Assessment of Informed Consent and the Impact of Simulation on Anesthesia Trainees
Original Article
Muhammad Adeel Bashir, Asma A. Khan, Sanaa A. Khan
Cureus, 21 November 2021
Abstract
Introduction
Over the years, the process of obtaining informed consent has evolved and now places an emphasis on the concept that patients should play a major role in medical decision making. Failure to adequately involve patients in making decisions regarding their health can lead to medicolegal consequences. Therefore, taking informed consent is a fundamental component of anaesthesia training. Simulation, for training, is an excellent tool that is being utilised widely in the training of medical professionals. The use of simulated training for teaching the process of informed consent is an innovative initiative that can provide improved results.
Material and methods
After approval from the institutional review board, a prospective clinical study was conducted at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, from August 2019 to September 2020. Sixteen anaesthesia trainees were randomly selected for the study. The study was divided into pre-interventional, interventional and post interventional phases. For data collection, a predesigned checklist was used. Data collected was analysed using SPSS version 23 (IBM Inc., Armonk, New York). The McNemar test was deployed to assess the difference between the baseline assessment and post-simulated training assessment; p-value < 0.05 was taken to be significant.
Results
Of the 16 participants, the majority were males (n= 13). A positive impact was observed in terms of improvement of the outcome of the following study components i.e., description of benefits of the procedure (p=0.01), disclosure of associated minor risks (p=0.005), disclosure of major risks (p=0.01), discussion of alternatives (p=0.001), teach back (p=0.001), documentation of patients’ verbal agreement (p=0.01), and communication skills involving utilising the process of connecting, introduction, communication, permission, response, and exit (p = 0.01).
Conclusion
Simulated training had a positive impact in improving outcomes in the following study components: description of benefits of the procedure, disclosure of associated risks, discussion of alternatives, teach back, documentation of patients’ verbal agreement, and utilisation of the process of connecting, introduction, communication, permission, responding, and exiting.

Patient and proxies’ attitudes towards deferred consent in randomised trials of acute treatment for stroke: A qualitative survey
Research Article
Noa van den Bos, Sophie A van den Berg, Catalina MM Caupain, Jeannette AJ Pols, Tessa van Middelaar, Vicky Chalos, Diederik WJ Dippel, Yvo BWEM Roos, Manon Kappelhof, Paul J Nederkoorn
European Stroke Journal, 13 November 2021
Open Access
Abstract
Introduction
Deferral of consent for participation in a clinical study is a relatively novel procedure, in which informed consent is obtained after randomisation and study treatment. Deferred consent can be used in emergency situations, where small therapeutic time windows limit possibilities for patients to provide informed consent. We aimed to investigate patients’ or their proxies’ experiences and opinions regarding deferred consent in acute stroke randomised trials.
Patients and methods
For this qualitative study, Dutch Collaboration for New Treatments of Acute Stroke (CONTRAST) trial participants were selected. Study participants were either patients or their proxies who provided consent and were selected with theoretical sampling based on patient characteristics. Semi-structured interviews were conducted face-to-face or by telephone. Themes and subthemes were iteratively defined.
Results
Twenty of the 23 interviewed participants (16 patients and 7 proxies) considered deferred consent acceptable. The received study treatment and consent conversation were remembered by 18 participations, although the concept of randomisation and treatment comparison were generally not well understood. Sixteen participants felt capable of overseeing the decision to give deferred consent. Distress in the first days after stroke, lack of understanding and neurological deficits were reasons for feeling incapable of providing consent. Four participants would have preferred a different timing of the consent conversation, of whom two prior to treatment.
Conclusion
Our study found that deferred consent was considered acceptable by most study participants who provided consent for acute stroke randomised trials. Though they felt capable, the recall and comprehension of consent were overall limited.

Informed Written Consent for Orthopaedic Trauma in the Emergency Setting at a Tertiary Referral Centre: A Closed-Loop Audit
Original Article
Martin S. Davey, Matthew G. Davey, Kunal Mohan, Conor S. O’Driscoll, Colin G. Murphy
Cureus, 11 November 2021; 13(11)
Abstract
Introduction
The purpose of this investigation was to perform an audit of the standards of consent forms in which patients sign prior to operative intervention for orthopaedic trauma in an emergency setting in our institution, with comparison to the ‘Orthopaedic Surgical Consent’ standards, as set by the American Association of Orthopaedic Surgeons (AAOS). If required, the investigator aimed to close the loop in this audit by educating orthopaedic surgeons on the necessary standards of obtaining written consent for orthopaedic trauma.
Methods
Following being granted approval by our institutional audit committee, a pre-intervention cycle was performed to assess the quality of consent obtained in written format using electronic patient records in consecutive patients over a four-week period. Following the analysis of this data, an education session was provided for all orthopaedic doctors responsible for obtaining informed written consent from patients who are planned to undergo operative management of a soft tissue or bony injury by the trauma and orthopaedic service in the emergency setting. Thereafter, a post-intervention cycle was performed with subsequent descriptive analysis using the GraphPad software.
Results
In the pre-intervention audit cycle, all included (n = 107) consent forms (100%) correctly included the patient’s name, date of birth (DOB) and institutional board number (BN). However, only 79 consent forms (74.5%) were completed without using abbreviations or acronyms of any kind, whilst 81 consent forms (76.4%) were completed without correctly stating the side or site of the planned intervention. In the post-intervention cycle, all included (n = 40) consent forms (100%) correctly included the patient’s name, DOB and institutional BN. Additionally, a total of 37 consent forms (92.5%) were correctly completed without using abbreviations or acronyms of any kind (74.5% versus 92.5%, p = 0.02). Furthermore, a total of 39 consent forms (97.5%) were completed correctly stating the side or site of the planned intervention (76.4% versus 97.5%, p = 0.0015).
Conclusion
This closed-loop audit found that the quality of informed consent obtained by orthopaedic surgeons in the emergency setting might potentially be significantly improved with at least one virtual education session. Such simple education sessions may potentially improve the documentation of the planned potential operative intervention by orthopaedic surgeons for cases of orthopaedic trauma to ensure patient safety is optimised. As the turnover of non-consultant hospital doctors is high in university teaching hospitals, regular education sessions on such topics may introduce a cultural shift in maintaining high standards when marking and consenting patients in the emergency setting.

Implicit Surgeon Perceptions of Patient Personas: a Framework for Surgical Informed Consent Design
Jasmine Panton, Jayson S. Marwaha, Gabriel Brat
Journal of the American College of Surgeons, 1 November 2021; 233(5)
Open Access
Abstract
Introduction
Surgeons communicate risk with patients in different ways based on patient and contextual factors. To optimize risk communication for surgeons, there has to be a detailed understanding of how surgeons think about using risk in preoperative conversations with patients. In this study, we sought to identify personas leveraged by surgeons to facilitate risk communication during informed consent.
Methods
We conducted interviews with 13 surgeons regarding strategies for discussing patient-specific risk, and completed a narrative review on risk communication across surgical contexts. With these data, we created a framework to characterize the implicit patient personas used by surgeons during informed consent to appropriately communicate risk.
Results
In our analysis, we identified 7 key elements implicitly evaluated by surgeons during preoperative consent. These included the patients’ health profile, acuity of illness, health literacy, perception of and receptiveness to risk, clinical and procedural context, and encounter scenario. By accounting for these, we found that additional outputs beyond perioperative complications, such as postoperative quality-of-life complications and pain, are needed to provide personalized risk to lower acuity patients.
Conclusion
Understanding the implicit heuristic used by surgeons during informed consent has the potential to significantly inform efforts to improve preoperative consent. Tools using risk data to facilitate shared decision-making may benefit from patient personas to improve generalizability across patient populations. Because surgeons’ communication strategies and priorities are driven by key components of the patient’s persona, next-generation shared decision-making tools should use personas to optimize surgeon risk communication in the context of patient needs.

Please Sign Here: Evaluating Differences Between Resident and Attending Informed Consent for Cholecystectomy
Kathleen E. Singer, Jennifer E. Baker, Nora C. Elson, Taylor E. Wallen, Ann E. Salvator, Ralph Quillin, Jeffrey J. Sussman, Amy T. Makley, Michael D. Goodman
Journal of the American College of Surgeons, 1 November 2021; 233(5)
Open Access
Abstract
Introduction
There is considerable variability in surgeons’ approach to write and obtain informed consent for surgery, particularly among resident trainees. We analyzed differences in procedures and complications described in surgical consents for cholecystectomy between residents and attendings. We hypothesized that attending consents would list more comprehensive procedures and complications than those done by residents.
Methods
A retrospective analysis of 334 patients who underwent cholecystectomy at an academic tertiary care center was conducted. Charts were queried for demographics, surgical approach, whether the consent was completed electronically, and which provider completed the consent. Specifically, consents were evaluated for inclusion of possible conversion to open procedure, intraoperative cholangiogram, bile duct injury, injury to nearby structures, reoperation, bile leak, as well as if the consent matched the actual procedure performed.
Results
Of all consents analyzed, 46% included possible intraoperative cholangiogram, 47% included bile duct injury, 24% included injury to nearby structures, 7% included reoperation, and 20% included bile leak. In comparing residents and attendings, residents were more likely to consent for more possible complications and additional procedures, except for possible conversion to open and consenting for the complete procedure (Table 1). Junior residents were more likely than senior residents to include injury to nearby structures but senior residents were more likely to include reoperation.
Conclusion
Significant variation exists between resident and attending cholecystectomy consents, with residents including more complications than attendings on their consent forms. These data suggest that experience alone does not predict content of written consents, particularly for common ambulatory procedures.

Breast Core Biopsy Information and Consent: Do we Prepare or do we Scare?
Research Article
Jennifer Pollard, Heather Rose, Russell Mullen, Nick Abbott
Journal of Patient Experience, 28 October 2021
Open Access
Abstract
Informed consent has important ethical considerations for invasive procedures. Anecdotal evidence suggests an informed consent policy could heighten anxiety. We evaluated whether detailed information about breast biopsy prior to appointment negatively impacted patient experiences. Phase 1 surveyed patients receiving a standard appointment letter who underwent core biopsy (group A). Phase 2 surveyed two groups receiving standard letter plus biopsy leaflets: those who underwent core biopsy (group B) and those who did not (group C). The analysis included descriptive statistics and qualitative thematic analysis. Hundred percent of group A felt they were given enough information prior to biopsy and 72% felt it would not be helpful having information to read in the clinic beforehand. Hundred percent of group B and 94.1% of group C found it helpful to receive information with their letter. Common themes were good service, verbal explanation, and appreciation of written information. Despite concerns that too much information would heighten anxiety, this has not resulted in negative clinic experiences. Most patients found detailed information included with their appointment letter helpful, regardless of whether they had a biopsy or not.