486 www.pccmjournal.org May 2017 • Volume 18 • Number 5 Information on the amount of high quality of evidence supporting interventions in Pediatric Critical Care Medicine (PCCM) is readily available.… Click to show full abstract
486 www.pccmjournal.org May 2017 • Volume 18 • Number 5 Information on the amount of high quality of evidence supporting interventions in Pediatric Critical Care Medicine (PCCM) is readily available. Duffett et al (1) at McMaster University went to considerable effort to maintain a database of all randomized controlled trials (RCTs) ever published in the field. Available at PICUtrials.net, the database is searchable by intervention, indication, population, and country. After their October 2016 update, they identified 338 RCTs published between 1986 and 2016 from enrollments in 38 countries (picutrials.net, accessed February 19, 2017). Their website shows a network diagram of trial size and coauthorship with clusters of interconnected researchers in the field. Although the number of large trials is small, it visually appears that about one-third of the investigators coauthored multiple trials. Their current study (2) surveyed published trialists, asking their opinions on barriers and facilitators to conduct RCTs in PCCM. The responding 125 PCCM trialists from 16 countries identified the five most important barriers impeding RCTs as: “We need more money!” (2) This was somewhat surprising. What about the purported lack of eligible patients, not enough trained investigators, parental unwillingness to participate, or competing studies? These were not listed by PCCM trialists as very important. What could facilitate more RCTs in this field? Notably, lacking in the responses was promotion of alternate statistical or study designs such as Bayesian (3) or pragmatic (4) approaches, aimed in part at improving statistical power. Lack of clinically important nonmortality outcome measures was also not a major barrier. Survey respondents identified protected time for research for investigators, the ability to recruit participants 24 hours a day 7 days per week, participating in a research network, government funding for PCCM research networks, and academic support for conducting RCTs (2). Those surveyed clearly understood that to enroll sufficient critically ill children to answer a question requires participation of numerous PICUs (5, 6). Unfortunately, there are no clear funding mechanisms to support the infrastructure of large, national, and multinational research networks. Currently, at least three different types of PCCM network models exist with pros and cons for each. The U.S. National Institutes of Health supports the Collaborative Pediatric Critical Care Research Network (www.CPCCRN.org), paying for an independent data coordinating center, and a fraction of a principal investigator salary and most of a research nurse salary at seven sites chosen by a grant review panel. This model optimizes rigor, but the expense is high, severely limiting site numbers and therefore eligible patients. The Pediatric Acute Lung Injury and Sepsis Investigator’s Network (www.palisi.org, with over 80 institutions) and the Canadian Critical Care Trials Group pediatric subgroup (www.CCCTG.ca) have a more open site membership approach. Member dues support the meeting costs and a part-time network coordinator, but network leaders must volunteer their time. The Pediatric Intensive Care Audit Network (www.picanet.org.uk) is funded by the National Health Service in the United Kingdom and Ireland to perform quality assessments across over 30 PICUs. Although not a trials network per se, a recent pragmatic trial capitalized on their infrastructure, employing it to collect part of the data required for the trial (7). International network funding mechanisms are even more challenging because taxpayers like to support initiatives closer to home; however, a network of networks approach has worked to fund individual critical care trials for adult patients across multiple countries (8). A major strength of this survey (2) is that most of responding researchers had extensive experience in completing and publishing trials in PCCM. These zealous individuals overcame seeming insurmountable odds to enroll and randomize children into comparative groups. Their wisdom and experience have culminated in a clear message that RCTs are feasible, necessary, and they are poised to conduct them. They need their colleagues and institutions to support their research and to create a culture that values and prioritizes it (2). They need the PCCM-related societies to advocate for national funding streams to support trial network infrastructure. A more efficient Institutional Review Board process is needed to facilitate *See also p. 405.
               
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