Page 204 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

Chapter 9
The external validity of a study is the main goal of scienti c research and exact description of the study parameters is thus important.
Several clinicians and researchers feel that for most clinical questions we have, we will never get answers from RCT’s and meta-analyses because the amount of variables is too large. Their frustration is that at this moment guidelines are focused mainly on this type of EBM research. Registers may be an important source of information for health care. In our particular eld of research, a population based register like the Danish Ventral Hernia Database or large surgical datasets of variables and outcomes like the Herniamed database and from the Würzburg Univesity, provides us with very interesting data(4, 29, 30). However, the statements resulting from the analysis of register data, even by sound scienti c multivariate statistical analysis, can be limited by various sources of bias. The selective inclusion of patients and their data may introduce selection bias. Some confounding variables may not be included in the dataset of the register and thus result in confounder bias. Nevertheless we think that in practice registers may be good to generate scienti c hypotheses and consider safety questions.
The EuraHS working group encourages researchers in abdominal wall surgery to use of the EuraHS platform to gather the data of their patients(1). The platform can be used for clinical studies like RCT’s and observational studies or for prospective registration of consecutive patients. The platform can be used individually, as an institutional registry, or in groups of participants (e.g. as national registry). Use of the platform will conform to the recommendation of using the consensus-based de nitions and classi cations of the EuraHS working group.
Knowledge of study design and statistical issues is of minimal interest to many surgeons. We think that a series of short statistical reviews related speci cally to abdominal wall surgery would be a good start to improve awareness of the importance of a sound statistical approach to hernia repair research. Moreover we would encourage the surgical societies to include courses on clinical research and statistical items in the program or in pre- congress courses during meetings of the societies.
202