Exploring the role of the oncologist in promoting shared decision making during treatment planning for older adults with acute myeloid leukemia
Research Letter to the Editor
Marissa LoCastro, Marielle Jensen-Battaglia, Chandrika Sanapala, Rachel Rodenbach, Jason H. Mendler, Jane Liesveld, Eric Huselton, Kah Poh Loh
Journal of Geriatric Oncology, June 2024
Introduction
Shared decision making (SDM), a process that promotes both patient autonomy and engagement, is associated with increased patient knowledge and decreased decisional regret [1]. Due to acute myeloid leukemia’s (AML) sudden onset and frequent need for rapid management decisions, achieving SDM in older patients is challenging [2]. Older adults with AML also have various vulnerabilities (e.g., functional and cognitive impairments) which further complicate decision making. This study evaluated oncologists’ current practices to promote SDM among older adults with AML using a communication tool designed to systematically elicit patient preferences regarding treatment planning.

Clear aligner therapy informed consent forms: A quality and readability evaluation
Original Article
Maurice J. Meade, Sven Jensen, Xiangqun Ju, David Hunter, Lisa Jamieson
International Orthodontics, June 2024
Open Access
Summary
Objective
The aim of the present study was to evaluate the quality and readability of content contained within clear aligner therapy (CAT) informed consent forms.
Methods
CAT informed consent forms were identified via an online search. The presence of details related to CAT-related processes, risks, benefits and alternatives in each form was recorded. A 4-point Likert type scale was used to determine the quality of content (QOC). The readability of content was evaluated with the Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES).
Results
A total of 42 forms satisfied selection criteria. Nineteen (45.2%) were authored by companies who provided aligners to patients via clinicians. The QOC regarding CAT-related treatment processes [median 2.0; IQR 0, 2] and benefits [median 2.0; IQR 1, 2] was adequate. The QOC scores regarding treatment alternatives, consequences of no treatment and relapse were poor. There was no difference (P = 0.59) in the median (IQR) QOC of the informed consent forms provided by direct-to-consumer (DTC) aligner providers [10 (8.25, 16.25)] and non-DTC aligner providers [12 (10, 14)]. The median (IQR) SMOG score was 12.1 (10.9, 12.7) and FRES was 39.0 (36.0, 44.25).
Conclusions
The QOC of the evaluated forms was incomplete and poor. The content was difficult to read and failed to reach recommended readability standards. Consent is unlikely to be valid if it is based solely on the content of the forms. Clinicians need to be aware of the limitations of informed consent forms for CAT particularly in relation to alternatives, prognosis, risks, and the need for long-term maintenance of results.

Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices
Leanne N. S. Torgersen, Stefan M. Schulz, Ricardo G. Lugo, Stefan Sütterlin
Plos Digital Health, 23 May 2024
Open Access
Abstract
Advancements in digitalisation with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life, and a potential increase in life expectancy. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. If a digital network were to be hacked, a CIED patient could experience both the loss of sensitive data and the loss of functional control of the CIED due to an unwelcome party. Moreover, if a CIED patient were to become victim of a cyber attack, which resulted in a serious or lethal event, and if this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient’s health but also the confidentiality, integrity, and availability of the CIED, and these cyber threats could be considered “patient-targeted threats.” Informed consent is a key component of ethical care, legally concordant practice, and promoting patient-as-partner therapeutic relationships [1]. To date, there are no standardised guidelines for listing cybersecurity risks within the informed consent or for discussing them during the consent process. Providers are responsible for adhering to the ethical principles of autonomy, beneficence, non-maleficence, and justice, both in medical practice generally and the informed consent process specifically. At present, the decision to include cybersecurity risks is mainly left to the provider’s discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by carrying such a device. Therefore, cyber risk factors should be covered within the patients’ informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.

Patient Consent for Medical Student Pelvic Exams under Anesthesia: An Exploratory Retrospective Chart Review
Jessica A. Jushchyshyn, Lakeisha Mulugeta-Gordon, Cara Curley, Florencia Greer Polite, and Jon F. Merz
The Journal of Clinical Ethics, 10 May 2024
Abstract
Objective
We performed this study to examine patients’ choices to permit or refuse medical student pelvic examinations under anesthesia (EUAs) during planned gynecologic procedures.
Design
We conducted an exploratory retrospective chart review of electronic consent forms at a single academic medical center using contingency tables, logistic regression, and nonparametric tests to explore relationships between patient and physician characteristics and consent.
Results
We identified and downloaded electronic consent forms for a census of 4,000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022. Forms were linked to anonymized medical record information. Of the 4,000 patients, 142 (3.6%) were removed from analysis because consent forms were incomplete. Of 3,858 patients, 308 (8.0%) were asked for EUA consent more than once, 46 of whom were not consistent. Overall, 3,308 (85.7%) patients consented every time asked, and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and two patients refused medical student participation at all. We performed exploratory multiple logistic regression analyses exploring differences in rates of consent across patient and physician demographic groups.
Conclusions
We find that some patients are more likely than others to refuse a pelvic EUA, magnifying the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuating historic wrongs visited upon vulnerable people of color and religious minorities. Patients’ rights to respect and control over their bodies require that physicians take seriously the ethical obligation to inform their patients and ask them for permission.

Overlapping Surgery Verbiage in Informed Consent Documents
Original Study
Margaret B. Mitchell, George Lin, Kavita Prasad, Daniel R. S. Habib, Alexander Langerman
Annals of Surgery, 6 May 2024
Abstract
Objective
To assess informed consent documents from United States (US) institutions for verbiage regarding overlapping surgery.
Summary background data
Overlapping surgery remains a controversial practice. Recent guidance from the Senate Finance Committee and American College of Surgeons emphasizes transparency with patients regarding this practice through the informed consent process, but it remains unclear how many institutions adopted their recommendations.
Methods
Informed consent documents were collected from a national sample of 104 institutions and assessed for verbiage regarding overlapping surgery and/or attending absence during a surgical case. The verbiage of these forms was further analyzed for inclusion of key terms (e.g., “overlapping surgery,” “critical portions”) as well as transparency regarding surgeon absence.
Results
Thirty (29%) forms included verbiage regarding overlapping surgery and/or surgeon absence during a case. Most of these 30 utilized the terms “overlapping surgery” or “critical portions” (18 [60%] and 25 [83%], respectively), although only 3 (10%) explicitly stated that portions of the procedure that may be performed in the absence of the attending surgeon. Six forms (20%) specifically stated who may perform the procedure without the attending present, and 3 forms (10%) had patients acknowledge this section of the consent form with an additional signature or initial. Only 2 of the forms (7%) fulfilled all of the criteria set forth by the SFC.
Conclusion
Detailed information regarding overlapping surgery is infrequently included in hospitals’ procedure informed consent documents. Forms that include this information rarely provide explicit statements of attending presence and trainee participation, raising concerns regarding surgeon-patient transparency.