학술논문

Patients with hepatitis C lost to follow-up: ethical-legal aspects and search results
Document Type
Academic Journal
Source
Revista Espanola de Enfermadades Digestivas (REED). July, 2020, Vol. 112 Issue 7, p532, 6 p.
Subject
España
Language
Spanish
ISSN
1130-0108
Abstract
Introduction: data on the prevalence and characteristics of hepatitis C patients lost to follow-up are lacking. In addition, the identification of this population clashes with data protection regulations. Methods: the identification and contact protocol was submitted to the Health Care Ethics Committee. The protocol was based on anti-HCV serology test results for 2010-2018, which were obtained from the Microbiology Department. In addition, the situation of the patients in the hospital and regional database was analyzed, based on the following classification: a) chronic hepatitis C, if the last HCV RNA determination was positive; b) cured hepatitis C, if the last HCV RNA determination was negative after 12 weeks of treatment; and c) possible hepatitis C, if anti-HCV antibodies were positive with no result for HCV RNA. Lost patients were defined as those with chronic or possible hepatitis C and no follow-up in the Digestive Diseases or Internal Medicine Departments. The patients were contacted by postal mail and then by telephone, so that they could be offered treatment. Results: the Ethics Committee considered that the protocol fulfilled the bioethical principles of autonomy, beneficence, non-maleficence and justice and that contact was ethically desirable. From 4,816 positive anti-HCV serology results, 677 patients were identified who were lost to follow-up (14.06 %; 95 % CI, 13.2-15.2). The mean age was 54 years, 61 % were male, 12 % were foreign born and 95 % were mono-infected. The study of each serology result took 1.3 minutes. One-quarter (25 %) of the losses corresponded to the Digestive Diseases and Internal Medicine Departments. Of the 677 losses, serology testing had only been ordered for 449 patients (66.3 %) and the remaining 228 (33.7 %) also had a positive HCV RNA result. Conclusion: a large number of patients with hepatitis C are lost to follow-up. Searching for and contacting these patients is legally and ethically viable. Keywords: Hepatitis C. Lost to follow-up. Medical ethics. Data protection.
INTRODUCTION Spain aspires to the eradication of the hepatitis C virus (HCV). In fact, Spain is one of the few countries in the world following the road map laid out [...]