Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.

OBJECTIVE: The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. METHOD: Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. RESULTS: At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). CONCLUSIONS: No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. Lessons learnt can inform future studies.

Using objective robotic automated performance metrics and task-evoked pupillary response to distinguish surgeon expertise.

PURPOSE: In this study, we investigate the ability of automated performance metrics (APMs) and task-evoked pupillary response (TEPR), as objective measures of surgeon performance, to distinguish varying levels of surgeon expertise during generic robotic surgical tasks. Additionally, we evaluate the association between APMs and TEPR. METHODS: Participants completed ten tasks on a da Vinci Xi Surgical System (Intuitive Surgical, Inc.), each representing a surgical skill type: EndoWrist® manipulation, needle targeting, suturing/knot tying, and excision/dissection. Automated performance metrics (instrument motion tracking, EndoWrist® articulation, and system events data) and TEPR were recorded by a systems data recorder (Intuitive Surgical, Inc.) and Tobii Pro Glasses 2 (Tobii Technologies, Inc.), respectively. The Kruskal-Wallis test determined significant differences between groups of varying expertise. Spearman's rank correlation coefficient measured associations between APMs and TEPR. RESULTS: Twenty-six participants were stratified by robotic surgical experience: novice (no prior experience; n = 9), intermediate (< 100 cases; n = 9), and experts (≥ 100 cases; n = 8). Several APMs differentiated surgeon experience including task duration (p < 0.01), time active of instruments (p < 0.03), linear velocity of instruments (p < 0.04), and angular velocity of dominant instrument (p < 0.04). Task-evoked pupillary response distinguished surgeon expertise for three out of four task types (p < 0.04). Correlation trends between APMs and TEPR revealed that expert surgeons move more slowly with high cognitive workload (ρ < - 0.60, p < 0.05), while novices move faster under the same cognitive experiences (ρ > 0.66, p < 0.05). CONCLUSIONS: Automated performance metrics and TEPR can distinguish surgeon expertise levels during robotic surgical tasks. Furthermore, under high cognitive workload, there can be a divergence in robotic movement profiles between expertise levels.

The Relationship Between Technical Skills, Cognitive Workload, and Errors During Robotic Surgical Exercises.

Purpose: We attempt to understand the relationship between surgeon technical skills, cognitive workload, and errors during a simulated robotic dissection task. Materials and Methods: Participant surgeons performed a robotic surgery dissection exercise. Participants were grouped based on surgical experience. Technical skills were evaluated utilizing the validated Global Evaluative Assessment of Robotic Skills (GEARS) assessment tool. The dissection task was evaluated for errors during active dissection or passive retraction maneuvers. We quantified cognitive workload of surgeon participants as an index of cognitive activity (ICA), derived from task-evoked pupillary response metrics; ICA ranged 0 to 1, with 1 representing maximum ICA. Generalized estimating equation (GEE) was used for all modelings to establish relationships between surgeon technical skills, cognitive workload, and errors. Results: We found a strong association between technical skills as measured by multiple GEARS domains (depth perception, force sensitivity, and robotic control) and passive errors, with higher GEARS scores associated with a lower relative risk of errors (all p < 0.01). For novice surgeons, as average GEARS scores increased, the average estimated ICA decreased. In contrast, as average GEARS increased for expert surgeons, the average estimated ICA increased. When exhibiting optimal technical skill (maximal GEARS scores), novices and experts reached a similar range of ICA scores (ICA: 0.47 and 0.42, respectively). Conclusions: This study found that there is an optimal cognitive workload level for surgeons of all experience levels during our robotic surgical exercise. Select technical skill domains were strong predictors of errors. Future research will explore whether an ideal cognitive workload range truly optimizes surgical training and reduces surgical errors.

The clinical effectiveness and cost-effectiveness of a 'stepping into day treatment' approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial.

BACKGROUND: Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. METHODS: 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. DISCUSSION: The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision. TRIAL REGISTRATION: ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Virtual Reality vs Dry Laboratory Models: Comparing Automated Performance Metrics and Cognitive Workload During Robotic Simulation Training.

Background: This study compares surgical performance during analogous vesico-urethral anastomosis (VUA) tasks in two robotic training environments, virtual reality (VR) and dry laboratory (DL), to investigate transferability of skill assessment across the two platforms. Utilizing computer-generated performance metrics and pupillary data, we evaluated the two environments to distinguish surgical expertise and ultimately whether performance in the VR simulation correlates with performance in live robotic surgery in the DL. Materials and Methods: Experts (≥300 cases) and trainees (<300 cases) performed analogous VUAs during VR and DL sessions on a da Vinci robotic console following an Institutional Review Board (IRB) approved protocol (HS-16-00318). Twenty-two metrics were generated in each environment (kinematic metrics, tissue metrics, and biometrics). The DL included 18 previously validated automated performance metrics (APMs) (kinematics and event metrics) captured by an Intuitive system data recorder. In both settings, Tobii Pro Glasses 2 recorded the task-evoked pupillary response (reported as Index of Cognitive Activity [ICA]) to indicate cognitive workload, analyzed by EyeTracking cognitive workload software. Pearson correlation, Mann-Whitney, and independent t-tests were used for the comparative analyses. Results: Our study included six experts (median caseload 1300 [interquartile range 400-3000]) and 11 trainees (25 [0-250]). A total of 8/9 metrics directly comparable between VR and DL showed significant positive correlation (r ≥ 0.554, p ≤ 0.032); 5/22 VR metrics distinguished expertise, including task time (p = 0.031), clutch usage (p = 0.040), unnecessary needle piercing (p = 0.026), and suspected injury to the endopelvic fascia (p = 0.040). This contrasts with 14/22 APMs in DL (p ≤ 0.038), including linear velocities of all three instruments (p ≤ 0.038) and dominant-hand instrument wrist articulation (p = 0.013). Trainees experienced higher cognitive workload (ICA) in both environments when compared with experts (p < 0.036). Conclusions: Most performance metrics between VR and DL exhibited moderate to strong correlations, showing transferability of skills across the platforms. Comparing training environments, APMs during DL tasks are better able to distinguish expertise than VR-generated metrics.

Eye metrics as an objective assessment of surgical skill.

OBJECTIVE: Currently, surgical skills assessment relies almost exclusively on subjective measures, which are susceptible to multiple biases. We investigate the use of eye metrics as an objective tool for assessment of surgical skill. SUMMARY BACKGROUND DATA: Eye tracking has helped elucidate relationships between eye movements, visual attention, and insight, all of which are employed during complex task performance (Kowler and Martins, Science. 1982;215:997-999; Tanenhaus et al, Science. 1995;268:1632-1634; Thomas and Lleras, Psychon Bull Rev. 2007;14:663-668; Thomas and Lleras, Cognition. 2009;111:168-174; Schriver et al, Hum Factors. 2008;50:864-878; Kahneman, Attention and Effort. 1973). Discovery of associations between characteristic eye movements and degree of cognitive effort have also enhanced our appreciation of the learning process. METHODS: Using linear discriminate analysis (LDA) and nonlinear neural network analyses (NNA) to classify surgeons into expert and nonexpert cohorts, we examine the relationship between complex eye and pupillary movements, collectively referred to as eye metrics, and surgical skill level. RESULTS: Twenty-one surgeons participated in the simulated and live surgical environments. In the simulated surgical setting, LDA and NNA were able to correctly classify surgeons as expert or nonexpert with 91.9% and 92.9% accuracy, respectively. In the live operating room setting, LDA and NNA were able to correctly classify surgeons as expert or nonexpert with 81.0% and 90.7% accuracy, respectively. CONCLUSIONS: We demonstrate, in simulated and live-operating environments, that eye metrics can reliably distinguish nonexpert from expert surgeons. As current medical educators rely on subjective measures of surgical skill, eye metrics may serve as the basis for objective assessment in surgical education and credentialing in the future. Further development of this potential educational tool is warranted to assess its ability to both reliably classify larger groups of surgeons and follow progression of surgical skill during postgraduate training.

Brief report: eye-movement patterns during an embedded figures test in children with ASD.

The present study examined fixation frequency and duration during an Embedded Figures Test (EFT) in an effort to better understand the attentional and perceptual processes by which individuals with autism spectrum disorder (ASD) achieve accelerated EFT performance. In particular, we aimed to elucidate differences in the patterns of eye-movement in ASD and typically developing (TD) children, thus providing evidence relevant to the competing theories of weak central coherence (WCC) and enhanced perceptual functioning. Consistent with prior EFT studies, we found accelerated response time (RT) in children with ASD. No group differences were seen for fixation frequency, but the ASD group made significantly shorter fixations compared to the TD group. Eye-movement results indicate that RT advantage in ASD is related to both WCC and enhanced perceptual functioning.

Identifying cognitive state from eye metrics.

INTRODUCTION: This paper describes a new approach for identifying cognitive state by using information obtained only from the eye. Data are collected from cameras mounted on a lightweight headband. A set of eye metrics captures essential eye information from the raw data of pupil size and point-of-gaze. The metrics are easily calculated every second, so that the entire set of metrics can be computed in real time. METHODS: Three studies provide empirical evidence to test whether the eye metrics are sufficient to discriminate between two different cognitive states. The first study examines the states of relaxed and engaged in the context of problem solving. The second study looks at the states of focused and distracted attention in the context of driving. The third study inspects the states of alert and fatigued in the context of visual search. Two statistical models are used to classify cognitive state for all three studies: linear discriminant function analysis and non-linear neural network analysis. Data for the models are eye metrics computed at 1-, 4-, and 10-s intervals. RESULTS: All discriminant function analyses are statistically significant, and classification rates are high. Neural network models have equal or better performance than discriminant function models across all three studies. DISCUSSION: The seven eye metrics successfully discriminate between the states in all studies. Models from individual participants as well as the aggregate model over all participants are successful in identifying cognitive states based on task condition. Classification rates compare favorably with similar studies.

Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye Tracking Study.

Direct-to-consumer (DTC) television ads must disclose a drug's most important risks. Currently, the risks must be in audio at a minimum. Studies have shown that presenting information with both audio and superimposed risk text (dual-modality) improves recall beyond that of using audio alone. However, distracting elements in DTC ads may draw attention away from the superimposed risk text. This study combined eye-tracking data with questionnaire data to examine whether distracting elements decrease attention to the risk text in DTC ads, in turn affecting risk retention and risk perceptions. The authors randomly assigned 300 U.S. opt-in panel members to view either a low-distraction or a high-distraction DTC television ad. The authors found that distracting elements during risk presentation drew attention away from the risk text and, in turn, reduced retention of drug risk information. Risk perceptions were not affected. These results suggest that even if dual-modality is used to increase consumer's comprehension of drug risk information, distracting visuals should still be avoided in order to help consumers focus on key information in the ad.

Culture-fair cognitive ability assessment: information processing and psychophysiological approaches.

Valid assessment with diverse populations requires tools that are not influenced by cultural elements. This study investigated the relationships between culture, information processing efficiency, and general cognitive capacities in samples of Caucasian and Mexican American college students. Consistent with the neural efficiency hypothesis, pupillary responses (indexing mental effort) and detection accuracy scores on a visual backward-masking task were both significantly related to the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Full Scale scores. These measures of information processing efficiency were similar in the two groups. However, they were related only to Caucasian American, but not to a comparable sample of Mexican American, students' WAIS-R scores. Therefore, the differential validity in prediction suggests that the WAIS-R test may contain cultural influences that reduce the validity of the WAIS-R as a measure of cognitive ability for Mexican American students. Information processing and psychophysiological approaches may be helpful in developing culture-fair cognitive ability measures.

Harness technology for sustainable regulatory compliance.

Translate each new regulation into a process change that can be implemented and sustained economically, with reasonable effort.

Predictors of adherence to treatment for latent tuberculosis infection in high-risk Latino adolescents: a behavioral epidemiological analysis.

The objective was to test whether theoretical variables predict adherence to treatment for latent tuberculosis infection in high-risk Latino adolescents. 286 Latino adolescents, age 13-18 years, were recruited from 10 middle/high schools in San Diego County, San Diego, USA. Participants completed a baseline interview and up to 9 monthly interviews. The cumulative number of pills consumed in 9 months was regressed on 16 independent variables, entered hierarchically in seven blocks. The final model accounted for 25% of the variance in adherence to isoniazid (INH), F (16, 230)=4.69, p<0.001. Adherence counseling (+), age (-), grades (+), being bicultural (+), and risk behaviors (-) were significantly related to adherence. Learning theories presume that adherence to medical regimens requires social support and freedom from physical and social barriers. Results support these theories. Future studies should explore additional precepts in order to identify additional predictors and to maximize adherence to INH among Latino adolescents and other high-risk populations. Doing so should decrease the risk of active TB among high-risk racial/ethnic and foreign-born populations.

Pupillary responses on the visual backward masking task reflect general cognitive ability.

Cognitive processing efficiency requires both an ability to attend to task-relevant stimuli with quickness and accuracy, also while filtering distracting or task-irrelevant stimuli. This study investigated cognitive processing efficiency by using pupillary responses as an index of attentional allocation to relevant target and irrelevant masks on a visual backward masking task. The relationship between attentional allocation on this task and general cognitive ability on the scholastic aptitude test (SAT) was examined in college students (n=67). A principle components analysis of the pupillary response waveform isolated a late component that appeared to index the attentional demands associated with processing masks on the backward masking task. This pupillary response index of wasteful resource allocation to the mask accounted for significant variance in SAT scores over and above that accounted for by socio-economic status and target detection accuracy scores. Consistent with the neural efficiency hypothesis, individuals who allocated more resources to processing irrelevant information performed more poorly on cognitive ability tests.

EEG and eye-tracking based measures for enhanced training.

This paper describes a project whose goal was to establish the feasibility of using unobtrusive cognitive assessment methodologies in order to optimize efficiency and expediency of training. QUASAR, EyeTracking, Inc. (ETI), and Safe Passage International (SPI), teamed to demonstrate correlation between EEG and eye-tracking based cognitive workload, performance assessment and subject expertise on X-Ray screening tasks. Results indicate significant correlation between cognitive workload metrics based on EEG and eye-tracking measurements recorded during a simulated baggage screening task and subject expertise and error rates in that same task. These results suggest that cognitive monitoring could be useful in improving training efficiency by enabling training paradigms that adapts to increasing expertise.

Doctors' rights and patients' obligations.

KIE: Marshall examines arguments for and against physicians breaching their duty of confidentiality to persons diagnosed with HIV or AIDS by notifying third parties such as sexual partners or general practitioners who give care unrelated to HIV or AIDS. The arguments presuppose that the confidentiality right is not absolute, but may give way under certain circumstances. A physician's obligations to the larger community, for instance, may outweigh the obligation to keep a diagnosis of AIDS or HIV confidential. Marshall also argues that physicians who incur risks by treating patients with AIDS or HIV have a right to knowledge that will help them protect themselves. A patient with AIDS or HIV may be obliged to reveal this fact to physicians when seeking care for other health problems, or to allow the diagnosing physican to do so. These arguments may have implications for the debate over testing patients for AIDS or HIV without consent.^ieng