Do we achieve the Montgomery standard for consent in orthopaedic surgery?
Xenia N Tonge, Henry Crouch-Smith, Vijay Bhalaik, William D Harrison
British Journal of Hospital Medicine, 21 April 2021
Abstract
Aims/Background
The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernisation of consenting practice. Failure to demonstrate informed consent is a common source of litigation. This quality improvement project aimed to provide pragmatic guidance for surgeons on consent and to improve the patient experience during decision making.
Methods
Elective orthopaedic patients were assessed and the quality of documented consent was recorded. Data were collected over two discrete cycles, with cycle 1 used as a baseline in practice. The following criteria were reviewed: grade of consenting clinician, alternative treatment options, description of specific risks, place and timing of consent and whether the patient received written information or a copied clinic letter. Cycle 1 results were presented to clinicians; a teaching session was provided for clinicians on the standard of consent expected and implementation of a change in practice was established with a re-audit in cycle 2.
Results
There were 111 patients included in cycle 1, and 96 patients in cycle 2. Consent was undertaken mostly by consultants (54%). Specific patient risks were documented in 50% of patients in cycle 1 and 60% in cycle 2. Risks associated with a specific procedure were documented in 42% in cycle 1 and 76% in cycle 2, alternative options in 48% (cycle 1) and 66% (cycle 2). A total of 14% of patients in cycle 1 and 8% in cycle 2 had documented written information provision. Copied letters to patients was only seen in 12% of all cycles. Documentation from dedicated consenting clinics outperformed standard clinics.
Conclusions
Highlighting poor documentation habits and refining departmental education can lead to improvements in practice. The use of consenting clinics should be considered and clinicians should individually reflect on how to address their own shortcomings. Other units should strongly consider a similar audit. This article provides stepwise advice to improve consent and specifics from which to audit.

Informed consent in interventional radiology – are we doing enough?
Akash Prashar, Saqib Butt, Davide Giuseppe Castiglione, Nadeem Shaida
British Journal of Radiology, 21 April 2021
Abstract
Objectives
Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure.
Methods
A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined.
Results
39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this.
Conclusion
The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential.

Pre-Abortion Informed Consent Through Telemedicine vs. in Person: Differences in Patient  Demographics and Visit Satisfaction
Original Article
Shelly Kaller, Sara Daniel, Sarah Raifman, M. Antonia Biggs, Daniel Grossman
Women’s Health Issues, 5 April 2021
Abstract
Purpose
Utah law requires patients to have a face-to-face “informed consent” visit at least 72 hours prior to abortion. Planned Parenthood Association of Utah (PPAU) offers this visit via telemedicine as an alternative to an in-person visit, which can require burdensome travel. This novel study identifies factors associated with using telemedicine for informed consent, patients’ reasons for using it, and experiences with it, compared to in-person informed consent.
Methods
In 2017 and 2018, patients 18 years and older seeking abortion at PPAU completed a self-administered online survey about their experiences with the informed consent visit. We used linear and logistic regression models to compare participants’ demographic characteristics by informed consent visit type, and descriptive statistics to describe reasons for using each visit type and experiences with the visit. Multivariable logistic regression models examined associations between visit type and satisfaction.
Results
Responses from 166 telemedicine patients and 217 in-person informed consent patients indicate that telemedicine participants would have had to travel significantly further than in-person participants traveled to attend the visit at the clinic (mean of 65 miles versus 21 miles, p < .001). In multivariable analyses, telemedicine participants had higher odds of being “very satisfied” with the visit (aOR, 2,89; 95% CI: 1.93–4.32) and “very comfortable” asking questions during the visit (aOR, 3.76; 95% CI: 2.58–5.49), compared to participants who attended in-person visits.
Conclusions
Telemedicine offers a convenient, acceptable option for mandated pre-abortion informed consent visits and reduces the burden of additional travel and associated barriers for some patients, particularly those who live further away from clinics.

[In search of open minds and shared consent – Information, treatment options and postoperative care from the patient’s perspective]
Ganz-Blättler U
Therapeutische Umschau. Revue Therapeutique, 1 April 2021; 78(3) pp 149-157
Abstract
This paper addresses knowledge gaps which are prone to handicap the ongoing communication process between medical / care personnel and patients of breast cancer, due to everyday routine and presumed lack of time. The respective qualitative studies do point to divergent expectations with regards to medical consultations and indicate that patients’ satisfaction with therapeutic measures, which were decided in advance, might be improved. Three exemplary aspects of doctor-patient communication are then looked at closer: first the variety of treatment options offered, second the risk of expressing unconscious bias regarding patients’ physical appearance and identity, and third the increasingly acknowledged desire of breast cancer patients to consult (… additionally, not alternatively) with other patients that are, or were previously affected by breast cancer and confronted with the decisions this condition entails.

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

Informed consent: What risks are material to patients consenting for urological procedures?
Research Article
Nadine McCauley, Siya Lodhia, Andrea Ong, Calum Clark, Tim Lane
Journal of Clinical Urology, 31 March 2021
Abstract
Objective
This study aimed to assess patient recall of the consent discussion for urological procedures and to identify which risks were material to urology patients.
Methods
A total of 102 patients undergoing urological procedures were interviewed in the 24-hour period surrounding the procedure. A self-designed, piloted questionnaire recorded information from the patient’s signed consent form and patient-reported data of the consent discussion.
Results
The mean patient recall was 2.06 risks, whereas the average number of risks listed by the operating surgeon on the consent form was 5.69 risks. The most frequently recalled risk was impotence (91%), followed by urinary incontinence (63%) and haematuria (61%). The risks associated with poorest patient recall were stent symptoms (0%), urethral catheter insertion (5%) and recurrence (8%).
Conclusions
Poor patient recall of the consent discussion has again been demonstrated in this study. However, certain urological procedure risks are better recalled by patients, with impotence, urinary incontinence and haematuria being most frequently recalled. Medical terminology such as stent or catheter may be poorly recalled due to a disparity in understanding between patient and clinician. Clinicians should be aware of poor patient recall when consenting for urology procedures and should ensure precise documentation.

Harming one to benefit another: The paradox of autonomy and consent in maternity care
Original Article
Elselijn Kingma
Bioethics, 11 December 2020
Open Access
Abstract
This paper critically analyses ‘the paradox of autonomy and consent in maternity care’. It argues that maternity care has certain features that increase the need for explicit attention to, and respect for, both autonomy and rigorous informed consent processes. And, moreover, that the resulting need is considerably greater than in almost all other areas of medicine. These features are as follows: (1) maternity care involves particularly socially sensitive body parts that are regularly implicated in consent-centred procedures, as well as in unconsented interventions, in ordinary, non-medical life; and (2) much of maternity care (especially intervening in childbirth) is medically unique, in that it harms one patient (the mother) not primarily for the promotion of her own health but for the benefit of another (the baby). The apt comparison, within medicine, is therefore with non therapeutic research and transplantation medicine—both of which have elevated consent requirements characterized by very rigorous consent processes. At the same time—and this delivers the titular paradox—the importance of autonomy and consent in maternity care is at particular risk of being denied or disregarded. Jointly, these considerations make a very strong case for change: attention to and respect for autonomy and consent should be (1) core values; (2) key points of practical attention in the years ahead; and (3) central quality indicators in maternity care.

Understanding Exception from Informed Consent in Planned Emergency Research
Understanding Research
CourtneyEdwards, Kimberly D. Johnson
Journal of Emergency Nursing, 11 March 2021
Abstract
Many of the current accepted treatment practices provided to patients in the first critical hour after a traumatic injury, stroke, or cardiac arrest have not been rigorously tested in clinical research trials. The inability to obtain informed consent is often a barrier to research in emergency, time-sensitive situations in which the patient is not able to provide informed consent nor is their family member immediately available to provide consent on behalf of the patient. Planned emergency research, often with exception from informed consent, is a type of research study that involves a patient with a life-threatening medical condition that requires urgent interventions, wherein the current treatments may be unproven or suboptimal, and who, because of their current condition, is unable to provide informed consent. This article summarizes the necessary components for using exception from informed consent in planned emergency research. Understanding the research design, particularly research processes specific to time-critical emergency situations, will ensure that the care provided by stretcher-side emergency nurses will result in optimal patient outcomes and is an integral aspect of emergency nursing practice.

Are we undermining the value of palliative care through advanced cancer clinical trial consent language?
Commentary
Puja J. Umaretiya, Jennifer P. Rubin, Jennifer M. Snaman, Christina Ullrich, Angela M. Feraco, Veronica Dussel, Joanne Wolfe, Elisha Waldman
Cancer, 10 March 2021
Abstract
Informed consents for advanced cancer trials contain language that misrepresents palliative care as an alternative to trial participation. This language should be revised to highlight that palliative care is appropriate at any point in the illness trajectory and alongside disease‐directed therapy.

[Expert consensus on informed consent for vaccination (part two)]
Zhonghua Liu Xing Bing Xue Za Zhi
Chinese Preventive Medicine Association, 1 March 2021; 42(3) pp 369-399
Abstract
The Vaccine Administration Law of the People’s Republic of China and other relevant laws require that vaccine recipients or their guardians be educated about vaccines and how they work, and described in general the methods and contents of such vaccination education. With the new law and “Standard Operational Procedures for Immunization” as foundation documents, and in consultation with experts at home and abroad, the Chinese Preventive Medicine Association developed a consensus statement about informed consent for vaccination. This consensus statement is written for disease control and prevention health care personnel in vaccination services and describes the educational content of informed consent, a theoretical framework for immunization and immunization knowledge, the informed consent processes, principles of planning for vaccination, and an informed consent form. Part Two of the consensus includes influenza vaccine, pneumococcal vaccine, haemophilus influenzae type b containing vaccine, enterovirus type 71 inactivated vaccine, rotavirus vaccine, varicella attenuated live vaccine, herpes-zoster vaccine, human papillomavirus vaccine, rabies vaccine, hemorrhagic fever with renal syndrome vaccine, leptospira vaccine, anthrax vaccine, hepatitis E vaccine, cholera vaccine, typhoid vaccine, and tick-borne encephalitis vaccine.

Editor’s Note: This is a Chinese language publication

The advantages of nurse-led consent for dialysis in improving shared decision-making and obtaining legal consent
Jo-Anne Moodie, Elaine Sanders, Brett Sobey, Jade Ryan, Jayne Amy, Jenny Beavis, Adele Montgomery, Stephen G Holt
Renal Society of Australasia Journal, March 2021; 17(1) pp 4-9
Abstract
The treatment/medical consent procedure has generally been performed by doctors. Despite the recognised importance of the consent process, formal initial consent for maintenance dialysis was poorly performed at in our service and rarely performed thereafter. As a large renal unit with a commitment to excellence in patient care, we felt this was out of keeping with our remit and sought to change the process to ensure we delivered useful information to allow our patients to have a meaningful discussion around consent issues. We trained senior nurses to perform the reconsent process, and took the opportunity to reassess patients’ decision-making competence, discuss advance care planning, blood consent and personal data privacy issues. We demonstrated a large improvement in the number of patients having a valid dialysis consent form, and realised the potential of this procedure to improve the care we give to our patient group. We recommend the benefits of nurse-led consent for dialysis to other services.