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.
Year: 2022
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.
Survey of Informed Consent Procedures in Urology
Survey of Informed Consent Procedures in Urology
Juliana Kim, Arnav Srivastava, Alexandra Tabakin, Eric A Singer
Journal of the American College of Surgeons, November 2022; 235(5)
Abstract
Introduction
The American Urological Association and American College of Surgeons codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. This study analyzes how these requirements are met by urology training programs.
Method
An anonymous electronic survey was distributed to the program directors (PDs) of the 143 ACGME urology residency programs in the US in 2021. Responses were procured during 3 months. Information was collected regarding program demographics, aspects of the program’s consent process, and the disclosure of the role and participation of residents to patients.
Result
Of 143 distributed surveys, 30.0% (n = 43) received a response. Of responding PDs, 67.4% reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25.1%), expected recovery time (22.8%), length of the surgery (22.2%), the people involved (18.0%), and their specific roles (7.2%). Of PDs, 48.8% and 87.8% of do not explicitly discuss trainee involvement or when a resident performs the majority of the case, respectively (Figure). Of PDs, 78.8% do not communicate medical student involvement. Of PDs, 73.2% reported having a patient decline participation of a trainee after describing their role.
Conclusion
Despite the American Urological Association and American College of Surgeons codes of professionalism, many urologists involved in the training of residents may not disclose resident participation in surgery to patients. Further discussions are needed to explore how to better balance resident education while strengthening the informed consent process.
How I Learned is How I Teach – Perspectives on How Faculty Surgeons Approach Informed Consent Education
How I Learned is How I Teach – Perspectives on How Faculty Surgeons Approach Informed Consent Education
Erin M. White, Andrew C. Esposito, Vadim Kurbatov, Xujun Wang, Michael G. Caty, Maxwell Laurans, Peter S. Yoo
Journal of Surgical Education, 15 October 2022
Abstract
Objective
To understand the variability of surgical attending experience and perspectives regarding informed consent and how it impacts resident education
Design
A novel survey was distributed electronically to explore faculty surgeon’s personal learning experience, knowledge, clinical practice, teaching preferences and beliefs regarding informed consent. Chi-square and Kruskal-Wallis testing was performed to look for associations and a cluster analysis was performed to elucidate additional patterns among.
Setting
Single, tertiary, university-affiliated health care system (Yale New Haven Health in Connecticut), including 6 teaching hospitals.
Participants
Clinical faculty within the Department of Surgery.
Results
A total of 85 surgeons responded (49% response rate), representing 17 specialties, both private practice and university and/or hospital-employed, with a range of years in practice. Across all ages, specialties, the most common method for both learning (86%) and teaching (82%) informed consent was observation of the attending. Respondents who stated they learned by observing attendings were more likely to report that they teach by having trainees observe them (OR 8.5, 95% CI 1.3-56.5) and participants who recalled learning by having attendings observe them were more likely to observe their trainees (OR 4.1, 95% CI 1.5-11.2).Cluster analysis revealed 5 different attending phenotypes with significant heterogeneity between groups. A cluster of younger attendings reported the least diverse learning experience and high levels of concern for legal liability and resident competency. They engaged in few strategies for teaching residents. By comparison, the cluster that reported the most diverse learning experience also reported the richest diversity of teaching strategies to residents but rarely allowed residents to perform consent with their patients. Meanwhile, 2 other cluster provided a more balanced experience with some opportunities for practice with patients and some diversity of teaching– these clusters, respectively, consist of older, experienced general surgeons and surgeons in trauma and/or critical care.
Conclusions
Surgeon’s demographics, personal experiences, and specialty appear to significantly influence their teaching styles and the educational experience residents receive regarding informed consent.
Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists’ attitudes and practices in Germany
Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists’ attitudes and practices in Germany
Leonie Gerke, Ann-Katrin Meyrose, Yvonne Nestoriuc
Clinical Psychology and Psychotherapy, 10 October 2022
Abstract
Objective
This study aimed to assess clinicians’ attitudes and their current clinical practices regarding informed consent for psychotherapy.
Method
A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey.
Results
Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%).
Conclusions
Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision-making and might have a positive influence on treatment expectations and outcomes.