Surgical Informed Consent: New Challenges
Claire Hoppenot, Ava Ferguson Bryan, Sean C. Wightman, Victoria Yin, Benjamin D. Ferguson, Sanam Bidadi, Margaret B. Mitchell, Alexander J. Langerman, Peter Angelos, Puneet Singh
Current Problems in Surgery, 10 December 2022
Introduction
Informed consent in medicine has evolved considerably over the 19th and 20th centuries to its current form which represents a practical application of the ethical principle respect for autonomy. Global and national historical events, rapid advances in medicine, the digital age, and shared decision making in the doctor-patient relationship have contributed and continue to shape our informed consent processes. This monograph highlights the history and current state of informed consent, intersection with the legal system, vulnerable populations, involvement of trainees, research and innovation, concurrent surgery, and non-medical factors to disclose. Informed consent refers to agreements with patients for treatment and also with subjects for experimentation. Thus, informed consent for treatment and informed consent for research, although distinctly different, both rely on the central ethical principle of respect for autonomy.

Role of electronic consent in emergency surgery – A QIP in a high volume surgical emergency unit at a tertiary hospital
Afroza Sharmin, Vishani Loyala, Ola Shams, Giles Bond-Smith
British Journal of Surgery, 7 December 2022
Abstract
Background
The Royal College of Surgeons of England discusses the significance of maintaining a written record of consent in addition to completing the consent form under section 4.10 of the supported decision-making guide to good practice – “any written information given to the patient should also be recorded and copies should be included in the patient’s notes”. Studies show high error rates (27–50%) with handwritten consent forms due to poor legibility, incomplete/ inaccurate information, increased variability, and risk of misplacement. The consequences of these errors can lead to poor patient experience as well as unfavourable outcomes at the operational and institutional levels. Missing or incomplete consent is also the most common reason for first case delay (average 1–75mins). This prompted the QIP and generation of a standard template for the common emergency general surgery procedures in a high-volume Surgical Emergency Unit (SEU) at the John Radcliffe Hospital.
Methods
Procedure-specific Electronic Surgical Consent (eSConsent) template for common emergency general surgery operations was added to the online database to easily be added to the electronic patient record. The format, as outlined below, was designed to allow even junior surgical trainees to adapt and perform the consent process early on in their placement-

• Patient details and occupation
• Operation
• Intended benefit
• All common procedures listed, risks and additional procedures pre-populated
• Additional information (eg: discussion with next of kin, P-POSSUM score, NELA score etc)
• Sign off

Results
The consent for all the emergency general surgery cases in a given week was reviewed and the compliance to maintaining eSConsent was audited. The first cycle between 20th-26th September 2021 showed compliance of only 18% (9 out of 49 operations). After discussing the audit findings with the members of the surgical team involved in the consenting process in the local meeting and implementing eSConsent, the compliance increased to 83.7% (36 of 43 cases) in the following week, 78% (33 of 43 cases) between 12th-18th November 2021 and 73% (28/38 operations) in the beginning of March 2022.
Conclusions
A consent form is a medicolegal document. Health care systems have taken advantage of technology to facilitate accuracy and robust monitoring. The emergency surgical consent process can benefit from this to avoid delays, errors and litigation. This transition is justifiable from our results and easily translated to practice particularly by using simple technology demonstrated in our QIP. Challenges including trainee changeover and new recruitments will expectedly affect the compliance of eSConsent but a proper induction to ensure adequate staff education will help overcome this. Weekly data capture has been adopted in our department as a surveillance protocol to ensure adherence and to standardize our practice.

Procedure Specific Consent Forms for Laparoscopic Cholecystectomy
David Manson, Gerard McKnight, Meabh Johnston, David O’Reilly, Giorgio Alessandri
British Journal of Surgery, 7 December 2022
Abstract
Background
Surgical consent forms can be difficult for patients to read and understand. Important points including procedure details, relevant complications and alterative treatment options are often lost in the communication process. Furthermore, surveys have found that patients struggle to grasp basic surgical concepts. Procedure specific consent forms (PSCFs) have been shown to improve the process of surgical consent. This is partly because they provide a standardised list of complications and their incidence, presented in a uniform, legible format without any abbreviations. However, despite their benefits, PSCFs are nationally underused. Cholecystectomy is one of the most common operations performed in the United Kingdom. Due to the pandemic disrupting elective surgical lists, the backlog of patients with biliary pathology has increased. More patients are therefore presenting to the on-call surgical team with biliary disease. Many trusts employ an Emergency Surgery Ambulatory Care (ESAC) list to offload the stretched emergency service. Our aim was to assess the variability of cholecystectomy consent forms amongst this cohort of patients, subsequently review patient understanding and evaluate whether the introduction of a procedure specific consent form improved this understanding.
Methods
We performed a prospective audit of laparoscopic cholecystectomy consent forms using the ESAC service. These consent forms were all obtained from patient’s paper notes and assessed individually for variables. The first loop of the audit assessed the consent form used for the first 20 patients allocated to the ESAC list. Subsequently, each patient was telephoned post-operatively and asked a series of standardised questions which were adapted from a published questionnaire. Following this, we introduced a Procedure Specific Consent Form (PCSF) for laparoscopic cholecystectomies, with the agreement of all consultant surgeons who perform this operation in the trust. The second loop of the audit assessed another 20 patients from the emergency list, after the introduction of the PCSF. Similarly, patients were later telephoned to assess understanding. Over both loops, each consent form was assessed for the scope of their included complications and measured against the NHS-recognised list of potential adverse outcomes. Secondly, the legibility of the consenter’s writing and the use of any abbreviations was noted. Legibility was evaluated by two doctors independently to reduce subjectivity.
Results
The first loop revealed that all forms contained infection and bleeding; 90% included injury to bile duct; 80% included injury to viscera and risks from general anaesthetic; 75% included blood clots and bile leak; and only 55% included post-cholecystectomy syndrome. The additional complications included were pain, herniae, covid risk, retained stone, collection, pancreatitis, failure and death; with an even higher degree of variability. The 20 forms were 95% legible, with 50% of them containing one or more acronyms. Relating to the post-op questionnaire, >80% of patients remembered details surrounding their operation, however only 60% could recall basic potential complications. After PCSF introduction, it was used in 10 of the second loop cases, with the remaining 10 using traditional Consent Form 1 (non-PSCF). The non-PSCF group demonstrated similar variability in the complications included, with identical legibility rates and acronym usage. Again, only 60% of patients were able to accurately define the associated complications. Of the PSCFs, 100% were legible and 0% used acronyms, and the list of complications was standardised with 100% compliance with NICE and RCS England guidance. Notably, 90% of patients accurately recalled potential complications and nearly all were satisfied with their level of understanding prior to signing the consent form.
Conclusions
This Quality Improvement Project demonstrated that hand written Consent Forms are highly variable, especially regarding the list of complications. We also found that while they were largely legible, half of the consent forms contained acronyms. Lastly, patients were satisfied with the information provided to them and could recall knowledge on the nature of the surgery, but many were not able to recollect important potential complications. The use of a PSCF allowed for a standardised, easily accessible, legible consent form devoid of misinterpretable acronyms. This was reflected in the patient questionnaire, where patients were able to recall details of the surgery and were satisfied with their level of understanding. This was reaffirmed by their grasp of the complications, where 90% of patients could recall potential adverse risks, compared to 60% in the Form 1 groups. This audit demonstrates the benefit of PSCFs from a legislative and litigative standpoint, but more importantly from the standpoint of patient understanding and holistic care. We recommend the use of PSCFs in the process of all surgical consent, to help ensure patient understanding and subsequent satisfaction.

[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]
Cabrera-Rodríguez A, Rico-Blázquez M, Sanz-Álvarez EJ, Schmidt-RioValle J
Atencion Primaria, 3 December 2022; 55(2)
Abstract
To know the knowledge, implementation and opinion on informed consent of generalist nurses, specialists and primary care residents. Descriptive cross-sectional study using an online self-administered ‘ad hoc’ questionnaire. Primary care nurses in Madrid, from November 2020 to March 2021. Sample of 114 nurses: 91 generalist, 20 specialists and 3 residents. Sociodemographics, knowledge, implementation and opinion. The response rate was 27.7%. As a general rule, 48.2% indicated that informed consent was collected verbally, as established by law, with differences being found between categories, this percentage being higher in specialists and residents (P=0.004), and within specialists in those who had obtained their speciality by internal resident nurse (IRN) (P<0.0001). In addition, specialists and residents were those who most identified the legal norm regulating informed consent (P<0.0001). In terms of implementation and opinion, all groups obtained similar results. There are no previous studies that have analysed these aspects of informed consent comparing the different categories. Studies from other healthcare and geographical areas show that nurses have greater knowledge, although the demand for specific training in bioethics and biolaw is greater in the nurses participating in this study. Nurses have adequate knowledge about informed consent, use it in clinical practice and have an appropriate conception of it, being higher in some items in specialist nurses IRN and in residents.

Editor’s note: Atencion Primaria is a Spanish language publication that publishes works relative to the field of Primary Healthcare

Informed Consent in Anesthesiology: An exploratory Study
Bárbara Fontes, Sílvia Marina, Diana Andrade, Sofia Dias, Miguel Ricou
Acta Bioethica, November 2022; 28(2) pp 281-289
Open Access
Abstract
In the literature Informed consent (IC) assumptions is well established. However, the different stages and the conditions under which the IC for anesthetic practices is obtained, is scarce. The aim of the present study is to explore the phases and conditions of IC in anesthesiology. Anonymized clinical records of 325 patients submitted to anesthetic procedures at the Institute of Oncology of Porto were analyzed. A total agreement between the anesthetic techniques established in the IC and those performed, was reach with 270 patients. The importance of IC in clinical practice is discussed and an ideal process for IC is argued.

Editor’s note: Acta Bioethica is publication of the University of Chile

The effects of modifying elements of written informed consent forms for elective surgical or invasive procedures: A systematic review
Stefanie Bühn, Elen Huppertz, Alina Weise, Julia Lühnen, Anke Steckelberg, Roland Brian Büchter, Simone Hess, Kyung-Eun (Anna) Choi, Tim Mathes
Patient Education and Counseling, February 2023; 107
Abstract
Objective
To study the effect of modifying content and design elements within written informed-consent-forms (ICF) for patients undergoing elective surgical or invasive procedures.
Methods
We included (quasi-)randomized trials in which a modified written ICF (e.g. visual aids) was compared to a standard written ICF. We searched PubMed, Web-of-Science and PsycINFO until 08/2021. Risk of Bias was assessed. The complexity of intervention was assessed using the Intervention Complexity Assessment Tool for Systematic Reviews.
Results
Eleven trials with 1091 participants were eligible. Effect sizes and levels of evidence varied from trivial to moderate and there were contradictory findings for some outcomes. Providing patients with more information in general or specific information on risks and complications mostly increased anxiety. The use of verbal risk presentation decreased anxiety and increased satisfaction. A lower readability level decreased anxiety and improved comprehension and knowledge.
Conclusion
Our results suggest that providing more information and addressing certain types of risks have differential effects. While more information improved knowledge, it also increased anxiety. We did not find any or only insufficient evidence for many other possible ICF modifications.
Practice implications
When developing ICFs the differential impact of different elements on patient important outcomes should be carefully considered.

An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study
Research
Marlies Ullrich, Oliver Findl, Katharina Kefer, Birgit Döller, Ralph Varsits, Julius Hienert, Nino Hirnschall
BMC Ophthalmology, 11 November 2022; 22(430)
Open Access
Abstract
Background
To assess whether informing patients with a computer-based tutorial in addition to standard informed consent influences the patient’s attitude towards surgery and increases patient’s knowledge.
Methods
In this prospective, exploratory, randomized clinical study, patients scheduled for their first eye cataract surgery were randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using an interactive computer-based tool (CatInfo) containing an audiovisual presentation about cataract and its treatment (study group). Cataract-related knowledge and decisional confidence (decisional conflict scale (DCS)) were assessed as well as one-month postoperatively decisional regret (decision regret scale (DRS)) and willingness to exchange face-to-face discussion time for the use of such a tool.
Results
The study comprised 134 patients, 64 patients in the study group and 70 in the control group. Patients in the study group answered more questions correctly, 16.3 ± 2.0 (median 16.5, 11.0–19.0) versus 15.5 ± 1.9 (median 16.0, 8.0–19.0; p = 0.01). Patients showed a high decisional confidence with a study group mean DCS score of 92.4 ± 9.8 (median 96.9, 65.6–100) and control group score of 91.6 ± 10.9 (median 95.3, 43.3–100; p = 0.52). Mean DRS score in the study group was 2.5 ± 8.0 (median 0, 0–40) and 4.3 ± 12.5 (median 0, 0–75) in the control group (p = 0.14). Of study group patients 23 (67.6%) were willing to trade time, on average 158 ± 180 s (median 120 s, 45–900). Satisfaction with the tool was high with a mean of 9.1 ± 1.3 out of 10 (median 9.7, 5.0–10).
Conclusions
Cataract-related knowledge was generally good, with slightly higher scores in the study group. In both groups, decisional confidence was high and regret after surgery was low. A tendency towards slightly higher decisional confidence and lower regret was found in the study group, although these differences were not statistically significant. Additional use of an interactive computer-based tool may prove useful in the informed consent process in a high-volume cataract outpatient setting.

The role of knowledge and medical involvement in the context of informed consent: a course or a blessing?
Caterina Milo
Medicine, Health Care and Philosophy, 1 November 2022
Open Access
Abstract
Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often over-medicalized, that is to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context.

The “teach-back” method improves surgical informed consent and shared decision-making: a proof of concept study
Research
Kevin D. Seely, Jordan A. Higgs, Lindsey Butts, Jason M. Roe, Colton B. Merrill, Isain Zapata, Andrew Nigh
Patient Safety in Surgery, 28 October 2022; 16(33)
Open Access
Abstract
Introduction
The teach-back method is a communication tool that can improve patient safety and shared decision-making. Its utility in patient care has been studied extensively in many areas of clinical medicine. However, the literature on teach-back in surgical patient education and informed consent is limited, and few studies have been conducted to test its impact on perioperative patient interactions. The objective of this study was to evaluate if the teach-back method can improve informed consent and surgeon trust. An assessment of the time required to be implemented was also evaluated.
Methods
A standardized interaction role-playing a pre-operative informed consent discussion was designed. Laparoscopic cholecystectomy was selected as the proposed procedure. Standardized patients were split into two groups: teach-back and a control group. The control group was delivered a script that discloses the risks and benefits of laparoscopic cholecystectomy followed by a concluding prompt for any questions. The teach-back group was presented the same script followed by the teach-back method. Interactions were timed and patients completed a quiz assessing their knowledge of the risks and benefits and a survey assessing subjective perceptions about the interaction. Statistical analysis through Generalized Linear Models (GLMs) was used to compare visit length, performance on the comprehension quiz, and subjective surgeon trust perceptions.
Results
34 participants completed the scenario, the comprehension quiz, and the survey (n = 34). Analysis of the subjective evaluation of the physician and encounter was significant for increased physician trust (p = 0.0457). The intervention group performed higher on the knowledge check by an average of one point when compared to the control group (p = 0.0479). The visits with intervention took an average of 2.45 min longer than the control group visits (p = 0.0014). People who had the actual procedure in the past (evaluated as a confounder) were not significantly more likely to display the same effect as the teach-back method, suggesting that the knowledge and trust gained were not based on previous experiences with the procedure.
Conclusion
When employed correctly by surgeons in the perioperative setting, the teach-back method enhances shared decision-making, comprehension, and surgeon trust. Incorporating the teach-back method into risk and benefit disclosures effectively informs and more fully engages patients in the informed consent process. Notably, the added benefits from using teach-back can be obtained without a burdensome increase in the length of visit.

Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent
N.Vartanian, M.Wilson, R.P.Ermoian
International Journal of Radiation Oncology*Biology*Physics, 1 November 2022; 114(3) pp e500-e501
Abstract
Purpose/Objective(s)
Informed consent is an essential component of cancer care. The terms “second tumors” or “secondary tumors” are sometimes used in radiation therapy consent. Their incidences are sometimes described as “rare,” although vary greatly from nearly negligible in patients treated with palliative intent, to 20% in young patients undergoing myeloablative total body irradiation. We evaluated whether patients without prior knowledge of radiation therapy interpret the terms in a way consistent with physician intent.
Materials/Methods
We screened 164 adult subjects who did not require medical interpreters at a university-affiliated family medicine clinic, excluding cancer patients and those with any prior knowledge of or experience with radiation treatment. One hundred subjects were eligible for and completed a 12-question multiple choice questionnaire, which assessed their understanding of the term “secondary tumor” or “second tumor”, and how they would interpret the terms “small chance” or “rare” in the context of a “bad side effect.”
Results
Twenty-nine percent of subjects correctly identified that “secondary tumors” referred to new and different tumors caused by treatment. Forty-nine percent thought the term referred to their original tumor recurring, and 22% thought the term referred to new and different tumors not caused by radiation therapy. Subjects with college degrees were not more likely to choose the correct answer than subjects without college degrees p=0.63. College degree status was not available for 5 subjects. Given choices between 1:10, 1:100, 1:1000, and 1:100,000, subjects associated “rare” with 1:1000 or 1:100,000 82% of the time. The term “small chance” was associated with 1:1000 or 1:100,000 59% of the time.
Conclusion
Adult non-cancer patients have a demonstrably different understanding than radiation oncologists of the terms “second tumor” or “secondary tumor.” Additionally, patient understanding of the terms “rare” or “small chance” varies from secondary malignancy incidences in many clinical scenarios. Radiation oncologists should use clearer terms for secondary malignancies and their incidence.