Aids to improve understanding of statistical risk in patients consenting for surgery and interventional procedures: A systematic review

BACKGROUND: Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about benefits, risks, and alternatives of a procedure. Statistical risk information is difficult to communicate and the effectiveness of aids aimed at supporting this type of communication is uncertain. This systematic review aims to study the impact of risk communication adjuncts on patients' understanding of statistical risk in surgery and interventional procedures. METHODS: A systematic search was performed across Medline, Embase, PsycINFO, Scopus, and Web of Science until July 2021 with a repeated search in September 2022. RCTs and observational studies examining risk communication tools (e.g., information leaflets and audio-video) in adult (age >16) patients undergoing a surgical or interventional procedure were included. Primary outcomes included the objective assessment of statistical risk recall. Secondary outcomes included patient attitudes with respect to statistical information. Due to the study heterogeneity, a narrative synthesis was performed. RESULTS: A total of 4348 articles were identified, and following abstract and full-text screening 14 articles, including 9 RCTs, were included. The total number of adult patients was 1513. The most common risk communication tool used was written information (n = 7). Most RCTs (7/9, 77.8%) showed statistically significant improvements in patient understanding of statistical risk in the intervention group. Quality assessment found some concerns with all RCTs. CONCLUSION: Risk communication tools appear to improve recall of statistical risk. Additional prospective trials comparing various aids simultaneously are warranted to determine the most effective method of improving understanding

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

Post-Operative Medium- and Long-Term Endocrine Outcomes in Patients with Non-Functioning Pituitary Adenomas—Machine Learning Analysis

Post-operative endocrine outcomes in patients with non-functioning pituitary adenoma (NFPA) are variable. The aim of this study was to use machine learning (ML) models to better predict medium- and long-term post-operative hypopituitarism in patients with NFPAs. We included data from 383 patients who underwent surgery with or without radiotherapy for NFPAs, with a follow-up period between 6 months and 15 years. ML models, including k-nearest neighbour (KNN), support vector machine (SVM), and decision tree models, showed a superior ability to predict panhypopituitarism compared with non-parametric statistical modelling (mean accuracy: 0.89; mean AUC-ROC: 0.79), with SVM achieving the highest performance (mean accuracy: 0.94; mean AUC-ROC: 0.88). Pre-operative endocrine function was the strongest feature for predicting panhypopituitarism within 1 year post-operatively, while endocrine outcomes at 1 year post-operatively supported strong predictions of panhypopituitarism at 5 and 10 years post-operatively. Other features found to contribute to panhypopituitarism prediction were age, volume of tumour, and the use of radiotherapy. In conclusion, our study demonstrates that ML models show potential in predicting post-operative panhypopituitarism in the medium and long term in patients with NFPM. Future work will include incorporating additional, more granular data, including imaging and operative video data, across multiple centres

Improving risk communication: a proof-of-concept randomised control trial assessing the impact of visual aids for neurosurgical consent

IntroductionInformed consent is a fundamental component in the work-up for surgical procedures. Statistical risk information pertaining to a procedure is by nature probabilistic and challenging to communicate, especially to those with poor numerical literacy. Visual aids and audio/video tools have previously been shown to improve patients' understanding of statistical information. In this study, we aimed to explore the impact of different methods of risk communication in healthy participants randomized to either undergo the consent process with visual aids or the standard consent process for lumbar puncture.Material and methodsHealthy individuals above 18 years old were eligible. The exclusion criteria were prior experience of the procedure or relevant medical knowledge, lack of capacity to consent, underlying cognitive impairment and hospitalised individuals. After randomisation, both groups received identical medical information about the procedure of a lumbar puncture in a hypothetical clinical scenario via different means of consent. The control group underwent the standard consent process in current clinical practice (Consent Form 1 without any illustrative examples), whereas the intervention group received additional anatomy diagrams, the Paling Palette and the Paling perspective scale. Anonymised questionnaires were received to evaluate their perception of the procedure and its associated risks.ResultsFifty-two individuals were eligible without statistically significant differences in age, sex, professional status and the familiarity of the procedure. Visual aids were noted to improve the confidence of participants to describe the risks by themselves (p = 0.009) and participants in the intervention group felt significantly less overwhelmed with medical information (p = 0.028). The enhanced consent process was found to be significantly more acceptable by participants (p = 0.03). There was a trend towards greater appropriateness (p = 0.06) and it appeared to have “good” usability (median SUS = 76.4), although this also did not reach statistical significance (p = 0.06)ConclusionVisual aids could be an appropriate alternative method for medical consent without being inferior regarding the understanding of the procedure, its risks and its benefits. Future studies could possibly compare or incorporate multiple interventions to determine the most effective tools in a larger scale of population including patients as well as healthy individuals

Efficacy of a Mindfulness-Based Intervention in Ameliorating Inattentional Blindness Amongst Young Neurosurgeons: A Prospective, Controlled Pilot Study

BACKGROUND: Human factors are increasingly being recognised as vital components of safe surgical care. One such human cognitive factor: inattention blindness (IB), describes the inability to perceive objects despite being visible, typically when one’s attention is focused on another task. This may contribute toward operative ‘never-events’ such as retained foreign objects and wrong-site surgery. METHODS: An 8-week, mindfulness-based intervention (MBI) programme, adapted for surgeons, was delivered virtually. Neurosurgical trainees and recent staff-appointees who completed the MBI were compared against a control group, matched in age, sex and grade. Attention and IB were tested using two operative videos. In each, participants were first instructed to focus on a specific part of the procedure and assessed (attention), then questioned on a separate but easily visible aspect within the operative field (inattention). If a participant were ‘inattentionally blind’ they would miss significant events occurring outside of their main focus. Median absolute error (MAE) scores were calculated for both attention and inattention. A generalised linear model was fitted for each, to determine the independent effect of mindfulness intervention on MAE. RESULTS: Thirteen neurosurgeons completed the mindfulness training (age, 30 years [range 27–35]; female:male, 5:8), compared to 15 neurosurgeons in the control group (age, 30 years [27–42]; female:male, 6:9). There were no significant demographic differences between groups. MBI participants demonstrated no significant differences on attention tasks as compared to controls (t = −1.50, p = 0.14). For inattention tasks, neurosurgeons who completed the MBI had significantly less errors (t = −2.47, p = 0.02), after adjusting for participant level and video differences versus controls. We found that both groups significantly improved their inattention error rate between videos (t = −11.37, p < 0.0001). In spite of this, MBI participants still significantly outperformed controls in inattention MAE in the second video following post-hoc analysis (MWU = 137.5, p = 0.05). DISCUSSION: Neurosurgeons who underwent an eight-week MBI had significantly reduced inattention blindness errors as compared to controls, suggesting mindfulness as a potential tool to increase vigilance and prevent operative mistakes. Our findings cautiously support further mindfulness evaluation and the implementation of these techniques within the neurosurgical training curriculum

Improving risk communication: a proof-of-concept randomised control trial assessing the impact of visual aids for neurosurgical consent

Introduction Informed consent is a fundamental component in the work-up for surgical procedures. Statistical risk information pertaining to a procedure is by nature probabilistic and challenging to communicate, especially to those with poor numerical literacy. Visual aids and audio/video tools have previously been shown to improve patients' understanding of statistical information. In this study, we aimed to explore the impact of different methods of risk communication in healthy participants randomized to either undergo the consent process with visual aids or the standard consent process for lumbar puncture. Material and methods Healthy individuals above 18 years old were eligible. The exclusion criteria were prior experience of the procedure or relevant medical knowledge, lack of capacity to consent, underlying cognitive impairment and hospitalised individuals. After randomisation, both groups received identical medical information about the procedure of a lumbar puncture in a hypothetical clinical scenario via different means of consent. The control group underwent the standard consent process in current clinical practice (Consent Form 1 without any illustrative examples), whereas the intervention group received additional anatomy diagrams, the Paling Palette and the Paling perspective scale. Anonymised questionnaires were received to evaluate their perception of the procedure and its associated risks. Results Fifty-two individuals were eligible without statistically significant differences in age, sex, professional status and the familiarity of the procedure. Visual aids were noted to improve the confidence of participants to describe the risks by themselves (p = 0.009) and participants in the intervention group felt significantly less overwhelmed with medical information (p = 0.028). The enhanced consent process was found to be significantly more acceptable by participants (p = 0.03). There was a trend towards greater appropriateness (p = 0.06) and it appeared to have “good” usability (median SUS = 76.4), although this also did not reach statistical significance (p = 0.06) Conclusion Visual aids could be an appropriate alternative method for medical consent without being inferior regarding the understanding of the procedure, its risks and its benefits. Future studies could possibly compare or incorporate multiple interventions to determine the most effective tools in a larger scale of population including patients as well as healthy individuals

Reducing Prediction volatility in the surgical workflow recognition of endoscopic pituitary surgery

PURPOSE: Workflow recognition can aid surgeons before an operation when used as a training tool, during an operation by increasing operating room efficiency, and after an operation in the completion of operation notes. Although several methods have been applied to this task, they have been tested on few surgical datasets. Therefore, their generalisability is not well tested, particularly for surgical approaches utilising smaller working spaces which are susceptible to occlusion and necessitate frequent withdrawal of the endoscope. This leads to rapidly changing predictions, which reduces the clinical confidence of the methods, and hence limits their suitability for clinical translation. METHODS: Firstly, the optimal neural network is found using established methods, using endoscopic pituitary surgery as an exemplar. Then, prediction volatility is formally defined as a new evaluation metric as a proxy for uncertainty, and two temporal smoothing functions are created. The first (modal, Mn) mode-averages over the previous n predictions, and the second (threshold, Tn) ensures a class is only changed after being continuously predicted for n predictions. Both functions are independently applied to the predictions of the optimal network. RESULTS: The methods are evaluated on a 50-video dataset using fivefold cross-validation, and the optimised evaluation metric is weighted-F1 score. The optimal model is ResNet-50+LSTM achieving 0.84 in 3-phase classification and 0.74 in 7-step classification. Applying threshold smoothing further improves these results, achieving 0.86 in 3-phase classification, and 0.75 in 7-step classification, while also drastically reducing the prediction volatility. CONCLUSION: The results confirm the established methods generalise to endoscopic pituitary surgery, and show simple temporal smoothing not only reduces prediction volatility, but actively improves performance