A multistage process leading to the development of a structured consent form and patient information leaflet for complex abdominal wall reconstruction (CAWR)
Original Article
Asarbakhsh, O. Smith, P. Chitsabesan, T. MacLeod, P. Lim, S. Chintapatla Hernia
Hernia, July 2020
Abstract
Purpose
Informed consent is vital in surgery. The General Medical Council, UK and Royal College of Surgeons of England provide clear guidance on what constitutes the process of informed patient consent. Despite this, evidence suggests that the consent process may not be performed well in surgery. We utilised a staged patient-centred approach and rigorous methodology to develop a standardised patient information leaflet (PIL) and pre-written structured consent form for complex abdominal wall reconstruction (CAWR).
Methods
We utilised the principles of Deming’s Plan-Do-Study-Act (PDSA) cycles to approach the process. Buzan’s mind maps were used to identify the stakeholders and deficiencies in the consent process (‘Plan’ phase). The content of the PIL and pre-written consent form was then developed in collaboration with stakeholders (‘Do’ phase). Multidisciplinary and multidepartmental feedback was obtained on the proposed content and amendments were made (‘Study’ and ‘Act’ phases).
Results
We successfully produced a clear, focused PIL and structured consent form, in Plain English, presenting accurate, relevant and detailed information in a highly understandable way. The PIL had a Flesch Reading Ease score of > 80, demonstrating a high level of readability and comprehensibility, with positive implications for informed patient decision making and preparedness for surgery.
Conclusion
Through sharing the process that we undertook, we aim to support other abdominal wall units who wish to develop and improve their own consent process.

Can incoming United States pediatric interns be entrusted with the essential communication skills of informed consent?
Research Article
Nicholas Sevey, Michelle Barratt, Emma Omoruyi
Journal of Educational Evaluation for Health Professions, 29 June 2020; 17(18)
Open Access
Abstract
Purpose
According to the Entrustable Professional Activities (EPA) for Entering Residency by the Association of American Medical Colleges, incoming residents are expected to independently obtain informed consent for procedures they are likely to perform. This requires residents to not only inform their patients but to ensure comprehension of that information. We assessed the communication skills demonstrated by 372 incoming pediatric interns between 2007 and 2018 at the University of Texas Health Science Center at Houston, obtaining informed consent for a lumbar puncture.
Methods
During a simulated case in which interns were tasked with obtaining informed consent for a lumbar puncture, a standardized patient evaluated interns by rating 7 communication-based survey items using 5-point Likert scale from “poor” to “excellent.” We then converted the scale to a numerical system and calculated intern proficiency scores (sum of ratings for each resident) and average item performance (average item rating across all interns).
Results
Interns received an average rating of 21.6 per 28 maximum score,) of which 227 interns (61.0%) achieved proficiency by scoring 21 or better. Notable differences were observed when comparing groups before and after EPA implementation (76.97% vs 47.0% proficient, respectively). Item-level analysis showed that interns struggled most to conduct the encounter in a warm and friendly manner and encourage patients to ask questions (average ratings of 2.97/4 and 2.98/4, respectively). Interns excelled at treating the patient with respect and actively listening to questions (average ratings of 3.16, each). Both average intern proficiency scores and each average item ratings were significantly lower following EPA implementation (P<0.001).
Conclusion
Interns demonstrated moderate proficiency in communicating informed consent, though clear opportunities for improvement exist such as demonstrating warmth and encouraging questions.

Evaluation of an Innovative Informed Consent Support Program for Individuals Considering a Living Kidney Donation
Chantal Fortin, Deitan Bourget
Nephrology Nursing Journal, May-June 2020; 47(3) pp 245-251
Abstract
Regulations require that consent be obtained before accepting a kidney donation, and respect for the competent adult requires the living donor to think, decide, and act freely, without any form of pressure or coercion. This article describes the results of a program, Les Compagnons de la Donation (Donation Companions), that attempts to meet these needs. A descriptive, non-experimental study was conducted to evaluate the degree of participant satisfaction and the program’s influence on consent. Thirty-nine (n = 39) potential donors took part in the study. For each of the items evaluated, the mean change of participants pre- and post-intervention perception was statistically significant. The change was even more marked for feeling informed or prepared compared to being convinced or confident about the decision. Almost all participants strongly agreed the program was satisfactory. This study demonstrated a structured program, such as the Les Compagnons de la Donation program, meets the needs of the target audience and appears to provide significant support to the decision-making process.

Cancer: a perspective of human dignity and informed consent from ethics and justice
Dora E. García-González, Xenia A. Rueda
National University of Colombia Journal of Public Health, 15 May 2020; 22(3) pp 1-5
Open Access
Abstract
This article attempts to reflect on the importance of thinking in general about illness and about cancer, from an ethical perspective. This approach reveals the central role of personal dignity and the moral relevance that supports the reasons for respecting people. The ethical values that sustain the practice of medicine must aim at uplifting this dignity and seeking situations of justice, since living in a community expresses intersubjectivity that cannot be truncated by illnesses like cancer. Therefore, situations involving poverty cannot justify the lack of health care, and if such lacks occur, they run counter to ethical awareness in the deepest sense and destroy intersubjectivity. As a result, cancer is suffered as a vital experience, in a framework of lives that are lived and are not simply objects of study; those stricken with cancer are individuals who are denied the human right to health, and undergo the elimination of their dignity, the cancelation of justice, and a death sentence. Society is part of these actions and at the same time, suffers from the disappearance of hope. In this sense, the process of informed consent is used as a tool that encourages dialog and understanding between doctors and patients during proper treatment, on a shared path.

Using biomarkers in acute medicine to prevent hearing loss: should this require specific consent?
Peta Coulson-Smith, Anneke Lucassen
Journal of Med Ethics, 11 March 2020
Open Access
Introduction
In this round table response, we discuss some of the problems inherent in insisting on specific consent for an activity that needs to happen rapidly as part of a package of care. The Human Tissue Authority (the UK regulator for human tissue and organs) consider that specific consent is mandatory to assess which antibiotics are appropriate on the neonatal unit, but this insistence may actually limit the autonomy which consent aims to promote. While genetic testing to determine which child will react adversely to particular antibiotics has been available clinically for several years, the research proposed here is to assess whether improving the speed of testing allows decisions to be made before treatment starts. Insisting on specific consent before this activity can take place is likely to delay appropriate care in some cases.