Workshop summary: Potential usefulness and feasibility of a US National Mesothelioma Registry

The burden and prognosis of malignant mesothelioma in the United States have remained largely unchanged for decades, with approximately 3200 new cases and 2400 deaths reported annually. To address care and research gaps contributing to poor outcomes, in March of 2019 the Mesothelioma Applied Research Foundation convened a workshop on the potential usefulness and feasibility of a national mesothelioma registry. The workshop included formal presentations by subject matter experts and a moderated group discussion. Workshop participants identified top priorities for a registry to be (a) connecting patients with high-quality care and clinical trials soon after diagnosis, and (b) making useful data and biospecimens available to researchers in a timely manner. Existing databases that capture mesothelioma cases are limited by factors such as delays in reporting, deidentification, and lack of exposure information critical to understanding as yet unrecognized causes of disease. National disease registries for amyotrophic lateral sclerosis (ALS) in the United States and for mesothelioma in other countries, provide examples of how a registry could be structured to meet the needs of patients and the scientific community. Small-scale pilot initiatives should be undertaken to validate methods for rapid case identification, develop procedures to facilitate patient access to guidelines-based standard care and investigational therapies, and explore approaches to data sharing with researchers. Ultimately, federal coordination and funding will be critical to the success of a National Mesothelioma Registry in improving mesothelioma outcomes and preventing future cases of this devastating disease.     

Independent Registries Are Cost-Effective Tools to Provide Mandatory Postauthorization Surveillance for Orphan Medicinal Products

ObjectivesOrphan medicinal products (OMPs) often receive market authorization under conditions imposed by regulators for ongoing postauthorization surveillance (PAS) to answer questions that remain at the time of market entry. This surveillance may be provided through industry-funded registries (IFRs). Nevertheless, data in these registries may not be of sufficient quality to answer these questions and may not always be accessible for regulatory review. We propose that a mandatory independent registry is an efficient and cost-effective tool for PAS for OMPs.MethodsUsing data from the Canadian Fabry Disease Initiative, we reviewed costs per unique patient from sites participating in both the independent national registry and IFRs for Fabry disease and compared data completeness from the Canadian Fabry Disease Initiative to that in published documents from IFRs.ResultsThe costs of data collection through the independent registry were 17% to 36% (depending on site) lower than costs to collect data in the IFRs, and completeness of data collected through the independent registry was higher than that through the IFRs. Data from the independent registry were reviewed annually to guide indications for publicly funded Fabry disease therapy. Even when enrollment ceased to be a requirement to receive therapy, 77% of patients continued to enroll in the registry, suggesting the structure was acceptable to patients.ConclusionsIndependent registries are cost-effective and efficient tools and should be mandated by regulatory agencies as the preferred tool for PAS for OMPs. Countries with publicly funded health systems should consider investment in registry infrastructure for OMPs.     

National epidemiologic surveillance systems of asbestos-related disease and the exposed workers register

INTRODUCTION: Italy was the main European producer of asbestos for most of the 20th century and raw asbestos imports wee also significant until the 1990's; there was a mean delay of about ten years in the pattern of asbestos consumption in Italy compared with the USA, Australia, UK and Scandinavian countries. METHODS: A national surveillance system (ReNaM) was implemented to identify cases of mesothelioma and investigate the modalities of asbestos exposure. A register of exposed workers and a database of companies presumably involved in the asbestos exposure problem was also developed. ReNaM has a regional structure and an operative centres (COR) have been established in 16 Italian regions. RESULTS: The ReNaM database currently contains more than 5,000 mesothelioma cases and for 3,500 of these exposure modalities have been defined. Cases of pleural mesothelioma represent 93% of the total but there were also 334 cases of peritoneal mesothelioma, 15 of the pericardium and 14 of the tunica vaginalis of the testicle. Cases with ascertained exposure are thus distributed: 67.4% occupational exposure (ascertained, probable, possible), 4.3% domestic, 4.2% environmental and 1.3% hobby-related exposure, totalling 77.2%; 22.8% had unlikely or unknown exposure. The latency period is very long: on average 43.6 years. The register of asbestos-exposed workers contains figures on exposed workers notified to ISPESL up to 2004 and refers to the exposure period 1993-2003. The data registered cover 160 firms and about 700 workers. CONCLUSIONS: A national, coordinated and uniform epidemiological surveillance system of cases of mesothelioma and the definition of asbestos exposure through active research is extremely important in identifying unexpected contaminating sources. The register of asbestos-exposed workers allows risk to be monitored and protection measures to be implemented.     

Immunization registry progress--United States, January-December 2002

Immunization registries are confidential, computerized information systems that collect vaccination data within a geographic area. By consolidating vaccination records from multiple health-care providers, generating reminder and recall notifications, and assessing clinic and vaccination coverage, registries serve as key tools to increase and sustain high vaccination coverage. One of the national health objectives for 2010 is to increase to 95% the proportion of children aged <6 years who participate (i.e., have two or more vaccinations recorded) in fully operational, population-based immunization registries. This report summarizes data from CDC's 2002 Immunization Registry Annual Report (2002 IRAR), a survey of registry activity among immunization programs in the 50 states and the District of Columbia (DC) that receive grant funding under section 317b of the Public Health Service Act. These data indicate that approximately 43% of children aged <6 years are enrolled in a registry; achieving the national health objective will require increased implementation of functional standards to improve data quality.     

Progress in development of immunization registries--United States, 2000

Immunization registries are confidential, population-based, computerized information systems that attempt to collect vaccination data about all children within a geographic area. Registries are an important tool to increase and sustain high vaccination coverage by consolidating vaccination records of children from multiple providers, generating reminder and recall vaccination notices for each child, and providing official vaccination forms and vaccination coverage assessments. One of the national health objectives for 2010 is to increase to 95% the proportion of children aged <6 years who participate in fully operational population-based immunization registries (objective 14.26). To assess the status of immunization registry development, CDC analyzed self-reported data from 62 immunization grantees on the basis of data from the 2000 Immunization Registry Annual Report (IRAR). This report summarizes the results of this analysis, which indicate that approximately half of the grantees are operating population-based immunization registries that target their entire catchment areas; however, approximately 75% of children aged <6 years still need to be included in an immunization registry to reach the national health objective.     

Association between asbestos exposure and pericardial and tunica vaginalis testis malignant mesothelioma: a case–control study and epidemiological remarks

Objectives:The purposes of this study are to describe the epidemiology of pericardial and tunica vaginalis testis mesothelioma and assess the role of asbestos exposure for these rare diseases.Methods:Based on incident pericardial and tunica vaginalis testis mesothelioma cases collected from the Italian national mesothelioma registry (ReNaM) in the period 1993–2015, incidence rates, survival median period and prognostic factors have been evaluated. A case–control study has been performed to analyze the association with asbestos exposure (occupational and non-occupational) for these diseases.Results:Between 1993 and 2015, 58 pericardial (20 women and 38 men) and 80 tunica vaginalis testis mesothelioma cases have been registered with a mean annual standardized (world standard population as reference) incidence rates of 0.049 (per million) in men and 0.023 in women for the pericardial site, and 0.095 for tunica vaginalis testis mesothelioma. Occupational exposure to asbestos was significantly associated with the risk of the diseases [odds ratio (OR) 3.68, 95% confidence interval (CI) 1.85–7.31 and OR 3.42, 95% CI 1.93–6.04 in pericardial and tunica vaginalis testis mesothelioma, respectively]. The median survival was 2.5 months for pericardial and 33.0 months for tunica vaginalis testis mesotheliomas. Age was the main predictive factor for survival for both anatomical sites.Conclusions:For the first time in an analytical study, asbestos exposure was associated with pericardial and tunica vaginalis testis mesothelioma risk, supporting the causal role of asbestos for all anatomical sites. The extreme rarity of the diseases, the poor survival and the prognostic role of age have been confirmed based on population and nationwide mesothelioma registry data.     

Immunization registry progress--United States, 2002

Immunization registries are confidential, population-based, computerized information systems that collect vaccination data about all children within a geographic area. By providing complete and accurate information on which to base vaccination decisions, registries are key tools to increase and sustain high vaccination coverage. Registries consolidate vaccination records of children from multiple health-care providers, identify children who are due or late for vaccinations, generate reminder and recall notices to ensure that children are vaccinated appropriately, and identify provider sites and geographic areas with low vaccination coverage. One of the national health objectives for 2010 is to increase to 95% the proportion of children aged <6 years who participate in fully operational, population-based immunization registries (objective 14.26). This report summarizes data from the calendar year 2001 Immunization Registry Annual Report (CY 2001 IRAR), a survey of registry activity among immunization programs in the 50 states and the District of Columbia (DC) that receive grant funding under Public Health Service Act 317b. Although these data indicate that approximately half of U.S. children aged <6 years are participating in a registry, achieving the national health objective will require increased immunization provider participation.     

Changing trends in US mesothelioma incidence

Aims: To report the temporal pattern and change in trend of mesothelioma incidence in the United States since 1973.

Methods: The Surveillance, Epidemiology, and End Results (SEER) programme of the National Cancer Institute has since 1973 provided annual age adjusted incidence for mesothelioma in representative cancer registries dispersed throughout the USA. SEER data are analysed to describe the trend of male mesothelioma incidence in the USA.

Results: The US male mesothelioma incidence data indicate that after two decades of increasing incidence, a likely decline has been observed since the early 1990s, when a highly significant change in the upward course occurred.

Conclusions: Increasing male mesothelioma incidence for many years was undoubtedly the result of exposure to asbestos. The high mesothelioma risk was prominently influenced by exposure to amphibole asbestos (crocidolite and amosite), which reached its peak usage in the 1960s and thereafter declined. A differing pattern in some other countries (continuing rise in incidence) may be related to their greater and later amphibole use, particularly crocidolite. The known latency period for the development of this tumour provides biological plausibility for the recent decline in mesothelioma incidence in the USA. This favourable finding is contrary to a widespread fear that asbestos related health effects will show an inevitable increase in coming years, or even decades.

     

Using Multivariate Capture-Recapture Techniques and Statewide Hospital Discharge Data to Assess the Validity of a Cancer Registry for Epidemiologic Use

Background: Cancer surveillance is essential for assessing patterns of cancer. State cancer registries do not capture all cases. We used a statewide hospital discharge file to estimate the capture rate and determine biases in capture by a state cancer registry. Methods: We merged the Virginia hospital discharge file and cancer registry for 1995, then used multivariate two- source capture-recapture techniques to control for heterogeneity and more accurately estimate the number and characteristics of missing breast, lung, colorectal and prostate cancer cases. Results: Results suggest heterogeneity of capture, with rates a function of demographics, surgery and being in a hospital with a cancer program certified by the American College of Surgeons(ACOS). Overall registry capture rates ranged from 66% (prostate)–79% (breast). Capture rates varied by subgroup, with differences larger according to surgery and ACOS certification status than for demographic subgroups. While the registry captured most cases who had surgery (85–89%), capture rates for those without surgery was much lower (37–71%). Conclusion: We conclude that hospital discharge data and multivariate capture-recapture techniques are useful to registries to estimate the number of missing cases and assess bias in capture. Epidemiologic research based on registry data alone would likely provide biased, misleading results.     

Using the national registry of HIV-infected veterans in research: Lessons for the development of disease registries

Disease-specific registries have many important applications in epidemiologic, clinical and health services research. Since 1989 the Department of Veterans Affairs has maintained a national HIV registry. VA's HIV registry is national in scope, it contains longitudinal data and detailed resource utilization and clinical information. To describe the structure, function, and limitations of VA's national HIV registry, and to test its accuracy and completeness. The VA's national HIV registry contains data that are electronically extracted from VA's computerized comprehensive clinical and administrative databases, called Veterans Integrated Health Systems Technology and Architecture (VISTA). We examined the number of AIDS patients and the number of new patients identified to the registry, by year, through December 1996. We verified data elements against information obtained from the medical records at five VA sites. By December 1996, 40,000 HIV-infected patients had been identified to the registry. We encountered missing data and problems with data classification. Missing data occurred for some elements related to the computer programming that creates the registry (e.g., pharmacy files), and for other elements because manual entry is required (e.g., ethnicity). Lack of a standardized data classification system was a problem, especially for the pharmacy and laboratory files. In using VA's national HIV registry we have learned important lessons, which, if taken into account in the future, could lead to the creation of model disease-specific registries.     

The use of national registries data in three European countries in order to improve health care quality

PURPOSE: The purpose of this paper is to highlight the role of national health registries in three European countries in order to improve patient care. DESIGN/METHODOLOGY/APPROACH: The methodology used was a literature review of databases in Sweden, the UK and Portugal, and a search on Medline and Pubmed as well. In addition case studies from the three countries are included. FINDINGS: In Sweden registries encompassing cardiac intensive care, hip-fractures and stroke are the most developed. In the UK, the collection of information on healthcare performance, both specific to particular specialties and general hospital performance, is widespread. There are some national and regional registries in Portugal, but the most developed areas are the Cardiovascular and the Oncology areas. The collection of information on health quality/performance indicators, based on administrative and clinical data is an important tool for quality improvement. ORIGINALITY/VALUE: This paper showed differences and similarities between the three countries with a common aim; to improve quality of care, delivered on equal terms for the whole populations, and in an effective and efficient way and will be useful to those in the field of patient care.     

Cancer registry data based estimation of regional cancer incidence: application to breast and colorectal cancer in French administrative regions

STUDY OBJECTIVE: In many countries, cancer registries cover only a small part of the national population. Cancer incidence for the rest of the country has therefore to be estimated. This can be done from mortality data using the relation between incidence and mortality observed in the cancer registry areas. Such an approach was used to study geographical variation and trend of colorectal and breast cancer incidence in France where 10% of the national population is covered by cancer registries. DESIGN: This study applies the incidence/mortality ratios of cancer registry areas to regional mortality data to obtain an estimation of cancer incidence at a given point in time. Age and period effects are included in the statistical models. MAIN RESULTS: The incidence estimations are given for 21 administrative regions and three time points (1985, 1990, 1995). The European standardised incidence rates for breast cancer ranged from 86.8 to 128.8. For colorectal cancer, these rates ranged from 48.2 to 79.6 for men, and from 32.5 to 48.8 for women. Breast cancer incidence has increased considerably between 1985 and 1995 with a higher increase in the north than in the south of France. The incidence of colorectal cancer has also increased, albeit to a lesser extent. CONCLUSION: The incidence estimation method proposed leads to regional incidence rates that are useful for planning health care services on a regional basis and may also be used to study regional differences in incidence. This method is useful when only partial incidence data are available.     

Considerations Before Establishing an Environmental Health Registry

Public health registries can provide valuable information when health consequences of environmental exposures are uncertain or will likely take long to develop. They can also aid research on diseases that may have environmental causes that are not completely well defined.We discuss factors to consider when deciding whether to create an environmental health registry. Those factors include public health significance, purpose and outcomes, duration and scope of data collection and availability of alternative data sources, timeliness, availability of funding and administrative capabilities, and whether the establishment of a registry can adequately address specific health concerns.We also discuss difficulties, limitations, and benefits of exposure and disease registries, based on the experience of the Agency for Toxic Substances and Disease Registry.The use of public health registries has become increasingly common in the past 2 decades.1,2 Although they are widespread in the context of immunizations, cancer epidemiology, and drug development research,3 the field of environmental health has also benefited from the establishment of a number of disease and exposure registries.A registry is generally defined as a set of records containing systematically collected, standardized data about individual people.4 These data are typically acquired, maintained, and updated over a prolonged period, usually years. Registries range from only a listing of exposed individuals with associated contact information to a research repository of information that includes demographics, exposure data, and health information. A public health registry is set up to accomplish a public health goal or activity. It might be used to obtain information on people who have a particular disease, a condition or a risk factor that predisposes them to illness from a health-related event, or previous exposure to substances or circumstances known or suspected to cause adverse health effects. The particular data assembled are a function of the purpose of the registry. The variables might be chosen to help study or detect specific health problems or to study treatments in specific individuals or disorders. In the context of environmental health, registries include information regarding individual exposures to chemical or physical environmental agents or the known or potential consequences of such exposures.The central purpose of a registry is to facilitate epidemiological research or provide information to registrants about a certain disease, exposure, or event. Registries are also used to generate relevant statistics about the group of registered people. We discuss the main factors to consider when deciding whether to create an environmental health registry. We also discuss some of the difficulties, limitations, and benefits of registries, based on the experience of their use by the Agency for Toxic Substances and Disease Registry (ATSDR) in the United States.     

Immunization registries in the EMR Era

Background: The CDC established a national objective to create population-based tracking of immunizations through regional and statewide registries nearly 2 decades ago, and these registries have increased coverage rates and reduced duplicate immunizations. With increased adoption of commercial electronic medical records (EMR), some institutions have used unidirectional links to send immunization data to designated registries. However, access to these registries within a vendor EMR has not been previously reported.Purpose: To develop a visually integrated interface between an EMR and a statewide immunization registry at a previously non-reporting hospital, and to assess subsequent changes in provider use and satisfaction.Methods: A group of healthcare providers were surveyed before and after implementation of the new interface. The surveys addressed access of the California Immunization Registry (CAIR), and satisfaction with the availability of immunization information. Information Technology (IT) teams developed a “smart-link” within the electronic patient chart that provides a single-click interface for visual integration of data within the CAIR database.Results: Use of the tool has increased in the months since its initiation, and over 20,000 new immunizations have been exported successfully to CAIR since the hospital began sharing data with the registry. Survey data suggest that providers find this tool improves workflow and overall satisfaction with availability of immunization data. (p=0.009).Conclusions: Visual integration of external registries into a vendor EMR system is feasible and improves provider satisfaction and registry reporting.Key Words: Electronic Medical Records, Immunization Registries, EMR integration, HITECH, Meaningful Use     

Perinatal epidemiology--a Nordic challenge.

The focus within perinatal epidemiology has to a large extent been on death and survival as the measures of outcome and less so on measures of morbidity. Too few studies have related perinatal events to measures of health beyond the infancy period, even in the Nordic countries where infant populations may easily be followed through time. Medical birth registries have been established in all the Nordic countries over the period 1967 (Norway) through 1987 (Finland). Unique ID-numbers facilitate linkage within and between these registries as well as record linkages with other data sets. Although outstanding examples of such research exist within perinatal epidemiology, till now we have not taken enough advantage of these valuable sources of data. In the Nordic countries three main areas of perinatal epidemiology would seem to attract considerable attention in the years to come. One area is the study of the association between social factors and adverse outcomes of pregnancy and childbirth. Studies based on record linkages of health registry and census data have recently revealed associations of a kind and magnitude which till now obviously have been disregarded in the Nordic countries. Two other areas of research are longitudinal studies where perinatal exposure is linked with health effects later in life or in later generations. Such studies will be feasible with increasing years of observation of the individuals included in the medical birth registries and the possibilities of generation studies will open up as our registries age.     

Trauma registry implementation and operation in low and middle income countries: A scoping review

ABSTRACT

Injury is a major public health crisis contributing to more than 4.48 million deaths annually. Trauma registries have proven highly effective in reducing injury morbidity and mortality rates in high income countries. They are a critical source of information for injury prevention, benchmarking care, quality improvement, and resource allocation. Historically, low and middle income countries (LMICs) have largely been excluded from trauma registry development due to limited resources. Recently, this has begun to change with low-resource hospitals adopting innovative strategies to implement trauma registries. Nonetheless, dissemination of these strategies remains fragmented. Hospitals looking to develop their own trauma registries have no current, comprehensive resource that summarises the implementation decisions of other registries in similar contexts. This scoping review aims to identify where trauma registries are located in LMICs, bringing up to date previous estimates, and to identify the most common approaches to registry implementation and operation in these settings.     

Vollzähligkeitsschätzungen von Krebsregisterdaten in Deutschland

In 1995, a federal cancer registry law became effective in Germany obliging all federal states to set up epidemiological cancer registries. As a result,numerous cancer registries have been established. However, it is essential to know the degree to which all relevant cases are recorded within a registry—particularly for those registries established recently—as only a high degree of completeness can prevent variations in the efficacy of registry procedures from distorting comparative studies. In this study, the completeness of the cancer registries was evaluated indirectly. Incidences for geographical areas covered by a cancer registry were estimated using incidence/mortality ratios of another registry known to have complete data sets. Log-linear models, successfully applied in a separate study, were fitted to incidence/mortality ratios using both the age and sex-specific data of the reference registry. These estimates were then compared with the actual data collected by the newly established registry, allowing the level of completeness to be assessed. The German Epidemiological Cancer Registry Study Group has agreed to this method and the "Dachdokumentation Krebs"—as a member of this group—performs the analyses. The first results of the study are presented in this contribution.     

Using national electronic health care registries for comparing the risk of psychiatric re-hospitalisation in six European countries: Opportunities and limitations

Psychiatric re-hospitalisation rates have been of longstanding interest as health care quality metric for planners and policy makers, but are criticized for not being comparable across hospitals and countries due to measurement unclarities. The objectives of the present study were to explore the interoperability of national electronic routine health care registries of six European countries (Austria, Finland, Italy, Norway, Romania, Slovenia) and, by using variables found to be comparable, to calculate and compare re-hospitalisation rates and the associated risk factors. A “Methods Toolkit” was developed for exploring the interoperability of registry data and protocol led pilot studies were carried out. Problems encountered in this process are described. Using restricted but comparable data sets, up to twofold differences in psychiatric re-hospitalisation rates were found between countries for both a 30- and 365-day follow-up period. Cumulative incidence curves revealed noteworthy additional differences. Health system characteristics are discussed as potential causes for the differences. Multi-level logistic regression analyses showed that younger age and a diagnosis of schizophrenia/mania/bipolar disorder consistently increased the probability of psychiatric re-hospitalisation across countries. It is concluded that the advantage of having large unselected study populations of national electronic health care registries needs to be balanced against the considerable efforts to examine the interoperability of databases in cross-country comparisons.