Improving Surgical Informed Consent, Unanswered Questions
Review Article
Raper, Steven E., Clapp, Justin T., Lee A.
Annals of Surgery, March 2021; 2(1)
Abstract
Objective
This study reviews randomized clinical trials that have attempted to improve the process of informed consent. Consent should be guided by the ethical imperatives of autonomy, beneficence, and social justice.
Summary Background
Informed consent is constantly evolving. Yet our review of the randomized trials done to improve the surgical informed consent process raises a number of questions: How does one define surgical informed consent? What interventions have been tried to measure and improve informed consent? Have the interventions in informed consent actually led to improvements? What efforts have been made to improve informed consent? And what steps can be taken to improve the process further?
Methods
A literature search for randomized controlled trials (RCTs) on informed consent identified 70 trials. Demographics, interventions, assessments, and a semi-quantitative summary of the findings were tabulated. The assessments done in the RCTs, show the surrogate for patient autonomy was comprehension; for beneficence, satisfaction and mental state (anxiety or depression); and, for social justice, language, literacy, learning needs, and cost.
Results
There were 4 basic categories of interventions: printed matter; non-interactive audiovisual tools; interactive multimedia; and a smaller group defying easy description. Improvement was documented in 46 of the 65 trials that studied comprehension. Thirteen of 33 trials showed improved satisfaction. Three of 30 studies showed an increase in anxiety. Few studies tried to assess primary language or literacy, and none looked at learning needs or cost.
Conclusions
No single study improved all 3 principles of informed consent. Validated interventions and assessments were associated with greater impact on outcomes. All 3 ethical principles should be assessed; autonomy (as comprehension), beneficence (as satisfaction, anxiety), and social justice. Not enough consideration has been given to social justice; appropriate language translation, standardized reading levels, assessment of learning needs, and cost to the individual are all important elements worthy of future study.

Informed Consent to Patients in Root Canal Treatment (Case Study: Melati Dental Clinic Jakarta, Indonesia)
Pudentiana Rr RE, Tedi Purnama, Syifa Yulia Lestari, Yulianti
Medico-legal Update, January-March 2021, 21(1)
Open Access
Abstract
Teeth with necrosis require root canal treatment. Before taking any action, the treatment plan that will be carried out along with the risks must be explained clearly to the patient and his family, and then must get informed consent for the treatment plan. The purpose of this study was to the description of informed consent in patients with root canal treatment at the Melati Dental Clinic in Jakarta. Method: This research uses descriptive method with research sample using technique total sampling of 50 respondents. The data used are secondary data taken from the patient’s medical record. Results: Respondents 33 people (66%) provided complete informed consent and 17 people (34%) did not give complete informed consent. Respondents doing root canal treatment caused by caries as many as 38 people (76%) and respondent root canal treatment caused not because of caries as many as 12 people (24%). Respondents provided complete informed consent in patients with root canal treatment because of caries by 27 people (71%) and giving complete informed consent not because of caries by 6 people (50%). Whereas giving informed consent was incomplete because of caries as many as 11 people (29%) and incomplete informed consent was not due to caries as many as 6 people (50%). Conclusion: Management of Informed Consent in Root Canal Treatment patients at Melati Dental Clinic in Jakarta has been carried out well.

Is waiver of consent for the use of health information for research acceptable to emergency department patients?
Perspective
Chase Schultz‐Swarthfigure, Anne‐Maree Kelly
Emergency Medicine Australasia, 27 January 2021
Abstract
Some emergency medicine research, especially retrospective studies using medical records review, rely on waiver of consent for use of personal health information (PHI) contained in clinical records. This is a secondary use of PHI and waiver of consent raises ethical, legal and practical issues. Granting of a waiver of consent is often (but not always) approved by a human research ethics committee and requires separate but inter‐related consideration of the legal and ethical issues. In part, this involves a balancing of the public interest versus the risk to privacy and an evaluation of whether subjects would, mostly likely, have agreed to the use of their PHI had they been asked. To date, there are no robust data about whether use of PHI without consent for research would be acceptable to people who attend Australasian EDs for care.

Liminal spaces in neurosurgery – tensions between expectations of the patient and their surgeon at the threshold of informed consent
Original Article
Nicole C. Keong
British Journal of Neurosurgery, 19 January 2021
Abstract
Purpose
The concept of ‘liminality’, describing the universal human experience of transition in status, has been shown to be relevant in addressing the provision of healthcare needs within clinical medicine. Consent may be viewed as a threshold which patients must cross between a state of integration of information to a state of transformation into knowledge. This article reframes gaps in the modern surgical approach to the process of ‘informed consent’ via the lens of liminality, drawing on key illustrative cases from the medicolegal evolution in the UK and Commonwealth.
Materials and methods
A focused literature search was performed for informative medical legal cases addressing or contributing to the understanding of “informed consent”. Searches and references to sources of case law were performed using Westlaw and Hein Online databases. Searches for secondary sources for interpretation and discussions of case law and concepts, as well as topics of liminality and autonomy, were performed via PubMed and Academia databases and relevant online resources.
Results
The paper organizes the illustrative material using the following approach: a discussion and dissection of the i) evolution of consent as a duty to warn, comprising a summary of landmark cases, ii) materiality of risks and what a particular patient would wish to know and iii) conceptual relevance of troublesome knowledge, relational autonomy and threshold concepts in learning to key examples in case law and the process of informed consent.
Conclusions
Modern surgical practice of informed consent must strive for clarity of mutual understanding. The framework of liminality allows us to understand the in-between states encountered during the patient’s journey. An ability to recognize such gaps in expectations, and develop tools to promote transformational learning, would allow the surgeon to evolve from prudent practitioner to patient mentor at the threshold of informed consent.

Consent in Surgical Practice
Review Article
Bindey Kumar, Mokarram Ali, Manish Kumar, Amit Kumar Sinha, Anil Kumar, Utpal Anand
Indian Journal of Surgery, 15 January 2021
Abstract
Informed consent addresses core principles of medical ethics—beneficence, nonmaleficence and autonomy. In this era of ever-increasing legal and social scrutiny of complex surgical procedures, informed consent is not just an ethical debate but a legal requirement. Unfortunately, many surgeons, to their own peril, still see it as a mere formality. This article deliberates upon informed consent process in surgical practice with emphasis on Indian perspectives and discusses common scenarios and special situations through legal citations in order to sensitize surgeons regarding their obligations pertaining to informed consent.

Failed consent in spinal surgery again. Minimum standards for consent must be adopted by all surgeons
Original Article
Nicholas V. Todd
British Journal of Neurosurgery, 11 January 2021
Abstract
Aim
To report another case of failed consent in spinal surgery leading to an award in damages of £4.4 million and to suggest an improved method of recording discussions in respect of consent.
Methods
A recent Court Judgment, previous Judgments and the relevant medical law were reviewed.
Results
A standardised proforma recording the necessary preoperative discussions that must be had with our patients is described.
Conclusions
Spinal surgeons must adhere to new standards in respect of the consenting process and, crucially, in recording the dialogue that has occurred between the patient and the surgeon.

Regional anaesthesia: risk, consent and complications
K McCombe, D Bogod
Anaesthesia, 10 January 2021; 76(Suppl 1) pp 18-26
Open Access
Abstract
The risks of regional anaesthesia relate primarily to the technical nature of the procedure, chief among them being neurological. While rare, the direct relationship between nerve damage and the procedure itself means that patients need to be aware of this complication when consent is sought. In order to give valid consent, a patient must be informed. The extent of the information required has been defined by a 2015 legal ruling which established that the standard is the expectation of a reasonable patient, rather than the information deemed consequential by a reasonable doctor. The implications of this for clinicians are profound, and mean that the process of consent must, for example, include alternatives to the proposed treatment. Additionally, patients must have capacity and give their consent without coercion. Effective communication of risk can be challenging. As well as the barriers to comprehension that can result from language, literacy and numeracy, clinicians need to be aware of their own biases, often in favour of a regional anaesthetic approach. Patients also have biases, and doctors must be aware of these in order to best target their provision of information. Careful use of language and employing adjuncts such as information leaflets and visual aids can help to maximise the individual’s autonomy. Particular care must be taken in special situations such as where patients have capacity issues or time is limited by the emergency nature of the intervention.

Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center
Original Article
Marie-Kristin Schwaegermann, Melanie Schranz, Markus Moehler, Christian Labenz, Alice Moringlane, Marcus Schmidt, Matthias Theobald, Georg Hess
Journal of Cancer Research and Clinical Oncology, 9 January 2021
Open Access
Abstract
Purpose
Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients’ individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients’ comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation.
Methods
Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician–patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire.
Results
In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients.
Conclusions
To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.

Redesign of an informed consent form to increase participation in a school‐based dental program
Original Article
Andres A. Mantilla Rodriguez, Armando Soto, E. Angeles Martinez Mier
Journal of Public Health Dentistry, 30 December 2020
Abstract
Objectives
The study aimed to determine if modifications to the design of a consent form and consenting process increased participation rates in the Indiana University School of Dentistry’s Mobile School‐Based Dental Program (Seal Indiana).
Methods
Kaizen methodology was followed to identify problem areas in the consenting process. Additionally, stakeholders were invited to participate in focus groups and fill out surveys to identify issues preventing participation in the Seal Indiana program (N = 48) and later to evaluate the changes made (N = 48). The redesigned form and process were then used in a pilot study at 14 sites to determine the impact that changes had on levels of participation as measured by the number of consent forms completed and returned.
Results
There was a statistically significant increase in the number of consent forms returned. The measured change represented a 32 percent increase in program participation (P value = 0.035). A statistically significant increase was observed in how participants viewed the attractiveness of the form and how easy it was to read and comprehend.
Conclusions
In order to increase consenting rates, our results indicate modifications to the consent form should be focused on the following characteristics: esthetics, ease of reading and comprehending information, and making the Health Insurance Portability and Accountability Act of 1996 (HIPPA) privacy regulations easier to read and comprehend.

Does Written Informed Consent Comprehensively Inform Surgical Patients and is This Effective in Patient’s Decision-Making?
Original Article
Muhammad Fahim Ahsan, Abeer Irshad, Isbah Rashid, SH Waqar, Jawaria Faisal, Abdul Qadir Khuram
Annals of Punjab Medical College, 28 November 2020
Open Access
Abstract
Background
Informed consent (IC) is first fundamental principal step in health care helps patients to be conscious of consequences of their treatment decisions. The importance of obtaining a valid inform consent before any procedure well established with surgery and it is an important aspect of doctor patient relationship.
Objective
To assess outcome of different management strategies in women presenting with primary postpartum hemorrhage (PPH).
Study Design
Observational, prospective.
Settings
General surgery department of Pakistan Institute of medical Sciences Hospital Islamabad Pakistan.
Duration
Five months from March 2019 to July 2019.
Methodology
All the patients were asked a set of standard questions, which related to the information they had provided before the operation as a part of standard informed consent practice. The surgeons had taken all the interviews with privacy and confidentiality after postoperatively at the earliest time the patient is comfortable to do so. The questions were asked in the simple languages, which were understandable to patients, so that patients could easily understand and respond to the same. The questionnaire sought information risks/benefits associated with a surgical procedure, alternate treatment options, whether providing additional detailed verbal and/or written information improved their understanding. All the information was recorded via study proforma.
Results
Total 183 patients were interviewed post-operatively regarding inform consent and most of them 42.1% were between age 18-40 years. Males were 58.5% and females were 41.5%. Almost all cases had received informed consent, while some said they received just before the surgeries. There were some controversial answers regarding question of oral information influence the decision to proceed to the surgical procedure. Almost all patient had answered that they were informed regarding their conditions, surgical and anesthetic complications prior the surgery. Only 7.7% patient said that the time was not given for the questions and 10.4% patient were unsatisfied regarding informed consent, while the most of the cases were satisfied.
Conclusion
In the study observation mostly, patients were satisfied and because mostly surgical consent element is generally understood, but some remained controversial and should consider its importance, beyond risks of the procedures, as well as acceptability and feasibility of intervention to surgical team and patients. Written information has not provided patients with adequate decision-making tools for imminent health matters, so pre-operative oral information also needed to adequate decision-making.