Presumed consent and the implications for eye donation
Editorial
Parwez Hossain
Eye, 9 November 2020
Open Access
Excerpt
…In this issue, Dimitry et al. remind us of the recent change in the law for England. In their letter, they provide an overview of the implications of the opt-out system on eye donation rates in countries in mainland Europe where there is a longer track record of this kind of legal change. Despite providing benefits to organ donation, increases in eye donation are not similarly matched. The authors highlight that in some countries, more specific measures such as education and infrastructure changes could be more effective. From personal experience of running an eye donation service, the training of allied health professionals such as trained eye retrievers, end of life care professionals would increase the capacity of a healthcare system to identify and retrieve potential eye donations. In many hospitals and healthcare organisations, this human infrastructure appears to be the rate limiting factor for higher eye donations…

Incorporating Evidence-Based Practice Into Informed Consent Practice
Research Article
James W. Drisko
Families in Society: The Journal of Contemporary Social Services, 6 November 2020
Abstract
This conceptual article argues that evidence-based practice (EBP) is best understood as a component of the informed consent process preceding treatment. The legally mandated informed consent/consent to treat process requires that professionals disclose to clients the nature of services along with potential risks, benefits, and alternatives. Informed consent is a long-standing part of professional practice ethics with over a century of legal precedents. The more recent EBP process also requires discussion with the client of the best research-supported treatments, which are explored in combination with the client’s values and preferences and the professional’s expertise, to develop a treatment plan. Yet, EBP has not been clearly linked to informed consent for treatment. EBP can be usefully understood as part of the more comprehensive informed consent ethics process. New practice and ethics competencies are examined.

Informed Consent for Percutaneous Coronary Intervention: A Patient Perspective of a Complex Process
Howard T. Blanchard, Diane L. Carroll, Felicity Astin
Cath Lab Digest, 4 November 2020; 28(11)
Open Access
Abstract
Background
Percutaneous coronary intervention (PCI) involves a complex informed consent process. Consent is sought simultaneously for a diagnostic angiography and the potential treatments that follow, including PCI, and fosters shared decision making. This process involves several healthcare providers, yet there has been limited data from the United States regarding the patient’s perspective of informed consent for PCI.
Objective
To describe U.S. patients’ perception of their PCI informed consent process, and of PCI treatment risks and benefits.
Methods
Patients admitted for coronary angiography were approached and if they volunteered for the study, completed a survey on their informed consent experience for PCI following their procedure. The survey asked about purpose of consent, attitudes, risks, benefits, and outcomes of PCI.
Results
There were 82 participants who had undergone PCI, with a mean age of 65 years. Participants included 64 males and 17 females. The majority of participants recognized the key components of choice (88%), risks (94%), and benefits (87%), and 65% of participants were aware of the alternatives for PCI from the informed consent experience. Participants expressed a desire for more information, but also admitted that they had trouble retaining the information. Eighty-nine percent had misconceptions that PCI would prevent a future myocardial infarction. Forty percent of the participants stated that they preferred family to be present during informed consent.
Conclusions
Healthcare providers can improve the informed consent experience by providing clear information, clarifying concerns, and by encouraging family questions and involvement.

Informed consent in neurosurgery: a systematic review
Nathan A. Shlobin, Mark Sheldon, Sandi Lam
Neurosurgical Focus, 20 August 2020; 49
Open Access
Abstract
Objective
Informed consent has served as a main principle of medical ethics and laws in the United States. The 1986 American Association of Neurological Surgeons Code of Ethics implied medicolegal liability for the failure to obtain informed consent without providing practical guidance regarding the application of informed consent to individual patient encounters in a medicolegal environment. Here, the authors aimed to identify baseline patient recall after discussions with neurosurgeons and their capacity to provide informed consent, describe the effects of interventions to improve patient comprehension, and elucidate the role of informed consent in malpractice litigation in neurosurgery. Their findings may guide neurosurgeons in discussions to properly inform patients and reduce the risk of litigation.
Methods
A systematic review was conducted to explore informed consent within neurosurgery and its application to medicolegal liability using the PubMed, Embase, and Scopus databases. Titles and abstracts from articles identified in the search were read and selected for full-text review. Studies meeting prespecified inclusion criteria were reviewed in full and analyzed for study design, aim, population, interventions, and outcomes.
Results
Of 1428 resultant articles, 21 were included in the review. Baseline patient recall was low, particularly for risks and alternatives of treatments, and even decreased over time. Cognitive impairment was noted as a factor limiting the ability to provide informed consent. Interventions incorporating a combination of modalities in informed consent discussions, a specialized consent form with points for neurosurgeons to check off upon discussion, interactive websites, question prompt lists, and illustrations were found to be effective in improving patient knowledge. Lack of informed consent was a common factor for malpractice litigation. Spine surgery was particularly prone to costly lawsuits. Payments were generally greater for plaintiff verdicts than for settlements.
Conclusion
The application of informed consent to patient encounters is an important facet of clinical practice. Neurosurgeons have a duty to provide patients with all pertinent information to allow them to make decisions about their care. The authors examined baseline patient comprehension and capacity, interventions to improve informed consent, and malpractice litigation; it appears that determining the proper capacity to provide informed consent and considering informed consent as a process that depends on the setting are important. There is room to improve the informed consent process centered on baseline patient health literacy and understanding as well as clear communication using multiple modalities.

Patient Centric Informed Consent in Orthodontic Practice: An Overview
Research Article
Prateeksha Bora, Poonam Agrawal, Dinesh Kumar Bagga, Madhurima Nanda, Prashant Kumar Shahi
Journal of Critical Reviews, 2020; 7(17) pp 3225-3229
Open Access
Abstract
Informed consent is a fundamental component of good clinical practice and clinical governance. Dental practitioners must be aware of the principal factors that need to be addressed to ensure that consent is valid. Consent, as defined by the Webster’s dictionary, is to give assent or approval. Informed consent is not just a signature on a consent form, it is a process of dialog between the dentist and the patient. It requires a full explanation of the nature, purpose and material risks of the proposed treatment in a language that the patient understands. The patient should have the opportunity to consider the information and ask questions in order to arrive at a balanced judgement of whether to proceed with the proposed treatment. The value of obtaining informed consent is of particular importance in orthodontics. Orthodontic treatment is usually of long duration, involves a number of appointments and is extremely reliant on the patient’s co-operation, in particular with appliance wear and maintenance of good oral hygiene. This article highlights the concept of informed consent which is based on the premise that each individual has a right to make decisions concerning his health, disease and treatment.

The value of communities and their consent: A communitarian justification of community consent in medical research
Original Article
Pepijn Al
Bioethics, 20 October 2020
Abstract
Community engagement is increasingly defended as an ethical requirement for biomedical research. Some forms of community engagement involve asking the consent of community leaders prior to seeking informed consent from community members. Although community consent does not replace individual consent, it could problematically restrict the autonomy of community members by precluding them from research when community leaders withhold their permission. Community consent is therefore at odds with one of the central principles of bioethics: respecting autonomy. This raises the question as to how community consent can be justified or even required. This paper aims to provide an answer to this question by arguing, based on the work of Taylor and Kymlicka, that community practices are important for the identity and autonomy of community members. When these practices are incompatible with a solitary focus on individual informed consent, they need to be protected by making these decision‐making practices (including asking permission to community authorities) part of the consent process. Since these decision‐making practices are important for the autonomy of community members, community consent with the goal of protecting these practices is not necessarily in conflict with autonomy.

Identification of Informed Consent in Patient Videos on Social Media: Prospective Study
Original Paper
Jane O’Sullivan, Cathleen McCarrick, Paul Tierney, Donal B O’Connor, Jack Collins, Robert Franklin
JMIR Medical Education, 13 October 2020; 6(2)
Open Access
Abstract
Background
The American Medical Association Code of Medical Ethics states that any clinical image taken for public education forms part of the patient’s records. Hence, a patient’s informed consent is required to collect, share, and distribute their image. Patients must be informed of the intended use of the clinical image and the intended audience as part of the informed consent.
Objective
This paper aimed to determine whether a random selection of instructional videos containing footage of central venous catheter insertion on real patients on YouTube (Google LLC) would mention the presence of informed consent to post the video on social media.
Methods
We performed a prospective evaluation by 2 separate researchers of the first 125 videos on YouTube with the search term “central line insertion.” After duplicates were deleted and exclusion criteria applied, 41 videos of patients undergoing central line insertion were searched for reference to patient consent. In the case of videos of indeterminate consent status, the posters were contacted privately through YouTube to clarify the status of consent to both film and disseminate the video on social media. A period of 2 months was provided to respond to initial contact. Furthermore, YouTube was contacted to clarify company policy. The primary outcome was to determine if videos on YouTube were amended to include details of consent at 2 months postcontact. The secondary outcome was a response to the initial email at 2 months.
Results
The researchers compiled 143 videos. Of 41 videos that contained footage of patient procedures, 41 were of indeterminate consent status and 23 contained identifiable patient footage. From the 41 posters that were contacted, 3 responded to initial contact and none amended the video to document consent status. Response from YouTube is pending.
Conclusions
There are instructional videos for clinicians on social media that contain footage of patients undergoing medical procedures and do not have any verification of informed consent. While this study investigated a small sample of available videos, the problem appears ubiquitous and should be studied more extensively.

Patients’ Experiences of Informed Consent and Preoperative Education
Research Article
Elif Akyüz, Yurdagül Erdem
Clinical Nursing Research, 7 October 2020
Abstract
The aim of this descriptive cross-sectional study was to determine adult surgery patients’ experiences of informed consent and preoperative education. Research was conducted between September 2018 and February 2019. The sample consisted of 201 adult patients of a university hospital in Turkey. Data were collected using a 48-item questionnaire developed by the researchers based on literature. More than half of the participants (54.2%) were fully informed while 36.8% were partially informed about their surgery process and 61.2% were informed by physicians. Overall, 33.3% had unanswered questions about surgery, with questions relating mostly to the type of surgery (26.8%) and its effect on their body (25.4%). Participants were least informed about preoperative deep breathing and cough exercises (47.8%). More than half (58.4%) of participants expected healthcare professionals to avoid using medical terminology when informing them. Physicians and nurses perform invasive interventions on patients and, therefore, should be sensitive about informing patients.

Consent for spine surgery: an observational study
Original Article
Angela Li Ching Ng, Lucinda S. McRobb, Sarah J. White, John A. Cartmill, Allan M. Cyna, Kevin Seex
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The tension between the ideal of informed consent and the reality of the process is under‐investigated in spine surgery. Guidelines around consent imply a logical, plain‐speaking process with a clear endpoint, agreement and signature yet surgeons’ surveys and patient interviews suggest that surgeons’ explanation is anecdotally variable and patient understanding remains poor. To obtain a more authentic reflection of practice, spine surgeons obtaining ‘informed consent’ for non‐instrumented spine surgery were studied via video recording and risk/benefit discussions were analysed.
Methods
A prospective observational study was conducted at a single neurosurgical institution. Twelve video recordings involving six surgeons obtaining an informed consent for non‐instrumented spine surgery were transcribed verbatim and blindly analysed using descriptive quantification and linguistic ethnography.
Results
Ten (83%) consultations discussed surgical benefit but less than half (41%) quantified the likelihood of benefit from surgery. The most discussed risks were nerve damage or paralysis (92%), bleeding (92%), infection (92%), cerebrospinal fluid leak (83%) and bowel and bladder dysfunction (75%). Surgeons commonly used a quantitative statement of risk (58%) but only half of the risks were explained in words patients were likely to understand.
Conclusions
This study highlights inconsistencies in the way spine surgeons explain risks and obtain informed consent for ‘simple’ spine procedures in a real‐world setting. There are wide disparities in the provision of informed consent, which may be encountered in other surgical fields. Direct observation and qualitative analysis can provide insights into the limitations of current informed consent practice and help guide future practice.

Are We Meeting the Current Standards of Consent for Anesthesia? An International Survey of Clinical Practice
Tomas Jovaisa, Ieva Norkiene, Juri Karjagin, Iveta Golubovska, Lukas Gambickas, Migle Kalinauskaite, Evaldas Kauzonas, Dhuleep Wijayatilake
Medical Science Monitor, 5 October 2020
Open Access
Abstract
Background
International application of existing guidelines and recommendations on anesthesia-specific informed consent is limited by differences in healthcare and legal systems. Understanding national and regional variations is necessary to determine future guidelines.
Material and Methods
Anonymous paper surveys on their practices regarding anesthesia-specific patient informed consent were sent to anesthesiologists in Estonia, Latvia, and Lithuania.
Results
A total of 233 responses were received, representing 36%, 26%, and 24% of the practicing anesthesiologists in Lithuania, Latvia, and Estonia, respectively. Although 85% of responders in Lithuania reported using separate forms to secure patient informed consent for anesthesia, 54.5% of responders in Estonia and 50% in Latvia reported using joint forms to secure patient informed consent for surgery and anesthesia. Incident rates were understated by 14.2% of responders and overstated by 66.4% (P<0.001), with the latter frequently quoting incident rates that are several to tens of times higher than those published internationally. Physicians obtaining consent in the outpatient setting were more satisfied with the process than those obtaining consent on the day of surgery, with 62.5% and 42.6%, respectively, agreeing that the informed consent forms provided a satisfactory description of complications (P=0.03). Patients were significantly less likely to read consent information when signing forms on the day of surgery than at earlier times (8.5% vs. 67.5%, P<0.001). Only 46.2% of respondents felt legally protected by the current consent process.
Conclusions
Anesthesia-specific informed patient consent practices differ significantly in the 3 Baltic states, with these practices often falling short of legal requirements. Efforts should be made to improving information accuracy, patient autonomy, and compliance with existing legal standards.