The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis

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dc.authorscopusid7005018012
dc.authorscopusid7102610425
dc.authorscopusid19534301600
dc.authorscopusid55194508200
dc.authorscopusid57216215244
dc.authorscopusid35926874100
dc.authorscopusid36774757800
dc.contributor.authorFeagan B.G.
dc.contributor.authorSandborn W.J.
dc.contributor.authorD'Haens G.
dc.contributor.authorPola S.
dc.contributor.authorMcDonald J.W.D.
dc.contributor.authorRutgeerts P.
dc.contributor.authorMunkholm P.
dc.date.accessioned2024-06-12T10:25:11Z
dc.date.available2024-06-12T10:25:11Z
dc.date.issued2013
dc.description.abstractBackground & Aims: Interobserver differences in endoscopic assessments contribute to variations in rates of response to placebo in ulcerative colitis (UC) trials. We investigated whether centralized review of images could reduce these variations. Methods: We performed a 10-week, randomized, double-blind, placebo-controlled study of 281 patients with mildly to moderately active UC, defined by an Ulcerative Colitis Disease Activity Index (UCDAI) sigmoidoscopy score ?2, that evaluated the efficacy of delayed-release mesalamine (Asacol 800-mg tablet) 4.8 g/day. Endoscopic images were reviewed by a single expert central reader. The primary outcome was clinical remission (UCDAI, stool frequency and bleeding scores of 0, and no fecal urgency) at week 6. Results: The primary outcome was achieved by 30.0% of patients treated with mesalamine and 20.6% of those given placebo, a difference of 9.4% (95% confidence interval [CI], -0.7% to 19.4%; P =.069). Significant differences in results from secondary analyses indicated the efficacy of mesalamine. Thirty-one percent of participants, all of whom had a UCDAI sigmoidoscopy score ?2 as read by the site investigator, were considered ineligible by the central reader. After exclusion of these patients, the remission rates were 29.0% and 13.8% in the mesalamine and placebo groups, respectively (difference of 15%; 95% CI, 3.5%-26.0%; P =.011). Conclusions: Although mesalamine 4.8 g/day was not statistically different from placebo for induction of remission in patients with mildly to moderately active UC, based on an intent-to-treat analysis, the totality of the data supports a benefit of treatment. Central review of endoscopic images is critical to the conduct of induction studies in UC; ClinicalTrials.gov Number, NCT01059344. © 2013 by the AGA Institute.en_US
dc.description.sponsorshipCity, University of London, City: 1; City, University of London, City; Ankara Universitesien_US
dc.description.sponsorshipDr Yury Marakhouski, City Clinical Hospital No. 1, Minsk, Belarus; Dr Leanid Sapeha and Dr Sergei Pimanov, Vitebsk Regional Clinical Hospital, Vitebsk, Belarus; Dr Valerii Rusinovich, Klumov City Clinical Hospital, Minsk, Belarus; Dr Elena Mikhailova, Gomel Regional Clinical Hospital, Gomel, Belarus; Dr Aliaksandr Varabei, Minsk Regional Clinical Hospital, Minsk, Belarus; Dr Mykhailo Zakharash, Clinical Hospital of Security Service of Ukraine, Kiev, Ukraine; Dr Olena Levchenko, Odessa Regional Clinical Hospital, Odessa, Ukraine; Dr Yuriy Lozynskyy, Lviv State Danylo Galytski Medical University/Lviv Regional Clinical Hospital, Lviv, Ukraine; Dr Oleksiy Datsenko, Kharkov City Clinical Hospital, Odessa, Ukraine; Dr Yuriy Stepanov, Dniepropetrovsk State Medical Academy, Dniepropetrovsk, Ukraine; Dr Anatoliy Svintsitskyy, O O Bogomolets National Medical University, Kiev, Ukraine; Dr Vasyl Neyko, Ivano-Frankivsk State Medical University, Ivan-Frankivsk, Ukraine; Dr Nataliya Kharchenko, Kyiv Medical Academy of Postgraduate Education, Kiev, Ukraine; Dr Ilkay Simsek, Dokuz Eylul University Medical School, Izmir, Turkey; Dr Belkis Unsal, Izmir Ataturk Egitim ve Arastirma Hospital, Izmir, Turkey; Dr Candan Tuncer, Gazi University Medical School, Ankara, Turkey; Dr Murat Toruner, Ankara University Medical School, Ankara, Turkey; Dr Bulent Sivri, Hacettepe University Medical School, Ankara, Turkey; Dr Abdurrahman Kadayifci, University of Gaziantep, Gaziantep, Turkey; Dr Canan Alkim, Sisli Etfal Research and Training Hospital, Istanbul, Turkey; Dr Vedat Goral, Dicle University Medical School, Diyarbakir, Turkey; Dr Ahmet Tezel, Trakya University Medical Faculty, Edirne, Turkey; Dr Bonthala Subbaraj Sathyaprakash, Ramajah Medical College & Hospital, Bangalore, India; Dr Boddu Prabhakar, Osmania General Hospital, Hyderabad, India; Dr Malladi Uma Devi, Medwin Hospitals, Hyderabad, India; Dr Kotacherry Trivikrama Shenoy, Sree Gokulam Medical College and Research, Kerala, India; Dr Mukesh Kalla, S.R. Kalla Memorial Gastro & General Hospital, Rajasthan, India; Dr Janaviculam Sankaran Rajkumar, Life Line Hospitals, Tamilnadu, India; Dr Premashish Kar, Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi, India. Supplementary Figure 1 Patient disposition. Supplementary Table 1 Site and Central Reader Endoscopic Assessments Jurisdiction Belarus (n = 91) India (n = 56) Turkey (n = 24) Ukraine (n = 108) Total (N = 279) Visit Screening Downgrade a 32 (35.2) 24 (42.9) 7 (29.2) 35 (32.4) 98 (35.2) Upgrade b 22 (24.2) 7 (12.5) 6 (25.0) 22 (20.4) 57 (20.4) Same 37 (40.6) 25 (44.6) 11 (45.8) 51 (47.2) 124 (44.4) Downgrade/upgrade ratio 1.45 3.43 1.12 1.59 Belarus (n = 80) India (n = 42) Turkey (n = 16) Ukraine (n = 79) Total (N = 217) Week 6 Downgrade 32 (40.0) 7 (16.7) 4 (25.0) 12 (15.2) 55 (25.3) Upgrade 9 (11.2) 5 (11.9) 2 (12.5) 13 (16.5) 29 (13.4) Same 39 (48.8) 30 (71.4) 10 (62.5) 54 (68.3) 13 (61.3) Downgrade/upgrade ratio 3.56 1.40 2.00 0.92 Belarus (n = 78) India (n = 40) Turkey (n = 16) Ukraine (n = 75) Total (N = 209) Week 10 Downgrade 20 (25.6) 2 (5.0) 0 (0) 5 (6.7) 27 (12.9) Upgrade 8 (10.3) 4 (10.0) 2 (12.5) 9 (12.0) 23 (11.0) Same 50 (64.1) 34 (85.0) 14 (87.5) 61 (81.3) 159 (76.1) Downgrade/upgrade ratio 2.50 2.00 0.05 0.56 NOTE. Values are expressed as n (%). A downgrade/upgrade ratio of 1 is consistent with random disagreement in distinction to systemic disagreement. a The site reader's score was higher than the central reader's score. b The site reader's score was lower than the central reader's score.en_US
dc.identifier.doi10.1053/j.gastro.2013.03.025
dc.identifier.endpage1.57E+04en_US
dc.identifier.issn0016-5085
dc.identifier.issue1en_US
dc.identifier.scopus2-s2.0-84879485530en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage149en_US
dc.identifier.urihttps://doi.org/10.1053/j.gastro.2013.03.025
dc.identifier.urihttps://hdl.handle.net/20.500.14551/16225
dc.identifier.volume145en_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherW.B. Saundersen_US
dc.relation.ispartofGastroenterologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectCentral Reading; Inflammatory Bowel Disease; Interobserver Agreement; Therapyen_US
dc.subjectMesalazine; Placebo; Adult; Article; Bleeding; Controlled Study; Delayed Drug Release; Double Blind Procedure; Drug Efficacy; Drug Safety; Endoscopy; Feces Culture; Female; Human; Image Analysis; Intention To Treat Analysis; Major Clinical Study; Male; Outcome Assessment; Physical Examination; Priority Journal; Randomized Controlled Trial; Reading; Remission; Risk Assessment; Sigmoidoscopy; Ulcerative Colitis; Unspecified Side Effecten_US
dc.titleThe role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitisen_US
dc.typeArticleen_US

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