Scientific evidence and guidelines in occupational medicine
Since early times, the relationship between science and philosophy has been one of correspondence, sometimes of opposition and even clear separation. During the time of the Athenian School, represented by philosophers such as Socrates (Athens, 470 BC - 399 BC), Plato (Athens, 428 BC - 348 BC) and Aristotle (Stagira, 384 BC - 322 BC), there was a symbiotic bond between the two and philosophy, as metaphysics and theology, was considered science. In fact, the goal of both was to achieve a truth relating to universal values — to the true, to the just and to the good — whose essence, according to Plato, was nothing more than the tool to do good for the community. He attributed to Democritus (Abdera, 460 BC - 370 BC), the one who took up the idea of Anaximander (Miletus, 610 BC - 546 BC) for which men would evolve from marine animals through a series of transformations and who also postulated the theory that at the basis of the system of nature was the atom, the “merit” of having first freed scientific thought from finalism, replacing the typical Aristotelian question “What is the purpose of phenomena?” followed by “For what cause do the phenomena occur?”. The Romans mostly confined themselves to repeating and exposing concepts from previous eras. Neoplatonic syncretism and pseudoscientific attitudes continually favored the development of astrology and alchemy, impoverished scientific thoughts and increased symbolism and mysticism. Until the Middle Ages, the scientific study had been purely Aristotelian and qualitative: there was no attempt to quantify natural phenomena so as to experiment and to understand the laws that govern nature. Instead, attempts were made to describe the various aspects of the world and to reconcile them with the dominant Christian culture in order to see them as aspects of the presence of God on earth. During the advent of Renaissance, when science, as a collection of knowledge drawn from experience and evidence, begins to investigate the field of nature using mathematical tools and an experimental mathematical method instead of the mathematical-deductive one of the classical age according to which it was instead possible to reach the essence of the reality investigated through an intellectual intuition, we witnessed the birth of science as a “detachment” from philosophy. The “scientific revolution” was a particularly fertile phase for the development of science. Up to the Renaissance, the medical point of view had been dominated by Galen’s thought until, in 1543, Vesalius (Brussels, 1514-1564) published “De humani corporis fabrica,” which revolutionized the anatomical vision of the body. In 1543, Nicolò Copernico (Toruń, 1473 - 1543) published “The revolutions of the celestial stars” (De revolutionibus orbium coelestium, also known as the Copernican revolution). With Galileo Galilei (Pisa, 1564 - 1642), the scientific method was born. In 1643, he published “Dialogue over the two greatest systems of the world.” The phrase “Measure what is measurable, and make measurable what is not” represents better than any other the methodology proposed by Galileo. Other scientists helped to make this period fruitful, such as Isaac Newton (Woolsthorpe-by-Colsterworth, 1642-1726) who in 1687 published “The mathematical principles of natural philosophy.” From the second half of the 18th century, the opinion that the recording of facts has a preponderant value over that of ideas came to prevail in the scientific community. In this century, the liberation from many metaphysical convictions is advancing and health begins to be recognized as an important value, which power must deal with, also in consideration with the social and economic failures resulting from epidemics and contagious and endemic diseases. Among those who attempted to re-establish medicine as a science having equal dignity with others, we remember Bernardino Ramazzini (Carpi, 1633 - 1714), who wrote the “De Morbis Artificum Diatriba” and who is also considered as the “Father” of occupational medicine. Through the publication of the “Introduction à l’étude de la médecine expérimentale” in 1866, Claude Bernard (Villefranche-sur-Saône, 1813 - 1878) tried to adopt the experimental method in medicine. The emergence of the human and social sciences from the late 1800s until the 1900s called into question this unique model of the scientific method and Karl Popper (Vienna, 1902-1994) was its main interpreter.   It has been remarked on several occasions how bizarrely and precisely, in the century in which science and medicine allow an improvement never seen before in the conditions of life and well-being (at least in the so-called “western world”), it is still present and is spreading an “anti-science” that feeds on prejudices, gossip, fanaticism and political exploitation rather than rational logic and scientific evidence. In the age of the Internet, the availability of communication technology and social media, such as YouTube, Facebook and Twitter, have made it easier for people, famous or otherwise, to spread misinformation and attract others to their anti-scientific theories on the most diverse topics (Astrology, Chemtrails, Anti-cancer therapies, Homeopathy, contrast to vaccines), but shortcomings of scientific references are mostly found in the judicial field. Of course, it is not easy to distinguish what can be defined as “scientific” from pseudosciences, philosophy, superstitions or religions. The problem is not to distinguish between what is true and what is false but to have criteria, methods, etc., to define what must be and must not be accepted as, at the moment, definable scientific evidence. The experimental method, also called Galilean or hypothetical-deductive originating from empiricism, is a cognitive procedure divided into different propositions called experimental reasoning for which it is necessary to apply the following rules: - Analysis of the problem through the observation and description of a given phenomenon - Formulation of a hypothesis that can explain it - Definition of the analysis method - Data collection - Processing of the collected data - Experimental verification of the hypothesis - Confirmation or refutation of the initial hypothesis - Communication of the result. In biology and medicine, the majority of the laws are probabilistic and cannot be expressed with a mathematical formula. So, to recognize the scientific nature of medical discourse, empirical control is used based on repeatability, with significant evidence, of observations by other researchers. In the English language, the term «evidence» can be understood both with the meaning that the word “evidenza” has in the Italian language, and with that of the word test or even with that of demonstration. The term evidence, which derives from the Latin ex-videre (see immediately, see clearly), indicates the characteristic of what is clearly seen and which cannot be doubted or needs no demonstration. Evidence-based medicine is the conscientious, explicit and judicious use of the best current evidence in making decisions about the treatment of individual cases. It is a combination of principles and methods which, once applied, ensure that medical decisions, guidelines and strategies are based on the best options regarding the effects of different ways of approaching the case in particular . To advance scientific knowledge, action taken by communities interested in research that share methods and make use of results is necessary. The most used tool for these purposes is the publication of scientific articles in journals with prior critical review by specialists in the discipline. The value of the individual publications is assessed through a metric of the scientific impact of each work which, thus, acquires value for the whole community. The study and systematic analysis of all the works (systematic reviews and meta-analyzes) form the basis of scientific evidence but in practice require effort often not within the reach of the individual doctor. In fact, they require specific training and skills, knowledge of methodologies, including statistics, and of the tools to identify their possible limits and bias.   Until the beginning of the 19th century, there was no record of meetings or organized meetings of scholars of scientific subjects in Italy. On the basis of similar German, Swiss and French experiences, scientific meetings, including medical ones, also began to be organized in Italy from 1839. The meetings of Italian scientists, including physicians, took place from 1839. The first Congress took place in Pisa under the patronage of Leopoldo II of Lorraine. Subsequently, the scientific meetings took place on an annual basis until 1847; however, they resumed with an extraordinary congress in Florence in 1861 and ended with the 1875 congress in Palermo, during which the regulation of the Italian Society for the Progress of Sciences was approved, which still exists today. Since then, many scientific societies have been established in Italy in the different branches of knowledge. The creation of a Scientific Society is an essential moment in the affirmation of a discipline or a specialty. It acts as a fundamental source of identity for the individual member, allowing him to maintain the awareness of belonging to a known and respected tradition as well as the certainty of its continuous evolution. The social role of Scientific Societies is also substantiated in the scientific education of its members. The Scientific Society, as a visible, stable and lasting institution, acts as a custodian of the values of the discipline, of its distinctive traditions and of the unitary body of knowledge and ability that characterizes it. By summarizing, as much as possible, the reasons for which a Scientific Society exists, we can indicate on the one hand advocacy, intended as a defense of professional interests and forums of standards and arbitration, on the other hand networking, as an exchange of information and research, useful knowledge and skills on a professional and scientific level. The duties and objectives of the Medical Scientific Societies include the following : - Monitoring the quality of research results published on the basis of a correct scientific method - Contributing to the definition of “evidence” according to the criteria of Evidence-Based Medicine (EBM) - Ensuring uniform procedures - Defining or helping to define or approve and disseminate evidence-based guidelines. The interaction of the researcher with the scientific community takes place, in addition to the sharing of the methods and contents of the scientific proposals, with participation in specialized conferences where, for example, different approaches to solving a problem or proposed projects can be compared to search results or partial results of ongoing searches.   Scientific Societies of Occupational Medicine exist in numerous countries around the world. The International Commission on Occupational Health (ICOH) is an international organization dedicated to scientific progress, knowledge and the improvement of health and safety at work. It was founded in Milan in 1906 where its first Congress was held. Currently, ICOH has more than 2,000 members from 93 countries and 33 scientific committees. Recognized by the United Nations as a non-governmental organization, it works closely with the International Labour Organization (ILO) and the World Health Organization (WHO). The Italian Society of Occupational Medicine (SIML) was established in Naples on October 12, 1929, and held its first National Congress in Rome in 1930.   A 2017 Italian law (Law 8 March 2017, n. 24) radically changed the role of “qualified” scientific societies and their guidelines. In fact, it stated that health workers in the execution of health services regarding preventive, diagnostic, therapeutic, palliative, rehabilitation and forensic purposes must comply with the recommendations provided by the guidelines ... elaborated ... scientific societies ... registered in a special list established and regulated by the decree of the Minister of Health “. If these Guidelines have been respected in the event of damage caused by inexperience, then the exclusion of criminal liability is provided with exceptions already reported by the jurisprudence. The list includes 293 companies and associations, including SIML. In February 2020, the new Operating Manual was published relating to the “Procedure for sending and evaluating Guidelines for publication in the National System of Guidelines (SNLG)” which states that Guidelines that comply with methodological standards can be accepted for drafting. The National Center for Clinical Excellence, Quality and Safety of Care (CNEC in Italian) will be the “methodological and independent guarantor for the evaluation of guidelines produced by third parties and for the production of good quality guidelines (LG in Italian), informed by the best available evidence and responding to the country’s health needs based on criteria of relevance and clinical, economic and social impact “ . The methodological standards for the publication of the LGs in the SNLG are “AGREE quality of reporting checklist”  and “AGREE II” . Both are composed of six dimensions: Application objectives Stakeholder involvement Methodological rigor Exhibition clarity Applicability Editorial independence. As regards the latter point, the authors of the LGs must declare that its contents have not been influenced by any institutional or commercial sponsors and that any conflicts of interest of the members of the group that developed the guideline have been explicitly declared and adequately governed. A special disclosure form is provided for the declaration of conflicts of interest. A common approach to all the LGs presented remains that of formulating the clinical question towards which the recommendation will be produced following the acronym P.I.C.O. (P = population; I = intervention; C = comparison; O = outcome). So, the question should be put in the following manner: P = population. Specify the characteristics of the population concerned I = intervention. Describe the type of intervention envisaged C = comparison. Describe the possible alternatives O = outcome. Describe the benefit and harmful outcomes During the process of producing recommendations with the “GRADE” method , a bibliographic search (exhaustive, sensitive and reproducible) of the sources is then carried out on the various medical-scientific databases (PubMed, Cochrane, Scopus and area-specific databases). In fact, it is necessary to carry out targeted systematic research with the aim of identifying all the available studies that have addressed the question. Once the articles identified by the search strategy have been obtained, the best evidence must be selected. If there are no systematic reviews of relevant randomized clinical trials, then the question will pass to single studies or systematic reviews of observational studies, etc., in summary following the known pyramid of evidence. In the “GRADE” method, once chosen, the outcomes will be classified in terms of the following relevance: - important and essential (indicated as “critical to be able to make a clinical decision”) - important but not essential - not important.   Although there are similarities between Occupational Medicine and other health disciplines, the clinical issues and professional focus of the latter mainly concern the risks of the working environment and the protection and promotion of workers’ health rather than the treatment of diseases. A fundamental paradigm is that of the quality of the performance of the occupational physician and the demonstration that these are effective . Is evidence-based medicine a viable and useful method for occupational medicine? Yes, of course. However, specific training is required for occupational health physicians to increase their research and critical assessment skills and tools that facilitate research in the literature . The specific themes of the discipline and the frequent references to the regulations, however, make it very difficult or impossible to base the LGs exclusively on scientific evidence. Indeed, many workplace health and safety guidelines are not based on the best available evidence . This also depends on the specificities of the matter. For example, the criteria for indicating supplementary health assessments of the medical examination of the competent doctor or for the expression of the suitability judgment for the job cannot be inferred from the systematic review of the scientific literature. A recent contribution by Teufer B et al. has allowed highlighting many systematic reviews concerning the prevention of accidents at work; musculoskeletal, skin and lung diseases; professional hearing impairment and other interventions without specific target diseases. Numerous interventions have led to consistently positive results on individual diseases, whereas other interventions have shown that no effect or studies are contradictory . An important contribution is offered by the Cochrane reviews. Each Cochrane review is a systematic review that has been prepared and supervised by a Cochrane review team (editorial team). It attempts to identify, evaluate and summarize all empirical tests that meet predefined eligibility criteria in order to answer a specific research question. The Cochrane working group conducted a series of systematic reviews, summarizing the body of health and safety at work related to knowledge and the site contains results on 111 different topics . In the majority of cases, the results of the systematic review of the literature led to unreliable results, especially due to the insufficient quality of the scientific literature. The striking case is that of the use of intrinsically safe devices, which all occupational physicians recommend to prevent needle injuries. The Cochrane review states that the tests on these devices are of low quality and contradictory. The lack of a strong and consistent useful effect could be due to distortions. This does not mean that these devices are not effective but that the published studies are usually of low quality and, therefore, are necessary randomized controlled trials of high-quality clusters that include cost-effectiveness measures, particularly in countries where both needle injury and blood-borne infections prevail . Therefore, one of the problems of the discipline is to promote scientific research on the most important issues relating to the activities of occupational physicians and on the choices to be made for the preventive measures to be taken. Even when there is no scientific evidence from the scientific literature, it is still necessary that the Guidelines or any other professional guidance document of occupational physicians are to be based on the following: Ethical criteria Consolidated experiences References to current standards and regulations Appropriateness Evaluation of the cost-benefit ratio Support and validation by stakeholders. It is also possible to prepare protocols and algorithms that facilitate the correct activity of the occupational physician . However, it is necessary for the occupational physician to have valid and updated sources of information that guarantee appropriate answers to the daily questions of his professional practice. The adoption of practices based on evidence of effectiveness must have, as a fundamental requirement, the acceptance by professionals of a model based on the evaluation of the quality of their performance .   The Italian Society of Occupational Medicine began in 2000 to deal with the topic of the guidelines in the field of training and accreditation of the occupational physician-company doctor and framing them among the useful tools with others (courses, conferences, symposia, workshop) to guarantee a constant and uniform technical and scientific increase and, consequently, to reaffirm the specific professional role of the occupational physician. In 2009, the Society’s new LG production method was produced . The guidelines are developed with the aim of ensuring the maximum degree of appropriateness of the interventions, minimizing the variability in decisions related to the lack of knowledge and subjectivity in the choice of intervention criteria, with the aim of obtaining an improvement in the delivery of performance. They are first of all useful tools to advance competence understood as the ability to orientate the skill acquired in a given field, or better yet as the knowledge, ability, expertise and aptitude to perform a task or play a role in order to guarantee the expected results of workers, employers and supervisory bodies. The entire program is guaranteed and coordinated by a Commission whose scientific and professional profile is a guarantee both for the participants and for the enhancement of the initiative in scientific and institutional areas. The production program of the Guidelines in Occupational Medicine has seen more than 30 Guidelines (LG) published today with four updates and two consensus documents and one position paper. In perspective, SIML intends to produce both Guidelines according to the SNLG procedures and other types of documents for occupational physicians, such as Consensus document, position paper and other scientific-professional orientation documents, produced by the study groups appointed by the Company’s National Board with the coordination of the SIML National Commission for Training and LG.   The activity of the occupational physician must be based, if possible, on the most advanced scientific evidence. There is a need for quality and scientific evidence in all the activities of the occupational physician and, in particular, in collaborative activities in risk assessment, health surveillance and in the diagnosis phases of work-related pathologies, especially for multifactorial pathologies widely spread among the general population. Scientific Societies accredited for updating the scientific orientation of occupational physicians play a central role in the production of evidence-based Guidelines. Even when it is not possible to base the Guidelines exclusively on scientific evidence, the indications to be provided to occupational physicians must comply with quality, appropriateness and ethical criteria. In any case, it is necessary that the tools prepared by the Scientific Societies have operational references for the professional activities of the occupational physician. The Italian Society of Occupational Medicine has for years made a very strong commitment with its members to offer them with the highest possible scientific evidence, various professional orientation tools and intends to carry out an ambitious program of adaptation of its methodologies and contents to produce Guidelines useful for an increasingly qualified activity of Italian occupational physician. No potential conflict of interest relevant to this article was reported by the authors   