Readability of foot and ankle consent forms in Queensland
Original Article
Giuseppe Pastore, Philip M. Frazer, Andrew Mclean, Tom P. Walsh, Simon Platt
ANZ Journal of Surgery, 5 October 2020
Abstract
Background
The aim of this study was to conduct a readability analysis on both patient take‐home information and consent forms for common foot and ankle procedures. Our hypothesis was that the objective reading skills required to read and comprehend the documentation currently in use would exceed the recommendations in place by both national and international bodies.
Methods
The current Queensland Health consent forms are divided into specific subsections. The readability of consent form subsections C and G (sections containing detailed information on risks of the procedure and pertaining to informed patient consent specifically) and patient take‐home information (provided as take‐home leaflet from the consent form which is procedure specific) was assessed by an online readability software program using five validated methods calculated by application of the algorithms for (i) Flesch–Kincaid grade level, (ii) the SMOG (Simple Measure of Gobbledygook), (iii) Coleman–Liau index, (iv) automated readability index and the (v) Linsear Wriste formula.
Results
The mean ± standard deviation reading grade level of risk (section C), grade level of patient consent (section G) and grade level for procedure‐specific take‐home patient information were 8.7 ± 0.9, 11.6 ± 1.2 and 7.5 ± 0.2, respectively.
Conclusion
The readability of sections C and G of the Queensland Health consent form exceeds the recommendations by national and international bodies, but the patient take‐home information appears suitable. Consideration should be given to lower the reading grade level of patient consent forms to better reflect the reading grade of the Australian population.

‘Hobson’s choice’: a qualitative study of consent in acute surgery
Anthony Howard, Jonathan Webster, Naomi Quinton, Peter V Giannoudis
BMJ Open, 25 August 2020; 10
Open Access
Abstract
Objectives
The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.
Participants, setting and intervention
The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software.
Results
The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient’s previous experience and the experience of others around them were a further theme. Patients sensed that there were no nonoperative options for their injuries.
Conclusion
This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.

Impact of new consent procedures on uptake of the schools-based human papillomavirus (HPV) vaccination programme
Harriet Fisher, Matthew Hickman, Joanne Ferrie, Karen Evans, Michael Bell, Julie Yates, Marion Roderick, Rosy Reynolds, John MacLeod, Suzanne Audrey
Journal of Public Health, 26 September 2020
Open Access
Abstract
Background
Local policy change initiating new consent procedures was introduced during 2017–2018 for the human papillomavirus (HPV) vaccination programme year in two local authorities in the south–west of England. This study aims to assess impact on uptake and inequalities.
Methods
Publicly available aggregate and individual-level routine data were retrieved for the programme years 2015–2016 to 2018–2019. Statistical analyses were undertaken to show: (i) change in uptake in intervention local authorities in comparison to matched local authorities and (ii) change in uptake overall, and by local authority, school type, ethnicity and deprivation.
Results
Aggregate data showed uptake in Local Authority One increased from 76.3% to 82.5% in the post-intervention period (risk difference: 6.2% P = 0.17), with a difference-in-differences effect of 11.5% (P = 0.03). There was no evidence for a difference-in-differences effect in Local Authority Two (P = 0.76). Individual-level data showed overall uptake increased post-intervention (risk difference: +1.1%, P = 0.05), and for young women attending school in Local Authority One (risk difference: 2.3%, P < 0.01). No strong evidence for change by school category, ethnic group and deprivation was found.
Conclusion
Implementation of new consent procedures can improve and overcome trends for decreasing uptake among matched local authorities. However, no evidence for reduction in inequalities was found.
Implications and discussion
The new consent procedures increased uptake in one of the intervention sites and appeared to overcome trends for decreasing uptake in matched sites. There are issues in relation to the quality of data which require addressing.

Consent In Forefoot Surgery; What Does It Mean To The Patient?
Leo D. Baxendale-Smith, Scott D. Middleton, John C. McKinley, Colin E. Thomson
The Foot, 25 September 2020
Abstract
Aims
This study aimed to assess patient risk recall and find risk thresholds for patients undergoing elective forefoot procedures.
Methods
Patients were interviewed in the pre-assessment clinic (PAC) or on day of surgery (DOS); some in both settings. A standardised questionnaire was used for all interviews, regardless of setting. Patients were tested on which risks they recalled from their consent process, asked for thresholds for five pre-chosen risks and asked about a sham risk.
Results
Across all interviews, risk recall on DOS (2.34 risks/patient interview) was significantly lower (p = .05) than in PAC (2.95 risks/patient interview) – this was repeated when comparing results from patients interviewed in both settings only with PAC mean recall of 2.93 risks/patient interview and DOS mean recall of 2.57 risks/patient interview. The mean reported risk thresholds greatly exceeded X’s observed complication rates for forefoot procedures. The five risks tested for thresholds produced the same order in each interview setting, suggesting a patient-perceived severity ranking. Patients answering the sham risk question incorrectly tended to recall fewer risks across all interviews.
Conclusions
This study shows that patient risk recall is poor, as previous literature outlines, reinforcing that consent process improvements could be made. It also illustrates the value of PAC visits in patient education, as shown by higher levels of recall when compared to DOS.

Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences?
Paul Burcher,Shazneen Hushmendy, Meredith Chan-Mahon, Megha Dasani, Jazmine Gabriel, Erin Crosby
AJOB Empirical Bioethics, 18 September 2020
Abstract
Background: Unplanned cesarean birth is associated with high levels of patient dissatisfaction and negative birth experiences, which in turn can negatively impact birth outcomes. Previous research has demonstrated that issues of physician-patient communication, mistrust, fear of the operating room (OR), and loss of control contribute to patient dissatisfaction with unplanned cesarean birth. We hypothesized that altering the nature and structure of the informed consent prior to the surgery might improve patient satisfaction and birth experience. Specifically, we explored whether educating resident physicians in counseling skills could shift the focus of informed consent from a checklist merely informing the patient of the risks, benefits, and alternatives to a discussion that informs the physician of the patient’s concerns and fears. By approaching consent in this manner, the goal of informed consent expands beyond autonomy rights to include beneficence as well. Methods: Residents received education to discuss issues of communication, fear, mistrust, and loss of control when seeking consent for an unplanned cesarean birth. Patients were randomized to receive either additional counseling that encouraged a discussion or a standard informed consent for cesarean birth. Participants were interviewed two weeks later and scored their satisfaction using a Likert scale on the four themes: communication, mistrust, fear of OR, and loss of control. Results: Both groups had very high patient satisfaction scores; there was no statistical difference between them. Conclusions: Both groups exhibited significantly higher levels of birth satisfaction than present in prior research. Training residents to discuss these issues while seeking consent for an unplanned cesarean birth may have improved patient satisfaction for all participants in this study. This suggests that educating residents to engage patients in a dialogue during informed consent counseling is more important than a specific script.

Informed consent: a shared decision-making process that creates a new professional obligation for care
Guidelines
Arthur Rawlings, Lelan Sillin, Phillip Shadduck, Marian McDonald, Peter Crookes, Bruce MacFadyen Jr, John Mellinger, SAGES Ethics Committee
Surgical Endoscopy, 15 September 2020
Abstract
This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).

Knowledge and Perception of Ethiopian Surgical Patients to Informed Consent Practice for Surgical Procedures
Original Research
Open Access Surgery, 7 September 2020; 13 pp 65-70
Befekadu Lemmu, Abebe Megersa, Engida Abebe, Kirubel Abebe
Open Access
Abstract
Background
Surgical informed consent (SIC) is an established ethical and legal requirement for surgical treatment. Patient understanding of the process is essential for efficient surgical care. This study aimed to assess the knowledge and perception of operated patients towards surgical informed consent.
Methods
An institution-based cross-sectional study of all adult surgical patients who signed informed consent and underwent surgery at St. Paul’s Hospital Millennium Medical College (SPHHMC) from February 1st to March 30th, 2018, was performed. Data were collected postoperatively before discharge using a pretested structured questionnaire.
Results
Of 420 patients identified, 385 (91.7%, M:F=2:1) agreed and interviewed. The mean age was 40.3 years (SD± 15.1), and many of the respondents (285, 74.0%) had some level of formal education. Even if most (336, 87.3%) knew the reason why they had surgery, less knowledge and awareness was reported regarding the options of alternative treatments (153, 39.7%), identifying the operating surgeon (129, 33.5%), the type of surgery (160, 41.6%), anesthesia-related risks (96, 24.9%), complications of surgery (69, 17.9%) and postoperative care (4, 1.0%). The legal requirement of surgical informed consent was reported by 267 (69.4%) subjects; however, more than half had no information on the right to change their mind after signed surgical informed consent (223, 57.9%) and whom it protects (224, 58.2%). Only 40 (10.5%) respondents had a good level of knowledge, and it was significant in those with some level of formal education (OR=4.8; 95% CI 1.45–16.01; P=0.010) and in patients who live in an urban area (OR=4.7; 95% CI 1.81–12.35; p=0.002) than their respective groups.
Conclusion
Our patients had limited knowledge and perception regarding surgical informed consent. Hence, the current consent process seems inadequate and needs a revisit.

Universal tumor screening for lynch syndrome: perspectives of patients regarding willingness and informed consent
Research Article
Anusree Subramonian, Doug Smith, Elizabeth Dicks, Lesa Dawson, Mark Borgaonkar, Holly Etchegary
Personalized Medicine, 2 September 2020
Open Access
Abstract
Aim: Lynch Syndrome is associated with a significant risk of colorectal carcinoma (CRC) and other cancers. Universal tumor screening is a strategy to identify high-risk individuals by testing all CRC tumors for molecular features suggestive of Lynch Syndrome. Patient interest in screening and preferences for consent have been underexplored. Methods: A postal survey was administered to CRC patients in a Canadian province. Results: Most patients (81.4%) were willing to have tumors tested if universal tumor screening were available and were willing to discuss test results with family members and healthcare professionals. The majority (62.6%) preferred informed consent be obtained prior to screening. Conclusion: Patients were supportive of universal screening. They expected consent to be obtained, contrary to current practice across Canada and elsewhere.

Ethical and legal challenges of informed consent applying artificial intelligence in medical diagnostic consultations
Kristina Astromskė, Eimantas Peičius, Paulius Astromskis
AI & Society, 27 August 2020
Abstract
This paper inquiries into the complex issue of informed consent applying artificial intelligence in medical diagnostic consultations. The aim is to expose the main ethical and legal concerns of the New Health phenomenon, powered by intelligent machines. To achieve this objective, the first part of the paper analyzes ethical aspects of the alleged right to explanation, privacy, and informed consent, applying artificial intelligence in medical diagnostic consultations. This analysis is followed by a legal analysis of the limits and requirements for the explainability of artificial intelligence. Followed by this analysis, recommendations for action are given in the concluding remarks of the paper.