Guidelines in Hernia Surgery and Evidence Based Medicine (EBM)

Governments and health insurers increasingly demand transparent quality control mechanisms. A new type of reimbursement “pay for performance” is under discussion. Therefore, the development and implementation of guidelines constitutes an important step towards the introduction of optimal diagnostic and therapeutic concepts with the aim to improve the quality of treatment. Guidelines are not intended to restrict the individual medical decision-making process, but guidelines should define standards to help the surgeon in his daily work to find the best surgical strategy for his patient. According the Institute for Medicine (USA 1990) clinical practice guidelines are systematically developed statements (evidence based) to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. Guidelines should close the gap between science and clinical praxis (Eccles M, Mason J, HTA 2001; 5: 1-69) aiming a nationwide improvement of quality.

The Guidelines are essentially based on a medicine which relies heavily on statistical methods (Evidence-Based Medicine, EBM), but also allow to deal with “eminence”-based statements in a critical way. Already 200 years ago, P.Ch.A. Louis postulated:” Thus a therapeutic agent cannot be employed with any discrimination or probability of success in a given case, unless its general efficacy, in analogous cases, has been previously ascertained; therefore I conceive that without the aid of statistics nothing like real medicine is possible.” Opponents of EBM argue that, in view of the uniqueness of the patient, clinical studies are of little value. However, in spite of these criticisms, it is generally accepted today that classifications, rules, laws and scientific theories cannot be developed without identifying the common features of large patient populations or diseases; variety in itself warrants statistical methods. To answer specific questions in a particular case, the surgeon should be able to draw from pertinent, high-quality, well-documented biometric studies to choose the most appropriate therapy for his patient. However, as the studies often suffer from methodical flaws, esp. from the heterogeneity of data, it needs caution and deep clinical experience when applying results of EBM to an individual case, even if elaborate metaanalytic techniques have been developed to allow for a differential evaluation of the study results.

Authors of guidelines should be aware of these problems and conscious of the responsibility they undertake when describing the scientific state of the art in laparo-endoscopic hernia repair according to the best external evidence available and when making recommendations for the individual case.

In summary, the practice of EBM means integration of individual clinical expertise with the best available external evidence that could be achieved from systematic research (D. Sackett, BMJ 1996; 312: 71-72). Therefore, during the past years the development of guidelines based on the rules of EBM was at the focus of the activities of the International Endohernia Society (IEHS), ultimately with the aim of improving clinical routine in hernia surgery. (see publication)