Consent and Complications in Health Care: The Italian Context
Maricla Marrone, Enrica Macorano, Giuseppe Lippolis, Pierluigi Caricato, Gerardo Cazzato,
Antonio Oliva, Benedetta Pia De Luca
Healthcare, 27 January 2023
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
Stuart Rennie, Walter Jaoko, Francis Masiye
BMC Medical Ethics, 19 January 2023
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.
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.
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.
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
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)
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.
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.
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.
We use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.
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
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
The informed consent form must contain all the relevant information about the procedure to be performed to guarantee the patient’s freedom to choose.
To analyze the formal quality of, and compliance with informed consent forms in critical care and surgical areas in a county hospital in Spain.
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.
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.
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.
A comprehensive analysis of the readability of consent forms for blood transfusion in Spain
Morales-Valdivia E, Brady AM, Mariscal-Crespo MI, Camacho-Bejarano R
Blood Transfusion, 22 December 2022
This study aimed to evaluate the readability of consent forms for blood transfusion in public hospitals in Spain.
Materials and methods
This was a cross-sectional, national study conducted within the Spanish healthcare system. Data were collected through the online retrieval of consent documents and direct consultation with 223 public hospitals. Consent forms were subjected to readability assessment including typographical, grammatical and lexical dimensions. The INFLESZ scale, a well-validated instrument adapted to the reading habits of Spaniards, was applied to determine the grammatical readability of the documents. The Spanish Mosby’s Dictionary and the Dictionary of Spanish were used together to systematically identify the number of medical terms contained in the text. Data were analyzed using descriptive and inferential statistics.
Forty-five written consent forms for blood transfusion, in use in 126 general public hospitals were evaluated for various parameters, including font size (=10.41), abbreviations (=10.58), word count (=595, 209 min-1,499 max) and length (1 to 7 pages). The overall readability score (=50.66) was indicative that consent forms are somewhat difficult to read. A heterogeneity of 116 different healthcare terminology words was identified. Word count was statistically and moderately positively related to the number of medical terms identified in the text (rho=0.496, p=0.001) and the INFLESZ score (rho=0.34, p=0.023).
In this first national study to assess the ease of reading written information on blood transfusion given to patients, deficiencies were found in the three dimensions of readability (typographical, grammatical and lexical) and a lack of uniformity among the written consent forms is pronounced. Further research is needed to develop more person-centered tools to support patients in the process of consenting for blood transfusion.
Remote consent approaches for mobile phone surveys of non-communicable disease risk factors in Colombia and Uganda: A randomized study
Joseph Ali, Madhuram Nagarajan, Erisa S. Mwaka, Elizeus Rutebemberwa, Andres I. Vecino-Ortiz, Angelica Tórres Quintero, Mariana Rodriguez-Patarroyo, Vidhi Maniar, Gulam Muhammed Al Kibria, Alain B. Labrique, George W. Pariyo, Dustin G. Gibson
PLOS ONE, 21 December 2022
Automated mobile phone surveys (MPS) can be used to collect public health data of various types to inform health policy and programs globally. One challenge in administering MPS is identification of an appropriate and effective participant consent process. This study investigated the impact of different survey consent approaches on participant disposition (response characteristics and understanding of the purpose of the survey) within the context of an MPS that measured noncommunicable disease (NCD) risk factors across Colombia and Uganda.
Participants were randomized to one of five consent approaches, with consent modules varying by the consent disclosure and mode of authorization. The control arm consisted of a standard consent disclosure and a combined opt-in/opt-out mode of authorization. The other four arms consist of a modified consent disclosure and one of four different forms of authorization (i.e., opt-in, opt-out, combined opt-in/opt-out, or implied). Data related to respondent disposition and respondent understanding of the survey purpose were analyzed.
Among 1889 completed surveys in Colombia, differences in contact, response, refusal, and cooperation rates by study arms were found. About 68% of respondents correctly identified the survey purpose, with no significant difference by study arm. Participants reporting higher levels of education and urban residency were more likely to identify the purpose correctly. Participants were also more likely to accurately identify the survey purpose after completing several survey modules, compared to immediately following the consent disclosure (78.8% vs 54.2% correct, p<0.001). In Uganda, 1890 completed surveys were collected. Though there were differences in contact, refusal, and cooperation rates by study arm, response rates were similar across arms. About 37% of respondents identified the survey purpose correctly, with no difference by arm. Those with higher levels of education and who completed the survey in English were able to more accurately identify the survey purpose. Again, participants were more likely to accurately identify the purpose of the survey after completing several NCD modules, compared to immediately following the consent module (42.0% vs 32.2% correct, p = 0.013).
This study contributes to the limited available evidence regarding consent procedures for automated MPS. Future studies should develop and trial additional interventions to enhance consent for automated public health surveys, and measure other dimensions of participant engagement and understanding.
Knowledge about and attitudes toward medical informed consent: a Lebanese population survey
Mary Deeb, Dana Alameddine, Rasha Abi Radi Abou Jaoudeh, Widian Laoun, Julian Maamari, Rawan Honeini, Alain Khouri,F adi Abou-Mrad, Nassib Elia, Aniella Abi-Gerges
Ethics & Behaviour, 19 December 2022
As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults with an average age of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC.
Analyzing online public commentary responding to the announcement of deemed consent organ donation legislation in the Canadian province of Nova Scotia
Alessandro R. Marcon, Darren N. Wagner, Christen Rachul, Matthew J. Weiss
Plos One, 15 December 2022
The Canadian province of Nova Scotia recently became the first jurisdiction in North America to pass deemed consent organ donation legislation. The announcement of this legislation generated substantial online discussion, which we analyzed to provide insights on public perception.
We performed directed content analysis on 2663 user-generated comments appearing on two widely-shared Canadian Broadcasting Company (CBC) articles published online in April 2019. We determined levels of support and opposition in comments and described the specific rhetoric used for doing so. We also performed one-way ANOVA and Pearson chi-square tests to determine how the comments were being received and engaged by other users.
A range of commentary was present in both support and opposition to the changes in legislation. There were more negative than positive comments, and negative commentary generated more replies. Positive comments were received more positively by other users while negative comments were received more negatively. The total sum of negative comments was greatly influenced by a small number of very active participants. Negative commentary focused more on broad concepts and principles related to government, power, and individual rights rather than specific issues in the Nova Scotian context. Substantial issues of trust in the government and healthcare system were evident.
There were strong positive and negative sentiments expressed in the comments, but the total sum of negativity in the comments was significantly influenced by a small number of commentators. Analysis on the presumed consent concerns can be helpful to inform public outreach efforts.
Nurse knowledge and attitudes towards organ donation and deemed consent: the Human Organ and Tissue Donation Act in Nova Scotia
Reports of Original Investigations
Robin Urquhart, Nelofar Kureshi, Jade Dirk, Matthew Weiss, Stephen Beed
Canadian Journal of Anesthesia, 1 December 2022
In April 2019, the Human Organ and Tissue Donation Act (HOTDA) in Nova Scotia was modified to incorporate a deemed consent model. In this study, we sought to understand intensive care unit (ICU) and emergency department (ED) nurses’ knowledge of and confidence around organ donation and transplantation, experiences with organ donors and recipients, attitudes toward organ donation and deemed consent, and perceived opportunities and barriers to a deemed consent approach in view of the legislative change.
We sent an electronic, self-administered survey to all ICU and ED nurses in Nova Scotia. The survey queried respondents on their knowledge of, experience with, and attitudes around organ donation and HOTDA, and opportunities and barriers to the implementation of HOTDA in clinical practice. Survey results were analyzed using descriptive statistics.
One-hundred and ninety-four nurses responded to the survey. Nearly all (98%) supported organ donation, with 86% having signed an organ donor card to donate organs and/or tissues after death. A considerable majority (89%) also supported the new legislation. Nevertheless, a minority of respondents (13%) believed that deemed consent legislation would be considered a violation of the general principles of freedom and autonomy. The three most identified topics for ongoing training were coordination of the donation process (70%), clinical management of donors (70%), and family issues in decision-making (70%).
Intensive care unit and ED nurses had positive attitudes toward organ donation, including deemed consent model. The findings should inform educational initiatives in Nova Scotia and beyond to optimize organ donation processes and outcomes.
Estimated Impact of Deemed Consent Legislation for Organ Donation on Individuals With Kidney Failure: A Dynamic Decision Analytic Model
Koto P., Vinson A. J., Kiberd B. A., Beed S., Krmpotic K., Dirk J., Weiss M. J., Karthik K. Tennankore
Canadian Journal of Kidney Health and Disease, 25 November 2022
There is little data modeling the impact of deemed consent legislation (eligible individuals who do not register their decision to decline to be a donor are presumed to consent after death) on outcomes for individuals with kidney failure.
To estimate the change in life-years (LYs) and quality-adjusted life-years (QALYs) resulting from different changes in the rate of deceased donor kidney transplantation associated with deemed consent legislation and health system transformation.
Dynamic Decision Analytic Model.
This modeling study included kidney failure patients in Atlantic Canada (all of whom receive their kidney transplants in Halifax, Nova Scotia). The adoption of deemed consent legislation was the intervention, and opt-in (the status quo) was the reference comparator.
Prevalent kidney failure patients at the end of 2019 in all of Atlantic Canada (N = 3615) served as the starting population.
We compared expected outcomes between the intervention and comparator. Changes in QALYs and total LYs were modeled under different changes to the proportion of patients receiving a deceased donor kidney transplant (from –10% to 20%) resulting from deemed consent relative to the status quo. Changes in QALYs and LYs were reported for 3 different time horizons (5, 10, and 30 years). Uncertainty around QALYs and total LYs was reported using 95% confidence intervals (CIs) constructed from a probabilistic sensitivity analysis using 1000 Monte Carlo Simulations.
The increase in QALYs ranged from 7 QALYs (95% CI: 5-10) with a 5% increase using a 5-year time frame to 882 QALYs (95% CI: 619-1144) with a 20% increase over a 30-year time frame. Parallel changes in total LYs were also observed. In contrast, decreases in deceased donor kidney transplantation resulted in a loss of QALYs (for example, –463 QALYs; 95% CI: –633 to –306 for a 10% decrease over a 30-year time frame). Using the most optimistic scenario (a 20% increase), there was an 18% increase in the cumulative number of deceased donor kidney transplant recipients over a 30-year observation period.
The results are subject to uncertainty depending on changes to the dialysis or transplant population that were not modeled and that may not be fully captured with probabilistic sensitivity analysis.
Deemed consent legislation will lead to variable changes in QALYs and total LYs for the kidney failure population, depending on the degree to which deceased donor transplantation rates change and the time horizon of observation. This modeling study may serve as a baseline to monitor the future impact of deemed consent legislation.