Grade Of Clinician Research Articles

Protocol-Stipulated Dose Modification to Manage Chemotherapy-Induced Peripheral Neuropathy in Children, Adolescents, and Young Adults With High-Risk Hodgkin Lymphoma.

Brentuximab vedotin (BV) incorporation into frontline chemotherapy regimens improved outcomes for classic Hodgkin lymphoma (cHL). The shared mechanism of action of BV and vinca alkaloids as microtubulin inhibitors increased the potential risk of chemotherapy-induced peripheral neuropathy (CIPN). Rates of CIPN and use of protocol-stipulated dose modifications of a microtubulin inhibitor were examined on the Children's Oncology Group AHOD1331 study, which compared BV, doxorubicin, vincristine (VCR), etoposide, prednisone, cyclophosphamide (BV-AVE-PC; BV arm) with bleomycin containing doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide (ABVE-PC; standard arm) in patients with high-risk cHL ages 2-21 years. AHOD1331 required clinician grading and reporting of ≥grade 2 CIPN. Protocol-stipulated dose modifications of VCR preceded modification of BV for ≥grade 2 CIPN in the BV arm, but only required modification of VCR for ≥grade 3 in the standard arm. Outcomes included CIPN rates, dose modification of microtubulin inhibitors by study arm, clinical factors associated with dose modifications, and event-free survival (EFS) by the presence of dose modification. Among the 582 patients who began protocol therapy, 112 developed ≥grade 2 CIPN. Cumulative incidence of CIPN did not differ by study arm (19.2 v 19.8%, P = .91). CIPN dose modifications occurred more frequently in the BV arm (9.5% v 2.8%, P = .001); however, most patients with CIPN on the BV arm received full-dose BV. EFS did not differ by the presence of dose modifications after accounting for study arm, age, sex, and stage, although older age was significantly associated with the risk of VCR dose modifications for CIPN. A staged dose modification plan for vinca alkaloids and BV as administered in AHOD1331 minimized the effect of incorporating a second microtubulin inhibitor on CIPN without compromising treatment efficacy in the BV arm.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery

BackgroundMany clinical trials use systematic methodology to monitor adverse events (AE) and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspective in the process remains lacking. ObjectivesTo compare clinician versus patient grading of AE severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association between patient grading of AEs with decision-making and quality of life outcomes and to determine if patient perspective changes over time. Study DesignThis was a planned supplementary study, “Patient-Perspectives in Adverse Event Reporting” (PPAR), to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, AEs experienced by patients were collected per a standardized protocol every 6 months where clinicians graded AE severity (mild, moderate, severe/life threatening). In this sub-study, we obtained additional longitudinal patient perspectives for 19 predetermined “PPAR AEs”. Patients provided their own severity grading (mild, moderate, severe/very severe/ life threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other’s reporting. The primary outcome was the interrater agreement (kappa statistic, κ) for AE severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. Association between AE severity and the Decision-Regret Scale (DRS), Satisfaction with Decision Scale (SDS), the Short-Form Health Survey-12 (SF-12), and Patient-Global Impression of Improvement (PGI-I) scores were assessed utilizing Spearman’s correlation coefficient (ρ) for continuous scales, Mantel-Haenszel chi-squared test for PGI-I, and T-tests or chi-squared tests comparing assessments of severe vs other grades. To describe patient perspective changes over time, the intra-observer agreement was estimated for AE severity grade over time using weighted kappa-coefficients. ResultsOf 360 patients randomized, 219 (61%) experienced a total of 527 PPAR AEs (91% moderate and 9% severe/life threatening by clinician grading). Mean patient age was 67 years, 87% were White, and 12% Hispanic. Of patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%).Overall agreement between clinician and participant grading of severity was poor (κ=0.24 (95%CI 0.14, 0.34). Of 414 AEs clinicians graded as moderate, patients graded 120 (29%) mild, and 80 (19%) severe. Of 39 AEs graded severe by clinicians, patients graded 15 (38%) mild or moderate. Initial patient grading of the most severe reported AE was mildly correlated with worse DRS (ρ=0.2, p=0.01), SF-12 (ρ=-0.24, p<0.01) and PGI-I (p<0.01). There was no association between AE severity and SDS. Patients with an initial grading of “severe” had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (p<0.05). Agreement between the patients’ initial severity and later timepoints was fair at 12 months (κ=0.48 (95% CI 0.39, 0.58)) and 36 months (κ=0.45 (95% CI 0.37, 0.53)). ConclusionsClinician and patient perceptions of AE severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

A prospective review of Cauda Equina Syndrome referrals received by an on-call orthopaedic department at a major trauma unit.

Cauda Equina Syndrome (CES) is one of the genuine orthopaedic emergencies. Diagnosis of acute CES is challenging and may be missed, resulting in considerable medicolegal claims. In Ireland, nearly €21 million in compensation has been paid out over a 10-year period due to the diagnosis being missed. As a result, defensive practices have resulted in an increased number of referrals for CES to the on-call orthopaedic service in a major trauma unit. A prospective data-capturing exercise was carried out of all referrals for acute CES to the orthopaedic on-call department in a tertiary-level university-affiliated teaching hospital between August and November 2023. Qualitative data was captured including referral source, referring clinician grade, in-hours or out-of-hours referral, MRI on referral, red flags as identified by the referring team, red flags as identified by the orthopaedic team, and outcome. Forty referrals for CES were made over the duration of this audit. Seventeen (42.5%) referrals were made in-hours, and 23 (57.5%) were referred out-of-hours. Only five (12.5%) of these referrals had an MRI done at the time of the referral. No patients were transferred for an out-of-hours MRI to another hospital. Only five (12.5%) patients required surgical decompression-none of these patients required an out-of-hours emergent decompression. There is a lack of understanding as to what exactly is being referred-resulting in a referral volume which is over ten times the expected number of CES cases being made to our unit. The lack of out-of-hours MRI access poses a significant concern for patient outcomes.

333 Inequity of Access to Investigations and Treatment of Varicose Veins by Clinician Grade: A Single Centre Retrospective Audit

Abstract Aim Following COVID-19, restrictions on investigations and theatre capacity led to a change in the Norfolk &amp; Waveney Clinical Commissioning Group (CCG) referral to treatment (RTT) criteria for varicose veins (VV); Only &amp;gt;C4 disease should be treated. An audit was performed to check for variability in outcomes between grade of surgeon. Method Retrospective audit of all VV referrals between 01/04/21-28/02/22. Case notes were reviewed assessing compliance with CCG criteria by surgeon grade and subsequent referrals for investigations and treatment. Results 250 VV referrals were made, 43.5% Male, mean (±SD) age 54.8 (16.9) years. 71 were rejected outright, 158 should have been rejected and 70 were subsequently reviewed in clinic. 20 were seen by SpRs and 50 by consultants. 62.9% (22) of ineligible patients attending clinic went on to have investigations. Of those seen in clinic, 35 did not meet the RTT criteria and should have been discharged. Significant differences in discharges were seen between SpRs &amp; Consultants (13.3% vs. 45% respectively (p = 0.046)). Duplex scans organised by SpRs (75%) were more likely to not meet the RTT criteria than Consultants (30.3%), p = 0.003. However, once a scan was performed there were no significant differences in proportion of these patients listed for treatment (64.3% vs. 29.4% (p = 0.247)). Conclusions SpRs are less likely to discharge patients from clinic who don’t meet RTT criteria than consultants and are more likely to request unnecessary investigations and treatment compared to consultants demonstrating inequity of care. SpRs should be educated on RTT criteria changes when working in different hospitals.

Peripheral Neuropathy in Children with High Risk Hodgkin Lymphoma (HL): The Role of Protocol-Stipulated Dose Modification in the Children's Oncology Group (COG) AHOD1331 Study

Background Peripheral neuropathy (PN) is commonly associated with several classes of chemotherapy, including vinca alkaloids and the novel anti-CD30-directed antibody-drug conjugate, Brentuximab vedotin (Bv). The drug moiety in Bv, monomethyl auristatin E, a potent microtubule tubulin inhibitor, is known to cause PN. In the 2018 Echelon-1 study, rates of PN among adults with advanced stage HL were 67% in the Bv arm as compared to 43% in the control arm (Connors, 2018) with dose modifications at the discretion of the treating physician of 66% for Bv and 57% for vinblastine (VBL). We examined rates of PN and use of protocol-stipulated dose modification in the COG AHOD1331, a Phase 3 randomized comparison of standard multi-agent chemotherapy (ABVE-PC) vs. Bv-AVE-PC among children and adolescents with high risk HL (Castellino, 2022). The combination of vincristine (VCR) with Bv warrants the formal study of PN in this trial. Methods Eligible patients (pts) ages 2-21 years with high risk HL were enrolled from 2015-2019 (NCT02166463). After randomization, pts received 5 cycles of chemotherapy. Pts in the standard (std) arm received VCR on Day 1 and 8 of each 21-day treatment cycle; pts in the experimental (exp) arm received Bv (1.8 mg/kg) on Day 1 and VCR on Day 8. Clinician grading of PN was required at each cycle, using the Balis PN Scale, with protocol-stipulated dose modifications of VCR preceding modification of Bv in cases of PN > grade 2. Rates of PN were calculated by treatment cycle by study arm. Dose modifications were summarized for each drug by treatment cycle. Median time to first dose modification was estimated by treatment arm. A Cox model estimated hazard ratios (HR) and 95% confidence intervals (CI) for dose modifications by treatment arm and pt and clinical characteristics. Progression-free survival (PFS) was compared with Log-rank test by study arms and within arm by presence or absence of PN. Results 587 pts were enrolled on the study. While the proportion of pts overall developing PN did not differ by study arm (19%, p=0.86), dose modification of Bv, VCR, or both occurred more frequently on the exp arm (50/298, 16.8%) than on the std arm (12/289, 4.2%). Among pts on the exp arm, Bv was dose modified in 8% of pts; VCR was dose modified in 13.4% of pts. The median time to first dose modification was 40.8 days (31.5-73.5) for the exp arm vs. 75.5 days (59.0-94.8) for the std arm (p=.0043). During cycle 5, the rate of any PN was 3.1% in the exp arm vs. 7.8% in the std arm. Compared to the std arm, the HR for dose modification was 5.4 in the exp arm (95% CI, 2.3-12.6, p<0.0001); none of the other pt or disease characteristics were significantly associated with dose modification of the tubulin inhibitors. PFS was significantly better in the exp arm and did not differ by PN status (Figure). Conclusions The rate of dose modifications for PN was consistent with protocol-specified dose modification among children and adolescents treated with known tubulin inhibitors as part of a multi-drug regimen for high risk HL. The strategy to preserve Bv dose in the experimental arm was successful. Overall rates of PN were substantially lower than previously reported in adults treated with Bv. While there were no significant differences in the rate of PN between study arms, we found shorter median time to dose modification in the exp arm, corresponding to the second treatment cycle, as compared to the 3rd cycle for the std arm. Despite dose modifications of vincristine and Bv as management strategies for PN in the experimental arm, patients treated with Bv-AVEPC had superior disease control in children with high-risk HL. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Early reattenders to the paediatric emergency department: A prospective cohort study and multivariate analysis.

The rate of unplanned reattendances is used as an indicator of the quality of care delivered in a paediatric emergency department (PED). With early reattendance in the UK well above the national target of 1-5%, we aimed to identify the factors which predict unplanned early reattendance to the PED. This is a prospective, single-centre cohort study undertaken over 12 months. Data were collected on all patients who reattended the PED within 7 days of their initial visit as well as for a comparative cohort of patients with no visit in the preceding or subsequent 7 days. Multiple patient and departmental variables were recorded and analysed using a multivariate regression model. There were a total of 19 420 index visits to the PED, of which 1461 patients had an unscheduled reattendance within 7 days - a rate of 7.5%. Factors associated with unplanned but related reattendance include young age and diagnosis with a respiratory or other medical illness. Interestingly, the grade of clinician appeared to be relevant with patients seen by junior members of the medical team less likely to reattend. Acuity of illness was not a significant factor. A substantial number of unplanned early reattenders (36.3%) would have been missed had a time period of 72 h been used rather than 7 days. This study identifies the typical patient who will have an unplanned, related early reattendance to a PED. This study also supports the use of a 7-day time period when using early reattendance as a performance indicator.

An investigation into the reliability of a mobile app designed to assess orthodontic treatment need and severity

Aim To investigate reliability of the Easy IOTN app between clinicians with different levels of experience in determining Index of Orthodontic Treatment Need (IOTN) Dental Health Component (DHC) and Aesthetic Component (AC) scores from study models. The accuracy of each clinician in discriminating treatment need using the app against the 'gold standard' conventional assessment at the threshold of treatment acceptance criteria was also explored.Materials and methods In total, 150 sets of pre-treatment study models were assessed by six clinicians using the app on two separate occasions (T1 and T2). A single IOTN-calibrated clinician also scored the models using the conventional technique. Clinician scores for both intra- and inter-rater reliability were assessed using Cohen's Kappa. The performance of each clinician in discriminating treatment need using the app against the conventional assessment method at the threshold of treatment acceptance criteria was also assessed using the area under the curve-receiver operating characteristic.Results The intra-rater agreement for the clinician undertaking the conventional assessment of the models was 1.0. Intra-rater agreement scores for clinicians using the Easy IOTN app ranged between 0.37-0.87 (DHC) and 0.22-0.44 (AC). Inter-rater agreement scores at T2 were 0.59 (DHC) and 0.23 (AC). Based on the IOTN DHC, all clinicians displayed an excellent level of accuracy in determining malocclusions qualifying for treatment (range 81.7-90.0%). Based on the IOTN AC, all clinicians showed an acceptable level of accuracy in determining malocclusions qualifying for treatment (range 71.9-79.2%).Conclusions The Easy IOTN app was shown to have moderate inter-rater reliability. Variation in the intra-rater reliability was evident between clinicians of different grades/level of experience. Importantly, the diagnostic accuracy of the app to discriminate between malocclusions that qualify for NHS treatment was rated as excellent (IOTN DHC) and acceptable (IOTN AC) and independent of clinician grade or level of experience.

Improving operative documentation in colorectal cancer surgery: synoptic notes pave the way forward.

Synoptic operative reports may improve reporting of key operative information. This study aimed to compare information included in synoptic reports with narrative notes following the introduction of a synoptic reporting system at a tertiary colorectal cancer referral centre. A standardized synoptic template incorporating the operative fields in the Australasian Bi-National Colorectal Cancer Audit (BCCA) was introduced for colorectal cancer surgery at the host institution in 2017. Colorectal cancer patients were identified from a prospectively collected database to collate samples of synoptic and narrative operative reports for comparison. The primary outcome was reporting of colon and rectal cancer-specific quality measures. Synoptic reporting of quality measures by clinician grade and uptake of synoptic reporting were also measured. Five hundred and ninety-five operative reports were reviewed; 84% of all quality measures were included in synoptic reports and 43% in narrative reports describing colon cancer surgery (P<0.001). Synoptic reports describing rectal cancer surgery included 84% of quality measures with 40% reported in narrative reports (P<0.001). Reporting for most individual quality measures did not change depending on clinician experience. Synoptic reporting methods were used to document 80% of all colon cancer surgery and 84% of rectal cancer surgery. Synoptic operative reports were superior to narrative reports in documenting quality measures. Synoptic reporting facilitates simultaneous data capture and bulk upload for audits including the BCCA. Development of synoptic operative reports standardized across Australasian colorectal cancer centres should be further investigated as a tool to facilitate collaborative audit and research.

Integrated approach to collecting patient reported toxicities in a colorectal cancer trial.

51 Background: Understanding the toxicities experienced by patients treated with advanced CRC is critical when considering appropriate dose modifications, standard drug dosing, and quality of life. A workflow that makes available Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) to clinicians to inform overall toxicity assessment should be easy to use and focus on clinically relevant issues. The value of a system that not only collects PRO-CTCAE but integrates it with clinician grading to inform overall symptomatic adverse event assessment during clinical trials is unclear. Methods: Patients were simultaneously enrolled in a phase II multi-center clinical trial that evaluated a genotype-guided dosing strategy for irinotecan by prospectively analyzing efficacy in 100 mCRC patients receiving FOLFIRI (5-fluorouracil, leucovorin, irinotecan) and bevacizumab. On day 1 and day 15 of each cycle patients provided PRO-CTCAE responses on 13 symptoms (26 questions) which were made available to clinicians at the time of their toxicity assessment. Descriptive statistics were used to summarize patient demographic and clinical characteristics. Concordance was defined as both patient and clinician giving the same response (both positive or both negative). Results: 100 patients participated in the study, of which 48% were female and 83% White. Overall, 96% of both patients and providers completed at least 80% of PRO-CTCAE forms available to them, demonstrating the feasibility of an integrated workflow for patient-clinician toxicity grading. Across all symptoms, concordance was high (73%) for the patient and provider reporting severe symptoms. 39% of patient-provider pairs reported at least 1 severe symptom and 34% of pairs never reported a severe symptom. In 23% of pairs the patient reported a severe symptom and the provider never did, and in 3% of pairs, the provider reported a severe symptom, but the patient never did. On the symptom level, the concordance was highest (&gt;90%) for dysphagia and vomiting, and lowest (74-82%) for abdominal pain, fatigue, and pain. 52 patients required dose decreases, with the first decrease most often due to hematologic toxicity (80%). In 46% of cases the patient reported at least one severe toxicity prior to or on the same day as the dose decrease, compared to 19% of cases where the provider reported at least severe toxicity prior to or on the same day as the dose decrease. Conclusions: A workflow that brings patient-reported toxicity to clinicians at the time of clinical toxicity rating is feasible. Nevertheless, discordance continues to exist between patient-reported and clinician-reported toxicity ratings, consistent with prior research. Further research could formally compare concordance when using an integrated vs a non-integrated toxicity rating workflow and could ascertain the reasons for continued discordance within an integrated workflow.

OCT Assisted Quantification of Vitreous Inflammation in Uveitis.

PurposeVitreous haze (VH) is a key marker of inflammation in uveitis but limited by its subjectivity. Optical coherence tomography (OCT) has potential as an objective, noninvasive method for quantifying VH. We test the hypotheses that OCT can reliably quantify VH and the measurement is associated with slit-lamp based grading of VH.MethodsIn this prospective study, participants underwent three repeated OCT macular scans to evaluate the within-eye reliability of the OCT vitreous intensity (VI). Association between OCT VI and clinical findings (including VH grade, phakic status, visual acuity [VA], anterior chamber cells, and macular thickness) were assessed.ResultsOne hundred nineteen participants were included (41 healthy participants, 32 patients with uveitis without VH, and 46 patients with uveitis with VH). Within-eye test reliability of OCT VI was high in healthy eyes and in all grades of VH (intraclass correlation coefficient [ICC] > 0.79). Average OCT VI was significantly different between healthy eyes and uveitic eyes without and uveitic eyes with VH, and was associated with increasing clinical VH grade (P < 0.05). OCT VI was significantly associated with VA, whereas clinical VH grading was not. Cataract was also associated with higher OCT VI (P = 0.03).ConclusionsOCT VI is a fast, noninvasive, objective, and automated method for measuring vitreous inflammation. It is associated with clinician grading of vitreous inflammation and VA, however, it can be affected by media opacities.Translational RelevanceOCT imaging for quantifying vitreous inflammation shows high within-eye repeatability and is associated with clinical grading of vitreous haze. OCT measurements are also associated with visual acuity but may be affected by structures anterior to the acquisition window, such as lens opacity and other anterior segment changes.

Recognition and Management of Button Battery Ingestion Amongst Emergency Practitioners.

IntroductionButton battery ingestion (BBI) carries a significant risk of morbidity and mortality. We conducted a regional analysis following an NHS England national patient safety alert to evaluate the knowledge base in the emergency management of BBI amongst emergency practitioners.MethodsA ten-point questionnaire was distributed electronically and in hardcopy formats to emergency departments across 15 hospitals within the West Midlands, United Kingdom. The questionnaire assessed participants’ knowledge of emergency management of BBI. The effect of clinician grade and previous otorhinolaryngology experience on knowledge scores was evaluated.ResultsA total of 176 responses were received from 11 hospitals. A small proportion (18%) were aware of a local department protocol. The majority of participants (70%) routinely screened for a button battery in their history taking. Our findings highlighted a lack of awareness of the timeframe for mucosal injury, potential complications, radiological signs, and the necessity for immediate retrieval. The median knowledge score was 18.8% (IQR=12.5-31.3%). Both registrars and consultants scored the highest (median 25%). Previous otorhinolaryngology experience was associated with a higher median score (P=0.002).ConclusionOur multi-center regional emergency medicine analysis demonstrated knowledge deficiency in the initial assessment and management of BBI. A high index of suspicion for button battery ingestion is needed. In view of the time-critical nature of button battery impaction in the esophagus, a “golden hour” concept should be integrated into acute management pathways with the early involvement of otorhinolaryngologists.

1434 An Audit of Surgical Consent Standards in Patients Undergoing Elective ENT Surgery

AimGood Surgical Practice (RCS England) and GMC guidelines inform a surgeon’s practice in the consent process for an operation. Since the Covid-19 pandemic, many surgical departments have converted from face-to-face to telephonic consultations. The clinic letter is of increased importance given that it forms a key part of the medical record which the patient should receive to ensure sufficient time and information to make an informed decision.MethodClinic letters of patients undergoing elective ENT surgery at our trust over a four-week period were examined in this retrospective audit of compliance with RCSEng and GMC guidelines. Additional data was collected on clinician grade and proportion of letters sent to patients. Patients rated satisfaction with consultation on a five-point Likert scale.Results135 eligible patients were included in our audit and the majority were listed by a consultant (57%). In all domains, consultant letters were more likely to be comprehensive as compared to registrars. Overall quality of clinic letters was highly variable regarding documentation of diagnosis (52%), surgical risks (50%), discussion of alternative or no treatment (30%) and registrar discussion with consultant (31%). There was also a stark difference between registrars and consultants sending patients copies of clinic letters (10% vs 47%). Only 10% of patients received a leaflet on their condition. 90% of patients were either satisfied or very satisfied with their clinic consultation.ConclusionsRefresher sessions on consent, updated template letters and increased provision of patient information leaflets will be introduced to the ENT department, and improvements monitored with further re-audit.

Virtual phone clinics in orthopaedics: evaluation of clinical application and sustainability

AimsAdoption of virtual clinics has been accelerated by the COVID-19 pandemic and they will continue to form an integral part of healthcare delivery. Our objective was to evaluate virtual clinics...

Management of sport-related concussion in emergency departments in England: a multi-center study

ABSTRACT Objective: To establish the current knowledge of sport-related concussion (SRC) management of clinicians in emergency departments in the North West of England. Methods: A cross-sectional, multi-center study design was used and included emergency department clinicians (EDCs) across 15 centers in the North West of England. A 22-question survey was issued with questions focused on the 5th International Conference on Concussion Consensus Statement. Absolute and percentages were presented, and comparisons in knowledge of guidelines and confidence between EDCs were made using the Kruskal-Wallis test. Results: Of an estimated 300 EDCs, 111 (37%) responded. Thirty (27%) were aware of the guidelines, whilst 63 (57%) had heard of a graduated return-to-sport protocol. Physical rest was advised by 106 (95%) respondents, with 68 (61%) advising cognitive rest and 47 (42%) providing written advice. There was no difference (p > .05) in awareness of SRC guidelines or confidence between clinician grade, with most receiving no SRC training. Conclusions: There is a lack of knowledge amongst EDCs in the North West of England in managing and providing discharge advice to patients with SRC. This is likely due to the limited awareness of guidelines and training, and therefore further education delivery on SRC management guidelines is required.

Semi-supervised generative adversarial networks for closed-angle detection on anterior segment optical coherence tomography images: an empirical study with a small training dataset.

BackgroundSemi-supervised learning algorithms can leverage an unlabeled dataset when labeling is limited or expensive to obtain. In the current study, we developed and evaluated a semi-supervised generative adversarial networks (GANs) model that detects closed-angle on anterior segment optical coherence tomography (AS-OCT) images using a small labeled dataset.MethodsIn this cross-sectional study, a semi-supervised GANs model was developed for automatic closed-angle detection training on a small labeled and large unsupervised training dataset collected from the Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong (JSIEC). The closed-angle was defined as iris-trabecular contact beyond the scleral spur in AS-OCT images. We further developed two supervised deep learning (DL) models training on the same supervised dataset and the whole dataset separately. The semi-supervised GANs model and supervised DL models’ performance were compared on two independent testing datasets from JSIEC (515 images) and the Department of Ophthalmology (84 images), National University Health System, respectively. The diagnostic performance was assessed by evaluation matrices, including the accuracy, sensitivity, specificity, and area under the receiver operating characteristic curve (AUC).ResultsFor closed-angle detection using clinician grading of AS-OCT imaging as the reference standard, the semi-supervised GANs model showed comparable performance, with AUCs of 0.97 (95% CI, 0.96–0.99) and 0.98 (95% CI, 0.94–1.00), compared with the supervised DL model (using the whole dataset) [AUCs of 0.97 (95% CI, 0.96–0.99), and 0.97 (95% CI, 0.94–1.00)]. When training on the same small supervised dataset, the semi-supervised GANs achieved performance at least as well as, if not better than, the supervised DL model [AUCs of 0.90 (95% CI: 0.84–0.96), and 0.92 (95% CI, 0.86–0.97)].ConclusionsThe semi-supervised GANs method achieves diagnostic performance at least as good as a supervised DL model when trained on small labeled datasets. Further development of semi-supervised learning methods could be useful within clinical and research settings.Trial registration numberChiCTR2000037892.

Patient experience of early high grade symptomatic adverse events on early phase clinical trials using the PRO-CTCAE.

12051 Background: There are limited data describing the patients’ experience of symptomatic adverse events (syAEs) on early phase clinical trials. This information is critical to understand the tolerability of experimental agents. The patient reported outcome version of the CTCAE (PRO-CTCAE) evaluates syAE components such as severity and interference in daily life. The aim of this study was to correlate clinician reported early, high grade (grade 3-4) AEs with patients’ reported experience of these toxicities. Methods: Advanced solid tumor patients (pts) enrolled on early phase clinical trials at Princess Margaret Cancer Centre were surveyed electronically using the full library of 78 items for PRO-CTCAE v1.0, which was administered at baseline (prior to therapy), mid-cycle 1, and mid-cycle 2. AEs on study were recorded by physicians using the CTCAE v4.0. Worst responses for severity items are ‘severe’ and ‘very severe’ and for interference items are ‘quite a bit’ and ‘very much’. A logistic regression model was used to assess the association between CTCAE grade and PRO-CTCAE severity and interference. Results: A total of 292 pts were approached in phase 1 clinics from May 2017 to January 2019, and 219 pts were included in the analysis: median age 60 years (range 18-82), 111 (51%) were male; all were ECOG ≤1. A total of 140 pts (64%) received combination therapy (immunotherapy and targeted therapy), and 73 pts (33%) had received ≥3 previous lines of treatment. In terms of patient reported syAEs, a total of 114 pts (52%) reported a symptomatic AE as either severe or very severe at any timepoint and 79 pts (36%) reported a syAE with an interference that was either ‘quite a bit’ or ‘very much’. With regards to clinician reported AEs, a total of 82 pts (37%) had a clinician reported grade 3 or 4 syAE, and of these 34 pts (41%) reported these as either severe or very severe; and 26 pts (32%) found these AEs interfered with daily life either ‘quite a bit’ or ‘very much’. Additionally 137 pts (66%) had a clinician reported grade 1 or 2 syAE, and of these 39 pts (28%) reported these as either severe or very severe; and 19 (14%) found these AEs interfered with daily life either ‘quite a bit’ or ‘very much’. Higher grade clinician reported syAEs (CTCAE grade 3-4 vs 1-2) was associated with higher patient reported severity levels (odds ratio, OR = 1.78, 95% CI 1-3.16, p = 0.049), and was associated with higher patient reported interference levels (OR = 2.88, 95% CI 1.47-5.64, p = 0.002). Conclusions: A majority of patients had a very negative experience of syAEs on a phase I trial. Higher grades of clinician reported AEs correlated with greater severity and interference with daily living. Future phase I studies could incorporate the PRO-CTCAE and other PRO tools which could inform the tolerability of experimental regimens and enhance the description of symptomatic AEs.

467 Impact of the Coronavirus Pandemic on Acute Surgical Patients’ Discharge Summaries

BackgroundThe emergence of the Coronavirus pandemic has placed increased demands on the NHS workforce, especially in medical and intensive care units. The subsequent redistribution of surgical house officers to accommodate this in a single centre has possibly negatively impacted on the effective discharge notification of acute surgical patients.Methods:Discharge summaries of all patients discharged from a Surgical Assessment Unit were collected and analysed, to identify the date of completion and grade of responsible clinician. Data collection was carried out over three weeks before the initiation of lockdown measures and continued for a further three weeks during the peak of the Coronavirus pandemic with a three-week interventional period in between.ResultsIn the initial audit, 36.2% of the 246 patients had delayed discharge summaries with an average of 7 days to complete. On re-evaluation, 45.3% of the 223 patients had delayed discharge summaries, with an average of 12 days to complete. A survey conducted post-re-audit identified that the most common reason for this was due to time constraints.ConclusionsThe reallocation of surgical staff has affected communication between primary and secondary care. Given the potential repercussions of these delays, healthcare systems should be made aware of this consequence, especially in preparation for any future resurgences.

Effect of human acellular dermal matrix (Megaderm™) on infra-auricular depressed deformities, Frey's syndrome, and first bite syndrome following parotidectomy: a multi-center prospective study.

Parotidectomy is the primary treatment for parotid gland tumors. However, complications may include a prominent facial scar or infra-auricular depressed deformity, Frey's syndrome, first bite syndrome, or other facial pain, numbness, and paralysis. Acellular dermal matrix (ADM) has been widely used to prevent these complications in parotid surgery, but there have been no prospective, multi-center trials documenting its efficacy. This study evaluates the effectiveness of ADM implantation in preventing infra-auricular depressed deformity, Frey's syndrome and first bite syndrome after parotidectomy. We analyzed 51 cases of standard parotidectomy and 58 cases of parotidectomy with implantation of Megaderm™ ADM through prospective multicenter trial. Acute complications including infection, seroma, hematoma, skin necrosis, and acute parotid area pain were evaluated 1 week postoperatively. Clinician grading of Frey's syndrome and blinded clinician evaluation of infra-auricular depressed deformities were conducted at 3, 6, and 12 months. Patients evaluated subjective satisfaction with neck appearance, Frey's syndrome quality, and acute parotid area pain at 3, 6, and 12 months. There was a higher incidence of seroma in the Megaderm™ group than in the control group at week 1. The incidence and total clinician-evaluated Frey's syndrome scores were significantly lower in the Megaderm™ group than in the control group at 3, 6, and 12 months. Both the objective and subjective evaluations of the facial contour showed a better outcome in the Megaderm™ group compared to the control group at 3, 6, and 12 months. There were no significant differences between the groups in the patient-reported Frey's syndrome quality scores at 3, 6, and 12 months, but the Megaderm™ group reported significantly less acute pain than the control group. ADM implantation can effectively reduce the occurrence of Frey's syndrome, infra-auricular depressed deformity, and first bite syndrome after parotidectomy. ADM may be especially advantageous in complex parotidectomy cases when significant complications are expected.

Noninvasive Instrument-based Tests for Detecting and Measuring Vitreous Inflammation in Uveitis: A Systematic Review

ABSTRACT Purpose This systematic review aims to identify instrument-based tests for quantifying vitreous inflammation in uveitis, report the test reliability and the level of correlation with clinician grading. Methods Studies describing instrument-based tests for detecting vitreous inflammation were identified by searching bibliographic databases and trials registers. Test reliability measures and level of correlation with clinician vitreous haze grading are extracted. Results Twelve studies describing ultrasound, optical coherence tomography (OCT), and retinal photography for detecting vitreous inflammation were included: Ultrasound was used for detection of disease features, whereas OCT and retinal photography provided quantifiable measurements. Correlation with clinician grading for OCT was 0.53–0.60 (three studies) and for retinal photography was 0.51 (1 study). Both instruments showed high inter- and intra-observer reliability (>0.70 intraclass correlation and Cohen’s kappa), where reported in four studies. Conclusion Retinal photography and OCT are able to detect and measure vitreous inflammation. Both techniques are reliable, automatable, and warrant further evaluation.

Closed reduction of glenohumeral dislocations with associated tuberosity fracture in the emergency department is safe

AimA fracture of the tuberosity is associated with 16% of glenohumeral dislocations. Extension of the fracture into the humeral neck can occur during closed manipulation, leading some to suggest that all such injures should be managed under general anaesthesia in the operating theatre. The purpose of this study was to establish the safety of reduction of glenohumeral dislocations with tuberosity fractures in the emergency department (ED). Patients and methodsWe reviewed 188 consecutive glenohumeral dislocations with associated tuberosity fractures identified from a prospective orthopaedic trauma database. Patient demographics, injury details, emergency department management and complications were recorded. The method of reduction, sedation, grade of clinician and outcome were documented. ResultsThe mean age was 61 years (range 18–96 years) with 79 males and 109 females. The majority of injuries (146, 78%) occurred after a fall from standing height. Closed reduction under sedation in the ED was successful in 162 (86%) cases. Of the remainder, 22 (11%) failed closed reduction under sedation and subsequently went to theatre and 6 (3%) were deemed not suitable for ED manipulation. At presentation 35 (19%) patients had a nerve injury, of which 29 (90%) resolved spontaneously. Two iatrogenic fractures occurred during close manipulation, one in the ED and the other in the operating theatre. Therefore, the risk of iatrogenic propagation of the fracture into the proximal humerus neck was 0.5% if the reduction was performed in the ED, and 1% over-all. More than two attempted reductions predicted a failed ED reduction (P = 0.001). ConclusionClosed reduction of glenohumeral dislocations with associated tuberosity fractures in the ED is safe, with a rate of iatrogenic fracture of 1%. These injuries should be managed by those with appropriate experience only after two adequate radiographic views. In cases where there is ambiguity over the integrity of the humeral neck, reduction should be delayed until multiplanar CT imaging has been obtained.