At first glance, design and psychology are not related to each other, except perhaps when building websites, when the individual wishes of the customer are taken into account. But the scope of application of the foundations of psychology can be much wider, absorbing the latest achievements in this field of science.

Architecture is sometimes poetically referred to as frozen music. Indeed, the influence appearance building, and especially its interior space, on the human psyche is comparable to the impact of the melody. Sometimes even a slight nuance can plunge into sadness or, conversely, cause a feeling of cheerfulness, a surge of strength and joy.

Fortunately, those times have sunk into oblivion when interior design was guided solely by pragmatic considerations of expediency and utilitarian benefits. The desire to fully follow the often very dubious criteria of fashion and prestige also ceases to be the main thing, but the personal and psychological aspect of the design of the room comes to the fore. apartment or private house gradually become not just a space for life, but a kind of expression inner peace hosts. The style of the dwelling is focused, first of all, on creating a comfortable and harmonious psychological climate, and with careful selection of all the components of the design, it can serve as a kind of passive psychotherapist.

Psychological design explores the complex of interactions in the "man-environment" system. This is the psychological rationale for design. Justification of its causality, its existence in general, its components in a broad sense and in each specific case.

Psi-design is based on the data of general psychology, social psychology (design as a channel of media systems), ethnopsychology, ethnography, sociology (approach from the point of view of the globalization of design), philosophy, cultural studies, synergetics, information science and physics.

Psi-design assimilates the data of all ways of knowing reality - science, art, religion, etc., as well as the empirically accumulated knowledge of traditional teachings.

The structure of psi-design includes the consideration of two-way relationships between a person and the environment: video ecology, color and light psychology, psychology of form, psychology of materials science, psychology of composition, psychology of individual differences, etc.

V applied aspect psi-design is divided into three main sections:

- the formation of the integrity of ideas about the environment of human existence (in other words, the diagnosis of the environment as a point of application of the transformative impact of design),

– methods for studying specific situations and interactions in the “man-environment” system,

– design recipe for the formation of the environment.

Psi-design develops non-standard and independent thinking, creativity, a broad view of the world of things and Nature, their connections. Those who have mastered it open up new bottomless sources for creativity, inspiration, and intuition. From this moment on, life becomes clearer, more meaningful, brighter, more interesting, “tastier”, its quality increases many times over. And no witchcraft.

Psychology is interesting to everyone because it concerns everyone. Because it is about the secrets of the psyche, it deeply knows about us even what we do not know ourselves. Apparently we don't know. In fact, not so deep, not everything and not always correct. But he tries. Conducts research, collects statistics, analyzes. He is often fond of theorizing and thinks like science for the sake of science. But the applied part of it works, although not one hundred percent. Nevertheless, the main developments were made a long time ago and, most importantly, in the West. The basis was European thinking. As subjects, and psychologists.

As a result, the methods do not fully fit the Russian mentality, and often they are not at all suitable for understanding the “mysterious Russian soul”. Strictly speaking, just as it is impossible to compare the intellect of representatives of different cultures, so it is impossible to apply the techniques created in a different mentality to analyze a different mentality.

To design in last years show increased attention. First, this is a new phenomenon for us. Secondly, interesting. Finally, just beautiful. And few people realize how influential. In terms of influence on a person as an environmental factor. No one argues about the importance of ecology as an environmental factor. Moreover, all troubles are now placed in this area. But the object environment has no less influence on a person. From this point of view, it is the responsibility of the designer to ensure that this influence is positive, not negative. This is a separate topic, but let's say that a violation of the rules of videoecology can lead to diseases, including provoking mental disorders. And the sick person will never guess that the reason is in poor design.

The second reason is that the designer often cannot take the position of the customer and design the environment for him. Fulfilling the order, he expresses his worldview, guided by his taste. No wonder almost everyone complains about psychological problems with the customer as the main ones. It has already become commonplace. The designer is the same person with his own system of views, and even if he tries to adapt to the taste of the customer, he rarely gets into the top ten. Lacks objectivity.

In addition, designers often act dishonestly, they “take the customer into circulation”, impose their taste and preferences. Many do it unintentionally. Partly due to the fact that the customer himself does not know what he wants. And even if he formulates his wishes, it is not at all a fact that in the realized form they will not harm him in the future. After all, the desire of the customer can be dictated by mood, fashion, someone's hint.

To be honest in the profession, we must admit that the designer, although he is an artist, is still a person from the service sector. That is, "whatever you want." The designer is obliged (literally like a doctor) to love all his customers (patients), to love all styles (diseases), all colors (syndromes) and textures and skillfully operate with them. But even this is not enough. There is not enough tool to objectify the design solution.

It turned out, however, that the creation of such psychological method really. Moreover, it has already been developed and tested. The beauty is that it helps to avoid subjectivity on both sides of the contract and to determine with a greater degree of certainty what the customer actually wants. As a result, a unique “design recipe” is formulated for this customer. Similar to individual tailoring in the atelier. Specific recommendations are given on style, form, space, texture of materials, light, according to the mental makeup of the individual. If the customer is a family, then an average general recipe is issued without “harmful” factors for any of its members.

As a result, the designer manages to express the worldview and self-perception of the customer by means of the interior. It is not easy to turn a client into a co-author (then the size of the fee will look unprofitable for the designer), but “tailor the suit to fit”.

It is also noteworthy that the technique provides a real opportunity to have a therapeutic effect by means of the interior. Yes, physics, in particular, its new sections - synergetics and eniology.

Of course, for the sake of justice, it must be said that a psychological technique is not a device, for the use of which one needs to know several buttons. It is necessary to acquire a minimum of psychological knowledge on the interpretation of the data obtained. But this is quite real for an ordinary person and does not require deep knowledge.

The psychological approach to interior design conditionally includes two main functions. The most common and well-known harmonizing function is when the decor of a separate room or the whole house reflects the temperament of a person, his habits and worldview. The task of such a room is to create an atmosphere of harmony and peace. Bold and non-trivial decisions are hardly justified here. In fact, such a technique suggests the passivity of the interior in relation to its owner. Thanks to the optimal combination of shades and textures of finishing materials, as well as decor elements and accessories, the interior adapts to one or another individual, being a continuation of his inner "I".

The second, much more interesting function can be called stimulating. Design now plays an active role: it favorably accentuates certain features of the owner's character and temperament, or, conversely, smoothes and levels out unwanted features. For example, such an interior can balance an impulsive choleric person or inspire a melancholic prone to depression. It is no secret that the popularity of Feng Shui these days is largely due to the variety of methods of organizing a stimulating space that this ancient teaching offers. However, the followers of Feng Shui look even deeper, stating that proper arrangement can mysteriously influence not only the psyche of the inhabitants of the house, but also events in their lives, business and personal success. Of course, the design of the room, which combines both stimulating and harmonizing functions, could be considered ideal.

Interior design begins with the layout of the premises, with the creation of a certain structure of the interior space. From the point of view of psychology, such structuring is of paramount importance. In fact, it sets the rhythm of life in the house and often dictates specific models of relations between its inhabitants and each other and guests. Although there are countless options for space planning, they can be summarized into two main types: indoor and outdoor interior. The interior of a closed type implies a clear and fixed division of a single whole into several isolated rooms, each of which performs certain function. For example, a living room cannot be a dining room, and a bedroom cannot be a study. From a psychological point of view, privacy, and even the intimacy of the life of the owners of the premises, is at the forefront here. The open interior, on the contrary, is a design embodiment of the concept of an accessible society, demonstrating a kind of life for show, an active, dynamic and sociable style of behavior and, perhaps, the priority of public and business interests over personal ones.

RESEARCH DESIGN IN MEDICINE

Prof. A.O.Gusan

Publication of many scientific materials in the domestic and foreign press, as well as the experience of editing collections of scientific papers, the 11th year of conferences of doctors in the Karachay-Cherkess Republic with the participation of many domestic and foreign scientists allow me to give some recommendations on the implementation of scientific research and the presentation of their results.

In each medical specialty, physicians use their own specific research methods. However, there are general principles methodology and methods of research work, which should be guided in the process of performing scientific work in any branch of medicine. The performance of any scientific work must be carried out in accordance with international requirements main methodological and methodological approaches. This is an urgent requirement of the time, given the pronounced integration of Russian medical science into the world.

Unfortunately, to date, the method of planning scientific work, and especially the issues of biostatistics, have not been studied at the Medical Higher Schools. educational institutions, therefore, I consider it appropriate and useful to briefly consider the main requirements that a doctor should be guided by when drawing up the results of his scientific research.

In this information message, we will focus on the most common form of presenting the results of a scientific study - a scientific article.

A scientific article is a scientific work limited in scope, which sets out a reasoned system of the author's views on a specific issue. The most important requirements for a scientific article: the relevance of the issue raised in it, the depth of the phenomena, events and facts covered, the specificity and validity of the conclusions and generalizations made.

Any scientific research includes several blocks of interrelated stages. The first one is pre-scheduled research, drawing up and approval of the research plan. The second includes the research process itself (collection of materials characterizing the problem under study, accumulation of factual data about it, their systematization, development of certain ideas about the problem). The third part of the study is the presentation of the results of scientific research (interpretation, report, publication).

When writing any scientific article, the author must submit an analytical review of the literature on the chosen topic with a rationale for the need for this work. Most often, these can be questions on a given topic that are not sufficiently covered by now, or the author puts forward new research methods that allow deepening knowledge on this issue, etc. The topic of the work can be a clinical case, an observation that is important for practical work experience, etc.

The next very important section of any study is the characteristics of its design. The results of research are largely determined by the correctness of the chosen research methods. To evaluate the effectiveness of new methods of diagnosis, prevention and treatment, to eliminate errors and correctly interpret the results of clinical trials, they must be carried out within the framework of randomized controlled trials, which are considered the "gold standard" for clinical comparisons.

A controlled clinical trial is a prospective study in which matched groups receive different kinds treatment: patients in the control group - standard (usually the best in terms of modern ideas), and patients of the experimental group - a new treatment. The most important condition, which ensures the reliability of a controlled study, is the homogeneity of a group of patients for all signs that affect the outcome of the disease (gender, age, the presence of concomitant diseases, the severity and stage of the underlying disease, etc.). Given the presence of many interrelated factors that determine the prognosis, as well as "hidden" prognostic factors, it is possible to achieve comparability of observation groups to the fullest extent only when using the method of random distribution of patients into groups, i.e., randomization (random - random). True randomization implies the obligatory observance unpredictable nature distribution of patients into groups (the researcher cannot predict which group the next patient falls into - “blind selection”). To increase the efficiency of randomization, preliminary stratification is carried out - the distribution of treatment options is carried out in homogeneous groups of patients formed according to leading prognostic signs (stratification randomization).

The section "Materials and methods of research" indicates the number of patients in the control and main groups, their homogeneity by sex, age, severity of the course, the presence of concomitant diseases. Credible clinical results can only be obtained with a sufficient number of observations in both groups.

Determining the optimal number of observation cases is milestone experiment planning. So, in cases where the results of the study will be expressed qualitatively, a much larger number of observations is required than when using quantitative estimates expressed by arithmetic mean values. In addition, it should be remembered that a small number of studies reduces their accuracy and reliability. To increase the accuracy of the study by 2 times, it is necessary to increase the number of observations by 4 times. At the same time, the number of observed cases in the control and experimental groups does not have to be the same. The number of cases required for the experiment is determined when planning R&D in each case individually according to special formulas described in a number of reference books on medical statistics.

In accordance with the "International Ethical Requirements for Biomedical Research Involving Humans" and international convention on civil and political rights, all medical research involving humans should be based on three ethical principles: respect for the individual, the achievement of benefit, justice. In all biomedical research involving humans (sick or healthy), the investigator must obtain informed consent from the subjects who will participate in the trial, and if the research subject (SI) is not able to give it, informed consent close relative or authorized representative. Informed consent means the consent of a competent SI who has received all necessary information who adequately understands it and makes a decision freely, without excessive influence, motivation or threat. The SI should receive information about the purpose, methods, duration of the study, expected risk or discomfort, alternative procedures, degree of confidentiality, the ability to withdraw from the study at any time.

The section "Material and methods of research" should be described in such detail that any other researcher could, if desired, reproduce the work. At the end of this section, the methods of statistical processing of the obtained result and the software used for this are indicated. The analysis of statistical data is carried out by appropriate mathematical processing of the results obtained, the techniques and methods of which are described in detail in special manuals on medical statistics. In recent years, statistical data processing has been carried out on a PC using special software packages (for example, Statgraph, etc.), which allow you to quickly calculate the average values ​​and relative coefficients, identify the nature and strength of the relationship, the degree of reliability, build analytical tables, charts and graphs.

The scientific processing of research materials is completed in the “Results and Discussion” section and involves the following main elements: comparison of data, assessment of their reliability and the results of the study as a whole. This section usually includes the necessary illustrative material (tables, figures, graphs, etc.). At the same time, it must be remembered that the description of the illustrations should not be a repetition of what has already been reflected in the text of the article.

The conclusions of the work should correspond to the title of the article, the goals and objectives set by the author.

The list of references should contain all sources used. In this case, the citation system may be different. Each Science Magazine, the editors of any collection of works impose their own requirements on the structure of the article, the design of illustrative material and the list of references used. In this regard, each author should familiarize himself with the rules of the publication to which he is preparing to send his research materials.

In the domestic medical literature the most common is the Harvard system. After a reference to the opinion of the author, his initials, surname, after a comma, the year of publication of the work are indicated in brackets. In the bibliography, sources are listed in alphabetical order by the names of the authors. A more advanced version of this system involves replacing the names of the authors and the year of publication with the serial number of the work in the attached list of references, also compiled in alphabetical order. This number is usually enclosed in square brackets.

The output of each literary source, indicating the surname and initials of the author (or authors), the title of the article or section of the monograph, then the name of the journal or other printed publication, indicate the year (for books, the year and place) of publication, volume, journal number, pages. First, a list of domestic authors is compiled in alphabetical order, then foreign ones.

Examples of compiling a list of references.

Samples of bibliographic writing of literature (GOST R 7.0.5-2008. Bibliographic reference. General requirements and compilation rules. — M.: Standartinform. - 2008. - 19 p.)

1. VoyachekV. I. Fundamentals of otorhinolaryngology. - L .: Medgiz, 1963. - 348 p.

2. Blotsky A. A., Pluzhnikov M. S. Snoring phenomenon and obstructive sleep apnea syndrome. - SPb.: Spets.lit., 2002.-176 p.

3. Preobrazhensky B. S., Temkin Ya. S., Likhachev A. G. Diseases of the ear, throat and nose. - M .: Medicine, 1968. - 495 p. More than three authors

4. Fundamentals of audiology and hearing aid / V. G. Bazarov [et al.]. — M.: Medicine, 1984. — 252 p.

5. Borzov E. V. The role of perinatal factors in the formation of the pathology of the pharyngeal tonsil // news of otorhinolaryngology and logopathology. - 2002. - No. 2. - S. 7-10.

6. Kovaleva L. M., Mefedovskaya E. K. Etiology and pathogenesis of sphenoiditis in children // News of otorhinolaryngology and logopathology. - 2002. - No. 2. - S. 20-24.

7. Vocal cord injection with autogenous fat: A long-term magnetic resonance. nee imaging evaluation / J.H. Brandenburg // Laryngoscope. - 1996. - Vol. 106, No. 2, pt. 1. - P. 174-180.

By the same principle, articles from collections of papers and (or) abstracts of reports are cited.

Articles from collections:

8. Korobkov G. A. The pace of speech. Contemporary Issues physiology and pathology of speech: Sat. tr. Mosk.NIIuha, throat and nose; Leningrad. Research Institute of Ear, Throat, Nose and Speech. - M., 1989. - T. 23. - S. 107-111.

Theoretical Validation in Sociological Research: Methodology and Methods

The very essence of mixed research is research designs. Having gone almost all the way through the "Study Materials", you are ready to receive this lesson.

0 Click if it's useful =ъ

Research design is a combination of data collection and analysis requirements necessary to achieve research objectives. If we talk about ICT, then the corresponding research designs are related, first of all, to the peculiarities of the combinatorics of the elements of qualitative and quantitative approaches within the framework of one study.
The main principles of organizing designs in ICT are: 1) awareness of the theoretical orientation (theoretical drive) research project; 2) awareness of the role of borrowed components in a research project; 3) compliance with the methodological assumptions of the base method; 4) work with the maximum available number of data sets. The first principle has to do with the purpose of the inquiry (search vs. confirmation), the appropriate types of scientific reasoning (induction vs. deduction), and the appropriate methods. According to the second principle, the researcher should pay attention not only to the main data collection and analysis strategies, but also to additional ones that could enrich the main part of the research project with data that are important and cannot be obtained using the main methods. The third principle is related to the need to adhere to the fundamental requirements of working with data of one type or another. The essence of the last principle is quite obvious and is related to the attraction of data from all available relevant sources.
Often ICTs are “placed” on a continuum between qualitative and quantitative research (see Figure 4.1). So, in the presented figure, zone "A" denotes the use of exclusively qualitative methods, zone "B" - mostly qualitative, with some quantitative components, zone "C" - the equivalent use of qualitative and quantitative methods (fully integrated studies), zone "D" - mostly quantitative with some qualitative components, zone "E" - exclusively quantitative methods.


Rice. Qualitative-mixed-quantitative continuum

If we talk about specific designs of ICT, then there are two main typologies. One is suitable for the case when qualitative and quantitative methods are used on different stages one study, the other for the case when the research project uses alternating or parallel qualitative and quantitative research.
The first typology includes six mixed designs (see Table 4.2). An example of research that uses qualitative and quantitative methods at different stages is concept alignment. Within this research strategy, data is collected using qualitative methods (for example, brainstorm or focus groups) and the analysis is quantitative (cluster analysis and multivariate scaling). Depending on the tasks being solved (search or descriptive), it can be attributed either to the second or to the sixth design.
According to the second typology, nine mixed-type designs can be distinguished (see Table 3). This typology is based on two main principles. First, in mixed-type research, it is important to determine the status of each of the paradigms - whether qualitative and quantitative research have the same status, or whether one of them is considered as the main one, and the second one is subordinate. Secondly, it is important to determine how the research will be conducted - in parallel or sequentially. In the case of a sequential solution, it is also necessary to determine which of them is the first and which is the second in the time dimension. An example of a research project that fits this typology is when the first phase is a qualitative research to build a theory (for example, using the "grounded theory" of Anselm Strauss), and the second - a quantitative survey of a specific group of people, to which the developed theory is applicable and in relation to which it is necessary to formulate a forecast for the development of the corresponding social phenomenon or problems.

Table 1. Mixed study designs using qualitative and quantitative methods within the same study*

Research objectives

Data collection

Data analysis

Qualitative Goals

Quality data collection

Quantitative data collection

Quality data collection

Performing Quantitative Analysis

Quantitative data collection

Holding qualitative analysis

quantitative goals

Quality data collection

Conducting a qualitative analysis

Quantitative data collection

Performing Quantitative Analysis

Quality data collection

Performing Quantitative Analysis

Quantitative data collection

Conducting a qualitative analysis

* In this table, designs 2-7 are mixed, design 1 is completely qualitative, design 8 is completely quantitative.

Table 2. Mixed Research Designs Using Qualitative and Quantitative Research as Different Phases of the Same Research Project*

* "quality" means qualitative research, "quant" - quantitative; "+" - simultaneous research, "=>" - sequential; capital letters indicate the main status of the paradigm, small letters - subordinate.

Of course, these typologies are not limited to the full range of research designs and should be considered as possible guidelines for ICT planning.
ICT Designs in Evaluation Studies.
According to the typology of ICT designs used in assessment, two main types can be distinguished - component and integrative. In component design, although qualitative and quantitative methods are used within the framework of one study, they are used separately from each other. In integrative design, methods belonging to different paradigms, on the other hand, are used together.
The component type includes three types of designs: triangular, complementary, and expansive. In triangulation design, results from one method are used to validate results from other methods. In the case of complementary design, the results obtained using the main method are specified and refined on the basis of the results obtained using methods that are of secondary importance. When using expansive design, apply various methods to obtain information on various aspects of evaluation, i.e. each method is responsible for a specific piece of information.
The integrative type includes four types of designs: iterative, unstitched, holistic, and transformational. In iterative design, the results obtained with a method prompt or direct the use of other methods that are relevant in a given situation. Nested design is associated with situations where one of the methods is integrated into another. Holistic design involves the combined use of integrated qualitative and quantitative methods in order to comprehensively evaluate a particular program. In this case, both groups of methods have an equivalent status. Transformational design takes place when different methods are applied together to fix value views, which are subsequently used to reconfigure a dialogue whose participants adhere to different ideological positions.

Research types and focus

How to use research to transform disorganized creative process into a technological chain of actions that lead to a predictable result.

Designers with a lot of experience sometimes skip the research stage, riding on the fact that they have accumulated many patterns of ready-made solutions in their heads. But there is a high degree of randomness in this - you can make a mistake and use the wrong pattern, or simply not find what you need. For beginners, it's even more difficult.

Research helps both of them, allowing you to formalize the design process, qualitatively (with deep immersion and on high level) develop analytics and a creative concept in the allotted time.

Any unorganized creative process is like a black box. You give a designer a task, he disappears for a week, then brings something. What happened at that time and where it came from is not clear. Magic. This creates two big problems:

1. The decision is highly dependent on the life experience of the designer. The more a designer knows about the world around him, the more likely he is to draw a good design. This is a limitation. Quality is determined by subjective parameters, and should be stable.

2. Impossible to plan work by time and result. If you rely only on inspiration, insight and divine providence, then sometimes it happens that the result is obtained in three days. But if you didn’t guess correctly, then the solution of the problem stretches for three weeks.

To open the black box, you need to understand what stages the process consists of and formalize it. Then the result will be predictable.

It is very important to analyze the design process in order to move further beyond the initial ideas and emerging images. As a result, you do all this on autopilot, freeing your head to get an extraordinary result.

A sign of stagnation - if you think the same as before. This is a signal: most likely, you have stopped in development. A good sign is when from project to project all processes look more and more technologically advanced and the range of processed conventions tends to infinity. This is the only way to “dig up” truly worthwhile solutions.

Better not to use the word "guessed". It is better to appeal with facts, whether it was possible to solve the problem or not. "No" - when the decision does not stand up to criticism, and this happens if the result is based on an intuitive search. The result should always be based only on the rational and logical.

What does research provide?

Immerses the designer in context, and decisions are justified. The designer offers not just something cool, but builds logical relationships.

Allows you to build better relationships with your customers. Research is communication. You study not just the business, but also the customer and his client, and in the process you begin to better understand what the user needs, what the customer wants and how to implement it.

Primary Research

Primary research is a method of collecting information through direct interaction: interviews, observation, experiments, etc.

Primary research is divided into qualitative (in-depth interviews, observation of a person all day long) and quantitative (statistics, surveys, site analytics).

Among qualitative research allocate:

ethnography- study method Everyday life consumers. The name of the method is taken from historical science when ethnographers, exploring unfamiliar tribes, describe the way of life of people in order to understand their motives and actions. Ethnography is used when information about target audience minimal. Observations make it possible to understand different scenarios of user behavior and "entry points" - in what situations a person needs to use the product.

reflection- observation, analysis own experience. Fixation and awareness of their feelings and experiences.

Shadow Method- repetition of human actions. For example, you capture user behavior on the site, and then copy it, marking significant points.

Observations are recorded using a camera, audio and video recordings. Record the conversation on a voice recorder, give the recording for transcription, and you will have a ready-made document that will help you return to any point in the conversation. Take pictures of the people you are interviewing. If another person will work with the material in the future, the photo will help to better understand the user. Capture the interaction with the product on camera, and then you can watch the video and see some moments that you didn’t notice right away.

Design of medical clinical trials The concept of design in translation from English (design) means a plan, project, outline, construction. Methods of qualitative and quantitative research in evidence-based medicine. Clinical trials, definition, classification. Statistical analysis in evidence-based medicine. Levels of Evidence and Grades of Recommendations from Clinical Trial Results

A clinical trial is any prospective study in which patients are included in an intervention or comparison group to determine causal relationships between a medical intervention and a clinical outcome. This is the final stage of clinical research, in which the validity of new theoretical knowledge is tested. CI design is a way of conducting scientific research in a clinic, i.e. its organization or architecture.

CI design type is a set of classification features that correspond to: 1) certain typical clinical tasks; 2) research methods; 3) methods of statistical processing of results.

Classification of studies by design Observational studies (observation) are studies in which one or more groups of patients are described and observed for certain characteristics, and the researcher collects data by simply observing events in their natural course without actively interfering with them; Pilot studies - the results of an intervention (drug, procedure, treatment, etc.) are evaluated, one or two or more groups participate. The subject of research is observed.

1. Observational ↓ Descriptive Analytical ↓ Case-control case reports Cohort 2. Experimental ↓ Clinical trials

The most important requirements for medical research Proper organization(design) of the study and mathematically based method of randomization. Clearly defined and followed criteria for inclusion and exclusion from the study. Right choice criteria for outcome of the disease under the influence of treatment and without it. Location of the study Duration of the study Correct use of statistical processing methods

General principles of classical scientific research. Clinical trials Controlled - Comparison of a drug or procedure with other drugs or procedures - More common, more likely to detect differences in treatment Uncontrolled - Experience with a drug or procedure, but not compared with another treatment option - Less common, less reliable - Likely to compare procedures more than for drug comparison

Types of Clinical Questions Physicians Face in Care Deviation from the norm - Healthy or sick? Diagnosis - How accurate is the diagnosis? Frequency - How common is the condition? Risk - What factors are associated with an increased risk of the disease?

Prognosis - What are the consequences of the disease? Treatment - How will the course of the disease change with treatment? Prevention - Are there methods for preventing disease in healthy people? Does the course of the disease improve with early recognition and treatment? Cause - What factors lead to the disease? Cost – How much does it cost to treat this condition?

Types of medical studies Systematic reviews, meta-analysis Randomized clinical researches(RCT) Cohort studies Case-control study Case series, single case description In vitro and animal studies

Systematized reviews (SR) is a scientific work, where the object of study is the results of a number of original studies on one problem, i.e., the results of these studies are analyzed using approaches that reduce the possibility of systematic and random errors; are a summary of the results of various studies on a given topic and are one of the most "readable" options scientific publications, because they allow you to quickly and most fully get acquainted with the problem of interest. The purpose of the JI is a balanced and impartial study of the results of previous studies

A qualitative systematic review examined the results of original research on a single problem or system, but did not perform a statistical analysis.

Meta-analysis - the pinnacle of evidence and serious scientific research: a quantitative assessment of the total effect established on the basis of the results of all scientific studies (H. Davies, Crombie I. 1999); quantitative systematic literature review or quantitative synthesis of primary data to obtain summary statistics.

Randomized controlled trials (studies) - RCTs RCTs - in modern medical science are the universally recognized standard of scientific research for evaluation clinical effectiveness. Randomization is a method used to generate a sequence of random assignment of trial participants to groups (rand - French - chance). RCTs - Treatment Evaluation Criteria

Structure of the study in RCTs 1. Presence of a control group 2. Clear selection criteria (inclusion and exclusion) of patients 3. Inclusion of patients in the study before randomization into groups 4. Random distribution of patients into groups (randomization) 5. "Blind" treatment 6. « Blind" assessment of treatment outcomes

Design of the study - presentation of results 7. Information about complications and side effects treatment 8. Information about the number of patients who dropped out during the experiment 9. Adequate statistical analysis, there are links to the use of the article, program, etc. 10. Information about the size of the identified effect and the statistical power of the study

RCTs - comparison of the final results should be carried out in two groups of patients: Control group - no treatment is carried out or standard, traditional (conventional) treatment is carried out or patients receive a placebo; Active treatment group - treatment is being carried out, the effectiveness of which is being investigated.

A placebo is an indifferent substance (procedure) for comparing its effect with the effects of a real drug or other intervention. In clinical trials, placebo is used when using a blind method so that participants do not know what treatment they are prescribed (Maltsev V., et al., 2001). Placebo control technology is ethical in cases where the subject does not receive significant harm by doing without drugs.

Active control - a drug is used that is effective in relation to the studied indicator (the "gold standard" drug is more often used - well studied, long and widely used in practice).

Homogeneity of the compared groups - groups of patients should be comparable and homogeneous in terms of: Clinical features of the disease and comorbidities Age, gender, race

Representativeness of groups The number of patients in each group should be sufficient to obtain statistically significant results. The distribution of patients into groups should occur randomly, i.e., by random sampling, which allows to exclude all possible differences between the compared groups that could potentially affect the result of the study.

Blinding method - in order to minimize the conscious or unconscious possibility of influence on the results of the study by its participants, i.e., in order to exclude the subjective factor, the “blinding” method is used in evidence-based medicine.

Types of "blindness" Simple "blind" (single - blind) - the patient does not know about belonging to a certain group, but the doctor knows; Double "blind" (double - blind) - the patient and the doctor do not know about belonging to a certain group; Triple-blind (triple - blind) - the patient, doctor and organizers do not know about belonging to a certain group (statistical processing) Open study (open - label) - all participants in the study are aware

The results of RCTs should be practically meaningful and informative: This can only be done with a sufficiently long follow-up of patients and a low number of patient refusals to continue participation in the study (<10%).

True criteria for the effectiveness of treatment - Primary - the main indicators associated with the life of the patient (death from any cause or the main - the disease under study, recovery from the disease under study) - Secondary - improvement in the quality of life, reduction in the incidence of complications, relief of symptoms of the disease - Surrogate (indirect), tertiary - the results of laboratory and instrumental studies, which are expected to be associated with the true endpoints, i.e. with primary and secondary.

Randomized clinical trials – objective endpoint criteria should be used: Mortality from the disease Total mortality Rate of major complications Rate of rehospitalization Quality of life assessment

Cohort study (cohort group) A group of patients is selected for a similar feature that will be followed up in the future Starts with a risk factor assumption Groups of patients: - exposed to a risk factor - not exposed to a risk factor exposed group Answers the question: Will people get sick (in the future) if they are exposed to a risk factor? » . Mostly prospective, but there are also retrospective ones. Both groups are monitored in the same way. Outcome Estimates Historical cohort - selection of a cohort according to case histories, and observation at the present time.

Case-control study A study designed to determine the relationship between a risk factor and a clinical outcome. Such a study compares the proportion of participants who experienced harmful effects in two groups, one of which developed and the other did not have the clinical outcome under study. Core and control groups belong to the same risk population Core and control groups should be equally exposed Classification of disease at t = 0 Exposure is measured in the same way in both groups Can be the basis for new scientific research, theories

Case-control study (retrospective): - Outcome unknown at baseline - Cases: presence of disease or outcome - Control: no disease or outcome - Answers the question: “What happened? » -This is a longitudinal or longitudinal study

Case series or descriptive study Description of a case series - a study of the same intervention in individual consecutive patients without a control group For example, a vascular surgeon can describe the results of carotid revascularization in 100 patients with cerebral ischemia A certain number of characteristics of interest in the observed small groups are described patients Relatively short study period Does not include any research hypotheses Does not have control groups Precedes other studies This type of study is limited to individual patient data