用Kruskal-Wallis检验和有序逻辑回归分析来确定参与者回答的差异。
共接触了2893名符合条件的受试者，最终分析纳入了1841份调查问卷。在十个激励因素中的八个方面，发现急诊医学与其他一个或多个专科之间存在统计学显著差异（p≤0.009）。无论患者的性别、种族和教育程度如何，与医生的关系对其他专科的患者比急诊医学患者更具激励作用（家庭医学[优势比{OR}：1.752，95%置信区间{CI}{1.285 - 2.389}]，传染病[OR：3.281，95% CI{2.293 - 4.695}]，妇产科[OR：2.408，95% CI{1.741 - 3.330}]）。急诊医学将“研究解释得有多好”以及“所学知识是否会使他人受益”列为前两大激励因素，这在其他专科中类似。所有九个障碍在急诊医学与其他一个或多个专科之间均显示出统计学显著差异（p≤0.008）。所有专科的参与者都将“未知副作用风险”列为最主要的障碍。无论患者的种族如何，与急诊医学相比，“时间投入”被认为对其他专科是更大的障碍（家庭医学[OR：1.613，95% CI{1.218 - 2.136}]，传染病[OR：1.340，95% CI{1.006 - 1.784}]，或妇产科[OR：1.901，95% CI{1.431 - 2.526}]）。在评估的六项有助于患者决定是否参与临床试验的资源中，只有一项在急诊医学方面得分有统计学显著差异（p<0.001）。急诊医学患者将“以我自己的语言提供所有资料”列为最有帮助的资源。
急诊医学患者与其他专科患者在影响其参与临床试验的因素方面存在显著差异。以患者自己的语言提供资料、很好地解释研究以及阐明他们的参与在未来可能如何使他人受益，可能有助于提高基于急诊医学的临床试验的入组率。
