Surgical Consent Process Research Articles

Development and early Evaluation of a novel tool for assessment of individualised risk tolerance during surgical consent

Purpose The legal interpretation of consent has transitioned over the last decade. Surgeons must identify what patients value to individualise surgical consent. This presents a considerable challenge during busy ward rounds or outpatient clinics. We aimed to develop and evaluate a novel risk tolerance tool to aid surgical consent. Methods This prospective, longitudinal cohort study evaluated the views of adult, elective surgical patients from a single centre. Attitudes to the existing surgical consent process were assessed (n = 48) and responses underwent thematic analysis. From these responses and a stakeholder focus group, a novel risk tolerance tool was developed. The risk tool was evaluated using questionnaires in 25 pre-operative patients. Post-operatively, the same cohort were followed-up with a telephone clinic 6–8 weeks after discharge. Results Overall patients were satisfied with the current consent process, but negative themes emerged including that it is generalised, impersonal, and time pressured. The developed risk tool contained six domains: death, pain, loss of physical function, loss of cognitive function, need for repeat medical interventions, and social disability. Loss of physical function (mean = 34.0, SD = 12.8) and loss of cognitive function (mean = 34.0, SD = 6.1) had lowest risk tolerance, and need for repeat medical interventions (mean = 18.8, SD = 10.9) had the highest risk tolerance. Thirteen (93%) patients had a positive experience of the consent process vs 85% of patients in pre-consent tool cohort. Conclusions The tool demonstrated good patient acceptability and patient reported experience. The tool gathered data that may enhance understanding of patient risk tolerance and personalise the surgical consent process.

Analysis of British Columbia practice patterns in the management of female stress urinary incontinence with emphasis on mesh use.

Female stress urinary incontinence (SUI) is common and has a profound impact on quality of life. Suburethral slings are the most common treatment for SUI in this population. These can be placed with synthetic mesh or autologous fascia. Mesh-related complications after midurethral sling procedures are documented in the literature but the risk of complications and reoperation is lower than the use of transvaginal mesh for pelvic organ prolapse repair. In this study, we sought to evaluate local practice patterns of management of female SUI with specific emphasis on mesh use. A survey created by an expert panel was disseminated to respective provincial societies. Sixty-eight percent of respondents offer midurethral slings in their practice but only 60.6% of these respondents would offer surgical removal of the sling if there were complications, such as mesh erosion or pain. A large portion (39.4%) of respondents are performing transobturator slings as compared to retropubic midurethral slings (36.3%) and only 8.5% have removed the leg component associated with the transobturator sling in their practice. Furthermore, compared to most respondents offering midurethral slings (64.8%), only a minority of surgeons offer alternatives: 23.9% of respondents offer periurethral bulking agent injections, 15.5% offer pubovaginal slings, and 12.7% offer retropubic urethropexies. Our study supports that surgeons should continue to review surgical risks and alternative treatment options as part of the surgical consent process. As such, surgeons should be able to offer a variety of surgical approaches to manage female SUI.

Digital consent in gynecology: an evaluation of patient experience

IntroductionThe surgical consent process is a crucial discussion between patient and surgeon, which is predominantly documented utilizing hand-written forms. The exchange of individualized information allows the patient to make a truly informed decision. Digital consent (also known as electronic consent or e-consent) has been shown to improve accuracy of information provided without increasing the time taken to consent patients. We aimed to evaluate patient experience and effectiveness of digital consent in a gynecology department in a tertiary London Teaching Hospital.MethodsA questionnaire was designed and completed by 100 patients undergoing gynecological surgery: 50 consented using paper and 50 consented digitally. The questionnaire included 8 statements, with five possible answers to select, ranging from strongly agree to strongly disagree, on a standard five-point Likert Scale. Patients were all female and categorized into age groups (deciles) and asked whether consent was taken digitally or on paper. Data were collected between January and July 2021.ResultsMost responses were positive with 87% (694/800) of responses to the questions being either strongly agree or agree. Patients who were consented using paper selected ‘strongly agree’ 43.5% (174/400) of the time in comparison to 64.8% (259/400) of the time when they were consented digitally. The majority, 86% (43/50), of digitally consented patients received a copy of the consent form in comparison to 18% (9/50) of those consented using paper. On average, the patients consented digitally were older than their paper-consented counterparts (49–58 and 59–68 respectively). The mean scores for the questions relating to the ease of reading the form, ease of understanding the form, understanding of the potential complications, and overall satisfaction were higher in those digitally consented (p < 0.05).DiscussionOverall, patients were satisfied with both methods of consent. However, individuals who were consented digitally reported higher levels of satisfaction throughout the consent process, compared to paper consent. These data suggest that digital consent is an acceptable alternative to paper consent for patients and facilitates adherence to national consent guidance, which stipulates patients should be given the information they request.

A Conduit for a Culturally Competent Consent: Medical Interpreters' Perspectives on Surgical Informed Consent Discussions.

To understand medical interpreter's perspectives on surgical informed consent discussions and provide feedback for surgeons on improving these conversations. Informed consent is a critical component of patient-centered surgical decision-making. For patients with limited English proficiency (LEP), this conversation may be less thorough, even with a medical interpreter, leaving patients with an inadequate understanding of their diagnosis or treatment options. A semi-structured interview guide was developed with input from interpreters and a qualitative research expert. We purposively sampled medical interpreters representing multiple languages until thematic saturation was achieved. Participants discussed their experience with the surgical consent discussion and process. Interview transcripts were analyzed using emergent thematic analysis. Among 22 interpreters, there were ten languages represented and an average experience of 15 years (range 4-40y). Four major themes were identified. First, interpreters consistently described their roles as patient advocates and cultural brokers. Second, interpreters reported unique patient attributes that influence the discussion, often based on patients' cultural values/expectations, anticipated decisional autonomy, and family support. Third, interpreters emphasized the importance of surgeons demonstrating compassion and patience, using simple terminology, conversing around the consent, providing context about the form/process, and initiating a pre-encounter discussion. Finally, interpreters suggested reducing legal terminology on consent forms and translation into other languages. Experienced interpreters highlighted multiple factors associated with effective and culturally tailored informed consent discussions. Surgeons should recognize interpreters' critical and complex roles, be cognizant of cultural variations among patients with LEP, and improve interpersonal and communication skills to facilitate effective understanding.

Not just for surgeons: A qualitative exploration of the surgical consent process

Not just for surgeons: A qualitative exploration of the surgical consent process

A quality analysis of internet patient information for immediate, sequential, bilateral cataract surgery (ISBCS).

Due to surgical capacity pressures, induced by the COVID-19 pandemic, immediate bilateral simultaneous cataract surgery (ISBCS) has been utilised increasingly throughout the U.K. This surgical method comes with both novel risks and benefits, so the consent process must be modified. Prior randomised trials have demonstrated that appropriate online information may act as an adjunct to the surgical consent process. This study aims to assess the quality of available internet information for ISBCS. Terms searched were 'bilateral cataract surgery patient information', 'double cataract surgery patient information', and 'immediate sequential bilateral cataract surgery patient information'. The Google search engine was used. The DISCERN instrument and JAMA benchmarks were used to assess healthcare information for quality. The Flesch Reading Ease Score (FRE), Flesch Kincaid Grade (FKG) Level and Gunning Fog Score (GFS) were used to assess for readability. HONcode certification was used to assess transparency and quality. Forty-six websites were found. The average DISCERN score was 41.3, meaning a "fair" quality which is below what many patients would anticipate discovering when trying to find information. National Healthcare Service websites had higher DISCERN scores than private healthcare-provided websites (p < 0.01; 95% CI: 1.13-1.88.). Fair patient information for ISBCS has been demonstrated. Specific internet information sources with appropriate information should be further developed, with cited sources, and patients signposted to them if felt appropriate.

Exploring healthcare professionals' perspective of the process of obtaining consent for adult patient's having planned surgery: A scoping review.

The aim of this scoping review was to provide an overview of the literature about the process of obtaining consent from adult patients undergoing planned surgery from the healthcare professionals' perspective and analyse knowledge gaps. The process of obtaining consent for planned elective surgery manifests an individual's fundamental right to decide what happens to their body. The process is often suboptimal and problematic, placing a significant resource burden on health systems globally. Deficiencies in the documentation on consent forms have also been shown to increase the risk of operating room error. Scoping review. Arksey and O'Malley's (International Journal of Social Research Methodology, 8, 2005 and 19) five-step scoping review methodology was used. Fifty-three articles were included; 39 primary and 14 secondary research publications. Three key findings were identified; there is currently low-level evidence about surgical consent processes to inform clinical practice; junior doctors obtain surgical consent frequently, yet this process was likely undertaken sub-optimally; and current knowledge gaps include capacity assessment, decision-making and pre-procedural consent checks. Planned surgical consent processes are complex, and both surgeons and perioperative nurses are essential during the process. While surgeons have responsibility to obtain consent, perioperative nurses provide a safety net in the surgical consent process checking the surgical consent information is correct and has been understood by the patient. Such actions may influence consent validity and patient safety in the operating room. Knowledge gaps about capacity assessment, decision-making, pre-procedural checks and the impact of junior doctors obtaining consent on patient understanding, safety and legal claims are evident. This review highlights the importance of the surgical nurse's role in the planned surgical consent process. While the responsibility for obtaining surgical consent lies with the surgeon, the nurse's role verifying consent information is crucial as they act as a safety net and can reduce error in the operating room. The authors declare that no patient or public contribution was made to this review in accordance with the aim to map existing literature from the healthcare professionals' perspective.

EGS P15 Role of electronic consent in emergency surgery – A QIP in a high volume surgical emergency unit at a tertiary hospital

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- 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.

Exploring the Impact of Using Patient-Specific 3D Prints during Consent for Skull Base Neurosurgery.

Objectives Informed consent is fundamental to good practice. We hypothesized that a personalized three-dimensional (3D)-printed model of skull base pathology would enhance informed consent and reduce patient anxiety. Design Digital images and communication in medicine (DICOM) files were 3D printed. After a standard pre-surgery consent clinic, patients completed part one of a two-part structured questionnaire. They then interacted with their personalized 3D printed model and completed part two. This explored their perceived involvement in decision-making, anxiety, concerns and also their understanding of lesion location and surgical risks. Descriptive statistics were used to report responses and text classification tools were used to analyze free text responses. Setting and Participants In total,14 patients undergoing elective skull base surgery (with pathologies including skull base meningioma, craniopharyngioma, pituitary adenoma, Rathke cleft cyst, and olfactory neuroblastoma) were prospectively identified at a single unit. Results After 3D model exposure, there was a net trend toward reduced patient-reported anxiety and enhanced patient-perceived involvement in treatment. Thirteen of 14 patients (93%) felt better about their operation and 13/14 patients (93%) thought all patients should have access to personalized 3D models. After exposure, there was a net trend toward improved patient-reported understanding of surgical risks, lesion location, and extent of feeling informed. Thirteen of 14 patients (93%) felt the model helped them understand the surgical anatomy better. Analysis of free text responses to the model found mixed sentiment: 47% positive, 35% neutral, and 18% negative. Conclusion In the context of skull base neurosurgery, personalized 3D-printed models of skull base pathology can inform the surgical consent process, impacting the levels of patient understanding and anxiety.

Counseling for stress urinary incontinence in the era of adverse publicity around mesh usage: Results from a large-sample global survey.

To investigate doctors' opinions of the use of synthetic mesh for the treatment of stress urinary incontinence (SUI) and the effect on patient's attitude following recent adverse publicity and legal findings. Electronic survey approved by International Urogynecological Association (IUGA) and American Urogynecologic Society (AUGS), distributed to their members. A total of 593 respondents completed the survey. The preferred initial surgical treatment for SUI was retropubic midurethral sling (MUS) (62%), followed by trans-obturator MUS (19%), mini-slings (10%), and then bulking agents (5%). Despite prolongation of consultation, most respondents (87%) believed that clinicians should provide a patient information leaflet (PIL) for their patients. However, only 70% of respondents were doing this. Most participants would use either the IUGA PIL or their institution PIL (61%). Only 8% felt that patients have a positive preconception of synthetic mesh for SUI. Eighty-three per cent of respondents had not changed their recommendations for treatment and the consent process. A logistic regression model identified preferences of certain geographic areas as predictors of consenting practices. Despite the negative publicity and the current medicolegal litigation involving MUS for SUI treatment, the majority of respondents still prefer this as the initial surgical treatment. Most clinicians value PIL in the surgical consent process.

P-OGC64 High Fidelity Patient-Reported Outcome Monitoring following Upper Gastrointestinal and Hepato-Pancreato-Biliary Cancer Surgery. Early Experience with a Novel Application

Abstract Background Patients undergoing complex upper-gastrointestinal and hepatopancreatobiliary resections experience a high incidence of post-operative symptoms. There is significant scope to expand clinicians’ understanding of longitudinal symptom progression and recognise a greater range of post-operative symptoms than those traditionally recorded. By identifying symptoms most troublesome to patients we anticipate improvement in patients’ symptom management, the surgical consent process and, ultimately, patient experience. The myICUvoice application provides patients with the opportunity to report symptoms across a wide range of domains in real-time. We report our early experience using this application with patients in the post-operative setting. Methods Following institutional governance approval, consecutive patients undergoing pancreatic, or hepatic (H) or oesophagogastric (U) resectional surgery during a four week period at a single tertiary centre were offered the opportunity to use the application. From day-1 post-op to discharge, each patient completed surveys at least twice daily, reporting their experience across a list of 34 symptoms together with pain, breathing, mood and physical state. Both individual and cohort time-series data were obtained for each symptom and stratified by resection type. A dashboard has been developed as part of the application to allow summary data to be easily displayed. Results 342 symptom surveys were completed by a total of 15 patients (5U, 10H). The median length-of-stay was 11-days and 91% of patients completed 2 surveys/day (Table-1). High frequency symptoms were tiredness (reported in H:80%;U:86% of surveys), dry mouth (14/15 patients, H:91%,U:59%) and uncomfortable position (13/15 patients, H:27%,U:43%). Whilst most patients remained happy, there were frequent reports of psychological distress; 53% reported nightmares (H:6%,U:12% of surveys), 67% felt depressed, (H:12%,U:6% of surveys) and 53% anxious (H:14%,U:6% of surveys). Pain statement analysis (Figure-1) revealed distinct profiles providing high resolution data on the efficacy of analgesic regimes/techniques. Conclusions As expected, our patient cohort experienced a wide range, and high frequency, of post-operative symptoms. Experience conducting symptom surveys demonstrated a high incidence of disconnect between clinical expectations and reported symptoms. Our data illustrate the value of detailed symptom monitoring and this application could be used routinely to measure and improve the patient experience. Further research is planned to compare the performance of these standardised symptom surveys to current methods of identifying symptoms. Furthermore, data from specific patient populations could better inform patient expectations of the post-operative symptoms they may experience, thus improving the surgical consent process.

EP.WE.568Compliance with the Royal College of Surgeons of England Guidelines on the Surgical Consenting Process in the Era of the COVID-19 Pandemic

AimsDue to the current COVID-19 pandemic, The Royal College of Surgeons of England released guidelines advising on additional considerations which should be discussed with patients as part of the informed consent process prior to surgery.We conducted a prospective audit on whether COVID-19 infection was mentioned as a possible complication during the consenting process for patients undergoing emergency and elective general surgical procedures at a District General Hospital.MethodologyWe prospectively collected data on the patients admitted for surgical procedures over a 2-week period. Consent forms were reviewed noting whether COVID-19 infection was listed as a possible complication.Results35 patients were audited with a median age of 54 (12-94) years including 17 males and 18 females. Patients presented with varying surgical diagnoses, with 16 and 19 undergoing emergency and elective operations, respectively. 77.1% (27) of patients had COVID-19 infection mentioned as a possible complication on their consent forms. Five out of six consent forms completed by Clinical Fellows or CT trainees, 10 out of 13 by Registrars, 12 out of 16 by Consultants mentioned COVID-19 infection. We found no significant correlation between the grade of the consent taker and COVID-19 infection being mentioned as a possible complication.ConclusionMost of the consent takers were aware of the guidelines and mentioned COVID-19 infection as a possible complication during consenting. However, this awareness could be expanded. The results will be presented to the department before a plan to re-audit and close the loop in a few weeks.

Patient Reported Experience on Consenting for Surgery – Elective Versus Emergency Patients

IntroductionInformed consent for surgery is a medical and legal requirement, but completing these does not necessarily translate to high patient satisfaction. This patient-reported experience study aimed to examine the surgical consent process, comparing the patients’ experience in elective and emergency settings. MethodsOver a 6-mo period, postoperative patients at The Alfred Hospital Breast and Endocrine Surgical Unit were invited to participate in a survey on the surgical consent process – including perceived priorities, information provided and overall experience. Standard statistical techniques were used, with a significant P-value of < 0.05. ResultsA total of 412 patients were invited, with 130 (32%) responses. More patients underwent elective surgery (N= 90, 69%) than emergency surgery (N = 40, 31%). Emergency patients were more likely to sign the consent form regardless of its contents (93% versus 39%, P < 0.001) and more likely to be influenced by external pressures (63% versus 1%, P < 0.001). Elective patients were more likely to want to discuss their surgery with a senior surgeon (74% versus 23%, P < 0.001) and more likely to seek advice from external sources (83% versus 10%, P < 0.001). Both groups highly valued the opportunity to ask questions (67% versus 63%, P = 0.65). ConclusionThis study shows patients have a range of different priorities in preparation for surgery. Therefore, each consent process should be patient-specific, and focus on providing the patient with quality resources that inform decision-making.

The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study.

The objective of this study is to investigate the impact of support person participation during the preoperative appointment. This is a prospective cohort study involving patients scheduled to undergo pelvic reconstructive surgery. Eligible patients were enrolled at the preoperative appointment and compared by presence or absence of a support person. Questionnaires were completed before and after the preoperative appointment, 1-3 days before surgery, and at the postoperative appointment. Previsit questionnaires included the Generalized Anxiety Disorder-7, 6-item short form of the Spielberger State-Trait Anxiety Inventory (STAI-6), and Brief Health Literacy screen. Postvisit questionnaires included the STAI-6, satisfaction with decision scale for pelvic floor disorders, preoperative preparedness questionnaire, and knowledge questionnaire. At the postoperative appointment, participants completed the patient global impression of improvement and postoperative symptom and satisfaction questionnaire. Primary outcome was patient anxiety measured by the STAI-6. Seventy-six patients participated in the study: 37 were categorized in the support person cohort and 39 were categorized in the no support person cohort. The mean scores of the STAI-6 did not differ between the support person and no support person cohorts at all time points (previsit: 42.97 ± 13.23 vs 41.53 ± 17.11, P = 0.68; postvisit: 38.11 ± 12.76 vs 36.33 ± 11.72, P = 0.53, and 1-3 days before surgery: 42.61 ± 13.0 vs 41.05 ± 16.39, P = 0.65). Overall preparedness, satisfaction with decision scale for pelvic floor disorders, and knowledge questionnaire did not differ between cohorts at both time points. Perioperative phone calls were similar between cohorts. Our study suggests that the presence of a support person at preoperative counseling for pelvic floor surgery should be a personal preference and not a recommendation.

Informed Consent for Surgery at Resumption of Elective Activity After the First Wave of COVID-19.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has changed the dynamics of healthcare, and the elective surgical consent process has also evolved. The Royal College of Surgeons of England published guidance on consent during COVID-19. Through this study, we aimed to assess our local consent adherence to these guidelines on the resumption of elective activity after the first wave of COVID-19.MethodsThis prospective review of consecutive elective surgical consent forms was conducted from 20 July 2020 to 16 August 2020 at the Princess Alexandra Hospital NHS Trust, England. The primary outcome was evidence of COVID-19 risk documentation on the consent forms.ResultsA total of 116 patients’ consent forms were reviewed. Most patients were American Society of Anaesthesiologists (ASA) grade 2 (n=70; 60.34%). Only 25 consent forms (21.55%) had COVID -19 and its associated risks documented, with registrars being the most compliant (19/46; 41.3%) followed by consultants (6/51; 11.7%). With regards to the surgical sub-specialities, general surgery, orthopaedics and ENT had the highest compliance with the guidance.ConclusionsAs the elective activity resumes, peri-operative risks of COVID-19 should be weighted in during the informed consent process, as mentioned in the latest international guidelines on consent to avoid litigation and negligence claims.

Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database.

Use of hypoglossal nerve stimulator implantation has dramatically improved the surgical treatment of multilevel airway collapse during obstructive sleep apnea (OSA). Understanding causes of adverse events and their impact on patients undergoing stimulator implantation will help improve patient preparation and surgical practices to avoid future complications. This study is a retrospective review of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, a publicly available voluntary reporting system. National patient event database. The MAUDE database was searched for reports associated with the terms "hypoglossal nerve stimulator" and "Inspire," being the only currently FDA-approved system for upper airway stimulation for OSA. All records were searched with the events limited in dates between May 2014 and September 2019. A total of 132 patient reports were identified over the 5-year inclusion period, containing 134 adverse events. The reported adverse events resulted in 32 device revision procedures as well as 17 explantations. Device migration and infection were 2 of the most commonly reported adverse events. Complications not witnessed in previous large-scale clinical trials included pneumothorax, pleural effusion, and lead migration into the pleural space. Previous data have demonstrated hypoglossal nerve stimulator implantation results in reliable OSA improvement. However, a number of technical difficulties and complications still exist during the perioperative period, which should be communicated to patients during the surgical consent process.

Improving the surgical consenting process for patients with acute hip fractures: a pilot quality improvement project

BackgroundConsenting patients for trauma procedures following hip fracture is a key stage in the treatment pathway from admission to the operating theatre. Errors in this process can result in delayed procedures which may negatively impact patient recovery. The aim of this project was to identify and reduce errors in our consenting process for patients with capacity.MethodsConsent forms for all adult patients with capacity admitted for surgical repair of traumatic hip fracture were reviewed over a 4-week period. The baseline measurement (n = 24), identified errors in three key process measures: clarity of documentation, failure to record procedure-specific risks and not offering a copy of the consent form to the patient. Pre-printed stickers and targeted teaching were then introduced as quality improvement measures. Their impact was evaluated over subsequent 4-week review of the same patient demographic, with further refinement of these interventions being carried out and re-evaluated for a final cycle.ResultsCycle 1 (n = 26) following targeted teaching demonstrated a reduction in abbreviations from 38 to 20%, while doubling the documentation of discussion of procedure-specific risks from 31 to 72%. More patients were offered a copy of their consent form, rising from 12 to 48%. Cycle 2 (n = 24) saw the introduction of pre-printed “risk of procedure” stickers. Although clarity measures continued to improve, quality of pre-procedure risk documentation remained static while the number of forms being offered to patients fell to 8%.ConclusionsOur project would suggest that while pre-printed stickers can be useful memory aids, specific teaching on consenting produces the greatest benefit. The usage of such tools should therefore be limited, as adjuncts only to specific training.

The Effect of Fronto-Orbital Advancement on Frontal Sinus Development and Function in Non-Syndromic and Syndromic Craniosynostosis.

The impact of fronto-orbital advancement (FOA) on frontal sinus development and function is anecdotally variable. The aim of this study was to assess the impact of FOA on development of frontal sinuses, and additionally to identify the complications that might arise out of such procedures. This was a retrospective case-control study. Non-syndromic and syndromic craniosynostosis patients (n = 58) who underwent FOA at an early age and also had a skull radiograph or CT scan after the age of 12 were selected. Age matched trauma patients with CT scans done beyond 12 years of age were used as controls. Age at first FOA surgery, total number of procedures and age at imaging was noted. Presence or absence of frontal sinuses was assessed using imaging studies initially. Patients with a formed frontal sinus and a CT scan were further chosen for volumetric studies. Complications related to frontal sinus and secondary surgeries were recorded. One of 27 non-syndromic patients had absent frontal sinuses. Seven of 31 syndromic patients had absent sinuses. Among 20 controls, only 1 patient did not develop frontal sinuses. The mean age at first FOA was 11.81 months and 18.25 months for non-syndromic and syndromic groups, respectively. The average number of procedures before 12 years of age was 1.25 and 1.51 for non-syndromic and syndromic patients, respectively. The mean age at imaging was 17.74, 20.96, and 20.25 years for non-syndromic, syndromic and control groups, respectively. The mean frontal sinus volumes were 13050.36, 15039.02, and 8459.48 mm for non-syndromic, syndromic and control groups, respectively. In conclusion, FOA does not seem to have an impact on rate of pneumatization in the background of similar rates in the non-syndromic and control groups. The low pneumatization rate in syndromic group might be a virtue of the disease itself. There were significant frontal sinus complications that occurred after fronto orbital advancement and this should be borne in mind during the surgical consenting process.

"Uninformed" Consent: Patient Recollection From Surgical Consent in Hand Surgery-A Quality Improvement Initiative.

Background: Informed surgical consent is necessary and routine; however, it can have significant inadequacies. Our purpose was to investigate patient recollection of the surgical consent process and evaluate adequacy from the patient's perspective. Methods: A quality improvement framework was used. Two patient surveys capturing information recall and satisfaction of the consent process were administered in 5 consecutive hand clinics. All patients who previously underwent elective hand surgery were included. Results: There was exceptionally low recall of the risks and benefits of surgery in 103 consecutive patients who underwent hand surgery. Patients under age 35 had slightly better recall of surgical risks. Unexpected postoperative events affected patient perceptions of the consent process. Conclusions: Patients who have undergone elective hand surgery have poor recollection of the information discussed during the surgical consent process, and therefore the process is lacking. Surgeons may falsely assume that the consent process is sound because it is erroneously perceived as being sufficient by most patients.

Engaging the patient and family in the surgical safety process utilizing

BackgroundOwing to the vulnerable nature of children, parental/caregiver engagement in surgical safety is a crucial aspect of care. Historically, the surgical safety process has been isolated from parent involvement. The digital, tablet-based surgical safety application, SafeStart, requires parent participation and provides multiple instances of verification of patient safety information from preoperative clinic visit, to perioperative care, and into the operating room. MethodThe SafeStart application was utilized for 100 pediatric general surgery patients in an IRB approved prospective study. Parent assessments of the surgical consent and safety processes were collected in pre- and postoperative surveys with a 100% response rate. Standard consent forms were used and compared as a control. ResultsOnly 31% of parents had knowledge of the surgical safety checklist process prior to their exposure to the study. 96% of the parents reported that the SafeStart patient portal was easy to use. A majority would prefer SafeStart to the standard consent process. ConclusionThe SafeStart program connected the surgical safety process from the preoperative clinic visit through postoperative care. Parent's preferred SafeStart to the standard surgical safety checklist and consent process, felt that they were instrumental in protecting their child's safety, and would recommend SafeStart for the surgical care of others. Level of evidenceII