PhD-student
Signe Freja Storgaard
Infectiouse Disease Department
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 18.08.2025 | |
| Slut | 01.05.2027 | |
Call-In Recruitment and treatment of Hepatitis C diagnosed patients identified in Danish national registers
Short summary
Through registeres we identified individuals infected with Hepatitis C (HCV), a cureable infection since 2014. This project reaches out to these indivduals to offer testing and treatment.
Rationale
In Denmark a new prevalence estimate of HCV in 2022 identified 2,577 individuals living with untreated HCV infection. The estimate was based on different registries cross-linked by a personal identification (PIN) that all registered residents in Denmark have. The population targeted in this study (Call-In) are patients who have been identified from national registers as being possibly infected with HCV as part of a research project estimating the total HCV population in Denmark. These patients were identified in the following registers: Laboratory register (DANVIR), communicable diseases register (SSI) and National Patient Register (LPR), but not in the register of patients who have attended care for hepatitis C (DANHEP/InfCare Hepatitis). Once identified all patients will be contacted and offered treatment and care, directly or via their general practitioner (GP), as we have previously done in the national Danish HCV look-back in the nineties' (10) and in Call-In 1.0 in 2020-2023. This project, Call-In 2.0, is a replica of the Call-In 1.0 project, following the same procedure for identifying and contacting these individuals. In Denmark it is not permitted to contact patients that do no longer attend a clinic (11). However patients may be contacted "if this has a significant importance to the patients' health" according to the current Danish "Dataprotection law" (§10, paragraph 5). The implementations of this have been expressed in different approaches in the five Danish regions in Call-In 1.0. In some regions, clinicians reviewed the clinical records of each patients to assure that the patient could benefit from being contacted, and this identified a significant proportion of patients who did not have Chronic Hepatitis C (In Funen 67% (314/470), in Region Sealand 65% (632/969). In the Capital Region all patients in the register (2536) were contacted directly by letter and informed to contact the Hospital outpatient clinic without prior revision of the clinical records. To contact and evaluate the efficacy of recalling probable Hepatitis C infected individuals with a diagnosis of Hepatitis C found in different registries (Call-In 2.0).
Description of the cohort
All individuals with a valid PIN who had been registered with HCV in one of four national health registers were included. Individuals were excluded if they had received HCV treatment or if their most recent HCV test was negative. Additional exclusions applied to those who were deceased, had emigrated, were lost to follow-up, or were under 18 years of age at the end of follow-up. Reinfected individuals were included, defined as entering date in one of the four sources registers after negative test or treatment The four registers: - Laboratory Register (DANVIR): The Laboratory Register contains information on viral hepatitis tests and results from the mid-90ties to 2023. Initially Laboratory Register covered only 85% of tests in Denmark (14 of the 18 laboratories), but after 2010 all laboratories performing hepatitis C tests were included. The case definition for HCV in Laboratory Register was a positive HCV-RNA result as the most recent test. - Clinical Database (DANHEP and InfCare): The clinical databases DANHEP and InfCare Hepatitis contain information on all patients receiving specialized care for chronic viral hepatitis in Denmark. At the time of data extraction, DANHEP and InfCare were in the process of becoming one database, therefore information on treatment for the eastern part of Denmark from 2020-2022 were manually collected. The case definition for HCV in the clinical databases was the presence of a positive HCV-RNA result as the most recent test or registered as chronic hepatitis C (CHC) and no sustained virological response or DAA (Direct Active Antiviral treatment) recorded. In addition, all treatment information was extracted from this database. HCV treatment was defined based on variables indicating treatment status (registered date for treatment start, end or SVR12), specific antiviral medications. - Communicable Diseases Register (SSI): Since May 2000, mandatory reporting of CHC has been required in Denmark. The responsibility for reporting lies with the diagnosing physician. The case definition in the Communicable Diseases Register follows national guidelines requiring notification of both HCV-RNA and HCV antibody (HCV-Ab) positive cases. However, this register is known to have low coverage, estimated at less than 50%. - National Patient Register (LPR): The National Patient Register captures all hospital contacts in Denmark and has been in operation since 1977. Since 1994, all emergency contacts have also been included. In 2019, the register underwent significant updates, particularly regarding how treatment courses are recorded. The case definition for HCV in this register was the presence of an ICD-10 diagnosis code B18.2, which has been used since 1994. The validity of diagnostic codes in the register was approximately 67% for gastroenterology diseases in 2002.
Data and biological material
See the dispcription above. Furthermore, the database will contain information on responing, when responding and outcome of contact (eg. is treatment offered? Is SVR12 achived?)
Collaborating researchers and departments
All Demartment of Infectious Diseases in Denmark.