Costs of Health Registries: An Exploration for Health Services Research.

Health registries are an established methodology in health services research. Regarded as cheap bidder for observation studies in earlier times, many registries now benefit from an appropriate funding. However, reference figures for costs of registries in health services research are missing. Based on literature data as well as figures from a German funding initiative, the relationship between costs per newly recruited case and the annual sample size was analyzed. One can assume that a standard multicenter registry in health services research with 1,000 new patients each year will be appropriately financed with 1.1 to 2.2 million Euro in a period of five years. So smaller the sample size, so higher the costs for a newly recruited patient. The cost model of health registries should be further elaborated taking into account specifics of individual registries and differences in the level of case money.

Safety and Effectiveness of Debulking for the Treatment of Infrainguinal Peripheral Artery Disease. Data From the Recording Courses of vascular Diseases Registry in 2910 Patients.

We investigated the safety and efficacy of debulking infrainguinal lesions in patients with peripheral artery disease (PAD) undergoing endovascular revascularization (EVR) as part of the RECording Courses of vascular Diseases (RECCORD) registry. Patient and lesion specific characteristics, including the lesion complexity score (LCS) were analyzed. The primary endpoint encompassed: (i) clinical improvement in Rutherford categories, (ii) index limb re-interventions, and (iii) major amputations during follow-up. The secondary endpoint included the need for bail-out stenting. Overall, 2910 patients were analyzed; 2552 without and 358 with debulking-assisted EVR. Patients were 72 (interquartile range (IQR) = 15) years old and 1027 (35.3%) had diabetes. Overall complication rates were similarly low in the debulking vs the non-debulking group (4.7 vs 3.2%, P = .18). However, peripheral embolizations rates were low but more frequent with debulking vs. non-debulking procedures (3.9 vs 1.1%, P < .001). After adjustment for clinical and lesion-specific parameters, including LCS, no differences were noted for the primary endpoint (odds ration (OR) = 0.99, 95%CI = 0.69-1.41, P = .94). Bail-out stenting was less frequently performed in patients with debulking-assisted EVR (OR = 0.5, 95%CI = 0.38-0.65, P < .0001). Debulking-assisted EVR is currently used in ∼12% of EVR with infrainguinal lesions and is associated with lower bail-out stent rates but higher peripheral embolization rates; no differences were found regarding index limb re-intervention and amputation rates.

Coding Diagnoses from the Electronic Death Certificate with the 11th Revision of the International Statistical Classification of Diseases and Related Health Problems: An Exploratory Study from Germany.

The 11th Revision of the International Statistical Classification of Diseases, Injuries, and Causes of Death (ICD-11) will replace its predecessor as international standard for cause-of death-statistics. The digitization of healthcare is a main motivation for its introduction. In parallel, the replacement of the paper-based death certificate with an electronic format is under evaluation. At the moment, the death certificate is used in paper-based format with ICD-10 for coding in Germany. To be prepared for the switch to ICD-11, the compatibility between ICD-11 and the electronic certificate should be assured. Objectives were to check the appropriateness of diagnosis-related information found on death certificates for an ICD-11 coding and to describe enhancements to the certificate's structure needed to fully utilize the strengths of ICD-11. As part of an exploratory test of a respective application, information from 453 electronic death certificates were provided by one local health authority. From a sample of 200 certificates, 433 diagnosis texts were coded into the German version of ICD-11. The appropriateness of the results as well as the further requirements of ICD-11, particularly with regard to post-coordination, were checked. For 430 diagnosis texts, 649 ICD-11 codes were used. Three hundred and sixty two diagnosis texts were rated as appropriately represented through the coding result. Almost all certificates contained diagnosis texts that lacked details required by ICD-11 for a precise coding. The distribution of diseases was very similar between ICD-10 and ICD-11 coding. A few gaps in ICD-11 were identified. Information requested by ICD-11 for a mandatory post-coordination were almost entirely absent from the death certificates. The structure and content of the death certificate are currently not well prepared for an ICD-11 coding. Necessary information was frequently missing. The line-oriented structure of death certificates has to be supplemented with a more flexible approach. Then, the semantic knowledge base of ICD-11 should better guide the content related input fields of a future electronic death certificate.

Recommended data elements for health registries: a survey from a German funding initiative.

BACKGROUND: The selection of data elements is a decisive task within the development of a health registry. Having the right metadata is crucial for answering the particular research questions. Furthermore, the set of data elements determines the registries' readiness of interoperability and data reusability to a major extent. Six health registries shared and published their metadata within a German funding initiative. As one step in the direction of a common set of data elements, a selection of those metadata was evaluated with regard to their appropriateness for a broader usage. METHODS: Each registry was asked to contribute a 10%-selection of their data elements to an evaluation sample. The survey was set up with the online survey tool "LimeSurvey Cloud". The registries and an accompanying project participated in the survey with one vote for each project. The data elements were offered in content groups along with the question of whether the data element is appropriate for health registries on a broader scale. The question could be answered using a Likert scale with five options. Furthermore, "no answer" was allowed. The level of agreement was assessed using weighted Cohen's kappa and Kendall's coefficient of concordance. RESULTS: The evaluation sample consisted of 269 data elements. With a grade of "perhaps recommendable" or higher in the mean, 169 data elements were selected. These data elements belong preferably to groups' demography, education/occupation, medication, and nutrition. Half of the registries lost significance compared with their percentage of data elements in the evaluation sample, one remained stable. The level of concordance was adequate. CONCLUSIONS: The survey revealed a set of 169 data elements recommended for health registries. When developing a registry, this set could be valuable help in selecting the metadata appropriate to answer the registry's research questions. However, due to the high specificity of research questions, data elements beyond this set will be needed to cover the whole range of interests of a register. A broader discussion and subsequent surveys are needed to establish a common set of data elements on an international scale.