A checklist guide development for adherence and persistence studies in pat ients with hepatitis b

Introduction: Hepatitis B virus infection affects more than two billion people infected worldwide and 350 million suffering from chronic hepatitis B virus. The treatment of chronic hepatitis B suppresses the virus replication but does not eradicate the virus. Patients require long treatment duration to maintain viral suppression. Tenofovir and entecavir are new nucleos(t)ide analogues. They have high genetic barrier to resistance and the therapies are longer. The medication adherence and persistence is very important to promote clinical benefit. Depending on the quality of studies, providers can apply the research to clinical practice. It is necessary a tool for the development and evaluation of the scientific evidence. The aim of this study is to make a checklist for assessing the quality of retrospective studies on adherence and persistence in the treatment of chronic hepatitis B and to apply it to published studies of adherence and persistence currently available. Method: A bibliographic search was carried out using the terms «Patients Compliance», «Retrospective Studies», «Drug Therapy» and «Societies Pharmaceutical ». The studies, which had no connection with the subject of analysis, were excluded. A group of experts designed a checklist based in the definition developed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Medication Compliance and Persistence Work Group. The checklist had five sections: Title and Abstract (0-6), Introduction (0-3), Objectives and Definitions (0-3), Design and Methods (0-34), Presentation and Discussion of findings (0-12) and References (0-2). In order to validate the usefulness of the checklist and determinate the quality of the studies, we apply the checklist to the published studies. Results: The articles that met the established criteria inclusion were four. The quality of them was evaluated using the checklist, and a mean total score of 34 (SD ±3.37) points was obtained. The mean score obtained was 5.18 (SD ±0.48) points in the Title section, 2.75 (SD ±0.5) points in the Introduction section, 2.5 (SD ±0.5) in the Objective and Definitions section, 13 (SD ±3.14) points in the Design and Methods section, 9.75 (SD ±0.21) points in the Presentation and Discussion section and 0.92 (SD ±0.06) points in the References section. Discussion: The designed tool is useful to determine the quality of the studies on adherence and persistence to the treatment of chronic hepatitis B. The quality of the published studies is limited, mainly due to the design and methodology and the bibliography