Industry Bibliographical Databases: Perspectives of Use in The Fmba of Russia for Scientific Expertise in Decision-Making. Report 3. Methodology of Estimation a Hypothetical R&D Program for Nuclear Workers

The presented review of three reports is devoted to bibliographic databases on medical-biological and other effects in nuclear workers (NW) and uranium miners (U miners), developed within the framework of the research theme of the Federal Medical and Biological Agency of Russia and registered with Rospatent. Report 1 outlined the introductory issues of the theory of databases, as well as registers, and provided information on the database for NW; Report 2 was devoted to the database for U miners. This Report 3 describes the application of the named databases: a) a scheme of the methodology for the examination of the declared research programs on the effects in NW and U miners based on the databases is presented and b) an example of using this methodology for the examination of a hypothetical program dedicated to the risk of mortality from testicular cancer for NW (rare effect) is analyzed. The six-stage methodology involves various types of searches for sources in databases with their subsequent analysis according to the main approach of Evidence-Based Medicine – the formation of a systematic review or a review close to it. At stage 1 of the examination, based on fundamental materials included in the database (manuals and reviews on radiation disciplines, as well as thematic documents of international and internationally authoritative organizations – UNSCEAR, ICRP, IAEA, BEIR, etc.), the most general assessment of the R&D program is carried out in relation to the presence/absence of attribution of the effect to radiation. Stage 2 is based on the operational search for data on the effect of interest in two auxiliary fragments of the database (separately for Russian and foreign NW; in total 13 % of the entire database), subjected to three-level thematic cataloging in accordance with the identified areas of effect study in NW. At stage 3, a sample of studies similar in theme to the R&D program undergoing examination is formed by means of a visual or software search in the entire NW or U miners database (both by catalog names and by all source texts). At stage 4, the total sample undergoes a review analysis for the expected risk value and the presence of a dose–effect relationship. At stages 5 and 6 of the examination, the epidemiological and statistical justification of the R&D program is assessed, respectively. In the first case, by the expected risk value – ‘ignorable’ (up to 1.2), ‘weak’ (1.2–1.5), ‘moderate’ (1.5–3.0), etc., according to the gradations from R.R. Monson, 1990; in the second case, by assessing the possibility of obtaining significant changes in the expected risk in the declared sample. As a result of the analysis using the example, it was concluded that the examination of the feasibility of implementing the research program for studying mortality from testicular cancer for NW does not lead to a positive conclusion at any stage. This is due to the low background level of the effect (~1 per 100,000 men per year) and the small risk value shown in those few studies where the tendency to the effect was recorded. The conducted study confirms the feasibility of using the developed databases for NW and U miners in the expert information activities of institutions in the system of the Federal Medical and Biological Agency of Russia and other health departments covering contingents with the exposure of radiation and non-radiation factors.