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University of Copenhagen, Roskilde, Clinicians and Researchers The Danish National Chronic Myeloid Neoplasia Registry Bak, Marie; Ibfelt, Else Helene; Stauffer Larsen, Thomas; Rønnov-Jessen, Dorthe; Pallisgaard, Niels; Madelung, Ann; Udby, Lene; Hasselbalch, Hans Carl; Bjerrum, Ole Weis; Andersen, Christen Lykkegaard Published in: Clinical Epidemiology DOI: 10.2147/CLEP.S99462 Publication date: 2016 Document version Publisher's PDF, also known as Version of record Document license: CC BY-NC Citation for published version (APA): Bak, M., Ibfelt, E. H., Stauffer Larsen, T., Rønnov-Jessen, D., Pallisgaard, N., Madelung, A., Udby, L., Hasselbalch, H. C., Bjerrum, O. W., & Andersen, C. L. (2016). The Danish National Chronic Myeloid Neoplasia Registry. Clinical Epidemiology, 8, 567-572. https://doi.org/10.2147/CLEP.S99462 Download date: 27. sep.. 2021 Clinical Epidemiology Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW The Danish National Chronic Myeloid Neoplasia Registry Marie Bak1 Aim: The Danish National Chronic Myeloid Neoplasia Registry (DCMR) is a population-based Else Helene Ibfelt2 clinical quality database, introduced to evaluate diagnosis and treatment of patients with chronic Thomas Stauffer Larsen3 myeloid malignancies. The aim is to monitor the clinical quality at the national, regional, and Dorthe Rønnov-Jessen4 hospital departmental levels and serve as a platform for research. Niels Pallisgaard5 Study population: The DCMR has nationwide coverage and contains information on patients diagnosed at hematology departments from January 2010 onward, including patients with Ann Madelung6 essential thrombocythemia, polycythemia vera, myelofibrosis, unclassifiable myeloproliferative Lene Udby1 neoplasms, chronic myelomonocytic leukemia, and chronic myeloid leukemia. Hans Carl Hasselbalch1 Main variables: Data are collected using standardized registration forms (so far up to four Ole Weis Bjerrum7 For personal use only. forms per patient), which are consecutively filled out online at time of diagnosis, after 2-year and Christen Lykkegaard 5-year follow-ups, and at end of follow-up. The forms include variables that describe clinical/ 1,7 Andersen paraclinical assessments, treatment, disease progression, and survival – disease-specific variables 1Department of Hematology, Zealand – as well as variables that are identical for all chronic myeloid malignancies. University Hospital, University of Descriptive data: By the end of 2014, the DCMR contained data on 2,690 patients with an Copenhagen, Roskilde, 2Research Centre for Prevention and Health, inclusion rate of ∼500 patients each year. Since the registry was established, annual reports Rigshospitalet Glostrup, University of have shown consistently high national coverage and data completeness, $90% and $88%, 3 Copenhagen, Glostrup, Department respectively. of Hematology, Odense University Hospital, Odense, 4Department of Conclusion: The DCMR is a national database used for monitoring the quality of patient care Hematology, Vejle Hospital, Vejle, in patients with chronic myeloid malignancies, but until validation has been conducted, the 5 Department of Surgical Pathology, data must be used with caution. However, the DCMR is a valuable data source accessible to Clinical Epidemiology downloaded from https://www.dovepress.com/ by 130.225.178.2 on 06-Jan-2018 Zealand University Hospital, University of Copenhagen, Roskilde, clinicians and researchers. 6Department of Surgical Pathology, Keywords: myeloproliferative disorders, database, treatment, health care quality assurance, Zealand University Hospital, outcome assessment, epidemiology, research University of Copenhagen, Næstved, 7Department of Hematology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Introduction The Danish National Chronic Myeloid Neoplasia Registry (DCMR) was established on January 1, 2010, to monitor the clinical quality of diagnosis and treatment in patients with chronic myeloid malignancies. This population-based clinical quality database with nationwide coverage contains information on patients with essential Correspondence: Marie Bak thrombocythemia, polycythemia vera, myelofibrosis, unclassifiable myeloprolifera- Department of Hematology, Zealand tive neoplasms, chronic myelomonocytic leukemia, and chronic myeloid leukemia. University Hospital, University of The DCMR is part of the Danish Common Hematological Database established by Copenhagen, Sygehusvej 10, 4000 Roskilde, Denmark the Danish Society of Hematology, to evaluate patients with various hematological Tel +45 4732 4894 malignancies and to ensure the quality of diagnostic evaluation, treatment, and patient Fax +45 4732 4890 Email [email protected] care at the national level, as well as in each hematology department. submit your manuscript | www.dovepress.com Clinical Epidemiology 2016:8 567–572 (Thematic series on clinical quality databases in Denmark) 567 Dovepress © 2016 Bak et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you http://dx.doi.org/10.2147/CLEP.S99462 hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Bak et al Dovepress Aim of the database version 9.2 (SAS Institute Inc, Cary, NC, USA). The entered The aim of the DCMR is to collect information on patients data are securely stored electronically. The online registra- with different subtypes of chronic myeloid malignancies, to tion system is easily accessible from every department in gain insight into disease epidemiology, and to characterize Denmark, and physicians do not need patients’ consent when patients by clinical and paraclinical evaluation at predefined entering data. Data are collected from patients’ pathology and intervals throughout the course of the cancers. The DCMR laboratory reports, medical files, and assessments by the con- enables nationwide monitoring of the quality of diagnosis sulting hematologists. Trained health care professionals enter and treatment in patients with chronic myeloid malignan- data on all eligible patients into the system manually, using cies in Denmark. As with all government-approved clinical standardized registration forms. Instructions for entering quality databases, a continuous aim is also to ensure cover- data are available online to ensure a homogeneous national age .90% and registration completeness .80% each year, registration. Validation rules, including field and cross-vali- at the national, regional, and hospital departmental levels. dation, restrict what can be entered, and each variable must The database can also be used to compare different patient- be answered before the registration forms can be submitted, and treatment-related outcomes between departments. The thus optimizing the completeness of the registration. DCMR serves as a quality database as well as a research database. Registration forms and main variables For each patient, data collected on up to four registration Study population forms entered at predefined intervals are included in the Danish citizens with chronic myeloid malignancies, referred DCMR so far. The registration algorithm for the DCMR is to hematology departments for evaluation since January 1, shown in Figure 1. The different forms contain detailed infor- 2010, are eligible for registration in the DCMR. All nine mation on administrative and clinical data. Main variables hematology departments in Denmark are obliged to collect are shown in Table 1. At time of diagnosis, the department and enter data. Patients diagnosed or treated outside Denmark that verifies the diagnosis enters the first registration form For personal use only. are included only if their treatment is continued in Denmark. (Registration Form), which must be entered within 6 months The patients must fulfill the current World Health Organiza- after diagnosis. The form contains information about the tion classification criteria for essential thrombocythemia, diagnosis and date of diagnosis, symptoms, and paraclinical, polycythemia vera, myelofibrosis, unclassifiable myelopro- cytogenetic, and molecular profiles. The second registration liferative neoplasms, chronic myelomonocytic leukemia, or form (the 2-Year Registration Form), entered 2 years after chronic myeloid leukemia to be included in the DCMR.1 diagnosis, includes information on disease progression and The Danish health care system provides free health care the treatment initiated within the first 2 years. The third to all 5.5 million inhabitants,2 which enables nationwide registration form (the 5-Year Registration Form), submitted coverage of the DCMR. In 2009, the Danish Health and 5 years after diagnosis, was introduced in 2015 and includes Clinical Epidemiology downloaded from https://www.dovepress.com/ by 130.225.178.2 on 06-Jan-2018 Medicines Authority introduced the hematological cancer variables related to disease progression, cytogenetic and care packages, as part of the national initiative termed molecular assessment, and treatment. At end of follow- The National Integrated Cancer Pathways.3 The
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