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S. V. Masiuk, A. G. Kukush, S. V. Shklyar, M. I. Chepurny, I. A. Likhtarov†
Radiation Risk Estimation
De Gruyter Series in
Mathematics and Life Sciences

|
Edited by
Alexandra V. Antoniouk, Kyiv, Ukraine
Roderick V. Nicolas Melnik, Waterloo, Ontario, Canada

Volume 5
S. V. Masiuk, A. G. Kukush, S. V. Shklyar,
M. I. Chepurny, I. A. Likhtarov†

Radiation Risk
Estimation

|
Based on Measurement Error Models
Mathematics Subject Classification 2010
Primary: 62P10; Secondary: 62J12

Authors
Dr. Sergii Masiuk Mykola Chepurny
Ukrainian Radiation Protection Institute National Research Center for Radiation Medicine
National Research Center for Radiation Medicine National Academy of Medical Sciences of
National Academy of Medical Sciences of Ukraine
Ukraine Melnykova Street, 53
Melnykova Street, 53 Kiev 04050, Ukraine
Kiev 04050, Ukraine [email protected]
[email protected]
Prof. Dr. Illya Likhtarov†
Prof. Dr. Alexander Kukush Ukrainian Radiation Protection Institute
Taras Shevchenko National University of Kyiv National Research Center for Radiation Medicine
Faculty of Mechanics and Mathematics National Academy of Medical Sciences of
Volodymyrska Street, 64 Ukraine
Kiev 01033, Ukraine Deceased on January 14, 2017
[email protected]

Dr. Sergiy Shklyar

Taras Shevchenko National University
Faculty of Mechanics and Mathematics
Volodymyrska Street, 64
Kiev 01033, Ukraine
[email protected]

ISBN 978-3-11-044180-2
e-ISBN (PDF) 978-3-11-043366-1
e-ISBN (EPUB) 978-3-11-043347-0
Set-ISBN 978-3-11-043367-8
ISSN 2195-5530

Library of Congress Cataloging-in-Publication Data

A CIP catalog record for this book has been applied for at the Library of Congress.

Bibliographic information published by the Deutsche Nationalbibliothek

The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie;
detailed bibliographic data are available on the Internet at http://dnb.dnb.de.

© 2017 Walter de Gruyter GmbH, Berlin/Boston

Typesetting: le-tex publishing services GmbH, Leipzig
Printing and binding: CPI books GmbH, Leck
♾ Printed on acid-free paper
Printed in Germany

www.degruyter.com
List of authors
Masiuk Sergii
PhD, Head, Laboratory of Statistical Methods, Ukrainian Radiation Protection Institute, Kyiv,
Ukraine; Head, Laboratory of Radiological Protection, State Institution “National Research Center for
Radiation Medicine of the National Academy of Medical Sciences of Ukraine”, Kyiv, Ukraine.

Kukush Alexander
Doctor of Sciences in Physics and Mathematics, Professor, Department of Mathematical Analysis,
Taras Shevchenko National University of Kyiv, Kyiv, Ukraine.

Shklyar Sergiy
PhD, Senior Scientist, Department of Probability Theory, Statistics and Actuarial Mathematics, Taras
Shevchenko National University of Kyiv, Kyiv, Ukraine.

Chepurny Mykola
Scientist, Laboratory of Radiological Protection, State Institution “National Research Center for
Radiation Medicine of the National Academy of Medical Sciences of Ukraine”, Kyiv, Ukraine.

Likhtarov Illya†
Doctor of Sciences in Physics and Mathematics, Professor, Head, Department of Dosimetry and
Radiation Hygiene, State Institute “National Research Center for Radiation Medicine of the National
Academy of Medical Sciences of Ukraine”, Kyiv, Ukraine; Principal Director, Ukrainian Radiation
Protection Institute, Kyiv, Ukraine.
|
Dedicated to the Heavenly Hundred and all those who gave their lives for Ukraine
Editor’s Foreword
Radiation risks and tools for their estimation relate to the most fundamental concepts
and methods used in designing a safe system of interaction between humans and nu-
clear radiation technologies. This holds true for normal operation of civilian and mil-
itary facilities as well as for emergency situations (Chornobyl, Fukushima, Kyshtym,
etc.) and extraordinary events (atomic bombings of Hiroshima and Nagasaki). As a
matter of fact, without knowing the quantitative value of radiation risk it is impossible
to construct an acceptable system of safety standards for the personnel of industrial
facilities employing nuclear radiation technologies and for the population involved to
some extent in contact with sources of ionizing radiation.
Quantitative estimation of radiation risks has a long and productive history that
undoubtedly deserves a separate monograph. Here, it is worth to dwell on a rather
specific feature of the risk estimates that we have available and widely use in mod-
ern international and national documents regulating acceptable levels of radiation
for an individual and for the human population as a whole. This peculiarity consists
in that when analyzing the results of numerous radio-epidemiological studies – the
main purpose of which is precisely to determine the radiation risk value – considera-
tion has always been given to a stochastic link between the effects (i.e. the distribution
of various radiation-induced pathologies), on the one hand, and the “exact” values of
the exposure doses, on the other hand. That is, only the stochastic nature of the effects
was taken into account, while ignoring the obvious fact that the “exact” dose values
are unknown to us and that they are substituted for by a point statistical parameter
(e.g. expectation) of the true dose distribution. It is clear that this results in disregard
for errors inevitably arising in the instrumental measurements and in the computa-
tions of doses and their components. This particular approach to risk estimation is
implemented in the best-known and popular interpretive software package EPICURE.
Below, this approach as well as the estimates themselves will be referred to as “naive.”
As regards risk analysis methods they usually involve mathematical tools that
were quite comprehensively developed already in the fundamental works of David
Cox, where the naive approach was also employed. Further developments, per se,
merely refined the Cox models for various versions of epidemiological studies (ecolog-
ical, cohort, “case-control” ones). Again, however, their analysis of results was always
based on the naive approach; therefore, by definition, the resulting risk estimates were
also naive.
It is perfectly obvious that under the naive approach, with its disregard for expo-
sure dose errors, the obtained risk estimates can be distorted; the extent of the distor-
tions, however, is a priori unclear. Naturally, the consequences of the naive approach
automatically apply to the bounds of permissible doses and their derivatives. It should
be noted that this problem did not go unnoticed; and so in the past twenty years pub-
lications began to appear in which attempts were made to take into account the dose
X | Editor’s Foreword

uncertainty in the risk analysis. Unfortunately, the problem has not been completely
solved so far.
These are some of the difficulties that are bound to arise once we try to substitute
dose distributions for their point estimates in the risk analysis procedure.
– When determining dose estimates, one inevitably has to use the results of different
types of measurements, each type involving its own classical or Berkson errors;
and so, special statistical procedures need to be developed for obtaining the final
dose as a result of an overlap of individual distributions. In this case, the dose
distributions are formed due to errors of two types: classical and Berkson. There-
fore, proper risk analysis requires separate estimation of the contributions of the
classical and Berkson errors to the total dose error.
– At present, more or less established methods for risk estimation in the presence of
a mixture of classical and Berkson errors in the exposure doses are still unavail-
able.

It is clear that the above problems cannot be addressed by using the results of field
epidemiological studies with different types of dose error, as there are no such field
studies and none can be conducted in principle. The only way is to widely use the
so-called stochastic experiment which involves simulation modeling.
Since this concerns the estimation of not just risks, but of risks associated with ex-
posure, all the above-stated problems can be resolved only through the joint efforts of
dosimetry physicists and mathematical statisticians. That is why the team of authors
of this monograph is made up of experts in the aforementioned fields of science. At the
same time, the material in this book is radically focused on mathematical problems
of estimation of radiation risks in the presence of errors in exposure doses, while the
error level estimation methods (which definitely deserve a separate monograph) are
presented in a shorthand form.
Finally, it should be emphasized that, based on the results obtained in the book, a
software product similar to the above-mentioned EPICURE is worth creating, provided
that it includes risk estimation procedures having regard for dose errors. In that case,
experts engaged in epidemiological data processing would have a convenient tool for
obtaining not only naive risk estimates, but also estimates taking into account the
classical and Berkson errors in covariate.
The material and results presented in this monograph will be useful to epidemi-
ologists, dosimetrists, experts engaged in statistical processing of data or working in
the field of modern methods of Mathematical Statistics, as well as to undergraduate
and graduate university students.

Doctor of Sciences in Physics and Mathematics, Professor I. A. Likhtarov†

Preface
As a result of the Chornobyl accident in 1986, most of the territories of Ukraine, Be-
larus, and Russia were radio-contaminated and the residents of these areas underwent
radioactive exposure. The most affected by the radiation was the thyroid, due to the
intake of iodine radioisotopes, primarily 131 I (Likhtarov et al., 1993a, 2005, 2006b).
As early as 5–6 years after the accident, a sharp increase in thyroid cancer inci-
dence among children and adolescents residing in areas with a rather high radiation
exposure of this organ was revealed (Likhtarov et al., 1995a; Buglova et al., 1996; Ja-
cob et al., 2006). In fact, the increase in thyroid cancer incidence among children and
adolescents due to internal thyroid irradiation resulting from Chornobyl’s radioac-
tive emissions was the main statistically significant long-term effect of the Chornobyl
accident. Not surprisingly, this phenomenon generated great interest among radio-
epidemiologists around the world and led to a series of epidemiological studies in
Ukraine, Belarus, and Russia (Likhterev et al., 2006a; Tronko et al., 2006; Kopecky et
al., 2006; Zablotska et al., 2011). The exceptional interest in this problem is also ac-
counted for by the presence of sufficiently complete and reliable information about
the risk of radiation-induced thyroid cancer in case of exposure of this organ to exter-
nal radiation (Ron et al., 1995). As to internal exposure, data on the related radiation
risk value are extremely scarce (Likhterev et al., 2006a; Tronko et al., 2006; Kopecky
et al., 2006; Zablotska et al., 2011).
When interpreting the results of the most radio-epidemiological studies described
in the above-cited papers, a series of general assumptions were made, primarily con-
cerning the estimation of the radiation factor, namely the exposure dose:
– It was noted that the exposure dose estimates contain errors which are usually
significant.
– Even in the case where the variances of dose errors were determined, the analyti-
cal tools of risk analysis ignored this fact.
– In the dosimetric support for radio-epidemiological studies, instrumental mea-
surements of any types were practically always absent.

Thus, the interpretation of the most radio-epidemiological studies was based on risk
estimation methods failing to take into account the presence of errors in the exposure
doses. One of the consequences of the assumption about the absence of errors in the
doses is a bias of the risk coefficient estimates and a distortion of the form of the “dose–
effect” curve. Note that such distortions result not only from systematic errors in dose
estimates, which is obvious, but also from random errors as well.
It is known that a measured or estimated dose is inevitably accompanied by errors
of the classical or Berkson type, or by a mixture of them (Lyon et al., 2006; Li et al.,
2007; Kukush et al., 2011; Mallick et al., 2002; Masuk et al., 2016). And at the same time,
there is still no final conclusion as to the impact of a classical, Berkson, or mixed error
XII | Preface

in dose estimates on the end result of risk analysis, which is usually expressed in terms
of relative (ERR) or absolute (EAR) risk (Health Risks from Exposure to Low Levels of
Ionizing radiation, 2006).
A prominent example of the importance and urgency of this problem is the inter-
pretation of the results of long-term radio-epidemiological studies of a cohort of chil-
dren with thyroid exposure caused by the accident at the Chornobyl nuclear power
plant (Jacob et al., 2006; Likhtarov et al., 2006a; Tronko et al., 2006; Zablotska et al.,
2011). It is vital to note that the incidence of thyroid cancer in this cohort were de-
termined quite accurately. Also, there were obtained not only determined (i.e., point)
estimates, but stochastic (i.e., interval) dose estimates as well (Likhtarov et al., 2005,
2006b). However, no more or less acceptable mathematically reasonable computa-
tional procedure for combining two-dimensional error in dose and in effect within a
unified procedure of risk analysis is available at present. EPICURE, the most popular
software package in radio-epidemiology (Preston et al., 1993), operates upon deter-
mined dose values and is not adapted to account for any uncertainty of the input data.
This book is devoted to the problem of estimation of the radiation risk as a result of
the thyroid exposure by radioactive iodine. The focus is primarily on the binary model
of disease incidence in which the odds function is linear in exposure dose. The thyroid
exposure dose is not measured directly by a device; the estimated dose is based on
primary individual and environmental data, the model of atmospheric radioactivity
transfer, the biokinetic model of radioiodine transport, individualized thyroid masses,
and lastly, data from direct individual radioiodine measurements of the thyroid made
in May and June, 1986. As a result, the final estimates of exposure doses contain both
classical and Berkson errors. The mixture of measurement errors of different types
makes risk estimation quite a hard task to accomplish. The main goal of the book is to
develop modern methods of risk analysis that would allow taking into consideration
such uncertainties in exposure doses.
This book describes known methods of risk estimation in the binary model of dis-
ease incidence in the presence of dose errors: maximum likelihood, regression calibra-
tion, and also develops original estimation methods for this model, namely, the cor-
rected score method and SIMEX (simulation–extrapolation method). The efficiency of
the methods was tested by a stochastic experiment based on the results of radio-epi-
demiological studies of thyroid cancer incidence rate after the Chornobyl accident.
The essence of the experiment is as follows: the real thyroid doses were contaminated
with generated measurement errors, and also thyroid cancer cases were generated
based on the binary model of disease incidence with realistic risk coefficients. After
that, radiation risk estimation was performed in the presence of errors in exposure
doses. Such a risk analysis requires a deep study of observation models with errors
in covariates which conceptually are not reduced to ordinary regression models and
are characterized by most complicated parameter estimation. Such models are widely
used in various fields of science, particularly in epidemiology, meteorology, econo-
metrics, signal processing, and identification of dynamic systems. Recently, a series
 Preface | XIII

of fundamental papers devoted to this subject matter was published. Thus, the books
by Schneeweiss and Mittag (1986) and Fuller (1987) study linear models, both scalar
and vector ones; the manual by Cheng and Van Ness (1999) investigates the linear
and polynomial models; the book by Wansbeek and Meijer (2000) discloses the use
of linear and quadratic models in econometrics; finally, both editions of the book by
Carroll et al. (1995, 2006) describe various nonlinear models and their applications in
epidemiology.
This book comprises two parts, a list of references and appednices. The first part
of the book (Chapters 1–4) is based on a special course “Regression Measurement Er-
ror Models” that one of the authors has been teaching for a long time at the Mechanics
and Mathematics Faculty of Taras Shevchenko National University of Kyiv. The second
part (Chapters 5–7) contains the results of long-term studies performed at the Depart-
ment of Dosimetry and Radiation Hygiene of the Institute of Radiation Hygiene and
Epidemiology of the National Research Center for Radiation Medicine of the National
Academy of Medical Sciences of Ukraine. Chapter 1 provides a general overview of
regression errors-in-variables models and a comparison of the main methods for esti-
mating regression parameters. Chapter 2 presents the mostly used linear model with
the classical error, Chapter 3 analyzes the polynomial regression model, and Chapter 4
studies other popular nonlinear models, including the logistic one. Chapter 5 makes
an overview of risk models implemented in the software package EPICURE. Chapter 6
deals directly with radiation risk estimation in the binary model with linear risk in the
presence of measurement errors in thyroid doses. It analyzes in detail combined mul-
tiplicative errors in exposure doses as a mixture of the classical and Berkson errors.
Finally, Chapter 7 undertakes a thorough analysis of procedures for thyroid dose esti-
mation and considers a more realistic model for errors in doses, namely, a mixture of
the classical additive and the multiplicative Berkson errors. The four appendices con-
tain the mathematical foundations for the proposed estimation methods. In particu-
lar, Appendix A outlines with mathematical rigor the elements of the theory of unbi-
ased estimating equations, including the conditions for the existence and uniqueness
of a solution, which defines the parameter estimator, and asymptotic properties of the
estimators.
Knowledge of the basics of calculus and probability theory as presented in the
standard obligatory courses (Burkill, 1962; Kartashov, 2007) is sufficient to under-
stand the material. It is desirable to know the Lebesgue integral theory (Halmos,
2013), although utilizing conventional mathematical formalism when calculating
expectations is enough to comprehend most of the contents.
The book will be useful to experts in probability theory, mathematical and applied
statistics, specialists in biomedical data processing, epidemiologists, dosimetrists,
and university students enrolled in specialties, “statistics,” “applied statistics,” or
“mathematics”.
The authors express their sincere gratitude to Doctor of Technical Sciences Leonila
Kovgan for comprehensive support and assistance in writing this book.
In memoriam
Illya Likhtarov (1935–2017)
Prof. Dr. Illya A. Likhtarov, an outstanding Ukrainian biophysicist, an expert in radia-
tion dosimetry, radiological protection and risk analysis, and a scientist of world level,
passed away suddenly and unexpectedly on January 14, 2017.
Illya Likhtarov was born on February 1, 1935 in the town of Pryluky in Cherni-
hiv Oblast of Ukraine. He spent his childhood in Kyiv, which became his lifelong
hometown. He started his carrier in 1960 with the radiology group of Kyiv Regional
Sanitary–Epidemiological Station. In 1962 he graduated with honors from the All-
Union Correspondence Polytechnic Institute in Moscow as an engineer-physicist.
In 1964, I. Likhtarov enrolled in graduate school at the Leningrad Institute of Ra-
diation Hygiene (IRH). Illya’s early charge was experimental and theoretical work on
the safety of radioactive iodine. This included studies in animals and in human volun-
teers, the development of a model of iodine metabolism in the body, the application
of protective agents of stable iodine, and the radiobiological effect of radioiodine in
the thyroid gland. Upon successful completion of this work in 1968, I. Likhtarov re-
ceived his Ph.D. degree.
From 1966 to 1986 Dr. Likhtarov led the Laboratory of Radiation Biophysics within
the IRH responsible for studying radionuclide metabolism and dosimetry of internal
human exposure. Under his leadership studies were conducted on the metabolism
of tritium, iodine, strontium, calcium, plutonium and other radionuclides in hu-
mans and animals, and mathematical models and methods for calculation of internal
doses were developed. Radiation safety standards were developed and implemented
for workers and the public. In 1976, Dr. Likhtarov obtained the degree of Doctor of
Sciences with a specialty in Biophysics.
Immediately after the Chernobyl accident on April 26, 1986 Dr. Likhtarov returned
to Ukraine, where he was an expert advisor to the Ukrainian Minister of Health. He su-
pervised the work under emergency conditions of numerous radiation measurements,
assessing current and future doses of the populations of the affected areas, and in the
development and implementation of protective measures.
In October 1986, Illya created and headed the Department of Dosimetry and Ra-
diation Hygiene of the newly established All-Union Scientific Center for Radiation
Medicine (now the National Research Center for Radiation Medicine of Ukraine). The
Department became the base of the prolific Ukrainian scientific school of dosimetry
and radiological protection, which has been functioning for over 30 years. As a part
of his legacy, Dr. Likhtarov trained many young professionals in this field.
In the aftermath of the Chernobyl accident Illya Likhtarov and his team were faced
with the task of large-scale assessment of the radiation situation in more than 2,200
towns that were home to more than 3.5 million people. This task was complicated
due to a variety of environmental and social conditions. Under his guidance numer-
XVI | In memoriam Illya Likhtarov (1935–2017)

ous measurements of cesium and strontium radionuclides in the body of citizens of

Ukraine were made, and a set of eco-dosimetric models was developed. Appropriate
measures for radiation protection of the population and rehabilitation of Ukrainian
territories were carried out. Dr. Likhtarov’s team also developed and implemented a
system of thyroid dose reconstruction of the entire population of Ukraine.
In 1995 Dr. Likhtarov and his co-workers founded the Ukrainian Radiation Protec-
tion Institute (RPI). The RPI has developed into the Ukrainian center of expertise for
radiation protection and dosimetry: Core regulations have been drafted and support
has been provided to the national authorities and industries. During the last 15 years,
the RPI has been providing the occupational safety and internal dosimetry services
for the international project for the erection of the Chernobyl’s New Safe Confinement.
Professor Likhtarov’s team implemented an unprecedented large-scale program of in-
dividual monitoring of internal exposure, which is focuses on the intake of transuranic
elements and covers more than 17,000 workers.
In the early 1990s, the incidence rate of thyroid cancer increased in children re-
siding in the affected areas of Ukraine. Initial analysis showed significant correlation
between the thyroid dose caused by ingestion of radioiodine and the cancer incidence
rate. The results were published in 1995 in Nature and attracted the interest of re-
searchers from many countries. In the mid-1990s, a cohort of about 13,000 children (as
of 1986) was formed for a long-term Ukrainian–US epidemiological study of radiogenic
thyroid cancer. The dosimetry team led by Dr. Likhtarov created an original model for
dose assessment that considers individual behavior of subjects and the environmen-
tal characteristics in places of their residence. At the moment when point estimates
of doses were obtained, it became clear that ignoring errors in exposure doses causes
essential underestimation of radiation risks, and therefore, underestimation of harm-
ful effect of ionizing exposure on human health. That is why Dr. Likhtarov organized
a working group on elaboration of methods for radiation risk estimation, which take
into account dose uncertainties. The activity of the group resulted in this monograph,
which shows the way how to estimate correctly the risk of the radiation incidence rate
of thyroid cancer in Ukraine after the Chornobyl accident.
In recognition of Dr. Likhtarov’s scientific achievements, he was elected a member
of the USSR National Radiological Protection Commission in 1978. Since 1992, he has
headed the Commission on Radiation Standards of Ukraine that developed and im-
plemented into practice basic national regulatory documents. In 1993 he was elected
to Committee 2 (Dosimetry) of the International Commission of Radiation Protection
(ICRP), where he worked successfully until 2005. Since 2002 he was also a member of
the IAEA Radiation Safety Standards Committee (RASSC).
Dr. Likhtarov carried out extensive international cooperation with specialists from
the USA, Europe and Japan since the Soviet times and afterwards. He participated in
international congresses and conferences, where his papers and participation in dis-
cussions invariably aroused keen interest of the audience.
 In memoriam Illya Likhtarov (1935–2017) | XVII

The scientific heritage of Dr. Likhtarov includes more than 600 scientific papers;
among them are articles in prestigious journals, monographs, and documents of the
ICRP, UNSCEAR, WHO and IAEA. Professor Likhtarov is included in the list of the 50
most cited scientists of Ukraine. Under his guidance, 25 students have earned Ph.D.
and 10 have earned Doctor of Science degrees.
Illya Likhtarov is survived by his wife Lionella Kovgan, sons Mikhail and Dmitry,
step daughter Tamila Kovgan, six grandchildren, and his sister Elena. He was pre-
ceded in death by his parents, twin sister Rosa, and his first wife Tamara Likhtarova.
Contents
Editor’s Foreword | IX

Preface | XI

In memoriam Illya Likhtarov (1935–2017) | XV

List of symbols, abbreviations, units, and terms | XXV

Part I Estimation in regression models with errors in covariates

1 Measurement error models | 3

1.1 Structural and functional models, linear, and nonlinear models | 5
1.2 Classical measurement error and Berkson error | 7
1.3 Explicit and implicit models | 9
1.4 Estimation methods | 10
1.4.1 Naive estimators | 10
1.4.2 Maximum likelihood estimator (MLE) | 13
1.4.3 Quasi-likelihood estimator (QLE) | 15
1.4.4 Corrected score (CS) method | 22
1.4.5 Regression calibration (RC) | 24
1.4.6 SIMEX estimator | 25
1.4.7 Comparison of various estimators in models with the classical
error | 30

2 Linear models with classical error | 31

2.1 Inconsistency of the naive estimator: the attenuation effect | 32
2.2 Prediction problem | 35
2.3 The linear model is not identifiable | 37
2.4 The model with known error variance | 40
2.4.1 The adjusted naive estimator of the slope | 40
2.4.2 The corrected score estimator of regression parameters | 41
2.4.3 Maximum likelihood estimator of all the parameters | 42
2.4.4 Asymptotic normality of the estimator for the slope | 44
2.4.5 Bias of the naive estimator and nonexistence of expectation of ALS
estimator | 48
2.4.6 The adjusted least squares estimator in the vector model | 53
2.5 The model with known ratio of error variances | 58
2.5.1 The MLE and its consistency | 58
2.5.2 Asymptotic normality of the slope estimator | 61
 Another Random Document on
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