Navigating the perils and pitfalls throughout the consent process in hematopoietic cell transplantation
Review
Rachel Cusatis, Carlos Litovich, Ryan Spellecy, Andrew Liang, Anita D’Souza
Blood Reviews, 20 December 2022
Abstract
Hematopoietic cell transplantation (HCT) is a complex treatment used in malignancies and some non-malignant diseases. The informed consent process for HCT can also be complex due to patient- and process-related barriers. The informed consent process needs to be a dynamic and ongoing process, not simply a checklist. As a result of the realities of HCT, we highlight some potential pitfalls to the informed consent process including uncertainty, sociocultural and communication barriers, and decisional regret. The purpose of this comprehensive review is to highlight unique situations which can result in failure of the informed consent process. We also offer potential solutions to these pitfalls, primarily making the informed consent more patient focused through dynamic and continuous processes to mitigate decisional regret.

Hands-on Clinical Clerkship at the Department of General Medicine in a University Hospital Improves Medical Students’ Self-Evaluation of Skills of Performing Physical Examinations and Informed Consent: A Questionnaire-Based Prospective Study
Yoshinori Tokushima, Masaki Tago, Midori Tokushima, Shun Yamashita, Yuka Hirakawa, Hidetoshi Aihara, Naoko E Katsuki, Motoshi Fujiwara, Shuichi Yamashita
International Journal of General Medicine, 19 December 2022; pp 8647–8657
Open Access
Abstract
Introduction
The educational effects of a hands-on clinical clerkship on medical students at the Department of General Medicine of Japanese university hospitals remain to be clarified. This study aimed to determine how such education affects medical students’ self evaluation of their clinical skills.
Methods
We enrolled 5th-year-grade students at the Department of General Medicine, Saga University Hospital, Japan in 2017. The students were divided into those who were going to have Japanese traditional-style observation based training mainly in the outpatient clinic (Group O) and those in the 2018, new-style, hands-on clinical clerkship as one of the group practice members in outpatient and inpatient clinics (Group H). A questionnaire survey using the 4-point Likert scale for self-evaluation of the students’ clinical skills at the beginning and the end of their training was conducted in both groups. The pre- and post-training scores of each item in both groups were compared and analyzed using the Mann–Whitney test.
Results
All 99 students in Group O and 121 of 123 students in Group H answered the questionnaires. The response rate was 99%. Two items regarding the abilities of “can perform a systemic physical examination quickly and efficiently” and “can clearly explain the current medical condition, therapeutic options, or risks associated with treatment, and discuss the process for obtaining informed consent” showed higher scores in the post-training survey in Group H than in Group O. There were no differences in these scores in the pre-training survey between the two groups.
Conclusion
A hands-on clinical clerkship at the Department of General Medicine in a university hospital in Japan provided medical students with higher self-confidence in their skills of performing a physical examination and better understanding of patients’ treatment options and the process of informed consent than observation-based training.

Dispelling the ethical apprehensions surrounding same day cataract consent
Comment
Rosina Zakri, Hasan Naveed, Robert Hill, Rashid Zia
Eye, 12 December 2022
Open Access
Excerpt
…Despite there being no legal length of time between obtaining consent and performing a procedure, the Department of Health clearly states that consent cannot be taken under duress [4]. It is therefore stipulated by Kerns J. in the Fitzpatrick case (2008), risks of surgery should not be provided to the patient at the ‘eleventh hour’ and thus a ‘cooling off’ period may be required [5]. Although the same day procedures for many retinal conditions, such as intravitreal injections and laser, are commonly recognised as patient centric, there is still opposition to similar benefits when it comes to cataract surgery…

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