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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

Affiliations

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

Summary

AI Generated

B-PROM is the first systematically validated Barrett's esophagus-specific patient reported outcome measure, developed through modified Delphi consensus and multicentre testing, covering disease knowledge, symptom burden, cancer worry, and surveillance burden.

B-PROM was developed from an initial 49-item bank refined to 31 items through online modified Delphi process involving patients, patient representatives, and clinicians, followed by cognitive interviews and multicentre validation across four UK hospitals.
The tool covers five key themes: disease-specific knowledge, trust in clinicians, burden of symptoms, cancer worry, and burden of surveillance.
Multicentre validation with 387 participants (40.8% response rate) showed 93.3% completed over 95% of the tool, with mean completion time of 5 minutes 34 seconds and all individual items achieving over 95% completion rate.
Psychometric testing demonstrated strong internal consistency with overall Cronbach Alpha of 0.846, low missingness, satisfactory test-retest reliability (p less than 0.001), and exploratory factor analysis producing five components.
The authors conclude B-PROM is ready for use in clinical trials and clinical practice as the first Barrett's esophagus-specific PROM to be systematically evaluated.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

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

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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RAPID ONSET OF ACTION OF USTEKINUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (RAUCU STUDY)

Iria Bastón-Rey 1,2, María García-Alvarado 3, Natalia Garcia Morales 4,5, Brais Fernández Suárez 6, Irene Latras Cortés 7, Rocío Ferreiro-Iglesias 1,2, Javier Santos Fernández 8, Coral Tejido Sandoval 9, Maria Teresa Vázquez Rey 10, Francisco Javier Garcia-Alonso 11, Alberto Guerrero Montañés 12, Gema Molina Arriero 13, Benito Velayos Jiménez 14, Maria Jesús Ruiz Barcia 15, Mercedes Ibáñez García 16, María del Sol Porto-Silva 2, Laura Tejerizo García 3, Patricia Ucha Abal 4,5, Eva Marti Marques 6, Laura Nieto-Garcia 2, María García-Alvarado 3, Jose Fernando Muñoz Nuñez 3, Manuel Barreiro de Acosta 17,2

Affiliations

1 University Hospital of Santiago de Compostela, Santiago de Compostela, Spain

2 Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain

3 University Hospital of Salamanca, Salamanca, Spain

4 University Hospital of Vigo CHUVI, Vigo, Spain

5 Galicia Sur Health Research Institute ISS Galicia Sur, Vigo, Spain

6 University Hospital Lucus Augusti, Lugo, Spain

7 University Hospital of León, León, Spain

8 Hospital Río Carrión, Palencia, Spain

9 University Hospital of Ourense CHOU, Ourense, Spain

10 University Hospital of A Coruña CHUAC, A Coruña, Spain

11 University Hospital Río Hortega, Valladolid, Spain

12 Hospital Virxe da Xunqueira, Cee, Spain

13 University Hospital of Ferrol CHUF, Ferrol, Spain

14 University Hospital of Valladolid HCUV, Valladolid, Spain

15 Hospital da Costa, Burela, Spain

16 Hospital Medina del Campo, Valladolid, Spain

17 University Hospital of Santiago, Santiago de Compostela, Spain