The Problem of Guidelines in Modern Medicine

When the Scottish physician George Fordyce, presented his 1793 seminal work "An attempt to improve the Evidence of Medicine", he certainly could not have guessed in the least, in what direction or extent, the use of the terms “evidential” and “medical” would evolve. Ever since, there have been numerous attempts to bring more science into the discipline of medicine. The basis for the modern concept of "evidence based medicine" was put forward by British epidemiologist Professor Archie Cochrane with his 1972 publication: "Effectiveness and Efficiency: Random Reflections on Health Services", based on his work in epidemiology and controlled trials. An increasing trend has developed acceptance of these criteria in clinical research. Rightly, an international network for evaluating efficacy in medicine was named after him - the Cochrane Collaboration. Until then, efforts had been focused on translating and using statistical methods to increase understanding of study methodology for the benefit of patients.

In the early 1990s, the concept of a randomized study literally evolved into a holy grail in medicine and thus, surgery. This advancement would rightly be crowned by appropriate meta-analyses. Critical aspects, in particular with regard to the lack of publication of negative results and industry sponsorship, were successfully moderated time and again. In a separate publication on the importance of clinical observational studies from 2002, the working group around Gastinger, Lippert and Koch had already pointed out the problems of randomized studies in surgery.

Correctly performed RCS are of high quality and require a lot of effort as a price for data quality. As a rule, RCS are planned with a "primary outcome criterium" and statistically calculated. This leads to few but well-tested results. For example, while a protocol can be traced at any time in pharmacological studies where pharmacodynamic parameters can be measured, the situation in surgery is much more complex while the implementation and in particular the reproducibility of the results obtained in randomized trials is more difficult. Different surgical methods/techniques are rarely used in parallel in different departments or centres. Furthermore, the individual surgeon represents a variable prognostic factor that is not negligible but difficult to measure (Surgeon 2002). We already pointed out in this work that due to the problems of randomized studies in surgery, especially in this field of research, alternative methods should be considered, especially with the focus on health services research. It took another 10 years for the acceptance of such nationwide prospective observational studies to improve.

Along with the dissemination of evidence based medicine as a basis for medical decisions, we have begun to see the development of guidelines based on this progress. The new findings, as systematically developed, would support the decision-making processes in everyday clinical practice. Within that same time period, however, the decade saw the highest increase in innovations in medicine and is is now on the wane.

The 1990s and 2000s saw an exponential rise in innovations, growing influence of the industry with ever-increasing marketing strategies. Medical  research and professional development were barely able to keep pace with this hurried pace. Studies are becoming increasingly funded by industry, and professors are appointed or assessed according to the amount of third-party funds raised. This resulted in a medical industrial complex, which developed a barely controllable momentum. The resulting key opinion leaders are then also found in expert groups, which are responsible for drawing up guidelines.

A critical independent and influential analysis by guidelinewatch.de (www.leitlinenwatch.de) underlined that only 11% of 165 Guidelines in Medicine were rated as “good” with enough transparency and without conflicts of interests.

There is increasing evidence in the current literature for the lack of documentation of conflicts of interest and the associated critical evaluation of study results, while industrial sponsorship leads to an overvaluation of benefits. In a comprehensive analysis of the surgical literature, the research group around Probst and Büchler pointed out that industrial sponsorship is an independent risk factor when associated with positive reviews. Guidelines also play an important role in decision-making in a "modern" medicine, which is increasingly characterized by flat hierarchies and responsibility delegation. One might think that the existence of a guideline replaces the reflection of the individual with his personal wishes for a therapy. Guidelines that are not developed under the supervision of independent institutions such as the AWMF (Association of the Scientific Medical Societies in Germany) should be no more than a recommendation from an expert group, at best but still subject to individual expertise and experience.

Technocratization, the delegation of responsibilities and therapy according to a scheme determined by others, are increasingly replacing what constitutes medicine in the true sense: empathy, caring, patient orientation, the search for the individual therapy tailored to the patient. Evidence-based medicine and guidelines can be helpful, provided that they are free of external interests, influences and manipulation and this is currently not the case.  These are the shortcomings of the 2018 EHS-Hernia Surge guidelines and the reason for which they have not been readily accepted by many segments of our profession! They would have exposed our everyday clinical practice to the danger of becoming a tool for introducing new therapies and methods. This was emphasized by the reflections of an acknowledged marketing expert and professor in his personal correspondence with Robert Bendavid.

EVERT  GUMMESSON
EMERITUS PROFESSOR
STOCKHOLM UNIVERSITY, SWEDEN
MAY 4, 2017

COMMENTS TO THE HERNIA MEMO ON THE "WORLD GUIDELINES"
Today evidence-based medicine has appointed itself to be the gold standard of science. It is nothing of the kind. Having been in marketing and management all my life I sense when marketing thinking takes over. It may well be that evidence-based and life science are labels that have been invented by PR-people and lobbyists and are used to impress ignorant people, i.e. fool them. I have just finished a book called "Case Theory in Business and Management" (SAGE, UK, 350 pp.) to be published on May 27, 2017. The book took 7 years to write and one of its conclusions is that quant studies with lots of statistics are inferior to case studies in learning about the real world.

 

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