Jaramillo Vélez Andrea G, Aguas Compaired Margarita, Granados Plaza Montserrat, Mariño Eduardo L, Modamio Pilar
Unidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica, y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona, Spain.
Unidad de Farmacia Clínica y Atención Farmacéutica, Departamento de Farmacia y Tecnología Farmacéutica, y Fisicoquímica, Facultad de Farmacia y Ciencias de la Alimentación, Universidad de Barcelona, Barcelona, Spain; Comité Ético de Investigación con medicamentos (CEIm) Idcsalud a Catalunya, Hospital Universitari General de Catalunya, Sant Cugat del Vallès, Barcelona, Spain.
Farm Hosp. 2023 Mar-Apr;47(2):T64-T68. doi: 10.1016/j.farma.2023.01.002. Epub 2023 Mar 16.
The activity of sponsors and Ethics Committees for Research with medicines has increased in recent years. The objective was to design and validate 2 instruments to analyze and evaluate the formal quality of the patient information sheet and the informed consent form of clinical trials with drugs, in accordance with the legislation.
Design (Guideline for good clinical practice and European and Spanish regulations); validation (Delphi method and expert consensus: concordance ≥ 80%); reliability (inter-observer method, Kappa index). 40 patient information sheets/informed consent forms were evaluated.
Very good concordance was obtained in both checklists (k ≥ 0.81, p b 0.001). The final versions consisted of checklist-patient information sheet: 5 sections, 16 items and 46 sub-items; and checklist-informed consent form: 11 items.
The instruments developed are valid, reliable and facilitate the analysis, evaluation, and decision-making on the patient information sheets/informed consent forms of clinical trials with drugs.
