[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]. / Conocimiento, implementación y opinión acerca del consentimiento informado por escrito de las enfermeras de atención primaria: proyecto piloto CONOSER.

OBJECTIVE: To know the knowledge, implementation and opinion on informed consent of generalist nurses, specialists and primary care residents. DESIGN: Descriptive cross-sectional study using an online self-administered 'ad hoc' questionnaire. SETTING: Primary care nurses in Madrid, from November 2020 to March 2021. PARTICIPANTS: Sample of 114 nurses: 91 generalist, 20 specialists and 3 residents. MAIN MEASUREMENTS: Sociodemographics, knowledge, implementation and opinion. RESULTS: The response rate was 27.7%. As a general rule, 48.2% indicated that informed consent was collected verbally, as established by law, with differences being found between categories, this percentage being higher in specialists and residents (P=0.004), and within specialists in those who had obtained their speciality by internal resident nurse (IRN) (P<0.0001). In addition, specialists and residents were those who most identified the legal norm regulating informed consent (P<0.0001). In terms of implementation and opinion, all groups obtained similar results. DISCUSSION: There are no previous studies that have analysed these aspects of informed consent comparing the different categories. Studies from other healthcare and geographical areas show that nurses have greater knowledge, although the demand for specific training in bioethics and biolaw is greater in the nurses participating in this study. CONCLUSIONS: Nurses have adequate knowledge about informed consent, use it in clinical practice and have an appropriate conception of it, being higher in some items in specialist nurses IRN and in residents.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension.

BACKGROUND: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. OBJECTIVE: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. RESULTS: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. CONCLUSION: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

ANTECEDENTES: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. OBJETIVO: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. RESULTADOS: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. CONCLUSIÓN: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Readability analysis of informed consent forms for genetic tests in Mexico.

INTRODUCTION: Knowing if the document that supports the informed consent (IC) granted by the patient who undergoes genetic laboratory tests is legible and understandable is important. OBJECTIVE: To analyze the readability of IC documents for laboratory genetic tests (LGT) in Mexico. METHODS: Readability of 10 free IC forms on the internet used for LGT was analyzed using the Legible.es program; the Flesh index, Fernández-Huerta version, and the INFLESZ scale were evaluated. The number of syllables, words, phrases, paragraphs and strange words, time to read the document and minimum years of education required to understand it were counted. RESULTS: 60 % of the analyzed IC documents were found to have poor readability. On average, 3,290 syllables, 1,459 words, 124 sentences, 58 paragraphs and 52 strange words were counted. The time required for reading it was seven minutes and minimum level of education to understand it was six years. CONCLUSIONS: The analyzed IC forms for LGT have low readability rates and exceed the recommended number of words. We propose an IC model for LGT in Mexico that complies with appropriate readability indexes for a correct understanding of the document.

INTRODUCCIÓN: Es importante conocer si el documento que ampara el consentimiento informado (CI) del paciente a quien se le realizan pruebas genéticas de laboratorio (PGL) es legible y comprensible. OBJETIVO: Analizar la legibilidad de documentos de consentimiento informado (CI) para pruebas genéticas de laboratorio (PGL) en México. MÉTODOS: Se analizó la legibilidad de 10 formatos de CI libres en internet utilizados para PGL mediante el programa Legible.es; se evaluó índice de Flesh, versión de Fernández Huerta, y la escala INFLESZ. Se contabilizó el número de sílabas, palabras, frases, párrafos y palabras raras, tiempo para leer el documento y años de escolaridad mínima para entenderlo. RESULTADOS: Se identificó que 60 % de los formatos de CI analizados son poco legibles. En promedio, se contabilizaron 3290 sílabas, 1459 palabras, 124 frases, 58 párrafos y 52 palabras raras. El tiempo requerido para la lectura fue de siete minutos y la escolaridad mínima de seis años. CONCLUSIONES: Los formatos de CI analizados tuvieron bajos índices de legibilidad y exceden el número recomendado de palabras. Proponemos un modelo de CI para PGL en México, que cumple con los índices de legibilidad para la correcta comprensión del documento.

Informed consent: its importance for retrolective research and medical science progress.

In retrolective research, the information necessary to answer the research question is directly generated from medical records and other clinical-documentary sources. This article analyzes the waiver of informed consent and privacy notice when research is retrolective, from which two lines of argument emerge: one is the physician's duty to protect patient dignity, integrity, right to self-determination and privacy, as well as the confidentiality of the information obtained from him; the other is retrolective research contribution to the control of diseases and society's health improvement. Waiver of informed consent or privacy notice documented in the medical record is important for retrolective research, but it has ethical implications for researchers who do not comply with the rationality and personal responsibility they have before society.

En la investigación retrolectiva, la información necesaria para responder la pregunta de investigación se genera directamente de expedientes clínicos y de otras fuentes clínico-documentales. Este artículo analiza la dispensa del consentimiento informado y el aviso de privacidad cuando la investigación es retrolectiva, de lo cual emergen dos líneas de argumentación: una es el deber del médico de proteger la dignidad, la integridad, el derecho a la autodeterminación, la intimidad del enfermo y la confidencialidad de la información obtenida de él; la otra es la contribución de las investigaciones retrolectivas al control de las enfermedades y a la mejora de la salud de la sociedad. La dispensa del consentimiento o el aviso de privacidad en el expediente clínico es importante para la investigación retrolectiva, pero tiene implicaciones éticas para los investigadores que no cumplan con la racionalidad y responsabilidad personal que tienen ante la sociedad.

National survey on the indicators of quality in Bioethics of the SEMICYUC in the departments of Intensive Care Medicine in Spain. / Encuesta nacional sobre los indicadores de calidad en Bioética de la SEMICYUC, en los servicios de Medicina Intensiva en España.

INTRODUCTION: Multiple interventions are performed in critical patients admitted to Intensive Care Units (ICUs). This study explores the presence in the daily practice of ICUs of elements related to the 6 bioethics quality indicators of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and the participation of their members in the hospital ethics committees. MATERIALS AND METHODS: A multicenter observational study was carried out, using a survey exploring descriptive aspects of the ICUs, with 25 questions related to bioethics quality indicators, and assessing the participation of ICU members in the hospital ethics committees. The ICUs were classified by size (larger or smaller than 10 beds) and type of hospital (public/private-public concerted center, with/without teaching). RESULTS: The 68 analyzed surveys revealed: daily informing of the family (97%), carried out in the information room (82%); end-of-life care protocols (44%); life support limitation form (48.43%); and physical containment protocol (40%). Compliance with the informed consent process referred to different procedures is: tracheostomy (92%), vascular procedures (76%), and extrarenal clearance (25%). The presence of ICU members in the hospital ethics committee is currently frequent (69%). CONCLUSIONS: Information supplied to relatives is adequate, although there are ICUs without an information room. Compliance with the informed consent requirements of various procedures is insufficient. The participation of ICU members in the hospital ethics committees is frequent. The results obtained suggest a chance for improvement in the bioethical quality of the ICU.

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners]. / Ensayos clínicos y consentimiento informado: visión de investigadores, pacientes y médicos de familia.

OBJECTIVE: Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. DESIGN: A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. SETTING: GPs, researchers and patients involved in clinical trials. PARTICIPANTS: Included, 504 GPs, 108 researchers, and 71 patients. RESULTS: Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. CONCLUSIONS: GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.

Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law. / Autonomía, consentimiento y responsabilidad. Parte II. El consentimiento informado en la medicina asistencial y en la jurisprudencia.

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent. / Autonomía, consentimiento y responsabilidad. Parte 1: limitaciones del principio de autonomía como fundamento del consentimiento informado.

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility.

Participation in medical research as a resource-seeking strategy in socio-economically vulnerable communities: call for research and action.

The freedom to consent to participate in medical research is a complex subject, particularly in socio-economically vulnerable communities, where numerous factors may limit the efficacy of the informed consent process. Informal consultation among members of the Switching the Poles Clinical Research Network coming from various sub-Saharan African countries, that is Burkina Faso, The Gambia, Rwanda, Ethiopia, the Democratic Republic of Congo (DRC) and Benin, seems to support the hypothesis that in socio-economical vulnerable communities with inadequate access to health care, the decision to participate in research is often taken irrespectively of the contents of the informed consent interview, and it is largely driven by the opportunity to access free or better quality care and other indirect benefits. Populations' vulnerability due to poverty and/or social exclusion should obviously not lead to exclusion from medical research, which is most often crucially needed to address their health problems. Nonetheless, to reduce the possibility of exploitation, there is the need to further investigate the complex links between socio-economical vulnerability, access to health care and individual freedom to decide on participation in medical research. This needs bringing together clinical researchers, social scientists and bioethicists in transdisciplinary collaborative research efforts that require the collective input from researchers, research sponsors and funders.

[The adaptation and validation to Spanish of the questionnaire Aid to Capacity Evaluation (ACE), for the assessment of the ability of patients in medical decision-making]. / Adaptación y validación al español del cuestionario Aid to Capacity Evaluation (ACE) , para la valoración de la capacidad del paciente en la toma de decisiones médicas.

OBJECTIVE: To adapt and validate the Spanish version of the Aid to Capacity Evaluation scale, designed to assess the capacity of the adult in medical decision-making, both in diagnosis and treatment processes. DESIGN: Observational study of prospective validation. SETTING: Primary and hospital care of the basic health area of Jaen. PARTICIPANTS: One hundred twenty-nine patients. MAIN MEASUREMENTS: Questionnaire which included sociodemographic variables, concerning the decision (scope, type of decision, the need for written informed consent), assessment of the capacity to the Aid to Capacity Evaluation scale and other related comorbidity (hearing loss, alcoholism, cognitive level variables with the Mini-Mental State Examination and depression by Goldberg or Yesavage test). RESULTS: The tool is considered viable. The conclusions of the expert panel were favorable. The result of the criteria' validity, comparing the results with the assessment of the experts (forensic and psychiatrist) was very satisfying (P<.001). The intra-observer reliability was low (kappa=0,135). Interobserver reliability remained high (kappa=0.74). The internal consistency was awarded an alpha of Cronbach's 0,645 for the reduced model of 6 items. CONCLUSIONS: The Aid to Capacity Evaluation scale was adapted to Spanish, demonstrating adequate internal consistency and construct validity. Its use in clinical practice could contribute to the identification of patients unable to make a particular medical decision and/or to give an informed consent.

Informed consent in colonoscopy: A comparative analysis of 2 methods.

BACKGROUND: The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. MATERIALS AND METHODS: A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. RESULTS: The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). CONCLUSIONS: The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure.

Informed consent comprehension in African research settings.

OBJECTIVE: Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. METHODS: We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. RESULTS: Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. CONCLUSIONS: Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure.

[Readability of surgical informed consent in Spain]. / Legibilidad del consentimiento informado quirúrgico en España.

INTRODUCTION: To assess the readability of informed consent documents (IC) of the different national surgical societies. METHODS: During January 2012 we collected 504 IC protocols of different specialties. To calculate readability parameters the following criteria were assessed: number of words, syllables and phrases, syllables/word and word/phrase averages, Word correlation index, Flesch-Szigriszt index, Huerta Fernández index, Inflesz scale degree and the Gunning-Fog index. RESULTS: The mean Flesch-Szigriszt index was 50.65 ± 6,72, so readability is considered normal. There are significant differences between specialties such as Urology (43.00 ± 4.17) and Angiology and Vascular Surgery (63.00 ± 3.26, P<.001). No IC would be appropriate for adult readability according to the Fernández-Huerta index (total mean 55.77 ± 6.57); the IC of Angiology and Vascular Surgery were the closest ones (67.85 ± 3.20). Considering the Inflesz scale degree (total mean of 2.84 ± 3,23), IC can be described as «somewhat difficult¼. There are significant differences between the IC of Angiology and Vascular Surgery (3.23 ± 0.47) that could be qualified as normal, or Cardiovascular Surgery (2.79 ± 0.43) as «nearly normal readability¼; and others such as Urology (1, 70 ± 0.46, P<.001) and Thoracic Surgery (1.90 ± 0.30, P<.001), with a readability between «very¼ and «somewhat¼ difficult. The Gunning-Fog indexes are far from the readability for a general audience (total mean of 26.29 ± 10,89). CONCLUSIONS: IC developed by scientific societies of different surgical specialties do not have an adequate readability for patients. We recommend the use of readability indexes during the writing of these consent forms.

Informed consent in urology.

Appropriate professional practice includes the diagnostic and treatment process of urologic pathology, as well as patient information and respect for patient autonomy in decision making. Informed consent is the gradual process of providing information to the patient and their subsequent decision making. The informed consent document (ICD), when required, demonstrates that information has been provided sufficiently in advance to allow for the patient's deliberation. The dual need for simple yet complete documents make the preparation of adequate ICDs extremely difficult. If the information process is not carried out properly, the professional may incur a medical malpractice liability that is treated as a loss of opportunity. To avoid such situations, the work of scientific societies in the preparation, accessibility, and dissemination of ICD models is fundamental.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

[Colonoscopy quality control as a requirement of colorectal cancer screening]. / Controles de calidad de la colonoscopia como requisito de las campañas de cribado del cáncer colorrectal.

The strategies used in population-based colorectal screening strategies culminate in colonoscopy and consequently the success of these programs largely depends on the quality of this diagnostic test. The main factors to consider when evaluating quality are scientific-technical quality, safety, patient satisfaction, and accessibility. Quality indicators allow variability among hospitals, endoscopy units and endoscopists to be determined and can identify those not achieving recommended standards. In Spain, the working group for colonoscopy quality of the Spanish Society of Gastroenterology and the Spanish Society of Gastrointestinal Endoscopy have recently drawn up a Clinical Practice Guideline that contains the available evidence on the quality of screening colonoscopy, as well as the basic requirements that must be met by endoscopy units and endoscopists carrying out this procedure. The implementation of training programs and screening colonoscopy quality controls are strongly recommended to guarantee the success of population-based colorectal cancer screening.

[Analysis of informed consent readibility in intensive care]. / Análisis de legibilidad de consentimientos informados en cuidados intensivos.

OBJECTIVE: To analyze the readability of informed consent documents (IC) used in an intensive care department and in the Andalusian Healthcare System (AHS). DESIGN: A descriptive study was carried out. SCOPE: The Intensive Care Unit of a tertiary Hospital, and the AHS. INTERVENTIONS: A review and analysis was made of the existing 14 IC models in the Intensive Care Unit and of another 14 IC models offered by the AHS, using the following readability scores: Flesch, Sentence complexity, LEGIN, Fernández-Huerta, Szigriszt and INFLESZ. RESULTS: Twenty-four IC (85.7%) failed to satisfy some of the indexes, while three (10.7%) did not satisfy any of them. Four documents (14.3%) satisfied all the indexes analyzed, and therefore are easy to understand. Flesch score: satisfied by one of the ICU IC (7.1%) and by three of the AHS documents (21.4%). Sentence complexity score: satisfied by 11 of the ICU IC (78.6%) and by 13 of the AHS documents (92.8%). Fernández-Huerta score: satisfied by four of the ICU IC (28.6%) and by 13 of the AHS documents (92.8%). Szigriszt score: satisfied by two of the ICU IC (14.3%) and by 11 of the AHS documents (64.3%). INFLESZ score: satisfied by two of the ICU IC (14.3%) and by 10 of the AHS documents (71.4%). CONCLUSIONS: The documents analyzed are generally difficult to read and understand by most people, and do not satisfy the basic purpose for which they were drafted.

[Quality of information in the process of informed consent for anesthesia]. / Calidad de la información en el proceso del consentimiento informado para anestesia.

OBJECTIVES: To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. MATERIAL AND METHODS: Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc¼ to assess the quality and comprehensiveness of the information provided in the informed consent. RESULTS: 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. CONCLUSIONS: Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics.

Evaluation of consent forms for clinical practice in Spanish Public Hospitals.

OBJECTIVE: To evaluate the access, development, and quality of consents forms for clinical practice within the Spanish Public Hospitals. METHOD: A cross-sectional study was conducted in a two-stage process (January 2018-September 2021). In stage 1, A nationwide survey was undertaken across all public general hospitals (n=223) in the Spanish Healthcare System. In stage 2, Data was taken from the regional health services websites and Spanish regulations. Health Regional Departments were contacted to verify the accuracy of the findings. Data was analyzed using a descriptive and inferential statistics (frequencies, percentages, Chi-square & Fisher's exact tests). RESULTS: The response rate was 123 (55.16%) of Spanish Public Hospitals. The results revealed 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%). The validation process of consent documentation is not in evidence in 13% of Spanish Hospitals. Regional Informed Consent Committees are not place in the majority (70.7%) of hospitals. Citizens can freely access to consent documents through the regional websites of Andalusia and Valencia only. CONCLUSION: Variability is found on access, development and quality of written consent across the Spanish Public Hospitals. This points to the need for a national informed consent strategy to establish policy, standards and an effective quality control system. National audits at regular intervals are necessary to improve the consistency and compliance of consent practice.

Completion of the informed consent in radioguided surgery by the General Surgery and Nuclear Medicine services of a radioguided surgery unit.

OBJECTIVE: To identify the frequency of errors in informed consent documents in radioguided surgery in a third level hospital and to detect possible causes or factors associated with a greater risk of error. MATERIAL AND METHODS: Informed consent forms of a total of 369 radioguided surgery interventions, completed by the Nuclear Medicine and General Surgery services, were analyzed, and the degree of completion of the forms and its correlation with the physicians responsible, type of pathology, intervention, and waiting time were compared with the completion of consent by another specialty. RESULTS: Errors were identified in 22 consent forms from Nuclear Medicine and 71 from General Surgery. The most common error was the absence of identification of the physician responsible (17 in Nuclear Medicine, 51 in General Surgery), and the second most common was the absence of a document (2 in Nuclear Medicine, 20 in General Surgery). There were significant differences in the errors made depending on the doctor in charge, with no significant correlation with the other variables. CONCLUSIONS: The physicians responsible were the main factor associated with a greater risk of error in the completion of informed consent forms. Further studies are needed to analyze the causal factors and possible interventions to minimize errors.