Duffett Mark, Choong Karen, Foster Jennifer, Meade Maureen, Menon Kusum, Parker Melissa, Cook Deborah J
1Departments of Pediatrics, McMaster University, Hamilton, ON, Canada. 2Departments of Pediatrics and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 3Department of Pediatrics, Dalhousie University, Halifax, NS, Canada. 4Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 5Departments of Pediatrics and Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada.
Pediatr Crit Care Med. 2017 May;18(5):405-413. doi: 10.1097/PCC.0000000000001144.
High-quality, adequately powered, randomized controlled trials are needed to inform the care of critically ill children. Unfortunately, such evidence is not always available. Our objective was to identify barriers and facilitators of conducting high-quality randomized controlled trials in pediatric critical care, from the perspective of trialists in this field.
Self-administered online survey. Respondents rated the importance of barriers and effectiveness of facilitators on seven-point scales.
Authors of 294 pediatric critical care randomized controlled trials (published 1986 to June 2015).
One hundred sixteen researchers from 25 countries participated.
None.
Respondents reported a median (Q1, Q3) of 21 years (15, 26 yr) of experience and 41 (36%) had authored more than one randomized controlled trial. More survey respondents, compared with nonrespondents, had published more than one trial (35% vs 26%; p = 0.002) and their trials were more often cited (median citations/yr, 2.4 vs 1.5; p < 0.001). Of the barriers listed, the five most important were primarily related to lack of funding. The five facilitators perceived as most effective were protected time for research, ability to recruit participants 24 hours per day/7 days per week, conducting randomized controlled trials in collaboration with a research network, funding from government agencies specifically for randomized controlled trials in critically ill children, and academic department support for conducting randomized controlled trials. Respondent experience and country income level were associated with differences in importance ratings for eight of 41 barriers. There were fewer such differences for facilitators.
Lack of funding and time are major barriers to conducting pediatric critical care randomized controlled trials worldwide. Although barriers varied among country income levels, the facilitators of such trials were more consistent. In addition to increased funding, respondents identified other strategies such as research networks that are within the purview of the pediatric critical care research community, to facilitate the conduct of rigorous randomized controlled trials.
需要高质量、有足够样本量的随机对照试验来指导危重症儿童的护理。遗憾的是，此类证据并非总能获取。我们的目标是从该领域试验研究者的角度，确定在儿科重症监护中开展高质量随机对照试验的障碍和促进因素。
自行管理的在线调查。受访者在七点量表上对障碍的重要性和促进因素的有效性进行评分。
294项儿科重症监护随机对照试验的作者（发表时间为1986年至2015年6月）。
来自25个国家的116名研究人员参与。
无。
受访者报告的中位（四分位间距）经验为21年（15年，26年），41人（36%）撰写过不止一项随机对照试验。与未回复者相比，更多参与调查的受访者发表过不止一项试验（35%对26%；p = 0.002），且他们的试验被引用的频率更高（每年中位被引用次数，2.4对1.5；p < 0.001）。在所列出的障碍中，最重要的五项主要与资金短缺有关。被认为最有效的五项促进因素是有受保护的研究时间、每周7天每天24小时招募参与者的能力、与研究网络合作开展随机对照试验、政府机构专门为危重症儿童随机对照试验提供资金，以及学术部门对开展随机对照试验的支持。受访者的经验和国家收入水平与41项障碍中8项的重要性评分差异有关。促进因素方面的此类差异较少。
资金和时间短缺是全球开展儿科重症监护随机对照试验的主要障碍。尽管不同国家收入水平的障碍有所不同，但此类试验的促进因素更为一致。除了增加资金外，受访者还确定了其他策略，如儿科重症监护研究界范围内的研究网络，以促进开展严格的随机对照试验。
