Compromised informed consent due to functional health literacy challenges in Chinese hospitals
Research
Dangui Zhang, Zhilin Hu, Zhuojia Wu, Ting Huang, Tingting Huang, Junhao Liu, Hongkun Sun, William Ba-Thein
BMC Medical Ethics, 23 August 2024
Open access
Abstract
Background
Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study’s aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent.
Methods
In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs —teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05.
Results
The median age (IQR and range) of participants was 35.5 (28 – 49 and 13 – 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments—teach-back, perception, and cognizance—was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent.
Conclusions
This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

CLARA-MeD Tool – A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish
Leonardo Campillos-Llanos, Federico Ortega-Riba, Ana R Terroba, Ana Valverde-Mateos, Adrián Capllonch-Carrión
Studies In Health Technology and Informatics, 22 August 2024
Abstract
We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.

The Role Of Husbands And Midwives’ Motivation For Compliance With Providing Informed Consent In Cito Sc Actions At Merauke Regional Hospital
Hermin Langdo Layuk, Reny Yuli Astutik, Eri Puji Kumalasari, Devy Putri Nursanti
Journal Of Health Science Community, August 2024; pp70-78
Abstract
Informed consent is a critical aspect of medical practice, including emergency caesarean section (SC) or Cito. Compliance with informed consent becomes more complex because it involves quick decisions in emergency situations, Informed consent compliance with Cito SC actions can be influenced by the husband’s role and midwife’s motivation. This study aims to determine the influence of the role of husbands and midwives’ motivation on compliance with the provision of informed consent in cito SC actions at Merauke Regional Hospital. This study used an Observational Analytics research design with a cross sectional approach. Sampling was carried out using the total sampling technique and a sample of 15 respondents was obtained, the independent variable consists of the role of the husband and the motivation of the midwife then the dependent variable used is the adherence of giving informed consent. The Chi-Square test is used to determine the relationship between two categorical variables. The results of the study of 15 respondents were obtained, most respondents had supporting husband role criteria, namely as many as 8 respondents (53.3%), Most respondents received poor midwife motivation which was as many as 8 respondents (53.3%) and most respondents included the criteria for compliance with informed concent on Cito SC Actions. The results of the analysis using the Chi-Square statistical test obtained the results of p = 0.005 and 0.019 <0.05, then H0 was rejected and H1 was accepted, which means that there is an influence on the role of the husband and the motivation of midwives on Compliance with Giving Informed Consent to Pregnant Women Who Perform Cito SC Actions at Merauke Regional Hospital. The role of the husband and the motivation of midwives play a very significant role in shaping the compliance of informed consent to pregnant women. Collaboration between patients, husbands, medical teams is the main key.

Editor’s note: Merauke Regional Hospital is located in Indonesia.

Surfactants and the importance of informed consent: Nurturing culturally competent care in healthcare settings
Priyanka Gupta, Vishwajeet Singh, Prince Pareek
Indian Journal Of Medical Ethics, July-September 2024
Abstract
Background
Culturally competent healthcare improves patient satisfaction and clinical outcomes. Many drugs, dressings and implants have human or animal-derived content which may conflict with patients’ religious beliefs, and may even have medicolegal implications.
Methods
This cross-sectional study (anonymous web-based survey) was done to understand the informed consent process followed by paediatricians and neonatologists in India, their views regarding disclosure pertaining to the animal origin of exogenous surfactants to patients’ families, and their willingness and ability to provide alternative surfactants based on parental preferences.
Results
A total of 114 neonatologists/paediatricians involved in neonatal care and using surfactants in their practice responded to the survey. Although 61(53.5%) neonatal care units stocked two or more brands of surfactant in their inventory, only 38(33.3%) units had both bovine and porcine preparations. Most (104, 91.2%) of the doctors always take parental consent before administering surfactants; but only a few (12,10.5%) said they always inform parents about its animal origin. None of the respondents offer parents a choice between bovine or porcine-origin surfactants, most (73, 64%) presuming that it would be irrelevant for the parents. However, many respondents (27, 23.7%) mentioned that they want to offer the choice to parents but are unable to do so because they do not stock both bovine and porcine preparations.
Conclusion
Although most parents might agree to a life-saving medicine in emergency situations, this does not mean they do not want to be informed. Healthcare professionals should not have a dismissive attitude to parental belief systems. They must use the antenatal period to take the cultural/spiritual history and the necessary consent.

Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist
Yoon Jin Lee, Sun Ju Lee, Su Jin Kang, Dae Ho Lee, Kyun-Seop Bae, Jong Woo Chung, Byung Soo Kim, Byung Soo Kim, Jin Seok Kim, Myung Ah Lee
Journal of KAIRB, 2024; 6(1) pp 5-16
Abstract
Purpose
The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children’s comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials.
Methods
The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics.
Results
Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents’ consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th–6^th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lowergrade elementary school students (1st–4th grade) could understand the explanations if they were made simpler.
Conclusion
It is suggested that not only elementary school students (7–12 years old) but also middle school students (13–15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

Editor’s note: This is a Korean language publication of the Korean Association of Institutional Review Boards.

Qualitative Content and Discourse Analysis Comparing the Current Consent Systems for Deceased Organ Donation in Spain and England
Original Research
Kate Rees, Leah Mclaughlin, David Paredes-Zapata, Cathy Miller, Nicholas Mays, Jane Noyes
Transplant International, 4 July 2024
Abstract
England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England’s ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals’ decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals.

Self-Rated Competence of Ugandan Healthcare Workers to Obtain Informed Consent for Autopsy
Felix Bongomin, Winnie Kibone, Ritah Nantale, Robert Lukande, Ruth Bromley, Conrad Muzoora, Davidson H Hamer
American Journal of Tropical Medicine and Hygiene, 25 June 2024
Abstract
We examined the self-rated competence of Ugandan healthcare workers (HCWs) in obtaining informed consent for autopsies, considering the challenges of low autopsy acceptance rates globally. In September and October 2023, we conducted a nationwide cross-sectional study of HCWs, who provided informed consent to participate and completed an online, self-administered questionnaire. Participants’ self-rated competence in obtaining informed consent for autopsy was assessed through Likert scale questions. Knowledge and practices were also assessed. All scores were converted to percentages, with scores ≥80% indicating higher competence. We enrolled 216 HCWs (including 145 [67.1%] doctors), with a mean age of 31.6 ± 7.2 years. Overall, 55.6% (n = 120) had ever assisted in obtaining consent for autopsy, 43.6% (n = 100) had ever obtained consent for autopsy themselves, and 13.4% (n = 29) had ever attended training on obtaining consent for autopsy. The mean competency score was 59.8 ± 17.0% (perfect score, 100%), with 29 (13.4%) participants demonstrating high competence. Healthcare workers with adequate knowledge had higher competence scores (odds ratio [OR]: 15.0, 95% CI: 6.17-36.58, P <0.001). Compared with nurses/midwives, doctors had 73% lower odds of having a high competence score (adjusted OR: 0.27, 95% CI: 0.08-0.94, P = 0.040). Fewer than one in five Ugandan HCWs demonstrated high self-rated competence or possessed adequate knowledge regarding informed consent for autopsies, and only a few had received specialized training on how to obtain consent for an autopsy. Therefore, there is a pressing need for enhanced training and increased awareness among Ugandan HCWs in obtaining informed consent for autopsies.

Translating informed consent in Scottish maternity services: Perspectives from providers and researchers of both maternity care and translation/interpreting services
Jenny Patterson, Sebnem Susam-Saraeva
Language and Health, 22 June 2024
Abstract / Description of output
Background
Failing to meet the communication and information needs of childbearing women leaves them unable to provide true informed consent. Lack of control or lack of involvement in decision making contribute to birth trauma. For those with Limited English Proficiency (LEP) receiving information requires use of interpreters often hindered within pressurised maternity services and urgent situations. Women with LEP are often of ethnicities at risk of poorer maternity outcomes and from cultures where maternity service practices differ from Scottish maternity services.
Question
How do maternity care professionals (MCPs) and translation & interpreting (T&I) providers experience their role around informed consent when caring for women with LEP in Scotland; what do they identify as barriers or facilitators?
Methods
Data were collected using qualitative methodology through online focus groups and interactive workshops including a mix of MCPs and T&I providers. Recruitment used a snowball approach via word of mouth and email. Focus groups were audio recorded and transcribed verbatim, workshops were audio-visually recorded and closely examined. Data were analysed using Framework analysis.
Results
Four themes emerged from the study: 1) Limited resources; 2) Inter-professional concerns; 3) Cultural heritage; and 4) Power.
Discussion
Limited resources affect women, MCPs and interpreting services. A lack of cultural awareness and power differentials create pressure for everyone within the process.
Conclusion
LEP increases complexity around informed consent. Challenges are multifaceted compounded by lack of time and resources alongside power differentials. Trust, respect and continuity are key facilitators.

Evolution of Organ Donation Consent, Retrospective Data on Potential Organ Donors
Petru Cotraua, Marcel Negraub, Viviana Hodosana, Adriana Vladua, Cristian Marius Dainab, Dorel Dulaua, Lucia Georgeta Dainab, Carmen Pantis
Journal of Clinical Medicine, 18 June 2024; 19(2) pp 292-297
Abstract
Introduction and aim
Identifying the best practices to obtain consent for organ donation involves several strategies. This retrospective analysis of the activity in the field of organ donation identifies the most critical impediments, of which the refusal of families to donate is one of the most frequently encountered. Our main aim was to determine the factors that negatively influence the activity of organ and tissue donations from brain dead donors and to summarize the total number of potential and actual deceased donors, their yearly characteristics, and the organ and tissue donation types performed.
Materials and methods
A retrospective descriptive study, covering data from 1 January 2014 to 31 December 2023, was conducted in the intensive care unit of the Emergency Clinical County Hospital of Bihor, a recognized facility engaged in organ donation and transplantation from Romania. All potential and actual deceased donors were included in our research.
Results
During a period of 10 years, between 2014 and 2023, of the 488 potential and actual deceased donors, 355 (72.7%) were potential donors and 133 (27.3%) actual deceased donors.
Conclusions
From 2014 to 2023, a significant percentage [15.28% (133)] of the total number of actual deceased organ donors registered at the national level (870) were identified by us in the Emergency Clinical County Hospital of Bihor.