"CUNSTCAMERA (CABINET OF CURIOSITIES) OF CLINICAL SCIENCE"

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Exhibit №2 Results of independent metrological testing of programs for calculation of the heart rate variability parameters
1.Pre-conditions for the discussion of theme The method of estimation of separate descriptions of the functional state of organism from data of different indexes of cardiac rhythm variability (HRV) began to be utillized in scientific laboratories from 60th of past century. Due to explosion growth of information technologies this method purchased large popularity in scientific researches in modern physiology and clinical medicine. There are number of factors which determine the real actuality of problem. In spite of large enough period of study of HRV, this method can not be named a traditional diagnostic method. High-quality investigation of HRV requires the collaboration of mathematicians, programmers, developers of electronic biomedical apparatus, physiologists etc. Unfortunately, it is necessary to acknowledge that more frequent than all in clinical researches this method is utillized as a mysterious decoration of advanced study. It has a halo of pseudo-scientificness. So, there are a lot of unconscientious scientists that utillize this method in dissertation research, including wherein from it it is not the use. But it is a separate theme. In this case we want to show the depth of more simple, but non-obvious conflict existence of which discredits potentially the valuable for clinical science method of diagnnosticsAuthor of these lines studies the method of HRV more than 20 years. The results of these researches are expounded in the proper section of author site http://www.vkp.dsip.net (on Rus) In 1995 our method (program) was certificated by Ukraine Ministry of Health. We also have an original device for providing HRV monitoring. Every step in development of own method of HRV-analysis found out the great number of problems which remain out of the field of attention of inexperienced researcher. From the moment of origin of international standard of HRV (1996), new devices began to appear for the analysis of HRV. An acquaintance with these devices and comparison of results of different researches with the results of own researches created the steady feeling, that processing of the same basic data on different devices gives different digital HRV-values! The most actual and contradictory problem is an algorithm of calculation of spectral descriptions of HRV. As a researcher I sharply needed in expert estimation of own software product of calculation of spectral HRV-parameters, which was utillized in my doctoral dissertation. This circumstance created steady motivation to estimate the degree of own incompetence. I began to search the proper expert. During I-st of international conference "Analysis of heart rate variability in clinical practice" (Kyiv, 24-25.11.2002) I appealed to one of researchers of this problem to Yevgen A. Palamarchuk, associate professor of department of economic cybernetics of the Vinnytsya state agrarian university with a request to take part in the project of metrology certification of the HRV-programs. Yevgen A. Palamarchuk vividly answered and we began to work. On round of international symposium table on HRV (Kharkiv, 2003) we marked actuality of problem. We also marked to the absence of repetition of HRV-results from devices of different producers. We proposed the program of actions for development the proper system metrology attestation. Yevgen A. Palamarchuk read a lecture in which grounded the using of harmonic standard sequences of RR-intervals for the leadthrough of metrology attestation. The proper program of generator of standard sequences of RR-intervals was shown. It allowed to get RR-intervals with the set spectral descriptions. These materials were published at http://www.pallar.com.ua (on Ukr) . It is here necessary to notice that along with us (K.P.Vorobyov and Y.A.Palamarchuk) there were members of scientific committee. Among them - about 40 scientists and producers of electronic medical devices from different countries (Ukraine, Russia, Byelorussia, Italy, Belgium), including patriarch of HRV methodics R.M.Bayevsky, who also took part in that round table. One of the leaders of scientific committee of this symposium, professor O.Y.Mayorov in the appearance offered to us to continue this work. That we considered as a commission of scientific committee of international quorum to create the system of metrology attestation of the programs of calculation of indexes of HRV. In 2004 in the magazine "Clinical informatics and telemedicine" published our problem article in which by using the example of verification the Russian program with opened import of RR-intervals (ORTO Science,v 4.9.61, Izhevsk) we showed the depth of methodical problem (http://www.vkp.dsip.net/Papers/HRV_imitat04.htm) (on Ukr). In 2005 at the quorum of specialists in Kharkiv (23-25.05.2005) we proposed the project of metrology attestation mechanism for programs of calculation HRV-parameters. We also offered for interested producers of the proper software products to pass such independent attestation (http://www.vkp.dsip.net/papers/HRV_Ch_05.html).(on Rus) Unfortunately, none of that Ukraine producers did not offer to us his programs for testing. Only on the last of peat-time of this work we found out the personal interest of original "Cardiospectrum" (Solvaig, Kyiv) programmer and who hoped to improve of metrology parameters of this program. This situation reflects the depth of problems in a medical instrument-making and in domestic science.. It is possible to understand producers of HRV-devicies and systems. They are interested only in an income. But it is a short-sighted position which characterizes immaturity of market of domestic electromedical instrument-making also. The right way is when the questions of metrology attestation are the field of activity of proper public organs, but not two free researchers. At least the proper state structures could charge us this work and to pay. But it did not happen. The second part of problem characterizes the level of scientific ethics and touches scientists, which understand (an association is informed) that they work on devices which give out them information, with exactness of indefinite level. This situation is the reflection of general crisis of moral and ethics in society. But scientists, according to the stage in society, must be the ethics standard. Moreover, on this stage we ran into the attempt of officials from scientists to block the acquaintance of specialists with the results of our research. It causes bewilderment only, because it is simply impossible in our age of "Third of wave" by E.Toffler (information technologies). In mature society in a similar situation of such official-scientist loses status of scientist forever. But we hope on prudence and evolutional processes. In connection with an arising up situation we created a hardware-program complex which allows to execute testing of the proper devices and programs without participation of producers, that regardless of their desire to pass metrology attestation.. This work demanded a lot of forces, but research results were surpassed by all of our expectations.

CUNSTCAMERA (CABINET OF CURIOSITIES) OF CLINICAL SCIENCE

Exhibit №2
Results of independent metrological testing of programs for calculation of the heart rate variability parameters

1.Pre-conditions for the discussion of theme
The method of estimation of separate descriptions of the functional state of organism from data of different indexes of cardiac rhythm variability (HRV) began to be utillized in scientific laboratories from 60th of past century. Due to explosion growth of information technologies this method purchased large popularity in scientific researches in modern physiology and clinical medicine. There are number of factors which determine the real actuality of problem.
In spite of large enough period of study of HRV, this method can not be named a traditional diagnostic method. High-quality investigation of HRV requires the collaboration of mathematicians, programmers, developers of electronic biomedical apparatus, physiologists etc. Unfortunately, it is necessary to acknowledge that more frequent than all in clinical researches this method is utillized as a mysterious decoration of advanced study. It has a halo of pseudo-scientificness. So, there are a lot of unconscientious scientists that utillize this method in dissertation research, including wherein from it it is not the use.
But it is a separate theme.
In this case we want to show the depth of more simple, but non-obvious conflict existence of which discredits potentially the valuable for clinical science method of diagnnosticsAuthor of these lines studies the method of HRV more than 20 years. The results of these researches are expounded in the proper section of author site http://www.vkp.dsip.net (on Rus) In 1995 our method (program) was certificated by Ukraine Ministry of Health. We also have an original device for providing HRV monitoring. Every step in development of own method of HRV-analysis found out the great number of problems which remain out of the field of attention of inexperienced researcher.

From the moment of origin of international standard of HRV (1996), new devices began to appear for the analysis of HRV. An acquaintance with these devices and comparison of results of different researches with the results of own researches created the steady feeling, that processing of the same basic data on different devices gives different digital HRV-values! The most actual and contradictory problem is an algorithm of calculation of spectral descriptions of HRV.

As a researcher I sharply needed in expert estimation of own software product of calculation of spectral HRV-parameters, which was utillized in my doctoral dissertation. This circumstance created steady motivation to estimate the degree of own incompetence. I began to search the proper expert.
During I-st of international conference "Analysis of heart rate variability in clinical practice" (Kyiv, 24-25.11.2002) I appealed to one of researchers of this problem to Yevgen A. Palamarchuk, associate professor of department of economic cybernetics of the Vinnytsya state agrarian university with a request to take part in the project of metrology certification of the HRV-programs. Yevgen A. Palamarchuk vividly answered and we began to work.

On round of international symposium table on HRV (Kharkiv, 2003) we marked actuality of problem. We also marked to the absence of repetition of HRV-results from devices of different producers. We proposed the program of actions for development the proper system metrology attestation. Yevgen A. Palamarchuk read a lecture in which grounded the using of harmonic standard sequences of RR-intervals for the leadthrough of metrology attestation. The proper program of generator of standard sequences of RR-intervals was shown. It allowed to get RR-intervals with the set spectral descriptions. These materials were published at http://www.pallar.com.ua (on Ukr) .
It is here necessary to notice that along with us (K.P.Vorobyov and Y.A.Palamarchuk) there were members of scientific committee. Among them - about 40 scientists and producers of electronic medical devices from different countries (Ukraine, Russia, Byelorussia, Italy, Belgium), including patriarch of HRV methodics R.M.Bayevsky, who also took part in that round table.

One of the leaders of scientific committee of this symposium, professor O.Y.Mayorov in the appearance offered to us to continue this work. That we considered as a commission of scientific committee of international quorum to create the system of metrology attestation of the programs of calculation of indexes of HRV. In 2004 in the magazine "Clinical informatics and telemedicine" published our problem article in which by using the example of verification the Russian program with opened import of RR-intervals (ORTO Science,v 4.9.61, Izhevsk) we showed the depth of methodical problem (http://www.vkp.dsip.net/Papers/HRV_imitat04.htm) (on Ukr).
In 2005 at the quorum of specialists in Kharkiv (23-25.05.2005) we proposed the project of metrology attestation mechanism for programs of calculation HRV-parameters. We also offered for interested producers of the proper software products to pass such independent attestation (http://www.vkp.dsip.net/papers/HRV_Ch_05.html).(on Rus)
Unfortunately, none of that Ukraine producers did not offer to us his programs for testing.
Only on the last of peat-time of this work we found out the personal interest of original "Cardiospectrum" (Solvaig, Kyiv) programmer and who hoped to improve of metrology parameters of this program.

This situation reflects the depth of problems in a medical instrument-making and in domestic science..

It is possible to understand producers of HRV-devicies and systems. They are interested only in an income. But it is a short-sighted position which characterizes immaturity of market of domestic electromedical instrument-making also. The right way is when the questions of metrology attestation are the field of activity of proper public organs, but not two free researchers. At least the proper state structures could charge us this work and to pay. But it did not happen.
The second part of problem characterizes the level of scientific ethics and touches scientists, which understand (an association is informed) that they work on devices which give out them information, with exactness of indefinite level. This situation is the reflection of general crisis of moral and ethics in society. But scientists, according to the stage in society, must be the ethics standard.
Moreover, on this stage we ran into the attempt of officials from scientists to block the acquaintance of specialists with the results of our research. It causes bewilderment only, because it is simply impossible in our age of "Third of wave" by E.Toffler (information technologies). In mature society in a similar situation of such official-scientist loses status of scientist forever.
But we hope on prudence and evolutional processes.

In connection with an arising up situation we created a hardware-program complex which allows to execute testing of the proper devices and programs without participation of producers, that regardless of their desire to pass metrology attestation..
This work demanded a lot of forces, but research results were surpassed by all of our expectations.

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