Ministry of Health status of clinical recommendations. Clinical guidelines or treatment protocols

Over the past few decades, the so-called "treatment protocols" or, as they are also called, "clinical recommendations" have firmly entered the medical practice of most developed countries. First of all, it concerns the countries of Europe and North America. In the Russian Federation, these concepts have appeared relatively recently, and not all domestic doctors have an exhaustive idea of what it is. Very often, medical professionals are concerned with questions such as: “What benefit can treatment protocols bring to me or my patient?” or “Where can I find or buy them?”, Or, perhaps, one of the most important questions “Are clinical recommendations mandatory for use?”. This article was written by us precisely in order to answer many questions of concern to doctors and healthcare organizers and thereby help our readers understand such an undoubtedly important topic.

Often, in their work, doctors get used to relying solely on their experience and some already established system of knowledge. However, we live in an era when science, including medicine, is developing rapidly and every year more effective methods of treatment are being developed in the world, the latest drugs are being patented, and more modern equipment is being mass-produced. It is obvious that the application of any innovations requires a certain qualification and it can be quite difficult for an ordinary person to keep up with technological progress. It was in connection with the need to systematize the latest achievements and discoveries of medical science that there was a need to create some "guidelines for action". Such guidelines are called, as mentioned earlier, "treatment protocols" or "clinical guidelines".

There is no clear concept of the terms "clinical recommendations" or "treatment protocols" in the current legislation of the Russian Federation. In various literary sources, this term may sound differently, however, with regard to the general essence of the definition, most authors still agree.

For example, in the book "Clinical recommendations - ophthalmology", the authors of which are Moshetova L.K., Nesterova A.P. and Egorova E.A., the concept of "clinical recommendations" means systematically developed documents that describe the algorithms for the doctor's actions in the diagnosis, treatment and prevention of diseases and help him make the right clinical decisions.

Ekaterina Ivanova, a special correspondent of the Urology Today newspaper, puts a very similar meaning into the term “clinical recommendations” in her article “Clinical recommendations for urologists: by whom, how and why are they created?”. The author uses the concept of "clinical recommendations" as systematically developed statements that help doctors and patients make the right medical decisions in certain clinical situations.

Federal Law No. 323-FZ of November 21, 2011 “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation” (hereinafter - Federal Law No. 323), being a fundamental regulatory legal act in the field of healthcare, Article 37 establishes that medical care is organized and provided in accordance with the procedures for the provision of medical care, binding on the territory of the Russian Federation by all medical organizations, as well as on the basis of standards of medical care. In addition, Part 1 of Art. 79 of the same law establishes the obligation of a medical organization to carry out medical activities in accordance with the legislation and other subordinate regulatory legal acts of the Russian Federation, including the procedures for providing medical care and standards of medical care.

It is obvious that in the Federal Law No. 323 there is a clear obligation to comply with the procedures for the provision of medical care and standards of medical care in the implementation of medical activities. However, as we can see, none of the norms cited by us contains any mention of clinical recommendations. In addition, there are no references to clinical recommendations to date in judicial practice. Treatment protocols appear only in those litigations where they were approved as mandatory for compliance with local acts of the medical organization, and the doctor was guilty of violating official duties. In addition, at the moment there is also no procedure for approving clinical recommendations, which, in fact, also indirectly indicates the impossibility of treatment protocols to be the basis for making legal decisions.

However, in Part 2 of Art. 64 of the Federal Law No. 323 states that clinical recommendations, along with the procedures for providing medical care and standards of medical care, serve as the basis for the formation of criteria for assessing the quality of medical care. This means that non-compliance with treatment protocols can be qualified as the provision of poor-quality medical care. This will be discussed in more detail below. Thus, it follows that adherence to treatment protocols is mandatory for medical organizations.

At the same time, it should be understood that clinical recommendations are a kind of “adviser”, whether or not to listen to which, it is up to the medical worker to decide. At the same time, refusal to comply with clinical recommendations, in contrast to non-compliance with the procedures for the provision of medical care and standards of medical care, will not entail any legal consequences for the medical worker (with the exception of medical organizations providing medical care under compulsory medical insurance), since today clinical recommendations do not have the status of a regulatory legal act, unlike most procedures for the provision of medical care and standards of medical care that are mandatory for all medical organizations. However, clinical recommendations (treatment protocols) can serve as a good source of evidence-based medical practice and, in the absence of other legal norms, can serve as evidence, for example, of the correct choice of a treatment or diagnostic method by a medical worker, the correctness of changing treatment tactics in the event of a particular complication, etc.

In our opinion, treatment protocols can be qualified as customs, that is, using the terminology of the Civil Code of the Russian Federation (Article 5 of the Civil Code of the Russian Federation) - a rule of conduct that has developed and is widely used in a particular area of medical activity, not provided for by law. Recall that, in accordance with Article 309 of the Civil Code of the Russian Federation, obligations must be performed properly in accordance with the terms of the obligation and the requirements of the law, other legal acts, and in the absence of such conditions and requirements, in accordance with customs or other usually imposed requirements. Therefore, the observance by medical workers of the provisions of clinical recommendations (treatment protocols) that do not contradict the provisions of existing regulations can and should be regarded as the proper fulfillment of obligations within the framework of the provision of medical services.

Based on evidence-based medicine, clinical guidelines are primarily intended to introduce the most effective and safe medical technologies (including medicines) into everyday clinical practice. In practice, treatment protocols prevent the doctor from making a spontaneous, wrong decision, conducting unreasonable intervention and, thus, contribute to improving the quality of medical care. Naturally, the main positive moment for patients should be the improvement of clinical outcomes (decrease in morbidity and mortality, improvement in quality of life). In other words, the patient will be able to gain greater confidence that the treatment tactics will not depend very much on who and where treats him, although, of course, the application of protocols in practice should in any case be accompanied by an individual approach to each patient.

For clinicians, the benefit of using guidelines lies primarily in improving the quality of clinical decisions. Clinical guidelines are especially useful in cases where clinicians experience difficulty in making decisions due to lack of information, while sufficient scientific evidence has been accumulated to make the right choice.

Of course, there are positive and negative aspects of standardization and unification of diagnostic methods, treatment, rehabilitation, etc., however, we note that, unlike the standards of medical care approved by the Russian Ministry of Health in recent years, clinical recommendations carry not only legal, but also practical meaning and value. Let's take the liberty of calling clinical guidelines "standards with a human face."

A little earlier, we stated that in practice the main mission of clinical recommendations is to improve the quality of medical care. Therefore, it is very important for the state to take into account the relationship that arises between the introduction of treatment protocols into medical practice and improving the quality of medical services, which, of course, is reflected in legislation.

Particular attention is paid to compliance with clinical recommendations when conducting an examination of the quality of medical care provided under compulsory medical insurance, which is carried out in accordance with the Order of the Federal Compulsory Medical Insurance Fund No. Assistance for Compulsory Medical Insurance” (hereinafter referred to as the Procedure). In particular, paragraph 21 of the Procedure clearly states that the examination of the quality of medical care is carried out by checking the compliance of the medical care provided to the insured person with the contract for the provision and payment of medical care under compulsory medical insurance, procedures for the provision of medical care and standards of medical care, clinical recommendations (treatment protocols ) on the provision of medical care, established clinical practice.

With regard to the examination of the quality of medical care provided outside the framework of compulsory medical insurance, we note that the procedure for such an examination is established by Order of the Ministry of Health of Russia dated May 16, 2017 No. of the Russian Federation on Compulsory Medical Insurance. It is worth noting that the said order does not mention (unlike FFOMS Order No. 230 of December 1, 2010) clinical recommendations, although the expert must check the compliance of the medical care provided to the patient with the criteria for assessing the quality of medical care.

In addition, as you know, the examination of the quality of medical care is carried out in order to determine the degree of compliance of the medical services provided with the criteria for the quality of medical care. At the same time, in Part 2 of Art. 64 of the Federal Law No. 323 expressly states that the basis for the formation of such criteria, along with the procedures for the provision of medical care and standards of medical care, are clinical recommendations. As you know, on July 1, 2017, new criteria for assessing the quality of medical care began to operate (Order of the Ministry of Health of Russia dated May 10, 2017 No. 203n). Section 2 of this document stipulates that some quality criteria are formed in particular on clinical guidelines (treatment protocols).

As we can see, from the point of view of the examination of the quality of medical care, compliance with treatment protocols by medical organizations is an integral aspect of the provision of quality medical services.

Traditionally, clinical guidelines have been developed by medical professional communities. For example, in the USA it is the American Academy of Ophthalmology, the American Association of Urology, in Europe it is the British Society of Ophthalmologists, the European Association of Urology and so on.

In the Russian Federation, this issue is regulated by law. So, in part 2 of Art. 76 of the Federal Law No. 323 states that only medical professional non-profit organizations can develop and approve clinical recommendations on the provision of medical care.

Today in Russia there are many such professional organizations. For example, some of the representatives of this cohort are the Interregional Public Organization "Association of Ophthalmologists", the All-Russian Public Organization of Transplantologists "Russian Transplant Society" and many others. They already have dozens of developed treatment protocols on their account.

As indicated above, the procedure for approving clinical guidelines has not yet been established at the regulatory level. This leads to the fact that, in general, the structure and content of treatment protocols differ depending on which professional organization developed them.

Since the structure of clinical guidelines is different for each organization, it is rather difficult to single out a single structure for the content of such documents. Attempts to develop uniform requirements for the creation of treatment protocols have recently been made by the Interregional Public Organization "Society for Pharmacoeconomic Research", which developed "GOST R 56034-2014. National standard of the Russian Federation. Clinical guidelines (treatment protocols). General Provisions". This standard establishes general provisions for the development of clinical guidelines (treatment protocols). In particular, GOST also establishes requirements for the structure of clinical recommendations.

So, according to GOST, the treatment protocol includes the following sections:

general provisions;
protocol requirements;
graphical, schematic representation of the protocol (if necessary);
protocol monitoring.

The Protocol Requirements section, in turn, contains the following subsections:

patient model;
criteria and features that define the patient model;
a list of medical services of the main and additional range, depending on the conditions for the provision and functional purpose of medical care;
characterization of algorithms and features of the use of medical services in this patient model;
list of groups of medicines of the main and additional assortment;
characterization of algorithms and features of drugs in this patient model;
requirements for the regime of work, rest, treatment or rehabilitation for this patient model;
requirements for dietary prescriptions and restrictions;
features of the informed voluntary consent of the patient during the implementation of the protocol and additional information for the patient and his family members;
possible outcomes for this patient model.

Note that this GOST is voluntary, as expressly stated in paragraph 1 of the Order of Rosstandart dated 06/04/2014 No. 503-st, which actually approved this standard. Therefore, the structure indicated in it is also not exhaustive and can serve for our readers only as an example of which main headings can be covered in treatment protocols.

In Russia, treatment protocols are mainly published on the websites of the organizations that developed them. In addition, a selection of some clinical recommendations is collected on the Roszdravnadzor website ( http://www.roszdravnadzor.ru/medactivities/statecontrol/clinical) and the Federal Electronic Medical Library (http://www.femb.ru/feml).

On our website () you can also familiarize yourself with the current protocols in the "" section. This section will be gradually developed and supplemented, and in the near future we hope to fill it with all available treatment protocols, dividing them into relevant areas of medical practice. In particular, today our readers already have access to clinical recommendations on:

Allergology and Immunology
Anesthesiology and resuscitation
Gastroenterology
Hematology
Clinical and laboratory diagnostics
Neonatology
Palliative Care
Ophthalmology
dentistry
Transplantology

If we focus on the statement of the Minister of Health Skvortsova V.I. at the VII All-Russian Congress of Patients “The State and Citizens in Building Patient-Centered Healthcare in Russia” (November 2016), then in the very near future we will be replacing the standards of medical care with clinical recommendations (or rather clinical guidelines), which will have legal force and become mandatory. And the standards of medical care will be assigned only an economic role. The Minister announced that the Ministry of Health has developed a draft law on clinical guidelines, which should replace the current standards for the provision of medical care. The minister also noted that 1,200 clinical guidelines have already been prepared and that from now on they will be called clinical guidelines, and not clinical recommendations, because they will be mandatory. For our part, we note that so far the ministry's grandiose plans have not been implemented at the legislative level.

So, according to GOST, the treatment protocol includes the following sections:

general provisions;
protocol requirements;
graphical, schematic representation of the protocol (if necessary);
protocol monitoring.

The Protocol Requirements section, in turn, contains the following subsections:

patient model;
criteria and features that define the patient model;
a list of medical services of the main and additional range, depending on the conditions for the provision and functional purpose of medical care;
characterization of algorithms and features of the use of medical services in this patient model;
list of groups of medicines of the main and additional assortment;
characterization of algorithms and features of drugs in this patient model;
requirements for the regime of work, rest, treatment or rehabilitation for this patient model;
requirements for dietary prescriptions and restrictions;
features of the informed voluntary consent of the patient during the implementation of the protocol and additional information for the patient and his family members;
possible outcomes for this patient model.

Allergology and Immunology
Anesthesiology and resuscitation
Gastroenterology
Hematology
Clinical and laboratory diagnostics
Neonatology
Palliative Care
Ophthalmology
dentistry
Transplantology