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. 2020 Jul;112(7):532-537.
doi: 10.17235/reed.2020.7077/2020.

Patients with hepatitis C lost to follow-up: ethical-legal aspects and search results

Irene Andaluz García  1 , María Del Mar Arcos Rueda  2 , María Dolores Montero Vega  3 , Pilar Castillo Grau  1 , Luz Martín Carbonero  4 , Javier García-Samaniego Rey  1 , Miriam Romero Portales  1 , Araceli García Sánchez  1 , Carmen Busca Arenzana  2 , Juan González García  2 , María Luisa Montes Ramírez  2 , Antonio Olveira Martín  1
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Free article

Patients with hepatitis C lost to follow-up: ethical-legal aspects and search results

Irene Andaluz García et al. Rev Esp Enferm Dig. 2020 Jul.
Free article

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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