Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis

Samaan, Mark A; Shen, Bo; Mosli, Mahmoud; Zou, Guangyong; Sandborn, William J.; Shackelton, Lisa M.; Nelson, Sigrid A; Stitt, Larry; Bloom, Stuart; Pardi, Darrell S.; Gionchetti, Paolo; Lindsay, James O.; Travis, Simon; Hart, Ailsa; Silverberg, Mark S.; Feagan, Brian G.; D’Haens, Geert R.; Jairath, Vipul

doi:10.1016/j.gie.2018.04.2330

Cited by 35 publications

(18 citation statements)

References 21 publications

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“…Sample size for reliability was based on the one-way random effects model, which tends to provide more liberal estimates compared to those based on the two-way models. Assuming a true ICC of 0.8, evaluation of 25 videos 2 times by 20 readers would yield an approximately 90 % chance of obtaining a lower bound for the two-sided 95 % CI for an ICC greater than 0.6 [23].…”

Section: Statistical Analysesmentioning

confidence: 99%

KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy

et al. 2020

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Background and study aims A reliable outcome measure is needed for bowel preparation quality during capsule endoscopy. Currently, no scales are adequately validated. Our objective was to update an existing small bowel preparation score, create a standardized training module, then determine its inter-rater and intra-rater reliability. Patients and methods Modification to produce standardized scoring of an existing small bowel preparation score was performed followed by development of a training module and validation to create the new Korea-Canada (KODA) score. Twenty readers from a range of backgrounds, including capsule endoscopists, gastroenterology fellows, residents, medical students, and nurses rated bowel cleanliness in 25 capsule videos consisting of 1,233 images, in duplicate 4 weeks apart, after completing the training module. Sequential images selected in 5-minute intervals during small bowel transit were rated on a scale between 0–3 based on the amount of visualized mucosa and the degree of obstruction. Reliability was assessed using estimates of intraclass correlation coefficients (ICCs). Results Intraclass correlation coefficients for inter-rater (ICC 0.81, 95 % CI 0.70–0.87) and intra-rater (ICC 0.92, 95 % CI 0.87–0.94) reliability were almost perfect among the 20 readers. Inter-rater reliability ranged between 0.72 (95 % CI 0.57–0.81) and 0.89 (95 % CI 0.79–0.93) for nurses and residents, respectively. Intra-rater reliability was greater than 0.90 for all groups except for nurses, which was still almost perfect (ICC 0.86, 95 % CI 0.79–0.90). Conclusions Almost perfect inter-rater and intra-rater reliability was observed for the KODA score. This simple score could be used for future clinical trials after completion of the training module.

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Section: Statistical Analysesmentioning

confidence: 99%

KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy

et al. 2020

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“…Reported measures in our study included the endoscopic subscore of the PDAI, as this is the most widely used metric for reporting endoscopic findings in pouchitis [11]. We also described the ulcerated surface area before and after ustekinumab treatment as this measure was found to have the highest interobserver reliability when grading pouchitis severity in a recent large prospective study and it was recommended that it be part of any future endoscopic score of pouchitis [13]. We believe that using objective endpoints in trials of pouchitis is essential due to the poor correlation between clinical and endoscopic findings in such patients [5].…”

Section: Discussionmentioning

confidence: 99%

“…We used objective outcomes such as endoscopic disease activity and characterized the severity of pouch inflammation using measures which have been shown to have high interobserver reliability [13]. However, none of the physicians were blinded to the treatment or evaluations, and so, treatment effects and endoscopic objectivity might have been biased.…”

Section: Discussionmentioning

confidence: 99%

Ustekinumab Is Effective for the Treatment of Chronic Antibiotic-Refractory Pouchitis

et al. 2019

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Background Chronic antibiotic-refractory pouchitis (CARP) occurs in up to 15% of patients with ulcerative colitis (UC) following proctocolectomy with ileal pouch-anal anastomosis (IPAA). Aim To investigate the effectiveness of ustekinumab in the treatment of CARP. Methods This was a retrospective single-center study of UC patients with an IPAA, who subsequently developed CARP and received ustekinumab with standard Crohn’s disease (CD) dosing between 2016 and 2018. Patients with CD of the pouch were excluded. Demographic, clinical, and endoscopic data were collected. Outcomes included a change in the endoscopic subscore of the Pouchitis Disease Activity Index (PDAI), change in the ulcerated surface area, clinical response, and the number of bowel movements per 24 h. Results Twenty-four patients with CARP were included for analysis. Median follow-up time was 12.9 months (IQR 7.9–16). Twelve patients (50%) had a clinical response with the median number of bowel movements within 24 h decreasing from 8 (IQR, 5–12) to 6 (IQR, 5–8) P = 0.002. Thirteen patients had pouchoscopies available post-ustekinumab treatment. In these patients, the median endoscopic subscore of the PDAI decreased from 5 (IQR, 3–6) to 4 (IQR, 2–5), P = 0.016. Likewise, among these thirteen patients, nine (69%) had an ulcerated surface area > 10% before ustekinumab treatment; after treatment with ustekinumab, only four patients (31%) still had an ulcerated surface area of > 10%. Conclusions This is the largest study of ustekinumab treatment for patients with chronic antibiotic-refractory pouchitis. We found that ustekinumab therapy led to the improvement in clinical and endoscopic endpoints.

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“…A systematic literature review was previously conducted to identify and evaluate indices previously employed to measure endoscopic pouchitis disease activity. 11 This review identified a total of five indices used for assessment of pouchitis disease activity, and included four composite indices (clinical, endoscopic and histologic items: PDAI, Heidelberg Pouchitis Activity Score [HPAS], 14 Japanese Diagnostic Criteria for Pouchitis [JDCP] 15 and St Mark's Score 16 ) and one endoscopic index (Endoscopic Pouch Activity Index [EPAI]). 13 This review was updated, and the scope was expanded in order to identify clinical, endoscopic and histological items that have been used to measure pouchitis disease activity (Table S1).…”

Section: Identification Of Indices and Component Itemsmentioning

confidence: 99%

An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials

Sedaño¹,

Ma²,

Pai³

et al. 2021

Aliment Pharmacol Ther

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SummaryBackgroundPouchitis is a condition with large unmet medical needs and no approved therapies. Lack of validated instruments to measure disease activity and treatment response is a major barrier to drug development.AimTo conduct a modified RAND/University of California Los Angeles appropriateness process to produce a standardised assessment of pouchitis disease activity in clinical trials.MethodsA list of 164 items generated upon a systematic review and expert opinion were rated based on a 9‐point scale (appropriate, uncertain and inappropriate), by a panel including 16 gastroenterologists, surgeons and histopathologists.ResultsItems rated as appropriate to evaluate in pouchitis clinical trials were: (a) clinical: stool frequency and faecal urgency; (b) endoscopic: primary assessment in the pouch body according to the percentage of affected area (<50%, 50%‐75% and >75%), evaluation of the presence of ulcers/erosions according to size (erosions <5 mm, ulcers ≥5 mm to 2 cm and large ulcers >2 cm) and ulcerated area (<10%, 10%‐30% and >30%); (c) histologic: two biopsies from each segment, from the ulcer's edge when present, or endoscopically normal areas, assessment of lamina propria chronic inflammation, epithelial and lamina propria neutrophils, epithelial damage, erosions and ulcers; and (d) clinical trial inclusion/outcome criteria: minimum histologic disease activity for inclusion, a primary endpoint based on stool frequency and assessment of clinical, endoscopic and histologic response and remission. The overall majority of items surveyed (100/164) were rated ‘uncertain’.ConclusionWe conducted a RAND/UCLA appropriateness process to help inform measurement of pouchitis disease activity within clinical trials and foster the development of novel therapies.

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Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis

Abstract: Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.

Cited by 35 publications

References 21 publications

KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy

KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy

Ustekinumab Is Effective for the Treatment of Chronic Antibiotic-Refractory Pouchitis

An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials

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