NORA Manufacturing Sector Strategic Goals
9278532 - Development of Epidemiologic Research Methods
Principal Investigator (PI)
Primary Goal Addressed
Secondary Goal Addressed
Attributed to Manufacturing
The goal of this project is to develop methods and systems to analyze epidemiologic studies and create data systems to store and update information in cohort master files. Project outputs are used by researchers worldwide in the conduct of etiologic epidemiology research. Although most research is conducted within the Manufacturing, Agriculture, and Mining Sectors, study findings apply to workers in every Sector who encounter similar occupational hazards. Outcomes of this project indirectly benefit worker health by providing tools for the evaluation of health hazards. The elucidation of these hazards may lead to listing or delisting of potential carcinogens by the national and international agencies. It may also lead to changes in the workplace, e.g., in reducing worker exposures or in providing incentive for the development of new control technologies.
The overall purpose of this project is to provide support for infra-structure activities necessary for conducting occupational epidemiologic studies. Specifically, the goal of this project is to develop appropriate methods and computer programs to analyze epidemiologic cohort and case-control studies, to create incidence and mortality rate files for use in epidemiologic analyses, and to create data systems to store, preserve, and update information in cohort master files. These methods, programs and rates are used by researchers worldwide in the conduct of etiologic epidemiology research. This methods development project realizes outcomes that indirectly benefit worker health, by providing tools for the evaluation of health hazards. The elucidation of these hazards may lead to changes in the workplace, for example, in reducing worker exposures or in providing incentive for the development of new control technologies.
This project is comprised of five sub-projects:
1) NIOSH LIFE TABLE COMPUTER PROGRAM. The NIOSH Life Table Analysis System (LTAS) is used by hundreds of researchers within and outside of NIOSH to analyze occupational cohort studies. Half the registered users of LTAS reside outside the U.S. A conversion of LTAS to a Windows-based platform has been completed and is made freely available to users within and outside of NIOSH. The program is currently in an ongoing maintenance phase, in which modifications are made to accommodate the changing computing environment at CDC (e.g., the pending switch to the MS-Vista operating system). This maintenance work has no anticipated completion date, as it is required for as long as NIOSH conducts cohort studies. In FY09, enhancements to the program will be added and tested, including new tests for statistical trend, and the ability to export person-year weighted exposure means for regression analyses. A manuscript describing the improvements to LTAS will be submitted for publication. Completion date: 9/30/2009
2) RATE FILE DEVELOPMENT. NIOSH maintains a number of mortality rate files stratified by age, race, sex, and calendar time. These files must be continually updated with new mortality and population data. These files include state-, and national-level mortality rate files made publicly available through CDC. In addition, special rate files for mortality and cancer incidence must be updated continually. New International Classification of Diseases (ICD) codes must be incorporated when appropriate, such as when new ICD revisions occur, or when old ones are modified (e.g., use of the ICD-10 revision beginning in 1999). In FY08, rates were updated with data through 2005 and multiple-cause rates were created. In FY09, rates will be updated with data through 2006 and additional race category breakouts will be created. This subproject has no anticipated completion date, as it is required for as long as NIOSH conducts cohort studies.
3) IWSB DATABASE MANAGEMENT SYSTEM (IDMS). EDMS and HEDS legacy systems provide relational database functionality for epidemiologic study data, providing excellent data accessibility to researchers and support staff. The systems facilitate the collection and updating of cohort member's vital status, causes of death, contact information, and work history records. The systems ensure high data quality. Records for over 865,000 workers are housed in these systems, including cohorts from IWSB studies, OERP research, and the Surveillance Branch. With the merger of HERB and IWSB branches, maintaining separate systems is not tenable. The IDMS system merges EDMS and HEDS, and is slated for completion by 9/30/2009. The maintenance phase of this subproject has no anticipated completion date, as it is required for as long as NIOSH conducts cohort studies.
4) METHODS FOR EVALUATING POTENTIAL BIASES IN COHORT AND CASE-CONTROL STUDIES. NIOSH has developed software for selecting (in an unbiased manner) controls in nested case-control studies. The methods underlying this software have recently been challenged as potentially biased. This sub-project entails conducting cohort simulations to evaluate potential bias associated with different methods of selecting controls, compared to a full cohort analysis. A manuscript has been submitted for publication describing this method, and simulations are being conducted in support of a second manuscript. Completion date: 9/30/2009.
5) ISIS. The ISIS database management system will allow staff to access historical and ongoing study information, such as study definitions, physical and vital electronic record holdings, and publications. It better positions the branch to address records management, sensitive data security, and FOIA mandates, while leveraging vast branch historical study knowledge, and decreasing dependence on staff for institutional knowledge. The project phase is slated for completion by 9/30/2009, while maintenance and operational needs will endure.
Information will continue to be captured electronically about registered users of LTAS.NET. The literature will be searched annually for citations of the NIOSH life table analysis program. OSHA, EPA, NTP and IARC documents will be reviewed to determine whether NIOSH studies employing the NIOSH life table analysis program were considered in their evaluations.
Infra-structure tools are critical for the conduct of occupational epidemiologic studies. This epidemiologic methods project develops database and computer systems as well as methods to analyze large cohort mortality and incidence studies and nested case-control studies. These studies are designed to determine whether workplace exposures to chemical and physical agents lead to adverse health outcomes, such as cancer, non-malignant respiratory diseases, cardiovascular and circulatory disease, neurological disorders, and injury. The methods and tools developed in this project (e.g., the NIOSH Life Table Analysis System for Windows) are described via the scientific literature and are distributed free-of-charge as a service to occupational health and safety researchers throughout the US and the world via the NIOSH internet site.
Although these methods are developed for use in all Sectors, the Manufacturing Sector has been most frequently represented in the studies based on these methods. This project relates to the Strategic Goals of reducing the prevalence of cancer and respiratory diseases due to occupational exposures, as well as enhancing the state of knowledge related to emerging hazards, in the Manufacturing Sector. These methods are also used in studies of the Mining Sector.
This project contributes to etiologic studies of the harmful effects of silica, diesel and radon exposures (and their interactions) in mines, which are very important exposures of concern. For example, a mortality study of Uranium Miners is currently underway (CAN 8542).
This project also contributes to several intermediate and activity/output program goals for the Cancer, Reproductive and Cardiovascular (CRC) Cross-Sector: Intermediate Goal 1.1: Conduct research to reduce work-related cancer. Activity/Output Goal 1.1.1: Conduct analytic epidemiology studies of high-priority, high-feasibility populations and exposures. Activity/Output Goal 1.1.5: Develop methods for quantitative cancer risk assessments, in support of authoritative recommendations for limiting occupational exposures.
Intermediate Goal 1.3: Enhance global workplace safety and health through international collaborations. Activity/Output Goal 1.3.1: Provide world leadership in the development of international standards and documents, and the sharing of study methods and findings.
Intermediate Goal 4.1: Conduct research to better define the contribution of workplace exposures … to the overall incidence of and mortality from cardiovascular disease (CVD). Activity/Output Goal 4.1.1: Conduct analytic epidemiology studies of high-priority, high-feasibility populations to identify and quantify risk of CVD associated with workplace exposures.
This project contributes to the following intermediate goals of the Respiratory Diseases Cross-Sector:
Intermediate Goal 1.2: prevent and reduce work-related COPD.
Activity/Output Goal 1.2.1: conduct surveillance and epidemiological studies to assess the extent, severity, and burden of work-related COPD and identify industries and occupations associated with COPD.
Activity/Output Goal 1.2.6: study associations between irritant inhalation exposures during disasters, such as dust at the site of the World Trade Center collapse, and development of obstructive lung disease.
Intermediate Goal 2.3: prevent and reduce "fiber"-induced respiratory diseases. Activity/Output Goal 2.3.4: conduct epidemiological investigations to better characterize the relationships between exposures to asbestos and other elongated mineral particles, including elongated cleavage fragments of amphibole minerals, and health effects such as interstitial lung disease, lung cancer, and mesothelioma.
Intermediate Goal 4.1: reduce the incidence of work-related cancer through research, promotion of carcinogen-free workplaces, and international collaborations. Activity/Output Goal 4.1.2: complete a reanalysis of respiratory malignancies in a cohort of chrysotile asbestos textile workers, previously studied only by light microscopy, whose exposures will be reanalyzed by EM. Activity/Output Goal 4.1.3: conduct epidemiological investigations to better characterize the relationships between exposures to asbestos and other elongated mineral particles, including elongated cleavage fragments of amphibole minerals, and health effects such as interstitial lung disease, lung cancer, and mesothelioma. Activity/Output Goal 4.1.5: Evaluate a cohort of workers at three beryllium processing facilities to assess the association between lung cancer mortality and quantitative metrics of cumulative, average and peak exposures. Activity/Output Goal 4.1.6: continue to follow the Colorado Plateau uranium miners' cohort to assess lung cancer risk associated with radon exposure 20 to 40 years after exposure, as well as interactions between radon exposure and smoking.
The project also contributes to the Global Collaborations strategic goal of enhancing global occupational safety and health through international collaborations. The NIOSH Life Table Analysis System for Windows program has been transmitted to 159 occupational health researchers and others in at least 50 countries since its release in 2007.