Background/Objectives: The wording of informed consent forms for medical or surgical clinical procedures can be difficult to read and comprehend, making it difficult for patients to make decisions. The objective of this study was to analyze the readability of informed consent forms for medical or surgical clinical procedures. Methods: A systematic review was performed according to the PRISMA statement using PubMed, Embase, and Google Scholar databases. Primary studies analyzing the readability of informed consent forms using mathematical formulas published in any country or language during the last 10 years were selected. The results were synthesized according to the degree of reading difficulty to allow for the comparison of the studies. Study selection was performed independently by the reviewers to avoid the risk of selection bias. Results: Of the 664 studies identified, 26 studies were selected that analyzed the legibility of 13,940 forms. Of these forms, 76.3% had poor readability. Of the six languages analyzed, only English, Spanish, and Turkish had adapted readability indexes. Flesch Reading Ease was the most widely used readability index, although it would be more reliable to use language-specific indices. Conclusions: Most of the analyzed informed consent forms had poor readability, which made them difficult for a large percentage of patients to read and comprehend. It is necessary to modify these forms to make them easier to read and comprehend, to adapt them to each specific language, and to carry out qualitative studies to find out the real legibility of each specific population.
(1) Background: In the current healthcare environment, there is a large proportion of female staff of childbearing age, so, according to existing conflicting studies, the teratogenic effects that inhalational anesthetics may have on exposed pregnant workers should be assessed. This investigation aims to analyze the teratogenic effects of inhalational anesthetics in conditions of actual use, determining any association with spontaneous abortion or congenital malformations. (2) Methods: A systematic review was carried out according to the PRISMA statement based on PICO (problem of interest–intervention to be considered–intervention compared–outcome) (Do inhalational anesthetics have teratogenic effects in current clinical practice?). The level of evidence of the selected articles was evaluated using the SIGN scale. The databases used were PubMed, Embase, Scopus, Web of Science, Google academic and Opengrey. Primary studies conducted in professionals exposed to inhalational anesthetics that evaluate spontaneous abortions or congenital malformations, conducted in any country and language and published within the last ten years were selected. (3) Results: Of the 541 studies identified, 6 met all inclusion criteria in answering the research question. Since many methodological differences were found in estimating exposure to inhalational anesthetics, a qualitative systematic review was performed. The selected studies have a retrospective cohort design and mostly present a low level of evidence and a low grade of recommendation. Studies with the highest level of evidence do not find an association between the use of inhalational anesthetics and the occurrence of miscarriage or congenital malformations. (4) Conclusions: The administration of inhalational anesthetics, especially with gas extraction systems (scavenging systems) and the adequate ventilation of operating rooms, is not associated with the occurrence of spontaneous abortions or congenital malformations.
(1) Background: The wording of informed consent forms could hinder their comprehension and hinder patients’ autonomous choice. The objective of this study was to analyze the readability and comprehension of anesthesia informed consent forms in a Spanish county hospital. (2) Methods: Descriptive and cross-sectional study carried out on patients who were going to undergo anesthetic techniques. The readability of the forms was analyzed using the INFLESZ tool and their subjective comprehension using an ad hoc questionnaire. (3) Results: The analyzed forms presented a “somewhat difficult” legibility. A total of 44.2% of the patients decided not to read the form, mainly because they had previously undergone surgery with the same anesthetic technique. The language used in the forms was considered inadequate by 49.5% of the patients and 53.3% did not comprehend it in its entirety. A statistically significant negative correlation of age and INFLESZ readability score with the overall questionnaire score was found. A statistically significant association was observed as a function of age and educational level with the different criteria of the questionnaire. (4) Conclusions: The anesthesia informed consent forms presented low readability with limited comprehension. It would be necessary to improve their wording to favor comprehension and to guarantee patients’ freedom of choice.
(1) Background: The informed consent form must contain all the relevant information about the procedure to be performed to guarantee the patient’s freedom to choose. (2) Objective: To analyze the formal quality of, and compliance with informed consent forms in critical care and surgical areas in a county hospital in Spain. (3) Methods: The formal quality of informed consent forms in critical care and surgical areas from the hospital were analyzed, following the established formal quality criteria for informed consent forms. The compliance with specific criteria for each of the operated patients during the period of study was also evaluated. (4) Results: The formal quality of 224 informed consent forms was analyzed from 8 disciplines observing a median of non-compliances of 4 with a minimum of 1 and a maximum of 5, with the most breaches being in verifying the delivery of a copy to the patient and showing contraindications. The compliance of 376 documents from 188 operated patients were assessed, highlighting that the non-complied items were: the personalized risks and complete identification of the patient and the physician. A significant association was found between disciplines analyzed and the identification of the physician and personalized risks, with anesthesia and critical care showing the best compliance. (4) Conclusions: The informed consent forms in critical care and surgical areas were shown to have a deficient formal quality and an inadequate compliance. These deficiencies should be corrected to improve the information received by the patients and to guarantee their freedom to choose. As nurses have a responsibility to ensure that patients are adequately informed about both nursing interventions and care, as well as the surgical treatments they receive, consideration should be given to the possibility of nursing professionals taking the lead in obtaining informed consent.
Background/Objectives: The complexity of modern healthcare requires teamwork. Healthcare teams must be cohesive to ensure efficient and quality care. The objective of this study was to validate the Spanish short version of the Group Environment Questionnaire (GEQ) in undergraduate nursing students undergoing clinical simulation training. Methods: The psychometric properties of the questionnaire were analyzed. We began with a statistical analysis of the items. Internal consistency was assessed using McDonald’s omega coefficient. Test-retest reliability was determined using Spearman’s correlation coefficient. An exploratory factor analysis was performed using the principal components analysis method with varimax rotation. Finally, a confirmatory factor analysis of the proposed theoretical models was performed to select the most appropriate one using the weighted least squares method adjusted for mean and variance (WLSMV) and goodness-of-fit indices. Results: The questionnaire items showed a standard deviation higher than 1 and a negative skewness lower than 0.5. Internal consistency and test-retest reliability were higher than 0.8. The item-total correlation coefficient values were above 0.44. The exploratory factor analysis confirmed the presence of four factors, each with three items. Confirmatory factor analysis determined that the four-factor cohesion model was the one that obtained the best fit. Conclusions: The Spanish short version of the Group Environment Questionnaire (GEQ) is a valid and reliable instrument for analyzing group cohesion in teams of nursing students undergoing clinical simulation training.
(1) Background: Because of their direct and continuous contact with the patient, nurses play a relevant role in ensuring that informed consent forms are complete and easy to read and comprehend. The objective of this study was to analyze the legibility and formal quality of informed consent forms for non-surgical procedures in a county hospital. (2) Methods: The readability of these forms was analyzed using the INFLESZ scale and the information they provided according to the formal quality criteria established for these forms. (3) Results: Readability was difficult in 78.08% of the forms analyzed. No form fulfilled all the criteria, the most non-compliant being the non-appearance of the verification of delivery of a copy to the patient (100%), the contraindications (94.59%), and the alternatives (83.78%) of the procedure. Statistically significant differences were observed between disciplines with respect to the INFLESZ readability score and the formal quality score, but no statistically significant correlation was found between the two scores. (4) Conclusions: The informed consent forms for non-surgical procedures analyzed presented mostly difficult readability and poor formal quality, making it difficult for patients to have understandable and complete information. Nursing professionals should be actively involved in their improvement to facilitate patient decision making.
About Me
Medical Degree. Family and Community Medicine Specialist.
Medical Degree. Family and Community Medicine Specialist.