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Introduction

Patients with Barrett’s esophagus (BE) carry significant cancer worry, burden of symptoms, and lack disease specific knowledge. Currently there is no validated BE patient reported outcome measure (PROM) for use in clinical practice and research, hence we devised a novel, validated Barrett’s specific tool, B-PROM.

Aims & Methods

Literature review, quantitative and qualitative research informed the initial item generation(1,2,3). The item bank (49items) was refined to 31 items through an online modified Delphi process involving patients, patient representatives and clinicians. The PROM was then tested through rounds of cognitive interviews and validated via multicentre testing across four UK hospitals.

Results

B-PROM covers key themes of disease-specific knowledge, trust in clinicians, burden of symptoms, cancer worry and burden of surveillance.
During the modified Delphi process, out of the 49 items, 24 reached consensus and were kept unchanged. 14 were borderline or needed rewording were revised with acknowledgement of comments from the Delphi group. Nine items were merged with other items. Two items which were clearly not favoured by the group were reviewed and removed from the draft PROM. After round 2, a further 8 items achieved consensus, the other items did not achieve consensus and final agreed items were reviewed by the steering group.
Cognitive interviews to refine the PROM tool to confirm patients comprehension resulted in changes to the formating of the knowledge section responses, and rewording of some items to more lay appropriate language.
Multicentre validation results from 387 participants (response rate 40.8%) showed 93.3% of participants completed >95% of B-PROM. All individual items scored a completion rate of >95%. Mean completion time was 5mins 34s for a sample group. Nineteen items showed a ceiling effect, 3 items showed a floor effect. Internal consistency overall demonstrated a Cronbach Alpha of 0.846, while predetermined subsections showed Cronbach alphas of 0.335, 0.718, 0.736, and 0.896.
Inter-item analysis found 2 pairs of items with strong correlation, with only 6 items correlating weakly. Item-total correlation showed 19 items correlated well. EFA with principal component analysis produced 5 components with Eigenvalues >1 of which 4/5 had satisfactory Cronbach alphas. Test-retest reliability showed no significant differences across single and average measures (p=<0.001).

Conclusion

B-PROM is the first BE-specific PROM to be systematically evaluated. B-PROM’s psychometric properties show strong internal consistency and low missingness, it covers the important priorities of BO patients found at systematic review of qualitative research. B-PROM is ready for use in clinical trials and clinical practice.

References

1) Britton J, Hamdy S, McLaughlin J, Horne M, Ang Y. Barrett’s oesophagus: A qualitative study of patient burden, care delivery experience and follow-up needs. Health expectations : an international journal of public participation in health care and health policy. 2019;22(1):21-33. doi:10.1111/hex.12817
2) Britton J, Taxiarchi P, Martin G, et al. Comparative quantitative survey of patient experience in Barrett’s oesophagus and other gastrointestinal disorders. BMJ open gastroenterology. 2020;7(1):e000357. doi:10.1136/bmjgast-2019-000357
3) Britton J, Keld R, Prasad N, Hamdy S, McLaughlin J, Ang Y. Effect of diagnosis, surveillance, and treatment of Barrett’s oesophagus on health-related quality of life. The Lancet Gastroenterology and Hepatology. 2018;3(1):57-65. doi:10.1016/S2468-1253(17)30213-3

Disclosure

YA has received funding from cancer research UK and Medtronic Ltd.
ER has received research funding from Medtronic UK for this project

B-PROM: DEVELOPMENT AND VALIDATION OF A NOVEL BARRETT’S OESOPHAGUS PATIENT REPORTED OUTCOME MEASURE

Elizabeth Ratcliffe 1, James Britton 2, Sharon Baines 2, neeraj prasad 1, Richard Keld 1, Mark Murgatroyd 3, Miguel Montenegro 4, Elaine Viloria 4, John McLaughlin 5, Shaheen Hamdy 6, Yeng Ang 7

1 Wrightington Wigan and Leigh NHS Trust, Wigan, United Kingdom

2 Northern Care Alliance Salford, Salford, United Kingdom

3 NHS, Manchester, United Kingdom

4 Imperial College Hospitals, London, United Kingdom

5 University of Manchester Salford Royal Hospital Gastrointestinal Centre, Manchester, United Kingdom

6 Salford Royal Hospital, Salford, United Kingdom

7 Salford Royal NHS Foundation, Salford, United Kingdom

Conference

UEG Week Copenhagen 2023

Topics

Oesophagus

Submission format

Abstract

Session

PP 01 Oesophageal, gastric and duodenal disorders (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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EXOPHIALA DERMATITIDIS EXACERBATES COLITIS THROUGH THE SYK-CARD9 SIGNALING PATHWAY

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Introduction

As a small but important component of the intestinal microbiota, the fungal community (mycobiota) has received increasing attention for its involvement in the pathogenesis of Crohn's disease (CD)¹. In our previous study, we identified a significantly increased relative abundance of Exophiala dermatitidis (E. dermatitidis) in the gut of patients with CD, particularly those with active disease². Caspase recruitment domain family member 9 (CARD9), a key adaptor molecule in antifungal immune responses³, has also been strongly associated with CD susceptibility⁴. In this study, we aimed to explore the potential role and underlying mechanisms of E. dermatitidis in intestinal inflammation.

Aims & Methods

To evaluate the impact of E. dermatitidis on intestinal inflammation, we generated Card9-knockout (KO) (Card9^-/-) mice and constructed a dextran sulfate sodium (DSS)-induced colitis model colonized by E. dermatitidis. The underlying molecular mechanisms were investigated by a range of biochemical approaches. Flow cytometry was performed to analyze the proportions of myeloid cells, including CX3CR1⁺ macrophages, in the colonic lamina propria (LP).

Results

Compared to mice with DSS-induced colitis alone (WT-DSS group), the DSS-treated mice colonized by E. dermatitidis (WT-DSS + Ed group) showed a significant weight loss, a worsening of disease activity, a shorter length of the large intestine, and more severe intestinal inflammation characterized by increased inflammatory cell infiltration and crypt destruction in the histological examination of colon hematoxylin and eosin (H&E) staining. Card9^-/- mice were used to further investigate whether E. dermatitis-mediated inflammation was dependent on the CARD9 signaling pathway. We observed that CARD9 deficiency protected against E. dermatitidis-exacerbated colitis, as measured by a higher trend of body weight, longer colon lengths, and amelioration of disease activity in the KO-DSS + Ed group. In addition, flow cytometric analysis of the colonic lamina propria revealed a higher percentage proportion of CX3CR1+ macrophages in the WT-DSS + Ed group and a markedly reduced proportion in the KO-DSS + Ed group. Furthermore, we identified the Mincle-Syk-CARD9-nuclear factor kappa-B (NF-κB) signaling pathway as playing an important role in mediating the inflammatory immune responses to E. dermatitidis.

Conclusion

E. dermatitidis exacerbates the DSS-induced colitis in mice through the Mincle-Syk-CARD9-NF-κB pathway with the participation of CX3CR1+ macrophages, providing a novel therapeutic strategy for CD targeting specific intestinal fungi.

References

1. Sokol H, Leducq V, Aschard H, et al. Fungal microbiota dysbiosis in IBD. Gut 2017;66:1039-1048.
2. Zeng L, Feng Z, Zhuo M, et al. Fecal fungal microbiota alterations associated with clinical phenotypes in Crohn's disease in southwest China. PeerJ 2022;10:e14260.
3. Hu A, Hu Z, Zou H, et al. CARD9 in host immunity to fungal, bacterial, viral, and parasitic infections: An update. Frontiers In Microbiology 2022;13:1021837.
4. Franke A, McGovern DPB, Barrett JC, et al. Genome-wide meta-analysis increases to 71 the number of confirmed Crohn's disease susceptibility loci. Nature Genetics 2010;42:1118-1125.