Is Surgical Literature Relevant?

S is a key element in the treatment of gynecological cancers. In contrast, screamingly little evidence is available in the literature to support surgical management for the most common of our cancers. In this issue of International Journal of Gynecological Cancer, two articles review the evidence supporting current practice in regards to tumor board review of gynecological cancer cases and in regards to followup of patients with gynecological cancer. In 1994, Lancet editor R Horton examined general surgical journals and found that only 7% of articles reported data from an RCT. I went through all issues of the IJGC in 2009 and found a total of 260 original research articles. Of those, 166 articles (63%) were case series, followed by in vitro/ animal laboratory studies (n = 45, 17%) and 22 articles (8.4%) each on case reports and nonrandomized trials. From the 22 reports on nonrandomized clinical trials, only 3 were on surgical technique. Finally, this journal published 5 RCTs (1.9%). Of these 5 RCTs, 1 (0.3%) was a surgical article reporting the results of a feasibility pilot in the prevention of lower limb lymphedema of a total of 14 patients with vulval cancer. The other 4 RCTs were on chemotherapy, vaginal vault brachytherapy, a human papillomavirus vaccine, and acupuncture. The situation in Gynecologic Oncology was similar. From 343 original research articles published in 2009, 9 articles (2.6%) presented the results of RCTs, of which only 3 articles (0.9%) were surgical. Whereas everyone would agree that surgical technique is difficult to quantify and that surgical RCTs are far from perfect and vulnerable to bias, they are still most appropriate to evaluate health outcomes. Case series are suitable for hypothesis generation, audit and quality control, and stimulating debate about unexpected outcomes. Undisputedly, case series are invalid to draw conclusions about treatment efficacy. In that case, is it not remarkable that we still rely on case series for our surgical decision making? Surgical trials are costly and enormously time consuming, which is no different frommedical trials investigating new medication. I can see 3 strategies to emphasize the importance of and support surgical trials. Firstly, our own attitude toward new surgical techniques and medical devices deserves critical appraisal. An attractive new device is too often carried forward by our fun to play with new Btoys[ and corporate marketing rather than science. Robotic surgery requires surgeons to complete a couple of animal laboratory studies, and they are Baccredited[ and ready to go. This attitude will produce law suits, such as the one publicly discussed in the Wall Street Journal. Instead, gynecological surgeons should attempt putting as many patients as possible on clinical trials. Surgery, as part of a clinical trial, will give patients and administrators safe backing. The main driver of drug trials is the pharmaceutical industry. A new chemotherapy agent will need to demonstrate superiority over the current standard regimen to qualify for reimbursement. In contrast, devices only have to demonstrate safety but not efficacy. Governments should consider efficacy testing not only of medication but also of medical devices. Support systems for surgical clinical trials are sparse. The pharmaceutical industry drives most medical trials, providing funds, skills, expertise, and infrastructure. It is estimated that in the United States of America, $32 billion will be spent this year on clinical trials. Surgical clinical trials are driven by enthusiasts, self-taught individual surgeons. They apply for competitive grant money through government agencies, which may take years to get granted and establish the required infrastructure on a shoe string budget. I estimate that less than 5% of the aforementioned amount will go into surgical trials. I would like to see health administrations and manufacturers to provide support for surgical clinical trials. Over the recent years, it has become a lot harder to publish case series, and I predict that this trend will increase even more so. As standards of research papers increase, case series submitted to the IJGC need to be meaningful and should demonstrate how they are the stepping stone for clinical trials. If we wish to optimize our patients’ outcomes, we will need to embrace clinical trials on diagnosis, staging, treatment, and follow-up more than ever so.