Qualitätsregister in der Kardiologie

Prospective registries performed in consecutive patients with frequent cardiac diseases and procedures are able to provide important information about therapies, complications, clinical outcome, and temporal trends in cardiology. Since 1992 all consecutive percutaneous coronary interventions (PCI) performed in over 80 hospitals of the ALKK (Arbeitsgemeinschaft Leitende Kardiologische Krankenhaus?rzte) have been centrally collected in a registry. This registry contains over 20% of all PCI procedures performed in Germany during the last 10 years. By restricting the documentation to a limited number of items, it was possible to establish this registry with a high degree of completeness of the data. A similar concept formed the basis for five consecutive registries in patients admitted with acute myocardial infarction. In these registries the participating investigators were asked to provide reasons for their treatment decisions, e. g., withholding guideline- adherent therapies. With this feature an increase in the use of guideline-adherent therapies could be observed, which was associated with an improvement in clinical outcome.     

Estimating the cumulative number of human immunodeficiency virus diagnoses by cross-linking from four different sources

BACKGROUND: We estimated the cumulative number of people diagnosed with human immunodeficiency virus (HIV) infection in a region of Italy by cross-linking data from four surveillance systems and applying capture-recapture methods. METHODS: The study was conducted using data referring to residents of the Veneto Region (population 4.4 million). We cross-linked data from the AIDS Registry (data 1983-2000), the HIV Registry (1988-2000), the Death Registry (1992-1999), and the Hospital-Discharge Registry (1997-2000), using a code based on name, birth date, and sex. A specific software for capture-recapture models (CARE-1) was used to estimate the size of the target population with two different statistical approaches (sample coverage and log-linear models). RESULTS: A total of 2801 people were reported to the AIDS Registry, 6415 to the HIV Registry, 1598 to the Death Registry as HIV/AIDS-related deaths, and 3330 to the Hospital-Discharge Registry with a diagnosis of HIV infection. Overall, 8723 people were present in at least one registry: 4896 people were present in only one registry, 2387 in two registries, 1286 in three registries, and 154 in all four registries. Using the sample coverage approach, we estimated that, since the beginning of the epidemic in Veneto, an estimated 11 281 people (95% CI: 10 981, 11 621) should have been reported to at least one registry; thus the estimated coverage of the four registries was 77.3% (i.e. 8723/11 281). Results obtained applying the log-linear approach were similar, although the fitting of this model was not adequate. CONCLUSIONS: Cross-linking data from four different sources and applying the capture-recapture method can improve the accuracy of the estimates of the dimensions of the HIV epidemic.     

The postwar hospitalization experience of Gulf War veterans participating in U.S. health registries

In response to concerns that Gulf War veterans were experiencing increased morbidity resulting from wartime exposures in the Gulf War, the Department of Veterans Affairs and the Department of Defense (DoD) initiated clinical registries to provide systematic health evaluations for self-referred Gulf War veterans. The authors used Cox's proportional hazard modeling with data from all DoD hospitals to estimate the probability of hospitalization resulting from any cause, resulting from diagnosis in a major diagnostic category, and resulting from a specific diagnosis of interest. After adjusting for other risk factors, registry participants were 1.43 times more likely to have a postwar hospitalization than registry nonparticipants (95% confidence interval, 1.40-1.46). These findings support the hypothesis that registry participants were more likely to experience postwar morbidity than veterans who chose not to enroll in the health registries.     

Estimating the sensitivity and specificity of matching name-based with non-name-based case registries

Because non-name-based case registries have recently been used for reporting human immunodeficiency virus infection, this study attempted to define the sensitivity, specificity and accuracy of case registry matches using non-name-based registries. The AIDS, sexually transmitted disease (STD), and tuberculosis (TB) case registries were matched using all available information to establish the standard. The registries were then matched again using five increasingly less specific criteria to compare sensitivity, specificity and accuracy. The registries were then also transformed into non-name-based codes as if they were the HIV registry and matched again. With name-based registries, sensitivities increased as the matching criteria became less exacting, while the accuracy declined slightly. Specificities remained close to 100% due to the relatively small number of matched cases. Results from matches of non-name-based registry matches were similar to those of the name-based registry matches. Non-name reporting can be used for data matching with acceptable accuracy.     

An overview of existing mesothelioma registries worldwide,and the need for a US Registry

The association between asbestos exposure, mainly in occupational settings, and malignant mesothelioma has been well established; this has prompted several countries to establish mesothelioma epidemiologic surveillance programs often at the request of national agencies. This review compares currently existing mesothelioma registries worldwide to develop a concept model for a US real-time case capture mesothelioma registry. Five countries were identified with a mesothelioma specific registry, including Italy, France, UK, Australia, and South Korea. All, except the UK, used interviews to collect exposure data. Linkage with the national death index was available or was in future plans for all registries. The registries have limited information on treatment, quality of life, and other patient-centered outcomes such as symptoms and pain management. To thoroughly collect exposure data, “real-time” enrollment is preferable; to maximize the capture of mesothelioma cases, optimal coverage, and a simplified consent process are needed.     

Ten years and 100,000 participants later: occupational and other factors influencing participation in US Gulf War health registries

For more than a decade after the Gulf War, there has been concern that wartime exposures have resulted in significant morbidity among Gulf War veterans. After the end of the war, the Department of Veterans Affairs (VA) and the Department of Defense (DoD) initiated health registries to provide systematic clinical evaluations of Gulf War veterans who chose to participate. By September 1999, there were 32,876 participants in the DoD Comprehensive Clinical Evaluation Program and 70,385 participants in the VA Gulf War Registry Health Examination Program. We identified demographic and military service factors, as well as potential war-related exposures associated with subsequent registry participation after 10 years of observation. Veterans potentially exposed to oil well fire smoke, those near Khamisiyah, Reserve and National Guard, Army veterans, and veterans in the theater of operations during intense combat periods were most likely to elect to participate in a registry. These findings support the hypothesis that certain occupational factors and wartime exposures may influence subsequent health care-seeking behavior.     

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.     

Evaluation and implementation of public health registries

A rapid proliferation of registries has occurred during the last 20 years. Given the long-term commitment of resources associated with registries and limited public health funding, proposals for new registries should be carefully considered before being funded. A registry is defined as a data base of identifiable persons containing a clearly defined set of health and demographic data collected for a specific public health purpose. Criteria for evaluating whether a registry is needed, feasible, or the most effective and efficient means of collecting a specific set of health data are presented. They include an evaluation of the stated purpose; a review of the function, duration, and scope of the registry; consideration of existing alternative data sources; an assessment of the practical feasibility of the registry; the likelihood of sufficient start-up and long-term funding; and an evaluation of the cost effectiveness of the registry. Creating a public health registry is a complex process. A range of technical and organizational skills is required for a registry to be successfully implemented. Eight requirements are identified as crucial for the successful development of a new registry. They include an implementation plan, adequate documentation, quality control procedures, case definition and case-finding (ascertainment) procedures, determination of data elements, data collection and processing procedures, data access policy, and a framework for dissemination of registry data and findings.     

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.     

Testing electronic algorithms to create disease registries in a safety net system

Electronic disease registries are a critical feature of the chronic disease management programs that are used to improve the care of individuals with chronic illnesses. These registries have been developed primarily in managed care settings; use in safety net institutions-organizations whose mission is to serve the uninsured and underserved-has not been described. We sought to assess the feasibility of developing disease registries from electronic data in a safety net institution, focusing on hypertension because of its importance in minority populations. We compared diagnoses obtained from algorithms utilizing electronic data, including laboratory and pharmacy records, against diagnoses derived from chart review. We found good concordance between diagnoses identified from electronic data and those identified by chart review, suggesting that registries of patients with chronic diseases can be developed outside the setting of closed panel managed care organizations.     

Mapping existing hip and knee replacement registries in Europe

The general shortage of evidence regarding benefits and harms of medical devices has been highlighted following the serious safety concerns with metal-on-metal hip replacements and silicone breast implants and was again pointed out in a recent survey of European Health Technology Assessment institutions. In this context the new European medical device regulation will enforce post-marketing surveillance of existing and new implants. The usefulness of registry data as a source of information for medical device real-world clinical performance and safety has been demonstrated. However, these data might be under-used by researchers and policy makers. One reason for this is the insufficient awareness of their existence. The aim of this review is to provide information to relevant stakeholders on the extent and breadth of the data currently collected in European joint replacement registries. We identified 24 registries, most of them of national coverage. Total numbers of primary total hip and knee replacements included were over 3.1 and 2.5 million records, respectively. The current focus of these registries is on whole-lifespan implant surveillance via revision rate monitoring, quality assessment of surgical and perioperative care, and hospital performance assessment. More recently, national and international comparison and benchmarking have increasingly become part of their endeavors.     

Information Management in Cancer Registries: Evaluating the Needs for Cancer Data Collection and Cancer Research

Cancer registry data collection involves, at a minimum, collecting data on demographics, tumor characteristics, and treatment. A common, identified, and standardized set of data elements is needed to share data quickly and efficiently with consumers of this data. This project highlights the fact that, there is a need to develop common data elements; Surveys were developed for central cancer registries (CCRs) and cancer researchers (CRs) at NCI-designated Cancer Centers, in order to understand data needs. Survey questions were developed based on the project focus, an evaluation of the research registries and database responses, and systematic review of the literature. Questions covered the following topics: 1) Research, 2) Data collection, 3) Database/ repository, 4) Use of data, 5) Additional data items, 6) Data requests, 7) New data fields, and 8) Cancer registry data set. A review of the surveys indicates that all cancer registries’ data are used for public health surveillance, and 96% of the registries indicate the data are also used for research. Data are available online in interactive tables from over 50% of CRs and 87% of CCRs. Some other survey responses indicate that CCR treatment data are not complete for example treatment data, however cancer researchers are interested in treatment variables from CCRs. Cancer registries have many data available for review, but need to examine what data are needed and used by different entities. Cancer Registries can further enhance usage through collaborations and partnerships to connect common interests in the data by making registries visible and accessible.     

Using Hospital Tumor Registries to Identify Research Subjects

Hospital tumor registries may permit efficient identification of relatively large numbers of patients for clinical and health services research. This study investigates the feasibility and cost of using hospital tumor registry data for identifying cancer patients with particular clinical characteristics, corresponding to the protocol entry criteria of four randomly sampled Phase III clinical treatment trials for cancer. We screened tumor registry data on 717 patients diagnosed with cancer in 1997 and 1998 who had been identified and abstracted by the registry of a large academic medical center by April, 1999; and we abstracted the medical records of the 122 patients who passed the registry screen. For each clinical profile, the registry screen eliminated a substantial fraction of patients who did not meet the relevant criteria. Of the patients identified from the tumor registry as potential matches, 41% matched the relevant clinical profile based on detailed medical records review. The cost and effort of the registry-based method were substantially lower than would have been necessary if we had reviewed medical records without the registry screen, suggesting that tumor registry data can be a relatively efficient tool for identifying research subjects.     

Measuring the cost of hospital adverse patient safety events

This paper estimates the excess cost of hospital inpatient care due to adverse safety events in the U.S. Department of Veterans Affairs (VA) hospitals during fiscal year 2007. We measured adverse events according to the Patient Safety Indicator (PSI) algorithms of the Agency for Healthcare Research and Quality. Patient level cost regression analyses were performed using generalized linear modeling techniques. Accounting for the heavily skewed distribution of costs among patients having adverse safety events, results suggested that the excess cost of nine different PSIs for VA patients are much higher than previously estimated. We tested sensitivity of results to whether costs were measured by VA's Decision Support System (DSS) that uses local costs of specific inputs, or by the average costing system developed by VA's Health Economics Resource Center. DSS costing appeared to better characterize the high cost patients.     

Cross-matching TB and AIDS registries: TB patients with HIV co-infection, United States, 1993-1994.

OBJECTIVES: Because of limited reporting of HIV status in case reports to the national tuberculosis (TB) surveillance system, the authors conducted this study to estimate the proportion of US TB cases with HIV co-infection and to describe demographic and clinical characteristics of co-infected patients. METHODS: The 50 states, New York City, and Puerto Rico submitted the results of cross-matches of TB registries and HIV-AIDS registries. The authors determined the number of TB cases reported for 1993-1994 that were listed in HIV-AIDS registries and analyzed data on demographic and clinical characteristics by match status. RESULTS: Of 49,938 TB cases reported for 1993-1994, 6863 (14%) were listed in AIDS or HIV registries. The proportions of TB-AIDS cases among TB cases varied by reporting area, from 0% to 31%. Anti-TB drug resistance was higher among TB-AIDS cases, particularly resistance to isoniazid and rifampin (multidrug resistance) and rifampin alone, In some areas with low proportions of multidrug-resistant TB cases, however, the difference in multidrug resistance between TB-AIDS patients and non-AIDS TB patients was not found. CONCLUSIONS: The proportion of TB cases with HIV co-infection, particularly in some areas, underscores the importance of the HIV-AIDS epidemic for the epidemiology of TB. Efforts to improve HIV testing as well as reporting of HIV status for TB patients should continue to ensure optimum management of coinfected patients, enhance surveillance activities, and promote judicious resource allocation and targeted prevention and control activities.     

Socioeconomic misclassification in Ontario's Health Care Registry

BACKGROUND: Addresses in some provincial health care registries are not systematically updated. If individuals are attributed to the wrong location, this can lead to errors in health care planning and research. Our purpose was to investigate the accuracy of socioeconomic classification based on addresses in Ontario's provincial health care registry. METHODS: The study setting was Toronto's inner city, an area with a population of 799,595 in 1996. We ordered enumeration areas by 1996 mean household income and divided them into five roughly equal income groups by population. We then assigned an income quintile to each individual using both the address from Ontario's provincial heath care registry and that from hospital discharge abstracts. We compared these two sets of income quintiles and also used them to generate quintile-specific rates of medical hospital admissions in the year 2000. RESULTS: Provincial registry and hospital-based addresses agreed on the exact enumeration area for 78.1% of individuals and for income quintile for 84.8% of individuals. Disagreement by more than one income quintile occurred for 7.4% of individuals. The two methods of assigning income quintiles yielded income-specific medical hospitalization rates and rate ratios that agreed within 1%. INTERPRETATION: Although address inaccuracy was found in Ontario's health care registry, serious socioeconomic misclassification occurred at a relatively low rate and did not appear to introduce significant bias in the calculation of hospital rates by socioeconomic group. Updating of addresses at regular intervals is highly desirable and would result in improved accuracy of provincial health care registries.     

Role of hospital claims databases from care units for estimating thyroid cancer incidence in the Rhône-Alpes region of France

BACKGROUND: Incidence measures are essentially based on the data collected by cancer registries. Hospital claims databases from care units (PMSI) can be used as a source of information for registries because they contain standard records of most cancer patients. Regarding thyroid cancer, we have evaluated the PMSI as a source of information for the Rh?ne-Alpes thyroid cancer registry and usefulness of PMSI as a tool for surveillance of thyroid cancer incidence. METHODS: Patients with incident thyroid cancer in 2002 were identified in the claims data of the Rh?ne-Alpes region using an algorithm based on DRG codes of thyroidectomy and on diagnosis codes of thyroid cancer in a principal or secondary position. The patients identified were compared to those in thyroid cancer registry of the Rh?ne-Alpes region regarding sex, age, ZIP code of residence, month of discharge and length of stay versus the diagnosis date. When the percentage of cases of claims data identified in the cancer registry and the percentage of cases of the cancer registry identified in claims data were obtained, the capture-recapture method was applied to estimate the number of missing cases and the total number of incident thyroid cancers in the region. RESULTS: 667 patients were identified in claims data while the cancer registry included 677 patients. 95.2% of patients identified in claims data were in the cancer registry and 82.3% of patients in the cancer registry were identified in claims data. Cases lacking in claims data mostly corresponded to micro-cancers which represented 41% of cases in the cancer registry. Regarding cancer above 1 cm, 92% of the cancer registry cases were identified in claims data. Sensitivity of combining information from cancer registry and claims data was 99.2%. Cases lacking in cancer registry, present in claims data base and considered as true cases after obtaining pathological confirmation represented 2% of the whole thyroid cancer population. CONCLUSION: Claims data obtained from anonymous regional or national bases can be helpful for checking the completeness of thyroid cancer registries and to provide a small amount of unknown cases. They can be considered an acceptable tool for surveillance of thyroid cancer incidence. The significance of the variations in incidence that could be observed from claims data remains to be evaluated in comparison with comparable data obtained from registries.     

Monitoring the impact of human papillomavirus vaccines on high-grade pre-invasive cervical lesions: Designing a framework of linked immunization information system and cancer registry data in Michigan

State immunization and cancer registries contain data that, if linked, could be used to monitor the impact of human papillomavirus (HPV) vaccine on cervical cancer and precancer. Michigan is uniquely positioned to examine these outcomes using two population-based resources: the state-wide cancer registry and immunization information system (IIS).We assessed the feasibility of identifying females in the IIS who had continuous Michigan residence and linking them to the cancer registry. We considered continuous residence necessary for future studies of vaccine impact to avoid misclassifying those who may have been immunized while residing out-of-state and whose immunization therefore may not have been reported in Michigan.We identified females with 1976–1996 birthdates in the IIS and used probabilistic linkage software to match them with Michigan birth records. A stratified random sample of IIS-birth matches was provided to a commercial locator service to identify females with continuous Michigan residence. Cervical carcinoma in situ cases diagnosed in 2006 among females aged 10 through 30 years were also matched with the birth records; cancer registry-birth matches were merged with the IIS-birth matches using the birth record identifier.Overall, 68% of the 1274,282 IIS and 61% of the 1358 cancer registry records could be matched with birth records. Among the sample of IIS-birth matches, most (86%) were continuous residents. Seventy percent or more of cancer registry-birth matches merged with IIS-birth matches for cases born after 1984.This is the first effort in the U.S. to show that linking records across IIS and cancer registries is practical and reasonably efficient. The increasing proportion of matches between the registries and live birth file with birth year, and the use of population-based data, strengthen the utility of this approach. Future steps include use of this method to examine incidence of cervical cancer precursors in HPV immunization-eligible females.     

Health reform and the VA medical care system

Although the Department of Veterans Affairs medical care system is literally the largest health care system in the free world, it's value has been largely overlooked in the debate on national health care reform. VA performs essential functions and provides special services that must not be lost in the process of reform. Restructuring the U.S. health care delivery and financing systems will certainly affect VA, therefore any serious plan for reform should specify the VA's role and responsibilities in tomorrow's national health care system.     

Do women simply complain more? National patient injury claims data show gender and age differences

The Swedish Counties Mutual Insurance (LOF) owns and operates the Swedish Patient Insurance Company, (PSR) a no-blame insurance system that compensates patients for injuries that result from errors in medical practice. We combined malpractice claims data (from PSR) with national hospital discharge registry data (National Board of Health and Welfare-Socialstyrelsen) and determined Swedish inpatient malpractice claims rates for the years 1996-2000. Women have higher claims rates than men, but their claims are adjudicated as valid more often than men's claims. The data are consistent with other lines of evidence suggesting poorer quality of care for women, e.g., heart disease, kidney disease, and cancer. Middle-aged (40- to 59-year-old) patients file malpractice claims at almost twice the national rate, whereas patients younger than 19 years and older than 80 years of age file at significantly below the average rate. Differences in claims rates have major financial and quality of care implications. Further studies are needed.