Knowledge about and attitudes toward medical informed consent
Mary Deeb, Dana Alameddine, Rasha Abi Radi Abou Jaoudeh, Widian Laoun, Julian Maamari, Rawan Honeini, Alain Khouri, Fadi Abou-Mrad, Nassib Elia, Aniella Abi-Gerges
Ethics & Behavior, 11 January 2023
Abstract
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.

Informed consent in dermatology: a narrative review
Review
Meredith Hengy, Marlee Hewitt, Victoria Dekany, Nastassja Bedford-Lyon, Steven Daveluy
International Journal of Dermatology, 11 January 2023
Abstract
Informed consent is a legal and ethical obligation of healthcare providers, and there are several steps that must be followed for informed consent to be obtained. Numerous challenges exist to obtaining informed consent including gaps in health literacy, language barriers, impaired decision-making capacity, and inadequacy of informed consent forms. Dermatologists must understand the importance and process for obtaining informed consent to protect patients as well as avoid litigation. This narrative review provides an overview of the process of obtaining informed consent, insight into the top challenges that clinicians may face with suggested recommendations, and a brief review of litigation from improper consent among dermatologists.

Two Practices to Improve Informed Consent for Intraoperative Brain Research
A Peabody Smith, N Pouratian, A Feinsinger
Neurosurgery, 4 January 2023
Abstract
As the clinical applications of neurologically implanted devices increase, so do opportunities for intracranial investigations in human patients. In some of these studies, patients participate in research during their awake brain surgery, performing additional tasks without the prospect of personal therapeutic benefit. These intraoperative studies raise persistent ethical challenges because they are conducted during a clinical intervention, in a clinical space, and often by the treating clinician. Whether intraoperative research necessitates innovative informed consent methods has become a pressing conversation. Familiar worries about inadequate participant understanding and undue influence dominate these discussions, as do calls for increasing information retention (e.g., using methods such as “teach-back”) and minimizing enrollment pressures (e.g., preventing surgeons from consenting their own patients). However, efforts have yet to inspire widespread consent practices that mirror the scope of ethical concern. Focusing on awake, intraoperative intracranial research, we identify 2 underappreciated problems in approaches to informed consent. The first is epistemic: Many practices do not fully consider when and under which conditions participants are adequately informed. The second is relational: Many practices do not fully consider the effects of trust between patient-participants and surgeon-researchers. In exploring these concerns, we also raise questions about whether additional steps beyond preoperative consent may improve the process because decisions at this time are decoupled from both the experiences and vulnerability of awake brain surgery. Motivated by these considerations, we propose 2 practices: first, requiring a third-party patient advocate in initial consent and second, requiring verbal intraoperative reconsent before initiating research.

Establishing Legal Obligations and Guidelines for Consent in Organ Transplants
Malik Zia-ud-Din, Driss Ed.daran, Hamid Mukhtar
Al-Qantara, 4 January 2023; 9(1)
Abstract
The process of obtaining consent in the medical field is layered with complexity. Risk assessment and informed consent are very important public health problems that have gotten even more attention as the COVID-19 outbreak has progressed. This article identifies pertinent elements that physicians should take into account while obtaining permission for solid organ transplantation. First, we determine the circumstances behind the patient’s permission. The implications of recent legal decisions are then discussed, along with the legal principles governing consent in medical practice as they apply in the UK. The third section focuses on particular consent challenges in organ transplantation and discusses important variables to consider when deciding consent for organ transplantation. Practical suggestions are provided in the fourth part. In order to get informed permission for transplantation, we suggest a unique “multi-factor approach” that takes into account risk awareness, strong communication, and thorough review procedures. In conclusion, our suggested strategy adds just a little bit to the ongoing discussion around consent in medicine. This research further suggests that many developing countries are conducting such processes but those countries have no effective regulations similar to the UK; hence, such developing countries can follow the same footprints as the UK has taken.

Allegations of Failure to Obtain Informed Consent in Otolaryngology: Evidenced-Based Recommendations for Sinus Surgeons
Research Article
Christian G. Fritz, Dominic J. Romeo, Anne S. Lowery, Karthik Rajasekaran
American Journal of Rhinology & Allergy, 2 January 2023
Abstract
Background
Informed consent requires preoperative discussion of surgical risks, complications, and alternative treatment options. Allegations of incomplete informed consent are common in the field of otolaryngology.
Objectives
Analyze outcomes and case variables in cases of alleged informed consent failure involving otolaryngologists.
Methods
A legal research database containing state and federal case records from across the United States was retrospectively reviewed for malpractice claims involving informed consent and otolaryngology.
Results
Among the 128 informed consent cases identified, 72.6% resulted in favorable verdicts for otolaryngologists. Functional endoscopic sinus surgery (FESS) was the most common source of informed consent litigation in the field of otolaryngology, with an incidence four-fold higher than the next most litigated procedure of uvulopalatopharyngoplasty (21.9% vs 5.4%). The top four factors cited in FESS-related cases were CSF leak (10), inadequate discussion of alternative therapies (4), diplopia (3), and meningitis (3). Cases resulting in a transient injury were significantly less likely to result in a payment from a plaintiff verdict or settlement (9.1%) as compared to payment-rates among cases involving permanent complications (34.6%) (p = 0.005).
Conclusions
Failure to obtain informed consent is an important factor in medical malpractice litigation. This report identifies specific, actionable recommendations aimed at protecting sinus surgeons from liability and ensuring that patients are better informed.

Consent for toxicology testing during pregnancy: a qualitative study of patient and clinician perspectives
Leah N. Schwartz, Ellis J. Yeo, Molly R. Siegel, Davida M. Schiff, Sarah N. Bernstein
American Journal of Obstetrics & Gynecology, 1 January 2023
Abstract
Objective
Although state, federal, and professional guidelines stipulate the need for informed consent prior to toxicology testing during pregnancy, consent is often inadequately obtained. Our objective was to explore patient and clinician experiences obtaining consent for toxicology testing during pregnancy.
Study Design
Semi-structured qualitative interviews were conducted with 25 obstetric clinicians and 10 patients who had toxicology testing performed during their delivery hospitalization at two institutions from December 2021-June 2022. Interviews assessed clinical decision-making, perceptions of testing utility, and consent and communication practices. Using a modified grounded theory approach, transcripts were double-coded and analyzed in Dedoose.
Results
When obtaining consent for toxicology testing, clinicians reported they routinely discuss testing indication but rarely address the patient’s right to refuse and the consequences of a positive result, both of which patients identified as important components of consent. Patients expressed discomfort asking questions during the consent process and an inability to decline testing, even among those who were told they could do so. The most frequently cited barriers by clinicians included limited experience with obtaining consent for toxicology testing, inability to explain the risks and benefits of testing, and a perceived erosion of the patient-clinician relationship. In contrast, clinicians reported increased comfort obtaining consent when testing indications were clearly outlined in a hospital policy they could reference.
Conclusion
Obstetric clinicians felt unprepared to obtain informed consent for perinatal toxicology testing, leaving patients without information necessary to make informed choices about their care. Additional provider education emphasizing shared decision-making and an improved understanding of the use of testing by child protective services are needed to adequately protect the rights of birthing persons.

Level of Patients’ Education and Knowledge About Informed Consent of Cesarean Section in Females Undergoing Planned Cesarean Section
Robina Zahoor, Rabia, Adila Ashraf, Hania Zafar, Shazia Abid
Journal of Akhtar Saeed Medical & Dental College, July-September 2022; 4(3)
Open Access
Abstract
Background
The consent-providing individual must not only have the appropriate mental ability but also have all of the required knowledge to give consent correctly. The patient must provide consent to accept or decline any treatment or examination. The study aimed to find the level of patients’ education and knowledge about informed consent of cesarean section in females undergoing planned cesarean section
Material and Methods
This study was cross-sectional and carried out at Unit I, Department of Obstetrics and Gynecology, Sir Gangs Ram Hospital, Lahore for a duration of six months after approval of synopsis from January 2022 to June 2022. All the enrolled patients were asked about the informed consent of cesarean section before undergoing cesarean section and their knowledge about informed consent was noted. The Female education about informed consent was obtained as per operational definition by the researcher herself after the procedure. Data analysis was done through SPSS version 21 software.
Results
A total of 100 cases were enrolled in the current study. Level of adequate knowledge about informed consent of cesarean section was recorded in 74 (74%) of the cases whereas adequate knowledge was not recorded in 26 (26%) cases. Level of adequate education about informed consent of cesarean section was recorded in 9 (9%) of the cases whereas adequate education was not recorded in 91 (91%) cases.
Conclusion
Our study concluded that a high number of patients have an adequate level of knowledge about informed consent for cesarean section in females undergoing planned cesarean section while the level of adequate education was very low.

Editor’s note: The Journal of Akhtar Saeed Medical & Dental College is in Lahore.

Navigating the perils and pitfalls throughout the consent process in hematopoietic cell transplantation
Review
Rachel Cusatis, Carlos Litovich, Ryan Spellecy, Andrew Liang, Anita D’Souza
Blood Reviews, 20 December 2022
Abstract
Hematopoietic cell transplantation (HCT) is a complex treatment used in malignancies and some non-malignant diseases. The informed consent process for HCT can also be complex due to patient- and process-related barriers. The informed consent process needs to be a dynamic and ongoing process, not simply a checklist. As a result of the realities of HCT, we highlight some potential pitfalls to the informed consent process including uncertainty, sociocultural and communication barriers, and decisional regret. The purpose of this comprehensive review is to highlight unique situations which can result in failure of the informed consent process. We also offer potential solutions to these pitfalls, primarily making the informed consent more patient focused through dynamic and continuous processes to mitigate decisional regret.

Hands-on Clinical Clerkship at the Department of General Medicine in a University Hospital Improves Medical Students’ Self-Evaluation of Skills of Performing Physical Examinations and Informed Consent: A Questionnaire-Based Prospective Study
Yoshinori Tokushima, Masaki Tago, Midori Tokushima, Shun Yamashita, Yuka Hirakawa, Hidetoshi Aihara, Naoko E Katsuki, Motoshi Fujiwara, Shuichi Yamashita
International Journal of General Medicine, 19 December 2022; pp 8647–8657
Open Access
Abstract
Introduction
The educational effects of a hands-on clinical clerkship on medical students at the Department of General Medicine of Japanese university hospitals remain to be clarified. This study aimed to determine how such education affects medical students’ self evaluation of their clinical skills.
Methods
We enrolled 5th-year-grade students at the Department of General Medicine, Saga University Hospital, Japan in 2017. The students were divided into those who were going to have Japanese traditional-style observation based training mainly in the outpatient clinic (Group O) and those in the 2018, new-style, hands-on clinical clerkship as one of the group practice members in outpatient and inpatient clinics (Group H). A questionnaire survey using the 4-point Likert scale for self-evaluation of the students’ clinical skills at the beginning and the end of their training was conducted in both groups. The pre- and post-training scores of each item in both groups were compared and analyzed using the Mann–Whitney test.
Results
All 99 students in Group O and 121 of 123 students in Group H answered the questionnaires. The response rate was 99%. Two items regarding the abilities of “can perform a systemic physical examination quickly and efficiently” and “can clearly explain the current medical condition, therapeutic options, or risks associated with treatment, and discuss the process for obtaining informed consent” showed higher scores in the post-training survey in Group H than in Group O. There were no differences in these scores in the pre-training survey between the two groups.
Conclusion
A hands-on clinical clerkship at the Department of General Medicine in a university hospital in Japan provided medical students with higher self-confidence in their skills of performing a physical examination and better understanding of patients’ treatment options and the process of informed consent than observation-based training.

Dispelling the ethical apprehensions surrounding same day cataract consent
Comment
Rosina Zakri, Hasan Naveed, Robert Hill, Rashid Zia
Eye, 12 December 2022
Open Access
Excerpt
…Despite there being no legal length of time between obtaining consent and performing a procedure, the Department of Health clearly states that consent cannot be taken under duress [4]. It is therefore stipulated by Kerns J. in the Fitzpatrick case (2008), risks of surgery should not be provided to the patient at the ‘eleventh hour’ and thus a ‘cooling off’ period may be required [5]. Although the same day procedures for many retinal conditions, such as intravitreal injections and laser, are commonly recognised as patient centric, there is still opposition to similar benefits when it comes to cataract surgery…