Statistical Monitoring of Data in Response–Adaptive

The objective: to study changes in the structure of mortality from tuberculosis and HIV infection in Russia from 2000 to 2017.Subjects and methods. The data of the Federal State Statistics Service on the mortality of the Russian population from tuberculosis and HIV infection (standardized ratio per 100,000 population) for 2000-2017 were studied. Data on the structure of patients with TB/HIV co-infection were obtained from Form no. 61 of the federal statistical monitoring for 2017.Results. In Russia, there has been a steady decrease in the mortality rate from tuberculosis, the value of which in 2017 reached 5.9 per 100,000 people. At the same time, the average values of the mortality rate from tuberculosis have shifted towards the older age groups reaching maximum values in the age group of 45 years and older. On the contrary, the analysis of mortality from HIV infection (2006-2017) detected its unprecedented increase from 1.6 to 12.6 per 100,000 population. The maximum concentration of mortality from HIV infection was observed in young age groups (35-44 years old). The increase in mortality from HIV infection was accompanied by a change in the structure of mortality from infectious diseases: the proportion of tuberculosis decreased from 79.1% (2000) to 27.4% (2017), and the proportion of HIV infection increased from 0.1% ( 2000) to 57.2% (2017). Currently, in Russia, mortality from HIV infection in young age groups has taken a leading position in the structure of causes of death from infectious diseases, displacing mortality from tuberculosis.

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Analysis of a continuous 24-hour glycemic curve by the symmetrization method

Problems of Endocrinology ◽

10.14341/probl20095513-7 ◽

2009 ◽

Vol 55 (1) ◽

pp. 3-7

Author(s):

A V Dreval ◽

B P Kovachev ◽

E G Starostina ◽

I V Misnikova ◽

O. A Dreval

Keyword(s):

Diabetes Complications ◽

Glycosylated Hemoglobin ◽

Self Control ◽

Statistical Monitoring ◽

Symmetrization Method ◽

Daily Dose ◽

Glycemic Indices ◽

History Of ◽

The Mean

The study included 18 patients (10 females and 8 males) with a not less than 2 year-history of type 1 diabetes (T1D), who had received insulin therapy since its diagnosis was established. The patients ’ mean age was 32.9± 13.0 years; the mean duration of TID was 15.1+11.5 years; the mean daily dose of insulin was 40.1+16.0 units; the mean level of glycosylated hemoglobin (HbAJ was 9.4±2.1% (the normal value 4.4-4.9%). The glycemic curve symmetrization method proposed for statistical analysis of glycemic self-control is also quite suitable for the statistical monitoring of a continuous daily glycemic curve. The high and low glycemic indices calculated from the symmetrized glycemic data correlate well with the level of HbAk and with the duration of hypoglycemia and hyperglycemia and hence they may be used as additional criteria for a risk of diabetes complications. The criteria, calculated from the symmetrized data of glycemia for the risk of hyper- and hypoglycemia, adequately reflect the behavior of a continuous glycemic curve and may be used as integral indices of the efficiency of glucose-reducing therapy in clinical practice.

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The Socio-Economic Development of Cross-Border Territories: Statistical Monitoring

Statistics of Ukraine ◽

10.31767/su.1(80).2018.01.08 ◽

2018 ◽

Vol 80 (1) ◽

pp. 61-67

Author(s):

О. М. Motuzka ◽

V. V. Parkhomenko

Keyword(s):

Economic Development ◽

Information Needs ◽

Market Competition ◽

Global Market ◽

Border Region ◽

Goods And Services ◽

Border Regions ◽

Cross Border ◽

Statistical Monitoring ◽

Socio Economic Development

Because the methodology for studying the socio-economic development of cross-border territories is still poorly developed in the Ukrainian science, this study aims to highlight its theoretical essence and justify the need for statistical monitoring and identification of practical problems related with its applications at personal, institutional and regional level. Given the global market competition, the socio-economic development of cross-border territories is impossible without creating favorable financial, institutional and infrastructure environment. The socio-economic development of cross-border territories is determined by a set of indicators reflecting the capabilities of territories located on both sides of the border to produce a certain output of goods and services using the available human and material resources. The importance of cross-border statistics grows with the expansion of cross-border cooperation. Cross-border statistics refers to the generalized information on the socio-economic development of cross-border territories; it has to support the CBC-related operation of central and local administration bodies and private entities in border regions, aimed at expanding business partnerships and meeting public needs on border territories. The source of data for cross-border statistics is the statistics of border regions. The analysis shows that trial decisions used now in the Ukrainian statistics system for testing border region statistics, such as statistics of tourism, including travels abroad, are not capable to meet information needs of the regional development policy, foreign trade statistics and statistics of internal and external migration. The statistics of cross-border regions has to face the following challenges: improve the comparability of statistical indicators by harmonizing statistical surveys’ methodology, terminology, definitions and classifications; expand and improve printing and publishing activities; develop analytical work; introduce and develop cross-border surveys; construct on-line cross-border database.

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Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review

10.1101/2020.04.01.20049627 ◽

2020 ◽

Author(s):

William J Cragg ◽

Caroline Hurley ◽

Victoria Yorke-Edwards ◽

Sally P Stenning

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Research Question ◽

Trial Data ◽

Monitoring Methods ◽

Central Monitoring ◽

Statistical Monitoring ◽

Site Monitoring ◽

Central Statistical ◽

Monitoring Activity

AbstractBackground/AimsIt is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have in recent years encouraged more risk-based monitoring. Risk assessment should take place before a trial begins in order to define the overarching monitoring strategy. It can also be done on an ongoing basis, in order to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like ‘central statistical monitoring’, ‘triggered monitoring’ or, as in ICH Good Clinical Practice guidance, ‘targeted on-site monitoring’. We conducted a scoping review to identify such methods, to establish if any published methods were supported by adequate evidence to allow wider implementation, and to point the way to future developments in this field of research.MethodsWe used 7 publication databases, 2 sets of methodological conference abstracts and an internet search engine to look for methods for using centrally held trial data to assess site conduct during a trial. We included only reports in English, and excluded reports published before 1996 and reports not directly relevant to our research question. We used reference and citation searches to find additional relevant reports. We extracted data using a pre- defined template. We contacted authors to request additional information about included reports and to check whether reports might be eligible.ResultsWe included 30 reports in our final dataset, of which 21 were peer-reviewed publications. 20 reports described central statistical monitoring methods (of which 7 focussed on detection of fraud or misconduct) and 9 described triggered monitoring methods. 21 reports included some assessment of their methods’ effectiveness. Most commonly this involved exploring the methods’ characteristics using real trial data with no known integrity issues. Of the 21 with some effectiveness assessment, most presented limited or no information about whether or not concerns identified through central monitoring constituted meaningful problems. Some reports commented on cost savings from reduced on-site monitoring, but none gave detailed costings for the development and maintenance of central monitoring methods themselves.ConclusionsOur review identified various proposed methods, some of which could be combined within the same trial. The apparent emphasis on fraud detection may not be proportionate in all trial settings. Although some methods have self-justifying benefits for data cleaning activity, many have limitations that may currently prevent their routine use for targeting trial monitoring activity. The implementation costs, or uncertainty about these, may also be a barrier. We make recommendations for how the evidence-base supporting these methods could be improved.

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