Clinical groups in oncology as part of former Soviet Health Care System – Georgian xperience

Tamar Lekashvili; Tamar Rukhadze

doi:10.29088/TCM-GMJ.2018-2.15

Clinical groups in oncology as part of former Soviet Health Care System – Georgian xperience

Tamar Lekashvili, Tamar Rukhadze

Abstract

Background: Number of new events of oncology diseases in Georgia ranges from 7 000 to 8 000 annually and is the second reason for population mortality indicators. Social challenges existing in the country and healthcare system during the years, structural reforms, problems with respect to medical service accessibility have evidently hindered availability of oncology diseases detection on their early stage of development. Reforms conducted in the healthcare system of the county, widening of screening programs availability, cancer diseases detection on the early stage and activation of population registry in the country have considerably contributed to the proper evaluation of epidemiological indicators, diagnosis and treatment results significant improvement. Notwithstanding conducted reforms and achieved success, current regulatory documents fail to correspond to the international standards and acknowledged regulations. They need certain refining in accordance with international guidelines and clinical experience.

Method: For the literature review we have revised articles, methodological guides, orders and manuals published PubMed, MEDLINE, CINAHL, CANCERLIT, EMBASE, PsychINFO and Google Scholar medical database. Unfortunately, databases not properly recognized the keyword – “clinical groups” in oncology despite the Soviet period regulatory documents and literature, which are still available and actual in current regulatory documents and orders in Georgia.

Conclusion: The concept Clinical Group in the practice of clinical oncology represents the unit of dispenser station remaining from the Soviet healthcare system. Unfortunately, in Georgia, it is to the date the indicator for assessment of incurable patient status. Notwithstanding the fact that throughout the world, there are several factors defining general criteria for assessment of incurable patient, such as general standing of the patient, incidence/outbreak of oncological disease, concomitant diseases, current complications and along with the all above-mentioned, life quality of the patient, the elements of the Soviet healthcare system remaining in Georgia precondition receipt of such significant treatment/service for the oncological patients, as adequate administration of the chronic pain, and build a kind of bureaucratic barrier between the patients and the medical service. To the date, use of the clinical groups in the medical practice is conditional and its presence interferes with the complete/perfect service rendering to the patients, making it impossible for the patients to be prescribed with opioids for medical needs in case of severe pain while anti-cancer radical treatment.

Keywords

Cancer; Clinical groups; Assessment; Incurable status; Opioids; Quality of life;

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n accordance with the literature data of post soviet region, through the years, attempt of scientists of this field was directed towards statistical analysis of oncology diseases, features of disease communication, early methods of diagnostics and possibilities, therapy effectiveness and their short or long term results improvement. Attention of scientists and field specialists was drawn to improvement of patients’ health examination, and definition of clinical groups existing in oncology practice till today is related to the latter, and definition of patients’ incurability was based thereon as well (1,2,3,7, 11,12).

In accordance with literature data, manuals and number of regulatory documents, standardization of oncology patients existed in healthcare system of post soviet countries including Georgia. Patients were divided into four main groups, called clinical groups:

Group (1a) – Patients with possible malignancy. This group used to unite patients initial research of which lasted for not more than 10 -14 days and afterwards, in case of suspected oncology disease they needed more detailed researches and they were moved to the following subgroup or they were removed from the group as further diagnostics was not necessary.

Group (1 b) – Patients with pre-cancer and/or benign diseases. Patients in this group are subject to further medical research and health examination.

In the second clinical group were united patients with malignant diseases, whose diagnosis was oncology disease and were subject to specific therapy. Majority of initial patients were in that group. In accordance with literature data and regulatory documents of clinical groups, majority of this group is subject to radical methods of treatment including, in most cases surgical intervention and much more rarely – radiation and chemo therapy, that may be disputable nowadays (2,3,4,5,6,14). In addition, it should be noted, that as some scientist thought, large number of patients of the second group represented objective indicator of successful operation of medical and diagnostic institutions.

The third clinical group consisted of practically healthy patients, who had oncology disease diagnosis even once throughout the life, they went through the specific therapy and were cured. They were on respective health examination registry. Patients of this group were subject to regular patronage and constant evaluation of condition with the following regimen: during the first year of radical treatment – once in a quarter; during the second and the third years – once in 6 months and afterwards, at least once in a year. In case of the third clinical group, patients’ health examination monitoring was recommended at least for 5 years and in case of certain localizations (disease) even during the whole life (2,3,4,5,6,14).

The forth clinical group consisted of patients with late stages of malignancies, when radical therapy was impossible and patient needed palliative and supportive therapy. Management of incurable patients’ severe, chronic pain management and medical application of strong opioids are related to the definition of the forth clinical group and incurable status (2,3,4,5,6,14). Definition of limited ability of patients is connected to that status as well. Notwithstanding the abovementioned, in accordance with various literature data and standard regulation, any surgical intervention, radiation or chemo therapy was not limited for the patient included in the forth clinical group for the purpose of life quality improvement. Patients of the forth group were subject to the constant health examination in accordance with the literature data (9,10,11,12).

Nowadays, healthcare system of Georgia doesn’t include above-mentioned scheme of health examination. Internationally acknowledged clinical guidelines and oncology diseases screening, early detection and follow-up monitoring programs are functioning in the country. However, definition of the second and the forth clinical groups is widely used in regulatory documents as well as in clinical practice till today (9,10).

In accordance with the abovementioned clinical groups, in order to prescribe strong opioid for the treatment of strong, chronic pain, the patient should have documentarily established fourth clinical group along with the pain. That provision opposites the management of those patients’ strong, chronic pain, who are still subject to the treatment and are included in the second clinical group. However, strong opioids application in the treatment of patients included in the second group may be medically necessary.

Regulations and experience of opioids application with medical purposes in oncology patients, differ for country to country, including Georgia. In accordance with the legislative and regulatory documents, oncologist, surgeon, general practitioner, physician and specialist owning the diploma of palliative medicine subspecialty has the right and competence to prescribe the opioid. In case of non-oncology patient (e.g. somatic patient), procedure foresees management of this process by the commission, that is significantly complicated. Due to the western experience, this is not limited for the other specialists (9,10,14).

Phasing is internationally acknowledged in contemporary clinical oncology for the evaluation of patient’s condition and disease status; ECOG and ECOG/Karnovsky scales are applied by oncologists for evaluation of patient’s general condition; evaluation of quality of life is recommended on radical as well as on palliative – supportive therapy phases of oncology treatment (34,35,36,37). Special questionnaires for evaluation of quality of life (QOL) is widely acknowledged, that thoroughly describes patient’s condition and further needs. Concept of quality of life is subjective, however, nowadays, in different searching systems (MEDLINE, CINAHL, CANCERLIT, EMBASE, PsychINFO) there are various information about systemized review, studies and works about evaluation of quality of patients’ life, results of which are available, including cases of different diseases (15,31,40,48). What concerns the incurability – majority of clinician scientists rely on oncologic patients’ general condition evaluation scales, that currently is deemed to be satisfactory instrument for patient’s general condition evaluation (ECOG, Karnovsky) (27,28,29). RECIST 1.1 evaluation system is used as the ideal instrument for the evaluation of specific treatment effectiveness, which provides detailed information on disease progression, stabilization or regress (25,26,32,37).

Thus, nowadays, in order to prescribe adequate treatment (strong opioid) for strong pain in Georgia, it is necessary to establish the compliance with the forth clinical group and incurability status. However, there are different experiences of the other countries (18,23,24). In accordance with the experience of the western countries and respective regulatory documentations, opioids prescription and their medical application is defined due to strong, chronic pain described by the patient and respective medical necessity (including dispnea, etc), specific QOL questionnaires enabling detailed evaluation of quality of life (16,17,21,22,38,39); while effectiveness of specific treatment is evaluated under RECIST 1. Thus, division of patients into clinical groups is not accepted in western practice and above-mentioned systems give possibilities to define patient’s incurability as well as to evaluate quality of their lives and general condition, which is impossible in case of clinical groups system. What concerns the management of strong, chronic pain, based on long-term studies and clinical experience it appeared that patient needs proper pain reliving therapy on every stage of treatment notwithstanding the clinical group (33,37,38, 41, 54, 55, 56).

In addition, clinical group doesn’t provide information about quality of patients’ life. Often, organizational barrier is created during the oncology diagnosis and treatment and therefore patient’s medical needs are not completely and timely met (42,50, 52,53). Disease specific treatment toxicity, even reasons created during radical treatment shall not become bureaucratic barrier for the patient in obtaining qualitative medical service. The aim of medical action shall be maintaining of quality of patient’s life on each stage of the treatment (43,44,45,46,47). In conditions of limited regulatory documents, quality of patient’s life and care is left out of attention while there exists experience of many countries about medical service oriented on the patient, meaning and necessity of evaluation of quality of patient’s life (19,20,30,49).

Conclusions

Clinical group is the unit of health examination of oncology patients and that system doesn’t function in Georgia for the recent decades;

Application of clinical groups in medical practice is provisional; it represents the part of post-soviet system and the unit of oncology patients’ health examination. Clinical group creates a barrier in providing complete service to patients, makes it impossible to prescribe opioids to patients with medical means during anti-cancer radical treatment in case of strong pains;

Clinical group fails to provide complete information on general condition of patient, quality of life. It is nor applied in accordance with international clinical guidelines and is maintained only in the countries of post-soviet region;

In order to obtain qualitative medical service it is internationally acknowledged: disease course and progression shall be evaluated in accordance with respective guideline; patient’s condition shall be evaluated using respective evaluation scales (ECOG and Karnovky), and quality of patient’s life shall be evaluated in accordance with the special questionnaire for quality of life (QOL);

International recommendation shall be always be applied in case of strong pain: strong, chronic pain shall be managed due to medical necessity.