A Review of Activity Indices and Efficacy End Points for Clinical Trials of Medical Therapy in Adults With Ulcerative Colitis

D’Haens, Geert R.; Sandborn, William J.; Feagan, Brian G.; Geboes, Karel; Hanauer, Stephen B.; Irvine, E. Jan; Lémann, Marc; Marteau, Philippe; Rutgeerts, Paul; Schölmerich, Jürgen; Sutherland, Lloyd R.

doi:10.1053/j.gastro.2006.12.038

Cited by 958 publications

(691 citation statements)

References 142 publications

(149 reference statements)

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“…Although this classifi cation of mild, moderate, and severe disease is based on the original Truelove -Witts criteria of 1,955 ( 52 ), more recent clinical trials, especially with ambulatory patients, have relied more frequently on composite scores based on the number of loose or soft stools, frequency of rectal bleeding, sigmoidoscopic appearance, and a physician global assessment. Th ese scores are variably termed the Mayo Clinic index, Sutherland index, or the UC Disease Activity Index ( 54,55 ). Despite the widespread adoption of these indices in clinical trials, they do not take into account symptoms of abdominal pain, nocturnal bowel movements, urgency, or the dreadful fear of episodes of incontinence, which are oft en the patients ' greatest concerns.…”

Section: In a Patient Presenting With Persistent Bloody Diarrhea Recmentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,154

977

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Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifi cally valid research. Double-blind placebo controlled studies are preferable, but compassionate-use reports and expert review articles are used in a thorough review of the literature conducted through Medline with the National Library of Medicine. When only data that will not withstand objective scrutiny are available, a recommendation is identifi ed as a consensus of experts. Guidelines are applicable to all physicians who address the subject regardless of specialty training or interests and are aimed to indicate the preferable but not necessarily the only acceptable approach to a specifi c problem. Guidelines are intended to be fl exible and must be distinguished from standards of care, which are infl exible and rarely violated. Given the wide range of specifi cs in any healthcare problem, the physician must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the board of trustees. Each has been intensely reviewed and revised by the Committee, other experts in the fi eld, physicians who will use them, and specialists in the science of decision analysis. The recommendations of each guideline are therefore considered valid at the time of composition based on the data available. New developments in medical research and practice pertinent to each guideline will be reviewed at a time established and indicated at publication to assure continued validity. The recommendations made are based on the level of evidence found. Grade A recommendations imply that there is consistent level 1 evidence (randomized controlled trials), grade B indicates that the evidence would be level 2 or 3, which are cohort studies or case -control studies. Grade C recommendations are based on level 4 studies, meaning case series or poor-quality cohort studies, and grade D recommendations are based on level 5 evidence, meaning expert opinion.

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Section: In a Patient Presenting With Persistent Bloody Diarrhea Recmentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,154

977

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“…Disease activity was assessed by the Mayo Disease Activity Index (DAI). 20 The latter is calculated by summing the scores of four variables each of which is graded on a scale from 0 to 3: stool frequency, bleeding, physician's assessment of disease activity and mucosal appearance. The maximum potential score is 12, with mild to moderate disease activity defined as a score <10.…”

Section: Methodsmentioning

confidence: 99%

Randomised clinical trial: the effectiveness of Lactobacillus reuteri ATCC 55730 rectal enema in children with active distal ulcerative colitis

Oliva

Nardo

Ferrari

et al. 2011

Aliment Pharmacol Ther

247

138

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“…A unified single definition for MH in IBD is lacking. For UC, several endoscopic scoring systems have been developed but none were validated until recently [46][47]. In 2012, the UCEIS has been developed and validated [16,17].…”

Section: Discussionmentioning

confidence: 99%

Treatment Targets in Inflammatory Bowel Disease: Current Status in Daily Practice

Römkens

Gijsbers

Kievit³

et al. 2016

JGLD

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Background & Aims: Recently, treatment goals in inflammatory bowel disease (IBD) in clinical trials have shifted from mainly symptom-based to more mucosa-driven. Real world data on treatment priorities are lacking. We aimed to investigate the current practice and most commonly used definitions of IBD treatment targets among Dutch gastroenterologists. Methods: Dutch gastroenterologists were asked to participate in a computer-based nation-wide survey. We asked questions on demographics, opinion and current practice regarding IBD treatment targets. Results: Twenty-four percent (134/556) of the respondents completed the survey. For both Crohn’s disease (CD) (47.3%, 61/129) and ulcerative colitis (UC)(45%, 58/129) the main treatment goal was to achieve and maintain deep remission, defined as clinical, biochemical and endoscopic remission. Seventy-six percent of the participants use mucosal healing (MH) as a potential treatment target for IBD, whereas 22.6% use histological remission. There is no single definition for MH in IBD. The majority use Mayo score ≤ 1 in UC (52%) and ‘macroscopic normal mucosa’ in CD (66%). Conclusion: More stringent and mucosa-driven treatment targets as ‘deep remission’ and ‘mucosal healing’ have found traction in clinical practice. The most commonly used definition for MH in routine practice is endoscopic MAYO score ≤ 1 in UC and ‘macroscopic normal mucosa’ in CD. Abbreviations: CD: Crohn’s disease; CDEIS: Crohn‘s Disease Endoscopic Index of Severity; IBD: Inflammatory Bowel Disease; IBDU: IBD unclassified; IOIBD: International Organization for the Study of Inflammatory Bowel Diseases; MH: Mucosal healing; MMH: Microscopic mucosal healing; PROMS: Patient reported outcome measures; SES-CD: Simple endoscopic score for Crohn’s disease; UC: ulcerative colitis; UCEIS: Ulcerative Colitis Endoscopic Index of Severity.

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A Review of Activity Indices and Efficacy End Points for Clinical Trials of Medical Therapy in Adults With Ulcerative Colitis

Cited by 958 publications

References 142 publications

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Randomised clinical trial: the effectiveness of Lactobacillus reuteri ATCC 55730 rectal enema in children with active distal ulcerative colitis

Treatment Targets in Inflammatory Bowel Disease: Current Status in Daily Practice

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