Pilot study design. Psychological research design

Experimental psychology It is based on practical application plans of the so-called true experiment, when in the course of the study control groups are used, and the sample is in laboratory conditions. Experimental schemes of this kind are designated as plans 4, 5 and 6.

Plan with pre-test and post-test and control group (plan 4). Scheme 4 is a classic "design" of a psychological laboratory study. However, it is also applicable in the field. Its peculiarity lies not only in the presence of a control group - it is already present in pre-experimental scheme 3 - namely, in the equivalence (homogeneity) of the experimental and control samples. An important factor in the reliability of an experiment built according to scheme 4 is also two circumstances: the uniformity of the research conditions in which the samples are located, and complete control of the factors that affect the internal validity of the experiment.

The choice of an experiment plan with preliminary and final testing and a control group is made in accordance with the experimental task and research conditions. When it is possible to form at least two homogeneous groups, the following experimental scheme is applied:

Example. For practical assimilation of the possibilities of implementing experimental plan 4, we give an example real research in the form of a laboratory formative experiment, which contains a mechanism for confirming the hypothesis that positive motivation affects the concentration of a person's attention.

Hypothesis: the motivation of the subjects is a significant factor in increasing the concentration and stability of the attention of people in the conditions of educational and cognitive activity.

Experiment procedure:

1. Formation of experimental and control samples. Participants in the experiment are divided into pairs, carefully equalized according to the indicators of preliminary testing or according to variables that are significantly correlated with each other. Members of each bunk are then “randomly” (randomized) randomly assigned to the treatment or control group.
2. Both groups are invited to work out the test "Correction test with rings" (O, and 0 3).
3. The activity of the experimental sample is stimulated. Let us assume that the test subjects are given an experimental stimulating setting (X): “Students who scored 95 or more points (correct answers) on the basis of the results of testing concentration and stability of attention, receive credit in this semester“ automatically ”.
4. Both groups are invited to work out the test "Correction test with syllables" (0 2 and OD

Algorithm for analyzing the results of the experiment

5. The empirical data are tested for the "normality" of the distribution 1. This operation makes it possible to clarify at least two circumstances. First, as a test used to determine the stability and concentration of the subjects' attention, it discriminates (differentiates) them according to a measurable attribute. IN this case normal distribution shows that the indicators of features correspond to the optimal relationship with the development situation of the applied test, i.e. the technique optimally measures the target area. It is suitable for these conditions. Secondly, the normality of the distribution of empirical data will give the right to correctly apply the methods of parametric statistics. Statistics can be used to estimate the distribution of data. A s and E x or at.
6. The calculation of the arithmetic mean M x and 5 L. standard deviations of the results of preliminary and final testing.
7. Comparison of the average values of test indicators in the experimental and control groups (О, 0 3; Oh, OD
8. Comparison of the mean values is carried out according to the Student's t-criterion, i.e. determination of the statistical significance of differences in mean values.
9. The proof of the relationships Oj = O e, O, 0 4 as indicators of the effectiveness of the experiment is carried out.
10. A study of the validity of the experiment is carried out by determining the degree of control of the factors of invalidity.

To illustrate the psychological experiment on the influence of motivational variables on the process of concentration of the subjects' attention, let us turn to the data presented in Table. 5.1.

Experiment results table, points

table 5.1

The end of the table. 5.1

Subjects		Measurement before exposure X		Measurement after exposure X
Experimental	Control group	Experimental	Control group 0 3	Experimental group 0 2	Control group 0 4

Comparison of the data of the primary measurement of the experimental and control samples - Oh! and О3 - is performed in order to determine the equivalence of experimental and control samples. The identity of these indicators indicates the homogeneity (equivalence) of the groups. It is determined by calculating the level of statistical significance of the differences in the means in the confidence interval R t-criterion of Styodeita.

In our case, the value of the Student's /-criterion between the empirical data of the primary examination in the experimental and control groups was 0.56. This shows that the samples do not differ significantly in the confidence interval /?

Comparison of the data of the primary and repeated measurements of the experimental sample - Oj and 0 2 - is carried out in order to determine the degree of change in the dependent variable after the influence of the independent variable on the experimental sample. This procedure is carried out using the / -styodeite test if the variables are measured on the same test scale or are standardized.

In this case, the preliminary (primary) and final examinations were carried out using different tests that measure concentration of attention. Therefore, it is not feasible to compare average indicators without standardization. Let's calculate the coefficient of correlation between the indicators of the primary and final research in the experimental group. Its low value can serve as indirect evidence that data change has taken place. (R xy = 0D6).

The experimental effect is determined by comparing the data of repeated measurements of the experimental and control samples - 0 2 and 0 4. It is performed in order to identify the degree of significance of the change in the dependent variable after exposure to the independent variable. (X) on an experimental sample. The psychological meaning of this study is to assess the impact of X on the subjects. In this case, the comparison is made at the stage of the final measurement of the data of the experimental and control groups. Impact analysis X is carried out using the Student's / -criterion. Its value is 2.85, which is more than the table value of the / -criterion 1. This shows that there is a statistically significant difference between the mean test values in the experimental and control groups.

Thus, as a result of the experiment according to plan 4, it was revealed that in the first group of subjects, which does not differ from the other group in terms of the setting psychological characteristics(according to the indicator of concentration of attention), except for the influence on it of the independent variable X, the value of the indicator of concentration of attention is statistically significantly different from the analogous indicator of the second group, which is in the same conditions, but outside the influence X.

Consider a study of the validity of an experiment.

Background: controlled due to the fact that events occurring in parallel with the experimental impact are observed both in the experimental and in the control groups.

Natural development: controlled due to the short period between tests and the period of exposure and takes place in both the experimental and control groups.

Testing effect and instrumental error: controlled because they appear in the same way in the experimental and control groups. In our case, there is a sampling bias of 1.

Statistical Regression: controlled. First, if randomization led to the emergence of extreme results in the experimental group, then they will appear in the control group, as a result of which the regression effect will be the same. Secondly, if the randomization of ns led to the appearance of extreme results in the samples, then this question is removed by itself.

Selection of subjects: controlled because the explanation for differences is excluded to the extent that randomization ensures that the samples are equivalent. This degree is determined by the sample statistics we have adopted.

Elimination: controlled completely, since the period between tests in both samples is relatively small, as well as through the need for the presence of the test subjects. In experiments with a long exposure period (the period between tests), a bias in the sample and the effect of the experimental results is possible. A way out of this situation is to take into account, when processing the results of the preliminary and final testing, all participants in both samples, even if the subjects of the experimental group did not receive an experimental effect. the effect X, apparently will be weakened, but there will be no sampling bias. The second solution entails a change in the experimental design, since it is necessary to achieve the equivalence of the groups by randomization before the final testing:

The interaction of the selection factor with natural development: controlled by forming a control equivalent group.

Reactive effect: pretesting really does tune the subjects to perceive the experimental impact. Therefore, the effect of exposure is "shifted". It is unlikely that in this situation it can be absolutely asserted that the results of the experiment can be extended to the entire population. Controlling the reactive effect is possible to the extent that repetitive surveys are common across the entire population.

Interaction of selection factor and experimental influence: in a situation of voluntary consent to participate in the experiment, there is a threat of validity ("bias") due to the fact that this consent is given by people of a certain personality type. Randomizing equivalent samples reduces invalidation.

Subjects' reaction to the experiment: the experimental situation leads to a bias in the results, as the subjects find themselves in "special" conditions, trying to understand the meaning of this work. Hence, manifestations of demonstrativeness, play, alertness, attitudes towards guessing, etc. are frequent. Any element of the experimental procedure can cause a reaction to the experiment, for example, the content of the tests, the randomization process, the division of participants into separate groups, the keeping of the subjects in different rooms, the presence of strangers, the use of an extraordinary X etc.

The way out of this difficulty is the "masking" of the study, i.e. drawing up and strict adherence to a system of legendary experimental procedures or their inclusion in the usual course of events. For this purpose, it seems the most rational to conduct testing and experimental exposure under the guise of regular verification activities. When researching even individual members of a group, it is desirable to participate in the experiment of the collective as a whole. It seems expedient to carry out testing and experimental influence by means of full-time managers, teachers, activists, observers, etc.

In conclusion, it should be noted that, as D. Campbell pointed out, the optimal method for determining the effect of an experiment can still be “ common sense"And" considerations of a non-mathematical nature. "

R. Solomon's plan for four groups (plan 5). In the presence of certain research conditions that allow the formation of four equivalent samples, the experiment is built according to scheme 5, which was named after its author - "Solomon's plan for four groups":

Solomon's plan is an attempt to compensate for factors that threaten the external validity of the experiment by involving in the experiment two additional (to plan 4) groups that are not subject to preliminary measurement.

Comparison of data for additional groups neutralizes the impact of testing and the influence of the experimental setting itself, and also makes it possible to better generalize the results. Revealing the effect of experimental exposure is reproduced by statistically proving the following inequalities: 0 2> Oj; 0 2> 0 4; 0 5> About b. If all three relations are satisfied, then the validity of the experimental conclusion much increases.

The use of plan 5 determines the likelihood of neutralizing the interaction of testing and experimental exposure, which facilitates the interpretation of the research results according to plan 4. Comparison of O b with O, and 0 3 reveals the combined effect of natural development and background. Comparison of averages 0 2 and 0 5, 0 4 and 0 0 makes it possible to assess the main effect of preliminary testing. Comparison of the average () 2 and 0 4, 0 5 and 0 G) allows us to estimate the main effect of the experimental exposure.

If the pretesting and interaction effects are small and negligible, then it is advisable to conduct a covariance analysis of 0 4 and 0 2 using the results of the pretest as a companion variable.

A plan with a control group and testing only after exposure (plan 6). Very often, when performing experimental tasks, researchers are faced with the situation of the need to study psychological variables in conditions of impossibility of preliminary measurement of the psychological parameters of the subjects, since the study is carried out after the influence of independent variables, i.e. when the event has already occurred and it is necessary to identify its consequences. In this situation, the optimal experimental design is a design with a control group and testing only after exposure. Using randomization or other procedures that ensure optimal selective equivalence, homogeneous experimental and control groups of subjects are formed. Testing of variables is carried out only after experimental exposure:

Example. In 1993, by order of the Research Institute of Radiology, a study of the effect of radiation exposure on the psychological parameters of a person was carried out 1. The experiment was built according to plan 6. A psychological examination was carried out of 51 liquidators of the consequences of the accident at Chernobyl nuclear power plant by battery psychological tests(personality questionnaires, SAN (Well-being. Activity. Mood), Luscher's test, etc.), EAF according to R. Voll and the automated situational-diagnostic game (ASID) "Test". The control sample consisted of 47 specialists who did not participate in radiological activities at the Chernobyl NPP. The average age of the subjects of the experimental and control groups was 33 years. The subjects of both samples were optimally correlated in terms of experience, occupation and structure of socialization; therefore, the formed groups were considered equivalent.

We will produce theoretical analysis the plan on which the experiment was built and its validity.

Background: controlled because the study used an equivalent control sample.

Natural development: was controlled as a factor of experimental influence, since there was no intervention of the experimenters in the process of socialization of the subjects.

Testing effect: controlled since ns was preliminary testing of the subjects.

Instrumental error: monitored as a preliminary plausibility check was carried out methodological tools and clarification of their normative indicators after the experiment, as well as the use of the same type of "test battery" in the control and experimental groups.

Statistical Regression: controlled by working out the experimental material on the entire sample, formed in a random order. However, there was a threat to validity due to the fact that there were no preliminary data on the composition of the experimental groups, i.e. probability of occurrence and polar variables.

Selection of subjects ", not fully controlled due to natural randomization. There was no special selection of subjects. In a random order, groups were formed from the participants in the liquidation of the accident at the Chernobyl nuclear power plant and chemical specialists.

Screening out test subjects, during the experiment was not.

Interaction of the selection factor with natural development ", a special selection of ns was carried out. This variable was monitored.

Interaction of group composition and experimental impact ", there was no special selection of subjects. They were not informed about which of the study groups (experimental or control) they belong to.

The reaction of the subjects to the experiment ", uncontrollable factor in this experiment.

Mutual interference (superposition) of experimental influences: was not controlled due to the fact that it was not known whether the subjects participated in such experiments and how this affected the results psychological testing... By observing the experimenters, it turned out that, in general, the attitude towards the experiment was negative. It is unlikely that this circumstance had a positive effect on the external validity of this experiment.

Experiment Results

1. A study of the distribution of empirical data, which had a bell-shaped appearance, close to the theoretical normal distribution curve, was carried out.
2. Using the Student's t-criterion, a comparison of the means Oj> 0 2 is made. Submitted by ASID "Test" and EAF, the experimental and control groups differed significantly in the dynamics of emotional states (among the liquidators - higher), the effectiveness of cognitive activity (the liquidators showed a decrease), as well as the functioning of the locomotor apparatus, liver, kidneys, etc. due to chronic endogenous intoxication.
3. Using Fisher's ^ -test, the influence of "fluctuations" (variance of the independent variable) was calculated X on the variance of the dependent variable 0 2.

As a conclusion of this study, appropriate recommendations were made to the participants in the experiment and their leaders, the diagnostic battery of psychological tests was validated, and psychophysiological factors affecting people in extreme radiological conditions were identified.

Thus, the experimental "design" 6 represents the optimal scheme of psychological research when it is not possible to make a preliminary measurement of psychological variables.

From the foregoing, it follows that the basis of the experimental method in psychology is the so-called true plans, in which control of almost all the main factors affecting internal validity is carried out. The reliability of the results in experiments designed according to schemes 4-6 does not raise doubts among the vast majority of researchers. The main problem, as in all other psychological studies, is the formation of experimental and control samples of subjects, the organization of the study, the search and use of adequate measuring instruments.

The R symbol in the scheme denotes that the homogeneity of the groups was obtained by randomization. This symbol can be arbitrary, since the homogeneity of the control and experimental samples can be ensured by other means (for example, pairwise selection, preliminary testing, etc.). The value of the correlation coefficient (0.16) reveals a weak statistical relationship between measurements, i.e. it can be assumed that there has been some change in the data. The values after exposure do not match those before exposure. EAF - the Voll method (German: Elektroakupunktur nach Voll, EAV) is a method of electrical express diagnostics in alternative (alternative) medicine by measuring the electrical resistance of the skin. The method was developed in Germany by Dr. Reynold Voll in 1958. In essence, it is a combination of acupuncture and the use of a galvanometer.
Assessment of the psychological status of servicemen - liquidators of the Chernobyl accident using the dynamic situational game "Test" / I. V. Zakharov, O.S. Govorukha, I. II. Poss [et al.] // Military Medical Journal. 1994. No. 7. S. 42-44.
Research B. II. Ignatkin.

A medical death certificate is an important medical document certifying the fact of a person's death for state registration with a civil registry office, and is the basis for statistics on causes of death.

In accordance with the Federal Law "On Acts of Civil Status" dated 15.11.97. No. 143-FZ, registration of a person's death is carried out on the basis of a document of the established form "Medical Certificate of Death". Registration of a child born dead, or born alive, but died in the first week of life, is carried out on the basis of the document "Medical certificate of perinatal death". These documents are issued by a medical organization or a private practitioner.

The previous revision of the Medical Certificate of Death (registration form 106 / y-98) and the Medical certificate of perinatal death (registration form 106 / 2u-98) was carried out in 1998. These forms (of the established sample) were approved by order of the Ministry of Health of Russia dated 07.08.98. No. 241.

In international practice, death certificates are revised after about 10 years. The purpose of the revision is to adapt the forms to the changed conditions, taking into account the achievements of domestic and foreign healthcare.

Over the past 10 years, a certain amount of experience has been accumulated in working with valid death and perinatal death certificates.

The aim of our study was to develop proposals to improve the reliability and international comparability of mortality statistics.

Research objectives:

Examine the existing system for collecting and processing statistics on mortality and the application of standards for medical certificates of death.
Analyze the filling and processing of medical certificates of death and perinatal death and, on the basis of an expert assessment, determine the reliability of the statistical data on mortality in the studied territories.
Develop proposals for improving mortality records.
To develop a system for training specialists on the methodological foundations of achieving the reliability of causes of death.
To develop and implement a methodological package of programs for the use of ICD-10 (RUTENDON ").
Develop a set of programs "Monitoring mortality" with automated selection and coding of the initial cause of death.

Materials, methods and research bases.

We analyzed 120,715 medical death certificates and 1,093 medical certificates of perinatal death for different years from 2000 to 2006 in Tula, Vladimir, Kurgan, Tyumen regions, Stavropol and Krasnoyarsk territories and the Republic of Buryatia.

In the present study, we used continuous and selective methods, expert assessment and the package of programs "Monitoring of fertility and mortality".

The materials, databases and methods used made it possible to solve the assigned tasks.

As a result of the study, it was found that the existing system of registration, processing and presentation of information on mortality in Russia basically corresponds to the WHO recommendations. At the same time, there are deviations from international definitions in state mortality statistics.

The quality of filling out the certificates was analyzed and shortcomings in the certificate itself, errors in filling out, coding and choosing the initial cause of death were identified.

Duplicate items were identified in the medical certificate of death (paragraphs 14, 15 and 18), which leads to errors and discrepancies when filling out the certificate in case of injuries and poisoning. In clause 8 of the spine and clause 18 "Cause of death" of the evidence, there are unnecessary interlinear translations, i.e. they are correct only when there is enough information for all three lines. If there is information on one or two lines, then the rules for filling out the certificate are violated, i.e. the third line is filled in with the first and second empty.

Established, albeit isolated, violations of registration of death. For example, in the Tula region, these violations amounted to 0.4%, in the Stavropol Territory - 5.5%.

Expert review filling out the medical certificate of death showed that basically all the points of the certificate are filled. At the same time, clause 12 "Education" is filled in only in 36.1% of cases, clause 13 "Where and by whom he worked" - in 50% of cases, and in other cases the information is unknown. At the same time, this information is very important, since explain the social status of the deceased and are widely used in the analysis of mortality.

Errors were found when filling out item 18 "Cause of death": from 23.6 to 47.4% in different territories, when choosing the initial cause of death - from 5.9 to 15.4% and when coding: from 27.9 to 52 ,nine%.

Thus, the problem lies in the fact that the reliability of information on mortality in general for the subjects Russian Federation is about 50%.

These errors distort the actual structure of the causes of total mortality in the studied regions and give an incorrect idea of the medical and demographic processes.

Serious shortcomings and distortions of the indicators of causes of death are explained by the lack of uniform training methods for specialists in filling out medical certificates of death and perinatal death.

The absence of instructions on the procedure for filling out and issuing a medical death certificate significantly reduces its quality.

Solving the research tasks, from 1999 to 2006, the following works were performed:

106 seminars were held on the use of ICD-10, the rules for filling out a medical certificate of death and coding, covering 6977 trainees;
a methodological package of programs for the use of ICD-10 "RUTENDON" was developed and implemented at 87 sites (30 in the constituent entities of the Russian Federation, 51 in the NIS, 6 in the countries of Eastern Europe);
a complex of programs "Monitoring of fertility and mortality" was developed with automated selection and coding of the initial cause of death and introduced into the health care of 19 constituent entities of the Russian Federation (Tula, Vladimir, Bryansk, Kirov, Sverdlovsk, Kurgan, Tyumen, Belgorod, Saratov, Yaroslavl regions, Krasnoyarsk and Stavropol Territories , Republic of Buryatia, Dagestan, Tyva, Udmurtia and Chuvashia, Yamalo-Nenets and Khanty-Mansi autonomous regions). The introduction of this complex of programs into health care practice makes it possible to increase the reliability of causes of death by 18%.

We consider the decision of the Ministry of Health and Social Development of the Russian Federation to revise the medical certificate of death and perinatal death with the simultaneous development of instructions for new certificates.

At the same time, we believe that the drafts of new certificates and instructions presented for discussion require revision, since they complicated and did not correct the shortcomings of the existing documents.

We propose to make the following changes to the draft of the new medical certificate of death:

remove "live__years, __months, __days", tk. the accounting statistical document should not be complicated if the dates of birth and death are recorded;
remove the records of the timing of prematurity, full-term and post-term, transfer these explanations to the instructions;
replace the entry for term of full-term pregnancy from (37-42 weeks) to (37-41 weeks), because in accordance with ICD-10, full-term pregnancy is considered from 37 complete weeks to less than 42 complete weeks (259-293 days);
replace the mother's date of birth with the mother's age (full years);
exclude clauses 13 and 15, since it duplicates paragraph 19, which is more informative;
remove subscripts from clause 19 "Causes of death" and transfer them to the instructions, where you can describe in detail the rules for filling out this clause;
replace in clause 19 "Causes of death" english letters in the names of lines a), b), c), d) into Russian letters a), b), c), d);
include in clause 19 "Causes of death" an additional column "Approximate period of time between the onset of the pathological process and death" recommended by ICD-10;
reduce item 20 to its previous size, limiting information about the current pregnancy and pregnancy during the year preceding death, because in Russia, monitoring of maternal mortality is carried out, where you can get all the information in paragraph 20.

The instruction "On the procedure for filling out and issuing a medical death certificate, approved by order of the USSR Ministry of Health No. 1300 dated November 19, 1984, was not reissued, despite the fact that the medical death certificate was revised in 1998, registration form No. 106 / u-98 approved by order of the Ministry of Health of Russia dated 07.08.98, No. 241.

Development and widespread implementation of the Instruction on the procedure for filling out and issuing a medical death certificate is relevant, since will reduce 10% of errors and will help to increase the reliability of the causes of death of the population of the Russian Federation.

The draft Instruction was prepared on the basis of the Instruction on the procedure for filling out and issuing a medical certificate of death, developed at the Central Research Institute of Health of the Ministry of Health of the Russian Federation in 1998, and in general complies with the requirements of ICD-10.

At the same time, in order to increase the reliability of the causes of death and in accordance with the WHO recommendations, we propose to introduce fundamental amendments to the draft Instructions:

to allow the nursing staff (paramedic, midwife) to write out a medical death certificate in the absence of a doctor and replace the entry "who do not have medical staff positions in the medical organization" with the entry "do not have medical personnel in the medical organization", because there may be a case when there is a doctor's position in the staff, but he is not physically, he is on vacation, in the hospital, etc.;
transfer the definitions "premature", "full-term" and post-term from the certificate to the instruction, correcting the term of full-term at 37-41 weeks of pregnancy;
to correct the entry "including as a result of an accident, poisoning and injury" in the case of pregnancy related to the entry "with the exception of an accident, poisoning and injury, HIV infection and obstetric tetanus", because deaths from these causes are not included in maternal mortality;
fix codes in examples 5, 7, 10 and 13

During the study, medical certificates of perinatal death were studied in detail in order to determine the correctness of filling out the document, coding and choosing the main disease (condition) of the child that led to death, and the main disease of the mother, which had an adverse effect on the child. An expert assessment was carried out separately for live-born and still-born children. Significantly more errors were found when filling in the causes of death and processing data on stillborn children.

Errors in paragraph 18 "Causes of death" in the dead were grouped into 5 groups (Tula region and Stavropol Territory, respectively):

when filling out a medical certificate of perinatal death "(18.9-40.5%),
when choosing the underlying disease in a child (10.8-20.3%),
when choosing the main disease of the mother that had an adverse effect on the child (62.2-60.8%),
in choosing the code of the child's underlying disease (73-77%),
in choosing the code of the main disease of the mother (67.5-91.9%)

Thus, as a result of the study, it was found that the existing system for collecting and processing medical certificates of perinatal death in the Tula region and the Stavropol Territory does not ensure the reliability of statistical indicators of the causes of death.

One of the important factors influencing the increase in the reliability of perinatal mortality statistics is the restructuring of the accounting system and bringing it in line with international rules.

The draft medical certificate of perinatal death proposed by the Ministry of Healthcare of the Russian Federation marked the transition to a new perinatal period, and also added separate items on the signs of life, recommended by WHO and corresponding to ICD-10.

The transition to a new perinatal period will somewhat worsen our indicators of perinatal mortality, taking into account that up to 2% of fetuses with a body weight of 500 g to 999 g are born in our country, but it will ensure the comparability of our indicators with those of developed countries.

At the same time, we propose to make some changes to the draft medical certificate of perinatal death:

exclude the entry "filled in for stillbirths and live births, who died during the first 0-6 days (169 hours) after birth" and transfer this entry to the instruction;
exclude from all points of the certificate the word "fetus", leaving in those points that relate to previous pregnancies, tk. medical certificates of perinatal death are not filled in for fetuses;
exclude in clause 30 the words "by a doctor who certified death", on the basis of "examination of the corpse" and "autopsy data can be obtained later," a preliminary certificate is issued.

We consider it expedient to simultaneously develop a new medical certificate of perinatal death and the instruction "On the procedure for filling out and submitting to the civil registration authorities a medical certificate of perinatal death and registration of deaths of children in the perinatal period"

The novelty of the proposed project is the transition to a new perinatal period from 22 full weeks of intrauterine life of the fetus to 7 full days after birth, which is in line with the WHO recommendations.

The transition to a new perinatal period will entail a transition to a new definition of the concept of a child and fetus. This means that previously considered fetuses weighing from 500 to 999g will be considered children and will be subject to universal registration, like children, including those who died before 7 days after birth and stillborn.

In order to increase the reliability of perinatal mortality statistics, we propose to include in the instruction the following definitions of the concepts of "child" and "fetus", if we count the perinatal period from 22 full weeks of fetal life to 7 full days after birth.

A child is a product of human conception after complete expulsion or removal from the body of a mother with a birth weight of 500 g or more, with a gestation period of 22 weeks or more, a body length of 25 cm or more from the apex of the crown to the heels, regardless of single or multiple childbirth.

The fetus is the product of human conception after complete expulsion or removal from the body of a mother with a birth weight of 499 g or less, with a gestational age of less than 22 weeks, a body length of less than 25 cm from the apex of the crown to the heels, regardless of single or multiple births.

The leading criterion in determining "child" or "fetus" is body weight, but if birth weight is unknown, appropriate criteria should be used to determine the gestational age or be guided by the body length from the top of the crown to the heels.

We suggest making changes to the draft instructions:

add the words "medical certificate of perinatal death (f.106 / 2u-98) is filled in for children, stillbirths and live births, who died within 0-6 days (169 hours) after birth";
exclude the word "fetus" in the instructions, except for cases related to previous pregnancies;
add the following established order of paperwork:
a medical certificate of birth and perinatal death is not issued for the "fetus"; "Fruits" are not subject to registration;
a “child” born dead is issued a medical certificate of perinatal death and a medical birth certificate is not issued;
for a "child" who was born alive and died in the first week of life, a medical certificate of birth and a medical certificate of perinatal death are simultaneously issued;
fix codes for Congenital anomalies on Q00-Q99;
clarify the text and correct the codes in examples 4 and 5.

Thus, the improvement of registration documentation of mortality statistics is one of the factors that can increase the reliability by 10%, and the transition to the perinatal period, recommended by WHO, will allow international comparison of demographic indicators. After the transition to a new perinatal period, it is important to define the concepts of "child" and "fetus".

Please leave comments only on the topic.
You can leave your comment using any browser other than Internet Explorer older than 6.0

The review tells about the methodological book of the American professor D. Morgan. Describes in detail the strategies for integrating qualitative and quantitative methods, options for research designs.

Strekalova N.D. state university... 2014. No. 4. S. 184-197.

The article reveals the essence of the case method as a research strategy, the foundations of the methodology and research design in management. The strengths and weaknesses of using the case method in conducting scientific research masters of management. Are given comparative characteristics research and educational cases. The experience of organizing research is highlighted, problems, opportunities and prospects of using the case method in the formation of research competencies of masters of management are discussed. In conclusion are given practical advice on the organization of scientific research of masters of management based on the case method. The article contributes to a comparative analysis of educational and research cases, a description of the research methodology and design, identification of the strengths and weaknesses of the case study as a research method.

The paper discusses methodological solutions to the problem typical for European Union research “ n= 1 "- the problem of the uniqueness of the EU, leading, it would seem, to the impossibility of conducting comparative studies. However, the penetration of comparative political science into European studies and the study of the EU within the framework of the new regionalism led to a surge in the number of articles using the comparative method. An analysis of four scientific journals shows that this trend is characteristic of English-language, but not Russian-language journals.

Savinskaya O.B. In the book: Sociology and Society: Social Inequality and Social Justice (Yekaterinburg, October 19-21, 2016). Materials of the V All-Russian Sociological Congress. M .: Russian society Sociologists, 2016.S. 8467-8475.

This work is a methodological reflection of the current discussions about the formation of a new methodological approach- a strategy of mixing methods (mixed methods research), in which it is supposed to combine qualitative and quantitative methods of collecting and analyzing data for a thorough study of a social phenomenon. The report examines the main steps in the development of a method mixing strategy (MMR), a discussion of the Russian-language translation of the term and the current classifications of research designs for multi-method studies. Achievements and outstanding issues are highlighted in the last part of the article.

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

First of all, a research program is being 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, collection, storage, processing and analysis of data, methodology for conducting a pilot study, a list of statistical tools used ...

Name themes usually formulated in one sentence, which should be consistent with 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 with the help of certain means. As a rule, the goal of medical and social research is not only theoretical (cognitive), but also practical (applied).

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

The most important component of the program are hypotheses (Expected results). Hypotheses are formulated using specific statistics. The main requirement for hypotheses is the ability to test them in the research process. Research results can confirm, correct or disprove the hypotheses put forward.

Before the collection of the material, the object and the unit of observation are determined. Under object of medical and social research understand the statistical population, consisting of relatively homogeneous separate objects or phenomena - units of observation.

Observation unit- the primary element of the statistical population, endowed with all the characteristics to be studied.

The next important operation in the preparation of the study is the development and approval of the work plan. If the research program is a kind of strategic design that embodies the ideas of the researcher, the work plan (as an appendix to the program) is a research implementation mechanism. The work plan includes: the order of selection, training and organization of work of direct executors; development of regulatory and methodological documents; determination of the required volume and types of resource support for research (personnel, finance, material and technical, information resources, etc.); determination of the terms and those responsible for the 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 sample studies are distinguished. With a continuous study, all units of the general population are studied, with a sample - only a part of the general population (sample).

The general population call a set of qualitatively homogeneous units of observation, combined by one or a group of signs.

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 the indicators of the general population.

The real provision of representativeness of the sample is guaranteed by random selection, those. such a selection of observation units in the sample, in which all objects of the general population have the same chances of being selected. To ensure randomness of selection, specially developed algorithms are used that implement this principle, either tables of random numbers, or a random number generator available in many computer software packages. The essence of these methods consists in indicating in a random way the numbers of those objects that must be selected from the entire general population ordered in some way. For example, the general population “population of the 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, the following methods of forming a sample are also used:

Mechanical (systematic) selection;

Typological (stratified) selection;

Serial selection;

Multi-stage (screening) selection;

Cohort method;

Copy-pair method.

Mechanical (systematic) selection allows for the formation of a sample using a mechanical approach to the selection of observation units of an ordered general population. In this case, it is necessary to determine the ratio of the volumes of the sample and the general population 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 who left the hospital is formed. In this case, among all the "medical records of an inpatient" (f. 003 / y), sorted by numbers, every fifth card should be selected.

Typological (stratified) selection assumes a breakdown of the general population into typological groups (strata). When conducting medical and social research, age-sex, social, professional groups, individual settlements, as well as the urban and rural population are taken as typological groups. In this case, the number of observation units from each group is selected in the sample by a random or mechanical method in proportion to the size of the group. For example, when studying the causal relationships of risk factors and oncological morbidity, the population is preliminarily divided into subgroups by age, sex, 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 whole series or groups (municipalities, health care institutions, schools, kindergartens, etc.). The selection of series is carried out using proper random or mechanical sampling. Within each series, all observation units are examined. This method can be used, for example, to assess the effectiveness of the immunization of the child population.

Multistage (screening) selection assumes gradual sampling. By 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 the municipality, at the first stage, working women are selected, who are 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 purposeful selection according to a specific feature, all objects - carriers of the studied feature on the territory of the municipality - are included in the sample.

Cohort method are used to study the statistical population of relatively homogeneous groups of persons united by the onset 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 on the basis of a single date of birth (study of fertility by generations) or on the basis of a single age of marriage (study of fertility by the length of family life).

Copy-pair method provides for the selection for each observation unit of the investigated group of an object that is close in one or several characteristics ("copy-pair"). For example, it is known that the infant mortality rate is influenced by factors such as body weight and sex of the child. Using this method for each death of a child under 1 year old, 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. It is advisable to use this selection method to study risk factors for the development of socially significant diseases, individual causes of death.

At the first stage, research is also developed (ready-made is used) and replicated statistical toolbox (maps, questionnaires, table layouts, computer programs control of incoming information, formation and processing of information databases, etc.), in which the studied information will be entered.

In the study of public health and the performance of health systems, it is often used sociological research using special questionnaires (questionnaires). Questionnaires (questionnaires) for medico-sociological research should be targeted, focused, ensure the reliability, reliability 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 possibility of revising 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 wording of questions, eliminating the need for various additional clarifications; fixed nature of most of the questions.

Skillful selection and combination of various 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 to obtain the information necessary to solve the main tasks of the research, which cannot be obtained in another way without conducting a questionnaire survey;

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

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

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

Special questionnaires (questionnaires) are widely used, among other things, to assess the quality of life of patients with a particular disease, the effectiveness of their treatment. They allow you 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 an international non-profit organization for the study of the quality of life - the MAPI Institute (France).

Already at the first stage of statistical research, it is necessary to draw up layouts of tables, which will subsequently be filled with the obtained data.

In tables as in grammatical sentences, distinguish between the subject, i.e. the main thing that is said in the table, and the predicate, i.e. what characterizes the subject. Subject - this is the main feature of the phenomenon under study - usually located on the left along the horizontal lines of the table. Predicate - signs that characterize 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 not be empty cells in the table (if there is no sign, put a dash).

Distinguish between simple, group and combination (complex) types of tables.

A simple table is called a table in which a summary summary of data is presented for only one criterion (Table 1.1).

Table 1.1. Simple table layout. Distribution of children by health groups,% of the 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 groups, sex and age,% of the total

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

Table 1.3. Combination table layout. Distribution of children by health groups, age and sex,% of the total

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