Histologic scoring indices for evaluation of disease activity in Crohn's disease

Gregor Novak, Claire E. Parker, Rish Pai, John K. Macdonald, Brian G. Feagan, William J. Sandborn, Geert D'Haens, Vipul Jairath, Reena Khanna

Research output: Contribution to journalReview article

1 Citation (Scopus)

Abstract

Background: Histologic assessment of mucosal disease activity has been increasingly used in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently existing histologic scoring indices remain unclear. Objectives: A systematic review was undertaken to evaluate the development and operating characteristics of available histologic disease activity indices in Crohn's disease. Search methods: Electronic searches of MEDLINE, EMBASE, PubMed, and the Cochrane Library (CENTRAL) databases from inception to 20 July 2016 were supplemented by manual reviews of bibliographies and abstracts submitted to major gastroenterology meetings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organisation). Selection criteria: Any study design (e.g. randomised controlled trial, cohort study, case series) that evaluated a histologic disease activity index in patients with Crohn's disease was considered for inclusion. Study participants included adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic or endoscopic criteria. Data collection and analysis: Two authors independently reviewed the titles and abstracts of the studies identified from the literature search. The full text of potentially relevant citations were reviewed for inclusion and the study investigators were contacted as needed for clarification. Any disagreements regarding study eligibility were resolved by discussion and consensus with a third author. Two authors independently extracted and recorded data using a standard form. The following data were recorded from each eligible study: number of patients enrolled; number of patients per treatment arm; patient characteristics: age and gender distribution; description of histologic disease activity index utilized; and outcomes such as content validity, construct validity, criterion validity, responsiveness, intra-rater reliability, inter-rater reliability, and feasibility. Main results: Sixteen reports of 14 studies describing 14 different numerical histological indices fulfilled the inclusion criteria. Inter-rater reliability was assessed in one study. For the Naini and Cortina Score, estimates of correlation were 'almost perfect', ranging from r = 0.94 to 0.96. The methodological quality of this study with respect to reliability was 'good'. With respect to validity, correlation estimates between various histological scoring systems and Crohn's disease activity as measured by objective markers of inflammation (including C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin); endoscopic disease activity scores; clinical disease activity scores; and quality of life questionnaires were reported. Comparisons between histologic scoring indices and endoscopic scoring indices ranged from no correlation to 'substantial' (r = 0.779). The methodological quality of the studies that explored validity ranged form 'poor' to 'good'. Responsiveness data were available in seven studies. After subjects were administered a treatment of known efficacy, statistically significant change in the index score was demonstrated in five studies with respect to six indices. Two studies failed to indicate whether there was statistically significant change in the index score post-treatment. With regard to methodological quality, six of the studies were rated as 'poor' and one of the studies was rated as 'fair'. Feasibility was assessed by one study. The Naini and Cortina Score was shown to be simple to use and feasible for every given case. Authors' conclusions: Currently there is no fully validated histological scoring index for evaluation of Crohn's disease activity. Development of a validated histological scoring index for Crohn's disease is a clinical and research priority.

Original languageEnglish (US)
Article numberCD012351
JournalCochrane Database of Systematic Reviews
Volume2017
Issue number7
DOIs
StatePublished - Jul 21 2017

Fingerprint

Crohn Disease
Gastroenterology
Leukocyte L1 Antigen Complex
Lactoferrin
Blood Sedimentation
Age Distribution
Bibliography
PubMed
MEDLINE
C-Reactive Protein
Patient Selection
Libraries
Cohort Studies
Therapeutics
Randomized Controlled Trials
Quality of Life
Research Personnel
Clinical Trials
Databases
Inflammation

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Novak, G., Parker, C. E., Pai, R., Macdonald, J. K., Feagan, B. G., Sandborn, W. J., ... Khanna, R. (2017). Histologic scoring indices for evaluation of disease activity in Crohn's disease. Cochrane Database of Systematic Reviews, 2017(7), [CD012351]. https://doi.org/10.1002/14651858.CD012351.pub2

Histologic scoring indices for evaluation of disease activity in Crohn's disease. / Novak, Gregor; Parker, Claire E.; Pai, Rish; Macdonald, John K.; Feagan, Brian G.; Sandborn, William J.; D'Haens, Geert; Jairath, Vipul; Khanna, Reena.

In: Cochrane Database of Systematic Reviews, Vol. 2017, No. 7, CD012351, 21.07.2017.

Research output: Contribution to journalReview article

Novak, G, Parker, CE, Pai, R, Macdonald, JK, Feagan, BG, Sandborn, WJ, D'Haens, G, Jairath, V & Khanna, R 2017, 'Histologic scoring indices for evaluation of disease activity in Crohn's disease', Cochrane Database of Systematic Reviews, vol. 2017, no. 7, CD012351. https://doi.org/10.1002/14651858.CD012351.pub2
Novak, Gregor ; Parker, Claire E. ; Pai, Rish ; Macdonald, John K. ; Feagan, Brian G. ; Sandborn, William J. ; D'Haens, Geert ; Jairath, Vipul ; Khanna, Reena. / Histologic scoring indices for evaluation of disease activity in Crohn's disease. In: Cochrane Database of Systematic Reviews. 2017 ; Vol. 2017, No. 7.
@article{9810e2e84a6f4e1caebf8ba83341d95f,
title = "Histologic scoring indices for evaluation of disease activity in Crohn's disease",
abstract = "Background: Histologic assessment of mucosal disease activity has been increasingly used in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently existing histologic scoring indices remain unclear. Objectives: A systematic review was undertaken to evaluate the development and operating characteristics of available histologic disease activity indices in Crohn's disease. Search methods: Electronic searches of MEDLINE, EMBASE, PubMed, and the Cochrane Library (CENTRAL) databases from inception to 20 July 2016 were supplemented by manual reviews of bibliographies and abstracts submitted to major gastroenterology meetings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organisation). Selection criteria: Any study design (e.g. randomised controlled trial, cohort study, case series) that evaluated a histologic disease activity index in patients with Crohn's disease was considered for inclusion. Study participants included adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic or endoscopic criteria. Data collection and analysis: Two authors independently reviewed the titles and abstracts of the studies identified from the literature search. The full text of potentially relevant citations were reviewed for inclusion and the study investigators were contacted as needed for clarification. Any disagreements regarding study eligibility were resolved by discussion and consensus with a third author. Two authors independently extracted and recorded data using a standard form. The following data were recorded from each eligible study: number of patients enrolled; number of patients per treatment arm; patient characteristics: age and gender distribution; description of histologic disease activity index utilized; and outcomes such as content validity, construct validity, criterion validity, responsiveness, intra-rater reliability, inter-rater reliability, and feasibility. Main results: Sixteen reports of 14 studies describing 14 different numerical histological indices fulfilled the inclusion criteria. Inter-rater reliability was assessed in one study. For the Naini and Cortina Score, estimates of correlation were 'almost perfect', ranging from r = 0.94 to 0.96. The methodological quality of this study with respect to reliability was 'good'. With respect to validity, correlation estimates between various histological scoring systems and Crohn's disease activity as measured by objective markers of inflammation (including C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin); endoscopic disease activity scores; clinical disease activity scores; and quality of life questionnaires were reported. Comparisons between histologic scoring indices and endoscopic scoring indices ranged from no correlation to 'substantial' (r = 0.779). The methodological quality of the studies that explored validity ranged form 'poor' to 'good'. Responsiveness data were available in seven studies. After subjects were administered a treatment of known efficacy, statistically significant change in the index score was demonstrated in five studies with respect to six indices. Two studies failed to indicate whether there was statistically significant change in the index score post-treatment. With regard to methodological quality, six of the studies were rated as 'poor' and one of the studies was rated as 'fair'. Feasibility was assessed by one study. The Naini and Cortina Score was shown to be simple to use and feasible for every given case. Authors' conclusions: Currently there is no fully validated histological scoring index for evaluation of Crohn's disease activity. Development of a validated histological scoring index for Crohn's disease is a clinical and research priority.",
author = "Gregor Novak and Parker, {Claire E.} and Rish Pai and Macdonald, {John K.} and Feagan, {Brian G.} and Sandborn, {William J.} and Geert D'Haens and Vipul Jairath and Reena Khanna",
year = "2017",
month = "7",
day = "21",
doi = "10.1002/14651858.CD012351.pub2",
language = "English (US)",
volume = "2017",
journal = "Cochrane Database of Systematic Reviews",
issn = "1361-6137",
publisher = "John Wiley and Sons Ltd",
number = "7",

}

TY - JOUR

T1 - Histologic scoring indices for evaluation of disease activity in Crohn's disease

AU - Novak, Gregor

AU - Parker, Claire E.

AU - Pai, Rish

AU - Macdonald, John K.

AU - Feagan, Brian G.

AU - Sandborn, William J.

AU - D'Haens, Geert

AU - Jairath, Vipul

AU - Khanna, Reena

PY - 2017/7/21

Y1 - 2017/7/21

N2 - Background: Histologic assessment of mucosal disease activity has been increasingly used in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently existing histologic scoring indices remain unclear. Objectives: A systematic review was undertaken to evaluate the development and operating characteristics of available histologic disease activity indices in Crohn's disease. Search methods: Electronic searches of MEDLINE, EMBASE, PubMed, and the Cochrane Library (CENTRAL) databases from inception to 20 July 2016 were supplemented by manual reviews of bibliographies and abstracts submitted to major gastroenterology meetings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organisation). Selection criteria: Any study design (e.g. randomised controlled trial, cohort study, case series) that evaluated a histologic disease activity index in patients with Crohn's disease was considered for inclusion. Study participants included adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic or endoscopic criteria. Data collection and analysis: Two authors independently reviewed the titles and abstracts of the studies identified from the literature search. The full text of potentially relevant citations were reviewed for inclusion and the study investigators were contacted as needed for clarification. Any disagreements regarding study eligibility were resolved by discussion and consensus with a third author. Two authors independently extracted and recorded data using a standard form. The following data were recorded from each eligible study: number of patients enrolled; number of patients per treatment arm; patient characteristics: age and gender distribution; description of histologic disease activity index utilized; and outcomes such as content validity, construct validity, criterion validity, responsiveness, intra-rater reliability, inter-rater reliability, and feasibility. Main results: Sixteen reports of 14 studies describing 14 different numerical histological indices fulfilled the inclusion criteria. Inter-rater reliability was assessed in one study. For the Naini and Cortina Score, estimates of correlation were 'almost perfect', ranging from r = 0.94 to 0.96. The methodological quality of this study with respect to reliability was 'good'. With respect to validity, correlation estimates between various histological scoring systems and Crohn's disease activity as measured by objective markers of inflammation (including C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin); endoscopic disease activity scores; clinical disease activity scores; and quality of life questionnaires were reported. Comparisons between histologic scoring indices and endoscopic scoring indices ranged from no correlation to 'substantial' (r = 0.779). The methodological quality of the studies that explored validity ranged form 'poor' to 'good'. Responsiveness data were available in seven studies. After subjects were administered a treatment of known efficacy, statistically significant change in the index score was demonstrated in five studies with respect to six indices. Two studies failed to indicate whether there was statistically significant change in the index score post-treatment. With regard to methodological quality, six of the studies were rated as 'poor' and one of the studies was rated as 'fair'. Feasibility was assessed by one study. The Naini and Cortina Score was shown to be simple to use and feasible for every given case. Authors' conclusions: Currently there is no fully validated histological scoring index for evaluation of Crohn's disease activity. Development of a validated histological scoring index for Crohn's disease is a clinical and research priority.

AB - Background: Histologic assessment of mucosal disease activity has been increasingly used in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently existing histologic scoring indices remain unclear. Objectives: A systematic review was undertaken to evaluate the development and operating characteristics of available histologic disease activity indices in Crohn's disease. Search methods: Electronic searches of MEDLINE, EMBASE, PubMed, and the Cochrane Library (CENTRAL) databases from inception to 20 July 2016 were supplemented by manual reviews of bibliographies and abstracts submitted to major gastroenterology meetings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organisation). Selection criteria: Any study design (e.g. randomised controlled trial, cohort study, case series) that evaluated a histologic disease activity index in patients with Crohn's disease was considered for inclusion. Study participants included adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic or endoscopic criteria. Data collection and analysis: Two authors independently reviewed the titles and abstracts of the studies identified from the literature search. The full text of potentially relevant citations were reviewed for inclusion and the study investigators were contacted as needed for clarification. Any disagreements regarding study eligibility were resolved by discussion and consensus with a third author. Two authors independently extracted and recorded data using a standard form. The following data were recorded from each eligible study: number of patients enrolled; number of patients per treatment arm; patient characteristics: age and gender distribution; description of histologic disease activity index utilized; and outcomes such as content validity, construct validity, criterion validity, responsiveness, intra-rater reliability, inter-rater reliability, and feasibility. Main results: Sixteen reports of 14 studies describing 14 different numerical histological indices fulfilled the inclusion criteria. Inter-rater reliability was assessed in one study. For the Naini and Cortina Score, estimates of correlation were 'almost perfect', ranging from r = 0.94 to 0.96. The methodological quality of this study with respect to reliability was 'good'. With respect to validity, correlation estimates between various histological scoring systems and Crohn's disease activity as measured by objective markers of inflammation (including C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin and fecal lactoferrin); endoscopic disease activity scores; clinical disease activity scores; and quality of life questionnaires were reported. Comparisons between histologic scoring indices and endoscopic scoring indices ranged from no correlation to 'substantial' (r = 0.779). The methodological quality of the studies that explored validity ranged form 'poor' to 'good'. Responsiveness data were available in seven studies. After subjects were administered a treatment of known efficacy, statistically significant change in the index score was demonstrated in five studies with respect to six indices. Two studies failed to indicate whether there was statistically significant change in the index score post-treatment. With regard to methodological quality, six of the studies were rated as 'poor' and one of the studies was rated as 'fair'. Feasibility was assessed by one study. The Naini and Cortina Score was shown to be simple to use and feasible for every given case. Authors' conclusions: Currently there is no fully validated histological scoring index for evaluation of Crohn's disease activity. Development of a validated histological scoring index for Crohn's disease is a clinical and research priority.

UR - http://www.scopus.com/inward/record.url?scp=85024854442&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85024854442&partnerID=8YFLogxK

U2 - 10.1002/14651858.CD012351.pub2

DO - 10.1002/14651858.CD012351.pub2

M3 - Review article

C2 - 28731502

AN - SCOPUS:85024854442

VL - 2017

JO - Cochrane Database of Systematic Reviews

JF - Cochrane Database of Systematic Reviews

SN - 1361-6137

IS - 7

M1 - CD012351

ER -