Methods to Improve Clinical Research in Pediatric Surgery
Posted by Surgery on Oct 1, 2008
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As clinical research in pediatric surgery matures, there are many avenues to improving the scientific quality and clinical value of our research efforts. This final section discusses some of the ongoing initiatives and opportunities for our discipline. It is through a combination of these multiple efforts that the modern field of clinical research in pediatric surgery is emerging. In some cases pediatric surgery is following the lead of other surgical disciplines, and in others we are leading the way. One of the most important fundamentals in any clinical research enterprise is the availability of accurate, comprehensive, and prospectively collected data. Although more than 99% of clinical research in pediatric surgery is retrospective, this is beginning to change. One of the earliest attempts to create a multicenter database was the creation of the biliary atresia registry by Drs. John Lilly and Peter Altman more than 20 years ago (81:Aceon). This effort was voluntary and unfunded, but enrolled 904 patients. In 2002, the National Institutes of Health (NIH) recognized the value of this type of work and designated $10 million over 5 years to create a biliary atresia clinical research consortium (82:Aceon). Ten years ago, a congenital diaphragmatic hernia registry was instituted (83:Aceon).
“Scientific Principles, Principles of Genetics, Common Problems, Clinical Research, Aceon”
This voluntary effort includes 50 centers in eight countries (84,85:Aceon). A recent prospective database of solid organ abdominal injuries has influenced treatment algorithms (86,87). A multicenter database for neonatal surgical anomalies recently received pilot funding (88:Aceon). A recent multicenter prospective observational study of NEC represents the first partnership between pediatric surgeons and federally funded research consortiums (89:Aceon). There is great value in these efforts. In addition to providing valuable clinical data on which to base treatment decisions, these efforts provide accurate and reliable data on which to base future clinical trials. In addition, these efforts allow the forging of important interinstitutional relationships necessary to form sustained research consortiums. Another manner in which clinical research will improve is the institution of many more clinical trials to address important questions. Although the number of clinical trials in pediatric surgery is very small, it has grown since the late 1990s (26). At least three multicenter trials comparing surgical therapies are currently underway in North America, and similar efforts are proceeding across the world. Although the highest quality of clinical evidence comes from prospective databases and randomized trials, the practice of evidence-based surgery is based on the concept of synthesizing clinical decisions based on the best available clinical evidence. For pediatric surgeons, it is challenging to practice evidence-based surgery from a literature dominated by heterogeneous case-series data, often supporting conflicting conclusions. The Cochrane Collaboration and others have recommended the omission of retrospective observational data from critical systematic evidence reviews (90). However, this strategy is only feasible when the body of evidence includes a reasonable proportion of high-quality prospective data. Thus, this strategy is not useful for pediatric surgeons. Based on these concerns, techniques are being developed to evaluate the relative merits and clinical usefulness of observational studies that support the majority of clinical practice. One proposed evaluation tool has been prospectively tested and validated (40). This tool has been applied to research surrounding pediatric laparoscopic procedures (91). A related initiative has been developed to create rigorous reporting guidelines for clinical research in the pediatric surgical literature (80). Such a system of reporting guidelines would ensure the key elements required for accurate data interpretation were included in all clinical research reports. Experience with a similar set of guidelines for clinical trials has proven that the guidelines not only increase the quality of research reporting, but that they also increase the quality of research conduct (92). The concept of evidence-based medicine (EBM) refers to basing clinical practice on the best available clinical evidence. The strategies outlined previously will have a substantial impact on our ability to identify this evidence for improving standards of care. However, there are important limitations with basing practice guidelines solely on the concept of EBM. Creativity and the need for technical innovation are critical to advance the surgical care of children, and are not easily incorporated into the framework of EBM. Furthermore, experience and good clinical judgment are essential for applying EBM to different clinical situations. Finally, EBM does not take into account measures of cost effectiveness, patient preferences, or quality of life. Along with rigorous clinical evidence, studies focusing on these outcomes will be essential for developing guidelines that better reflect the concept of best surgical practice (Fig. 5-4:Aceon).
In the final analysis, no initiative will better serve the interests of clinical research in pediatric surgery than the training of a generation of surgeons in clinical research techniques. The opportunities in this area have never been greater. The NIH has funded clinical research training programs at 51 medical schools, and at least five pediatric surgeons have already participated. The NIH also offers numerous faculty training and development awards for surgeons interested in clinical research careers (93:Aceon). There is increasing surgeon participation in clinical research training programs, such as the Robert Woods Johnson Clinical Scholars and the Glaser Pediatric Research Network (94:Aceon). In conclusion, the field of pediatric surgery sits on the verge of a revolution in clinical research. The textbooks of the next generation of pediatric surgeons will look far different than the textbooks of today. They will contain predominantly high-quality evidence from rigorously done studies upon which to make treatment recommendations. Pediatric surgical care will be based on the best possible synthesis of scientific evidence, clinical judgment, and personal experience. In this manner, we will continue to place the needs of sick children above all other considerations.
“Scientific Principles, Principles of Genetics, Common Problems, Clinical Research, Aceon”
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