Egyptian patients’/guardians’ experiences and perception about clinical informed consent and its purpose: Cross sectional study
Ammal M. Metwally, Hala A. Amer, Hend I. Salama, Safaa I. Abd El Hady, Raefa R. Alam, Ahmed Aboulghate, Hanan A. Mohamed, Hanan M. Badran, Amal A. Saadallah, Marwa M. El-Sonbaty, Eman Eltahlawy, Walaa Saad, Amira Mohsen, Ghada A. Abdel-Latif, Asmaa M. Fathy, Amal I. Hassanain, Abdelmoneim Eldali
PLoS One, 14 June 2021
Informed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients’/guardians’ experiences about IC and their expectations about its practices’ purposes in general and according to the type of the healthcare facility.
Self-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced.
IC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: “Helping patient/guardian decide (64.9%)”, “Documenting patient’s/guardian’s decision (59.3%)”, and “Having shared decision (57.3%)”. The perceived purposes of IC to be practiced were: “Informing the patient/guardian (68.4%)”, “Making sure patient/guardian understand (65.3%)” and “Documenting patients/guardians decisions (65.1%)”. “Being a meaningless routine” was reported by the majority to be ranked as a low purpose for IC current and preferred practices.
The practice of IC is common within the Egyptian medical community. Participants believe that information disclosure “Making sure patients understand” has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient’s/guardian’s decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.
Promoting Patient Engagement in Medical Informed Consent – A Qualitative Study of Chinese Doctors’ Communication Strategies
Qianwen Joyce Yu, ack Pun
Health Communication, 3 June 2021
Patient engagement is now widely endorsed as an essential ingredient for high-quality healthcare, yet there has been limited research on how patient engagement can be facilitated in medical informed consent (IC) communication. To address this gap, a fine-grained discourse analysis was conducted to identify communication strategies adopted by doctors to facilitate information delivery and ascertain patients’ understanding, which translate into an increase in patient engagement. Data was collected from a public hospital in mainland China. Nonparticipating observations of 14 IC sessions were audio-recorded, followed by in-depth, semi-structured interviews with those observed patients. Four communication strategies emerged from the analysis: 1) seeking patients’ understanding of their condition; 2) explaining medical information by reference to shared knowledge and practice; 3) recognizing and addressing patients’ psychological concerns; 4) repeating critical information and checking patients’ understanding through teach-back. The adoption of these strategies enables doctors to tailor the scope and delivery of information to accommodate and address patients’ preferences, rather than defaulting to one-way information dumping. This study sheds light on the complexity of IC and further contributes to the ongoing endeavors to improve IC communication by raising the awareness of the role of patients in making mutually acceptable decisions. These identified strategies can be incorporated into medical communication training to facilitate delivery of healthcare that is sensitive to patients’ needs and expectations.
Community Consent [BOOK CHAPTER]
Henk ten Have, Maria do Céu Patrão Neves
Dictionary of Global Bioethics [Springer 27 May 2021]
In medical practice and research the principle of individual prior informed consent has a crucial role to play. However, the emphasis on individuals is not the same across the world. Communities in many cultures and traditions play an important role in determining human well-being and in individuals living their lives to the full. From a global perspective the moral status of a community is recognized in the concept of community consent.
Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh
Maya Annie Elias, Kerry Woolfall, Maria Moreno Morales, Bensitta Lincy, Ismat Jahan, Samanmali P Sumanasena, Siddarth Ramji, Seetha Shankaran, Sudhin Thayyil
BMJ Global Health, 21 May 2021
Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.
Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.
Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.
Quality of written informed consent forms for electroconvulsive therapy in Australia: a comparative analysis
Karuppiah Jagadheesan, Frances Walker, Vinay Lakra
Australasian Psychiatry, 3 May 2021
We compared the quality of the written informed consent forms for electroconvulsive therapy (ECT) in Australian jurisdictions.
For this comparative audit-type study, a checklist was developed to compare informed consent forms from different jurisdictions. The main information sources for consent forms were government health department websites and Google. The directors of clinical services were contacted if a consent form was not available through a web source.
Majority of the informed consent forms covered information about ECT, general anaesthesia and alternative treatments, supports available for decision making, and a reference to the right to withdraw consent. Missing information affected information areas such as likely outcome if no ECT, lack of guaranteed response and cultural and linguistic supports.
A standardised consent form that can be used across all jurisdictions can help improve the ECT practice.
Normative framework of informed consent in clinical research in Germany, Poland, and Russia
Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger
BMC Medical Ethics, 1 May 2021; 22(53)
Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki.
For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed.
The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible.
The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements.
Informed consent process: ethical and practical challenges in clinical trials regarding subject enrollment, protection, and informed consent in developing countries (India, Pakistan & Iran)
History & Philosophy of Medicine, 21 April 2021
In this study, we are discussing the rationale behind informed consent in clinical trials in developing countries. It elaborates how informed consent has remained an ethical and practical issue. Poverty, endemic diseases, and a lack of investment in healthcare systems influence the ease of conducting and selecting trials that can benefit the people of developing countries. Differences in cultural perspectives, religious beliefs, a lack of formal training for clinical staff, children, time zone difference, literacy, vulnerable population, and language barriers for subject enrollment, protection, and informed are also challenges. This report doesn’t only highlight the right the wrongs of the past or reiterate cases where clinical trials have hurt subjects in developing countries. The current study investigates the conditions of human research in developing countries to make them more ethically sound. The extends proposals to investigators, scientists, governments, sponsors, and other groups who are interested where appropriate.
Knowledge and practices of seeking informed consent for medical examinations and procedures by health workers in the Democratic Republic of Congo
Doudou Nzaumvila, Patrick Ntotolo, Indiran Govender, Philip lukanu, JD Landu Niati, Didier Sanduku, Tombo Bongongo
African Journals Online, 16 April 2021; 21(1)
Informed consent (IC) is linked to the ethical principle of respecting patient autonomy, respect for human rights and ethical practice, while in many countries it is a standard procedure. Anecdotally, it should be noted that in the Democratic Republic of Congo (DRC) in many instances ICs are not obtained systematically. To date, no research appears to have been conducted on this matter. This study aimed to assess the knowledge and practice of obtaining IC from patients among health care providers (HCP) in the DRC.
This was a cross-sectional study, with a convenient sampling of 422 participants. Data from the questions were collected on an imported Microsoft Excel spreadsheet for review at INSTAT.TM The authors set IC’s accurate knowledge and practice at 80% or higher. The Fisher Exact test was used to compare categorical association results, and a p-value < 0.05 was considered statistically significant.
Results showed that giving information in detail to patients on their medical condition was associated with formal training on medical ethics and IC (p: 0.0028; OR: 1.894; CI: 1.246 to 2.881), which was also associated with answering the patient’s questions in detail (p: 0.0035; OR: 1.852; CI: 1.236 to 2.774). About 127(30.09 %) of participants scored 80% or higher. Extracurricular training was associated with withholding information from patients, up to 27 times more than other factors (p< 0.0001; OR: 27.042; CI: 13.628 to 53.657). when it comes to get IC, HCP with many years of practice scored better than others, in one of the question the odd ratio was closer to 7 ( p< 0.0001; OR: 6.713; CI: 4.352 to 10.356). Only 47(11.14%) of the participants scored 80% or more of the questions about practice of IC.
For a variety of reasons, knowledge and practice of IC among HCPs was very low. A common programme for the country as part of formal training might lead to an improvement. In addition, patients’ education on IC should be displayed in waiting areas at all medical centres.
Validation of the factors influencing family consent for organ donation in the UK
M. K. Curtis A. R. Manara S. Madden C. Brown S. Duncalf D. Harvey A. Tridente D. Gardiner
Anaesthesia, 16 April 2021
Between 2013 and 2019, there was an increase in the consent rate for organ donation in the UK from 61% to 67%, but this remains lower than many European countries. Data on all family approaches (16,896) for donation in UK intensive care units or emergency departments between April 2014 and March 2019 were extracted from the referral records and the national potential donor audit held by NHS Blood and Transplant. Complete data were available for 15,465 approaches. Consent for donation after brain death was significantly higher than for donation after circulatory death, 70% (4260/6060) vs. 60% (5645/9405), (OR 1.58, 95%CI 1.47–1.69). Patient ethnicity, religious beliefs, sex and socio‐economic status, and knowledge of a patient’s donation decision were strongly associated with consent (p < 0.001). These factors should be addressed by medium‐ to long‐term strategies to increase community interventions, encouraging family discussions regarding donation decisions and increasing registration on the organ donor register. The most readily modifiable factor was the involvement of an organ donation specialist nurse at all stages leading up to the approach and the approach itself. If no organ donation specialist nurse was present, the consent rates were significantly lower for donation after brain death (OR 0.31, 95%CI 0.23–0.42) and donation after cardiac death (OR 0.26, 95%CI 0.22–0.31) compared with if a collaborative approach was employed. Other modifiable factors that significantly improved consent rates included less than six relatives present during the formal approach; the time from intensive care unit admission to the approach (less for donation after brain death, more for donation after cardiac death); family not witnessing neurological death tests; and the relationship of the primary consenter to the patient. These modifiable factors should be taken into consideration when planning the best bespoke approach to an individual family to discuss the option of organ donation as an end‐of‐life care choice for the patient.
Obstacles to Obtaining Informed Consent from the Perspective of Transplant Coordinators: A Qualitative Study
Alireza Shamsaeefar, Nasrin Motazedian, Fatemeh Rahmanian, Saman Nikeghbalian, Seyed Ali Malek-Hosseini
Hepatitis Monthly, 5 April 2021; 21(2)
The lack of consent to donate body organs leads to an increase in the death rate of patients on the waiting list for transplantation. Unwillingness of families is known as the main obstacle to organ donation, and the media has an essential role in motivating organ donation.
This study aimed to explore obstacles to obtaining consent for organ donation from transplant coordinators’ perspective throughout Iran.
In this qualitative study, 13 in-depth semi-structured face-to-face interviews were conducted with transplant coordinators from November 2018 to March 2019. The participants were investigated using a purposive sampling method. The participants’ age and work experience ranged between 32 – 49 years and 6 – 25 years, respectively. Open-ended questions were asked from the participants in a private room. An experienced interviewer explained the study’s objectives to the coordinators, and each interview lasted on average 50 minutes. The interview scripts were analyzed using a content analysis method.
The findings highlighted the difficulty of obtaining consent from brain-dead patients’ families. The obstacles could be internal or external. External determinants were healthcare providers’ lack of empathy, inadequate consultation from doctors outside the hospital, media content, and uninformed comments from relatives. Internal determinants were hoping for recovery, denial, and disagreement among family members.
The healthcare team should have a better connection with families to obtain organ donation consent from them. Therefore, a training program must be developed for the treatment team so that they show more supportive behavior and improve quality of care in hospitals before and after brain death.