Evidence-based medicine design of medical research. Design of scientific research in medicine. Professor A.O. Gusan

In UX design, research is a fundamental part of solving relevant problems and/or reducing to the “right” problems that users face. A designer's job is to understand their users. This means going beyond initial assumptions to put yourself in other people's shoes to create products that meet human needs.

Good research doesn't just end in good data, it ends in good design and functionality that users love, want, and need.

Design research is often overlooked because designers focus on what design looks like. This leads to a superficial understanding of the people for whom it is intended. Having this kind of thinking is contrary to what it isUX. This is user-centricity.

UX design is centered around research to understand people's needs and how the products or services we create will help them.

Here are some research techniques that every designer should know when starting a project, and even if they don't do research, they can communicate better with UX researchers.

Primary Research

Primary research is essentially about finding new data to understand who you are designing for and what you are planning to design. This allows us to test our ideas with our users and develop more meaningful solutions for them. Designers typically collect such data through interviews with individuals or small groups, surveys, or questionnaires.

It's important to understand what you want to research before you stop searching for people, as well as the type or quality of data you want to collect. In an article from the University of Surrey, the author draws attention to two important points to consider when conducting primary research: validity and practicality.

Data validity refers to the truth, which is what it says about the subject or phenomenon being studied. It is possible for data to be reliable without being valid.
Practical aspects of the study should be carefully considered when designing the study, for example:
– cost and budget
– time and scale
– sample size

Bryman in his book Social Research Methods(2001) identifies four types of validity that can influence the results obtained:

Measurement validity or construct validity: whether the measure being measured does what it claims to do.

That is, do church attendance statistics really measure the strength of religious belief?

Internal validity: refers to causation and determines whether the conclusion of a study or theory is a developed true reflection of the causes.

That is, is it really unemployment that causes crime or are there other explanations?

External validity: considers whether the results of a particular study can be generalized to other groups.

That is, if one type of community development approach is used in this region, will it have the same impact elsewhere?

Environmental validity: considers whether “...social scientific findings are relevant to people's everyday natural environments” (Bryman, 2001)

That is, if a situation is observed in a false setting, how might this affect people's behavior?

Secondary Research

Secondary research uses existing data such as the Internet, books, or articles to support your design choices and the context behind your design. Secondary research is also used as a means to further validate information from primary research and build a stronger case for the overall design. Typically, secondary research has already summarized the analytical picture of existing research.

It's ok to only use secondary research to evaluate your design, but if you have time, I would definitely recommended doing primary research along with secondary research to really understand who you are developing for and collecting ideas that are more relevant and compelling than existing data. When you collect user data specific to your design, it will generate better ideas and a better product.

Evaluation studies

Evaluation studies describe a specific problem to ensure usability and ground it in the needs and wants of real people. One way to conduct evaluation research is for users to use your product and give them questions or tasks to think out loud as they try to complete the task. There are two types of evaluation studies: summative and formative.

Summative assessment study. Summative assessment aims to understand the results or effects of something. She emphasizes the result more than the process.

A summary study may evaluate things such as:

Finance: Impact in terms of costs, savings, profits, etc.
Impact: Broad effect, both positive and negative, including depth, spread and time factor.
results: Whether desired or undesired effects are achieved.
Secondary analysis: Analyze existing data to obtain additional information.
Meta-analysis: integration of results from several studies.

Formative evaluation research. Formative assessment is used to help strengthen or improve the person or thing being tested.

Formative research may assess things such as:

Implementation: Monitoring the success of a process or project.
Needs: A look at the type and level of need.
Potential: the ability to use information to form a goal.

Exploratory Research

Integrating pieces of data and making sense of them is part of the exploratory research process

Exploratory research is conducted around a topic that little or no one knows about. The goal of exploratory research is to gain a deep understanding and familiarity with the topic by immersing yourself in it as much as possible to create direction for potential future use of the data.

With exploratory research, you have the opportunity to gain new ideas and create meaningful solutions to the problems that matter most.

Exploratory research allows us to confirm our assumptions about a topic that is often overlooked (i.e., incarcerated people, homelessness), providing the opportunity to generate new ideas and developments for existing problems or opportunities.

Based on an article from Lynn University, exploratory research tells us that:

Design is a convenient way to obtain background information on a specific topic.
Exploratory research is flexible and can address all types of research questions (what, why, how).
Provides the ability to define new terms and clarify existing concepts.
Exploratory research is often used to create formal hypotheses and develop more precise research problems.
Exploratory research helps determine research priorities.

Evidence-based medicine
Medical Research Design
Pivina L.M., Ph.D., assistant
Department of Internal Medicine No. 2

Previous Events

Declining infant mortality and rapid population growth
Changing the structure of morbidity from acute diseases to the predominance of chronic ones
Changing the etiological nature of diseases - from infectious agents to behavioral factors
The rapid development of medical science and the growth of medical technologies
Development of social insurance systems

What does evidence-based medicine mean?

“…conscientious, accurate, and meaningful use of the best clinical research findings to inform decisions about patient-specific care.”

(Sackett D., Richardson W., Rosenberg W., Haynes R. Evidence-based medicine. How to practice and teach EBM. Churchill Livingstone, 1997.)

Evidence-based medicine concept

The goal of the concept of evidence-based medicine is to give doctors the opportunity to find and use scientifically based facts obtained in the course of correctly conducted clinical studies when making clinical decisions, and to increase the accuracy of predicting the outcomes of medical interventions.
The concept is based on two main ideas:
Every clinical decision by a physician must be made taking into account scientific evidence.
The weight of each fact is greater, the more rigorous the method of scientific research in which it was obtained.
Paltsev M.A. 2006

When did evidence-based medicine appear?

1940 - First randomized trials (use of streptomycin for tuberculosis)
1960 - thalidomide tragedy
1962 - The US Food and Drug Administration introduced regulations requiring controlled trials of new drugs.
1971 - Cochran raised the issue of insufficient scientific evidence
1980-90 - Raising awareness of the need to include systematic reviews in clinical guidelines
1994 - first Cochrane colloquium in Oxford
1994 - EBM term
1996 - Most British doctors already know the term EBM
1996 - The British Health Secretary stated that his main task was to promote the concept of EBM
1996 - EBM term in leading British newspaper headlines
1999 - BMJ publishes a guide to EBM (US circulation ½ million)
2001 – German, Spanish, Russian, Japanese editions

EBM was named after Archie Cochrane, an English epidemiologist who pointed out the need to evaluate the role of a specific clinical intervention using controlled clinical trials and store the results in a special database on the effectiveness of health care delivery.
He was the first to formulate the concept of evidence-based medicine.

Studies have shown that
for 2/3 of patients doctors
need information, but
receive it only in
a small number of cases. Where can I get the necessary information?

Observations show that in some domestic magazines up to ½ of the articles are of an advertising nature in content, design, or related to print advertising

To keep up with the times…….

“... a doctor needs to read 10 journals, approximately 70 original abstracts per month...”
Sackett D.L. (1985)
“...you need to read 15 articles 365 days a year...”
McCrory D.C. (2002)
The time available to a practitioner for reading is less than 1 hour per week.

The relationship between the practitioner and medical information

Information boom
Difficulties in finding reliable (“evidential”) information
Difficulties in analyzing information
Difficulty making effective clinical decisions
Medical errors
Prescribing unnecessary interventions

Justification for the need for regulation

In the US, 98,000 deaths per year from medical errors (IOM, 2000)
Only 30% of medical interventions with reliably proven effectiveness
Ineffective (and sometimes harmful) interventions are common
Not everyone in need receives interventions with proven effectiveness

Use of cocarboxylase, riboxin, asparkam
Parenteral administration of vitamins as an auxiliary treatment
Prescription of angioprotectors, absorbable drugs

Preventive administration of iron and folic acid to pregnant women– positive effect on the health of mother and newborn
Mammography for early detection of breast cancer

The influence of rehabilitation training programs on the outcomes of CAD in patients who suffered myocardial infarction over 3 years of rehabilitation (meta-analysis)

Components of quality health care (Haynes et al'96)

Clinical epidemiology

DM is based on clinical epidemiology is a branch of medicine that uses the epidemiological method to obtain medical information based only on strictly proven scientific facts, excluding the influence of systematic and random errors.

How scientific research makes us feel

FraminghamHeartStudy ( Framingham Study ) Massachusetts, under the auspices Heart, Lungand Blood

FraminghamHeartStudy ( Framingham Study ) a typical example of clinical epidemiology. This study began in 1948 to investigate cardiovascular health in Framingham, Massachusetts, under the auspices National Heart Institute (later renamed National Heart, Lung and Blood Institute: National Heart, Lungand Blood Institute; NHLBI). The study initially included 5,209 men and women. In 1971, it included 5,124 representatives of the second generation of participants - “offspring”. The researchers now plan to begin examining 3,500 grandchildren of those who entered the study more than 50 years ago—the “third generation.” The study has no equal in duration and size of the cohort, and its importance for modern medicine, and primarily cardiology, can hardly be overestimated. Over the years of careful observation of study participants, the main risk factors leading to diseases of the cardiovascular system were identified: high blood pressure, high blood cholesterol, smoking, obesity, diabetes, etc. Since its inception, the study has resulted in nearly 1,200 articles published in the world's major medical journals.

Deviation from the norm Healthy or sick
Diagnosis How accurate are the methods?
Frequency How common is this disease?
Risk What factors are associated with an increased risk of disease?
Prognosis What are the consequences of the disease
Treatment How will the course of the disease change with treatment?
Prevention Are there methods to prevent the 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 this treatment cost?
diseases?

Frequency

Frequency
Risk
Forecast
Treatment
Prevention
Cause

Retrospective

Retrospective(retrospective study) – events that have already passed are assessed (for example, from medical histories)
Prospective(prospective study) - first, a research plan is drawn up, the procedure for collecting and processing data is established, and then a study is conducted according to this plan.

Classification of research by design

1. Observational studies (studies - observations)
one or more groups of patients are described and observed for certain characteristics
2. Experimental studies
the results of an intervention (drug, procedure, treatment, etc.) are assessed and one, two or more groups are involved. The subject of the study is observed

Classification of scientific clinical trials

Research structure

By time:
Cross-sectional studies
Longitudinal studies

Longitudinal studies

Description of cases

Descriptive Reviews– the most “read” scientific publications that reflect the author’s position on a specific issue
Most often the medical history of a single patient is presented.
One way to understand complex clinical situations
But has no scientific evidence

Case series and clinical cases

Types of Observational Studies Case series or descriptive study

A case series is a study of the same intervention in individual consecutive patients without a control group.
For example, a vascular surgeon might describe the results of carotid artery revascularization in 100 patients with cerebral ischemia.

Types of observational studies Case series or descriptive study, features

describes a number of characteristics of interest in observed small groups of patients
relatively short study period
does not include any research hypotheses
has no control groups
precedes other studies
this type of study is limited to data on individual patients

Case control study

A study designed to compare two groups of participants who did and did not develop a clinical outcome (usually an unfavorable one) to identify differences in the influence of certain risk factors on the development of that clinical outcome.
This study design is most suitable when trying to determine the cause of rare diseases, for example, the development of central nervous system disorders in children after the use of pertussis vaccine.

Occasions:

Occasions: presence of disease or outcome
Control: absence of disease or outcome
Possible causes or risk factors for disease are assessed retrospectively, but are not historical controls
Answers the question “What happened?”
Longitudinal or Longitudinal Study

Case-control studies

Design

Advantages and disadvantages Case-control

Advantages

Best Design for Rare Diseases or Conditions Requiring Long Time Intervals
Used to test primary hypotheses
Very short term
Least expensive

Flaws

Large number of biases and systematic errors
Depends on the quality of primary descriptions and measurements
Difficulties in selecting an appropriate control group

A study whose design allows you to follow a group (cohort) of participants and identify differences in the incidence of certain clinical outcomes among them.

A group of patients is selected for a similar symptom, which will be followed in the future
Begins with an assumption of a risk factor or outcome
Exposed to RF and Unexposed
Prospective over time, determination of the sought factors in the exposed group
Answers the question “Will people get sick if they are exposed to a risk factor?”
Mostly prospective, but there are also historical cohort (retrospective)

Design

Design

Advantages and Disadvantages of Cohort Trials

Advantages

Better designs for studying the causes of conditions, diseases, risk factors and outcomes.
Enough time to obtain rigorous evidence
Many systematic errors can be avoided (occur if the outcome is known in advance)
Allows assessment of the relationship between exposure to a risk factor and several diseases

Flaws

Longitudinal
Expensive (studies of more people)
Allows assessment of the relationship between a disease and exposure to a relatively small number of factors (those that were identified at the beginning of the study)
Cannot be used for rare diseases (sample size must be larger than the number of individuals with the disease being studied)

Types of observational (descriptive) studies Cross-sectional study (prevalence)

Data is collected at a specific point in time
Types:

Disease prevalence or outcome
Study of the course of the disease, stages

They answer the question “How much?”

Prevalence studies

Design

TERMINOLOGY

Prevalence– prevalence. Example: prevalence of IHD in the population, number of people with IHD/total population as a percentage.
Incident– primary morbidity. Example: incident of bronchial asthma in children of Semey = number of new cases of asthma in children of Semey / number of children living in Semey.
The higher the incidence (I) and the longer the disease or condition, the higher the prevalence (P)
P = I x L

RANDOMIZED CONTROLLED TRIAL (RCT) (Controlled Clinical Trials (CCT))

- GOLD STANDARD FOR ANY DIAGNOSIS AND TREATMENT METHOD.
Typically, this is a study in which participants are randomly assigned to two groups - a study group (which receives the intervention being studied) and a control group (which receives a placebo or another intervention. This study design allows the effectiveness of the interventions to be compared.

Diagram of a typical RCT

Design

Design

Placebo control

Placebo control
Active treatment
Comparative characteristics of doses

Flaws

Flaws

often takes a long time
Very expensive
Not suitable for rare diseases
Limited generalizability

Advantages

the best data for patients
less bias (systematic error)
best for evaluating effectiveness and testing interventions
If randomized, the most rigorous in design and reliable

Development of the Study Protocol

A clinical trial protocol (program) is a document that contains instructions for everyone taking part in a clinical trial, with specific tasks for each participant and instructions for completing those tasks.
The protocol ensures qualified research, as well as the collection and analysis of data, which is then submitted for review to the authorities of the control and licensing system.

Development of an Individual Registration Card

The Individual Record Card (IRC) is a means of collecting data from a paper-based study conducted at a research site. Some studies also use electronic means for these purposes.

In the first stage (phase 1) of a clinical trial, researchers study a new drug or treatment in a small group of people (20-80 people) to first determine its safety, establish a range of safe doses, and identify side effects.
In the second stage (Phase II), the drug or treatment being studied is given to a larger group of people (100-300 people) to see if it is effective and to further test its safety.

Stages (phases) of a clinical trial

In the third stage (phase III), the drug or treatment being studied is prescribed to even larger groups of people (1000-3000 people) to confirm effectiveness and safety, monitor side effects, and also for comparison with commonly used drugs and treatments, accumulating information that will allow It is safe to use this medicine or treatment.

The fourth stage (phase IV) of research is carried out after the medicine or treatment method has been approved for use by the Ministry of Health of the Republic of Kazakhstan. These studies continue testing the drug or treatment being studied to further gather information about its effects on different groups of people and to identify any side effects that occur with long-term use.

A review is a serious scientific study that clearly states the question being studied, detailing the methods used to find, select, evaluate, and summarize the results of various studies relevant to the question being studied. Systematic analysis may include meta-analysis (but is not required).

Meta-analysis

Summarizing the results of several studies on the same topic

Mainly compiled from systematic reviews. A method of statistical analysis that combines the results of several studies and presents the resulting score as a single weighted score (with larger weights usually given to larger studies or studies of higher methodological quality).

Medical Research Design Conclusions

RCT– maximum in strength, but often expensive and time-consuming
Well prepared observational studies give good results in identifying the causes of diseases, but are not sufficiently conclusive
Cohort studies– best for studying the course of diseases and identifying risk factors
Case-control studies fast and inexpensive

Selection of research methodology

Quantitative research: designed to answer the questions: “How much” and “What quantity?” Aimed at identifying relationships, usually cause-and-effect relationships, between variables.
Collection of information on the problem of interest and mathematical analysis of the obtained quantitative data.
The goal is to identify general patterns that are characteristic not only of the examined group of people, but also of the entire population as a whole, which will allow the researcher to interpret the problem and make predictions.

Qualitative research

Designed to answer the questions: “Who? Why? When? and where?" and is aimed at a deeper study of the problem.
The problem is considered from different points of view.
The purpose of the study is to reveal the principles (patterns) characteristic of the population under study, according to which the phenomena of interest to us occur and which will allow us to provide a deeper understanding of the problem.

Qualitative research

Data collection methods:

Quantitative
Tests and various measurement methods
Questionnaires
Formalized data collection
The important elements are:

Presence of a control group
Randomization

Analysis of the received data

Quantitative
Statistics

Reliability of evidence

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

Architecture is sometimes poetically called frozen music. Indeed, the influence of the external appearance of a building, and especially its internal space, on the human psyche is comparable to the influence of melody. Sometimes even a minor nuance can plunge you into sadness or, conversely, cause a feeling of vivacity, a surge of strength and joy.

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

Psychological design explores the complex of interactions in the “person-environment” system. This is the psychological basis 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 data from general psychology, social psychology (design as a channel of media systems), ethnopsychology, ethnography, sociology (an approach from the point of view of globalization of design), philosophy, cultural studies, synergetics, information science and physics.

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

The structure of psi-design includes consideration of two-way connections 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.

In the applied aspect of psi-design there are three main sections:

– formation of the integrity of ideas about the environment of human existence (in other words, diagnostics of the environment as a point of application of the transformative influence of design),

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

– design recipe for creating an environment.

Psi-design develops non-standard and independent thinking, creativity, a broad view of the world of things and Nature, and their connections. For those who master it, new bottomless sources for creativity, inspiration, and intuition open up. From this moment, 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. Supposedly we don’t know. In fact, it’s not that deep, not everything is always correct. But he tries. Conducts research, collects statistics, analyzes. He often gets carried away with theorizing and thinks about science for science's sake. But the applied part of it works, although not one hundred percent. Still, the main developments were made a long time ago and, most importantly, in the West. The basis was European thinking. Both subjects and psychologists.

As a result, the methods do not fully fit the Russian mentality, and often are not at all suitable for understanding the “mysterious Russian soul.” Strictly speaking, just as you cannot compare the intelligence of representatives of different cultures, you cannot use techniques created in a different mentality to analyze a different mentality.

In recent years, increased attention has been paid to design. Firstly, this is a new phenomenon for us. Secondly, interesting. Finally, simply beautiful. And few people realize how influential it is. In the sense of influencing a person as an environmental factor. Nobody argues anymore about the importance of ecology as an environmental factor. Moreover, all the troubles are now placed in this area. But the subject 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 and not negative. This is a separate topic, but let’s say that violating the rules of video ecology can lead to illness, including causing mental disorders. And the sick person will never guess that the reason is poor design.

The second reason is that the designer often cannot take the position of the customer and design the environment for him. When executing an order, he expresses his worldview and is guided by his taste. It is not for nothing that almost everyone complains about psychological problems with the customer as the main ones. This has already become a 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 hits the mark. Lack of objectivity.

In addition, designers often act dishonestly; they “take advantage of the customer” and impose their taste and preferences. Many people do this 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, if implemented, they will not harm him in the future. After all, the customer’s desire can be dictated by mood, fashion, or someone’s advice.

To be honest in the profession, one must admit that a designer, even though he is an artist, is still a person from the service sector. That is, “whatever you want.” A designer is obliged (literally like a doctor) to love all his customers (patients), 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 a psychological method is real. Moreover, it has already been developed and tested. The beauty is that it helps to avoid subjectivity on both sides of the contract and determine with a greater degree of certainty what the customer actually wants. As a result, a unique “design recipe” is formulated for a given customer. Similar to individual tailoring in an atelier. Specific recommendations are given on style, form, space, texture of materials, light, in accordance with the mental make-up 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 client’s worldview and self-perception through interior design. It is not easy to turn a client into a co-author (then the size of the fee will be unprofitable for the designer), but to “sew a suit according to the figure.”

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

Of course, to be fair, it must be said that the psychological technique is not a device that requires you to know a few buttons to use. It is necessary to acquire a minimum of psychological knowledge to interpret the data obtained. But this is quite realistic for an ordinary person and does not require deep knowledge.

The psychological approach to interior design conventionally includes two main functions. The most common and well-known harmonizing function is when the decor of a single room or the entire house reflects a person’s temperament, his habits and worldview. The purpose 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 assumes 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 decorative elements and accessories, the interior adapts to a particular individual, being a continuation of his inner self.

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 out and levels out undesirable features. For example, such an interior can balance an impulsive choleric person or inspire a melancholic person prone to depression. It is no secret that the popularity of Feng Shui today is largely due to the variety of methods for organizing stimulating space that this ancient teaching offers. However, followers of Feng Shui look even deeper, declaring 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 ideal would be a room design that combines both stimulating and harmonizing functions.

Interior design begins with the layout of the premises, with the creation of a certain structure of the internal space. From a psychological point of view, such structuring is of paramount importance. In fact, it sets the rhythm of life in the house and often dictates specific patterns of relationships between its inhabitants and each other and guests. Although there are countless spatial layout options, they can be boiled down to two main types: indoor and outdoor interiors. A closed-type interior implies a clear and fixed division of a single whole into several isolated rooms, each of which performs a specific function. For example, the living room cannot double as a dining room, and the bedroom cannot double as a study. From a psychological point of view, privacy, and even the intimacy of the lives of the owners of the premises, is of paramount importance here. An open interior, on the contrary, is a design embodiment of the concept of an accessible society, demonstrating a kind of life on display, 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

The publication of many scientific materials in the domestic and foreign press, as well as the experience of editing collections of scientific works that have been taking place for the 11th year of conferences of doctors of 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, doctors use its own specific research methods. However, there are general principles of methodology and methods of research work that should be followed in the process of carrying out scientific work in any branch of medicine. Any scientific work must be carried out in accordance with the international requirements of basic 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 methodology for planning scientific work and especially the issues of biostatistics have not been studied in medical higher educational institutions, therefore I consider it appropriate and useful to briefly consider the basic requirements that a doctor should follow when preparing the results of his scientific research.

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

A scientific article is a scientific work limited in scope, which sets out a reasoned system of views of the author 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 is pre-planned research, drawing up and approval of a research plan. The second includes the research process itself (collection of materials characterizing the problem being studied, accumulation of factual data about it, their systematization, development of certain ideas about the problem). The third part of the research is the presentation of the results of the scientific search (interpretation, report, publication).

When writing any scientific article, the author must provide an analytical review of the literature on the chosen topic justifying the need for this work. Most often, these can be questions on a given topic that have not been sufficiently covered to date, or the author puts forward new research methods that allow one to deepen 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 research is the characteristics of its design. The results of research work are largely determined by the correctness of the chosen research methods. To evaluate the effectiveness of new methods of diagnosis, prevention and treatment, eliminate errors and correctly interpret the results of clinical studies, they must be carried out in 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 compared groups receive different types of treatment: patients in the control group receive standard treatment (usually the best according to modern ideas), and patients in the experimental group receive a new treatment. The most important condition for ensuring the reliability of a controlled study is the homogeneity of the group of patients in terms of all characteristics that affect the outcome of the disease (gender, age, presence of concomitant diseases, severity and stage of the underlying disease, etc.). Considering the presence of many interrelated factors that determine the prognosis, as well as “hidden” prognostic factors, it is possible to achieve the most complete comparability of observation groups only by using the method of random distribution of patients into groups, i.e. randomization (random). True randomization presupposes mandatory compliance with the unpredictable nature of the distribution of patients into groups (the researcher cannot predict which group the next patient will fall 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 gender, age, severity and presence of concomitant diseases. Reliable clinical results can only be obtained with a sufficient number of observations in both groups.

Determining the optimal number of observation cases is an important stage in experimental planning. Thus, 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 as arithmetic averages. 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. Moreover, the number of observed cases in the control and experimental groups does not have to be the same. The number of cases required to conduct an experiment is determined when planning research in each specific case individually using special formulas described in a number of reference books on medical statistics.

In accordance with the International Ethical Requirements for Biomedical Research Involving Human Subjects and the International Convention on Civil and Political Rights, all medical research involving human subjects must be based on three ethical principles: respect for the individual, achievement of benefit, and fairness. In all biomedical research involving human subjects (patients or healthy), the investigator must obtain informed consent from the subjects who will participate in the trial and, if the research subject (SR) is unable to give it, informed consent from a close relative or authorized representative. Informed consent means the consent of a competent SI who has received all the necessary information, understands it adequately and makes a decision freely, without undue influence, inducement or threat. The SI should receive information about the purposes, methods, duration of the study, expected risks or discomfort, alternative procedures, the degree of confidentiality, and the ability to withdraw from the study at any time.

The section “Material and research methods” should be described in such detail that any other researcher could, if desired, reproduce the work. At the end of this section, methods for statistical processing of the results obtained and the software used for this are indicated. 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 begun to be carried out on a PC using special software packages (for example, Statgraph, etc.), which make it possible to quickly calculate average values and relative coefficients, identify the nature and strength of the relationship, the degree of reliability, and construct analytical tables, charts and graphs.

The scientific processing of the 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.). 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 must correspond to the title of the article, the goals and objectives set by the author.

The bibliography should contain all sources used. However, the citation system may be different. Each scientific journal, the editors of any collection of works has its own requirements for 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 submit his research materials.

In the domestic medical literature, the Harvard system is the most common. After referring to the author's opinion, his initials, surname, and the year of publication of the work are indicated in parentheses. In the bibliography, sources are presented in alphabetical order by author's last name. 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 placed in square brackets.

You should carefully check the output data 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 - 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 rules for compilation. - M.: Standardinform. - 2008. - 19 p.)

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

2. Blotsky A. A., Pluzhnikov M. S. The phenomenon of snoring and obstructive sleep apnea syndrome. - St. Petersburg: Spets.lit., 2002.-176 p.

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

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

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

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

7. Vocal cord injection with autogenous fat: A long-term magnetic resona. nee imaging evaluation / J.H. Brandenburg // Laryngoscope. - 1996. - Vol. 106, N 2, pt. 1. - P. 174-180.

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

Articles from collections:

8. Korobkov G. A. Rate of speech. Modern problems of physiology and pathology of speech: collection. tr. Moscow Research Institute of Ear, Throat and Nose; Leningr. Research Institute of Ear, Throat, Nose and Speech. - M., 1989. - T. 23. - P. 107-111.

Good research doesn't just end in good data, it ends in good design and functionality that users love, want, and need.

UX design is centered around research to understand people's needs and how the products or services we create will help them.

Here are some research techniques that every designer should know when starting a project, and even if they don't do research, they can communicate better with UX researchers.

Primary Research

Data validity refers to the truth, which is what it says about the subject or phenomenon being studied. It is possible for data to be reliable without being valid.
Practical aspects of the study should be carefully considered when designing the study, for example:
– cost and budget
– time and scale
– sample size

Bryman in his book Social Research Methods(2001) identifies four types of validity that can influence the results obtained:

Measurement validity or construct validity: whether the measure being measured does what it claims to do.

That is, do church attendance statistics really measure the strength of religious belief?

Internal validity: refers to causation and determines whether the conclusion of a study or theory is a developed true reflection of the causes.

That is, is it really unemployment that causes crime or are there other explanations?

External validity: considers whether the results of a particular study can be generalized to other groups.

That is, if one type of community development approach is used in this region, will it have the same impact elsewhere?

Environmental validity: considers whether “...social scientific findings are relevant to people's everyday natural environments” (Bryman, 2001)

That is, if a situation is observed in a false setting, how might this affect people's behavior?

Secondary Research

Evaluation studies

Summative assessment study. Summative assessment aims to understand the results or effects of something. She emphasizes the result more than the process.

A summary study may evaluate things such as:

Finance: Impact in terms of costs, savings, profits, etc.
Impact: Broad effect, both positive and negative, including depth, spread and time factor.
results: Whether desired or undesired effects are achieved.
Secondary analysis: Analyze existing data to obtain additional information.
Meta-analysis: integration of results from several studies.

Formative evaluation research. Formative assessment is used to help strengthen or improve the person or thing being tested.

Formative research may assess things such as:

Implementation: Monitoring the success of a process or project.
Needs: A look at the type and level of need.
Potential: the ability to use information to form a goal.

Exploratory Research

Integrating pieces of data and making sense of them is part of the exploratory research process

With exploratory research, you have the opportunity to gain new ideas and create meaningful solutions to the problems that matter most.

Based on an article from Lynn University, exploratory research tells us that:

Design is a convenient way to obtain background information on a specific topic.
Exploratory research is flexible and can address all types of research questions (what, why, how).
Provides the ability to define new terms and clarify existing concepts.
Exploratory research is often used to create formal hypotheses and develop more precise research problems.
Exploratory research helps determine research priorities.

Primary Research

Secondary Research

Evaluation studies

Exploratory Research