Global analysis of the readability of informed consent documents used in hospitals

Analysis of the readability -Three Health Sciences professionals set out to analyze the readability of the consent documents (DCI) used in the Spanish public hospital network. Its objective was to verify that patients in a health decision situation were understandably informed. We share the results and conclusions of this work, which were echoed by the Journal of Healthcare Quality Research (formerly Healthcare Quality Magazine ).

A process that stems from Bioethics
The informed consent process, born from Bioethics, must necessarily be embodied in a series of laws that reflect the best way for professionals to act. Although it emerges as the conjunction of the ethical and legal, informed consent is not understood without emotional implications.

In Spain, in Law 41/2002, of November 14 -regulator of patient autonomy and of rights and obligations regarding information and clinical documentation-, the patient’s rights regarding information are explicit and defines informed consent as “the free, voluntary and conscious compliance of a patient, manifested in the full use of their faculties, after receiving the appropriate information, so that an action that affects their health takes place”.

The written consent collects all the verbal information offered in a document that allows the conformity of the person informed to receive or not receive a certain treatment or health action. Written informed consent must be included in certain cases included in Law 41/2002.

The information offered by the informed consent document (DCI) must be understandable to all citizens, regardless of their educational level. Many authors agreed that currently the information is not offered in the best conditions.

Escudero-Carretero et al. explained it this way: “Often, the information is transferred only verbally during the clinical act and linked to the communication of a diagnosis or a prognosis when people are less receptive and more concerned. Other times too much information is offered, without adapting it or taking care of the emotional implications. On the other hand, the information that professionals select and offer is not always enough or is what their patients want or need. ”

Information transmitted only verbally can often lead to misunderstanding or forgetting. Written information makes it possible to compensate for these deficiencies. Retention and understanding improve significantly when oral information is accompanied by written documentation.

Communication plays a fundamental role since access to truthful and understandable information from the beginning helps to positively face a disease process. In addition, it helps reduce anxiety, counteract fears and dismantle misconceptions, problems that concern professionals when it comes to reporting.

On the other hand, written informed consent must be understandable for the majority of citizens since it is an ethical and moral obligation of the medical professional to offer the patient clear and assimilable information when making a decision on health.

Poor readability of the aforementioned document is considered a sign of poor prognosis of the objective of correctly informing patients. On the other hand, complex concepts often appear in informed consents. A good way to avoid misunderstanding is to offer practical examples or include photos and drawings that, for anatomical allusions, help to facilitate understanding.

There are tables available with criteria to assess the quality of readability. The studies consulted Analysis of the readability of the documents used by different hospitals and services, but in no case was there a current study that analyzed the readability of the DCI of all hospitals in Spain.

Based on the principle of health equity, every citizen, regardless of their place of residence, must be informed correctly. After the bibliographic consultation, the authors observed the need to analyze the readability of the written information in the DCIs offered to citizens residing in Spain, which is why the main objective of the study was to analyze the readability of the DCIs of public hospitals in Spain to verify its intrinsic function of informing in an understandable way when making a health decision.


The main conclusion of the study was that the informed consents of Spain generally have “somewhat difficult” legibility – in 62% of cases -, on the Inflesz * scale. This scale is represented by a type of specialized publication, of scientific dissemination, for a level of Baccalaureate studies, so it gives an idea of ​​the difficulty of understanding for those citizens who do not possess this degree of education.

There is also a great diversity among the DCI of the Autonomous Communities (CC. AA). and also between hospitals of the same CC. AA .; This causes citizens to be exposed to a possible failure in the understanding of the DCI just by residing in a certain place in Spain. The authors suggest that this diversity should be minimized or the standardization of ICDs should be considered.