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