Abstract
BackgroundHigh quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia.Methods52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content.ResultsThe averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%.ConclusionsReadability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation.
Highlights
Informed consent is process whereby patients express their consent or refusal to medical intervention based on information provided by a health care professional regarding the nature and potential consequences of the proposed medical intervention [1]
52 informed consent forms from six Croatian hospitals on the secondary and tertiary healthcare level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content
Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially when Croatian hospitals are undergoing the process of accreditation
Summary
Informed consent is process whereby patients express their consent or refusal to medical intervention based on information provided by a health care professional regarding the nature and potential consequences of the proposed medical intervention [1]. Informed consent forms in Croatia consist of two parts: the statement of acceptance or refusal, and the written information part that provides patient with information regarding recommended diagnostic or therapeutic procedure [3]. The content of the written information part that provides patient with information regarding recommended diagnostic or therapeutic procedure is not defined by the ordinance. This part is left to be drafted by each medical institution with the prior opinion of the medical chamber and with the approval of the Agency for Quality and Accreditation in Health Care and Social Welfare [3].
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