by Doug Devens - Sr Analyst, Biosurgery, IT Product Director
Changes in hernia regulations and evolving views on how to study the performance of hernia matrices have fueled a growing interest among hernia researchers in using different methods and data sources to measure outcomes associated with these devices. In this article, SmartTRAK highlights current and emerging trends in hernia outcomes research presented at the European Hernia Society – Americas Hernia Society Joint Congress (Hernia2021), in Copenhagen, including the increasing use of registries and their relative advantages and disadvantages compared to the gold standard randomized controlled trial (RCT).
The Pros and Cons of Current Research Methods
Registries have been defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure and that serves a predetermined scientific, clinical, or policy purpose(s).” Registries have been especially popular for tracking hernia outcomes for decades in Denmark, Sweden and Germany. Globally, hernia researchers are forming more outcome registries, following the success of the Northern European registries.
Another research mechanism, the RCT, is defined as a “study in which people are allocated at random (by chance alone) to receive one of several clinical interventions.” Because of their perceived ability to eliminate bias in results through randomization and careful controls, medical researchers have viewed RCTs as the ‘gold standard’ in medical research. However, researchers are beginning to realize weaknesses inherent to RCTs. At the Hernia2021 Congress in Copenhagen, Dr. William Hope discussed the disadvantages of RCTs, while enumerating some of the advantages of registries. Moreover, Dr. Thomas Pinkney, even as the appointed ‘proponent’ of RCTs within his talk, also conceded various disadvantages of RCTs. Among these is the question of ...
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