Evaluación del consentimiento informado en los hospitales públicos españolesestandarización, calidad, accesibilidad y legibilidad

Resumen

ABSTRACT Background: The written consent is a support tool to provide verbal health information, whose quality ensures the individual’s right to make informed and autonomous healthcare decisions. Objective The aims of this PhD dissertation are to evaluate the access, development and quality of the consent forms in the Spanish Public Hospitals and to assess the readability of the documents for decision making in relation to blood transfusion and anesthesia. Method: A descriptive cross-sectional study conducted in a two-stage process. In stage 1, a national survey was undertaken in the Spanish public hospitals (n=223) using the VERGILS questionnaire. This was designed and validated prior to its implementation. Content validation was achieved through an expert panel and a pilot study. In stage 2, a comprehensive analysis of the readability of consent forms for blood transfusion and anesthesia was performed using GraLeTi instrument. This was designed and subjected to an expert panel to validate the theoretical construct. INFLESZ, which is a well-validated instrument, was applied to ascertain the grammatical readability and specific dictionaries were used to identify the technical words. Descriptive and inferential analyses were done using SSPS software version 25. Findings: The response rate was 171 public hospitals (76.23%). The VERGILS questionnaire was completed by 123 hospitals (55.16%) and a total of 85 consent forms were collected, 46 of which were written consents for blood transfusion (n= 126 hospitals, 56.50%) and 39 of which were related to anesthesia (n= 122 hospitals, 54.71%). The results reveal a range of hospital departments involved in the development of consent documents and the absence of a standardized approach to consent forms nationally. Consent audits are undertaken in 43.09% hospitals and translation of written consents into other languages is limited to a minority of hospitals (35.77%). There was no validation process of consent documentation in 13% of Spanish Hospitals. Citizens can freely access to these documents of health decision-making through the websites of Andalusia and Valencia only. These regions had established multidisciplinary committees which are in charge of the standardization, accreditation, updating and quality of consent forms. The global readability of consent forms is not appropriate. The main deficiencies are: font size (x=10.75), abbreviations (x=11.21) and word count (x=1.062 words). The mean of the readability score according to INFLESZ is indicative that consent forms are somewhat difficult to read (blood transfusion x= 51.76; anesthesia x= 49.29). There is a mean of 21 healthcare terminology words in the written consents for anesthesia and 18 technical words in the consent forms for blood transfusion. The standardized written consents of Andalusia and Valencia are statistically related to an improvement in the INFLESZ readability level (transfusion p= 0.001), bigger font size (transfusion p= 0.040; anesthesia p= 0.001) and a high number of technical words defined along the text (transfusion p= 0.001; anesthesia p= 0.001). Conclusion: Variability is found on access, development and quality of written consents across the Spanish Public Hospitals. The readability of the consent forms for blood transfusion and anesthesia is deficient in relation to font size, abbreviations, word count, INFLESZ readability level and score and number of technical words. It is advisable to develop a national informed consent strategy that establishes consent policy and quality standards.