Is it right to ignore learning‐curve patients? Laparoscopic colorectal trials

BACKGROUND: Increasingly complex, technically demanding surgical procedures utilizing emerging technologies have developed over recent decades and are recognized as having long 'learning curves'. This raises significant new issues. Ethically and scientifically, the outcome of a patient in the learning curve is as important as the outcome of a patient outside the learning curve. The aim of this study is to highlight just one aspect of our approach to learning-curve patients that should change. METHODS: The protocols of multicentre, prospective, randomized trials of patients undergoing either traditional open or laparoscopic surgery for colorectal cancer were reviewed. The number of patients excluded from the published trial results because they were in surgeons' learning curves was calculated. The seven editorials accompanying these publications were also examined for any mention of these patients. RESULTS: The eight studies identified had similar designs. All patients in the surgeons' laparoscopic learning curves, which were often several years long, were excluded from the actual trials. The total number of patients included in the trial publications was 5680. The number of patients excluded because they were in the surgeons' laparoscopic learning curves was >10 605. In none of the studies or accompanying editorials is there any mention of the total number of patients in the surgeons' learning curves, these patients' outcomes or how inclusion of their outcomes might have affected the overall results. CONCLUSION: Learning curves are inescapable in modern medicine. Our recognition of patients in these curves should evolve, with more data about them included in trial publications.