A Qualitative Content Analysis of Comments on Press Articles on Deemed Consent for Organ Donation in Canada

A Qualitative Content Analysis of Comments on Press Articles on Deemed Consent for Organ Donation in Canada
Danielle E. Fox, Maoliosa Donald, Christy Chong, Robert R. Quinn, Paul E. Ronksley, Meghan J. Elliott, Ngan N. Lam
Clinical Journal of the American Society of Nephrology, October 2022
Abstract
Background and objectives
In 2019, two Canadian provinces became the first jurisdictions in North America to pass deemed consent legislation to increase deceased organ donation and transplantation rates. We sought to explore the perspectives of the deemed consent legislation for organ donation in Canada from the viewpoint of individuals commenting on press articles.
Design, setting, participants, & measurements
In this qualitative descriptive study, we extracted public comments regarding deemed consent from online articles published by four major Canadian news outlets between January 2019 and July 2020. A total of 4357 comments were extracted from 35 eligible news articles. Comments were independently analyzed by two research team members using a conventional content analysis approach.
Results
Commenters’ perceptions of the deemed consent legislation for organ donation in Canada predominantly fit within three organizational groups: perceived positive implications of the bills, perceived negative implications of the bills, and key considerations. Three themes emerged within each group that summarized perspectives of the proposed legislation. Themes regarding the perceived positive implications of the bills included majority rules, societal effect, and prioritizing donation. Themes regarding the perceived negative implications of the bills were a right to choose, the potential for abuse and errors, and a possible slippery slope. Improving government transparency and communication, clarifying questions and addressing concerns, and providing evidence for the bills were identified as key considerations.
Conclusions
If deemed consent legislation is meant to increase organ donation and transplantation, addressing public concerns will be important to ensure successful implementation.

An ex-ante cost-utility analysis of the deemed consent legislation compared to expressed consent for kidney transplantations in Nova Scotia

An ex-ante cost-utility analysis of the deemed consent legislation compared to expressed consent for kidney transplantations in Nova Scotia
Research
Prosper Koto, Karthik Tennankore, Amanda Vinson, Kristina Krmpotic, Matthew J. Weiss, Chris Theriault, Stephen Beed
Cost Effectiveness and Resource Allocation, 6 October 2022; 20(55)
Open Access
Abstract
Background
This study was an ex-ante cost-utility analysis of deemed consent legislation for deceased organ donation in Nova Scotia, a province in Canada. The legislation became effective in January 2021. The study’s objective was to assess the conditions necessary for the legislation change’s cost-effectiveness compared to expressed consent, focusing on kidney transplantation (KT).
Method
We performed a cost-utility analysis using a Markov model with a lifetime horizon. The study was from a Canadian payer perspective. The target population was patients with end-stage kidney disease (ESKD) in Atlantic Canada waitlisted for KT. The intervention was the deemed consent and accompanying health system transformations. Expressed consent (before the change) was the comparator. We simulated the minimum required increase in deceased donor KT per year for the cost-effectiveness of the deemed consent. We also evaluated how changes in dialysis and maintenance immunosuppressant drug costs and living donor KT per year impacted cost-effectiveness in sensitivity analyses.
Results
The expected lifetime cost of an ESKD patient ranged from $177,663 to $553,897. In the deemed consent environment, the expected lifetime cost per patient depended on the percentage increases in the proportion of ESKD patients on the waitlist getting a KT in a year. The incremental cost-utility ratio (ICUR) increased with deceased donor KT per year. Cost-effectiveness of deemed consent compared to expressed consent required a minimum of a 1% increase in deceased donor KT per year. A 1% increase was associated with an ICUR of $32,629 per QALY (95% CI: − $64,279, $232,488) with a 81% probability of being cost-effective if the willingness-to-pay (WTP) was $61,466. Increases in dialysis and post-KT maintenance immunosuppressant drug costs above a threshold impacted value for money. The threshold for immunosuppressant drug costs also depended on the percent increases in deceased donor KT probability and the WTP threshold.
Conclusions
The deemed consent legislation in NS for deceased organ donation and the accompanying health system transformations are cost-effective to the extent that they are anticipated to contribute to more deceased donor KTs than before, and even a small increase in the proportion of waitlist patients receiving a deceased donor KT than before the change represents value for money.

The Current Practice and Medico Legal Aspects of Informed Consent in Obstetrics and Gynaecology in a Teritary Care Hospital, Can We Improve?: An Interventional Study

The Current Practice and Medico Legal Aspects of Informed Consent in Obstetrics and Gynaecology in a Teritary Care Hospital, Can We Improve?: An Interventional Study
Shreen R., Kagne R.N., Jayasree M
Indian Journal of Forensic Medicine and Toxicology, October-December 2022; 16(4)
Open Access
Abstract
The Informed Consent plays major role in both Patients and the Doctors to carry out various aspects in the surgical procedures. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. This study results will give importance on documenting the Informed Consent day to day life practice.

Informed Decision-Making and Capabilities in Population-based Cancer Screening

Informed Decision-Making and Capabilities in Population-based Cancer Screening
Ineke L L E Bolt, Maartje H N Schermer, Hanna Bomhof-Roordink, Danielle R M Timmermans
Public Health Ethics, 3 October 2022
Abstract
Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy—as a right and as an ideal—we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so.

Towards a technologically assisted consent in the upcoming new EU data laws?

Towards a technologically assisted consent in the upcoming new EU data laws?
Andrés Chomczyk Penedo
Privacy in Germany, 2 September 2022
Abstract
The European Commission (Commission) put forward an ambitious proposal package of new legislation for the digital economy, including the Digital Markets Act, the Digital Services Act, or the Data Governance Act. Despite their different scopes, they all share a recurring topic: the relevance of (personal) data in enabling a data-intensive economic model around data sharing and the role of data subjects in granting permission to do so. As such, the purpose of this article is to explore how the Commission and other EU institutions intended to strengthen consent in these novel data regulations through technological tools but also novel assistance duties, but also the potential shortcoming around this approach.

Cross Sectional Study on Knowledge and Awareness on Informed Consent Among Nurses in Tertiary Care Hospital Hyderabad

Cross Sectional Study on Knowledge and Awareness on Informed Consent Among Nurses in Tertiary Care Hospital Hyderabad
K Srinivasulu, Sannidhi Ramyasri, Thamba Pranavi, KB Ronitha Vasuki Devi, Fathima Ashraf
Indian Journal of Forensic Medicine and Toxicology, October-December 2022; 16(4)
Open Access
Abstract
Nurses have a legal duty to ensure and obtain informed consent from their patients before undertaking any examination or procedure. Informed consent allows patients to make their decisions with their healthcare providers, this collaborative decision making process is mandatory in medical practice. A cross sectional study on knowledge and awareness on informed consent among nurses working in a tertiary care teaching hospital was conducted at Hyderabad, Telangana, 200 nurses working in various departments of the hospital were participated in this study, a questionnaire was prepared in regard to informed consent and assessed their knowledge levels by grading. The data was taken into Excel sheet and statistic evaluation was done by using MS Excel software. We found 67.7% are having awareness on informed consent whereas 32.3% are unaware. Similar results were observed in studies conducted in India and abroad, periodical workshops and continuous medical education programs can achieve better results.

Factor Analysis of Incomplete Informed Consent in Medical Record Installation Bangil Hospital in 2021

Factor Analysis of Incomplete Informed Consent in Medical Record Installation Bangil Hospital in 2021
Mahbubah, Arma Roosalina, Holipah Holipah
Jurnal Kedokteran Brawijaya, 24 October 2022
Open Access
Abstract
Medical action is an action taken on a patient in the form of diagnostic or therapeutic. All medical procedures to be performed on the patient must in consent. To conduct an informed consent filling, is when the patient agrees to be used as a medical action after being given an explanation by the officer. The one whose in charges to take a medical action must be a medical personnel. According to the hospitals’ standard minimum services, the completeness informed consent filling must be 100%. Bangil Hospital achieved 37% of completeness informed consent filling. This study aims to analyze the causative factors of informed consent incompleteness at Bangil Hospital. This study using a descriptive data analysis. Data collection techniques in this study are using a document studies, interviews and FGD. Document studies were conducted on 100 informed consent documents, interviews and FGDs were conducted to related officers to determine the causative factors of informed consent incompleteness documents which were analyzed using fishbone diagrams. From the results of the analysis, were determined that the priority of the root of the problem to be solved first are the man factor and the method. Thus, The CARL method used to find out an alternative solutions to cope the priority of the root of the problem. From the results of the scoring conducted, the main factor of informed consent incompleteness at Bangil Hospital was due to the absence of a flow in filling out the informed consent. Keywords: Informed consent, medical action, incompleteness.

Editor’s note: Jurnal Kedokteran Brawijaya is published by the Faculty of Medicine at Universitas Brawijaya, Indonesia.

Evaluation of consent forms for clinical practice in Spanish Public Hospitals

Evaluation of consent forms for clinical practice in Spanish Public Hospitals
Original Article
Morales-Valdivia, R. Camacho-Bejarano, A.M. Brady, M.I. Mariscal-Crespo
Journal of Healthcare Quality Research, 27 September 2022
Abstract
Objective
To evaluate the access, development, and quality of consents forms for clinical practice within the Spanish Public Hospitals.
Method
A cross-sectional study was conducted in a two-stage process (January 2018–September 2021). In stage 1, A nationwide survey was undertaken across all public general hospitals (n = 223) in the Spanish Healthcare System. In stage 2, Data was taken from the regional health services websites and Spanish regulations. Health Regional Departments were contacted to verify the accuracy of the findings. Data was analyzed using a descriptive and inferential statistics (frequencies, percentages, Chi-square & Fisher’s exact tests).
Results
The response rate was 123 (55.16%) of Spanish Public Hospitals. The results revealed a range of hospital departments involved in the development of consent documents and the absence of a standardized approach to consent forms nationally. Consent audits are undertaken in 43.09% hospitals and translation of written consents into other languages is limited to a minority of hospitals (35.77%). The validation process of consent documentation is not in evidence in 13% of Spanish Hospitals. Regional Informed Consent Committees are not place in the majority (70.7%) of hospitals. Citizens can freely access to consent documents through the regional websites of Andalusia and Valencia only.
Conclusion
Variability is found on access, development and quality of written consent across the Spanish Public Hospitals. This points to the need for a national informed consent strategy to establish policy, standards and an effective quality control system. National audits at regular intervals are necessary to improve the consistency and compliance of consent practice.

Development and validation of informed consent for blood transfusion questionnaire

Development and validation of informed consent for blood transfusion questionnaire
Original Article
Mohd Hilmi Senin, Mastura Mohd Sopian, Bakiah Shaharuddin, Muhammad Jaffri Mohd Nasir
Asian Journal of Transfusion Science, 2022
Abstract
Introduction
Blood transfusion warrants written informed consent from the patient. However, patients have poor knowledge regarding blood transfusions as evidenced by nonstandardized information retained by patients from the informed consent discussion. The problem stems from suboptimal patient knowledge on the elements of informed consent. This study describes the development and validation of a new questionnaire to assess the knowledge on informed consent for blood transfusion from the patients’ perspective.
Subjects and Methods
The development phase consisted of literature review, small group discussion, expert review meeting, content, and face validity. We evaluated the psychometric properties of Informed Consent for Blood Transfusion Questionnaire (ICBTQ) using reliability test and item response theory among a sample of 95 patients in Hospital Universiti Sains Malaysia.
Results
ICBTQ was formulated to include sociodemographic and knowledge sections. ICBTQ possessed excellent content validity. The face validity index (FVI) of clarity and comprehension were both 0.97. Thus, the universal FVI was 0.96. One item was added following the advice given by one of the content experts. ICBTQ had excellent face validity. For the validation phase, ICBTQ demonstrated an acceptable Cronbach’s Alpha value. One item was omitted in view of low corrected item-total correlation. In the item response theory (IRT) analysis, ICBTQ exhibited good difficulty and discriminatory indexes. Assessments of item-fit indicated that all items of the model were well-fitted.
Conclusions
Based on the IRT and reliability analysis, the knowledge section of the ICBTQ was psychometrically valid to be used among patients.

Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent

Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent
N.Vartanian, M.Wilson, R.P.Ermoian
International Journal of Radiation Oncology*Biology*Physics, 1 November 2022; 114(3) pp e500-e501
Abstract
Purpose/Objective(s)
Informed consent is an essential component of cancer care. The terms “second tumors” or “secondary tumors” are sometimes used in radiation therapy consent. Their incidences are sometimes described as “rare,” although vary greatly from nearly negligible in patients treated with palliative intent, to 20% in young patients undergoing myeloablative total body irradiation. We evaluated whether patients without prior knowledge of radiation therapy interpret the terms in a way consistent with physician intent.
Materials/Methods
We screened 164 adult subjects who did not require medical interpreters at a university-affiliated family medicine clinic, excluding cancer patients and those with any prior knowledge of or experience with radiation treatment. One hundred subjects were eligible for and completed a 12-question multiple choice questionnaire, which assessed their understanding of the term “secondary tumor” or “second tumor”, and how they would interpret the terms “small chance” or “rare” in the context of a “bad side effect.”
Results
Twenty-nine percent of subjects correctly identified that “secondary tumors” referred to new and different tumors caused by treatment. Forty-nine percent thought the term referred to their original tumor recurring, and 22% thought the term referred to new and different tumors not caused by radiation therapy. Subjects with college degrees were not more likely to choose the correct answer than subjects without college degrees p=0.63. College degree status was not available for 5 subjects. Given choices between 1:10, 1:100, 1:1000, and 1:100,000, subjects associated “rare” with 1:1000 or 1:100,000 82% of the time. The term “small chance” was associated with 1:1000 or 1:100,000 59% of the time.
Conclusion
Adult non-cancer patients have a demonstrably different understanding than radiation oncologists of the terms “second tumor” or “secondary tumor.” Additionally, patient understanding of the terms “rare” or “small chance” varies from secondary malignancy incidences in many clinical scenarios. Radiation oncologists should use clearer terms for secondary malignancies and their incidence.