Patients with Hepatitis C Lost to Follow-Up: Ethical-Legal Aspects and Search Results.

Irene Andaluz,Maria del Mar Arcos,Maria Dolores Montero,Pilar Castillo,Luz Martin-Carbonero,Javier Garcia-Samaniego,Miriam Romero,Araceli Garcia,Carmen Busca,Juan Gonzalez,Maria Luisa Montes,Antonio Olveira

Revista Espanola de Enfermedades Digestivas（2020）SCI 4区

Hosp Univ La Paz

Cited 9|Views18

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.

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Key words

Hepatitis C,Lost to follow-up,Medical ethics,Data protection

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