Changes in the Quality of Life of Patients with Rheumatoid Arthritis (Prospective Follow-Up)

The dissertation is devoted to a comprehensive study of the quality of life and psychological characteristics of the personality of patients with rheumatoid arthritis. The study was carried out on patients of rheumatological profile from the city of Saratov and the Saratov region using Russian validated versions of international questionnaires (SF-36, EQ-5D, HAQ), as well as standardized methods for assessing psychological status and anxiety-depressive reactions. The work analyzes the influence of socio-demographic factors (sex, age, marital status, level of education, material status, disability) and clinical characteristics of the disease (duration, activity according to DAS-28, radiographic stage, functional class, systemic manifestations, comorbidity) on the somatic, psychological and social components of quality of life. The dynamics of quality of life indicators during therapy and their comparison with generally accepted clinical criteria for evaluating treatment effectiveness, including the EULAR criteria, are considered separately.

The work has a clinical and social orientation: it has been shown that disturbances in the psycho-emotional sphere significantly worsen the quality of life of RA patients and should be taken into account when selecting treatment and rehabilitation programs. The results obtained substantiate the inclusion of the assessment of quality of life and psychological profile in the standard procedures of follow-up of patients with rheumatoid arthritis in order to increase the objectivity of the evaluation of the effectiveness of the therapy administered and to individualize treatment programs.

Rheumatoid arthritis (RA) occupies one of the leading places among rheumatic diseases and, in terms of the severity of its clinical picture and consequences, has no equal among other types of arthritis [65]. Worldwide, approximately 58 million people suffer from RA; in the Russian Federation the figure is 289,000 people [11, 36, 46], and in Saratov and the Saratov region it is 4,442 people (according to 2005 data). RA is characterized by a chronic, progressive course, early loss of working capacity and a high percentage of disability. Thus, severe loss of working capacity within 5 years of the disease, despite treatment with "basic" drugs, is observed in 16% of patients [65]; 20 years after the onset of the disease approximately 90% of patients lose their working capacity to a greater or lesser extent, and one-third become totally disabled [44, 45]. The vital prognosis in RA patients is as unfavorable as in lymphogranulomatosis, insulin-dependent diabetes mellitus and three-vessel coronary artery disease [124]. RA is associated with a high level of pain sensations and functional impairments, on the one hand, and with serious disturbances in the psycho-emotional sphere, on the other, which significantly worsens the patients' quality of life (QoL).

Quality of life is an integral characteristic of the physical, psychological, emotional and social functioning of a patient, based on his or her subjective perception [51, 128, 129]; QoL is one of the key concepts of modern medicine, which makes it possible to analyze the components of a person's vital activity in accordance with the criteria of the World Health Organization (WHO) [6].

The concept of QoL research includes three basic principles: the multidimensionality of assessment, the variability of QoL parameters over time, and the participation of the patient in the assessment of his or her condition. The instruments for QoL assessment are general and specific questionnaires developed by experts from leading world clinical centers in accordance with the principles of evidence-based medicine and the requirements of Good Clinical Practice (GCP).

QoL indicators, along with other accepted clinical, laboratory and instrumental methods of investigation, make it possible to broaden the physician's understanding of the patient's condition as a whole and to overcome the one-sided biological approach to patients [51], since the goal of treatment is not only to reduce inflammatory activity and pain and to improve the functional state of the patient, but also to achieve a quality of life in RA patients comparable to that of the general population.

Despite the growing attention of researchers to QoL, including that of RA patients, this problem has not been sufficiently studied. Researchers hold different points of view regarding the relationship between QoL and the somatic state of patients [18, 53, 65, 111]. It remains unclear which particular factors, and to what extent, influence QoL indicators in patients. In addition, at the present stage further development of this scientific direction is hampered by the lack of a systematic approach against the background of the continuing accumulation of a large body of empirical evidence, sometimes contradictory, which complicates the development and implementation of measures for the prevention and timely correction of adverse changes.

Most of the generally accepted criteria for evaluating the effectiveness of therapy, in particular the criteria developed by the European League Against Rheumatism (EULAR), do not take into account such fundamental parameters of quality of life as the patient's self-assessment of his or her condition and his or her mental and social well-being in everyday life, which leads to treatment of the "disease" rather than of the patient.

Aim of the Study

To increase the objectivity of the evaluation of the effectiveness of the therapy administered on the basis of a comprehensive dynamic study of the quality of life of patients with rheumatoid arthritis.

Objectives of the Study

1. To identify the features of QoL in RA patients depending on socio-demographic factors such as sex, age, marital status, education, occupational employment, disability and material status.

2. To evaluate QoL in RA patients depending on the clinical features of the disease (duration of RA, radiographic stage, functional class, systemic nature of the disease manifestations, activity of the process, immunological characteristics) and concomitant pathology.

3. To investigate the psychological status of RA patients depending on socio-demographic factors and the clinical features of the disease, and to identify the influence of psycho-emotional disturbances on the quality of life of patients with RA.

4. To carry out a comprehensive study of QoL in RA patients during dynamic follow-up and to determine the possibility of using QoL indices as an additional criterion for evaluating the effectiveness of therapy alongside the generally accepted clinical criteria.

Scientific Novelty

A comprehensive assessment of QoL has been performed in RA patients from the city of Saratov and the Saratov region using Russian validated versions of international questionnaires. A significant decrease in the quality of life of RA patients was revealed in all its components — somatic, psychological and social — in comparison with the quality of life of persons in the control group according to the general questionnaire SF-36.

The degree of influence of a number of socio-demographic factors on QoL in RA patients has been determined. Significant correlations were found between the level of QoL and material status (improvement of functional activity and mental health, reduction of the severity of the pain syndrome in patients with good material status), sex (in female patients compared with male patients there is a decrease in QoL according to the HAQ and EQ-5D indices and on the SF-36 scales associated with the psycho-emotional state), and age (deterioration of QoL with increasing age).

In patients with different levels of education and marital status, no significant differences in QoL were noted; however, the trends observed indicate better social protection and adaptation in persons with higher education, and a greater influence of emotional state on everyday activities in single RA patients.

The clinical characteristics of the disease that exerted a marked influence on QoL were the duration of RA and the activity of the process as assessed by the DAS-28 index. With an increase in the "length of service" of the disease, deterioration of QoL occurs in all its components, as evidenced by an increase in the HAQ index, which reflects the degree of functional impairment, a decrease in the EQ-5D index and in the scores of the scales constituting the physical component of health (PF, RP, GH), and in the vitality scale (VT) of the SF-36 questionnaire. The negative influence of disease activity on the quality of life of RA patients has been demonstrated, which is confirmed by a significant worsening of the HAQ and EQ-5D indices and by a decrease in the physical and mental components of health according to the SF-36 scales.

The presence of comorbid conditions is an "aggravating" factor that worsens the already reduced quality of life of RA patients and has a negative influence on the psychological profile of the patients' personality.

It was revealed that the psychological characteristics of the personality of RA patients reflect the presence of a "neurotic" personality profile (elevation of the first scales: 1 — hypochondriasis, 2 — depression, 3 — hysteria); elevation on the psychasthenia (7th) and schizoid (8th) scales. In the assessment of depressive manifestations by means of the Hospital Anxiety and Depression Scale, subclinical depression was found in approximately one-third of the patients and clinically overt depression in 21%. Anxiety disorders were present in the majority of patients, with both reactive and personal anxiety being high on the Spielberger-Khanin test.

The influence of a number of socio-constitutional factors, such as sex, age, level of education and marital status, on the psychological profile of the personality of RA patients has been determined. The influence of the clinical characteristics of the disease, in particular the duration of RA, the activity of the process, and the presence or absence of systemic manifestations, on changes in the psycho-emotional sphere of patients has also been revealed, manifesting themselves in an increase in anxiety-depressive reactions and in an increase in neurotic symptomatology.

It has been established that the administration of glucocorticosteroids provokes an intensification of neurotic and depressive symptomatology.

The influence of the psychological characteristics of the personality of RA patients on the quality of life has been evaluated: the deeper the disturbances in the psycho-emotional sphere and the more strongly the anxiety-depressive reactions in patients are expressed, the worse the patients' quality of life is.

Improvement of QoL in RA patients is interrelated with clinical improvement traditionally assessed by the physician. The HAQ questionnaire is more sensitive to these changes, distinguishing even moderate clinical improvement in RA patients. The dynamics of the EQ-5D index was detected only upon achieving a good treatment effect according to the EULAR criteria, whereas in patients with a moderate response to therapy the changes in the indicator were insignificant.

It has been proven that QoL indicators reflect the dynamics of the patient's condition and can be used to evaluate the effectiveness of therapy in RA patients alongside the generally accepted criteria for evaluating the response to therapy, which makes it possible to overcome the established one-sided biological approach to the patient and to select an optimal comprehensive treatment for him or her. The study of indicators of quality of life and of the psychological profile of RA patients provides additional information about the course of the disease and increases the objectivity of the evaluation of the effectiveness of the therapy administered.

Practical Significance

Methods of determining the quality of life of patients with RA should be used alongside the standard procedures for assessing impairment of vital activity, as this makes it possible to form a more complete and objective picture of the disease and to individualize treatment.

QoL indicators can be used to evaluate the effectiveness of therapy in individual RA patients both in conducting scientific research and in general clinical practice.

For the assessment of functional activity of RA patients and of the effectiveness of the therapy administered in general clinical practice and for scientific research, the most sensitive HAQ index should be used; the general questionnaire EQ-5D, which provides an additional assessment of the severity of psychological disturbances in RA patients, may also be used.

For the assessment of QoL in RA patients in scientific research, the general QoL questionnaire SF-36 can be used. Evaluation of the effectiveness of therapy should be carried out using the reference base of population values of the standardized indicators of the SF-36 questionnaire in strict accordance with the sex and age of the patients and the characteristics of the region of residence.

When selecting programs of treatment and rehabilitation for RA patients, not only the clinical and laboratory features of the disease should be taken into account, but also QoL indicators and data from the psychological examination of the patient.

Statements Submitted for Defense

1. A comprehensive study of the quality of life of RA patients using Russian validated versions of international questionnaires has revealed a substantial dependence of QoL on socio-demographic factors (sex, age, level of material status) and on the main clinical characteristics of the disease (degree of activity, severity of the pain syndrome, duration of the disease, presence of comorbid conditions).

2. The majority of RA patients have disturbances in the psycho-emotional sphere that significantly worsen the patients' quality of life and the severity of which is related to a number of clinical and social features.

3. QoL indicators make it possible to carry out a comprehensive assessment of the patient's state of health and constitute an additional parameter for evaluating the effectiveness of therapy alongside the generally accepted clinical criteria.

4. QoL indicators have differing sensitivity in evaluating the effectiveness of the therapy administered. The HAQ index has the maximum sensitivity.

Implementation into Practice

The materials of the dissertation are used in conducting practical classes for students of the 5th and 6th courses and in "health schools" for patients of the rheumatology department of the State Healthcare Institution "Saratov Regional Clinical Hospital with a Pathological Anatomy Center"; they are included in the materials of lecture courses at the Department of Hospital Therapy of the Medical Faculty and at the Department of Therapy of the Pediatric and Stomatological Faculties of the State Educational Institution of Higher Professional Education "Saratov State Medical University named after V.I. Razumovsky" of the Federal Agency for Health Care and Social Development. The results of the study have been implemented in the practice of diagnostic and therapeutic work of the State Healthcare Institution "Saratov Regional Clinical Hospital with a Pathological Anatomy Center".

Approval of the Dissertation

The materials of the dissertation research were presented and reported at the scientific and practical conference of students and young specialists of the Saratov State Medical University "Young Scientists — to the Healthcare of the Region" (Saratov, 2005–2006); at the 6th Northwestern Scientific and Practical Conference "Current Problems of Rheumatology" (Petrozavodsk, 2006); at the 2nd All-Russian Conference "Social Aspects of Rheumatic Diseases" (Voronezh, 2006); at the interregional scientific and practical conference of students and young scientists with international participation "Youth and Science: Results and Prospects" (Saratov, 2007); at the 66th open scientific and practical conference of young scientists with international participation "Current Problems of Experimental and Clinical Medicine" (Volgograd, 2008); at the 9th Northwestern Scientific and Practical Conference (Saint Petersburg, 2009); at the 4th All-Russian Conference "Innovative Technologies in Rheumatology" (Nizhny Novgorod, 2008); at the 5th Congress of Rheumatologists of Russia (Moscow, 2009). On the topic of the dissertation, 16 scientific works have been published, among them 1 article in a journal included in the list of leading peer-reviewed scientific journals and publications recommended by the Higher Attestation Commission for the publication of the main scientific results of dissertation research.

Volume and Structure of the Dissertation

The dissertation is set out on 130 pages of typewritten text and consists of an introduction, a literature review, chapters presenting the materials and methods of the study, the author's own results, a conclusion, conclusions, practical recommendations and a bibliography. The dissertation is illustrated with 27 tables and 10 figures. The bibliography contains 165 sources, including 71 Russian and 94 foreign ones.