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Cochrane Database of Systematic Reviews

Índices de calificación endoscópica para la evaluación de la actividad de la enfermedad en la colitis ulcerosa

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DOI:
https://doi.org/10.1002/14651858.CD011450.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 16 enero 2018see what's new
Tipo:
  1. Methodology
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Salud digestiva

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Nadia Mohammed Vashist

    PRA Health Sciences, Victoria, Canada

  • Mark Samaan

    Academic Medical Center, Amsterdam, Netherlands

  • Mahmoud H Mosli

    King Abdulaziz University Hospital, King Abdulaziz University, Jeddah, Saudi Arabia

  • Claire E Parker

    Robarts Clinical Trials, London, Canada

  • John K MacDonald

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

    Department of Medicine, University of Western Ontario, London, Canada

  • Sigrid A Nelson

    Robarts Clinical Trials, San Diego, USA

  • GY Zou

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

    Department of Epidemiology and Biostatistics, University of Western Ontario, London, Canada

  • Brian G Feagan

    Cochrane IBD Group, Robarts Clinical Trials, London, Canada

    Department of Medicine, University of Western Ontario, London, Canada

    Department of Epidemiology and Biostatistics, University of Western Ontario, London, Canada

  • Reena Khanna

    Robarts Clinical Trials, London, Canada

    Department of Medicine, University of Western Ontario, London, Canada

  • Vipul Jairath

    Correspondencia a: Robarts Clinical Trials, London, Canada

    [email protected]

    Department of Medicine, University of Western Ontario, London, Canada

    Department of Epidemiology and Biostatistics, University of Western Ontario, London, Canada

Contributions of authors

Development of concept: Mark Samaan, Mahmoud H Mosli, Claire E Parker, Sigrid A Nelson, John K MacDonald, Brian G Feagan, GY Zou, Vipul Jairath, Reena Khanna; drafting of manuscript: Nadia Mohammed Vashist, Claire E Parker; critical revision of the manuscript: Nadia Mohammed Vashist, Claire E Parker, Mark Samaan, Mahmoud H Mosli, Claire E Parker, Sigrid A Nelson, John K MacDonald, Brian G Feagan, GY Zou, Reena Khanna, Vipul Jairath.

Declarations of interest

Nadia Mohammed Vashist: None known

Mark Samaan: None known

Mahmoud H Mosl: None known

Claire E Parker: None known

John K MacDonald: None known

Sigrid A Nelson: None known

GY Zou: None known

Brian G Feagan has received Scientific Advisory Board fees from Abbott/AbbVie, Allergan, Amgen, Astra Zeneca, Atlantic Pharma, Avaxia Biologics Inc., Boehringer‐Ingelheim, Bristol‐Myers Squibb, Celgene, Centocor Inc., Elan/Biogen, Ferring, Galapagos, Genentech/Roche, JnJ/Janssen, Merck, Nestles, Novartis, Novonordisk, Pfizer, Prometheus Laboratories, Protagonist, Salix Pharma, Takeda, Teva, TiGenix, Tillotts Pharma AG, and UCB Pharma; consulting fees from Abbott/AbbVie, Ablynx, Akebia Therapeutics, Allergan, Amgen, Applied Molecular Transport Inc., Aptevo Therapeutics, Astra Zeneca, Atlantic Pharma, Avir Pharma, Baxter Healthcare Corp., Biogen Idec, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring Pharma, Roche/Genentech, Galapagos, GiCare Pharma, Gilead, Given Imaging Inc., GSK, Inception IBD Inc, Ironwood Pharma, Janssen Biotech (Centocor), JnJ/Janssen, Kyowa Kakko Kirin Co Ltd., Lexicon, Lilly, Lycera BioTech, Merck, Mesoblast Pharma, Millennium, Nektar, Nestles, Nextbiotix, Novonordisk, Pfizer, Prometheus Therapeutics and Diagnostics, Progenity, Protagonist, Receptos, Roche/Genentech, Salix Pharma, Serano, Shire, Sigmoid Pharma, Synergy Pharma Inc., Takeda, Teva Pharma, TiGenix, Tillotts, UCB Pharma, Vertex Pharma, Vivelix Pharma, VHsquared Ltd., Warner‐Chilcott, Wyeth, Zealand, Zyngenia; grants/grants pending from AbbVie Inc., Amgen Inc., AstraZeneca/MedImmune Ltd., Atlantic Pharmaceuticals Ltd., Boehringer‐Ingelheim, Celgene Corporation, Celltech, Genentech Inc/Hoffmann‐La Roche Ltd., Gilead Sciences Inc., GlaxoSmithKline (GSK), Janssen Research & Development LLC., Pfizer Inc., Receptos Inc. / Celgene International, Sanofi, Santarus Inc., Takeda Development Center Americas Inc., Tillotts Pharma AG, UCB; and lecture fees from Abbott/AbbVie, JnJ/Janssen, Lilly, Takeda, Tillotts, UCB Pharma.

Reena Khanna has received honoraria from AbbVie, Jansen, Pfizer, Shire, Takeda, and Robarts Clinical Trials for consultancy. All of these activities are outside the submitted work.

Vipul Jairath has received scientific advisory board fees from Abbvie, Sandoz, Ferring, Pfizer and Janssen; speakers fees from Takeda, Ferring, Shire Janssen, Pfizer; travel support for conference attendance from Vifor pharmaceuticals. All of these activities are outside the submitted work.

Acknowledgements

Partial funding for the Cochrane IBD Group (April 1, 2016 ‐ March 31, 2018) has been provided by Crohn's and Colitis Canada (CCC).

Version history

Published

Title

Stage

Authors

Version

2018 Jan 16

Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis

Review

Nadia Mohammed Vashist, Mark Samaan, Mahmoud H Mosli, Claire E Parker, John K MacDonald, Sigrid A Nelson, GY Zou, Brian G Feagan, Reena Khanna, Vipul Jairath

https://doi.org/10.1002/14651858.CD011450.pub2

2015 Jan 02

Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis

Protocol

Mahmoud Mosli, Mark Samaan, Sigrid A Nelson, Brian G Feagan, Simon Travis, Geert D'Haens, William J Sandborn, GY Zou, John K MacDonald, Barrett G Levesque

https://doi.org/10.1002/14651858.CD011450

Differences between protocol and review

The methods for assessing the risk of bias in included studies was modified from the protocol. It was planned that risk of bias was to be assessed using blinded design, independent observation, performance bias and detection bias. Since this is a review of scoring indices rather than interventions, the last two items are not applicable. We chose to assess blinded design and independent observation combined with the use of a system based on the COSMIN tool to further assess risk bias.

The method for interpreting correlation coefficients was modified from the protocol. In the protocol we indicated that we would use the Landis and Koch criteria for the interpretation of correlation coefficients that were generated to assess observer agreement (Landis 1977). For the interpretation of correlation coefficients calculated to assess the direction and strength of a relationship between two variables (e.g. UCEIS and CRP), we decided to use the Cohen criteria (Cohen 1992).

Keywords

MeSH

Medical Subject Headings Check Words

Humans;

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Table 1. Partially validated endoscopic scoring indices

Index

Reference

Validation study ID

1

Azzolini Classification

Azzolini 2005

Jun 2008

2

Baron Score

Baron 1964

Burger 2011; Hirai 2010; Jun 2008; Osada 2010; Thomas 2009; Walsh 2009

3

Blackstone Endoscopic Interpretation

Blackstone 1984

Osada 2010

4

CGSUC

Zou 2005

Jun 2008

5

Endoscopic Activity Index (EAI)

Naganuma 2010

de Lange 2004; Naganuma 2010

6

Jeroen Score

Jeroen 2002

Jun 2008

7

Magnifying Colonoscopy Grade

Nishio 2006

Nishio 2006

8

Matts Score

Matts 1961

Naganuma 2010; Osada 2010

9

Mayo Clinic Endoscopic Subscore

Schroeder 1987

Daperno 2011; Dhanda 2012; Osada 2010; Rubin 2012; Walsh 2009

10

Modified Mayo Clinic Endoscopic Subscore

Lobatón 2015

Levesque 2014

11

Modified Baron Score

Feagan 2005

Jun 2008; Levesque 2014; Walsh 2009

12

Osada Score (Modified 6‐Point Activity Index)

Osada 2010

Osada 2010

13

Rachmilewitz Endocopic Score

Rachmilewitz 1989

Hirai 2010; Naganuma 2010; Schoepfer 2009

14

St. Mark's Index (Powell‐Tuck Index)

Powell‐Tuck 1982

Higgins 2005a

15

Ulcerative Colitis Colonoscopic Index of Severity (UCCIS)

Samuel 2013

Samuel 2013

16

Ulcerative Coltiis Disease Activity Index (endoscopic) (Sutherland Index)

Sutherland 1987

Higgins 2005a

17

Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

Travis 2012

Levesque 2014; Travis 2013

18

Truelove and Witts Sigmoidoscopic Score

Truelove 1955

Jun 2008

19

Watson Grade

Kiesslich 2012

Kiesslich 2012

Figuras y tablas -
Table 1. Partially validated endoscopic scoring indices
Table 2. Non‐validated endoscopic scoring indices

Index

Reference

1

Beattie Score

Beattie 1996

2

Binder Score

Binder 1970

3

Carbonnel Score

Carbonnel 1994

4

Danielsson‐Löfberg Score

Danielsson 1987; Löfberg 1994

5

Dick Score

Dick 1964

6

Friedmann Score

Friedmann 1986

7

Froslie Endoscopic Score

Froslie 2007

8

Lemann Score

Lemann 1995

9

Levine Score

Levine 2002

10

Lindgren Score

Lindgren 2002

11

Maier Score

Maier 1988

12

McPhee Proctoscopic Grading Scale

McPhee 1987

13

Rutter Score

Rutter 2004

14

Saverymuttu Score

Saverymuttu 1986

15

Sigmoidoscopic Index

Hanauer 2004

16

Sigmoidoscopic Inflammation Grade Scale/Lemann Score

Lemann 1995

17

Truelove and Richards Sigmoidoscopic Appearance

Truelove 1956

18

van der Heide Index

van der Heide 1987

Figuras y tablas -
Table 2. Non‐validated endoscopic scoring indices
Table 3. Reliability

Study ID

Index

Inter‐rater ƙ

(between raters)

Inter‐rater ICC

(between raters)

Intra‐rater ƙ

(within rater)

Intra‐rater ICC

(within rater)

Internal

Consistency

Daperno 2011

Mayo Clinic Endoscopic Subscore

pre‐training: 0.445

post‐training: 0.713

Daperno 2014

Mayo Clinic Endoscopic Subscore

experts: 0.53

non‐experts: 0.71

de Lange 2004

EAI

experts: 0.97 (95% CI 0.92‐1.00)

non‐experts: 0.79 (95% CI 0.71‐0.49)

Kiesslich 2012

Watson Grade

0.87

Osada 2010

Modified 6‐point Activity Index

experts: 0.65

trainees: 0.54

experts: 0.79

trainee: 0.64

Matts Score

experts: 0.76

trainees: 0.44

experts: 0.78

trainees: 0.41

The Mayo Endoscopic Subscore

experts: 0.74

trainees: 0.46

experts: 0.75

trainees: 0.48

Baron Score

experts: 0.61

trainees: 0.47

experts: 0.62

trainees: 0.46

Blackstone Score

experts: 0.57

trainees: 0.46

experts: 0.73

trainees: 0.51

Samuel 2013

UCCIS

Vascular pattern

rectum: 0.75

sigmoid: 0.81

descending colon: 0.74

transverse colon: 0.86

ascending/cecum: 0.85

Granularity

rectum: 0.70

sigmoid: 0.78

descending colon: 0.73

transverse colon: 0.88

ascending/cecum: 0.82

Ulceration

rectum: 0.80

sigmoid: 0.75

descending colon: 0.72

transverse colon: 0.73

ascending/cecum: 0.73

Bleeding/Friability

rectum: 0.68

sigmoid: 0.58

descending colon: 0.56

transverse colon: 0.73

ascending/cecum: 0.77

SAES

rectum: 0.79

sigmoid: 0.78

descending colon: 0.71

transverse colon: 0.84

ascending/cecum: 0.85

Travis 2013

UCEIS

0.50

0.72

0.863*

* Cronbach alpha analysis

SAES: segmental assessment of endoscopic severity

Figuras y tablas -
Table 3. Reliability
Table 4. Criterion Validity

Study ID

Index

Comparison

Correlation

Nishio 2006

Magnifying Colonscopy Grade

Mucosal IL‐8 activity

ρ = NS (P < 0.001)

Samuel 2013

UCCIS

C‐reactive protein

r = 0.56 (P < 0.001)

albumin

r = ‐0.55 (P < 0.001)

hemoglobin

r = ‐0.39 (P < 0.01)

platelet count

r = 0.19 (P > 0.05)

Schoepfer 2009

Rachmilewitz Endoscopic Score

Fecal calprotectin

r = 0.834 (P < 0.001)

C‐reactive protein

r = 0.503 (P < 0.001)

Blood leukocytes

r = 0.461 (P < 0.001)

Figuras y tablas -
Table 4. Criterion Validity
Table 5. Construct Validity

Study ID

Index

Comparison

Correlation

Burger 2011

Baron Score

SCCAI

ƙ = 0.27

Truelove and Richards Index

ƙ = 0.58

Dhanda 2012

Mayo Clinic Endoscopic Subscore

Riley Score

Week 4

r = 0.55

Higgins 2005a

St. Mark's Index

UCDAI

r = 0.881 (95% CI 0.814‐0.925); ρ = 0.867

SCCAI

r = 0.908 (95% CI 0.855‐0.924); ρ = 0.866

Seo Index

r = 0.803 (95% CI 0.699‐0.873); ρ = 0.705

Hirai 2010

Baron Score

Rachmilewitz Score

Week 0

r = 0.39 (95% CI 0.18‐0.57, P = 0.0004)

Week 4

r = 0.56 (95% CI 0.36‐0.71, P < 0.0001)

Week 8

r = 0.76 (95% CI 0.60‐0.85, P < 0.0001)

UCDAI

Week 0

r = 0.49 (95% CI 0.29‐0.64, P < 0.0001)

Week 4

r = 0.72 (95% CI 0.57‐0.82, P < 0.0001)

Week 8

r = 0.85 (95% CI 0.74‐0.91, P < 0.0001)

Seo Index

Week 0

r = 0.29 (95% CI 0.06‐0.49, P = 0.01)

Week 2

r = 0.29 (95% CI 0.04‐0.51, P = 0.02)

Week 4

r = 0.53 (95% CI 0.29‐0.70, P < 0.0001)

Lichtiger Index

Week 0

r = 0.47 (95% CI 0.26‐0.62, P < 0.0001)

Week 4

r = 0.56 (95% CI 0.35‐0.71, P < 0.0001)

Week 8

r = 0.78 (95% CI 0.64‐0.78, P < 0.0001)

Rachmilewitz Endoscopic Score

Rachmilewitz Score

Week 0

r = 0.34 (95% CI 0.11‐0.52, P = 0.0003)

Week 2

r = 0.66 (95% CI 0.48‐0.78, P < 0.0001)

Week 4

r = 0.89 (95% CI 0.73‐0.71, P < 0.0001)

UCDAI

Week 0

r = 0.44 (95% CI 0.23‐0.60, P < 0.0001)

Week 4

r = 0.79 (95% CI 0.67‐0.87, P < 0.0001)

Week 8

r = 0.89 (95% CI 0.82‐0.94, P < 0.0001)

Lichtiger Index

Week 0

r = 0.35 (95% CI 0.13‐0.54, P =0.002)

Week 4

r = 0.28 (95% CI 0.02‐0.49, P = 0.003)

Week 8

r = 0.65 (95% CI 0.44 to 0.78, P < 0.0001)

Seo Index

Week 0

r = 0.33 (95% CI 0.10‐0.51, P = 0.005)

Week 4

r = 0.67 (95% CI 0.50‐0.79, P < 0.0001)

Week 8

r = 0.80 (95% CI 0.67‐0.88, P < 0.0001)

Jun 2008

CGSUC

Truelove and Witts Score

ρ = 0.750 (P < 0.001)

Baron Score

ρ = 0.740 (P < 0.001)

Modified Baron Score

ρ = 0.742 (P < 0.001)

Jeroen Score

ρ = 0.799 (P < 0.001)

Azzolini Score

ρ = 0.685 (P < 0.001)

Truelove and Witts Score

CGSUC

ρ = 0.750 (P < 0.001)

Baron Score

ρ = 0.814 (P < 0.001)

Modified Baron Score

ρ = 0.760 (P < 0.001)

Jeroen Score

ρ = 0.782 (P < 0.001)

Azzolini Score

ρ = 0.756 (P < 0.001)

Baron Score

CGSUC

ρ = 0.740 (P < 0.001)

Truelove and Witts Score

ρ = 0.814 (P < 0.001)

Modified Baron Score

ρ = 0.750 (P < 0.001)

Jeroen Score

ρ = 0.828 (P < 0.001)

Azzolini Score

ρ = 0.732 (P < 0.001)

Modified Baron Score

CGSUC

ρ = 0.742 (P < 0.001)

Baron Score

ρ = 0.760 (P < 0.001)

Truelove and Witts Score

ρ = 0.750 (P < 0.001)

Jeroen Score

ρ = 0.761 (P < 0.001)

Azzolini Score

ρ = 0.693 (P < 0.001)

Jeroen Score

CGSUC

ρ = 0.799 (P < 0.001)

Baron Score

ρ = 0.782 (P < 0.001)

Truelove and Witts Score

ρ = 0.828 (P < 0.001)

Modified Baron Score

ρ = 0.761 (P < 0.001)

Azzolini Score

ρ = 0.788 (P < 0.001)

Azzolini Score

CGSUC

ρ = 0.685 (P < 0.001)

Truelove and Witts Score

ρ = 0.756 (P < 0.001)

Baron Score

ρ = 0.732 (P < 0.001)

Modified Baron Score

ρ = 0.693 (P < 0.001)

Jeroen Score

ρ = 0.788 (P < 0.001)

Naganuma 2010

EAI

Lichtiger Index

r = 0.77 (P < 0.001)

Matts Score

r = 0.91 (P < 0.001)

Rachmilewitz Endoscopic Score

r = 0.87, (P < 0.001)

Nishio 2006

Magnifying Colonoscopy Grade

Riley Score

ρ = NS (P < 0.001)

Rubin 2012

Mayo Clinic Endoscopic Subscore

SCCAI

r = 0.525 (P < 0.0001)

Rubin Histologic Score

r = 0.597 (P < 0.0001)

Samuel 2013

UCCIS

SCCAI

r = 0.62 (P < 0.0001)

Rachmilewitz Score

r = 0.5 (P < 0.001)

Patient‐Defined Remission Score

r = 0.43 (P < 0.01)

Schoepfer 2009

Rachmilewitz Score (endoscopic)

Rachmilwitz Score (clinical)

r = 0.672 (P < 0.01)

Thomas 2009

Baron Score

Truelove and Richards Score

ƙ = 0.58

SCCAI

ƙ = 0.27

Travis 2013

UCEIS

Visual Analogue Scale

median 0.93 across investigators (minimum 0.78, maximum 0.99)

statistically significant P > 0.05

Walsh 2009

Baron Score

Modified Baron Score

ƙ = 0.89

Baron Score

Mayo Endoscopic Subscore

ƙ = 0.83

ρ = Spearman's rank correlation coefficient

Abbreviations: CGSUC, Chinese Grading Score for Ulcerative Colitis; EAI, Endoscopic Activity Index; IL, Interleukin; NS, Not Stated; SCCAI, Simple Clinical Colitis Activity Index

Figuras y tablas -
Table 5. Construct Validity
Table 6. Responsiveness

Study ID

Index

Treatment

Effect size

(95% CI)

Guyatt's responsiveness statistic

(95% CI)

Area under the ROC curve

(95% CI)

Mean change (P value)

Levesque 2014

Mayo Clinic Endoscopic Subscore

Asacol

0.49 (0.28, 0.71)

0.32 (0.11, 0.53)

0.66 (0.55, 0.78)

Modified Baron Score

0.49 (0.28, 0.71)

0.33 (0.13, 0.54)

0.65 (0.54, 0.77)

UCEIS

0.58 (0.36, 0.81)

0.47 (0.25, 0.69)

0.68 (0.58, 0.79)

Ikeya 2016

Mayo Clinic Endoscopic Subscore

Tacrolimus

2.9 (+/‐ 0.9) to 2.0 (+/‐ 1.0) (P < 0.001)

UCEIS

6.2 (+/‐ 0.9) to 3.4 (+/‐ 2.1) (P < 0.001)

Figuras y tablas -
Table 6. Responsiveness
Table 7. The Methodological Quality of Endoscopic Index Measurement Properties as Described in the Original Development Articles (COSMIN Checklist)

A

B

C

D

E

F

G

H

I

J

Study ID

IC

RB

ME

COV

FA

HT

CCV

CRV

RP

IT

GN

Burger 2011

good

Daperno 2011

good

Daperno 2014

de Lange 2004

good

Dhanda 2012

excellent

Higgins 2005a

good

Hirai 2010

good

Ikeya 2016

fair

Jun 2008

good

Kiesslich 2012

good

Levesque 2014

excellent

Naganuma 2010

excellent

Nishio 2006

good

good

Osada 2010

excellent

Rubin 2012

good

good

Samuel 2013

excellent

excellent

excellent

Schoepfer 2009

excellent

excellent

Thomas 2009

good

Travis 2013

good

good

Walsh 2009

excellent

IC ‐ internal consistency; RB ‐ reliability; ME ‐ measurement error; COV ‐ content validity; FA ‐ factor analysis; HT ‐ hypothesis testing; CCV ‐ cross cultural validity; CRV ‐ criterion validity; RP ‐ responsiveness; IT ‐ interpretability; GN ‐ generalizability

Figuras y tablas -
Table 7. The Methodological Quality of Endoscopic Index Measurement Properties as Described in the Original Development Articles (COSMIN Checklist)
Table 8. Summary of operating properties of histologic scoring indices for Crohn's disease

Scoring index

Validity

Reliability

Responsiveness

Feasibility

Content validity

Criterion validity

Construct validity

Intra‐rater

Inter‐rater

Test‐retest

Internal consistency

Azzolini Classification

?

?

+

?

?

?

?

?

?

Baron Score

?

?

+

+

+

?

?

?

?

Blackstone Endoscopic Interpretation

?

?

?

+

+

?

?

?

?

CGSUC

?

?

+

?

?

?

?

?

?

Endoscopic Activity Index (EAI)

?

?

+

?

+

?

?

?

?

Jeroen Score

?

?

+

?

?

?

?

?

?

Magnifying Colonscopy Grade

?

+

+

?

?

?

?

?

?

Matts Score

?

?

+

+

+

?

?

?

?

Mayo Clinic Endoscopic Subscore

?

?

+

+

+

?

?

+

?

Modified Mayo Clinic Endoscopic Subscore

?

?

?

?

?

?

?

+

?

Modified Baron Score

?

?

+

?

+

?

?

+

?

Osada Score (Modified 6‐Point Activity Index)

?

?

?

+

+

?

?

?

?

Rachmilewitz Endocopic Score

?

+

+

?

?

?

?

?

?

St. Mark's Index (Powell‐Tuck Index)

?

?

+

?

?

?

?

?

?

Ulcerative Colitis Colonoscopic Index of Severity (UCCIS)

?

?

?

?

?

?

?

?

?

Ulcerative Coltiis Disease Activity Index (endoscopic) (Sutherland Index)

?

?

?

?

?

?

?

?

?

Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

?

?

?

?

?

?

?

?

?

Truelove and Witts Sigmoidoscopic Score

?

?

?

?

?

?

?

?

?

Watson Grade

?

?

?

?

+

?

?

?

?

+ positive rating

? no information or indeterminate rating

‐ Negative rating

Figuras y tablas -
Table 8. Summary of operating properties of histologic scoring indices for Crohn's disease