« PHARMACOLOGICAL ECONOMIC STUDY SOCIETY»
INTER-REGIONAL PUBLIC ORGANIZATION(IRPO)
REPORT
ALMAG-01 DEVICE APPLICATION EFFICIENСУ
CLINICAL ECONOMIC ANALYSIS FOR PATIENTS THERAPY WITH GONARTHROSIS DISEASE
Moscow, 2011
Report objective:
ALMAG-01 device application efficiency clinical economic analysis for gonarthrosis disease therapy
Research manager:
Pavel Andreevich Vorobjev – President of (IRPO)« Pharmacological Economic Study Society», Doctor of Medicine, Professor
Executors:
Oleg Vasiljevitch Borisenko – (IRPO)« Pharmacological Economic Study Society» Chief executive director, Candidate of Medicine;
Irina Valerjevna Telegina – (IRPO)« Pharmacological Economic Study Society» researcher;
Ludmila Yurjevna Bezmelnitsyna – (IRPO)« Pharmacological Economic Study Society» researcher;
Madlena Yurjevna Hersesjan – Russian State Medical University named after I.M.Sechenov public health services department medical aid and medicine problem quality control laboratory leading engineer.
Summary
Prospective, controllable, randomized, double – blind examination with Almag-01device use has been carried out for magneto-therapy efficiency study. All patients have been divided into 2 groups: in the basic group there was used the working device Almag-01, in control one – placebo device in appearance and design looking like the working device.
Both Almag-01 device and placebo device have been applied according to application manual, the course treatment included 18 procedures. In examination there was allowed the combination of physiotherapeutic and medicamentous treatment in accordance with the standard practice. All prescribed medical procedures and medical preparations have been recorded in the patient medical individual card To make therapy efficiency estimation there were used criterions as follows: functional abnormalities intensity ( under International Classifier ), and also changes of life quality value ( to study life quality value questionnaire EQ-5D was used). Besides there was used ALMAG-01 device application efficiency clinical economic analysis according to “ expenditures – advantages ” criterion.
The total number of patients involved into examination was 170 ( 75 (44,1 %) of them applied ALMAG-01 the working variant, 95 ( 55,9 %) – ALMAG-01 device placebo variant). To the moment of examination beginning the groups haven`t been comparable: the patient in ALMAG-01 placebo- device group , had the worse characteristics both of articulation function ( according to objective parameters and International Classifier indexes ) and life quality values ( except life quality value being evaluated according to visual- analogous scale).
According to examination results, the life quality dynamic evaluated according to visual- analogous scale in ALMAG-01 device group came to 0,11 points; in placebo – device group – 0,1 points. While studying life quality being evaluated according to ED-5D questionnaire 5 indexes, in both groups there was noted statistically considerable reduction of patients number with life quality moderate or severe abnormalities according to ED-5D questionnaire all 5 indexes except self-service factor in ALMAG-01 device group.
And at the same time in placebo – device group as compared with ALMAG-01 device group there was noted much more considerable reduction of patient number having life quality moderate or severe abnormalities ( except pain and discomfort value index ) according to : space movement index – 29,4% and 26,7% accordingly; self-service index – 26,3% and 1,3% accordingly; daily activity index – 52% and 33,3% accordingly) ; pain and discomfort index 37,9% and 57,3% accordingly; worry and depression index – 43,2% and 30,6% accordingly. So Almag-01 device as compared to placebo – device had more expressed effect to life quality value concerned with pain and discomfort.
Making joints` function characteristics evaluation according to function abnormalities International scale there were not revealed statistically significant value differences between groups but however there was noted more positive dynamic of joints` mobility function values in Almag-01 device group as compared with placebo – device group (21,3% and 9,5% accordingly). Inside Almag-01 device group there were not noted “ Walking and moving” indexes statistically significant changes according to function abnormalities International scale. As for placebo – device group there were no noted any statistically significant changes according to short-distance walking index.
At the same time in the placebo – device group there was noted statically significant reduction of the patients number with severe and mean abnormalities according to 1 km walking distances ( from 69,4 % up to 46,3 %) and increase of a number of the patients with slight abnormalities according to this value index (from 10,5 % up to 31,6 %). In Almag-01 patients group as well there were evidently revealed a greater number of the patients having slight abnormalities or their absence according to «short distances walking » value as being compared with placebo – device patients group (14,6 % and 4,2 % accordingly).
The total costs for one patient treatment in Almag-01 device group came to 7648,04 roubles. The total costs for one patient treatment in the placebo-device group came to 9 604,12 roubles.
Magneto-therapy with a help of ALMAG-01 device clinical-ecomonic analysis turned out to be an effective policy decision from the position of expenses at carrying “ expenses – efficiency” analysis out according to life quality value severe and mean abnormalities dynamic criterion in relation with pain and discomfort. So it required to spend 13 417 rub. in order to reduce life quality severe and mean abnormalities per patient in ALMAG-01 device group that is practically twice less as compared with the expenses in placebo-device group for achieving the same goal ( 25 956 rub. per patient).
Thus, the performed prospective, randomize, double blind, controllable magnetotherapy efficiency study with Almag-01 device has shown, that the device has an effect on patients revealing itself in pain and discomfort decrease, however as for the other values (parameters) there were no differences in its efficiency evaluation.
STUDY URGENCY
At present оsteoarthrosis takes leading position in the world mong joints degenerate diseases, and for their prevalence – the first place among rheumatic illnesses, being only after bone and joint illnesses and back pain syndrome.
Osteoarthrosis represents itself a serious medical and social problem, it often has chronical clinical picture and results in patients disability. This is frequent and important course of elderly people joints pain and reduction of their physical activity. Disease clinical course is joints pain and reduction of elderly people physical activity. Osteoarthrosis сlinical appearance as a rule, begins at the age of more than 40-45 years , radiological characteristics of osteoarthrosis are defined at 50 % of population at the age of 55 years and 80 % -at the age more than 75 years.
В настоящее время это заболевание уже не считается простым следствием старения и дегенерации хряща, как ранее [13, 14, 15]. At present this disease is not considered simply as a result of cartilage both aging and degeneration as it was early but in its basis there is active processes both of degenerative-destructive and reparative character. Hyaline cartilage, ubchondral bone, synovial membrane, intraarticular ligament, articular capsule, paraarticular muscles and tendons are involved into pathological process. Last year it is noted that there is inflammatory process in the basis of osteoarthrosis as well as other rheumatologic diseases with injury of articular apparatus.
Complexity of physiotherapeutic treatment application is that the age inevitable consequence is polymorbidity , that is often an essential restriction for preformed physical therapy administaration (the problem of especially actual is cardiovascular pathology ).
One of the methods of physiotherapeutic treatment widely recommended even at presence of concomitant diseases is magnetic field exposure on an human organism. АЛМАГ-01 is magneto-therapy device indicated for organism local exposure with a help of traveling pulsed magnetic field . Study of magnetotherapy with the help of Almag-01device indicated for knee joints osteoarthrosis treatment is also presents interest.
Work objective: osteoarthrosis therapy with ALMAG-01 device clinical -economic analysis
Examination tasks :
· To carry out analysis of the literature on magnetotherapy application (in particular, device Almag-01) efficiency and safety for osteoarthrosis disease treatment.
· To choose criteria for magnetotherapy efficiency evaluation and draw up test report
· To carry out clinical examination of Almag-01 device application efficiency and safety according to test report
· To calculate direct medical expenses for both Almag-01device physiotherapy and comparison therapy.
· To carry-out ALMAG-01 device clinical-economic analysis.
Magnetic field is specific type of material providing connection and interaction between traveling electric charges. Magnetic field is being generated wherever there is traveling electric charge or current. It can exist both in material medium and in vacuum. Unlike the electric field the magnetic field can only produce effect on traveling charges and only through it external magnetic fields it can effect the particles. This is due to the fact that only traveling charges have their own magnetic field Its important particular feature is its unlimited extension in space: though when moving away from traveling charges the field becomes considerably weaker but has no limiting boundaries.
Classification of magnetic field.
· According to its origination: natural ( Earth`s and Sun`s geomagnetic fields, magnet fields), artificial fields, magnetic field of bio-objects.
· According to their alteration in time: permanent magnetic field, alternating magnetic field, pulsed magnetic field, pulsating magnetic field and noise -type magnetic field
· According to their modification in space: uniform and non-uniform fields.
· According to their intensity: weak, mean, strong and super-strong.
Permanent magnetic fields do not change at a particular point either in time or in direction. It is induced by both direct current inductors and hard and flexible magnets.
Alternating magnetic field changes in time relative to its value and direction . It is generated by inductors powered with alternating electric current; Sinusoidal magnetic field is a particular case of alternating magnetic field. It is generated by industrial alternating current or special sinusoidal oscillations generator.
Pulsed magnetic field is changes in time relative to its value but does not change in direction. It is generated by the pulsating current inductors.
Pulsed traveling magnetic field is a field traveling in space relative to motionless patient and pulse -changing in time.
Pulsed traveling magnetic field possesses the greatest number of biotropic parameters and is characterized by the greatest magneto-biological activity
Magnetic field is represented graphically as a system of lines called as magnetic flux lines. They present themselves imaginary closed magnetic lines drawn so that tangents to them indicates the direction of field vectors or magnetic induction vectors at any point in the field. Line density correlates with the numerical values of corresponding quantities.
The direction from the North to the South Pole is conventionally taken as the direction of a magnetic field vectors in the environment and in permanent magnets.
.The term” biotropic parameters” means physcical characteristics of a magnetic field determining primary physio-chemical and informative mechanisms of the field effect causing the formation of corresponding reactions both of individual organs and the organism as a whole.( M.A. Shishlo). The term” biotropic parameters” include: the type of the field, its induction, energy, gradient, vector and frequency. Form of the field in time and space, effect exposition and localization. Particular disease therapeutic efficiency is significantly depend on each of these parameters as well as on their combination.
Induction (В) is magnetic field basic feature. It is magnetic flux density in the area confined by closed conductive contour. The unit of its measurement is tesla (Tl.) and millitesla (1mTl = 10‾³Tl) in physiotherapy. 1 mTl induction magnetic field causes tissue threshold changes providing initial therapeutic effect. That is why the distance from the source within which induction value comes to 1 mTl. is defined as this particular source magnetic field “ penetrating effect depth”.
Frequency is magnetic field another important biotropic parameter. Yu.A. Kholodov and M.A.t Shishlo (1979) researchers revealed hat electromagnetic fields with α – rhythm frequency of human ECG (8-14 Hz) causes greater effect than adjacent frequencies of similar intensity.
Magnetic field gradient is the value of magnetic induction which changes with 1cm. distance change away from the source. It shows the direction of magnetic induction value change at a particular vertical and horizontal distance.
Field intensity is the strength a magnetic field effects rectilineal conductor located perpendicularly to the direction of field lines with current intensity of 1 unit. The vector shows the direction of magnetic power lines and with its change there is the change of its biological effect character.
Therapeutic effect depends on a field pulse shape. According to Yu.A. Kholodov (1987), pulse rectangular form possesses greater activity compared to a sinusoidal one.
Exposure time is of a similar significance. Traditionally defined procedure duration is in the range of 10-30 minutes daily procedures with procedure course from 5 to 25 days. Further studies should be undertaken taking into consideration patient`s age, individual features, magnetosensitivity as well as pathological form, stage and severity.
Local magnetic exposure is defined , as usual, by pathological area added with the effect on Zakharyin-Ged`s reflex zones and biologically active points. It is well known that there are two types of magnetotherapeutic exposure: local ( to pathologic focus) and general ( to the patient`s body as a whole)Being quite different these two types should not be considered as completely dissimilar since any local exposure inevitably initiates reflex mechanisms stimulating the response of central control mechanisms (though this response would be undoubtedly weaker compared to a general exposure) Thus, local magnetic exposure effects a concrete anatomical area making the devices for local magnetotherapy more efficient and convenient.
Biophysical and biochemical bases of magneto-therapy
Under the effect of magnetic fields in macromolecules ( enzymes, nucleic acids, proteins etc.) there are both generation of charges and the change of their magnetic susceptibility. Macromolecules magnetic field energy can exceed the energy of thermal movement, thus even therapeutic doses of magnetic fields cause orientation and concentration changes of biologically active macromolecules resulting in kinetics of biochemical reactions and biophysical processes speed.
In magnetic field primary effect the great importance is given to liquid crystal oriental rebuilding making the basis of cell membrane and many intracellular structures. Liquid crystal ( membranes, mitochondrion) orientation and deformation under magnetic field effect manifests itself on their permeability playing important role in the regulation of biochemical processes and the performance of their biological function.
Magnetic field effect on elementary currents in atoms and molecules of intra-and- extra-cellular water results in its quasi-crystal structure change. Due to specific spatial orientation of elementary currents in atoms and molecules there is change of water properties:surface tension, viscosity, conductivity, dielectric permeability etc. This promotes the molecules of proteins, nucleic acids, polysaccharides and other macromolecules to perform their specific functions; they form a common system with water and their transport and metabolism dependent on the water-bonded state .
One of the important regulatory mechanisms in living systems is ion activity. It is primarily determined by their hydration and connection with macromolecules. Under the effect of magnetic field system components differ in the magnetic and electronic properties ( ion-water, protein-ion, protein-ion-water) there would be oscillatory motions with the parameters that might not coincide. As a result there will be both ions release out of macromolecules connection and decrease of their hydration thus promoting ion activity. This ion activity increase under the magnetic field effect is considered as a precondition for cell metabolism stimulation.
With a magnetic effect on the vessels not only biologically active macromolecules but also super-molecular and cellular structures would be oriented. Erythrocyte alignment under the effect of magnetic fields is a marked manifistation of such orientation. The less diameter of the vessel, the weaker magnetodynamic effect is. Among other macroscopic effects of magnetic fields, their ponderomotor influence on nerve trunks and muscular fibers should be mentioned. The result of which is their electro-physical activity and functional behavior change.
Specific effect of alternating and paramagnetic interaction are of special attention. In addition to diamagnetic and paramagnetic interaction there is interaction with ac current in casae of any magnetic field alteration.. Since in tissues there are charges, ions and electrons the induced electric field would cause their motion, i.e. would generate electric current possessing manifold biological effect.
Taking the above mechanisms into consideration it can be stated that a permanent magnetic field effects the body through dia-and-paramagnetic effects while alternating and pulsed field produce an additional effect through generated electrical currents. When effecting the living systems, submolecular, molecular and supramolecular structures become activated resulting in cellular, systemic and body level changes.
The mechanism of physiologic and therapeutic effect
The magnetic field effect on human body is characterized by:
· individual sensitivity and unstable response of the body and its systems to magnetic field exposure;
· correcting magnetic field effect on the body and its functional systems resulting in normalization of hyper-and-hypofunctioning organs and systems. Effect on the background of organs or system hyperactivity results in its decrease and the application of the magnetic field in the conditions of its function depression is followed by its increase;
· the change of body response phase direction to the opposite one under the magnetic field effect ;
· therapeutic efficiency degree dependent on magnetic field characteristics. The effect is more evident in case of alternating and pulsed magnetic field exposure compared to a permanent one;
· a great number of body responses are of a liminal or resonance character, particularly, when pulsed magnetic fields are applied;
· trace character of magnetic field exposure. After a magnetic field single exposure body response lasts for 1-6 days, while the course of procedures is followed by 30-45 days` response this fact sets conditions for making an interval between repeated procedure courses.
The response of various organs and systems to magnetic field is not similar. Selectivity of body response depends on electrical and magnetic behavior of tissues, the difference in their micro-circulation, metabolism intensity and the state of neuro-humoral circulation. Sensitivity of nervous system to magnetic field exposure puts it in the first place among the others; then goes endocrine system which is followed by sense organs, cardiovascular system, blood, muscular, digestive, excretory, respiratory and bone systems.
Magnetic field short-term exposure has various effect to organism promoting the development of individual favourable reversible processes. The most evident and more important for disease clinical picture is sedative, hypotensive, anti-inflammatory, anti-edematous, analgetic and trophicoregenarative action. Under certain conditions e.g. when exposing large vessels, magnetotherapy produces deaggregation and hypocoagulation effect, improves micro-and-regional circulation, effects favorably on immunorealtive and neurovegetative processes.
Magnetic exposure as a rule neither generate endogenic heat not causes temperature rise or skin irritation. It is well tolerated by weak and elderly patients suffering from concomitant cardiovascular diseases. This fact allows to apply the device when the other physical procedures are not indicated.
Despite of their beneficial effect magnetic fields with the intensity over 70 mTl can become stress agents acting unfavorably on various functional systems resulting in discoordination of endocrene activity; decrease of energy processes intensity; glycolysis activation; disturbance of cellular membrane permeability; development of hypoxia and dystrophy processes. Taking these factors into account it should be noted the necessity of safety measures and dosage control strict observation.
ALMAG-01 magneto-therapeutic device is designed for local effect on the human body with a traveling pulsed magnetic field.
It presents itself a flexible four inductor unit of 0.5 m total length which is placed on the human body affected area. The weight of the device with the power supply unit is not more than 0.55 kg. The penetration depth of a magnetic field into patient`s body in therapeutic doses is 6-8 cm. which allows direct exposure both the surface pathalogical focus and inner organs.
The device action is characterized by its high biological activity due to the greatest nummber of biotropic parameters of generated travelling pulsed magnetic field. Patient`s adaptation to the device electromagnetic action has not been noted.
Electromagnetic pulse repetition rate (6.25 Hz).Total duration of an operating cycle is set with a timer.
Though the ALMAG-01 has two operating surfaces its inductor is designed so that 15 cm distance away from it its magnetic induction is comparable with the common Earth background ( 0,05mTl), so there is no “ magnetization” of surrounding objects that is of gear significance for the personnel of physio-therapeutic rooms.
Patients noted good tolerance of conducted procedures. Almag-01 device application assessment general clinical efficacy showed that 79% of patients had reduction of clinical signs and the improvement of patients` general condition and only 21% of patients had only slight improvement of their condition. There was no noted a case of patients` progressive deterioration. ( Maligin and co-authorship).
When studying the state of vegetative nervous system, neuroendocrine regulation and central nervous systemactivity during device ALMAG-01 therapeutic exposure on patients organism on the hardware-software complex intended for the analysis of biological rhythms of person organism allocated from electrocardiosignal in a wide frequency band it was marked, that the functional conditions parameters of patients suffering from acute and chronic diseases showed dynamics drastic increase ( growth) up to the treatment 6th day and later on smooth, stable and simultaneous increase. This is the evidence of all organs and systems function harmonic change as a result of ALMAG-01 device course treatment and the proof of its application expediency for the above said disease groups.
At the same time, randomized study with use of device ALMAG-01 it had not been carried out.
MATERIALS AND METHODS
Method of study : prospective, controllable, randomized, double – blind. All patients were divided into 2 groups: working Almag-01device was applied in the basic group ,while in the control one – the placebo device which did not differ from the working ALMAG-01 device in appearance and design. The only difference between them was the absence of contact between the generator and electromagnetic radiation effector (unit body).
The period of study duration – 21 days.
Object under study – patients suffering from gonarthrosis, taking treatment in a hospital.
The number of patients involved in medical examination in each medical center is 20-40. The patient`s card have been drawn up for each patient. Partient`s cards included the data both on medical expense, procedure tolerance and efficiency. The treatment of the patients of the main group has been carried out with the use of ALMAG-01 device, in the control group placebo-device was used. Magneto-therapy has been carried out in accordance with operating manual for the device taking into account existing clinical experience.
Before examination there were carried out both medical centers initial randomization and patients randomization in the clinical center; besides there were prepared 6 device-sets included ALMAG-01 working devices and ALMAG -01 placebo-devices. All devices in the sets have been marked with figure «1» and «2» The device numeration was known only by medical center employees. Beforehand there were prepared the required number of envelops marked with figures «1» and «2» adequate to the number of patients («1» – working device and «2»- placebo device). Unawareness of patients and doctors of the placebo device real nature was reached by using specially manufactured placebo devices ( devices not generating magnetic field) which were not differ from the ALMAG-01 working device and placed in the same physiotherapy room. In medical center, after selection patients` group in accordance with appropriate criteria , the doctor opened an envelope where number of the device had been identified
Criteria to the patients to be included into groups for medical examination :
· men and women of 18 years old and elder
· the patients suffering from gonarthrosis and/or coxarthrosis, except their severity conditions ( the patients have been diagnosed on the basis of clinical criteria ( given below) and in compliance with existing clinical practice. Gonarthrosis clinical criteria : (sensitivity- 89 %, specificity – 88 %) [V.V.Tsurko, 2004]:
§ Pain + crepitation + morning constraint less than 30 minutes + age- more than 38 years old or
§ Pain + morning constraint less than 30 minutes+ joint size expansion
§ Pain + joint size expansion.
o Coxarthrosis clinical criteria : (sensitivity- 91 %, specificity – 89 %) [V.V.Tsurko, 2004]:
§ Pain + osteophyte or
§ Pain + ESR less than 20 mm/h + joint cartilage space constriction
· Absence of severe or unstable somatic, neurologic or mental diseases which can prevent the examination
· Presence of the patient consent to participation in examination
Medical examination contraindications:
· the age below 18 year old,
· osteoarthrosis severity,
· Presence of absolute and relative indications to Almag-01device application
– acute inflammatory diseases ,
– bleeding ( hemorrhage) and susceptibility to it
– high-grade hypotonia,
– purulent processes before surgical operation ,
– heart ischemic disease severe stage ,
– early postinfarction period ,
– stroke
– pregnancy,
– blood systemic disease ,
– oncological diseases
– thyrotoxicosis,
– diencephalic syndrome,
– presence implanted cardiostimulator in a zone of influence.
Almag-01working device and Almag-01 placebo devices were used according to application instruction: course of treatment included 18 procedures, with a day break after 6-th and 12-th procedures depending on organism reaction; procedure time for the first 3 procedures was 10 minutes, with the increase of its further duration by 2 minutes per procedure and up to the 8th procedure the procedure time came to 20 minutes, and further on duration of each procedure was 20 minutes; in case of disease aggravation to 3th -4 th treatment day, procedure time was reduced by 1/4; procedures were carried out once a day.
.In examination ,according to the standard practice, the the combination of physiotherapeutic treatment with medicamentous treatment was used.
All medical preparations were put down into patient individual card.
Examination process.
Patient informed consent to take part in examination: before examination it is necessary to get patient`s consent to involve him/her into examination .
During randomization each patient was given individual identification number one for all examination period .
It is supposed that patient should see doctor -physiotherapist twice:
· the first visit – when he/she was included into examination list ;
· the second one – 20-24 th day after the examination beginning .
During his/her first visit to the doctor the patient signed the informed consent on his/her participation in examination. If the patient`s state of health met the required criteria, doctor filled in examination card appropriate section concerning patient demographic data, state of health before being involved in the process of examination, prescribed both diagnostic procedures, their results and medical preparation the patient took before examination, gave the assessment of patient functional disorders and magneto-sensitivity. The patient filled in questionnaire EQ-5D.
Magneto-sensitivity was measured as follows: at first ABP was measured; then there was conducted heels electromagnetic exposure for 5 minutes; after that ABP was measured again. Magneto-sensitivity was considered as low if ABP hadn`t been changed ; as mean – if ABP ( systolic and diastolic ) had 5-10 mm.Hg change , high – if ABP had changed more than 10 mm. Hg.
During the second visit, the treatment tolerance was evaluated . If the result of the evaluation was satisfactory the treatment was kept on.
During the patient third visit to the doctor ( 20-24th examination day or the day of discharge from hospital) the information of all medical services and medical preparations taken by the patient during the medical examination period, the number of laboratory examinations, the availability of side effects , change of therapy scheme were being put down the patient card. After medical examination termination the doctor made reassessment of the degree of the patient functional disorders. And the patient filled in questionnaire EQ-5D again.
The following criteria were used for therapy efficiency assessment: intensity of functional disorders (according to Functional Disorders International Classification) , and also the change of life quality parameters ( questionnaire EQ-5D was used to study life quality ).
Assessment of functional disorders has been carried out according to on Functional Disorders International Classification 5 points scale: 1 point – “ no any disorders”, 2 points – “ low-grade disorders”, 3 points – “ mean-grade disorders”, 4 points – «evident disorder ”, 5 points -”absolute disorders”
There were used 6 scales :
· «some joints mobility»,
· « joints total mobility»,
· «some joints stability »,
· «joints total stability»,
· «short- distance walk»,
· «long- distance walk».
The choice of scales was stipulated by concrete illness symptomatology.
Estimation of safety: presence of by-effects and presence of cause -and -effect interrelations according to Naranzho scale was estimated.
The termination of medical examination : examination was stopped on the expiration of 18 magnetotherapy procedures, or at the appearance of by-effect presenting in opinion of the doctor the hazard to the patient relating to the application of the device, or patient refusal to take part in examination .
ECONOMOC ASSESSMENT
Within the examination process the information on all treatment -and- diagnostic procedures and medical preparations taken by patient have been put down into examination card. Direct medical expenses have been estimated.
PRICE INFORMATION
Medical procedure costs have been calculated according to Затраты на услуги рассчитывалась по формуле (1):
У = С х Ч х К, (1)
Where :
У – rendered medical service cost ,
С – medical service price under per medical service tariff ,
Ч – rendered medical service ferequency ,
К – rendered medical service ratio.
Medicinal preparation avarage prices have been taken on information site “ PHARM -index” (www.pharmindex.ru) (24.12.2010).
Hospital accommodations expenses were calculated as hospital avarage stay duration multiplication by per bed-day artrology hospital treatment price ( 176,17 rub).
Per patient total costs in both Almag-01 working device group and Almag-01 placebo device group were calculated according to formular (2):
C = Cm + Cs + Cг,
where :
C – per patient total cost ,
Cm – medicinal preparation costs per patient ,
Cs – medical service expences per patient ,
Ca – hospital accommodations expenses per patient .
“COSTS — EFFECTIVENESS ” ANALYSIS .
The study of the situation when one and the same treatment purpose have been reached by two medical methods. In this particular case “costs-effectiveness” analysis method is more expedient one. This type of analysis allowes to take into consideration and correlate both taken treatment procedurtes expenses and efficiency (effect). It usually consistes of two stages :
1). Medical technoligies application results clinical and economic analysis with the purpose to define value of avarage expenses per patient in both group.
2). «Costs-effectiveness”coefficients calculation and comparison for each of patient treatment variants.
It should be taken into consideration that the main condition for «Costs-effectiveness” analysis application is efficiency calculation uniform criterias
«Costs-effectiveness” ratio is calculated under the formula (3):
СЕА = ,
where
СЕА «Costs-effectiveness” ratio gives expenses per efficiency
numerator – treatment avarage expenses per patient ;
denominator – treatment effeciency .
From the economical point of view the most acceptable technology of two is that which is chracterised by the less expenses per efficiency.
RESULTS and DISCUSSION
In research centers were supplied with ALMAG-01 working device and ALMAG-01 placebo device. The data of the number of patients involved into medical examination see table 2.
Table 2
| № |
The name of the research center |
The group of Almag-01 working device |
The group of placebo-device | ||
|
The number of devices |
The number of patients |
The number of devices |
The number of patients |
||
|
1. |
Kazan, Republican clinical hospital |
1 |
26 |
1 |
25 |
|
2. |
G.Kazan, war veterans hospital ( rheumatology department) |
1 |
4 |
1 |
5 |
|
3. |
Goluboe urban settlement, Moscow region, the Central hospital of regenerative treatment |
1 |
10 |
1 |
10 |
|
4. |
Ryazan, LLC ” Sanatorium ” Solodche » |
1 |
15 |
1 |
15 |
|
5. |
Yaroslavl, Regional clinical hospital |
2 |
20 |
– |
– |
|
6. |
Moscow, City clinical hospital №17 |
– |
– |
2 |
40 |
| Total |
6 |
75 |
6 |
95 |
|
The total number of patients is 170 (75 of them applied Almag-01 working devi ( 44,1 %) ; and 95 patients applied Almag-01 placebo-device ( 55,9 %).
Groups general characteristic.
Patients description is given in table 3. Patients applied Almag-01 working device were older than those applied placebo-device (68 and 53 years old correspondingly ).
Table 3
Medical examinations participants demographic and clinical characteristic
|
Characteristics and parameters |
Алмаг-01 device group (n = 75), абс. |
Placebo-device group (n = 95) , абс. |
|
Men |
19 |
32 |
|
Women |
56 |
43 |
|
Middle age |
68,74±11,9 |
53,8±12,8 |
|
Disease |
||
|
Gonarthrosis : – unilateral |
15 18 |
27 23 |
|
Knee-joints deforming osteoarthrosis : – >unilateral |
15 7 |
17 9 |
|
Generalized osteoarthrosis |
16 |
10 |
|
Posttraumatic arthrosis |
1 |
9 |
|
Rheumatoid arthritis |
3 |
0 |
|
Disease aftereffects |
||
|
Synovitis |
6 |
8 |
|
Baker`s cyst |
0 |
4 |
|
Concomitant diseases |
||
|
Essential hypertension |
21 |
16 |
|
Coronary heart disease (CHD) |
3 |
5 |
|
Decompensated diabetes |
6 |
4 |
|
Kidney and urinary tracts diseases |
2 |
2 |
|
Gastrointestinal tract diseases |
4 |
7 |
|
Respiratory apparatus diseases |
3 |
5 |
|
Varicosity |
3 |
4 |
|
Generalized atherosclerosis |
2 |
2 |
|
Obesity |
10 |
8 |
4.The description of patients under medical examination .magnetic sensitivity
Table 4
|
Magnetic sensitivity parameters |
Аlmag -01 device group (n = 75), абс. (%) |
Группа Placebo-device group (n = 95) , абс. (%) |
|
Low |
31 (44%) |
39 (41%) |
|
Mean |
41 (54,7%) |
40 (42,1%) |
|
High |
3 (1,3%) |
16 (16,9%)* |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
Looking through the table we could not but notice the great part of patients with high magnetic sensitivity in group of the patients using the placebo – device with an identical part of low sensitivity.
The data on joints functional activity parameters under the functional disorders international scale at the moment of the medical examination beginning are given in table 5.
Functional disorders characteristics at the moment of examination beginning according to functional disorders Inrerenational scale indications
Table 5
|
Characteristics and parameters |
Аlmag-01 device group (n = 75), абс. (%) |
Placebo-device group (n = 95) , абс. (%) |
|
Knee-joint mobility function |
||
|
Absolute disorders |
0 |
0 |
|
Severe disorders |
4 (5,3%) |
4 (4,2%) |
|
Mean disorders |
39 (52%) |
55 (57,9%) |
|
Light disorders |
20 (26,7%) |
32 (33,7%) |
|
No disorders |
6 (8%) |
1 (1%)* |
|
Disorders are not noted in the card |
6 (8%) |
3 (3,2%) |
|
Knee joint unrestricted (free) movement function |
||
|
Absolute disorders |
0 |
0 |
|
Severe disorders |
3 (4%) |
8 (8,4%) |
|
Mean disorders |
35 (46,7%) |
50 (52,6%) |
|
Light disorders |
14 (18,7%) |
19 (20%) |
|
No disorders |
3 (4%) |
1 (1%) |
|
Disorders are not noted in the card |
20 (26,6%) |
17 (18%) |
|
Short -distance walk |
||
|
Absolute disorders |
0 |
0 |
|
Severe disorders |
3 (4%) |
7 (7,4%) |
|
Mean disorders |
27 (36%) |
34 (35,8%) |
|
Light disorders |
26 (34,7%) |
33 (34,7%) |
|
No disorders |
5 (6,7%) |
3 (3,2%) |
|
Disorders are not noted in the card |
14 (18,6%) |
18 (18,9%) |
|
Not less than 1 km distance walk |
||
|
Absolute disorders |
1 (1,3%) |
0 |
|
Severe disorders |
9 (12%) |
20 (21%) |
|
Mean disorders |
30 (40%) |
46 (48,4%) |
|
Light disorders |
11 (14,7%) |
8 (8,4%) |
|
No disorders |
3 (4%) |
2 (2,1%) |
|
Disorders are not noted in the card |
21 (28%) |
19 (20,1%) |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
As it is seen from the table 5 the given groups according to knee joint both function, walk and mobility indications in group of the patients applied Almag-01 working device ( besides evidently bigger number of patients with no knee joint disorders mobility indications) , as compared to placebo- device group patients is practically equal to 8 % and 1 % accordingly, p <0,05.
Data of extremity injury joint flextion angle and area of its extention at the moment of examination begging are given in table 6
|
Characteristics and parameters |
Аlmag -01 device group (n = 75), абс. |
Placebo-device group (n = 95) , абс. |
|
Injury joint flexion (bending) angle (◦) |
71,88 |
64,9 |
|
Injury joint extension angle (◦) |
119,62 |
116,32 |
|
Injury joint area (volume), cm |
47,15±10,35
|
50,05±8,35
|
As it is seen from the data of table 6, at the beginning of medical examination both groups were practically comparable according objective indications : parameters of affected extremity injury joint bending angle and injury area size, however in Almag-01 device group the affected extremity joint bending angle was bigger (71,88о and 64,9оaccordingly) and the area of injured joint was less (47,15 сm and 50,05 см accordingly) than that one in placebo-device group. So at the begging of examination the ALMAG-01 device group patients had better objective indications of injuried joint as compared to placebo device group.
Estimated data on patients life quality according to questionnaire EQ-5D 5 criteria at the beginning of medical examination is given in the table 7. As it is seen from the table at the beginning of medical examination in Almag-01 group the number of patients with mean and severe life quality disorders according to both self-service and daily activity factor was less as compare to the number of placebo-group that is 18,7% and 55,8% and 61,3% and 80% accordingly .
Table 7
Assessment of patients state of health at the beginning of medical examination
( according to questionnaire EQ-5D 5 criteria)
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
In Almag-01 device group life quality index avaluated according to a visual – analog scale had come to 0,51 (+/-0,11; median – 0,50, the 1-st quartile – 0,45, the 3rd quartile – 0,60) and in placebo- device group it was equal to 0,59 (+/-0,13; a median – 0,58, the 1-st quartile – 0,50, the 3rd quartile – 0,70). Thus, patients`life quality index, evaluated according to visual – analog scale, in Almag-01device group was a little bit lower, than that placebo device group.
Thus, the data analysis showed that, despite randomization carried (clauster one and inside clasters in 3 cases), at the moment of the medical examination the groups were not comparable. On the whole, patients in the placebo-device group had the worse indications both of joint function ( according to objective parameters and functional state international parameters classifier ) and life qualities ( evaluated according to visual – analog scale).
Clinical results
Treatment mean duration in Almag-01 device group has come to 13,2 days (+/- 5,2 days , median – 13 ( the 1-st quartile – 10, the 3rd quartile – 17), in placebo-device group – 10,4 days (+/- 6,9 days) , median – 10 ( the 1-st quartile– 3, the 3rd quartile – 17).
Information on magneto-therapy tolerance according to both groups examination results is given in the table 8 .
Table 8
Magneto-therapy tolerance according to examination results
| Tolerance |
Аlmag -01 device group (n = 75), абс. (%) |
Placebo-device group (n = 95) , абс. (%) |
|
Good |
43 (57,3%) |
84 (88,4%)* |
|
Satisfactory |
15 (20%) |
11 (11,6%) |
|
No data |
17 (22,7%) |
0 |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
Thus, therapy good tolerance was more often noted in placebo- device group as compared with Almag-01 device group (88,4 % and 57,3 %, accordingly, p <0,05), so it is perhaps the evidence of the fact that Almag-01device exposure.
Both in Almag-01 device group and in placebo-device group there was no notices of any therapy complications.
The analysis of injured joint both bend angle dynamics and volume has shown, that in Almag-01 device group there was noted the bigger , but statistically not big reduction of injured joint volume as compared to placebo-device group (3,9 sm and 2,9 sm accordingly) (tab. 9). Also it was noted that in ALMAG-01 device group injured joint bend angle had been reduced by 0,31о while in placebo-device group it is increased by 2,4о. Injured joint extension angle increased in both groups, but it is necessary to notice that the increase in ALMAG-01 device group was bigger as compared to placebo-device group (-7,41 о and -3,15 о accordingly).
Table 9
Injured extremity function indications dynamic ( both bending angle and injured joint volune )
|
Characteristics and parameters |
Аlmag-01 device group (N = 75) |
Placebo-device group (N = 95) |
||||
|
Index before examination |
Index after examination |
Δ |
Index before examination |
Index after examination |
Δ |
|
|
Affected joint bending angle (◦) |
71,88 |
71,57 |
0,31 |
64,9 |
67,3 |
-2,4 |
|
Affected joint extension angle (◦) |
119,62 |
127,03 |
-7,41 |
116,32 |
119,47 |
-3,15 |
|
Affected joint volume, см |
47,15±10,35
|
43,25±4,4
|
3,9 |
50,05±8,35
|
47,15±9,4
|
2,9 |
Впрочем, и на момент начала исследования в группе Алмаг-01 по сравнению с группой аппарата-плацебо, так же было достоверно меньше больных с тяжелыми и умеренными нарушениями по показателям самообслуживания и повседневной активности.Patient life quality data estimated according to questioning EQ-5D 5 indexes at the moment of examination termination are given in table 13. On the whole there was no difference on quality life indications, but in ALMAG-01 device group as compared to placebo -device group the number of patients suffering from pain and discomfort moderate and severe disorders was less. (38,7% and 62,1%).
In Almag-01 device group life quality indix estimated according to a visual – analog scale has come to 0,62 (+/-0,12; median – 0,63, the 1-st quartile – 0,5, the 3rd quartile – 0,7) and in placebo- device group – 0,69 (+/-0,14; a median – 0,70, the 1-st quartile – 0,60, the 3rd quartile – 0,75).Thus, patients`life quality dynamic , estimated according to visual – analog scale in Almag-01device group came to 0,11 points. Thus, life quality dynamic, estimated according to visual – analog scale in placebo-01device group came to 0,1 points. So there were no noted evident differences in life quality dynamic estimated according to questioning EQ-5D 5 parameters.
Data on life quality dynamics, estimated according to ED-5D questionnaire 5 parameters are given in tab. 10. In both groups there was noted statically considerable reduction of the number of patients suffering from life quality moderate or severe disorders according to questioning EQ-5D 5 parameters, except for self-servicing parameter in Almag-01 device group.
In placebo-device group as compared to Almag-01 device group there was noted more evident reduction of the number of patients suffering from suffering from moderate or severe disorders ( except for pain and discomfort) according to: space removal index ( 29,4% and 26,7% accordingly); self-servicing index (26,3% and 1,3% accordingly); day-to-day activity (52% and 33,3% accordingly); pain and discomfort index (37,9% and 57,3% accordingly); anxiety and depression (43,2% and 30,6% accordingly. So Almag-01 device greatly influenced only the life quality relating to pain and discomfort as compared to placebo-device. But taking into account the course of treatment which is not long it is impossible to speak about considerable change of functional indexes. But nevertheless the pain reduction is the evidence of Almag-01 positive clinical effect.
Table 10
Life quality indexes dynamic ( according to questioning EQ-5D 5 parameters.)
|
Index |
Аlmag-01 device (n = 75) , абс. (%) |
Plcebo device (n = 95), абс. (%) |
|||||||
|
Index before treatment |
Index after treatment |
Δ , % patients |
Index before treatment |
Index after treatment |
Δ , % patients |
||||
|
абс. |
(%) |
||||||||
|
абс. |
(%) |
||||||||
|
Patients suffering from moderate or severe disorders according to “Space removal “ index |
48 (64%)* |
28 (37,3%)* |
20 |
26,7 |
73 (76,8%)* |
43 (47,4%)* |
30 |
29,4 |
|
|
Patients suffering from moderate or severe disorders according to “Self-servicing” index |
14 (18,7%) |
13 (17,4%) |
1* |
1,3 |
53 (55,8%)* |
28 (29,5%)* |
25* |
26,3 |
|
|
Patients suffering from moderate or severe disorders according “Day-to-day activity” |
46 (61,3%)* |
21 (28%)* |
25* |
33,3 |
76 (80%)* |
21 (28%)* |
55* |
52 |
|
|
Patients suffering from moderate or severe disorders according «pain and discomfort “ index |
71 (96%)* |
29 (38,7%)* |
42 |
57,3 |
95 (100%)* |
59 (62,1%)* |
36 |
37,9 |
|
|
Patients suffering from moderate or severe disorders according «Anxiety and depression» index. |
40 (53,3%)* |
17 (22,7%)* |
23* |
30,6 |
62 (65,3%)* |
21 (22,1%)* |
2* |
43,2 |
|
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
Functional indications dynamic data estimated according to Functional Disorders International Scale is given in table 11 and 12.
Table 11 says that there was not find out any statistically evident differences inside the groups, but the joints mobility function positive dynamic with their light disorders was more marked in ALMAG-01device group as compared to placebo-device group ( 21,3% and 9,5% accordingly)
Table 11
“ Knee-joint mobility function” index dynamic
( functional disorders international scale)
|
Index |
Аlmag-01 device (n = 75) |
Placebo device (n = 95) |
||||||
|
Knee -joint mobility function |
Index before treatment |
Index after treatment |
Δ, % patients |
Index before treatment |
Index after treatment |
Δ, % patients |
||
|
абс. |
(%) |
абс. |
(%) |
|||||
|
Absolute disorders |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Severe and moderate disorders |
43 (57,3%) |
31 (41,3%) |
-12 |
16 |
59 (62,1%) |
44 (46,3%) |
-15 |
15,8 |
|
Light disorders and their absence |
26 (34,7%) |
42 (56%) |
-16* |
21,3 |
33 (34,7%) |
42 (44,2%) |
-9* |
9,5 |
|
No data |
6 (8%) |
2 (2,7%) |
4 |
5,3 |
3 (3,2%) |
9 (9,5%) |
-6 |
-6,3 |
|
Knee joint both volume and free mobility function |
Index before treatment |
Index after treatment |
Δ, % patients |
Index before treatment |
Index after treatment |
Δ, % patients |
||
|
абс. |
(%) |
абс. |
(%) |
|||||
|
Absolute disorders |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Severe and moderate disorders |
38 (50,7%) |
31 (41,5%) |
-7 |
9,2 |
58 (61%) |
44 (46,4%) |
-14 |
14,6 |
|
Light disorders and their absence |
17 (22,7%) |
24 (31,9%) |
-7 |
9,2 |
20 (21%) |
31 (32,6%) |
-11 |
11,6 |
|
No data |
20 (26,6%) |
20 (26,6%) |
0 |
0 |
17 (18%) |
20 (21%) |
-3 |
-3 |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
The table 12 says that there are no statistically evident changes of “ Walking and locomotion ” inications .In placebo device group there was no statistically significant changes according to short distance walking. But nevertheless in placebo device group there was noted statistically big reduction of patients` number with severe and moderate abnormalities on not less than 1km walk distance indications from 69,4% до 46,3%) and increase in patients` number with slight abnormalities on the same indication ( from 10,5% to 31,6%). If we compare two groups it is necessary to note the bigger number of patients with slight abnormalities or their absence on “ Short distance wealking” indications in Almag-01 device group as compared to the patients in placebo device group ( 14,6% and и 4,2% accordingly )
Table 12
Dynamic of “ Walking and locomotion” index
( Functional disorders international scale)
|
Index |
Аlmag-01device (n = 75) |
Placebo device (n = 95) |
||||||
|
Short distance walk |
Index before treatment |
Index after treatment |
Δ , % patients |
Index before treatment |
Index after treatment |
Δ , % patents |
||
|
абс. |
(%) |
абс. |
(%) |
|||||
|
Absolute disorders |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Severe and moderate disorders |
30 (40%) |
22 (29,3%) |
-8 |
10,7 |
41 (43,2%) |
32 (33,7%) |
-9 |
9,5 |
|
Light disorders and their absence |
31 (41,4%) |
42 (56%) |
11* |
14,6 |
36 (37,9%) |
40 (42,1%) |
4* |
4,2 |
|
No data |
14 (18,6%) |
11 (14,7%) |
3 |
3,9 |
18 (18,9%) |
23 (24,2%) |
5 |
5,3 |
|
One km ( not less) walk |
Index before treatment |
Index after treatment |
Δ, % patients |
Index before treatment |
Index after treatment |
Δ, % patients |
||
|
абс. |
(%) |
абс. |
(%) |
|||||
|
Absolute disorders |
1 (1,3%) |
0 |
1 |
1,3 |
0 |
0 |
0 |
0 |
|
Severe and moderate disorders |
39 (52%) |
30 (40%) |
-9* |
12 |
66 (69,4%)* |
44 (46,3%)* |
-22* |
23,1 |
|
Light disorders and their absence |
14 (18,7%) |
25 (33,3%) |
11 |
14,7 |
10 (10,5%)* |
30 (31,6%)* |
20 |
21,1 |
|
No data |
21 (28%) |
20 (26,6%) |
1 |
1,4 |
19 (20,1%) |
21 (22,1%) |
-2 |
-2 |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
Information on treatment in the hospital conditions is given into table 13.
Table 13
|
Аlmag -01 device group (n = 75), абс. (%) |
Placebo device group (n = 95) , абс. (%) |
|
|
Treatment in hospital conditions |
44 (58,7%) |
61 (64,2%) |
|
No treatment in hospital conditions |
21 (28%) |
25 (26,3%) |
|
No data |
10 (13,3%) |
9 (9,5%) |
The patients stay in hospital from Almag-01 device group – 15,7 days (+/-3,9 days; medine – 16, 1st quartile – 12, 3rd quartile – 18), from placebo device – 20,4 days (+/-3,8 days; medine – 21, 1st quartile – 18, 3rd quartile – 22). Though equal number of patients have got treatment in hospital ( 58,7% from Almag-01 device group and 64,2% in placebo-device group) the treatment course was different for both groups. This can be explained by impossibility to compare groups equally at the moment of examination beginning (in placebo-device group the patients had much more severe disease condition) .
Information on temporary invalidity are given in tab. 14.
Table 14
|
Аlmag -01 device group (n = 75), абс. (%) |
Placebo device group (n = 95) , абс. (%) |
|
|
Temporary invalidity |
32 (42,7%) |
43 (45,3%) |
|
No signs of temporary invalidity |
2 (2,6%)* |
10 (10,5%)* |
|
No data |
41 (54,7%) |
42 (44,2%) |
Note : * -Difference of statistical adequacy (p <0,05), Fisher criterion with Yets amendment
Thus, summarizing the received data on clinical efficiency, it is possible to make the following conclusions:
· Device Almag-01 greatly influenced life quality with regard to pain and discomfort as compared to placebo- device, as for the other questionnaire EQ-5D indications the results were better in placebo-device group.
Общее количество используемых лекарственных средств составило 128 наименований (табл. 15). В группу «А» затрат вошли 26 наименования ЛС, в группу «В» затрат вошли 26 наименования ЛС, в группу «С» затрат вошли 75 наименований ЛС. Общие затраты на лекарственные средства в двух группах (n=170) составили 469 238 рублей.
The clinical-economic analysis
The total amount of used medical preparations came to 128 names: (tab. 15). group ” A ” included 26 names of medical preparations; group ” B ” – 26 names; group ” C ” – 75 names. The total expenses for medical preparation in two groups came to 469238 roubles.
Table 15
Medical preparations general АВС-analysis
|
The international not patented name |
Total costs , rub. |
Percent |
Cumulative percent |
|
«А» group expenses |
|||
| Diclofenac, ampoule . |
44138,00 |
9,41% |
9,41% |
| Nimesulid, tablet . |
40185,00 |
8,56% |
17,97% |
| Cephatholine |
33945,00 |
7,23% |
25,20% |
| Betametazon |
29624,00 |
6,31% |
31,52% |
| Nimesulid,suspension . |
27377,60 |
5,83% |
37,35% |
| Cyanocabolamin |
19140,00 |
4,08% |
41,43% |
| Ibuprofen, tablet. |
18768,00 |
4,00% |
45,43% |
| Diacerin |
16833,00 |
3,59% |
49,02% |
| Aphlutop , amp. |
14740,00 |
3,14% |
52,16% |
| Diclofenac, tabl. |
13950,00 |
2,97% |
55,13% |
| Benfotiamine + Pyridoxine |
12285,90 |
2,62% |
57,75% |
| Chloride natrium |
11836,00 |
2,52% |
60,27% |
| Sulphate chondoitinume |
8560,00 |
1,82% |
62,10% |
| Dexamethasone |
7840,00 |
1,67% |
63,77% |
| Dextrose |
7820,00 |
1,67% |
65,43% |
| Meldonium |
7140,00 |
1,52% |
66,96% |
| Methoprolol |
7068,00 |
1,51% |
68,46% |
| Nimesulyd, suspen. |
7040,00 |
1,50% |
69,96% |
| Omeprazol |
6859,00 |
1,46% |
71,42% |
| Ascorbic acid |
6832,00 |
1,46% |
72,88% |
| Glucosamine+ chondroitin sulfate |
6543,00 |
1,39% |
74,27% |
| Hesperidin +Diosmin |
6300,00 |
1,34% |
75,62% |
| Pentoxyphillin , tabl. |
6222,00 |
1,33% |
76,94% |
| Alphluton, amp. |
6000,00 |
1,28% |
78,22% |
| Pyridoxine |
5776,00 |
1,23% |
79,45% |
| Thiamine +Escin |
5363,20 |
1,14% |
80,60% |
|
«B» group expenses |
|||
| Actovegin |
4720,00 |
1,01% |
81,60% |
| Magnesium sulfate |
4678,00 |
1,00% |
82,60% |
| Chondroitin sulfate , solution |
4400,00 |
0,94% |
83,54% |
| Alphosphate choline |
4320,00 |
0,92% |
84,46% |
| Amlodipinum |
4287,00 |
0,91% |
85,37% |
| Melocsicam, solution |
3712,50 |
0,79% |
86,16% |
| Nifedipine |
3537,00 |
0,75% |
86,92% |
| Cerebrolizin |
3000,00 |
0,64% |
87,55% |
| Thioctic acid , tabl. |
2688,00 |
0,57% |
88,13% |
| Lornoxicam |
2672,00 |
0,57% |
88,70% |
| Perindopril |
2620,00 |
0,56% |
89,26% |
| Ketorolak, solution |
2610,00 |
0,56% |
89,81% |
| Pentoxyfiline, solution |
2369,00 |
0,50% |
90,32% |
| Xanthol nicotinat |
2160,00 |
0,46% |
90,78% |
| Hondoitine Sulphate , capsule |
2154,00 |
0,46% |
91,24% |
| Indapamid retard , tabl. . |
1916,4 |
0,41% |
92,06% |
| Enalapril |
1886,00 |
0,40% |
92,46% |
| Thioctic acid , solution |
1668,00 |
0,36% |
92,82% |
| Meloxicam , tabl. |
1663,00 |
0,35% |
93,17% |
| Traumel С, ampoule. |
1584,00 |
0,34% |
93,51% |
| Pyracetam |
1552,00 |
0,33% |
93,84% |
| Natrium enoxaparin |
1238,00 |
0,26% |
94,10% |
| Thrimetazin |
1156,40 |
0,25% |
94,35% |
| Isosorbide dinitrate |
1143,60 |
0,24% |
94,59% |
| Amino-phenylbutyric acid |
1000,00 |
0,21% |
94,81% |
| Levofloxacin |
960,00 |
0,20% |
95,01% |
|
«C» group expenses |
|||
| Procaine |
928,40 |
0,20% |
95,21% |
| Rozuvastatinum |
920,00 |
0,20% |
95,41% |
| Formoterol |
910,00 |
0,19% |
95,60% |
| Methylphenylthiomethyl-dimethylaminomethyl -hydrooxibromindol carboxylic acid ethyl alcohol |
900,00 |
0,19% |
95,79% |
| Levothyroxine natrium |
891,00 |
0,19% |
95,98% |
| Lozatran |
850,00 |
0,18% |
96,16% |
| Natrium metamizol |
805,60 |
0,17% |
96,33% |
| Ipidakrin, solution |
783,00 |
0,17% |
96,50% |
| Phelodipin |
754,78 |
0,16% |
96,66% |
| Lysinopril |
690,00 |
0,15% |
96,81% |
| Diclofenac, tablet . |
651,00 |
0,14% |
96,95% |
| Sibutramin |
637,50 |
0,14% |
97,08% |
| Indapamid+ Perindapril, tabl. |
624,00 |
0,13% |
97,22% |
| Bisoprolol |
615,00 |
0,13% |
97,35% |
| Indapamid+ Perindapril forte, tabl. |
610,60 |
0,13% |
97,48% |
| Indapamid, tabl. |
606,25 |
0,13% |
97,61% |
| Nicotinic acid |
606,00 |
0,13% |
97,74% |
| Ethylmetilhidroxipiridin sukcinat |
576,00 |
0,12% |
97,86% |
| Pyridoxin +Tiamin +Cyancobalamin |
512,00 |
0,11% |
97,97% |
| Vinpocetine |
502,20 |
0,11% |
98,08% |
| Tamsulocin |
494,00 |
0,11% |
98,18% |
| Ipidakpin , tabl. |
487,20 |
0,10% |
98,28% |
| Aminophylline |
472,50 |
0,10% |
98,39% |
| Sandy Bessmertnic flowers flavonoid |
441,00 |
0,09% |
98,48% |
| Fosinopril |
436,80 |
0,09% |
98,57% |
| Atorvastatin |
409,40 |
0,09% |
98,66% |
| Nimesulid, gel |
398,70 |
0,08% |
98,74% |
| Metronidasol |
360,00 |
0,08% |
98,82% |
| Chondroitin sulfate, ointment |
353,32 |
0,08% |
98,90% |
| Methyletylpyridinol |
332,00 |
0,07% |
98,97% |
| Soluble insulin |
328,68 |
0,07% |
99,04% |
| Furosemid |
257,40 |
0,05% |
99,09% |
| Diclofenac, ointment |
228,00 |
0,05% |
99,14% |
| Paracetamol +Tramadol |
219,78 |
0,05% |
99,19% |
| Acetylsalicylic acid |
204,50 |
0,04% |
99,23% |
| Thrombo-АСС, tabl.. |
182,70 |
0,04% |
99,27% |
| Acetylcystein |
180,00 |
0,04% |
99,31% |
| Zopyclon |
180,00 |
0,04% |
99,35% |
| Spironolactone |
180,00 |
0,04% |
99,39% |
| Acetylsalicylic acid |
176,40 |
0,04% |
99,42% |
| Pancreatine |
170,10 |
0,04% |
99,46% |
| Iprathropy bromide +phenotherol |
162,00 |
0,03% |
99,49% |
| Ketoprofen , cream |
160,66 |
0,03% |
99,53% |
| Rosa brier fruits extract |
151,20 |
0,03% |
99,56% |
| Dipiridamol |
146,25 |
0,03% |
99,59% |
| Glyclasid |
140,40 |
0,03% |
99,62% |
| Acetylsalicylic acid+ magnesium hydroxide |
121,88 |
0,03% |
99,65% |
| Natrium heparine |
115,94 |
0,02% |
99,67% |
| Agomelatin |
113,75 |
0,02% |
99,70% |
| Karbamasepin |
108,00 |
0,02% |
99,72% |
| Domperidon |
107,50 |
0,02% |
99,74% |
| Tramadol |
102,00 |
0,02% |
99,76% |
| Allopurinol |
100,80 |
0,02% |
99,79% |
| Loratadine |
100,00 |
0,02% |
99,81% |
| Almagel, suspension. |
96,00 |
0,02% |
99,83% |
| Hydrochloriasid |
90,00 |
0,02% |
99,85% |
| Phenotherol |
79,96 |
0,02% |
99,86% |
| Glibenclamid |
64,80 |
0,01% |
99,88% |
| Diazepam |
64,50 |
0,01% |
99,89% |
| Aloes, ampul . |
60,00 |
0,01% |
99,90% |
| Theopek, tabl. |
60,00 |
0,01% |
99,92% |
| Thiamine |
51,00 |
0,01% |
99,93% |
| Аminodaron |
48,00 |
0,01% |
99,94% |
| Diclofenac, cream |
45,20 |
0,01% |
99,95% |
| Baclofen , 10 mg. |
40,50 |
0,01% |
99,96% |
| Ginkgo biloba ( maidenhair tree) leaves extract |
40,00 |
0,01% |
99,96% |
| Ibuprofen +Levomentol |
33,88 |
0,01% |
99,97% |
| Verapamil |
32,76 |
0,01% |
99,98% |
| Bile |
26,5 |
0,01% |
99,98% |
| Trokserutin |
24,36 |
0,01% |
99,99% |
| Thioredasin |
23,00 |
0,00% |
99,99% |
| Kaptopril |
20,00 |
0,00% |
100,00% |
| Bromhexine |
11,52 |
0,00% |
100,00% |
| Bromdygidrochlorphenylbenzodiazepin |
2,28 |
0,00% |
100,00% |
| Aphlegan , amp. |
2,25 |
0,00% |
100,00% |
Medical preparation expenses in Almag-01 device group (n=75) came to 173 494 roubles. Expenses АВС-Analysis is given in tab. 16. Medical services expenses per patient came to 2 313 roubles.
Table 16
Medical preparation expenses АВС-Analysis in Almag-01 device group
|
The international not patented name |
Obligatory medical insurance costs , rub. |
Cost % |
Expenses cumulative % |
|
«А» group Expenses |
|||
| Nimesulide, tabl. |
31929,00 |
18,33 |
18,33 |
| Nicotinic acid, ampuls |
19720,64 |
11,32 |
29,65 |
| Nimesulid, suspension.. |
14133,88 |
8,11 |
37,77 |
| Ibuprofen, tabl.. |
14115,83 |
8,10 |
45,87 |
| Magnesium sulfate, amp. |
11422,86 |
6,56 |
52,43 |
| Alflutop |
11086,28 |
6,36 |
58,79 |
| Chondiotin sulphate, powder |
7886,75 |
4,53 |
63,32 |
| Chondiotin sulphate, capsule |
6712,69 |
3,85 |
67,17 |
| Pentoxyilline tabl. |
6107,23 |
3,51 |
70,68 |
| Metoprolol, tabl. |
4616,53 |
2,65 |
73,33 |
| Aflutop |
4512,73 |
2,59 |
75,92 |
| Aktovegen |
4452,56 |
2,56 |
78,48 |
| Tiamin+Escin |
4033,78 |
2,32 |
80,80 |
|
«В» group Expenses |
|||
| Glucosamin +Chondroitine sulphate |
2700,87 |
1,55 |
82,35 |
| Benphotiamin +Pyridoxin |
2692,75 |
1,55 |
83,89 |
| Omepazol |
2454,93 |
1,41 |
85,30 |
| Cerebrolisin |
2256,37 |
1,30 |
86,60 |
| Cyanokabolamin |
2181,15 |
1,25 |
87,85 |
| Thioctic acid, tab. |
1654,67 |
0,95 |
88,80 |
| Meloxikam |
1432,04 |
0,82 |
89,62 |
| Thioctic acid am. |
1286,13 |
0,74 |
90,36 |
| Amlodipin, tab. |
1204,34 |
0,69 |
91,05 |
| Nifedipine |
1175,12 |
0,67 |
91,73 |
| Hesperidin +Diosmin |
1094,34 |
0,63 |
92,35 |
| Doxilamin |
1077,98 |
0,62 |
92,97 |
| Sybutamin |
972,49 |
0,56 |
93,53 |
| Meloxikam , amp. |
863,06 |
0,50 |
94,03 |
| Phormotherol |
694,00 |
0,40 |
94,43 |
| Sodium chlorides |
661,87 |
0,38 |
94,81 |
| Traumel С |
595,68 |
0,34 |
95,15 |
| Pyridoxin |
571,61 |
0,33 |
95,48 |
|
«С» group expenses |
|||
| Perindopril |
541,53 |
0,31 |
95,79 |
| Metphormin |
524,23 |
0,30 |
96,09 |
| Diclofenac,tabl. |
489,63 |
0,28 |
96,37 |
| Meltdown , amp. |
473,84 |
0,27 |
96,64 |
| Lysinopril |
458,79 |
0,26 |
96,90 |
| Diclofenac, аmp. |
455,03 |
0,26 |
97,17 |
| Enlapril, tabl. |
415,17 |
0,24 |
97,40 |
| Aminophenilbutyric acid |
376,06 |
0,22 |
97,62 |
| Ipidakrin |
366,43 |
0,21 |
97,83 |
| Vinocetin |
362,90 |
0,21 |
98,04 |
| Chondriotin sulphate, ointment |
294,83 |
0,17 |
98,21 |
| Lozatran |
272,64 |
0,16 |
98,36 |
| Natrium levothyroxine |
260,61 |
0,15 |
98,51 |
| Pentoxifiline , amp. |
259,48 |
0,15 |
98,66 |
| Pyridoxin+Тiamin+Cyanko-balamin |
252,71 |
0,15 |
98,81 |
| Bysoprolol |
203,07 |
0,12 |
98,92 |
| Nymesulid, gel |
184,53 |
0,11 |
99,03 |
| Paracetamol +Tramadol |
165,30 |
0,09 |
99,12 |
| Thrombo-АСС |
137,41 |
0,08 |
99,20 |
| Ketorolac |
135,38 |
0,08 |
99,28 |
| Acetylsalicylic acid |
132,67 |
0,08 |
99,36 |
| Dexamethasone |
126,36 |
0,07 |
99,43 |
| Methylethylpyridinol |
124,85 |
0,07 |
99,50 |
| Atorvastatin |
120,49 |
0,07 |
99,57 |
| Indapamid+Perindapril |
90,25 |
0,05 |
99,62 |
| Karbamazepin |
81,23 |
0,05 |
99,67 |
| Loratadin |
75,21 |
0,04 |
99,71 |
| Acetylsalicylic acid+Magnesium hydroxide |
74,74 |
0,04 |
99,76 |
| Phelodipin |
69,4 |
0,04 |
99,80 |
| Hydrochlorotiasid |
67,69 |
0,04 |
99,84 |
| Spironolactone |
67,69 |
0,04 |
99,88 |
| Glylaside |
52,80 |
0,03 |
99,91 |
| Natrium heparin |
47,38 |
0,03 |
99,94 |
| Allopurinol |
37,91 |
0,02 |
99,96 |
| Diclofenac, gel |
34,00 |
0,02 |
99,98 |
| Imbuprophen+Levomentol |
25,48 |
0,01 |
99,99 |
| Lornoxikam |
24,07 |
0,01 |
99,99 |
| Isosorbide dinitrate |
21,06 |
0,01 |
99,99 |
| Troxerutin |
18,32 |
0,01 |
99,99 |
| Indapamid |
17,3 |
0,01 |
99,99 |
| Dilaciniate ginkgo leaves extract |
15,04 |
0,01 |
99,99 |
| Glibenclamid |
12,64 |
0,01 |
99,99 |
| Verapamil , tabl. |
7,82 |
0,00 |
99,99 |
| Medical bile |
3,35 |
0,00 |
100,00 |
Medical preparation expenses in Almag-01 placebo-device group (n=95) came to 295 744 roubles. АВС-Analysis is given in tab. 17. Medical procedures expenses per patient came to 3 113 roubles.
Таble 17
Medical preparation expenses АВС-Analysis in placebo device group
|
The international not patented name |
Costs , rub. |
Cost % |
Expenses cumulative % |
|
«А» group expenses |
|||
| Pyracetam |
36892,15 |
17,64 |
17,64 |
| Omeprazol |
15250,60 |
7,29 |
24,94 |
| Cephasolin |
14937,72 |
7,14 |
32,08 |
| Magnesium sulfate |
13366,72 |
6,39 |
38,47 |
| Nicotinic acid |
13360,12 |
6,39 |
44,86 |
| Betametazin |
13036,24 |
6,23 |
51,09 |
| Nimesulid |
12596,80 |
6,02 |
57,12 |
| Alphlutop |
11327,06 |
5,42 |
62,54 |
| Diacerin |
7407,47 |
3,54 |
66,08 |
| Cyanokabolamin |
7146,52 |
3,42 |
69,50 |
| Diclofenac, tabl. |
6138,79 |
2,94 |
72,43 |
| Sodium chlorides |
4821,26 |
2,31 |
74,74 |
| Chondroitine Sulfate , capsule . |
4716,97 |
2,26 |
76,99 |
| Benphotiamin +Piridoxin |
3831,00 |
1,83 |
78,83 |
| Dextroza, vial. |
3441,24 |
1,65 |
80,47 |
|
«В» group expenses |
|||
| Dexametasone |
3376,11 |
1,61 |
82,09 |
| Diclofenac, amp. |
3188,65 |
1,52 |
83,61 |
| Ascorbic acid |
3006,47 |
1,44 |
85,05 |
| Meldony |
2864,77 |
1,37 |
86,42 |
| Alphosfat cholina , аmp. |
2772,36 |
1,33 |
87,74 |
| Piridoxin |
2207,32 |
1,06 |
88,80 |
| Hesperidin +Dyosmin |
2132,07 |
1,02 |
89,82 |
| Pentoxiphillin , аmp. |
1301,25 |
0,62 |
90,44 |
| Glucosamine +chondroitin sulfate |
1299,05 |
0,62 |
91,06 |
| Lornoxikam |
1161,75 |
0,56 |
91,62 |
| Meloxikam, аmp. |
1128,75 |
0,54 |
92,16 |
| Ketorolak |
1069,34 |
0,51 |
92,67 |
| Nicotinat xantole |
950,52 |
0,45 |
93,12 |
| Perindopril |
836,11 |
0,40 |
93,52 |
| Thioctic acid , аmp. |
752,50 |
0,36 |
93,88 |
| Enalapril |
587,04 |
0,28 |
94,16 |
| Indapamid |
576,65 |
0,28 |
94,44 |
| Metphormin |
549,19 |
0,26 |
94,70 |
| Natrium Enoxaparin |
544,79 |
0,26 |
94,96 |
| Indapamid+Perindapril |
510,29 |
0,24 |
95,21 |
|
«С» group expenses |
|||
| Thrimetazin |
508,88 |
0,24 |
95,45 |
| Aktovegin |
492,86 |
0,24 |
95,69 |
| Levophloxacin |
422,45 |
0,20 |
95,89 |
| Methoprolol |
409,25 |
0,20 |
96,08 |
| Procain |
408,55 |
0,20 |
96,28 |
| Rozuvastatin |
404,85 |
0,19 |
96,47 |
| Methylpheniltheometil-dimethylaminomethyl – hydrooxibgromindol carboxelic acid ethyl alcohol |
396,05 |
0,19 |
96,66 |
| Natrium metamizol |
354,51 |
0,17 |
96,83 |
| Traumel С |
348,52 |
0,17 |
97,00 |
| Ipidakrin , amp. |
344,56 |
0,16 |
97,16 |
| Lisinopril |
303,64 |
0,15 |
97,31 |
| Idroxipiridin Ethylmethyl succinate |
253,47 |
0,12 |
97,43 |
| Natrium levothyroxine |
239,61 |
0,11 |
97,54 |
| Sibutramine |
225,53 |
0,11 |
97,65 |
| Vinocetine |
221,00 |
0,11 |
97,76 |
| Aminophenilbutyric acid |
220,03 |
0,11 |
97,86 |
| Pentoxyphillin, tab. |
219,59 |
0,11 |
97,97 |
| Tamsulozine |
217,39 |
0,10 |
98,07 |
| Lozathran |
214,53 |
0,10 |
98,17 |
| Ipidakrine , tab. |
214,40 |
0,10 |
98,28 |
| Thioctic acid |
211,23 |
0,10 |
98,38 |
| Aminophilline |
207,93 |
0,10 |
98,48 |
| Flavonoid of sandy immortelle flowers |
194,06 |
0,09 |
98,57 |
| Fosinopril |
192,22 |
0,09 |
98,66 |
| Verapamil |
171,62 |
0,08 |
98,74 |
| Methronidazol |
158,42 |
0,08 |
98,82 |
| Chondroitin sulfate, inntment |
155,48 |
0,07 |
98,89 |
| Bisoprolol |
151,82 |
0,07 |
98,97 |
| Soluble insulin |
144,64 |
0,07 |
99,04 |
| Furosemide |
113,27 |
0,05 |
99,09 |
| Atorvastatinum |
109,66 |
0,05 |
99,14 |
| Diclifenac , inntment |
100,33 |
0,05 |
99,19 |
| Nimesulide, suspension . |
98,57 |
0,05 |
99,24 |
| Acetylsalicylic acid |
89,99 |
0,04 |
99,28 |
| Acetylcysteine |
79,21 |
0,04 |
99,32 |
| Zopiklon |
79,21 |
0,04 |
99,36 |
| Pyridoxin+Тiamin+Cyankobalamin |
77,45 |
0,04 |
99,39 |
| Isosorbide dinitrate |
76,39 |
0,04 |
99,43 |
| Thrombo-АСС |
75,69 |
0,04 |
99,47 |
| Pancreatine |
74,85 |
0,04 |
99,50 |
| Methylethylpyridinol |
73,05 |
0,03 |
99,54 |
| Iprathronia bronide +Phenothiazine |
71,29 |
0,03 |
99,57 |
| Ketoprofen, cream |
70,70 |
0,03 |
99,61 |
| Аmlodipin |
68,74 |
0,03 |
99,64 |
| Nimesulide, gel. |
67,49 |
0,03 |
99,67 |
| Flavonoid of sandy immortelle flowers |
66,54 |
0,03 |
99,70 |
| Dipiridamol |
64,36 |
0,03 |
99,73 |
| Agomelatin |
50,06 |
0,02 |
99,76 |
| Domperidon |
47,31 |
0,02 |
99,78 |
| Tramadol |
44,89 |
0,02 |
99,80 |
| Loratadin |
44,01 |
0,02 |
99,82 |
| Almagel |
42,25 |
0,02 |
99,84 |
| Spironolackton |
39,61 |
0,02 |
99,86 |
| Phenothrol |
35,19 |
0,02 |
99,88 |
| Glyclazid |
30,89 |
0,01 |
99,89 |
| Bile |
29,57 |
0,01 |
99,90 |
| Diazepam |
28,38 |
0,01 |
99,91 |
| Aloe , amp. |
26,40 |
0,01 |
99,92 |
| Teopek |
26,40 |
0,01 |
99,93 |
| Thiamine |
22,44 |
0,01 |
99,94 |
| Allopurinol |
22,18 |
0,01 |
99,95 |
| Amiodaron |
21,12 |
0,01 |
99,96 |
| Glibenclamid |
21,12 |
0,01 |
99,97 |
| Natrium heparinum |
18,55 |
0,01 |
99,97 |
| Baklophen |
17,82 |
0,01 |
99,98 |
| Acetylsalicylic acid+ magnesium hydroxide |
9,90 |
0,00 |
99,98 |
| Dilaciniate ginkgo leaves extract |
8,80 |
0,00 |
99,99 |
| Ambroxol |
0,99 |
0,00 |
99,99 |
| Hydrochlorotiasid |
0,87 |
0,00 |
100,00 |
While in carrying medical preparations expenses АВС-Analysis out it was found out , that the expenses for not steroid anti-inflammatory means in Almag-01 device group were higher, than those in placebo group device . In order to exclude a possibility of medical preparation influence the effect which has been shown in medical examination, the frequency analysis of non steroid anti-inflammatory medicament means application in both groups (tab. 18) has been carried out.
Table 18
Not steroid anti-inflammatory means application
frequency analysis
|
The international not patented name |
Number of NSAIMM in Аlmag-01device group (n=75), абс. (%) |
Number of NSAIMM in placebo-device group (n=95), абс. (%) |
| Acetylsalicylic acid |
7 (9,3%) |
10 (10,5%) |
| Diclofenac |
16 (21,3%) |
53 (55,7%) |
| Ketoprofen |
2 (2,6%) |
4 (4,2%) |
| Ketorolak |
1 (1,3%) |
14 (14,7%) |
| Natrium metamizol |
0 |
11 (11,5%) |
| Nimesulid |
16 (21,3%) |
13 (13,6%) |
| Total : |
55,8% |
110,2% |
As it is seen from the above table, in group of placebo-device group NSAIM were used twice as much often (diclofenac is much more than often , ketoprofen is practically twice often), as compared to Almag-01device group, except nimesulid which was used practically twice more often in Almag-01device group.
Thus, the most patients in placebo device group took NSAIM , that could influence results of medical examination.
The total number of the rendered medical services amounted to 135. Rendered medical services АВС-analysis is given in table 19. «А» group expenses included 29 medical services, «В» group – 37 medical services , «С» group – 69 medical services. The carried analysis showed that among the medical services the most expensive ones were as follows: therapist and physiatrist сonsultations(9,2 % and 9,0 % expenses accordingly), application of medical bile compress (5,4 %), measurement of arterial pressure (7,3 %), magnetotherapy and exercise magnetomagnetotherapy (4,5 % and 3,8 % accordingly), magnetoresonance therapy (4,5 %), both compresses and diet prescription (3,5 % and 3,3 % accordingly), electrocardiography (2,4 %), the common urine analysis (2,1 %), coagulogramm (2,0 %), measurement of both pulse and cardiac contraction frequency (2,0 % and 2,0 % accordingly), knee joints X-ray photography (2,0 %). Thus the great share of magnetoresonance therapy, compresses are caused by services high cost at their rather infrequent application. At the same time arterial pressure measurement , exercises therapy, pulse and cardiac reductions examination were carried out very often with these services low cost .
Thus the great part of magnethresonance therapy and compresses are stipulated for by services high cost, with their rather infrequent use. At the same time both the arterial pressure, pulse and cardiac contraction rate measurement, physiotherapy exercises were carried out very often with services low cost.
Table 19
Medical services АВС-analysis
|
Medical services |
Tariff per med.service. |
Total number |
Total cost rub. |
% |
Cumulative interest |
|
«А» group expenses |
|||||
| Therapist consultation |
77,82 |
554 |
43112,28 |
9,213 |
18,223 |
| Physiotherapist consultation |
93,27 |
452 |
42158,04 |
9,009 |
25,541 |
| Peripheric arterias arterial pressure measurement |
11,4 |
3004 |
34245,6 |
7,319 |
30,972 |
| Night medical bile compress |
488,7 |
52 |
25412,4 |
5,431 |
35,566 |
| Knee joint magnetotherapy |
26,28 |
818 |
21497,04 |
4,594 |
39,459 |
| The physiotherapy exercises aimed to left knee joint function and mobility recovery. |
15,45 |
1179 |
18215,55 |
3,893 |
43,152 |
| Backbone lumbar part magnetic resonant tomography |
5760 |
3 |
17280 |
3,693 |
46,703 |
| Knee-joint compress |
488,7 |
34 |
16615,8 |
3,551 |
50,018 |
| Diet |
74,94 |
207 |
15512,58 |
3,315 |
52,462 |
| Electrocardiography |
87,96 |
130 |
11434,8 |
2,444 |
54,629 |
| Urine overall analysis |
47,16 |
215 |
10139,4 |
2,167 |
56,725 |
| Coagulogramme |
121,08 |
81 |
9807,48 |
2,096 |
58,775 |
| Pulse examination |
3,3 |
2907 |
9593,1 |
2,050 |
60,821 |
| Heartbeat rate measurement |
3,3 |
2902 |
9576,6 |
2,047 |
62,837 |
| Knee joint Х-ray photograph |
168,45 |
56 |
9433,2 |
2,016 |
64,717 |
| Blood group and rhesus factor |
118,89 |
74 |
8797,86 |
1,880 |
66,384 |
| Blood protein and protein fraction analysis |
86,64 |
90 |
7797,6 |
1,666 |
68,009 |
| Blood general clinical analysis |
28,59 |
266 |
7604,94 |
1,625 |
69,412 |
| Both haemoglobin, leucocytes determination |
25,74 |
255 |
6563,7 |
1,403 |
70,514 |
| Novocainum compress |
76,98 |
67 |
5157,66 |
1,102 |
71,606 |
| Blood electrolits |
86,58 |
59 |
5108,22 |
1,092 |
72,697 |
| Traveling pulsed magneto-therapy |
37,26 |
137 |
5104,62 |
1,091 |
73,769 |
| physiotherapy exercises doctor`s consultation |
100,41 |
50 |
5020,5 |
1,073 |
74,840 |
| Surgeon consultation |
82,14 |
61 |
5010,54 |
1,071 |
75,896 |
| Spinal column lumbosacral part massage |
42,96 |
115 |
4940,4 |
1,056 |
76,935 |
| Physio-procedures |
26,28 |
185 |
4861,8 |
1,039 |
77,935 |
| Blood glucose determination |
23,16 |
202 |
4678,32 |
1,000 |
78,882 |
| Variational intervalometric |
94,26 |
47 |
4430,22 |
0,947 |
79,790 |
| Knee joint massage |
42,96 |
99 |
4253,04 |
0,909 |
80,664 |
|
«В» group expenses |
|||||
| Acupuncture |
46,47 |
88 |
4089,36 |
0,874 |
81,483 |
| Neurologist consultation |
75,15 |
51 |
3832,65 |
0,819 |
82,251 |
| Hydromassage |
69,03 |
52 |
3589,56 |
0,767 |
82,963 |
| Sea salt bath |
42,75 |
78 |
3334,5 |
0,713 |
83,671 |
| Vibromassage spinal column |
69,03 |
48 |
3313,44 |
0,708 |
84,309 |
| Cervico-callar zone massage |
28,68 |
104 |
2982,72 |
0,637 |
84,919 |
| Blood analysis |
22,83 |
125 |
2853,75 |
0,610 |
85,504 |
| Blood kreatine analysis |
22,83 |
120 |
2739,6 |
0,585 |
86,065 |
| Medical phonophoresis |
37,5 |
70 |
2625 |
0,561 |
86,621 |
| Blood bilirubin analysis |
18,99 |
137 |
2601,63 |
0,556 |
87,134 |
| Curative swimming |
80,04 |
30 |
2401,2 |
0,513 |
87,612 |
| Laser therapy |
44,7 |
50 |
2235 |
0,478 |
88,044 |
| Knee joint dry heat procedure |
40,47 |
50 |
2023,5 |
0,432 |
88,462 |
| Blood general protein analysis |
15,39 |
127 |
1954,53 |
0,418 |
88,868 |
| Inhalation |
31,65 |
60 |
1899 |
0,406 |
89,247 |
| Massage |
19,74 |
90 |
1776,6 |
0,380 |
89,615 |
| Cardiologist consultation |
81,99 |
21 |
1721,79 |
0,368 |
89,965 |
| Anti-HBchepatitis antibody determination |
26,37 |
62 |
1634,94 |
0,349 |
90,313 |
| Rhematoid factor deteremination |
77,67 |
21 |
1631,07 |
0,349 |
90,650 |
| Thoracal cell massage |
39,33 |
40 |
1573,2 |
0,336 |
90,981 |
| Water medical gymnastics |
13,47 |
115 |
1549,05 |
0,331 |
91,283 |
| Knee joint dry heat procedure |
40,47 |
35 |
1416,45 |
0,303 |
91,576 |
| Mechanic therapy |
39,18 |
35 |
1371,3 |
0,293 |
91,868 |
| Ozokeritotherapy |
75,81 |
18 |
1364,58 |
0,292 |
92,140 |
| Knee joints ultrasonic scanning |
98,01 |
13 |
1274,13 |
0,272 |
92,404 |
| Pelvic bones and hip joints Х-ray photograph |
154,2 |
8 |
1233,6 |
0,264 |
92,651 |
| Blood thrombinogen analysis |
10,05 |
115 |
1155,75 |
0,247 |
92,896 |
| Backbone massage |
28,68 |
40 |
1147,2 |
0,245 |
93,139 |
| Aerocryotherapy |
75,81 |
15 |
1137,15 |
0,243 |
93,379 |
| Ophthalmologist consultation |
124,5 |
9 |
1120,5 |
0,239 |
93,604 |
| HIV antibody determination |
26,37 |
40 |
1054,8 |
0,225 |
93,829 |
| Gynecologist consultation |
131,64 |
8 |
1053,12 |
0,225 |
94,046 |
| Wassermann reaction |
26,76 |
38 |
1016,88 |
0,217 |
94,258 |
| Endocrinologist consultation |
76,2 |
13 |
990,6 |
0,212 |
94,467 |
| Thoracal cell Х-ray photograph |
195,93 |
5 |
979,65 |
0,209 |
94,674 |
| Medical gymnastics in group |
16,68 |
58 |
967,44 |
0,207 |
94,879 |
| Cholesterin |
18,78 |
51 |
957,78 |
0,205 |
95,081 |
|
«С» group expenses |
|||||
| Blood С-reactive fiber level examination |
7,74 |
122 |
944,28 |
0,202 |
95,272 |
| Circulatory shower |
29,88 |
30 |
896,4 |
0,192 |
95,460 |
| Abdominal cavity organs ultrasonic scanning |
146,07 |
6 |
876,42 |
0,187 |
95,642 |
| Iodide-bromine bath |
42,75 |
20 |
855 |
0,183 |
95,825 |
| Foot vortical bath |
42,75 |
20 |
855 |
0,183 |
95,994 |
| Psychologist consultation |
263,49 |
3 |
790,47 |
0,169 |
96,157 |
| Urea blood analysis |
6,48 |
118 |
764,64 |
0,163 |
96,317 |
| Acupuncture therapeutist consultation |
93,27 |
8 |
746,16 |
0,159 |
96,474 |
| Dry СО2 bath |
36,9 |
20 |
738 |
0,158 |
96,631 |
| Simulator practical training |
36,69 |
20 |
733,8 |
0,157 |
96,787 |
| Small pelvis organs ultrasonic scanning |
121,74 |
6 |
730,44 |
0,156 |
96,938 |
| Kinesy therapeutist consultation |
100,41 |
7 |
702,87 |
0,150 |
97,077 |
| Definition of red blood cells sedimentation rate |
7,77 |
84 |
652,68 |
0,139 |
97,216 |
| Backbone lumbar part segmentary massage |
19,74 |
33 |
651,42 |
0,139 |
97,341 |
| Glucocorticoid electrophoresis |
27,27 |
20 |
545,4 |
0,117 |
97,570 |
| Darsonval -effect |
26,28 |
20 |
525,6 |
0,112 |
97,680 |
| Knee joint puncture
|
515,37 |
1 |
515,37 |
0,110 |
97,789 |
| Colonoscopy |
502,86 |
1 |
502,86 |
0,107 |
98,003 |
| Dermatolo- venereologist consultation |
124,8 |
4 |
499,2 |
0,107 |
98,104 |
| «Soluks” lamp exposure |
26,28 |
18 |
473,04 |
0,101 |
98,200 |
| Oethopedist consultation |
149,37 |
3 |
448,11 |
0,096 |
98,280 |
| Diadynamic currents on foot |
37,56 |
10 |
375,6 |
0,080 |
98,356 |
| Rehabilitation -doctor`s consultation |
118,38 |
3 |
355,14 |
0,076 |
98,430 |
| Knee joint arthroscopy |
173,37 |
2 |
346,74 |
0,074 |
98,504 |
| Backbone cervical spine Х-ray photograph |
173,25 |
2 |
346,5 |
0,074 |
98,576 |
| Individual medical gymnastics |
66,48 |
5 |
332,4 |
0,071 |
98,717 |
| Gastroenterologist consultation |
82,11 |
4 |
328,44 |
0,070 |
98,787 |
| Traumatologist consultation |
81,96 |
4 |
327,84 |
0,070 |
98,855 |
| Urinologist consultation |
104,58 |
3 |
313,74 |
0,067 |
98,919 |
| Lungs flurography |
74,85 |
4 |
299,4 |
0,064 |
98,981 |
| Ankle joint Х-ray photograph |
98,01 |
3 |
294,03 |
0,063 |
99,044 |
| Hip joint ultrasonic scanning |
98,01 |
3 |
294,03 |
0,063 |
99,105 |
| Back relaxing massage |
28,68 |
10 |
286,8 |
0,061 |
99,167 |
| Otorhinolaryngologist consultation |
43,19 |
2 |
286,38 |
0,061 |
99,218 |
| Lower extremities vesselsultrasonic |
60,36 |
4 |
241,44 |
0,052 |
99,269 |
| Abdominal cavity dopplerography |
118,02 |
2 |
236,04 |
0,050 |
99,318 |
| Lung specialist сonsultation |
76,23 |
3 |
228,69 |
0,049 |
99,366 |
| Lower leg massage |
22,8 |
10 |
228 |
0,049 |
99,413 |
| Electroencephalography |
220,14 |
1 |
220,14 |
0,047 |
99,459 |
| Pickfluometry |
53,82 |
4 |
215,28 |
0,046 |
99,504 |
| Ophthalmoscopy |
103,71 |
2 |
207,42 |
0,044 |
99,547 |
| Manual therapist consultation |
100,41 |
2 |
200,82 |
0,043 |
99,588 |
| Nose sinus appendages Х-ray photograph |
192,66 |
1 |
192,66 |
0,041 |
99,628 |
| Triglyceride determination |
63,33 |
3 |
189,99 |
0,041 |
99,666 |
| Capnography |
58,71 |
3 |
176,13 |
0,038 |
99,703 |
| Backbone lumbar part Х-ray photograph |
57,75 |
3 |
173,25 |
0,037 |
99,736 |
| Stabilotraining |
15,45 |
10 |
154,5 |
0,033 |
99,768 |
| Pulsoximeter |
10,05 |
15 |
150,75 |
0,032 |
99,800 |
| Ultrasonic scanning kidney |
146,07 |
1 |
146,07 |
0,031 |
99,828 |
| Joints thermometry |
135,63 |
1 |
135,63 |
0,029 |
99,856 |
| Hair part head massage |
15,81 |
8 |
126,48 |
0,027 |
99,878 |
| Eye ground examination |
103,71 |
1 |
103,71 |
0,022 |
99,896 |
| Pneumotachometer |
28,41 |
3 |
85,23 |
0,018 |
99,914 |
| Vascular surgeon consultation |
76,08 |
1 |
76,08 |
0,016 |
99,944 |
| Alkaline phosphotasis deternination |
32,37 |
2 |
64,74 |
0,014 |
99,955 |
| International normalized relation determination |
50,85 |
1 |
50,85 |
0,011 |
99,965 |
| Smear cytologic examination |
49,95 |
1 |
49,95 |
0,011 |
99,971 |
| High density lipoproteids determination |
24,63 |
1 |
24,63 |
0,005 |
99,976 |
| Low density lipoproteids determination |
24,63 |
1 |
24,63 |
0,005 |
99,981 |
| Deteremination of atherogenic factor |
24,63 |
1 |
24,63 |
0,005 |
99,986 |
| Uric acid determination |
22,35 |
1 |
22,35 |
0,005 |
99,990 |
| Determination of hepatitis virus “C” to antibodies |
20,13 |
1 |
20,13 |
0,004 |
99,998 |
| Determination of prothrombin time |
18,33 |
1 |
18,33 |
0,004 |
100,000 |
| С-rebound protein determination |
7,74 |
1 |
7,74 |
0,002 |
100,000 |
Table 20
Medical services` expenses АВС-analysis in ALMAG-01 device group
|
Medical services |
Tariff per med.service. |
Services total number |
Expenses per service rub. |
Expenses % per medical service |
Expenses cumulative % per medical service |
|
«А» group expenses |
|||||
| Therapist consultation |
77,82 |
286 |
22256,52 |
11,55 |
20,747 |
| Physiotherapist consultation |
93,27 |
190 |
17721,3 |
9,197 |
26,352 |
| Knee joint magnetotherapy |
26,28 |
411 |
10801,08 |
5,605 |
31,097 |
| Diet |
74,94 |
122 |
9142,68 |
4,745 |
35,759 |
| Measurement of peripheral arteries arterial pressure |
11,4 |
788 |
8983,2 |
4,662 |
38,748 |
| Backbone lumbar part magnetic resonant tomography |
5760 |
1 |
5760 |
2,989 |
41,498 |
| The physiotherapy exercises aimed to left knee mobility function recovery |
15,45 |
343 |
5299,35 |
2,75 |
44,034 |
| Medical bile night compress |
488,7 |
10 |
4887 |
2,536 |
46,557 |
| Physioprocedures |
26,28 |
185 |
4861,8 |
2,523 |
48,760 |
| Blood general protein and protein fractions analysis |
86,64 |
49 |
4245,36 |
2,203 |
50,938 |
| Urine general analysis |
47,16 |
89 |
4197,24 |
2,178 |
53,038 |
| Electrocardiography |
87,96 |
46 |
4046,16 |
2,1 |
55,049 |
| Knee joints X-ray photography |
168,45 |
23 |
3874,35 |
2,011 |
57,047 |
| Novocaine compress |
76,98 |
50 |
3849 |
1,998 |
58,819 |
| Physiotherapy exercises specialist consultation |
100,41 |
34 |
3413,94 |
1,772 |
60,580 |
| Knee joints massage |
42,96 |
79 |
3393,84 |
1,761 |
62,220 |
| Acupuncture |
46,47 |
68 |
3159,96 |
1,64 |
63,840 |
| Surgeon consultation |
82,14 |
38 |
3121,32 |
1,62 |
65,457 |
| General blood clinical analysis |
28,59 |
109 |
3116,31 |
1,617 |
66,962 |
| Hydromassage |
69,03 |
42 |
2899,26 |
1,505 |
68,431 |
| Hemoglobin, leukocytes determination |
25,74 |
110 |
2831,4 |
1,469 |
69,813 |
| Coagulograme |
121,08 |
22 |
2663,76 |
1,382 |
71,173 |
| Thoracal cell massage |
42,96 |
61 |
2620,56 |
1,36 |
72,463 |
| Pulse examination |
3,3 |
753 |
2484,9 |
1,29 |
73,746 |
| Palpitation rate measurement |
3,3 |
749 |
2471,7 |
1,283 |
74,980 |
| Blood group and rhesus factor |
118,89 |
20 |
2377,8 |
1,234 |
76,189 |
| Neurologist consultation |
75,15 |
31 |
2329,65 |
1,209 |
77,265 |
| Variation intervalometer |
94,26 |
22 |
2073,72 |
1,076 |
78,335 |
| Determination of blood glucose |
23,16 |
89 |
2061,24 |
1,07 |
79,360 |
| Traveling magnetic field -therapy |
37,26 |
53 |
1974,78 |
1,025 |
80,363 |
|
«В» group expenses |
|||||
| Backbone vibromassage |
69,03 |
28 |
1932,84 |
1,003 |
81,217 |
| Blood electrolits |
86,58 |
19 |
1645,02 |
0,854 |
82,048 |
| Curative swimming |
80,04 |
20 |
1600,8 |
0,831 |
82,852 |
| Cervico-collar area massage |
28,68 |
54 |
1548,72 |
0,804 |
83,564 |
| Mechano-therapy |
39,18 |
35 |
1371,3 |
0,712 |
84,272 |
| Ozokerito-therapy |
75,81 |
18 |
1364,58 |
0,708 |
84,959 |
| Blood analysis |
22,83 |
58 |
1324,14 |
0,687 |
85,631 |
| Knee joint dry heat |
40,47 |
32 |
1295,04 |
0,672 |
86,269 |
| Cardiology consultation |
81,99 |
15 |
1229,85 |
0,638 |
86,890 |
| Sea salt bath |
42,75 |
28 |
1197 |
0,621 |
87,485 |
| Backbone massage |
28,68 |
40 |
1147,2 |
0,595 |
88,069 |
| Phonophoresis |
37,5 |
30 |
1125 |
0,584 |
88,629 |
| Knee joints ultrasonic scanning |
98,01 |
11 |
1078,11 |
0,56 |
89,188 |
| Water medical gymnastics |
13,47 |
80 |
1077,6 |
0,559 |
89,730 |
| Blood bilirubin analysis |
18,99 |
55 |
1044,45 |
0,542 |
90,263 |
| Creatinine blood analysis |
22,83 |
45 |
1027,35 |
0,533 |
90,747 |
| Rheumatoid factor determination |
77,67 |
12 |
932,04 |
0,484 |
91,211 |
| Laser therapy |
44,7 |
20 |
894 |
0,464 |
91,655 |
| Iodide-bromine bath |
42,75 |
20 |
855 |
0,444 |
92,094 |
| General protein blood analysis |
15,39 |
55 |
846,45 |
0,439 |
92,510 |
| Medical gymnastics |
16,68 |
48 |
800,64 |
0,416 |
92,918 |
| Thorax massage |
39,33 |
20 |
786,6 |
0,408 |
93,305 |
| Acupuncture specialist consultation |
93,27 |
8 |
746,16 |
0,387 |
93,670 |
| Kinesitherapeutist consultation |
100,41 |
7 |
702,87 |
0,365 |
93,953 |
| Glucocorticoid electroohoresis |
27,27 |
20 |
545,4 |
0,283 |
94,206 |
| C level blood reactive protein examination |
7,74 |
63 |
487,62 |
0,253 |
94,451 |
| “Solux” lamp exposure |
26,28 |
18 |
473,04 |
0,245 |
94,691 |
| Pelvic bones and hip-bone joints X-ray photography |
154,2 |
3 |
462,6 |
0,24 |
94,931 |
|
«С» group expenses |
|||||
| Prothrombin blood analysis |
10,05 |
43 |
432,15 |
0,224 |
95,379 |
| Cholesterol |
18,78 |
23 |
431,94 |
0,224 |
95,601 |
| Foot vortical bath |
42,75 |
10 |
427,5 |
0,222 |
95,811 |
| Knee joints dry heat |
40,47 |
10 |
404,7 |
0,21 |
96,016 |
| Massage |
19,74 |
20 |
394,8 |
0,205 |
96,214 |
| Endocrine specialist consultation |
76,2 |
5 |
381 |
0,198 |
96,411 |
| Aerocryotherapy |
75,81 |
5 |
379,05 |
0,197 |
96,606 |
| Feet diadynamic currents |
37,56 |
10 |
375,6 |
0,195 |
96,796 |
| Little pelvic organs ultrasonic scanning |
121,74 |
3 |
365,22 |
0,19 |
96,980 |
| Rehabilitation -doctor consultation |
118,38 |
3 |
355,14 |
0,184 |
97,160 |
| Backbone cervical part X-ray photography |
173,25 |
2 |
346,5 |
0,18 |
97,333 |
| Individual medical gymnastics |
66,48 |
5 |
332,4 |
0,173 |
97,497 |
| Inhalation |
31,65 |
10 |
316,5 |
0,164 |
97,658 |
| Determination of erythrocytes sedimentation speed |
7,77 |
40 |
310,8 |
0,161 |
97,813 |
| Circulatory shower |
29,88 |
10 |
298,8 |
0,155 |
97,968 |
| Orthopedist consultation |
149,37 |
2 |
298,74 |
0,155 |
98,121 |
| Hip-bone joints ultrasonic scanning |
98,01 |
3 |
294,03 |
0,153 |
98,272 |
| Urea blood analysis |
6,48 |
45 |
291,6 |
0,151 |
98,409 |
| Gynaecologist consultation |
131,64 |
2 |
263,28 |
0,137 |
98,546 |
| Psychologist consultation |
263,49 |
1 |
263,49 |
0,137 |
98,682 |
| Darsonval -exposure |
26,28 |
10 |
262,8 |
0,136 |
98,811 |
| Oculist consultation |
124,5 |
2 |
249 |
0,129 |
98,939 |
| Traumatologist consultation |
81,96 |
3 |
245,88 |
0,128 |
99,053 |
| Electroencephalography |
220,14 |
1 |
220,14 |
0,114 |
99,157 |
| Manual therapeutist consultation |
100,41 |
2 |
200,82 |
0,104 |
99,259 |
| Backbone lumbar part segmentary massage |
19,74 |
10 |
197,4 |
0,102 |
99,335 |
| Belly cavity organs ultrasonic scanning |
146,07 |
1 |
146,07 |
0,076 |
99,409 |
| Otolaryngology specialist consultation |
143,19 |
1 |
143,19 |
0,074 |
99,475 |
| Triglycerides determination |
63,33 |
2 |
126,66 |
0,066 |
99,541 |
| Head hear part massage |
15,81 |
8 |
126,48 |
0,066 |
99,606 |
| Dermatologist-venereologist consultation |
124,8 |
1 |
124,8 |
0,065 |
99,660 |
| Ophthalmoscopy |
103,71 |
1 |
103,71 |
0,054 |
99,714 |
| Eye ground examination |
103,71 |
1 |
103,71 |
0,054 |
99,765 |
| Ankle joints X-ray photography |
98,01 |
1 |
98,01 |
0,051 |
99,808 |
| Gastroenterologist consultation |
82,11 |
1 |
82,11 |
0,043 |
99,848 |
| Pulmonologist consultation |
76,23 |
1 |
76,23 |
0,04 |
99,887 |
| Vascular surgeon consultation |
76,08 |
1 |
76,08 |
0,039 |
99,917 |
| Capnography |
58,71 |
1 |
58,71 |
0,03 |
99,947 |
| Backbone lumbar part X-ray photography |
57,75 |
1 |
57,75 |
0,03 |
99,973 |
| Pulsoximetry |
10,05 |
5 |
50,25 |
0,026 |
99,988 |
| Pneumotachometer |
28,41 |
1 |
28,41 |
0,015 |
100,00 |
| Atherogenic coefficient determination |
24,63 |
1 |
24,63 |
0,013 |
100,00 |
Table 21
Medical services` expenses АВС-analysis in placebo -device group
| Medical services |
Tariff per rendered service rub. |
Number of rendered services |
Expenses per service rub. |
Expenses % per medical service |
Expenses cumulative % per medical service |
|
«А» group expenses |
|||||
| Medical bile night compress |
488,7 |
76 |
37141,2 |
12,72585 |
21,38161 |
| Measurement of peripheral arteries arterial pressure |
11,4 |
2216 |
25262,4 |
8,655764 |
29,75448 |
| Physiotherapeutist consultation |
93,27 |
262 |
24436,74 |
8,372865 |
36,90038 |
| Therapeutist consultation |
77,82 |
268 |
20855,76 |
7,145898 |
42,59352 |
| Medical bile compress on knee joint |
488,7 |
34 |
16615,8 |
5,693143 |
47,01905 |
| The physiotherapy exercises amied to left knee joint function and mobility recovery |
15,45 |
836 |
12916,2 |
4,425533 |
50,9662 |
| Backbone lumbar part magnetic resonance tomography |
5760 |
2 |
11520 |
3,947147 |
54,631 |
| Knee joint magnetotherapy |
26,28 |
407 |
10695,96 |
3,664803 |
57,1626 |
| Electrocardiography |
87,96 |
84 |
7388,64 |
2,531601 |
59,61029 |
| Coagylogramme |
121,08 |
59 |
7143,72 |
2,447683 |
62,0458 |
| Pulse examination |
3,3 |
2154 |
7108,2 |
2,435513 |
64,48018 |
| Heart beat rate measurement |
3,3 |
2153 |
7104,9 |
2,434382 |
66,67992 |
| Blood group and rhesus factor |
118,89 |
54 |
6420,06 |
2,199733 |
68,86246 |
| Diet |
74,94 |
85 |
6369,9 |
2,182546 |
70,89845 |
| Urine general analysis |
47,16 |
126 |
5942,16 |
2,035988 |
72,8031 |
| Knee joints X-ray photography |
168,45 |
33 |
5558,85 |
1,904653 |
74,34106 |
| Blood clinical general analysis |
28,59 |
157 |
4488,63 |
1,537958 |
75,61987 |
| Hemoglobin, leukocytes determination |
25,74 |
145 |
3732,3 |
1,278814 |
76,83699 |
| Blood general protein and protein fractions analysis |
86,64 |
41 |
3552,24 |
1,217119 |
78,0236 |
| Blood electrolyte |
86,58 |
40 |
3463,2 |
1,186611 |
79,09599 |
| Traveling pulsed magnetic field therapy |
37,26 |
84 |
3129,84 |
1,07239 |
79,9927 |
| Determination of blood glucose |
23,16 |
113 |
2617,08 |
0,896701 |
80,80011 |
|
«В» group expenses |
|||||
| Variational intervalometry |
94,26 |
25 |
2356,5 |
0,807418 |
81,59497 |
| Backbone lumbosacral part massage |
42,96 |
54 |
2319,84 |
0,794857 |
82,32735 |
| See salt bath |
42,75 |
50 |
2137,5 |
0,732381 |
82,97466 |
| Surgery consultation |
82,14 |
23 |
1889,22 |
0,647312 |
83,56134 |
| Blood kreatine analysis |
22,83 |
75 |
1712,25 |
0,586676 |
84,12153 |
| НВС (hepatites) antibodies determination |
26,37 |
62 |
1634,94 |
0,560186 |
84,67199 |
| Physiotherapy exercises specialist consultation |
100,41 |
16 |
1606,56 |
0,550463 |
85,21421 |
| Inhalation |
31,65 |
50 |
1582,5 |
0,542219 |
85,74775 |
| Blood bilirubin analysis |
18,99 |
82 |
1557,18 |
0,533543 |
86,27185 |
| Blood analysis |
22,83 |
67 |
1529,61 |
0,524097 |
86,78683 |
| Neurologist consultation |
75,15 |
20 |
1503 |
0,514979 |
87,30078 |
| Medical phonophoresis |
37,5 |
40 |
1500 |
0,513951 |
87,79212 |
| Cervicocollar area massage |
28,68 |
50 |
1434 |
0,491338 |
88,26557 |
| Massage |
19,74 |
70 |
1381,8 |
0,473452 |
88,73861 |
| Backbone vibromassage |
69,03 |
20 |
1380,6 |
0,473041 |
89,19808 |
| Laser therapy |
44,7 |
30 |
1341 |
0,459473 |
89,64647 |
| Novocaine compress |
76,98 |
17 |
1308,66 |
0,448392 |
90,02614 |
| Blood general protien analysis |
15,39 |
72 |
1108,08 |
0,379666 |
90,38755 |
| HIV antibody determination |
26,37 |
40 |
1054,8 |
0,361411 |
90,73597 |
| Vasserman reaction |
26,76 |
38 |
1016,88 |
0,348418 |
91,08263 |
| Knee joint dry heat |
40,47 |
25 |
1011,75 |
0,34666 |
91,41829 |
| Thorax X – ray photography |
195,93 |
5 |
979,65 |
0,335662 |
91,73673 |
| Acupuncture |
46,47 |
20 |
929,4 |
0,318444 |
92,03534 |
| Oculist consultation |
124,5 |
7 |
871,5 |
0,298606 |
92,32973 |
| Knee joints massage |
42,96 |
20 |
859,2 |
0,294391 |
92,60398 |
| Curative swimming |
80,04 |
10 |
800,4 |
0,274244 |
92,8746 |
| Gynaecologist consultation |
131,64 |
6 |
789,84 |
0,270626 |
93,14412 |
| Thorax massage |
39,33 |
20 |
786,6 |
0,269516 |
93,40829 |
| Palvis bones and hip joints X – ray photography |
154,2 |
5 |
771 |
0,264171 |
93,66804 |
| Aerocriotherapy |
75,81 |
10 |
758,1 |
0,259751 |
93,9209 |
| Dry СО2 bath |
36,9 |
20 |
738 |
0,252864 |
94,17233 |
| Training exercises |
36,69 |
20 |
733,8 |
0,251425 |
94,42257 |
| Belly cavity organs ultrasonic scanning
|
146,07 |
5 |
730,35 |
0,250243 |
94,67217 |
| Knee joint dry heat |
40,47 |
18 |
728,46 |
0,249595 |
94,9201 |
| Blood prothrombin analysis |
10,05 |
72 |
723,6 |
0,24793 |
95,15961 |
|
«С» group expenses |
|||||
| Rheumatoid factor determination |
77,67 |
9 |
699,03 |
0,239512 |
95,39613 |
| Hydromassage |
69,03 |
10 |
690,3 |
0,23652 |
95,605 |
| Endocrinologist consultation |
76,2 |
8 |
609,6 |
0,20887 |
95,80976 |
| Circulatory bath |
29,88 |
20 |
597,6 |
0,204758 |
96,01016 |
| Psychologist consultation |
263,49 |
2 |
526,98 |
0,180561 |
96,37089 |
| Cholesterol |
18,78 |
28 |
525,84 |
0,180171 |
96,54747 |
| Knee joint puncture |
515,37 |
1 |
515,37 |
0,176583 |
96,71977 |
| Colonoscopy |
502,86 |
1 |
502,86 |
0,172297 |
96,88832 |
| Cardiologist consultation |
81,99 |
6 |
491,94 |
0,168556 |
97,0504 |
| Urine blood analysis |
6,48 |
73 |
473,04 |
0,16208 |
97,21194 |
| Water curative gymnastics |
13,47 |
35 |
471,45 |
0,161535 |
97,36841 |
| Blood C-reactive albumen level examination |
7,74 |
59 |
456,66 |
0,156467 |
97,52397 |
| Lumbar spine segment massage |
19,74 |
23 |
454,02 |
0,155563 |
97,67045 |
| Foot vortical bath |
42,75 |
10 |
427,5 |
0,146476 |
97,79873 |
| Dermatologist-venereologist consultation |
124,8 |
3 |
374,4 |
0,128282 |
97,92386 |
| Small pelvis organs ultrasonic scanning |
121,74 |
3 |
365,22 |
0,125137 |
98,04267 |
| Knee joint arthroscopy |
173,37 |
2 |
346,74 |
0,118805 |
98,15981 |
| Red blood cells sedimentation speed determination |
7,77 |
44 |
341,88 |
0,11714 |
98,27504 |
| Urologist consultation |
104,58 |
3 |
313,74 |
0,107498 |
98,48512 |
| Lungs fluorography |
74,85 |
4 |
299,4 |
0,102585 |
98,58339 |
| Backbone relaxing massage |
28,68 |
10 |
286,8 |
0,098268 |
98,67343 |
| Darsonval exposure |
26,28 |
10 |
262,8 |
0,090044 |
98,75783 |
| Gastroenterologist consultation |
82,11 |
3 |
246,33 |
0,084401 |
98,84056 |
| Lower extremities vessels ultrasonic diagnostics |
60,36 |
4 |
241,44 |
0,082726 |
98,92143 |
| Abdominal cavity X-ray photography |
118,02 |
2 |
236,04 |
0,080875 |
98,99956 |
| Lower leg massage |
22,8 |
10 |
228 |
0,078121 |
99,07332 |
| Picphloumetric |
53,82 |
4 |
215,28 |
0,073762 |
99,14048 |
| Knee joints ultrasonic scanning |
98,01 |
2 |
196,02 |
0,067163 |
99,20764 |
| Ankle joints X-ray photography |
98,01 |
2 |
196,02 |
0,067163 |
99,27366 |
| Sinus appendages X-ray photography |
192,66 |
1 |
192,66 |
0,066012 |
99,33081 |
| Curative gymnastics |
16,68 |
10 |
166,8 |
0,057151 |
99,38374 |
| Stabilotraining |
15,45 |
10 |
154,5 |
0,052937 |
99,43598 |
| Pulmonologist consultation |
76,23 |
2 |
152,46 |
0,052238 |
99,48716 |
| Orthopedist consultation |
149,37 |
1 |
149,37 |
0,051179 |
99,53721 |
| Kidneys ultrasonic scanning |
146,07 |
1 |
146,07 |
0,050049 |
99,58627 |
| Otorhinolaryngologist consultation |
143,19 |
1 |
143,19 |
0,049062 |
99,63274 |
| Joints thermometry |
135,63 |
1 |
135,63 |
0,046471 |
99,67297 |
| Capnography |
58,71 |
2 |
117,42 |
0,040232 |
99,71255 |
| Backbone loin X-ray photography |
57,75 |
2 |
115,5 |
0,039574 |
99,74808 |
| Ophthalmoscopy |
103,71 |
1 |
103,71 |
0,035535 |
99,78252 |
| Pulsoximetry |
10,05 |
10 |
100,5 |
0,034435 |
99,81093 |
| Specific antigen determination |
20,73 |
4 |
82,92 |
0,028411 |
99,83901 |
| Traumatologist consultation |
81,96 |
1 |
81,96 |
0,028082 |
99,86119 |
| Alkaline phosphatase determination |
32,37 |
2 |
64,74 |
0,022182 |
99,88289 |
| Triglyceride determination |
63,33 |
1 |
63,33 |
0,021699 |
99,90236 |
| Pneumotachometry |
28,41 |
2 |
56,82 |
0,019468 |
99,91978 |
| Determination of the international normalized relation |
50,85 |
1 |
50,85 |
0,017423 |
99,9369 |
| Smear cytologic examination |
49,95 |
1 |
49,95 |
0,017115 |
99,95274 |
| High density lipoprotein deternination |
24,63 |
1 |
24,63 |
0,008439 |
99,96962 |
| Low density lipoprotein deternination |
24,63 |
1 |
24,63 |
0,008439 |
99,97727 |
| Uric acid determination |
22,35 |
1 |
22,35 |
0,007658 |
99,98417 |
| Determination of antibody to C- hepatitis virus |
20,13 |
1 |
20,13 |
0,006897 |
99,99735 |
| Prothrombin time determination |
18,33 |
1 |
18,33 |
0,00628 |
100 |
| С-reactive albumen determination
|
7,74 |
1 |
7,74 |
0,002652 |
100 |
When doing analysis of medical services ( physioprocedures, massage) influencing knee joint functions, it turned out that in Almag-01device group (n=75) there were 1901 rendered services, and in placebo device group (n=95) – 2070 ones (tab. 22). In Almag-01device group the average number of rendered procedures per patient influencing knee joint functions came to 25,3 while in placebo device group the average number of procedures per patient amount to to 21,7. So we see that in Almag-01device group average number of carried out procedures was 3,6 more of those in placebo device group.
While carrying out medical procedures , influencing affected joints functions, quality analysis there were revealed the fact that in ALMAG-01 device the medical procedures ( such as hydromassage, accupuncture, iodide-bromine bath, Novocaine compress, water curative gymnastics, knee joint magneto-therapy, knee joints massage, backbone massage, mechanotherapy, ozokerite therapy, knee joint dry heat) had been carried out more frequently. But it is unlikely, that these differences considerably exerted examination final results.
Table 22
The list of rendered medical procedures
influencing knee joint function
| Medical procedures |
The number of procedures rendered in ALMAG-01 device group (n=75), абс. (%) |
The number of procedures rendered in placebo device group (n=95), абс. (%) |
| Aerocryotherapy Аэрокриотерапия |
5 (6,6%) |
10 (10,5%) |
| Magnetic traveling pulsed field therapy |
53 (70,6%) |
84 (88,4%) |
| Sea salt bath |
28 (37,3%) |
50 (52,6%) |
| Backbone massage |
28 (37,3%) |
20 (21%) |
| Foot vortical bath |
10 (13,3%) |
10 (10,5%) |
| « Solux” lamp exposure |
18 (24%) |
0 |
| Hydromassage |
42 (56%) |
10 (10,5%) |
| Darsonval exposure |
10 (13,3%) |
10 (10,5%) |
| Feet diodynamic currents |
10 (13,3%) |
0 |
| Training apparatus physical exercises |
0 |
20 (21%) |
| Acupuncture |
68 (90,6%) |
20 (21%) |
| Iodide-bromine bath |
20 (26,6%) |
0 |
| Knee joint medical bile compress |
0 |
34 (35,7%) |
| Medical bile night compress |
10 (13,3%) |
76 (80%) |
| Novocaine compress |
50 (66,6%) |
17 (17,8%) |
| Laser therapy |
20 (26,6%) |
30 (31,5%) |
| Water curative gymnastics |
80 (106,6%) |
35 (36,8%) |
| Individual curative gymnastics |
5 (6,6%) |
0 |
| Group curative gymnastics |
48 (64%) |
10 (10,5%) |
| The physiotherapy exercises aimed to left knee function and mobility recovery |
343 (457,3%) |
836 (880%) |
| Curative swimming |
20 (26,6%) |
10 (10,5%) |
| Knee joint magneto-therapy |
411 (548%) |
407 (428,4%) |
| Massage |
20 (26,6%) |
70 (73,6%) |
| Head hair part massage |
8 (10,6%) |
0 |
| Low leg massage |
0 |
10 (10,5%) |
| Thorax massage |
20 (26,6%) |
20 (21%) |
| Knee joints massage |
79 (105,3%) |
20 (21%) |
| Backbone massage |
40 (53,3%) |
0 |
| Backbone lumbar sacral part massage |
61 (81,3%) |
54 (56,8%) |
| Cervical collar area massage |
54 (72%) |
50 (52,6%) |
| Back relaxing massage |
0 |
10 (10,5%) |
| Mechanic therapy |
35 (46,6%) |
0 |
| Ozokerite therapy |
18 (24%) |
0 |
| Back lumber part segment massage |
10 (13,3%) |
23 (24,2%) |
| Stabilo-training |
0 |
10 (10,5%) |
| Dry СО2 bath |
0 |
20 (21%) |
| Knee joint dry heat |
10 (13,3%) |
25 (26,3%) |
| Joints thermo-therapy |
0 |
1 (1%) |
| Physio-procedure |
185 (246,6%) |
0 |
| Medical phonophoresis |
30 (40%) |
40 (42,1%) |
| Glucocorticoid electrophoresis |
20 (26,6%) |
0 |
| Procedures total number |
1901 |
2070 |
| Procedures average number per patient |
25,3 |
21,7 |
In Almag-01device patient group medical procedures expenses, from public health system position , (n=75) came to 192 688, 98 rub. Medical services expenses per patient came to 2 569,18 rub.
In placebo – Almag-01 device patient group medical procedures expenses, from public health system position, (n=95) came to 275 240, 58 rub. Medical services expenses per patient came to 2 897, 26 rub.
Hotel services expenses per patient staying in hospital came to :
Ø for patient group applying ALMAG-01 device : 176,17 rub. * 15,7 days = 2 765,86 rub.
Ø for patient group applying placebo Almag-01 device : 176,17 rub. * 20,4 days = 3 593,86 rub.
Almag-01 device applying group total expenses per patient came to: 2 313 rub. + 2 569,18 rub. + 2 765,86 rub. = 7 648,04 rub.
Placebo Almag-01 device applying group total expenses per patient came to: 3 113 rub. + 2 897,26 rub. + 3 593,86 rub. = 9 604,12 rub.
“Expenses-efficiency”analysis results are given in table 23. To make analysis the “ Pain and discomfort related dynamic of severe and moderate dysfunction life quality” factor have been taken because sedative effect is an important one in knee joints osteoarthritis therapy and the application of Almag-01 device ,in this particular case, proves its preferences regarding life quality effect as compared to placebo-device application.
Table 23
“Expenses-efficiency”analysis in connection with “ dynamic of pain and discomfort related severe and moderate dysfunction life quality ” factor
|
Аlmag-01 device group (n = 75) |
Placebo device group (n = 95) |
|
|
Treatment total expenses per patient rub. |
7 648,04 |
9 604,12 |
| “Dynamic of pain and discomfort related severe and moderate dysfunction life quality” factor, patients percent |
0,57 |
0,37 |
| Pain and discomfort related life quality moderate and severe abnormalities reduction «Expenses -profit »index, rub.
per patient |
13 417 |
25 956 |
As it is seen from the table Almag-01 magneto-therapy is an effective strategy from the point of expenses for carrying out “expenses-efficiency”analysis according to “ dynamic of pain and discomfort related severe and moderate dysfunction life quality” factor. Expenses in Almag-01 device group in this particular case ( reduction of pain and discomfort related severe and moderate dysfunction life quality per patient) came to 13 417 rub. per patient that is practically twice less than in placebo-device they were 25 956 rub. per patient for reaching the same effect .
Conclusion
Randomized, double-blind, placebo controllable examination of magnetotherapy clinico -economic efficiency with Almag-01device application for gonarthrosis has proved its cost efficiency being included in therapeutic process.
The most important differences between groups of Almag-01 device and placebo device groups have been taken according the indications as follows:
– «Pain and discomfort» index (indication) change (questionnaire ЕQ-5D);
– joint size change (according to International classifier)
According to life quality dynamic being evaluated under the ЕQ-5D questionnaire there was noted reduction of “ Pain and discomfort” indication (index) in Almag-01 device group ( patients with moderate and severe diseases abnormalities ) by 57,3% ( from 96% to 38,7%) as compared to 37,9% (from 100% to 62,1%) in placebo device group. According to K.A.. Litkina pain influence is one of the most important factors in arthrosis treatment.
When analysing the affected join size in Almag-01 device group it was noted the reduction of the joint size by 3,9 sm. as compared with placebo-device group – 2,9 sm. Taking into account the joint size, joint size change dynamic testifies the more evident therapy effect with Almag-01 device application. Affected joint flexion(bending)/extension angle dynamic analysis manifested joint mobility function change. In Almag-01 device group the bending angle was reduced by 7,40 in average and in placebo Almag-01 device group the reduction was by 3,50. This index testifies in general statistically not great increase of knee joint mobility function in Almag-01 device group though in placebo device group the number of procedures (services) aimed to knee joint function recovery and mobility was 2,44 times more than those in Almag-01 device group
An estimation of affected joints functional parameters dynamics estimated according to the International qualifier has shown results as follows:
– according to «Slight abnormalities and their absence” parameter in Almag-01 device group as compared to placebo-device group there was noted the more evident positive dynamic of joint mobility function (21,3% and 9,5%, accordingly).
– placebo Almag-01 device group there was noted the reduction of patients number with severe and moderate 1km walking parameter abnormalities (from 69,4% to 46,3%) and the increase of patient number with slight abnormalities according the same parameter (from 10,5% to 31,6%).
– the evident more number of patients with slight abnormalities or their absence according to “Short-distance walk” in Almag-01 device group as compared to placebo-device group (14,6% and 4,2% accordingly).
So the analysis of affected joint functional parameters evaluated according to International classifier and with a help of objective parameters ( joint size, flexion/extension angle) noted statistically evident differences in Almag-01 device and placebo-device groups. But it should be taken in account that treatment average time in groups ( Almag-01 device and placebo-device groups) was 13 and 10 days accordingly and didn`t allow to change joint`s functional characteristics greatly for such short period of time.
The effect of nonsteroidal anti-inflammatory medications and additional physio-procedures on joints characteristics and possibility of Almag-01 device effect overestimation have been studied.
Analysis of nonsteroidal anti-inflammatory medications application showed that the preparation of this group was prescribed 1,97 time more in placebo-device group as compared to Almag-01device group.
Analysis of different services as physiotherapy procedures application frequency showed that the last were prescribed 3,6 procedure more per patient in Almag-01 device group( 25,3 procedures per patient) than in placebo-device group ( 21,7 procedures per patient) .
Expenses analysis showed that in Almag-01 device group there was expended the sum of 7 648 rub per patient while in placebo-device group the sum was 9 604 rub.
« Expenses – efficiency” analysis showed that magneto therapy procedure with Almag-01 device was the effective strategy from the point of expenses according pain and discomfort related parameters of life quality severe and moderate abnormalities dynamic. So applying Almag-01 device to reduce life quality moderate and severe abnormalities in connection to pain and discomfort it was required to spend 13 417 rub. per patient that is 1,93 times less than with the application of placebo-device. ( 25 956 rub per patient to achieve to the same effect).
Examination restrictions are group incomparability ( according to average age, the quality of life affected joints functional characteristics ) and significant differences in medical treatment course in two groups ( frequency of both nonsteroidal anti-inflammatory medications and physiotherapeutic procedures administration in placebo-device group; the big frequency of medical procedures adminisration, including magnetotherapy in Almag-01 device group).
CONCLUSIONS
Carried out randomized, double – blind, placebo controllable examination of magnetotherapy clinico -economic efficiency with Almag-01device electro-magnetic exposure (frequency – 6,24 Hz, a magnetic field intensity -20 mTl ) in gonarthrosis treament identified its clinico-economic efficiency. Its influence on life quality characteristics in connection with pain and discomfort is the most evident one.
Strategy of traveling pulsed magnetic field introduction into medical process is an efficient one from a point of expenses while carrying the “expense – efficiency” analysis out according to life quality severe and moderate abnormalities dynamics criterion in connection with pain and discomfort ( “expenses – profit ” effect index is 13417 rub. per patient as compared with expenses equal to 25956 rub. for the achievement of the same effect per patient in placebo device group) .
It is required to carry our more extensive examination of administrated both physio-therapeutic procedures number and denomination and nonsteroidal anti-inflammatory medications to make magneto therapy effect on joints functional characteristics assessment.
Literature reference list
1.ОСТ «Clinical-economic study. General guidelines » (RF PH No. 163 of 27.05.02).
2.P. A. Vorobjev, M. V. Avksentjeva …. Clinical-economic analysis – М.:Njudiamed. – 2008.
3.K. A. Litkina , L.V. Sidorova., P. A. Vorobjev, M. V. Avksentjeva, V.V. Tsurko Patients suffering from osteoarthrosis life quality. Problems of standardization in public health services. 2006. – No.6. – С. 12-27.
4.V. N Amirdzhanova, G. M. Kojlubaeva // Sientific- practical rheumatology — 2003. — № 2. — С. 72—76.
5.Сизова Л. В. // Научно-практическая ревматология. — 2000. — № 2. — С. 38—42.
6.Anderson R. T., Aaronson N. K., Wilkin D. // Qual. Life Res. — 1993. — 2. — P. 369—395.
7.Bowling A. Measuring disease. A review of disease-specific quality of life measurement scales. — Philadelphia: Open University Press, 1996.
8.Kind P. // Quality of Life and Pharmaco-economics in Clinical Trials. 2th ed. / Ed. Spiker. — Philadelphia: Lippincott — Raven Publishers, 1996. — P. 191—201.
9.Laxafoss E, Jacobsen S, Gosvig KK, Sonne-Holm S. Case definitions of knee osteoarthritis in 4,151 unselected subjects: relevance for epidemiological studies : The Copenhagen Osteoarthritis Study. Skeletal Radiol. 2010 Jan 30. [Epub ahead of print]
10.Toivanen AT, Heliövaara M, Impivaara O, Arokoski JP, Knekt P, Lauren H, Kröger H. Obesity, physically demanding work and traumatic knee injury are major risk factors for knee osteoarthritis–a population-based study with a follow-up of 22 years. Rheumatology (Oxford). 2010 Feb;49(2):308-14.
11.Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33.
12.Roux CH, Saraux A, Mazieres B, Pouchot J, Morvan J, Fautrel B, Testa J,Fardellone P, Rat AC, Coste J, Guillemin F, Euller-Ziegler L; KHOALA Osteoarthritis Group. Screening for hip and knee osteoarthritis in the general population: predictive value of a questionnaire and prevalence estimates. Ann Rheum Dis. 2008 Oct;67(10):1406-11.
13.Gosvig KK, Jacobsen S, Sonne-Holm S, Palm H, Troelsen A. Prevalence of malformations of the hip joint and their relationship to sex, groin pain, and risk of osteoarthritis: a population-based survey. J Bone Joint Surg Am. 2010 May;92(5):1162-9.
14.Dagenais S, Garbedian S, Wai EK. Systematic review of the prevalence of radiographic primary hip osteoarthritis. Clin Orthop Relat Res. 2009 Mar;467(3):623-37.
15.Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7.
16.Bieleman HJ, Oosterveld FG, Oostveen JC, Reneman MF, Groothoff JW. Work participation and health status in early osteoarthritis of the hip and/or knee: a comparison between the Cohort Hip and Cohort Knee and the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2010 May;62(5):683-9.
Appendix 1
“ PHARMACOLOGY -ECONOMIC RESEARCH SOCIETY ”
INTER-REGIONAL PUBLIC ORGANIZATION
Examination card No.
Examination date _______________________________ ____________________
City/town__ ________________________________________________________
Medical prophylactic establishment_________________________________________________________________________________________________________________________________________________________________________________________________
PATIENT WITH OSTEOARTHRITIS
CLINICAL EXAMINATION CARD No.
DOCTOR ______________________________________________________
( full name )
DEVICE RANDOMIZATION TAKEN RESULTS :
АЛМАГ-01
PLACEBO
(check the required device )
THE FORT OF PATIENT CONSENT TO EXAMINATION PARTICIPATION
|
This is to certify my free-will consent to take part in “ Almag-01 clinical-economic examination for patients suffering from rheumatoid arthritis “ carried out by“ Pharmacology -Economic Research Society ” Inter- Regional Public Organization.
Hereby I prove my notification of the facts as follows : · the purpose of examination is to make magneto-therapy application (for rheumatoid arthritis treatment ) economic calculation · participation in examination does not cause any risk and side effect . · guarantee to terminate participation in examination any time I like · confidentiality of information is guaranteed by examination organizers and the attending physician. Patient (full name) Date Дата Signature
|
The date of first examination __________
Patient name _______________
Sex: male; female
Age ______________
Main clinical diagnosis ________________________________________________
____________________________________________________________________
Complication ________________________________________________________ ____________________________________________________________________
Concomitant diagnosis _________________________________________________ ____________________________________________________________________
MAGNETO-SENSITIVITY :
Low
Mean
High
The date of the patient next reception _____________________________________
Examination results____________________________________________________ ____________________________________________________________________________________________________________________________________________________________________________________________________________
ESTIMATION SCALES .
ORGANISM FUNCTION :
NO abnormalities ( no one, not available, little ,…) 0-4%
SLIGHT abnormalities (small, week ,..) 5-24%
MEAN abnormalities ( mean, significant ,..) 25-49%
SEVERE abnormalities (high-grade, intensive ,…) 50-95%
ABSOLUTE ABNORMALITIES (full,…) 96-100%
Joint mobility functions
-under examination : backbone, shoulder, elbow, wrist, hip, knee, mobility function, talocrural single or several joints , hands and feet little joints; general joints mobility; abnormalities as joints excessive mobility, joints, shoulders stiffness, arthritis.
-out of examination : joint stability, arbitrary functions control
| Function name | Evidence of functional abnormalities | ||||
| No abnormalities | Slight abnormalities | Mean abnor- malities | Severe abnormalities | Absolute
abnorm. |
|
| Several joints mobility.
More than one joints function volume and mobility freedom |
|||||
| Joints overall mobility Whole body function volume and mobility freedom | |||||
Joint stability functions
Joint integrity support function
-under examination: single and several joints stability function, joints general stability ; abnormalities as shoulder joint instability, joints or hip.
-out of examination : joints mobility functions .
| Function name | Functional abnormalities significance | ||||
| No abnormalities | Slight abnormalities | Mean abnor- malities | Severe abnormalities | Absolute
abnorm. |
|
| Several joints stability . Joints integrity support function | |||||
| Joints general stability Whole body joints integrity support function | |||||
Walking and movement
The movement over the surface on foot, step by step so that one foot touches the surface, for example, walking, walking ahead, walking back, walking aside
– under examination: short or long distance walk; walking over the different surfaces; walking around the obstacles .
– out of examination: body movement, movement by the ways different from walking .
| Function name | Functional abnormalities significance | ||||
| No abnormalities | Slight abnormalities | Mean abnor- malities | Severe abnormalities | Absolute
abnorm. |
|
| Short distance walking.
One km or less walking , for example, in rooms, corridors , house, or short distance walk outside. |
|||||
| Long distance walking.
Walking for the distance more than 1 km. , for example, from one part of the village or town to the other, between villages or any outside walking |
|||||
UNDESIRABLE FACTORS (EVENTS) EVALUATION ACCORDING TO NARANSHO SCALE (check the required answer )
1.Whether there were an earlier evident messages on this reaction. Yes – 1, No – 0, don`t know – 0.
2. Whether there was a reaction after suspected medicine introduction . Yes – 2, No – 1, don`t know – 0.
3. Whether there was any improvement of patient state after both medicine or specific antagonist introduction termination. Yes – 1, No – 0, don`t know – 0.
4.Whether there was any side reaction re-occurrence after medicine repeated introduction. Yes – 2, No – –1, don`t know – 0.
5. Whether there were any reasons (beside medicine) causing the reaction. Yes – –1, No- 0, don`t know – 0.
6. Whether there was re-occurrence of any reaction applying placebo device Yes – – 1, No – 1, don`t know – 0.
7. Whether there was medicine in the blood (or any other liquids) in the concentrations considered as a toxic ones? Yes – 1, No — 0, don`t know – 0.
8. Whether the reaction was more severe after increase of the dose and less severe after its decrease ? Yes – 1,No — 1, don`t know – 0.
9. Whether there was the same reaction of the patient to the same or similar medicine when the medicine was taken earlier. Yes-1,No-0, don`t know – 0.
10. Whether the side reaction had the evident prove. Yes – 1, No – 0, don`t know – 0.
When the points amount is 9 it is possible to speak about the definite relations , 5-8 — potential , 1 -4 — possible , 0 — doubtful
This questionnaire EQ-5D is filled in by the patient himself
Questionnaire EQ-5D
The purpose of this questionnaire is to study both patients and healthy people life quality
This questionnaire is aimed to reveal the attitude to your own health. It is presented in the form of your health state list. There are no right or wrong answers in relation to your health state, we are interested only in your personal opinion;.First of all we ask you to assess your state of health up to the present.
Below there is 5 questions in relation to your health state. Giving an answer you should check up one item.
Moving in space
Ø I have no problems with moving in space
Ø I have some problems with moving in space
Ø I am bedridden
Self-service
c I have no problem with self-service
c I have some problems with washing and dressing
c I can`t wash and dress myself
Daily routine
c I have no problems with daily routine to do (work, study, household activity , leisure)
c I have some problems with household daily routine
c I can`t do household daily routine
Pain and discomfort
c I don`t feel any pain and discomfort.
c I have the slight sensation of pain and discomfort.
c I suffer from pain and discomfort.
Anxiety and depression
· I don`t feel any sensation of anxiety and depression.
· I have the slight sensation of anxiety and depression.
· I have the sensation of high-grade anxiety and depression.
Your today health state as compared to those year ago :
· It is much better
· The same
· It becomes worse
In order to estimate you state of health there is a scale like thermometer according to which the best sate of health is estimated with 100 points and the worse one with 0.
Please mark your state of health on the thermometer according to your sensations
The date of examination______________________________________________
The name of the patient _______________________________________________
Sex: Мail Femail
Age (full years of age) ______________________________________________
|
EXAMINATION LABORATORY METHOD WITHIN 21 DAYS |
||||
| Examination type | Number per course of treatment | |||
| Blood clinical analysis | ||||
| Hemoglobin, leukocytes | ||||
| Bilirubin blood analysis | ||||
| Rothrombin blood analysis | ||||
| Blood glucose. | ||||
| AST,ALT blood analysis | ||||
| Kreatine blood analysis | ||||
| Urine blood analysis | ||||
| C-reactive protein level blood examination | ||||
| General protein blood analysis | ||||
| General protein and protein fraction blood analysis | ||||
| Coagulougram | ||||
| Blood electrolyte | ||||
| Group and Rhesus factor – blood factor | ||||
| Urine general analysis | ||||
| Others : | ||||
EXAMINATION INSTRUMENTAL METHOD WITHIN 21 DAYS
| Examination type | Number per course of treatment |
| Heartbeats rate measurement | |
| Pulse examination | |
| Peripheral arterial pressure measurement артериях | |
| Others: | |
EXPERTS CONSULTATIONS WITHIN 21 DAYS
| Expert name | Number per course of treatment |
PRESCRIBED PHARMACOTHERAPY ( the 21first examination day )
( List of all prescribed medication including medical solutions used for dissolution)
| Medication name | Dose
Per procedure |
Dose
Per day |
Number per day | Proce-dure means | Course of treat-ment |
| THERAPY AND PATIENT CARE PROCEDURES | Number per course of treatment |
THERAPY AFTEREFFECTS
SIDE EFFECTS ,UNDESIRABLE PHENOMENON .
1.Whether there were any side, undesirable effect ?
Yes No It is not known
If “YES” answer is marked , note the following: name, date, severity ( light, mean, strong), the cause of side effect development , taken measures
1 __________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
2__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
3__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
4__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
5__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
The date of form filling -____________________________________________________
Expert signature _______________________________________
Has Undergone in-patient treatment : yes no ( treatment duration) ______________
Temporary invalidity : ( duration, dates )__________________________
Remarks and additions ________________________________________________________________________________________________________________________________________________________________