Informed consent: who are we informing?
Michele O’Shea
Rural Remote Health, 26 July 2022; 22(3)
Open Access
Abstract
Communication is the foundation of informed consent in research. This article relays the reflections of an American urogynecology fellow and researcher in Kenya on the topic of informed consent. After learning of how a previous foreign researcher’s presence in the community had violated the trust that women placed in women’s health research, she reflects on how the standard eurocentric approach to obtaining written informed consent in research may sow breakdowns in communication and also perpetuate distrust in research. Particularly for settings in which the language is primarily spoken, or where there are varying literacy levels, the standard research consent should be reimagined to make the informed consent process more equitable and less of an exercise in documentation. Communication of research study information to patients must take into account the diverse and evolving ways in which patients best consume information, and in such a way that it ultimately enhances their autonomy.
Year: 2022
Disparities in Comprehension of the Obstetric Consent According to Language Preference Among Hispanic/Latinx Pregnant Patients
Disparities in Comprehension of the Obstetric Consent According to Language Preference Among Hispanic/Latinx Pregnant Patients
Rose L. Molina, Emily Adams, Ricardo Aguayo, Samantha Truong, Michele R. Hacker
Cureus, 21 July 2022; 14(7)
Open Access
Abstract
Background
We assessed understanding of the obstetric consent form between patients with English and Spanish language preference.
Methods
This observational study included pregnant patients who identified as Hispanic/Latinx with English or Spanish language preference (defined as what language the patient prefers to receive healthcare information) and prenatal care providers at a large academic medical center from 2018 to 2021. Patient demographics, language preference, literacy, numeracy, acculturation, comprehension of the obstetric consent, and provider explanations were collected.
Results
We report descriptive statistics and thematic analysis with an inductive approach from 30 patients with English preference, 10 with Spanish preference, and 23 providers. The English group demonstrated 72% median correct responses about the consent form; the Spanish group demonstrated 61% median correct responses. Regardless of language, the participants demonstrated limited understanding of certain topics, such as risks of cesarean birth.
Discussion
Overall comprehension of key information in an obstetric consent form was low, with differences in language groups, which highlights opportunities for improvements in communication across language barriers. Innovations in the communication of critical pregnancy information for patients with limited English proficiency need to be developed and tested.
The Need to Adjust the Informed Consent for Jewish Patients for Treatments Involving Porcine Medical Constituents
The Need to Adjust the Informed Consent for Jewish Patients for Treatments Involving Porcine Medical Constituents
Original Paper
Ya’arit Bokek-Cohen
Journal of Immigrant and Minority Health, 18 July 2022
Abstract
In order to obtain full informed consent for medical treatments, it is imperative to provide patients of diverse ethnic backgrounds with all relevant information. Since the pig is considered an impure animal in Judaism, Jewish patients may wish to be informed of porcine-derived substances used in treating. The present study is the first to explore the level of knowledge of Jewish participants as to whether the medical use of pig is permitted by their religion, and the extent to which they believe it should be permitted. 714 Jewish participants completed a study questionnaire that included 15 medical uses of pigs. Findings indicated that the knowledge of Jewish law regarding these uses is a significant mediator in predicting the attitude toward the permissibility of these uses. I conclude with practical recommendations as to how to enhance cultural competence and improve the informed consent process when treating Jewish patients with porcine-derived constituents.
Patient Perception of Informed Consent and Its Associated Factors among Surgical Patients Attending Public Hospitals in Dessie City Administration, Northeast Ethiopia
Patient Perception of Informed Consent and Its Associated Factors among Surgical Patients Attending Public Hospitals in Dessie City Administration, Northeast Ethiopia
Research Article
Hana Gebrehiwot, Nathan Estifanos, Yosef Zenebe, Tamrat Anbesaw
Critical Care Research and Practice, 1 July 2022
Open Access
Abstract
Background
Poor perception of informed consent compromises patients’ autonomy and self-determination; as a result, they feel powerless and unaccountable for their treatment. This study aimed to assess patients’ perception of informed consent and its associated factors among surgical patients attending public hospitals in Dessie City Administration, Northeast Ethiopia.
Methods
Facility-based cross-sectional study was conducted on 422 surgical patients. A systematic sampling technique was used to select the study participants. Data were collected using a pretested structured interviewer-administered questionnaire. EpiData version 3.1 was used for data entry, and then data were exported to SPSS version 25 for analysis. Multivariable logistic regression analysis was done to identify factors associated with the outcome variable among the participants. Variables with value less than 0.05 were considered statistically significant factors.
Results
The prevalence of poor perception of informed consent for surgical procedures was found to be 33.2% (95% CI: 28.8–37.8). In multivariable analysis, educational status with inability to read and write (AOR = 5.71; 95% CI: 2.76–11.80) and basic ability to read and write (AOR = 6.03; 95% CI: 2.57–14.16), rural residence (AOR = 3.71; 95% CI: 1.94–7.07), marital status being widowed and divorced (AOR = 3.85; 95% CI: 1.83–8.08), language of written informed consent different from mother tongue (AOR = 4.196; 95% CI: 1.12–15.78), poor patient-physician relationship (AOR = 2.35; 95% CI: 1.31–4.24), and poor knowledge of surgical informed consent (AOR = 3.05; 95% CI: 1.56–5.97) were significantly associated with poor perception of surgical informed consent.
Conclusion
In this study, one-third of surgical patients appear to have poor perceptions of informed consent for surgical procedures. Educational status, being rural residents, being widowed/divorced, language of written informed consent, poor patient-physician relationship, and poor knowledge of surgical informed consent were variables that are independent predictors of poor perception of informed consent for surgical procedures. The ministry of health and healthcare providers should develop a plan to raise patients’ awareness about the informed consent process for surgical procedures.
Family-oriented informed consent in China’s clinical settings: A sociological and ethical study
Family-oriented informed consent in China’s clinical settings: A sociological and ethical study
PhD Thesis
Jingru Li
University of Otago, 2022
Abstract
In China’s clinical settings, it is common for families to make decisions about the information and treatments that a patient will receive. This practice or model is referred to as ‘family-oriented informed consent’. It differs from the ‘individual model’ practiced in many Western countries. A standard explanation for this difference is based on perceived differences between Chinese and Western cultures. On this view it is argued that family-oriented informed consent is most compatible with the strong familial culture in China, while patient-centred informed consent reflects Western individualism.
This study aims to understand how and why families are involved in informed consent in China, and to critically assess the arguments for and against this involvement. It does this through a sociological investigation and an ethical analysis. Semi-structured, in-depth interviews were conducted with 13 patients, 14 family caregivers, and nine health professionals in Tianjin and Beijing, two mega cities in China. A thematic analysis approach was used to analyse the empirical material. The findings confirm the prevalence of the family-oriented practice. For family participants, two reasons were most often mentioned to support family-oriented informed consent: “reducing harms” and “increasing benefits”. Most patient participants preferred to make decisions on their own. Only a small number of patient participants indicated a preference for family-oriented model. They mainly referred to their reliance on the family for funding and care. As for medical professional participants, most of them disapproved of the family-oriented model but felt too powerless to act on the side of patients in face of family’s requirement as the decision makers.
On the basis of these findings, I argue that family-oriented informed consent is empirically groundless and ethically wrong, and that ‘patient-oriented informed consent’ should be adopted instead. Besides familial culture, the findings indicated at least four other factors explaining the family-oriented model, including doctor-patient mistrust, insufficient public funding to healthcare, the conflicting legal stipulations, and poor communication. Moreover, the argument that the practice benefits patients is specious, as in many ways it can be more harmful to patients. Argument based on cultural differences is also dubious because it incorrectly assumes that family-oriented pattern only exists in China, and that Chinese people do not support individual autonomy. Having shown the problems with family-oriented pattern, I move to argue in support of ‘patient-centred model’. On this model, patients should have the authority in informed consent, and doctors should be sensitive to patients’ requirement about family involvement. This model is both contextually sensitive and morally justifiable to China’s clinical context because it is in line with most Chinese patients’ preference for self-determination and is beneficial to patients. To make this possible, it is important to specify patient’s individual right to informed consent in law and to stipulate medical professionals’ legal duty to respect patient’s autonomy. Improvement in doctor-patient communication and more government funding in the healthcare sector are equally important means for a better implementation.
Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Informed Consent before coronary angiography and percutaneous coronary intervention from the patient’s perspective: A picture is worth a thousand words
Brand, C. Crayen, A. Hamann, S. Martineck, L. Gao, H. Brand, S.M. Squier, K. Stangl, F. Kendel, V. Stangl
IJC Heart & Vasculature, August 2022; 41
Abstract
Background
Patients scheduled for coronary angiography may feel insufficiently informed about the planned procedure. We aimed to evaluate the patient-rated quality of the Informed Consent (IC) process and to investigate the efficacy of medical graphics to assist and improve the IC procedure.
Methods
A graphic-based information broschure illustrating central steps of the procedure was created in collaboration with scientific illustrators. In a randomized, controlled, prospective trial, 121 patients undergoing coronary angiography/PCI were randomized to a group obtaining the usual IC (Control group) or to a group that additionally obtained a graphic-based IC (Comic group). The perceived quality of the IC was compared between groups using single items of the Client Satisfaction Questionnaire-8 and self-designed single items.
Results
Only 67.8% of patients stated to have completely read the standard written IC sheet. The quality of the IC was perceived to be very good in 45.0% of patients in the Comic group compared to 24.6% in the Control group (p =.023). 57.4% of the Control group compared to 76.7% of the Comic group stated that all of their questions were satisfactorily adressed (p =.015). 43.3% of the Comic group, in contrast to only 18.0% of the Control group, declared to feel „very satisfied“ with the obtained IC procedure (p =.002). The acceptance of this new IC approach was very high: no patient expressed feelings of not being taken seriously when reading medical graphics.
Conclusions
Our data confirm pronounced limitations of the usual IC practice. The use of medical graphics positively impacts on patient-evaluated endpoints and may significantly improve the IC procedure.
Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society
Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society
Frederik G. Dikkers, Michel R. M. San Giorgi, Rico N. P. M. Rinkel, Marc Remacle, Antoine Giovanni, Małgorzata Wierzbicka, Riaz Seedat, Guillermo Campos, Guri S. Sandhu
European Archives of Oto-Rhino-Laryngology, 12 July 2022
Open Access
Abstract
Introduction
Informed consent for any surgical intervention is necessary, as only well-informed patients can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. No consensus exists on informed consent for suspension microlaryngoscopy (SML).
Materials and methods
Informed consent procedures in nine countries on five continents were studied.
Results
Several risks can be discerned: risks of SML as procedure, anesthesiologic risks of SML, specific risks of phonosurgery, risks of inadequate glottic exposure or unexpected findings, risks of not treating. SML has recognized potential complications, that can be divided in temporary (minor) complications, and lasting (major) complications.
Conclusion
SML is a safe procedure with low morbidity, and virtually no mortality. Eleven recommendations are provided.
Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Patients’ satisfaction and associated factors towards preoperative informed consent process: A cross-sectional study
Tamiru Tilahun Ayele, Tadese Tamire Negash, Keder Essa oumer, Aderajew Mekuanint, Diriba Teshome, Efrem Fenta, Yewlsew Fentie, Aragaw Tesfaw Ashenafi Tolosa
Annals of Medicine and Surgery, 4 July 2022; 79
Abstract
Background
Informed consent is a process that needs time and effort to satisfy patients’ desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients’ satisfaction and associated factors of informed consent process among elective surgical patients.
Methods
A cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients’ satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.
Results
The overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47–9.16), primary school (AOR: 8.42, 95% CI: 4.74–7.55), secondary school (AOR: 2.17, 95% CI: 5.74–8.62), rural residence (AOR: 1.8, 95% CI: 2.1–3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62–5.26) were significantly associated with patients’ satisfaction with the informed consent process.
Conclusion
The overall patients’ satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients’ satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients’ level of satisfaction and factors affecting satisfaction.
Privacy Behaviour: A Model for Online Informed Consent
Privacy Behaviour: A Model for Online Informed Consent
Original Paper
Gary Burkhardt, Frederic Boy, Daniele Doneddu, Nick Hajli
Journal of Business Ethics, 14 July 2022
Open Access
Abstract
An online world exists in which businesses have become burdened with managerial and legal duties regarding the seeking of informed consent and the protection of privacy and personal data, while growing public cynicism regarding personal data collection threatens the healthy development of marketing and e-commerce. This research seeks to address such cynicism by assisting organisations to devise ethical consent management processes that consider an individual’s attitudes, their subjective norms and their perceived sense of control during the elicitation of consent. It does so by developing an original conceptual model for online informed consent, argued through logical reasoning, and supported by an illustrative example, which brings together the autonomous authorisation (AA) model of informed consent and the theory of planned behaviour (TPB). Accordingly, it constructs a model for online informed consent, rooted in the ethic of autonomy, which employs behavioural theory to facilitate a mode of consent elicitation that prioritises users’ interests and supports ethical information management and marketing practices. The model also introduces a novel concept, the informed attitude, which must be present for informed consent to be valid. It also reveals that, under certain tolerated conditions, it is possible for informed consent to be provided unwillingly and to remain valid: this has significant ethical, information management and marketing implications.
Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Malpractice Claims and Ethical Issues in Prison Health Care Related to Consent and Confidentiality
Review
Oana-Maria Isailă, Sorin Hostiuc
Healthcare, 12 July 2022
Open Access
Abstract
Respecting the consent and confidentiality of a patient is an underlying element in establishing the patient’s trust in the physician and, implicitly, obtaining the patient’s compliance. In particular, cases of inmate patients require increased attention in order to fulfill this goal against a background of institutional interferences, which, in certain situations, may endanger the autonomy of the physician and their respect for the inmate’s dignity. The purpose of this article is to depict the characteristics of consent and confidentiality in a prison environment, in special cases, such as hunger strikes, violent acts, HIV testing, COVID-19 measures, and drug use, bringing into focus the physician and the inmate in the context of the particular situation where the target is disciplining someone in order for them to conform to social and juridical norms. Respecting the dignity of the inmate patient requires an adequate approach of informed consent and confidentiality, depending on each case, considering the potential unspoken aspects of the inmate’s account, which can be key elements in obtaining their compliance and avoiding malpractice claims.