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result(s) for
"McGoran, John"
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Unusual cystic lesion adjacent to the stomach
by
McGoran, John J
,
Kadri, Sudarshan R
,
Sutton, Christopher D
in
Asymptomatic
,
Cardiomyopathy
,
Children
2020
Journal Article
Acceptability to patients of screening disposable transnasal endoscopy: qualitative interview analysis
2019
ObjectivesScreening in selected high risk populations for Barrett’s oesophagus (BO) and oesophageal varices (OVs) has been proposed, but there are obstacles with conventional oesophagogastroduodenoscopy (C-OGD), including patient acceptability. Portable and disposable office-based transnasal endoscopy (TNE) is a feasible and accurate alternative to C-OGD that may have use in primary and secondary care. This article outlines a qualitative analysis of patient experiences of TNE and C-OGD in order to gain an insight into an acceptable delivery of an endoscopic screening service.DesignPurposeful sampling identified 23 participants who then underwent semi-structured interviews to determine their experiences of both procedures. Thematic analysis was conducted to derive meaning from their lived experiences.SettingA secondary care endoscopy unit, clinic room and interview room.ParticipantsPatients referred for BO or OV surveillance and for endoscopy to investigate dyspepsia underwent unsedated TNE using the EG Scan II device followed by C-OGD with or without sedation (patient choice), as part of a clinical trial.ResultsThe themes that arose from our analysis were: inclusivity in one’s own healthcare, comfort level and convenience, validity of the procedure and application to a screening population and a sense of altruism and reciprocity. Positive aspects of TNE included participant empowerment, reduced discomfort and avoidance of conscious sedation. Participants felt that if TNE screening was of proven efficacy it would be welcomed, though views on use in a community setting were mixed.ConclusionsMost patients preferred TNE to unsedated C-OGD and the reasons they gave featured strongly in the emerging themes. Preferences between TNE and sedated C-OGD were more subtle, with equivalent comfort scores but merits and drawbacks of both being discussed. This information identifies opportunities and challenges in establishing an endoscopic screening service. Trial registration number ISRCTNregistry identifier: 70595405; Pre-results.
Journal Article
O55 Prospective evaluation of biomarker risk stratification using capsule sponge for surveillance of barrett’s oesophagus: results from uk real-world implementation pilots
2025
IntroductionEndoscopic surveillance is the standard of care for Barrett’s oesophagus (BO), but its effectiveness is inconsistent and operator-dependent. Pan-oesophageal cell collection devices with biomarkers provide patients with a less operator-dependent, cost-effective alternative. We previously developed a risk stratification score for capsule-sponge surveillance.1 Here, we prospectively evaluated this risk stratification tool in patients undergoing capsule-sponge triage to determine the timing of follow-up endoscopy. The aim of the study is to is to prospectively evaluate the accuracy of the risk stratification tool in patients undergoing capsule-sponge triage for BO surveillance.MethodsPatients were recruited from ten hospitals (DELTA study ISRCTN91655550, 2020-2022, and NHS England implementation study 2022–2024). We included patients with a history of BO who had capsule sponge and endoscopy follow-up with biopsies. All capsule sponge samples were processed centrally in an accredited laboratory (Cyted Medical), with positive biomarker results (p53, atypia) independently reviewed by two pathologists. Patients were assigned into one of three risk groups: low (clinical and sponge biomarkers negative), moderate (positive clinical biomarkers - age, sex and segment length), and high risk (positive sponge biomarkers- p53, atypia and atypia of uncertain significance (AUS)) (table 1, legend). Endoscopic follow-up intervals were guided by the risk result at a time interval directed by the clinician. The overall prevalence of dysplasia in the cohort and the prevalence of dysplasia for each risk category were calculated.Abstract O55 Table 1Demographics and histologic outcomes by capsule-sponge risk stratification categoryResults796 patients were included of which 415 (52.1%) were low, 253 (31.8%) moderate, and 128 (16.1%) were high-risk (table 1). Among the low-risk category, the prevalence of HGD, and any dysplasia was 0.7% (3/415), and 2.9% (12/415), respectively. No intramucosal or invasive OAC (≥T2) were detected in the low- or moderate-risk groups. The high-risk group was 4-fold enriched for any dysplasia: 38.3% (49/128) compared with the overall dysplasia detection rate of 9.8% (78/796). When both p53 and atypia were positive, 80.8% (21/26) had dysplasia, compared to single biomarker positivity of 44.4% (4/9) for p53 alone, and 66.7% (2/3) when atypia alone was positive. Among those with AUS, often linked to inflammation, 17.9% (4/67) had dysplasia.ConclusionThis large prospective study has shown that this risk stratification panel can accurately risk stratify patients undergoing BO surveillance with the low-risk group having <1% risk of HGD with no cases of missed OAC. This suggests that sponge-only surveillance is safe in low-risk patients, while positive high-risk biomarkers can successfully enrich for dysplasia and help direct resources towards patients at higher risk.ReferencePilonis ND, Killcoyne S, Tan WK, et al. Use of a cytosponge biomarker panel to prioritise endoscopic barrett’s oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot. The Lancet Oncology 2022.
Journal Article
Biomarker risk stratification with capsule sponge in the surveillance of Barrett's oesophagus: prospective evaluation of UK real-world implementation
by
Hill, Catherine
,
Mainie, Inder
,
Ross-Innes, Caryn S
in
Adenocarcinoma - diagnosis
,
Aged
,
Barrett Esophagus - diagnosis
2025
Endoscopic surveillance is the clinical standard for Barrett's oesophagus, but its effectiveness is inconsistent. We have developed a test comprising a pan-oesophageal cell collection device coupled with biomarkers to stratify patients into three risk groups. We aimed to prospectively evaluate the prespecified risk stratification tool to establish whether it can identify those at highest risk of dysplasia or cancer to prioritise the timing of endoscopy; and safely be used to follow up the low-risk group, thus sparing patients from unnecessary endoscopies.
Participants were recruited as part of two multicentre, prospective, pragmatic implementation studies from 13 hospitals in the UK. Patients with non-dysplastic Barrett's oesophagus had a capsule-sponge test which was assessed in an ISO-accredited laboratory. Patients were included if they were aged at least 18 years with a non-dysplastic Barrett's oesophagus diagnosis at their last endoscopy who were undergoing surveillance according to the published UK guidelines. Patients were assigned as low (clinical and capsule-sponge biomarkers negative), moderate (negative for capsule-sponge biomarkers, positive clinical biomarkers—age, sex, and segment length), or high risk (p53 abnormality or glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group assignment.
910 patients recruited between August, 2020, and December, 2024 participated, of whom 138 (15%) were classified as high risk, 283 (31%) moderate risk and 489 (54%) low risk. The positive predictive value for any dysplasia or worse in the high-risk group was 37·7% (95% CI 29·7–46·4). Patients with both atypia and aberrant p53 had the highest risk of high-grade dysplasia or cancer (relative risk 135·8 [95% CI 32·7–564·0] relative to the low-risk group). The prevalence of high-grade dysplasia or cancer in the low-risk group was 0·4% (95% CI 0·1–1·6); the negative predictive value for any dysplasia or cancer was 97·8% (95% CI 95·9–98·8). Applying a machine learning algorithm as part of a digital-pathology workflow reduces the proportion needing p53 pathology review to 32% without missing any positive cases.
The risk-panel substantially enriches for dysplasia and capsule-sponge-based surveillance could be used in low-risk Barrett's oesophagus in lieu of endoscopy.
Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance.
Journal Article
P235 Development and validation of the direct observation of barrett’s imaging/endotherapy skills (DOBES) assessment tools
2021
IntroductionEndoscopic resection (ER) and radiofrequency ablation (RFA) have become the standard of care worldwide for treatment of early Barrett’s neoplasia. Procedural outcomes are highly dependent on the operator skill and training. Validated tools for assessment of competency in these 2 procedures are currently lacking. We aimed to develop and validate ER and RFA tools for use in clinical practice.MethodsA working group of 15 experts who met one or more of the predefined inclusion criteria was set up. Using published evidence-based criteria, the group devised a structured checklist of graded competency descriptors (scores ranged from 1=required maximal supervision to 4=competent). The latter were grouped into four main competency domains, namely: pre-procedural; specific skills; post-procedural; and endoscopic non-technical skills (ENTS). Consensus agreement and piloting was undertaken to ensure content validity.Construct validity was measured by independent assessment of 60 videos per procedure of ER and RFA by 7 assessors (selected from the working group) in a random manner. Procedures were performed by 15 operators with variable expertise including experts and trainees. Statistical analysis was performed using Generalizability theory, which analysed ‘variability components’ between: operators; cases; assessors; assessors across (x) operators; and unexplained variation.ResultsData on a minimum of 45 videos per procedure were available for analysis. The mean (± standard deviation) competency scores were 3.4 (0.8) and 3.7 (0.6) for ER and RFA, respectively. The variability components for the analysis are detailed in table 1. Variation in scores between operators, assessors, and assessors across different operators was small accounting for <10% of the total variation suggesting good reliability. The majority of variance was explained by variation in cases or unexplained.Abstract P235 Table 1Variability components in assessment of construct validity of assessment tools using Generalizability theory Component ER RFA Variance Component % Variance Variance Component % Variance Operators (Vo) 1.1 x10–17 <0.1% 5.7 x10–14 <0.1% Cases (Vc:o) 0.282 45.0% 0.109 31.5% Assessors (Va) 0.052 8.3% 0.031 9.0% Assessors x operators (Vo:a) 0.055 8.7% (*) (*) Unexplained (Vca:o) 0.239 38.0% 0.206 59.5% (*) Unable to calculate due to model fitting problemsConclusionsThe DOBES assessment tools for ER and RFA appear to have good content and construct validity and were produced based on evidence and expert opinion. The analysis shows agreement on scores between expert assessors which strengthens the case for its adoption into clinical practice.
Journal Article
Initiation of subcutaneous infliximab (Remsima) therapy for the treatment of inflammatory bowel disease during the COVID-19 pandemic
by
Collins, Caroline
,
McErlain, Shannan
,
Morrison, Graham
in
Biological products
,
Coronaviruses
,
COVID-19
2022
Furthermore, immunogenicity data have suggested superior steady state therapeutic blood levels of IFX and lower rate of anti-IFX antibodies in a cohort of patients receiving SC Remsima following two intravenous induction doses in contrast to their counterparts who continued to receive intravenous therapy.1 2 In response to the challenges posed by the COVID-19 pandemic to patients with inflammatory bowel disease (IBD) receiving IFX, we embarked on a patient-partnered programme in switching to SC Remsima. The majority of adverse events related to injection site problems like pain and swelling, with at least 12 (29.3%) experiencing such issues. Besides concerns about injection site issues, suggestions for improvement focused on better interaction between healthcare provider and patient. Clear benefits of attending hospital were espoused by some respondents, from potentially obvious to the team: ‘I found the observations done before the IV very useful’; to more unique insights: ‘As someone who lives alone there was a ‘social’ element of hospital attendance’.
Journal Article
PTH-043 The accuracy of ultrathin endoscopy in the diagnosis of barrett’s oesophagus: systematic review and meta-analysis
by
Fernández-Sordo, Jacobo Ortiz
,
Caestecker, John SDe
,
Lovat, Laurence B
in
Accuracy
,
Barrett's esophagus
,
Clinical trials
2019
IntroductionScreening for Barrett’s oesophagus (BO) may be considered for those at high risk. Unsedated Ultrathin Endoscopy (UE) has been proposed as a more acceptable, cost-effective alternative to conventional oesophagogastroduodenoscopy (C-OGD) but individual studies on the diagnostic performance of UE are often underpowered. The pooled diagnostic accuracy of UE (via trans-nasal or trans-oral insertion route) for the diagnosis of BO in adult patients with upper GI symptoms was analysed in this meta-analysis.MethodsA systematic literature search and meta-analysis was performed of all primary studies comparing UE (index test) to C-OGD. Electronic databases were searched from 1980 to November 1st2018 and non-English language articles were excluded. We excluded studies where data on accuracy or BO presence were not extractable or if they used technology obsolete in current practice (fibreoptic and prototype models).Data extraction was undertaken by two reviewers independently of each other who then cross-checked the consistency of their findings. The quality of included studies was assessed using a validated tool (QUADAS-2). Heterogeneity was examined both by visual inspection of the Forest plots, and by statistical assessment using the chi square and inconsistency (I2 ) test. The bivariate model was used to obtain the estimates for accuracy. Data analysis was performed using Stata 12.1 software package (StataCorp, College Station, TX, USA).ResultsSeven studies including 613 patients met the inclusion criteria. The pooled sensitivity, specificity, and area under the curve (AUC) for the diagnosis of BO were 0.98 (95% confidence interval [CI] 0.84–1.00), 1.00 (95% CI 0.86–1.00) and 1.00 (95% CI 0.99–1.00) on a per-protocol analysis. There was significant heterogeneity between studies (I2= 0–95%; 95% CI 0–100). Success rate for both UE and C-OGD was lowest at 0.86 in a small study using unsedated trans-oral route, while all the other studies reported success rates ranging from 0.89 to 1.0 for UE (including unsedated trans-nasal route) and from 0.98 to 1.0 for SE. The majority (0.54–0.71) of patients preferred UE compared to C-OGD and said they were willing to have UE again in the future if necessary. The mean tolerability scores for unsedated UE were significantly better in 4 studies, similar in 1 and not reported in the others.Abstract PTH-043 Box 1Forest plot of trials including in meta-analysis.ConclusionsUnsedated UE is accurate in detecting BO and may be more acceptable to patients compared to C-OGD. However, there was significant heterogeneity across studies which limit the interpretation of the pooled results. This could have a bearing for future consideration of the value of Barrett’s screening but its utility warrants further evaluation.
Journal Article
PTH-030 Outcomes of hemospray use in peptic ulcer upper gastrointestinal bleeds: Outcomes from the hemospray registry
2019
IntroductionPeptic ulcers are the commonest cause of upper Gastrointestinal bleeding (UGIB). Hemospray (Cook Medical, North Carolina, USA) is a novel haemostatic powder aimed to treat UGIB. The aim of this study is to look at outcomes in patients with peptic ulcer GI bleeds treated with hemospray in 13 centres.MethodsData was prospectively collected on hemospray use in UGIBs in the UK, France and Germany (Jan’16-Sept’18). Hemospray was used for peptic ulcer UGIBs as a monotherapy, dual-therapy with standard haemostatic techniques or rescue therapy. Haemostasis was defined as cessation of bleeding within 5 minutes of hemospray application.Results196 patients with UGIBs secondary to peptic ulcers were recruited (133 M, 63 F, 123/196(63%) duodenal, 44/196(22%) gastric, 29/196(15%) oesophageal). Immediate haemostasis was achieved in 171/196(87%) patients. The median rockall score was 7 (IQR, 6–8).Rebleeding rates were significantly lower in forrest 2a relative to current predicted rebleeding rates based on forrest classifications, 2/21(10%, P<0.005). In the 25/196(13%) patients who did not achieve haemostasis 18/25 (72%) were Forrest 1b ulcers. In the total cohort, 33/169(20%) had a rebleed, median rockall score was 7(IQR,7–8).Outcomes with different Forrest classifications (table 1)Abstract PTH-030 Table 1 Forrest 1a (n=37) Forrest 1b(n=111) Forrest 2a (n=23) Forrest 2b(n=20) Haemostasis 31/37(84%) 93/111(84%) 23/23 (100%) 19/20(95%) Median Blatchford 13IQR: 11–14 12IQR:9–15 12IQR: 11–14 12IQR: 11–15 Median Rockall 7IQR: 6–8 7IQR:6–8 7IQR: 6–7 7IQR: 6–8 Rockall score 7 predicted re-bleeding rate: 25–40% Re-bleeding 8/31(26%) 19/94(20%) 2/21 (10%) 4/18(22%) Rockall score 7 predicted mortality: 20–30% 30-day mortality 9/31(29%) 21/94(22%) 3/21 (14%) 5/18(28%) ConclusionsHemospray is effective in achieving immediate haemostasis in peptic ulcer UGIBs. The baseline Blatchford/rockall scores in our cohort are high with patients recruited from tertiary centres with high-risk cases. The rebleeding and mortality rates are in keeping/below the predicted rate based on the scores. The best outcome with hemospray was with forrest 2a ulcers.
Journal Article
AWE-06 Outcomes of hemospray use in tumour related upper gastrointestinal bleeds: Outcomes from the hemospray registry
2019
IntroductionPatients with tumour related upper gastrointestinal bleeds (UGIBs) are challenging to treat. Hemospray (Cook Medical, North Carolina, USA) is a novel haemostatic powder for GI bleeding. The primary aim was to look at outcomes of UGIBs secondary to tumours who had Hemospray therapy in 13 centres.MethodsData was prospectively collected on the use of hemospray from specialist centres in the UK, France, Germany (Jan’16-September’18). Hemospray was used for UGIBs secondary to tumours as a monotherapy, dual-therapy with standard haemostatic techniques or rescue therapy. Haemostasis was defined as the cessation of bleeding within 5 minutes of the application of hemospray.Results75 patients with tumoural UGIBs were recruited (51 males, 24 females, 22/75 (29%) oesophageal, 49/75 (65%) gastric, 4/75 (5%) doudenal). The median rockall score was 8 (IQR,7–9).Immediate haemostasis was achieved in 73/75 (97%) of patients, 7/65 (11%) had a rebleed, 12/65 (18%) died within 30 days (all-cause mortality). Based on the baseline average total rockall score, the expected rebleed rate is 25–40%, and expected mortality rate was 40–45% in our cohort.100% immediate haemostasis was achieved in duodenal and gastric tumours, and 91% in oesophageal tumours.Outcomes with mono/combination therapy and rescue therapy (table 1)Abstract AWE-06 Table 1 Monotherapy (n = 51)Combination therapy (n = 17)Rescue Therapy (n=7) BlatchfordMedian10911 IQR7–127–1410–13RockallMedian887IQR7–97–94–7Haemostasis achieved51/51(100%)15/17(88%)7/7(100%)Rockall 7 and 8: Predicted rebleed rate: 25–40%Re-bleed4/44(9%)2/14(14%)1/7(14%)Rockall 7 predicted mortality rate: 20–30%Rockall 8 predicted mortality rate: 40–45%All cause 7-day mortality2/44(5%)0/140/7All cause 30-day mortality9/44(21%)3/14(21%)0/7ConclusionsHemospray is effective for achieving immediate haemostasis in UGIBs secondary to upper GI tumours, which are considered difficult to treat.When considering average rockall score the rebleed and mortality rate is better than predicted rates. Haemostasis is achieved in the majority allowing for patient stabilization and providing time for surgery/radiotherapy.
Journal Article