Is there a standardised consent process within the surgical specialties?
James Hall, Ian Farrell, Sujala Kalipershad, James Hill
The Surgeon, 5 July 2020
Abstract
Introduction
The consent process is central to surgical practice. Subsequent to landmark cases such as Montgomery and Thefaut there is increasing consensus that consent should be a staged process. The aim of our survey was to identify if there was any homogeneity in the practice of surgeons with regards to the consent process in comparison to national guidelines.
Methods
Our survey was distributed to a broad range of surgical specialties via an anonymous Google Forms questionnaire available online. Consultant Surgeons and Specialist registrars across the United Kingdom were then contacted via their relevant surgical societies and professional. Data collection was based on the Montgomery principles: consent location; face to face meetings; information leaflets (including their source); distribution of copies of letters and consent forms; use of percentage risks; use of pre-printed consent forms.
Results
The total number of replies was 325. The majority of consent was taken on the day of surgery (166/319; 50.8%). Scheduled meeting for the consent process occurred routinely in only 87 cases (87/319; 27.3%). 103 (103/319; 32.9%) responders indicated the use of pre-printed consent forms. Of which 93 (93/103; 90.3%) were produced locally. Risk percentages were routinely used by 103 responders (103/319; 32.9%) Nearly two-thirds never write specific risk percentages routinely (205/319; 64.3%). Copies of consent forms were routinely given out by 210 responders (210/319; 65.8%). Supporting information was routinely given to patients in 248 cases (248/319; 77.7%).
Conclusion
Our survey documents significant variation in the practice of consent despite clear guidance on best practice. We believe that most surgeons welcome a more thorough and robust consent process, but hey need the time and infrastructure to be able to do it Introduction.

Informed Consent in Patients Undergoing Primary Hip and Knee Arthroplasty: What Do Patients Want to Know?
Nemandra A Sandiford, Maalee Mahendra, Lilanthi Wickramarachchi, Diane Back, Mohit Bansal
Cureus, 5 June 2020; 12(6)
Abstract
Introduction
The consenting process has been surgeon-focused traditionally, but there is a recent trend towards making the process more patient and procedure-focused. The primary aims were to identify the risks considered most important and requiring further discussion by the patients undergoing primary total hip arthroplasty (THA) and primary total knee arthroplasty (TKA), as well as to identify the sporting and recreational activities these patients would like to pursue after surgery according to the age group, taking into consideration their values and expectations. The secondary aim is to assess the compliance of the current consenting process with guidelines set out by a governing body in a tertiary referral arthroplasty unit.
Material and method
A prospective study reviewing the consenting process was carried out on 137 patients undergoing THA or TKA over a 12-month period in a tertiary teaching hospital. Patients unable to complete a questionnaire and undergoing revision or uni-compartment arthroplasty were excluded. A standardized anonymous questionnaire was administered. Patients were asked to fill in the specific activities they considered important to be discussed. The data were tabulated in Microsoft Excel (Microsoft Corporation, Redmond, Washington) and subgroup analysis was performed using the student’s t-test. The level of statistical significance was p=0.05. Two-hundred consent forms were reviewed to assess whether the information entered correlated to the guidelines presented in Ortho-Consent.
Results
One-hundred thirty-seven questionnaires were reviewed. The mean age was 66 (range 45-91), with the majority of patients undergoing TKA (114) versus THA (23). The patients in active employment were more concerned about blood clots, pain, joint failure, limb length discrepancy, and infection. Patients undergoing TKA wanted more information on pain management and joint longevity, which achieved statistical significance. There was a significant difference in the activities patients would like to pursue as well as in expectations amongst different age groups. The quality of documentation in the consent form was quite variable in discussing complications, surgery benefits, and alternative treatments.
conclusion
Obtaining consent is a patient-specific process. Patient perception of important points that merit discussion can vary with age and employment status. Return to driving is important for all ages, however, as the population ages, the ability to return to activities of daily living becomes an increasingly important discussion point during the consent process.

Editor’s Note: the Cureus Journal of Medical Science is an open access general medical journal based in San Francisco, California.

Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of non‐invasive prenatal testing (NIPT)
Adriana Kater‐Kuipers, Inez D. de Beaufort, Robert‐Jan H. Galjaard, Eline M. Bunnik
Bioethics, 4 July 2020
Open Access
Abstract
Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non‐invasive prenatal testing (NIPT) in first‐trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to informed choice, and for a focus on value‐consistent choices and personalized informational preferences. We argue for a three‐step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical‐technical information and are asked to make a decision about screening; (3) during post‐test counselling, women are supported in decision‐making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre‐test) counselling, where techniques for expanding genome analysis and burdensome test‐outcomes challenge counselling of patients.

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.

Recall of consent information by day care prostate biopsy patients: An assessment of the role of a third-party check
Original Article
II Nnabugwu, FO Ugwumba, EI Udeh, SK Anyimba
Nigerian Journal of Clinical Practice, 11 June 2020
Open Access
Abstract                     
Background: To evaluate the extent of recall of consent information by daycare prostate biopsy patients in our low-literacy setting. And to evaluate the role of a 3rd party check on patient’s recall of consent information. Subjects and Methods: As part of our standard of care, a formal informed consent session for day care prostate biopsy takes place 3 days prior to the procedure. For this study, before leaving the outpatient clinic the same day, the patient acknowledged before a third-party that his concerns were or were not satisfactorily addressed. The extent of recall of consent information was assessed on the morning of the procedure using a researcher-administered questionnaire. Consecutive patients participated in this cross-sectional study for day care prostate biopsy at a tertiary hospital in southeast Nigeria from February to November 2015 after obtaining due consent. Results: The recall of the risks associated with the planned procedure was poorer than the recall of the nature of the disease condition or the nature of the planned procedure. However, it was observed that aggregate recall was significantly poorer among patients who negatively attested to a satisfying consent session (OR 0.125; P < 0.0005). Conclusion: The use of a third-party in determining patient satisfaction after a consent session may be a better indicator of patient comprehension and subsequent recall of consent information, especially in low-literacy settings. Using a third-party, in this manner, may assist in checking paternalism inherent in the patient-doctor relationship.

Women’s experiences of decision-making and informed choice about pregnancy and birth care: a systematic review and meta-synthesis of qualitative research
Research Article
Cassandra Yuill, Christine McCourt, Helen Cheyne, Nathalie Leister
BMC Pregnancy and Childbirth, 10 June 2020; 20(343)
Open Access
Abstract
Background
The purpose of this systematic review (PROSPERO Ref: CRD42017053264) was to describe and interpret the qualitative research on parent’s decision-making and informed choice about their pregnancy and birth care. Given the growing evidence on the benefits of different models of maternity care and the prominence of informed choice in health policy, the review aimed to shed light on the research to date and what the findings indicate.
Methods
a systematic search and screening of qualitative research concerning parents’ decision-making and informed choice experiences about pregnancy and birth care was conducted using PRISMA guidelines. A meta-synthesis approach was taken for the extraction and analysis of data and generation of the findings. Studies from 1990s onwards were included to reflect an era of policies promoting choice in maternity care in high-income countries.
Results
Thirty-seven original studies were included in the review. A multi-dimensional conceptual framework was developed, consisting of three analytical themes (‘Uncertainty’, ‘Bodily autonomy and integrity’ and ‘Performing good motherhood’) and three inter-linking actions (‘Information gathering,’ ‘Aligning with a birth philosophy,’ and ‘Balancing aspects of a choice’).
Conclusions
Despite the increasing research on decision-making, informed choice is not often a primary research aim, and its development in literature published since the 1990s was difficult to ascertain. The meta-synthesis suggests that decision-making is a dynamic and temporal process, in that it is made within a defined period and invokes both the past, whether this is personal, familial, social or historical, and the future. Our findings also highlighted the importance of embodiment in maternal health experiences, particularly when it comes to decision-making about care. Policymakers and practitioners alike should examine critically current choice frameworks to ascertain whether they truly allow for flexibility in decision-making. Health systems should embrace more fluid, personalised models of care to augment service users’ decision-making agency.