Digital technology in informed consent for surgery: systematic review
Aoife Kiernan, Brian Fahey, Shaista S Guraya, Fiona Boland, Daragh Moneley, Frank Doyle, Denis W Harkin
British Journal of Surgery, 24 January 2023
Open Access
Abstract
Background
Informed consent is an ethical and legal requirement in healthcare and supports patient autonomy to make informed choices about their own care. This review explores the impact of digital technology for informed consent in surgery.
Methods
A systematic search of EBSCOhost (MEDLINE/CINAHL), Embase, Cochrane Central Register of Controlled Trials and Web of Science was performed in November 2021. All RCTs comparing outcomes of both digital and non-digital (standard) consent in surgery were included. Each included study underwent an evaluation of methodological quality using the Cochrane risk of bias (2.0) tool. Outcomes assessed included comprehension, level of satisfaction and anxiety, and feasibility of digital interventions in practice.
Results
A total of 40 studies, across 13 countries and 15 surgical specialties were included in this analysis. Digital consent interventions used active patient participation and passive patient participation in 15 and 25 studies respectively. Digital consent had a positive effect on early comprehension in 21 of 30 (70 per cent) studies and delayed comprehension in 9 of 20 (45 per cent) studies. Only 16 of 38 (42 per cent) studies assessed all four elements of informed consent: general information, risks, benefits, and alternatives. Most studies showed no difference in satisfaction or anxiety. A minority of studies reported on feasibility of digital technology in practice.
Conclusion
Digital technologies in informed consent for surgery were found to have a positive effect on early comprehension, without any negative effect on satisfaction or anxiety. It is recommended that future studies explore the feasibility of these applications for vulnerable patient groups and busy surgical practice.
Month: February 2023
Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities
Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities
Applied Research
Susan Chimonas, Allison Lipitz-Snyderman, Kemi Gaffney, Gilad J. Kuperman
JCO Clinical Cancer Informatics, 3 January 2023
Abstract
Purpose
Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions.
Methods
We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions.
Results
Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes.
Conclusion
E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly.
Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways
Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways
Homa Amini, Andrew Carranco, Paul S. Casamassimo, Dennis McTigue, Jin Peng
Pediatric Dentistry, November-December 2022; 44(6) pp 400-403
Abstract
Purpose
The purpose of this study was to assess the understanding of Spanish-speaking caregivers consenting to dental core using general anesthesia (GA) utilizing two consent-delivery pathways.
Methods
Seventy-eight parents of children who never had GA were randomly assigned to one of two groups: (0) interpreter; or (2) video: they completed o survey to evaluate comfort level with GA and comprehension of areas of informed consent.
Results
Most parents in both groups understood the risks associated with GA (89 percent in the interpreter group and 90 percent in the video group). The majority of families had difficulty understanding indications for GA (64 percent in the interpreter group versus 60 percent in the video group). Overall, 97 percent of participants believed they sufficiently understood the information presented about GA. The mean score for comfort level with GA was 7.03 for the interpreter group and 6.82 for the video group.
Conclusion
Consent pathways used in this study were not significantly different for risk understanding and acquisition of consent-related knowledge.
Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?
Informed Consent: Legal Obligation or Cornerstone of the Care Relationship?
Margherita Pallocci, Michele Treglia, Pierluigi Passalacqua, Roberta Tittarelli, Claudia Zanovello, Lucilla De Luca, Valentina Caparrelli, Vincenzo De Luna, Alberto Michele Cisterna, Giuseppe Quintavalle, Luigi Tonino Marsella
International Journal of Environmental Research and Public Health, 24 January 2023
Open Access
Abstract
The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.
Case-Law on Informed Consent in Germany: A Model for Albania?
Case-Law on Informed Consent in Germany: A Model for Albania?
Ervin Pupe, Denard Veshi, Carlo Venditti, Raffaele Picaro, Kristel Haxhia
Liverpool Law Review, 10 January 2023
Abstract
Since the 1990s, Albania has recognized human dignity as one of the main constitutional principles. However, the national medical jurisprudence regarding informed consent has not been developed as in other Western European Countries. Germany is one of the countries that has a long tradition of protecting human dignity in patient-physician relations.This contribution studies the German law on informed consent to medical treatment, Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten of February 2013 through the application of a case-law study. This law, which codifies the national courts’ decisions, highlights the ethical principle of autonomy. In other words, in the absence of a solid national medical jurisprudence, this paper investigates the possibility that Albanian judges could apply the legal arguments of their German colleagues since in the case of case-law study there is an absence of political interference, which can better demonstrate the ethical principle of autonomy and the right to self-determination.
Is Consent Required for Clinicians to Make a Determination of Death by Neurologic Criteria?
Is Consent Required for Clinicians to Make a Determination of Death by Neurologic Criteria?
Book Chapter
Thaddeus Mason Pope
Death Determination by Neurologic Criteria, 1 January 2023; pp 287–303 [Springer]
Abstract
The overwhelming weight of authority in the United States, Canada, and the United Kingdom holds that clinicians are not legally or ethically required to obtain family consent before making a determination of death by neurologic criteria. There is a consensus among professional guidelines, a consensus in statutes, and a near consensus among court decisions. Moreover, prevailing practice does not require consent. Accordingly, increasingly vocal proponents of a consent requirement bear a heavy burden to overcome the presumptive legitimacy of the status quo. While their arguments have some validity, proponents cannot surmount the weightier considerations against imposing a consent requirement. Nevertheless, even though clinicians and hospitals are not legally required to obtain consent, they should still notify families about the intent to make a determination of death by neurologic criteria and offer temporary reasonable accommodations when feasible.
Consent and Complications in Health Care: The Italian Context
Consent and Complications in Health Care: The Italian Context
Review
Maricla Marrone, Enrica Macorano, Giuseppe Lippolis, Pierluigi Caricato, Gerardo Cazzato,
Antonio Oliva, Benedetta Pia De Luca
Healthcare, 27 January 2023
Open Access
Abstract
Informed consent is the manifestation of the will that a patient freely expresses toward a medical treatment. The physician is responsible for acquiring informed consent for both medical and nursing procedures. Informed consent represents a juridical–deontological tool that allows therapeutic choices to be shared with the user after having exhaustively explained the risks and benefits of the procedure itself. In fact, the physician has an obligation to provide the patient with clear and comprehensible information about the type of service, the methods of delivery, the benefits, the risks, even unforeseeable ones, and the complications. According to Italian legal guidelines, in cases of presumed health responsibility, the health professional accused of negligence will have to demonstrate that any complication that has arisen, although foreseeable, was not preventable. Through the analysis of a clinical case relating to the procedure of insertion of a bladder catheter performed by a nurse and a review of the literature, the authors explain the importance of the information that must be provided to the patient before carrying out any invasive procedure, even if not performed by the doctor. The authors describe the problem in the Italian context and propose a possible solution.
Stakeholder views on informed consent models for future use of biological samples in Malawi and South Africa
Stakeholder views on informed consent models for future use of biological samples in Malawi and South Africa
Stuart Rennie, Walter Jaoko, Francis Masiye
BMC Medical Ethics, 19 January 2023
Open Access
Abstract
Background
Current advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa.
Methods
This was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi.
Results
Most key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models.
Conclusions
This study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples.
Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam
Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam
Jennifer Ilo Van Nuil, Evelyne Kestelyn, Susan Bull, Phu Hoan Nguyen, Phuong Thanh Le, Ngoc Bao Hong Lam, Thuan Trong Dang, Yen Hong Thi Nguyen
BMC Medical Ethics, 16 January 2023; 24(3)
Open Access
Abstract
Background
The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and intertwined socio-cultural factors.
Objectives
This study explored the practices and meaning of the informed consent process in two clinical trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.
Methods
We used multiple data collection methods including direct observations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.
Results
We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.
Conclusions
Our findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.
Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study
Formal Quality and Compliance of Informed Consent Forms in Critical Care and Surgical Areas in Spain: An Observational Study
José Manuel García-Álvarez, José Luis Díaz-Agea, María Suárez-Cortés, Alonso Molina-Rodríguez, Ismael Jiménez-Ruiz, Alfonso García-Sánchez
Nursing Reports, 31 December 2022; 13(1) pp 43-50
Open Access
Abstract
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.
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.
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.
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.
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.
Center for Informed Consent Integrity 