Methods for determining the quality of life. The indicator of quality of life in modern medicine Development of the doctrine of the quality of life in medicine

For citation: Guryleva M.E., Zhuravleva M.V., Aleeva G.N. Criteria of quality of life in medicine and cardiology. breast cancer. 2006;10:761.

The history of the science of quality of life (QOL) begins in 1947, when D.A. Karnovsky published the work: "Clinical Evaluation of Chemotherapy in Cancer", where he comprehensively examined the personality of a person suffering from somatic diseases. The development of this direction was also promoted by the biopsychological model of medicine proposed in 1980 by Dr. Engel, the essence of which was the consideration of the psychosocial aspects of the disease. Since the 1980s, an avalanche-like growth of scientific publications on the fundamental study of the quality of life has been recorded. An important role in the development of the research methodology is played by the studies of A. McSweeny, who proposed to assess QOL based on four aspects (emotional, social functioning, daily activity and leisure), N. Wenger, who identified three main parameters for assessing QOL: functional ability, perception , symptoms and nine subparameters (daily routine, social and intellectual activity, perception of general health, symptoms of underlying and concomitant diseases, economic status, well-being, life satisfaction), and Sosso.G., who defined QoL as an individual ratio of one's position in society in the context of his culture and value systems with the goals of this individual, his plans, opportunities and degree of disorder. According to the definition of this concept presented in the Great Medical Encyclopedia of the United States, the quality of life is considered as “the degree of satisfaction of human needs”, and in the works of the Research Institute of Pulmonology of the Ministry of Health and Social Development of the Russian Federation “QoL is the degree of comfort of a person, both within himself and within his society ".

At the beginning of the 21st century, the concept of "quality of life" turned into a subject of scientific research and became more precise - "health related quality of life" (HRQL). QOL today is a reliable, informative and economical method for assessing the health of a patient, both at the individual and at the group level.
The World Health Organization made a great contribution to the development of the scientific study of QoL - it developed the fundamental criteria for the quality of life:
1. Physical (strength, energy, fatigue, pain, discomfort, sleep, rest).
2. Psychological (positive emotions, thinking, learning, concentration, self-esteem, appearance, experiences).
3. Level of independence (daily activity, performance, dependence on drugs and treatment).
4. Public life (personal relationships, social value of the subject, sexual activity).
5. Environment (life, well-being, safety, accessibility and quality of medical and social care, security, ecology, learning opportunities, information availability).
6. Spirituality (religion, personal beliefs).
Since 1995, an international non-profit organization that studies the quality of life, the MAPI Research Institute, has been operating in France and is the main coordinator of all research in the field of quality of life. The Institute annually holds congresses of the International Society of Quality of Life Research (ISOQOL), putting into practice the thesis that the goal of any treatment is to bring the quality of life of patients closer to the level of practically healthy people.
The main tool for studying QOL are profiles (assessment of each component of QOL separately) and questionnaires (for a comprehensive assessment), which, in turn, can be general (to assess health in general) and special (to study specific nosologies), and all of them do not evaluate clinical severity of the disease, but reflect how the patient tolerates his disease. For example, with a long-term course of the disease (CHF, HD), patients adapt and stop paying attention to the symptoms of their disease, they have an increase in the quality of life, but this does not mean a regression of the disease. About 400 quality of life questionnaires are known, there is a specialized periodical publication - the journal "Studying the quality of life". QoL questionnaires are used quite widely in clinical practice, they allow you to determine those areas that are most affected by the disease, and thus characterize the condition of patients with various forms of pathology.
But not everything is smooth in this scientific area. In addition to the supporters of the method, there are opponents of the study of QoL and the creation of questionnaires. So, D. Wade in his famous book “Measurement in Neurological Rehabilitation”, writes that without a clear definition of the quality of life, it is impossible to measure it. He and his co-authors believe that QoL is such an individual concept, so dependent on the level of culture, education or other factors that it cannot be measured or assessed, in addition, in addition to the disease, the assessment of the quality of life is influenced by many other factors not taken into account when forming questionnaires.
There are no single generally accepted criteria and norms of QoL. The assessment of QOL is influenced by age, gender, nationality, socio-economic status of a person, the nature of his work, religious beliefs, cultural level, regional characteristics, cultural traditions and many other factors. This is a purely subjective indicator of objectivity, and therefore the assessment of the QoL of respondents is possible only in a comparative aspect (sick versus healthy, with one disease versus a patient with another disease) with the maximum leveling of all external factors.
Currently, there is an intensive development of methods for determining the quality of life for the most common chronic diseases all over the world in connection with the recognition of QoL criteria as an integral part of a comprehensive analysis of new methods of diagnosis, treatment and prevention, health initiatives, evaluation of treatment outcomes, quality of care, etc. Observed boom in QOL research all over the world, and the Russian Federation did not stand aside. In Russia, the Concept of studying the quality of life in medicine, proposed by the Ministry of Health of the Russian Federation (2001), has been declared a priority, scientific research conducted using universal tools that meet the requirements of social, regional and linguistic differences is also recognized as a priority. Despite this, the study of the quality of life in our country is still not widely used.
In medical practice, the study of QoL is used for various purposes: to assess the effectiveness of modern clinical medicine methods and various rehabilitation technologies, to assess the severity of the patient, to determine the prognosis of the disease, and the effectiveness of treatment. QoL is an additional criterion for the selection of individual therapy and examination of working capacity, analysis of the ratio of costs and effectiveness of medical care, in medical audit, for identifying psychological problems and monitoring them in patients in the general practice system, individualization of treatment (selection of the optimal drug for a particular patient).
It should be noted that the assessment of QoL can become a prerequisite for testing drugs, new medical technologies and treatment methods at any stage, including phases 2–4 of drug testing. QoL criteria are indispensable in comparing different treatment approaches:
– if the treatment is effective but toxic;
- if the treatment is long, the possibility of complications is low, and patients do not feel the symptoms of the disease. The basic principle of M.Ya. Mudrova "to treat not the disease, but the patient" can be implemented by involving the assessment of QoL.
It is noted that QoL is lower in pessimists than in optimists, while pessimists have a higher risk of developing myocardial infarction and death. Depression significantly reduces QOL and life prognosis in patients with cardiovascular disease, with coronary artery bypass grafting (CABG) and heart transplantation. Positive emotions support high QOL. It has been established that the higher the labor activity, the higher the quality of life of the patient.
In a number of chronic diseases, diseases that are prone to progression and occur with exacerbations, the normal existence of a person is significantly limited, and these restrictions can become more important for the patient than the disease itself. A chronic illness leaves a strong imprint on the patient's psyche, exacerbating neurotic features. QoL in this case reflects the patient's ability to adapt to the manifestations of his disease. So, despite the fact that 80% of patients after coronary artery bypass grafting (ACS) get rid of the symptoms of angina pectoris, only a small number of them return to active work. When studying the effect of the disease on the patient's QOL, it was revealed that with stable exertional angina and coronary heart disease, the QOL is significantly reduced, depending on the patients' ability to work and their social adaptation.
Interestingly, the quality of life in patients with coronary artery disease is higher than in patients with syndrome X, although the prognosis for the latter is much better. This seems to be associated with a lower pain threshold in patients with syndrome X and, as a result, lower exercise tolerance.
In patients with cardiac arrhythmias, no significant relationship was found between QoL and gender, age, number of extrasystoles, and frequency of paroxysms; at the same time, it is recommended to start treatment of patients with arrhythmias that do not have an immediate adverse prognostic value, only in cases of a sharp decrease in QoL. At the same time, the quality of life of patients after implantation of a pacemaker was assessed as good in 71.8% of cases.
When comparing the QOL of patients with CHF, angina pectoris and supraventricular tachycardia, it was found that the lowest QOL is inherent in patients with angina pectoris, and the maximum - in patients with supraventricular tachycardia.
It was shown that the change in QoL in patients with essential hypertension (AH) depends on the characteristics of the clinical course of the disease. In a number of studies, data have been obtained that QoL in patients receiving antihypertensive therapy is lower than in untreated patients, and even the very fact of the need for long-term medication can reduce QoL.
For the treatment of such a common disease as arterial hypertension (AH), there is a huge arsenal of antihypertensive drugs that are comparable to each other in terms of the effectiveness of blood pressure control, prevention of premature death, and overall survival. Different antihypertensive drugs have different effects on QoL. Connecting to the criteria for assessing the QOL indicator in a multicenter randomized double-blind study led by S.H.Groog, it was possible to establish that the best QOL indicators were recorded in people who received captopril: they had less side effects of drug therapy and to a lesser extent observed sexual disorders . Methyldopa caused depression, life dissatisfaction, and cognitive impairment in patients. The use of propranolol resulted in improved cognitive functioning and social participation, but was accompanied by deterioration in physical performance and sexual dysfunction. In a joint Russian-German study "Captopril and QOL" it was shown that the most favorable effect on QOL was provided by monotherapy with captopril, less pronounced - by the use of nifedipine and propranolol, zero - by the appointment of hydrochlorothiazide.
You can use the QOL criterion to assess the effectiveness of the treatment. An American study of elderly patients with coronary heart disease after coronary angioplasty showed a significant increase in their quality of life in all respects. Russian study 2005–2006 in 3 cities (St. Petersburg, Arkhangelsk, Yaroslavl, more than 800 participants) on the use of carvedilol (manufactured by MAKIZ-PHARMA, Russia) in patients suffering from arterial hypertension and chronic heart failure (using the Minnesota questionnaire), revealed a significant positive trend QOL with minimal side effects.
Measuring QOL before and after medical intervention allows using the QOL criterion as a prognostic factor for choosing a strategy for individual treatment of a patient. So, in the works of J.S. Rumsfeld, S. MacWhinney, M. McCarthy 1992–1996 it was shown that the clinical status of the patient before surgery is the only predictor of mortality after CABG (and not depression, as was previously believed).
An adequate rehabilitation program has a significant impact on QoL. It is important both for patients with chronic cardiovascular insufficiency and myocardial infarction, and other nosologies, and further QoL of patients depends on its competent organization.
In cardiology, joint pharmacoeconomic studies and studies of QoL are quite widespread. So, in the review by K. Wenger on the role of assessing QoL in cardiovascular diseases, much attention is paid to the need for pharmacoeconomic calculations in the examination of new drugs. The figures obtained in the analysis of the effectiveness of the treatment of heart failure are given: the use of ACE inhibitors in congestive HF reduces the frequency and duration of hospitalizations, mortality, and saves up to 5 billion dollars a year in the United States. At the same time, the savings due to the reduction in the duration and frequency of hospitalizations of patients in the treatment with ACE inhibitors significantly exceeds the costs of treatment (the cost of the drug). The use of high-tech interventions should also be justified: for example, from the standpoint of QoL and pharmacoeconomics, the effectiveness of high-frequency ablation for patients under 50 years of age with paroxysmal supraventricular tachycardia has been proven.
Thus, we believe that the study of QoL will become one of the mandatory comprehensive assessment methods in the conduct of clinical trials of drugs and treatment methods in the future.

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The measurement of quality of life is based on the patient's assessment of his level of well-being in physical, mental, social and economic terms. QOL is a dynamic state, a function that changes over time, and therefore it should be evaluated over a certain period as a changing parameter depending on the type and course of the disease, the treatment process and the system of medical care.

The process of working with such a subtle matter as the patient's feeling of his own QOL is very complicated and time-consuming, and requires a professional approach. Quality of life studies are usually part of a broader clinical research protocol conducted in accordance with Good Clinical Practice (GCP) rules. The main components of QoL can be measured separately or as a whole using various questionnaires, tests, scales, and indices. Data can be obtained from a personal conversation with the patient, by telephone, based on the answers to the questionnaire.

Collecting standard answers to standard questions is the most effective method for assessing health status. Carefully built relationships of questions and answers, compiled for calculation by the method of summing ratings, formed the basis of modern QOL questionnaires (at present - more than 60). Instruments for measuring quality of life should be simple, reliable, concise, sensitive, understandable and objective. Modern tools for assessing the quality of life are developed using psychometrics - a science that translates people's behavior, their feelings and personal assessments into indicators that are accessible to quantitative analysis.

Each instrument should have psychometric properties such as reliability, objectivity, reproducibility and sensitivity.

The objectivity of an instrument means that it can measure what it was intended to measure. Within this property, meaningful objectivity is singled out, i.e. the degree to which the measured feature represents the phenomenon under study, and constructive objectivity, i.e. the correlation of this test with others that measure related characteristics.

The reliability of an instrument is the degree of freedom from random errors.

Sensitivity is the ability to reflect changes occurring over time, often minimal but clinically significant.

Questionnaires studying the quality of life are also presented with a number of other trainings:

• 1 universality (coverage of all health parameters);
• 2 reproducibility;
• 3 ease of use and brevity;
• 4 standardization (offering a single version of standard questions and answers for all groups of respondents);
• 5 evaluation (quantitative assessment of health parameters).

In assessing the quality of life, two groups of questionnaires are used - general and special. General questionnaires are designed to assess the health of the population as a whole, regardless of pathology, so it is advisable to use them to assess health care tactics in general and when conducting epidemiological studies. The advantage of general questionnaires is that their validity has been established for various nosologies, which allows a comparative assessment of the impact of various medical programs on the quality of life of both individual subjects and the entire population. The disadvantage of general questionnaires is their inadequate sensitivity to changes in health status within a single disease.

Special questionnaires are designed to measure the quality of life of patients with a certain group of diseases, which allows the researcher to focus on a specific nosology and its treatment. Special questionnaires allow you to catch changes in the quality of life of patients that have occurred in the last 2-4 weeks.

There are no single criteria and standard norms of QOL. Each questionnaire has its own criteria and rating scale. The calculation is carried out on each scale separately (profile measurement) or by summing the data of all scales (calculation of the total points).

The first official method was the WHO scale. In the WHO scale, according to the score obtained from the analysis of the questionnaire data, a certain characteristic of the standard of living is assigned. There are 6 possible gradations in the scale:

• 0 - normal state, full activity;
• 1 - symptoms of the disease are present, activity is reduced, the patient can stay at home;
• 2 - severe symptoms of the disease, disabled, spends less than 50% of the time in bed;
• 3 - severe condition, spends more than 50% of the time in bed;
• 4 - the condition is very serious, 100% or more time in bed;
• 5 - death.

The scale, apparently, is the most general and does not assess the functional activity of the patient and his acceptance of his condition, the reasons that led to this condition. This scale became the prototype of modern methods.

Among the general questionnaires, the most popular is the SF-36 (Short Form) questionnaire, a relatively simple questionnaire designed to meet minimum psychometric standards. SF-36, having a sufficiently high sensitivity, is short. It contains only 36 questions, which makes it very convenient to use for group comparisons, taking into account general concepts of health or well-being, that is, those parameters that are not specific to different age or nosological groups, as well as groups receiving certain treatment. The SF-36 questionnaire contains 8 health concepts that are most commonly measured in population studies and are most affected by disease and treatment. The SF-36 is suitable for patient self-completion, for computer-assisted interviewing, or for completion by a trained interviewer in person or by telephone, for patients 14 years of age and older.

The questionnaire contains 8 scales:

• 1. Physical activity restrictions due to health problems (illness).
• 2. Restrictions on social activity due to physical or emotional problems.
• 3. Restrictions on normal role-playing activities due to health issues.
• 4. Body pains (pain in the body).
• 5. General mental health (psychological distress or psychological well-being).
• 6. Restrictions on normal role-playing activities due to emotional problems.
• 7. Vitality (energy or fatigue).
• 8. General perception of one's health.

The SF-36 quality of life criteria are:

• 1. Physical activity (PA). Subjective assessment of the volume of daily physical activity, not limited by the state of health at the present time. Direct connection: the higher the FA, the greater the physical load, according to him, he can perform.
• 2. The role of physical problems in the limitation of vital activity (RF). Subjective assessment of the degree of limitation of daily activities due to health problems over the past 4 weeks. Feedback: the higher the score, the less health problems limit his daily activities.
• 3. Pain (B). Characterizes the role of subjective pain in limiting his daily activities over the past 4 weeks. Feedback: the higher the indicator, the less pain sensations interfere with his activity.
• 4. General health (OH). Subjective assessment of the general state of one's health at the present time. Direct connection: the higher the indicator, the better he perceives his health in general.
• 5. Viability (LS). Subjective assessment of your vitality (vigour, energy) for the last 4 weeks. Direct connection: the higher the indicator, the higher he estimates his vitality (more time in the last 4 weeks he felt cheerful and full of strength).
• 6. Social activity (SA). Subjective assessment of the level of your relationships with friends, relatives, work colleagues and other teams over the past 4 weeks. Direct connection: the higher the indicator, the higher the level of their social connections.
• 7. The role of emotional problems in the restriction of vital activity (RE). Subjective assessment of the degree of limitation of their daily activities due to emotional problems over the past 4 weeks. Feedback: the higher the RE, the less emotional status interferes with daily activities.
• 8. Mental health (MH). Subjective assessment of your mood (happiness, calmness, tranquility) for the last 4 weeks. Direct connection: the higher the score, the better the mood.

UDK 159.9.072.5 © Evsina O.V., 2013 QUALITY OF LIFE IN MEDICINE IS AN IMPORTANT INDICATOR OF PATIENT HEALTH (literature review)

Annotation. The science of studying the quality of life associated with health has not only taken a certain step in modern medicine, but continues to develop progressively. The article presents a review of literature data on the concepts of "quality of life", "quality of life associated with health", methodology, areas of application of quality of life.

Keywords: quality

life; health-related quality of life; questionnaire.

© Evsina O.V., 2013 THE QUALITY OF LIFE IN MEDICINE - AN IMPORTANT INDICATOR OF PATIENT HEALTH STATUS (review)

abstract. Studying of the health-related quality of life not even plays an important role in modern medicine, but also continues to develop progressively. The article presents the review of currently available data on the concept of "quality of life" and "health-related quality of life", the methodology, the applications of quality of life.

Key words: quality of life,

health-related quality of life, questionnaire.

Historical background and definition of the concept of "quality of life". The progress in the development of medical science, the change in the structure of the incidence of the population and the emphasis on respect for the rights of the patient as an individual have led to the creation of a new paradigm for understanding the disease and determining the effectiveness of treatment methods. When doctors began to realize more and more that an objective decrease in pathological changes (data from physical, laboratory and instrumental methods of examination) is not necessarily accompanied by an improvement in the patient's well-being and that the patient should be satisfied with the outcome of treatment, in

medicine arose an interest in the quality of life of the patient. In recent years, publications dedicated to the quality of life on the Internet have exceeded 4.5 million, and this trend of increased attention to the quality of life is growing every year. In addition to information on the Internet, special methodological guides and periodicals are available. Thus, judging by the frequency of use of this term in modern literature, the quality of life in medicine is a widely used concept, being an integral indicator that reflects the degree of adaptation of a person to a disease and the ability to perform his usual functions corresponding to his socio-economic status.

The term "quality of life" (QOL) first appeared in Western philosophy, and then quickly infiltrated sociology and medicine.

The history of QoL research in medicine begins in 1949, when D.A. Karnovsky published "Clinical Evaluation of Chemotherapy in Cancer". In it, using the example of oncological patients, he showed the need to study the whole variety of psychological and social consequences of the disease, not limited to generally accepted medical indicators. This work marked the beginning of a comprehensive study of the patient's personality, and from this date the history of the science of QoL began. The term QOL itself was first used in 1966 by J.R. Elkington in the Annals of Internal Medicine in the article "Medicine and quality of life", focusing on this problem as "harmony within a person and between a person and the world, the harmony that patients, doctors and society as a whole strive for" . The term QoL was officially recognized in medicine in 1977, when it was first included as a rubric in the Cumulated Index Medicus. In the 1970s-1980s, the foundations of the concept of QoL research were laid, and in the 1980s-1990s, the methodology for QoL research in various nosologies was developed.

Since 1995, an international non-profit organization studying QOL has been functioning in France - the MAPI Research Institute - the main coordinator of all research in the field of QOL in the world. The Institute annually holds congresses on the study of QoL (International Society for Quality of Life Research

ISOQOL), implementing the thesis that the goal of any treatment is to bring the QoL of patients closer to the level of practically healthy people. The ISOQOL branch in Russia has been operating since 1999, and since 2001 the concept of studying quality of life in medicine, proposed by the Ministry of Health of the Russian Federation, has been declared a priority, and scientific research conducted using universal tools that meet the requirements of social, regional and language differences is also recognized as a priority. Despite this, the study of QOL in our country is not widely used, mainly in clinical trials and writing dissertations.

To date, there is no single comprehensive definition of "quality of life". Below are definitions, each of which, to a greater or lesser extent, reflects the concept of "quality of life".

Quality of life is an integral characteristic of the physical, psychological, emotional and social functioning of a healthy or sick person, based on his subjective perception (Novik A.A. et al., 1999).

The quality of life is the degree of comfort of a person within himself and within the framework of the society in which he lives (Senkevich N.Yu., Belevsky A.S., 2000).

Quality of life - the functional impact of the state of health and / or subsequent therapy on the patient. Thus, this concept is subjective and multidimensional, covering physical and professional functions, psychological state, social interaction and somatic sensations.

According to WHO experts, the quality of life is "an individual ratio of the position in the life of society in the context of the culture and value systems of this society with the goals of this individual, his plans, opportunities and the degree of general disorder." WHO developed the fundamental criteria for QoL and their components:

Physical (strength, energy, fatigue, pain, discomfort, sleep, rest);

Psychological (positive emotions, emotions, thinking, learning, memorization, concentration, self-esteem, appearance, negative experiences);

Level of independence (daily activity, performance, dependence on treatment and drugs);

Public life (personal relationships, social value of the subject, sexual activity);

Environment (well-being, safety, life, security, accessibility and quality of medical and social security, availability of information, the possibility of training and advanced training, leisure, ecology).

In modern medicine, the term “Health-related quality of life” is widely used, which means an assessment of parameters associated and not associated with a disease, and allows differentially determining the impact of the disease and treatment on the psychological, emotional state of the patient, his social status.

The concept of "quality of life" is multidimensional at its core. Its components are: psychological well-being, social well-being, physical well-being, spiritual well-being.

Methodology for studying the quality of life. There are no single generally applicable criteria and norms for studying QoL. The assessment of quality of life is influenced by age, gender, nationality, socio-economic status of a person, the nature of his work activity, religious beliefs of culture.

level, regional peculiarities and many other factors. This is a purely subjective indicator of objectivity, and therefore the assessment of QoL of respondents is possible only in a comparative aspect (a patient is healthy, a patient with one disease is a patient with another disease) with the maximum leveling of all external factors.

The main tools for studying QoL are standardized questionnaires (indices and profiles) compiled using psychometric methods. The first tools for the study of quality of life - psychometric scales created 30-40 years ago for the needs of psychiatry - were a brief outline of a clinical conversation between a doctor and a patient and were initially cumbersome. In the US and Europe, special centers have been created to develop such questionnaires. In modern questionnaires, the signs contained in the scales are selected using standardization methods and then studied on large samples of patients. Subsequently, the selected features form the basis for carefully formulated questions and answer options selected by the summation of ratings method.

Thus, in international practice, standardized questionnaires are used, tested in clinical trials and clinical practice.

The following requirements are imposed on QOL questionnaires: multidimensionality, simplicity and brevity, acceptability, applicability in various linguistic and social cultures.

After the procedure of cultural and language adaptation, each questionnaire is tested for its psychometric properties: reliability, validity and sensitivity:

Reliability is the ability of a questionnaire to provide consistent and accurate measurements;

Validity - the ability of the questionnaire to reliably measure the main characteristic that it contains;

Sensitivity to change - the ability of the questionnaire to give significant changes in QoL scores in accordance with changes in the respondent's condition (for example, during treatment).

Such a complex methodology for the development, transcultural adaptation and testing of questionnaires before their widespread introduction into clinical practice is fully consistent with the requirements of Good Clinical Practice (GCP) .

Novik A.A., Ionova T.I. proposes the following classification of QoL research tools.

Depending on the application:

1. General questionnaires (for children and adults).

2. Special questionnaires:

By fields of medicine (oncology, neurology, rheumatology, etc.).

By nosology (breast cancer, peptic ulcer, rheumatoid arthritis, etc.).

State-specific questionnaires.

Depending on the structure, there are:

Profile questionnaires are several numerical values ​​that represent a profile formed by the values ​​of several scales.

Indexes are a single digital value.

The most common general questionnaires include:

MOS - SF-36 - Medical Outcomes Study-Short Form.

European Quality of Life Scale - European quality of life assessment questionnaire.

WHOQOL QOL-100 Questionnaire of the World Health Organization.

Nottingham Health Profile - Nottingham Health Profile.

Sickness Impact Profile - Sickness Impact Profile.

Child Health Questionnaire - Child Health Questionnaire.

The first six of the above questionnaires can be used in adults regardless of health status.

The last questionnaire is used to assess the QoL of children (under 18 years of age), also regardless of their state of health.

One of the important features of the study of QoL in children is the participation of the child and parents in the study procedure. Parents fill out a special questionnaire form. Another feature of the study of QoL in children is the presence of modules of questionnaires by age.

General questionnaires (non-specific, used regardless of a specific disease) are designed to assess QOL in both healthy people and patients, regardless of disease, age or treatment method. The advantage of general questionnaires is that they have a broad coverage of QoL components and allow for the study of QoL norms in a healthy population. However, their disadvantage is their low sensitivity to changes in QoL within a single disease. For example, the questions "How far can you walk?" or “What is the intensity of the pain?” may be useful for patients with cardiac or oncological diseases, but may be less relevant for patients with neurological disease (eg, epilepsy).

General questionnaires may be insensitive to the most important aspects of a particular nosology. Specialized questionnaires have the advantage in this regard, but they do not allow comparison of results in patients with different diseases or with a healthy population.

In many branches of medicine, special questionnaires for assessing QoL have been developed. They are considered as the most sensitive methods of control over

the ongoing treatment of specific diseases, which is ensured by the presence in them of components specific to these pathologies. With the help of special questionnaires, any one category of QoL (physical or mental state), or QoL for a specific disease, or certain types of treatment is assessed:

In cardiology:

The Seattle Angina Questionnaire (SAQ) (1992) - in patients with coronary artery disease.

Minnesota Living with Heart Failure Questionnaire (1993) - in patients with CHF.

The study of the quality of life in arrhythmia (1998) - in patients with arrhythmia and others.

In pulmonology:

Asthma Symptom Checklist (1992) - in patients with bronchial asthma

St George's Hospital Respiratory Questionnaire (SGRQ) (1992) and others.

In rheumatology:

Arthritis Impact Measurement Scales (AIMS, AIMS2, AIMS2-SF) (1980, 1990, 1997) and others - in patients with joint diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) and others.

Each questionnaire differs in the scope of the study, the time required to fill out the questionnaires, the methods of filling out and the quantitative assessment of QoL indicators. Most of the questionnaires have been translated into all major languages ​​with appropriate adaptation to them.

But not everything is smooth in this scientific area. In addition to the supporters of the method, there are opponents of the study of QoL and the creation of questionnaires. So, Wade D. in his famous book “Measurement in Neutrogical Reabiltation”, writes that without a clear definition of QOL, it is impossible to measure. He and his co-authors believe that QOL is such an individual concept, it depends so much on the level of culture,

development or other factors that it cannot be measured or assessed, in addition, in addition to the disease, the assessment of the quality of life is influenced by many other factors that are not taken into account when forming questionnaires.

The objectives of studying the quality of life in medicine. In the book "Guidelines for the study of quality of life in medicine" Novik A.A., Ionova T.I. focus on two key aspects. On the one hand, the concept made it possible to return at a new stage of evolution to the most important principle of clinical practice “to treat not the disease, but the patient”. The tasks in the treatment of patients with various pathologies that were not quite clearly outlined earlier, clothed in vague verbal categories, have gained certainty and clarity. In accordance with the new paradigm, the patient's QoL is either the main or additional goal of treatment:

1) QOL is the main goal of treating patients with diseases that do not limit life expectancy;

2) QOL is an additional goal in the treatment of patients with diseases that limit life expectancy (the main goal in this group is to increase life expectancy);

3) QoL is the sole goal of treating patients in the incurable stage of the disease.

On the other hand, the new concept offers a well-developed methodology that allows obtaining reliable data on the QoL parameters of patients, both in clinical practice and in clinical trials.

The application of QoL research in healthcare practice is extensive:

Standardization of treatment methods;

Examination of new methods of treatment using international criteria adopted in most developed countries.

Ensuring full individual monitoring of the patient's condition with an assessment of early and long-term results of treatment.

Development of prognostic models for the course and outcome of the disease.

Conducting socio-medical population studies with the allocation of risk groups.

Development of fundamental principles of palliative medicine.

Ensuring dynamic monitoring of risk groups and evaluating the effectiveness of preventive programs.

Improving the quality of expertise of new drugs.

Economic justification of treatment methods, taking into account such indicators as "price-quality", "cost-effectiveness" and other pharmacoeconomic criteria.

It should be noted that the assessment of QoL can become a prerequisite for testing drugs, new medical technologies and treatment methods at any stage, including phases 2-4 of drug testing. QoL criteria are indispensable in comparing different treatment approaches:

If the treatment is effective but toxic;

If the treatment is long, the possibility of complications is low, and patients do not feel the symptoms of the disease.

The study of the patient's QoL before and during therapy provides valuable information about the individual's response to the disease and the treatment being carried out. The basic principle of M.Ya. Mudrova "to treat not the disease, but the patient" can be implemented using the assessment of QoL.

The study of the quality of life is a highly informative tool that determines the effectiveness of the medical care system and allows you to give an objective assessment of the quality of medical care at the level of its main consumer - the patient. At present, the problem of improving the quality of life (including in medicine) is a key one in the state policy of Russia.

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The quality of life(QOL) in medicine is the degree of well-being and satisfaction with those aspects of life that are affected by a disease or its treatment. The interdependence of the quality of treatment and quality of life is quite complex. It is logical to assume that the more effective the treatment, the higher the quality of life. However, this pattern does not always occur.

For example, in patients with arterial hypertension, a decrease in blood pressure (BP) is not necessarily accompanied by an improvement in the quality of life. This is probably due to the fact that an increase in blood pressure is often not accompanied by symptoms and the patient may generally feel well without treatment.

When assessing the impact of treatment on QoL, the likelihood of side effects of drugs is taken into account, which can lead to the appearance of new symptoms, sometimes even worsening the condition of the body. In addition, often the very fact of the need to take medications and modern medical equipment, which is used for the early diagnosis of diseases, is negatively perceived by the patient and, accordingly, creates psychological problems. Some studies have found that QoL is a factor that determines a patient's predisposition to treatment (compliance).

Treatment can cause both positive and negative changes in quality of life. Therefore, in recent years, in a number of studies, in addition to the effect of treatment on the course of the disease and its prognosis, changes in the quality of life are evaluated as one of the criteria for effectiveness. QOL assessment can be used in combination with other parameters, such as a factor influencing the development of the disease, determining its prognosis. Data obtained in the Scandinavian study APSIS demonstrated the influence of psychosocial characteristics and overall life satisfaction (overall life satisfaction) on the outcome of the disease in patients with stable angina.

Deterioration in overall life satisfaction, especially due to alcohol problems, financial problems, sleep disturbance, or feeling of general fatigue, was accompanied by an increase in the risk of the main outcomes of the study (death, unstable angina, pulmonary embolism, stroke, myocardial infarction). A negative association of low quality of life with poor prognosis was also found in patients who survived myocardial infarction. The concept of “quality of life” is also freely used in pharmacoeconomic studies, in particular for cost useful analysis, becoming in this case the main criterion for the effectiveness of treatment.

Thus, it is possible to obtain the necessary information to compare the effectiveness of different treatment methods, develop new approaches and plan financing of various health sectors at the national level.

Year of issue: 2007

Genre: healthcare

Format: PDF

Quality: Scanned pages

Description: Traditionally, the criteria for the effectiveness of treatment in clinical trials are physical data and laboratory parameters. Thus, the effectiveness of the treatment of anemia is assessed by the level of hemoglobin or the number of necessary transfusions, and AIDS and cancer - by the response to treatment and survival. Despite the fact that standard biomedical parameters are often the main criteria for the effectiveness of treatment in clinical trials, they do not reflect the well-being of the patient and his functioning in daily life. In certain diseases, the patient's assessment of his condition is the most important indicator of health.
Sometimes clinicians and researchers believe that certain changes in therapy or in biomedical parameters indicate an improvement in the patient's quality of life. Despite the fact that in many cases this statement is true, in a number of clinical situations, when assessing the quality of life of a patient, the results are unexpected. One classic example is the study by Sugarbaker and colleagues comparing two approaches to treating soft tissue sarcomas. The first approach was to perform limb-sparing surgery followed by radiation therapy, and the second was to amputate the limb. The hypothesis was that "saving the limb, in contrast to amputation, leads to an improvement in the quality of life of the patient." As a result of the quality of life study, it was shown that in patients who underwent surgery with limb saving and subsequent radiation therapy, there was a decrease in motor and sexual activity. These data were confirmed when evaluating the functioning of the musculoskeletal system and the endocrine system by other methods. The results of this study led to the development of new radiotherapy regimens and rehabilitation programs that have changed the treatment strategy for soft tissue sarcomas. Thus, despite the fact that medical intuition rarely fails experienced professionals, the assumption that the quality of life has improved should be supported by research data.
There are various definitions of quality of life. However, it is generally accepted that quality of life is a multidimensional concept and reflects the impact of the disease and treatment on the well-being of the patient. The patient's quality of life characterizes how the physical, emotional and social well-being of the patient is affected by the disease or its treatment. In some cases, this concept also includes the economic and spiritual aspects of the functioning of the patient.
Currently, the patient's quality of life is an important, and in some cases the main, criterion for determining the effectiveness of treatment in clinical trials. In this regard, serious attention should be paid to the methods of its evaluation and analysis. The methodology for studying the quality of life should undergo scientific expertise and be universally recognized. Indeed, due to the fact that the assessment of the quality of life is carried out by the patients themselves, the requirements for methodology should be stricter than for clinical data. Strict requirements must be made both to specialists conducting a study of the quality of life and to educational materials devoted to various aspects of studying the quality of life. It is appropriate to note the role of such international organizations as the International Society for Quality of Life Research (ISOQOL), which contribute to the formation of knowledge and common approaches in the field of quality of life research among specialists.
My first meeting with the authors of this manual was at one of the ISOQOL conferences. This meeting was the beginning of our cooperation, which continues to this day. The authors of this book have been dealing with methodological aspects of quality of life research for a number of years and have extensive experience in studying quality of life in various branches of medicine. This guide analyzes all aspects of the study of quality of life and outlines the current conceptual and methodological issues of the study of quality of life. A guide to quality of life research in medicine may be difficult for beginners in the field of quality of life research, but this work is extremely important and useful for serious researchers in this field. The publication of such a comprehensive manual in Russian will expand the boundaries of the generally accepted methodology for studying the quality of life and will contribute to an increase in the number of studies in this area carried out in accordance with international standards.

"Guidelines for the study of quality of life in medicine"

Quality of Life Study: Clinical Research, Clinical Practice
Definition of the concept of "quality of life"
Components of the concept of quality of life
The main directions of the study of quality of life in medicine

Influence of treatment on parameters of patient's quality of life

The predictive value of quality of life parameters
Quality of life as a criterion for remission and recovery
Individual monitoring of quality of life indicators
Methodology for the study of quality of life
Fundamentals of the methodology for studying the quality of life

1. Study Protocol Development
2. Choice of research tool
3. Cultural and linguistic adaptation of the questionnaire
4. Questionnaire validation
5. Examination of patients
6. Ethical and psychological aspects of data collection
7. Database formation
8. Questionnaire data scaling
9. Statistical data processing
10. Analysis and interpretation of the results of the study of quality of life

1. Structure and adaptation algorithm
2. Stages of linguistic and cultural adaptation
3. Possible errors during adaptation

1. Reliability
2. Validity
3. Sensitivity

1. GSRS questionnaire validation protocol
2. Validation steps for the GSRS questionnaire
3. Validation results of the GSRS questionnaire

1. The concept of random and arbitrary choice. Randomization. Statistical criteria
2. Features of statistical analysis in the study of quality of life
3. Questionnaire data scaling
4. Analysis of longitudinal quality of life studies
5. Missing Data Analysis

1. Stages of testing statistical hypotheses
2. Errors in statistical processing of research results

1. Methodological approaches to assessing clinically significant differences
2. Definition of clinically significant differences

1. Methodology of a population study of quality of life
2. Components of a population-based quality of life study protocol
3. Statistical methods for analyzing data from a population study of quality of life

1. The impact of the disease on the physical, psychological and social functioning of the patient
2. Quality of life and pharmacoeconomic analysis

1. The impact of the disease on the physical, psychological and social functioning of the patient
2. Quality of life as a criterion for the effectiveness of drugs
3. Quality of life in evaluating the effectiveness of surgical interventions
4. Quality of life as the basis of rehabilitation programs

1. The impact of the disease on the physical, psychological and social functioning of the patient
2. Quality of life as a criterion for the effectiveness of treatment
3. Predictive value of quality of life indicators

1. Assessment of the impact of the disease on the quality of life of patients with rheumatoid arthritis
2. Evaluation of the impact of treatment on the quality of life of patients with rheumatoid arthritis
3. Evaluation of drug efficacy

1. Determining the impact of the disease on the physical, psychological and social state of the patient
2. Quality of life and expertise of new drugs
3. Quality of life as a predictor of disease progression
4. Quality of life as a benchmark in the development of rehabilitation programs
5. Quality of life in pharmacoeconomic calculations

1. Quality of life as a criterion for the effectiveness of treatment
2. Quality of life as a criterion for determining the effectiveness of new drugs
3. Quality of life as a prognostic factor
4. Quality of life as an indicator of the effectiveness of rehabilitation programs
5. Quality of life as a criterion for the effectiveness of symptomatic therapy and palliative care
6. Quality of life as a component of pharmacoeconomic calculations
7. Quality of life as an indicator of individual monitoring

1. Quality of life as a criterion for evaluating the effectiveness of treatment
2. Quality of life in clinical practice
3. Quality of life as a prognostic factor
4. Psychological and social support programs that improve the patient's quality of life

1. Pain assessment
2. Weakness assessment
3. Assessment of the main symptoms

1. The first stage is to determine the goal of treating the patient
2. The second stage is the determination of the method of treating the patient
3. The third stage is the identification of criteria for evaluating the effectiveness of the chosen treatment method