Development and validation of a novel Barrett's oesophagus patient reported outcome measure (B-PROM).
Barrett's oesophagus
Cancer
Endoscopy
Health related quality of life
Patient reported outcome measures
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Jun 2024
Jun 2024
Historique:
received:
09
08
2023
revised:
28
03
2024
accepted:
04
04
2024
medline:
15
5
2024
pubmed:
15
5
2024
entrez:
15
5
2024
Statut:
epublish
Résumé
Patients with Barrett's oesophagus (BO) carry significant cancer worry, burden of symptoms, and lack disease-specific knowledge. Currently there is no validated BO patient reported outcome measure (PROM) to measure these factors for use in clinical practice and research, hence the aim of this study was to devise a novel, validated BO-specific tool, B-PROM. Literature review, quantitative and qualitative research informed the initial item generation. The item bank was refined through a modified Delphi process between May and August 2021. The PROM was then tested through cognitive interviews and validated via multicentre testing between September 2021 and February 2023 with the aim to create a succinct tool which addresses the key important factors to BO patients and has strong psychometric properties. B-PROM covers key themes of disease-specific knowledge, trust in clinicians, burden of symptoms, cancer worry and burden of surveillance. 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 5 mins 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. Exploratory Factor analysis (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). B-PROM is the first BO-specific PROM to be systematically evaluated. Validation findings show strong internal consistency, short completion time, low missingness and excellent test-retest reliability. Medtronic Limited ISR-2016-1077.
Sections du résumé
Background
UNASSIGNED
Patients with Barrett's oesophagus (BO) carry significant cancer worry, burden of symptoms, and lack disease-specific knowledge. Currently there is no validated BO patient reported outcome measure (PROM) to measure these factors for use in clinical practice and research, hence the aim of this study was to devise a novel, validated BO-specific tool, B-PROM.
Methods
UNASSIGNED
Literature review, quantitative and qualitative research informed the initial item generation. The item bank was refined through a modified Delphi process between May and August 2021. The PROM was then tested through cognitive interviews and validated via multicentre testing between September 2021 and February 2023 with the aim to create a succinct tool which addresses the key important factors to BO patients and has strong psychometric properties.
Findings
UNASSIGNED
B-PROM covers key themes of disease-specific knowledge, trust in clinicians, burden of symptoms, cancer worry and burden of surveillance. 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 5 mins 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. Exploratory Factor analysis (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).
Interpretation
UNASSIGNED
B-PROM is the first BO-specific PROM to be systematically evaluated. Validation findings show strong internal consistency, short completion time, low missingness and excellent test-retest reliability.
Funding
UNASSIGNED
Medtronic Limited ISR-2016-1077.
Identifiants
pubmed: 38745966
doi: 10.1016/j.eclinm.2024.102606
pii: S2589-5370(24)00185-8
pmc: PMC11090893
doi:
Types de publication
Journal Article
Langues
eng
Pagination
102606Investigateurs
Anuj Abraham
(A)
Abhay Bagewadi
(A)
Ian Beales
(I)
Iosif Beintaris
(I)
Philip Boger
(P)
Sara Brogden
(S)
Rosie Bray
(R)
Jeffrey Butterworth
(J)
John De Caestecker
(J)
Anjan Dhar
(A)
Massimillano Di Petro
(M)
Guy Finch
(G)
Stephen Foley
(S)
David Gorard
(D)
Hasan Haboubi
(H)
Rehan Haidry
(R)
Chris Haigh
(C)
Jo Harvey
(J)
Neil Hawkes
(N)
Jamal Hayat
(J)
Kar Lau
(K)
Pradeep Mundre
(P)
Neeraj Prasad
(N)
Alix Rankin
(A)
Nigel Trudgill
(N)
Clare Ormerod
(C)
Laura Neilson
(L)
Informations de copyright
© 2024 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
YA has received funding from cancer research UK and Medtronic Ltd. ER has received research funding from Medtronic UK and speaker honoraria from Janssen and Takeda. SH has NIHR funding for other research studies, is on the board of ESSD and holds shares in the company Phagenesis Ltd.