[The presumed consent legislation – A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]

[The presumed consent legislation – A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts]
Kirchner K, Lauerer M, Nagel E
The Journal of Evidence and Quality in Health Care, 6 October 2023
Abstract
Introduction
Tissue transplantation can improve the quality of life of patients in a very wide range of applications. In 2021, around 900 people in Germany agreed to donate organs after death – the number of tissue donors was significantly higher. Nevertheless, there is a shortage of organs and tissues in Germany. In order to counteract this, the introduction of a presumed consent legislation has been discussed time and again. However, the debates focused on possible positive effects for organ donation, whereas potential consequences for tissue donation have so far not been considered in the political discourse or in research. Using an exploratory approach, this paper aims to contribute to closing this research gap: Multidisciplinary interviews with experts were conducted to investigate whether the presumed consent legislation is a key success factor for increasing the number of tissue donors in Germany and which other approaches might be promising.

Editor’s note: This is a German language publication.

Opt-out, mandated choice and informed consent

Opt-out, mandated choice and informed consent
Ben Saunders
Bioethics, 4 October 2023
Abstract
A number of authors criticise opt-out (or ‘deemed consent’) systems for failing to secure valid consent to organ donation. Further, several suggest that mandated choice offers a more ethical alternative. This article responds to criticisms that opt-out does not secure informed consent. If we assume current (low) levels of public awareness, then the explicit consent secured under mandated choice will not be informed either. Conversely, a mandated choice policy might be justifiable if accompanied by a significant public education campaign. However, if this entitles us to assume that members of the public are informed, then an opt-out system would also be justified in the same circumstances. The alleged advantages of mandated choice seem to rest on an unfair comparison, between mandated choice with a public education campaign and an opt-out system without one. While it may be that some countries with opt-out systems should do more to inform their publics, I see no reason to assume that this cannot be done. Indeed, advocates of mandated choice seem committed to thinking it possible to raise awareness. If opt-out systems adopt the same methods, such as writing to every individual, this should also address concerns about whether consent is informed.

Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN)

Informed Consent for Spine Procedures: Best Practice Guideline from the American Society of Pain and Neuroscience (ASPN)
Timothy Deer, Ankur A Patel, Dawood Sayed, Ashley Bailey-Classen, Ashley Comer, Benjamin Gill, Kiran Patel, Alaa Abd-Elsayed, Natalie Strand, Jonathan M Hagedorn, Zohra Hussaini, Nasir Khatri, Ryan Budwany, Melissa Murphy, Dan Nguyen, Vwaire Orhurhu, Morteza Rabii, Douglas Beall, Stephen Hochschuler, Michael E Schatman, Timothy Lubenow, Richard Guyer, Ahmed M Raslan
Journal of Pain Research, 24 October 2023; pp 3559-3568
Open Access
Abstract
Introduction
The evolution of treatment options for painful spinal disorders in diverse settings has produced a variety of approaches to patient care among clinicians from multiple professional backgrounds. The American Society of Pain and Neuroscience (ASPN) Best Practice group identified a need for a multidisciplinary guideline regarding appropriate and effective informed consent processes for spine procedures.
Objective
The ASPN Informed Consent Guideline was developed to provide clinicians with a comprehensive evaluation of patient consent practices during the treatment of spine pathology.
Methods
After a needs assessment, ASPN determined that best practice regarding proper informed consent for spinal procedures was needed and a process of selecting faculty was developed based on expertise, diversity, and knowledge of the subject matter. A comprehensive literature search was conducted and when appropriate, evidence grading was performed. Recommendations were based on evidence when available, and when limited, based on consensus opinion.
Results
Following a comprehensive review and analysis of the available evidence, the ASPN Informed Consent Guideline group rated the literature to assist with specification of best practice regarding patient consent during the management of spine disorders.
Conclusion
Careful attention to informed consent is critical in achieving an optimal outcome and properly educating patients. This process involves a discussion of risks, advantages, and alternatives to treatment. As the field of interventional pain and spine continues to grow, it is imperative that clinicians effectively educate patients and obtain comprehensive informed consent for invasive procedures. This consent should be tailored to the patient’s specific needs to ensure an essential recognition of patient autonomy and reasonable expectations of treatment.

FIGO best practice guidance in surgical consent

FIGO best practice guidance in surgical consent
Special Article
Goknur Topcu, Phil McClenahan, Koketso Pule, Hajra Khattak, S. Eda Karsli, Marijo Cukelj, Akaninyene E. Ubom, Esraa Algurjia, Kubra Ozpinar, Yotin Ramon Perez, Rashid Bunu, Leopoldo S. Sanabria, Francisco J. R. Portilla, Elizabete Pumpure, Priyankur Roy, Paul Fogarty
International Journal of Gynecology & Obstetrics, 14 October 2023
Abstract
Obtaining medical consent preoperatively is one of the key steps in preparing for surgery, and is an important step in informed decision making with the patient. According to good medical practice guidelines, doctors are required to have the knowledge and skills to treat patients as well as inform them, respect their wishes, and establish trust between themselves and their patients. Valid consent includes elements of competence, disclosure, understanding, and voluntariness. Documentation of these elements is also very important. The International Federation of Gynecology and Obstetrics (FIGO) Education Communication and Advocacy Consortium (ECAC) has realized that the quality of consent varies considerably across the world and has developed simple guidelines regarding consent and procedure-specific checklists for the most common obstetric and gynecological procedures.

Knee’d To Know Basis: Informed Consent in Total Hip and Knee Arthroplasty

Knee’d To Know Basis: Informed Consent in Total Hip and Knee Arthroplasty
Commentary
Kevin C. Chang, Benjamin Hershfeld, Peter B. White, Randy M. Cohn, Michael A. Mont, Adam Bitterman
The Journal of Arthroplasty, 9 October 2023
Abstract
Informed consent is the process by which a medical provider explains the benefits, risks, and alternatives to a proposed medical intervention. It is a crucial part of maintaining patient autonomy and is particularly important in the context of elective surgical procedures, such as joint arthroplasty. The goal of this article is to review the topic of informed consent in the context of total joint arthroplasty. In this review, we discuss informed consent in general, considerations for informed consent in general arthroplasty procedures, and special twelve considerations for both hip and knee arthroplasty.

Pathways to informed choices: The impact of freedom of choice and two-sided messages on psychological reactance and vaccination intentions among individuals who express concerns

Pathways to informed choices: The impact of freedom of choice and two-sided messages on psychological reactance and vaccination intentions among individuals who express concerns
Author links open overlay panelToni Claessens, Simone Krouwer, Heidi Vandebosch, Karolien Poels
Vaccine, 6 October 2023; 41(42) pp 6272-6280
Abstract
Background
Reducing the spread of infectious diseases through vaccination faces the challenge of vaccine hesitancy: referring to questions, concerns and doubts arising when making a vaccine-related decision. A motivational state often arising within people exposed to health messages supporting informed decision making is psychological reactance, functioning as a driver to behavior opposed to the one recommended through the health message. Hence, there is a pressing need for communication strategies effective in counteracting reactance to health messages.
Methods
This study tested two communication strategies that can potentially reduce psychological reactance and ameliorate evaluations of the message and subsequent behavioral vaccination intentions in the context of COVID-19. These were: (1) explicitly reminding individuals of their freedom of choice (to either accept or refuse the vaccine) and (2) providing a two-sided message, including, apart from evidence-based information on the necessity of vaccines, a set of concerns, and questions (about the vaccines) which are refuted immediately. A total of 234 participants who indicated having concerns about the COVID-19 vaccine participated in a 2 (freedom of choice: no choice vs. choice) × 2 (message sidedness: one-sided vs. two-sided) between-subjects online experiment where they received an informational brochure about COVID-19 vaccination.
Results
The results show that emphasizing freedom of choice significantly increased perceived credibility of the message, perceived information utility, and ultimately, vaccination intentions. A decrease in psychological reactance mediated these effects. Message sidedness did only show a significant direct effect on perceived information utility. No interaction effect was found.
Conclusion
These findings indicate the importance of freedom of choice in reducing psychological reactance, which in its turn can lead to an increase of positive message evaluations and vaccination intentions among individuals who express concerns. The opportunities of message sidedness as an efficacious vaccination communication strategy should be further investigated.

Informed choice and routinization of the second-trimester anomaly scan: a national cohort study in the Netherlands

Informed choice and routinization of the second-trimester anomaly scan: a national cohort study in the Netherlands
Research
Eline E.R. Lust, Kim Bronsgeest, Lidewij Henneman, Neeltje Crombag, Caterina M. Bilardo, Elsbeth H. van Vliet-Lachotzki, Robert-Jan H. Galjaard, Esther Sikkel, Monique C. Haak & Mireille N. Bekker
BMC Pregnancy and Childbirth, 26 September 2023; 23(694)
Open Access
Abstract
Background
Since 2007 all pregnant women in the Netherlands are offered the second-trimester anomaly scan (SAS) in a nationwide prenatal screening program. This study aims to assess the level of informed choice of women opting for the SAS and to evaluate the presence of routinization 16 years after its implementation. It further explores decisional conflict and women’s decision making.
Methods
This prospective national survey study consisted of an online questionnaire which was completed after prenatal counseling and before undergoing the SAS. Informed choice was measured by the adapted multidimensional measure of informed choice (MMIC) and was defined in case women were classified as value-consistent, if their decision for the SAS was deliberated and made with sufficient knowledge.
Results
A total of 894/1167 (76.6%) women completed the questionnaire. Overall, 54.8% made an informed choice, 89.6% had good knowledge, 59.8% had deliberated their choice and 92.7% held a positive attitude towards the SAS. Women with low educational attainment (p=0.004) or respondents of non-Western descent (p=0.038) were less likely to make an informed choice. Decisional conflict was low, with a significantly lower decisional conflict score in women that made an informed choice (p<0.001). Most respondents (97.9%) did not perceive pressure to undergo the SAS.
Conclusions
Our study showed a relatively low rate of informed choice for the SAS, due to absence of deliberation. Therefore, some routinization seem to be present in the Netherlands. However, most women had sufficient knowledge, did not perceive pressure and experienced low decisional conflict.

Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees

Navigating Informed Consent and Patient Safety in Surgery: Lessons for Medical Students and Junior Trainees
August A. Culbert, Alejandro Bribriesco, Michael S. O’Connor, Eric Kodish
The Journal of Clinical Ethics, Fall 2023; 34(4)
Abstract
In the operating room, patient safety is of paramount importance. Medical students and junior trainees, despite their primary role as students, may play active roles in assessing patient safety and reporting suspected errors. Active consent is one layer of patient safety that is continuously assessed by several team members. This article examines an instance where patient consent may have been violated. Through the lens of trainee and senior perspectives, we discuss the ethical principles at stake and provide recommendations for medical student and junior trainee involvement in patient care when an error is suspected.

Midshaft clavicle fractures treatment: proposal of informed consent for a shared-treatment decision

Midshaft clavicle fractures treatment: proposal of informed consent for a shared-treatment decision
Remo Goderecci, Stefano Di Filippantonio, Norman Ciprietti, Alessio Ciuffoletti
Lo Scalpello, August 2023
Abstract
Fractures of clavicle frequently occur in young active patients and the middle-third of the shaft is the most involved segment. Traditionally mid-shaft clavicle fractures have been treated mainly non-operatively. The literature of the first decade of the 2000s strongly supported a routine indication of surgical treatment for the fracture of this segment, resulting in a clear change of attitude compared to previous years. However, most recent systematic reviews demonstrated an uncertain superiority of surgery over conservative treatment in the acute management of these fractures. In fact, both types of treatment can result in complications that need to be balanced for the individual patient in order to determine the best indication; in addition, increasing attention is being given to the patient’s involvement in the decision-making process for the therapeutic choice, which also influences final treatment satisfaction. Herein, we propose an informed consent that is clearly understandable to the patient in which all the points relating to the two types of treatment (conservative vs surgical) are discussed: from a review of the literature, we report the factors and relative percentages that can influence the final result. We believe that this document can be a useful tool in the clinic for an informed and shared choice of treatment with the patient suffering from a fracture of the middle third of the clavicle, potentially influencing surgical practice from a legal point of view.

Editor’s note: Lo Scalpello is published by the Italian Journal of Orthopaedics and Traumatology.

Green bioethics, patient autonomy, and informed consent in health care

Green bioethics, patient autonomy, and informed consent in health care
Original Research
David B Resnik, Jonathan Pugh
Journal of Medical Ethics, 13 October 2023
Abstract
Green bioethics is an area of research and scholarship that examines the impact of health care practices and policies on the environment and emphasizes environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that health care providers should inform patients about the environmental impacts of treatments and advocate for options that minimize adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient-provider relationship in situations where patients have clearly expressed environmental concerns, it may have the opposite effect in other situations if it serves to make patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalizable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in health care financing, organization, and delivery and use discretion when bringing up environmental concerns in their encounters with patients.