Factors Associated with Clinical Research Recruitment in a Pediatric Academic Medical Center--A Web-Based Survey.
Factors Associated with Clinical Research Recruitment in a Pediatric Academic Medical Center--A Web-Based Survey.
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DOI：
10.1371/journal.pone.0140768
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发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Osganian SK
中科院分区：
文献类型：
--
作者：
Denhoff ER;Milliren CE;de Ferranti SD;Steltz SK;Osganian SK
进行临床研究最困难的方面之一是成功招募参与者的能力。儿科临床研究提出了独特的招聘挑战，涉及到需要父母同意代表未成年人，儿童同意，和学校出勤率。然而，这方面的研究却很少。我们对在一家大型学术儿科医院进行人体受试者研究的研究者进行了调查，以更好地了解成功招募的研究的特点。我们于2011年9月至2011年12月对波士顿儿童医院（一个儿科学术医学中心）的所有主要研究人员进行了一项基于网络的调查，调查人员遵循机构审查委员会批准的人类受试者协议。该调查捕获了研究方案的各种特征，包括研究设计、人员配备、资源、调查员经验和培训，以及受访者认为的招聘障碍和促进因素。我们使用卡方检验和Mantel-Haenszel线性趋势检验来检验所选预测变量与招募成功与不成功的二元结果之间的关系，并使用多变量逻辑回归分析来检验潜在预测变量对每个结果的同时影响。在349名符合条件的调查人员中，52%的人回应了调查，181名有效数据被纳入分析。在87个停止招募的方案中，有三分之二达到了目标人数的80%或更多，而在94个积极招募的方案中，只有三分之一达到了目标人数的80%。在封闭入组方案中，招募方法似乎是与达到80%或更多目标入组相关的唯一重要和独立因素。与使用其他招募方法相比，使用亲自招募的接近招募方案的患者达到80%或更多目标入学率的可能性高出4.55倍（95% CI 1.30至15.93;p = 0.02）。其他潜在可修改的因素，如研究访问次数、研究持续时间和研究者经验，都暗示着与招募有意义的关系。亲自招募可以促进在儿科和成人临床研究中达到可接受的目标招生。未来的研究需要更大、更多样化的样本，以更好地了解进行招募的个人的特征和资格如何影响参与者的招募，以及如何最好地接触患者和家属，让他们参与。
One of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment. We conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children’s Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents’ perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome. Among the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment. Recruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.