STUDY DESIGN DEVELOPMENT

At the first stage, the design is carefully worked out (from the English. design- creative idea) for future research.

First of all, a research program is developed.

Program includes the topic, purpose and objectives of the study, formulated hypotheses, definition of the object of study, units and volume of observations, glossary of terms, description of statistical methods for forming a sample population, collection, storage, processing and analysis of data, methodology for conducting a pilot study, list of statistical tools used .

Name Topics usually formulated in one sentence, which must correspond to the purpose of the study.

Purpose of the study- this is a mental anticipation of the result of an activity and the ways to achieve it using certain means. As a rule, the goal of medical and social research is not only theoretical (cognitive), but also practical (applied) in nature.

To achieve the goal, determine research objectives, which reveal and detail the content of the goal.

The most important components of the program are hypotheses (Expected results). Hypotheses are formulated using specific statistical indicators. The main requirement for hypotheses is the ability to test them during the research process. The results of the study can confirm, correct or refute the hypotheses.

Before collecting material, the object and unit of observation are determined. Under object of medical and social research understand a statistical aggregate consisting of relatively homogeneous individual objects or phenomena - units of observation.

Unit of observation- a primary element of a statistical population, endowed with all the characteristics to be studied.

The next important step in preparing a study is the development and approval of a work plan. If the research program is a kind of strategic plan that embodies the ideas of the researcher, then the work plan (as an appendix to the program) is a mechanism for implementing research. The work plan includes: the procedure for selecting, training and organizing the work of direct performers; development of normative and methodological documents; determination of the required volume and types resource provision research (personnel, finance, logistics, information resources, etc.); determination of deadlines and those responsible for individual stages of the study. Typically it is presented in the form network graphics.

At the first stage of medical and social research, it is determined by what methods the selection of observation units will be carried out. Depending on the volume, continuous and selective studies are distinguished. In a continuous study, all units of the general population are studied, in a selective study, only a part of the general population (sample).

General population call a set of qualitatively homogeneous observation units, united by one or a group of characteristics.

Sample population (sample)- any subset of observation units of the general population.

The formation of a sample population that fully reflects the characteristics of the general population is the most important task of statistical research. All judgments about the general population based on sample data are valid only for representative samples, i.e. for such samples, the characteristics of which correspond to those of the general population.

Real sample representativeness is guaranteed by random selection, those. such a selection of observation units into a sample in which all objects in the population have the same chance of being selected. To ensure random selection, specially developed algorithms that implement this principle or tables are used random numbers, or a random number generator, available in many computer software packages. The essence of these methods is to randomly indicate the numbers of those objects that need to be selected from the entire somehow ordered general population. For example, the general population of a region can be sorted by age, place of residence, alphabet (last name, first name, patronymic), etc.

Along with random selection, when organizing and conducting medical and social research, they also use following methods formation of the sample population:

Mechanical (systematic) selection;

Typological (stratified) selection;

Serial selection;

Multi-stage (screening) selection;

Cohort method;

Copy-pair method.

Mechanical (systematic) selection allows you to form a sample using a mechanical approach to selecting units of observation of an ordered population. In this case, it is necessary to determine the ratio of the volumes of the sample and general populations and thereby establish the proportion of selection. For example, in order to study the structure of hospitalized patients, a sample of 20% of all patients leaving the hospital is formed. In this case, among all the “medical records of an inpatient” (f. 003/u), sorted by number, every fifth card should be selected.

Typological (stratified) selection involves dividing the general population into typological groups (strata). When conducting medical and social research, age-sex, social, professional groups, individual settlements, as well as urban and rural populations. In this case, the number of observation units from each group is selected randomly or mechanically proportional to the size of the group. For example, when studying the cause-and-effect relationships of risk factors and cancer incidence in the population, the study group is first divided into subgroups by age, gender, profession, social status, and then the required number of observation units is selected from each subgroup.

Serial selection the sample is formed not from individual observation units, but from entire series or groups (municipalities, health care institutions, schools, kindergartens, etc.). The selection of series is carried out using purely random or mechanical sampling. Within each series, all units of observation are studied. This method can be used, for example, to assess the effectiveness of immunization of the child population.

Multi-stage (screening) selection involves a step-by-step sampling process. Based on the number of stages, one-stage, two-stage, three-stage selection, etc. are distinguished. For example, when studying the reproductive health of women living in the territory of a municipality, at the first stage working women are selected and examined using basic screening tests. At the second stage, a specialized examination of women with children is carried out, at the third stage - an in-depth specialized examination of women with children with congenital malformations. Note that in this case of targeted selection for a specific characteristic, the sample includes all objects that are carriers of the characteristic being studied on the territory of the municipality.

Cohort method used to study a statistical population of relatively homogeneous groups of people united by the occurrence of a certain demographic event in the same time interval. For example, when studying issues related to the problem of fertility, a population (cohort) is formed that is homogeneous based on a single date of birth (study of fertility by generation) or based on a single age at marriage (study of fertility by duration of family life).

Copy-pair method provides for the selection for each observation unit of the study group of an object that is similar in one or more characteristics (“copy-pair”). For example, it is known that the infant mortality rate is influenced by factors such as the body weight and sex of the child. When using this method, for each case of death of a child under 1 year of age, a “copy pair” of the same sex, similar in age and body weight, is selected from among living children under the age of 1 year. This selection method is advisable to use to study risk factors for the development of socially significant diseases and individual causes of death.

At the first stage, research is also developed (ready-made is used) and replicated statistical tools (maps, questionnaires, table layouts, computer programs for monitoring incoming information, creating and processing information databases, etc.), into which the information being studied will be entered.

In the study of public health and the performance of the health care system, sociological studies using special questionnaires are often used. Questionnaires for medical and sociological research they must be targeted, oriented, and ensure the reliability, authenticity and representativeness of the data recorded in them. During the development of questionnaires and interview programs, the following rules must be observed: the suitability of the questionnaire for collecting, processing and extracting the necessary information from it; the ability to revise the questionnaire (without violating the code system) in order to eliminate unsuccessful questions and make appropriate adjustments; explanation of the goals and objectives of the research; clear formulation of questions, eliminating the need for various additional clarifications; fixed nature of most issues.

Skillful selection and combination of different types of questions - open, closed and semi-closed - can significantly increase the accuracy, completeness and reliability of the information received.

The quality of the survey and its results largely depend on whether the basic requirements for the design of the questionnaire and its graphic design are met. There are the following basic rules for constructing a questionnaire:

The questionnaire includes only the most significant questions, the answers to which will help obtain the information necessary to solve the main objectives of the study, which cannot be obtained in any other way without conducting a questionnaire survey;

The wording of the questions and all the words in them must be understandable to the respondent and correspond to his level of knowledge and education;

The questionnaire should not contain questions that cause reluctance to answer them. You should strive to ensure that all questions evoke a positive reaction from the respondent and a desire to provide complete and true information;

The organization and sequence of questions should be subordinated to obtaining the most necessary information to achieve the goal and solve the problems posed in the study.

Special questionnaires (questionnaires) are widely used, among other things, to assess the quality of life of patients with a particular disease and the effectiveness of their treatment. They make it possible to capture changes in the quality of life of patients that have occurred in a relatively short period of time (usually 2-4 weeks). There are many special questionnaires, for example AQLQ (Asthma Quality of Life Questionnaire) and AQ-20 (20-Item Asthma Questionnaire) for bronchial asthma, QLMI (Quality of Life after Myocardial Infarction Questionnaire) for patients with acute myocardial infarction, etc.

The coordination of work on the development of questionnaires and their adaptation to various linguistic and economic formations is carried out by the international non-profit organization for the study of quality of life - MAPI Institute (France).

Already at the first stage of statistical research, it is necessary to create table layouts, which will later be filled with the received data.

In tables as in grammatical sentences, distinguish the subject, i.e. the main thing is what is said in the table, and the predicate, i.e. something that characterizes the subject. Subject - this is the main sign of the phenomenon being studied - usually located on the left along the horizontal rows of the table. Predicate - signs characterizing the subject are usually located at the top along the vertical columns of the table.

When compiling tables, certain requirements are observed:

The table should have a clear, concise title that reflects its essence;

The design of the table ends with the totals for columns and rows;

There should be no empty cells in the table (if there is no sign, put a dash).

There are simple, group and combinational (complex) types of tables.

A simple table is a table that presents a summary of data on only one attribute (Table 1.1).

Table 1.1. Simple table layout. Distribution of children by health groups, % of total

In the group table, the subject is characterized by several predicates that are not related to each other (Table 1.2).

Table 1.2. Group table layout. Distribution of children by health group, gender and age, % of total

In the combination table, the features characterizing the subject are interrelated (Table 1.3).

Table 1.3. Combination table layout. Distribution of children by health group, age and gender, % of total

An important place in the preparatory period is occupied by pilot study, whose task is to test statistical tools and check the correctness of the developed methodology for collecting and processing data. The most successful pilot study seems to be one that repeats the main one on a reduced scale, i.e. makes it possible to check all upcoming stages of work. Depending on the results of the preliminary analysis of the data obtained during piloting, adjustments are made to the statistical tools and methods of collecting and processing information.

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:

1. 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?

1. 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?

1. 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?

1. 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 of further validating information from primary research and creating a stronger case for general 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

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:

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

Theoretical validation in sociological research: Methodology and methods

The very essence of mixed methods research is exploratory designs. Having gone almost all the way through the “Training Materials”, you are ready to receive this lesson.

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Research design is a combination of requirements regarding the collection and analysis of data necessary to achieve the objectives of the study. If we talk about information technology, then the corresponding research designs are related, first of all, to the features of the combinatorics of elements of qualitative and quantitative approaches within the framework of one study.
The main principles of organizing designs in information technology are: 1) awareness of the theoretical drive of the research project; 2) awareness of the role of borrowed components in a research project; 3) compliance with the methodological assumptions of the basic method; 4) working with the maximum available number of data sets. The first principle has to do with the purpose of the research (search vs confirmation), the appropriate types of scientific reasoning (induction vs deduction) and the appropriate methods in this case. According to the second principle, the researcher should pay attention not only to basic strategies for collecting and analyzing data, but also to additional ones that could enrich the main part of the research project with data that is important and cannot be obtained using basic 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 has to do with attracting data from all available relevant sources.
Often IST is “situated” on a continuum between qualitative and quantitative research (see Figure 4.1). Thus, in the presented figure, zone “A” indicates the exclusive use qualitative methods, zone “B” - mainly qualitative, with some quantitative components, zone “C” - equal use of qualitative and quantitative methods(fully integrated research), zone "D" - mainly quantitative with some qualitative components, zone "E" - exclusively quantitative methods.

Rice. Qualitative-mixed-quantitative continuum

If we talk about specific IST designs, there are two main typologies. One is suitable for the case where qualitative and quantitative methods are used in 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-type designs (see Table 4.2). An example of a study that uses qualitative and quantitative methods at different stages is concept alignment. In this research strategy, data collection is done using qualitative methods (e.g., brainstorming or focus groups) and analysis is quantitative (cluster analysis and multidimensional scaling). Depending on the tasks being solved (search or descriptive), it can be classified as either the second or 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 a mixed-type study, 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 - 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 first and which is second in the time dimension. An example of a research project that fits this typology would be a case where the first phase is a qualitative study to build theory (for example, using Anselm Strauss' grounded theory), and the second is a quantitative survey of a specific group of people, to 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 problem.

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

* in this table, designs 2-7 are of a mixed nature, design 1 is completely qualitative, design 8 is completely quantitative.

Table 2. Mixed-method research designs using qualitative and quantitative research as different phases of the same research project*

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

Of course, these typologies do not limit the variety of research designs, and they should be considered as possible guidelines in IST planning.
IST designs in evaluation research.
According to the typology of IST 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 same study, they are used separately from each other. In integrative design, on the other hand, methods belonging to different paradigms are used together.
The component type includes three types of designs: triangulation, complementary and expansive. In a triangulation design, results obtained from one method are used to confirm results obtained 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 of secondary importance. When using an expansive design, different methods are used to obtain information regarding different aspects of the assessment, that is, each method is responsible for a specific piece of information.
The integrative type includes four types of designs: iterative, nested, holistic and transformational. In iterative design, the results obtained from a method suggest or guide the use of other methods that are relevant to the situation. Untested design deals with situations where one method is integrated into another. Holistic design involves the combined, integrated use of qualitative and quantitative methods to comprehensively evaluate a program. Moreover, both groups of methods have equivalent status. Transformational design occurs when different methods are used together to capture values ​​that are subsequently used to reconfigure dialogue in which participants hold different ideological positions.

• 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 is unparalleled in its duration and cohort size and its implications for modern medicine, and primarily cardiology, is difficult to overestimate. 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, increased level cholesterol in the blood, 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 periods of time
• Used to test primary hypotheses
• Very short term
• Least expensive

• Flaws

• A 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 disease and exposure to relatively low large number 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

At the third stage (phase III), the drug or treatment being studied is prescribed to even larger groups of people (1000-3000 people) to confirm the effectiveness and safety, control side effects, as well as for comparison with commonly used drugs and treatments, generating information that will allow the drug or treatment to be used safely.

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 various groups people and 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

Theoretical validation in sociological research: Methodology and methods

In the social sciences, there are a variety of types of research and, accordingly, opportunities for the researcher. Knowing about them will help you solve the most difficult problems.

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Research Strategies
In the social sciences, it is customary to distinguish two most common research strategies - quantitative and qualitative.
The quantitative strategy involves the use of a deductive approach to test hypotheses or theories, draws on the positivist approach of the natural sciences, and is objectivist in nature. A qualitative strategy focuses on an inductive approach to developing theories, rejects positivism, focuses on the individual interpretation of social reality, and is constructivist in nature.
Each strategy involves the use of specific data collection and analysis methods. The quantitative strategy is based on the collection of numerical data (coding data from mass surveys, aggregated testing data, etc.) and the use of mathematical statistics methods for their analysis. In turn, the qualitative strategy is based on the collection of textual data (texts of individual interviews, participant observation data, etc.) and their further structuring using special analytical techniques.
Since the early 90s, a mixed strategy began to actively develop, which consists of integrating the principles, methods of collecting and analyzing data from qualitative and quantitative strategies in order to obtain more valid and reliable results.

Research designs
Once the purpose of the study has been determined, the appropriate type of design must be determined. Research design is the combination of requirements regarding the collection and analysis of data necessary to achieve the objectives of the study.
Main types of design:
A cross-sectional design involves collecting data from a relatively large number of observation units. Typically involves the use of a sampling method to represent the general population. Data is collected once and is quantitative in nature. Next, descriptive and correlation characteristics are calculated, and statistical conclusions are drawn.
A longitudinal design consists of repeated cross-sectional surveys to establish changes over time. It is divided into panel studies (the same people take part in repeated surveys) and cohort studies (the same people take part in repeated surveys). different groups people who represent the same general population).
Experimental design involves identifying the influence of an independent variable on a dependent variable by leveling threats that may affect the nature of change in the dependent variable.
Case study designs are designed to study one or a small number of cases in detail. The emphasis is not on the generalization of results to the entire population, but on the quality theoretical analysis and explanation of the mechanism of functioning of a particular phenomenon.

Research objectives
Among the goals of social research are description, explanation, evaluation, comparison, analysis of relationships, and study of cause-and-effect relationships.
Descriptive tasks are solved by simply collecting data using one of the methods suitable for a given situation - questioning, observation, document analysis, etc. One of the main tasks is to record data in such a way that in the future it will allow their aggregation.
To solve explanatory problems, a number of research approaches (for example, historical studies, case studies, experiments) are used to deal with the analysis of complex data. Their goal is not only to simply collect facts, but also to identify the meanings of a large set of social, political, cultural elements associated with the problem.
The general purpose of evaluation studies is to test programs or projects regarding awareness, effectiveness, achievement of goals, etc. The results obtained are usually used to improve them, and sometimes simply to better understanding functioning of relevant programs and projects.

Comparative research is used to gain a deeper understanding of the phenomenon being studied by identifying its common and distinctive features in various social groups. The largest of them are carried out in cross-cultural and cross-national contexts.
Research to establish relationships between variables is also called correlation research. The result of such studies is the production of specific descriptive information (for example, see pairwise linkage analysis). This is fundamentally quantitative research.
Establishing cause-and-effect relationships involves experimental research. In the social and behavioral sciences, there are several types of this type of research: randomized experiments, true experiments (involve the creation of special experimental conditions that simulate the necessary conditions), sociometry (of course, as Ya. Moreno understood it), garfinkeling.