Medical Radiology and radiation safety Medical Radiology and radiation safety Медицинская радиология и радиационная безопасность 1024-6177 2618-9615 29562 10.12737/article_5d1adb25725023.14868717 Радиационная биология Radiation biology Радиационная биология Strength of Association. Report 1. Graduations of Relative Risk Сила связи. Сообщение 1. Градации относительного риска Котеров А. Н. Koterov A. N.

доктор биологических наук;

doctor of sciences in biology;

 Ушенкова Л. Н. Ushenkova L. N.

кандидат биологических наук;

candidate of sciences in biology;

 Зубенкова Э. С. Zubenkova E. S. Вайнсон А. А. Vaynson A. A.

доктор биологических наук;

doctor of sciences in biology;

 Калинина М. В. Kalinina M. V. Бирюков А. П. Biryukov A. P.

доктор медицинских наук;

doctor of medical sciences;

 Федеральный медицинский биофизический центр им. А.И. Бурназяна ФМБА России Москва Россия A.I. Burnasyan Federal Medical Biophysical Center of FMBA Moscow Russian Federation Федеральный медицинский биофизический центр им. А.И. Бурназяна ФМБА России Москва Россия A.I. Burnasyan Federal Medical Biophysical Center of FMBA Moscow Russian Federation Федеральный медицинский биофизический центр им. А.И. Бурназяна ФМБА России Москва Россия A.I. Burnasyan Federal Medical Biophysical Center of FMBA Moscow Russian Federation Национальный медицинский исследовательский центр онкологии им. Н.Н. Блохина Минздрава России Москва Россия N.N. Blokhin National Medical Research Center of Oncology Moscow Russian Federation Федеральный медицинский биофизический центр им. А.И. Бурназяна ФМБА России Москва Россия A.I. Burnasyan Federal Medical Biophysical Center of FMBA Moscow Russian Federation Федеральный медицинский биофизический центр им. А.И.Бур­на­зяна ФМБА России Москва Россия A.I. Burnasyan Federal Medical Biophysical Center (FMBC) FMBA Moscow Russian Federation 64 4 5 17 https://naukaru.ru/en/nauka/article/29562/view

Цель: Создание сводки данных по градациям величины эффекта для первого критерия причинности Хилла «сила ассоциации» по параметру относительного риска (RR). Материал и методы: Обзорное исследование опубликованных источников: монографии, пособия, статьи, учебный материал по статистике в различных дисциплинах (в том числе on-line) и др. (128 ссылок; из них порядка 30 пособий по эпидемиологии, канцерогенезу и статистике в медицине). Результаты: Для величины RR из собранной сводки данных (1980–2018) следует неоднородность в понятиях. Наиболее распространены ссылки на шкалу Монсона (два издания монографии по эпидемиологии профессиональных воздействий – Monson R.R., 1980; 1990). Оптимальная, на наш взгляд, градация может быть выработана на основе этой шкалы, которая должна включать как диапазон отсутствия эффекта (RR = 0,9–1,2), так и диапазоны слабой (RR = 1,2–1,5, или 0,7–0,9), умеренной (RR = 1,5–3,0, или 0,4–0,7), сильной (RR = 3,0–10,0; или 0,1–0,4) и очень сильной (RR = 10,0–40,0; или 0,0–0,1) связи. Представлены примеры эпидемиологических эффектов с подавляющей силой связи (RR > 40,0). Для воздействия талидомида RR достигал тысяч, для диэтилстилбестрола – условной бесконечности, а при облучении в детском возрасте частота некоторых раков возрастала в десятки и даже сотни раз. Кратко рассмотрены юридические аспекты выплаты компенсаций исходя из RR. Согласно правилу Дауберта (Daubert ruling, Daubert standard) по прецеденту 1993 г., в США значимыми признаются риски только при RR >2,0, когда вероятность причинности более 50 %. Выводы: Для оценки величины RR следует пользоваться наиболее распространенной и официально устоявшейся шкалой Монсона, хотя и с расширением в диапазоне сверхвысоких рисков. Настоящее исследование может быть использовано как справочное руководство по градациям силы эффекта по RR (OR) для самых разных описательных дисциплин.

Purpose: To summarize data on graduation of the effect size on the base of Hill’s first causality criterion ‘Strength of association’ on relative risk parameters (RR). Material and methods: Survey of published sources: monographs, handbooks, papers, educational material on statistics in various disciplines (including on-line), etc. (128 references; of which about 30 handbooks on epidemiology, carcinogenesis and medical statistics). Results: For the RR value, the collected data summary (1980–2018) implies non-homogeneity in concepts. The most common references are to the Monson scale (two editions of the monograph on the epidemiology of occupational exposures Monson R.R., 1980; 1990). In our opinion, the optimal graduation can be developed on the basis of this scale, and it should include both the range of no effect (RR = 0.9–1.2) and the weak (RR = 1.2–1.5, or 0.7–0.9), moderate (RR = 1.5–3.0, or 0.4–0.7), strong (RR = 3.0–10.0; or 0.1–0.4) and very strong’(RR = 10.0–40.0; or 0.0–0.1) ranges. Examples of epidemiological effects with overwhelming strength of association are presented (RR > 40.0). For the effects of thalidomide, RR reached thousands, for diethylstilbestrol, conditional infinity, and when irradiated in childhood, the frequency of some cancers increased tens and even hundreds of times. The juristic aspects of compensation payment based on RR are briefly reviewed. According to the Daubert rule (Daubert ruling, Daubert standard) on the 1993 precedent in the United States, risks are recognized only at RR > 2.0, when the probability of causality is more than 50 %. Conclusions: To estimate the RR value, one should use the most common and officially established Monson scale, albeit with an expansion in the range of dramatic or overhelming risks. This study can be used as a reference guide on the graduations of effect size on RR (OR) for a wide variety of observed disciplines.

 градации величины эффекта ординальные шкалы относительный риск эпидемиология graduation of effect size ordinal scales relative risk epidemiology

1. Введение и постановка проблемы для цикла сообщений: ассоциации и критерии их причинностиОценка причинности явлений и ассоциативных связей – краеугольный камень как нашей обыденной жизни [1], так и практически всех научных дисциплин, включая эмпирические и описательные: философии [2, 3], биологии, эпидемиологии, медицины, физики [4], химии [5], экономики [7], социологии [4, 8], юриспруденции [9], психологии [4] и др. [4, 10].Во всех этих областях (кроме философии) доказательность может основываться на выявлении статистически значимых ассоциаций: между причиной и следствием, между воздействием и эффектом, между характеристикой группы и ее последующими поведенческими особенностями, и пр. [4]. В экспериментальных дисциплинах с возможностью устанавливать условия опыта, получение подобных доказательств очевидно (экспериментальным называется подход, когда можно проконтролировать хотя бы один варьирующий фактор из многих [11]). Выявление в эксперименте статистически значимой ассоциации или корреляции – это конечный этап доказательности (что относится и к рандомизированным контролируемым испытаниям в медицине [4, 11]) [12]. Данное положение, вероятно, настолько глубоко входит в подсознание экспериментаторов, что нередко распространяется ими (а, затем, и массами населения) на все остальные дисциплины и области человеческого деятельности, где никаких контрольных опытов поставить нельзя. То, что для описательных дисциплин, включающих вместе с эпидемиологией экономику, социологию, психологию и др., «ассоциация не означает каузацию» (то есть причинность; парафраз из [13]), какой бы статистической значимости ни была корреляция, ясно далеко не всем. 

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