ID

31163

Description

INFLAMMATORY BOWEL DISEASE COLLECTION REFERENCE GUIDE Version 1.0.1 Revised April 10th, 2017 www.ichom.org ICHOM was sponsored by Oxford Academic Health Science Network for this guide, partly funded by an independent grand form AbbVie. Conditions Covered: An adult (>16) with a diagnosis of Inflammatory Bowel Disease (IBD) including Crohn’s disease, ulcerative colitis and indeterminate colitis (or IBD unclassified) Treatment Approaches: Medical | Surgical | Supportive This ODM-file contains Clinician Reported Outcome Factors. Timepoints: Baseline and Follow-up. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. Survey used: IBD-Control PROM : IBD-Control is made available to the IBD community without license or fees, but the authors retain copyright and request that the original paper is cited in any published output. For more details, see: Bodger et al. Development and validation of a rapid, generic measure of disease control from the patient’s perspective: the IBD-control questionnaire. Gut 2014;63(7):1092-102. (Please note, only some questions of the IBD-Control questionnaire are asked, therefore a total score is not applicable or requested within this guide)

Link

www.ichom.org

Keywords

  1. 7/24/18 7/24/18 - Sarah Riepenhausen
  2. 8/8/19 8/8/19 - Sarah Riepenhausen
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

ICHOM

Uploaded on

July 24, 2018

DOI

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License

Creative Commons BY-NC 3.0

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ICHOM Inflammatory Bowel Disease

Outcome (Clinican reported)

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Time Relative to Baseline (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
Description

This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Disutility of care
Description

Disutility of care

Alias
UMLS CUI-1
C0231185
UMLS CUI-2
C0086388
UMLS CUI-3
C0021390
Please indicate whether prednisolone has been used in the last 12 months
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C3887293
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0021390
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0021390
Did the complication lead to prolonged hospitalization
Description

(i.e. longer than reasonably expected) INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C0745041
If the complication lead to prolonged hospitalization, indicate the total number of days the patient was hospitalized for
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C0745041
UMLS CUI [1,5]
C3640790
days
Did the complication lead to an unplanned admission
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C0030673
UMLS CUI [1,5]
C3854240
If the complication lead to an unplanned admission, indicate the total length of stay for all unplanned admissions due to complication within 1 year
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0184788
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C0030673
UMLS CUI [1,5]
C3854240
UMLS CUI [1,6]
C3640790
days
Healthcare utilization
Description

Healthcare utilization

Alias
UMLS CUI-1
C0042153
UMLS CUI-2
C0086388
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months (IBD-related)?
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • times
Alias
UMLS CUI [1,1]
C0574846
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C3887293
times
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months ( IBD-related) for a planned admission?
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • times
Alias
UMLS CUI [1,1]
C0574846
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C0021390
UMLS CUI [1,5]
C3887293
times
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months (IBD-related) for a unplanned admission?
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • times
Alias
UMLS CUI [1,1]
C0574846
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C3854240
UMLS CUI [1,4]
C0021390
UMLS CUI [1,5]
C3887293
times
Total length of all, (all-cause) admissions and readmissions within 1 year
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C3640790
UMLS CUI [1,2]
C0021390
UMLS CUI [1,3]
C3887293
days
Total number of emergency room or emergency department visits within 1 year
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

integer

Alias
UMLS CUI [1,1]
C0574846
UMLS CUI [1,2]
C0583237
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C3887293
Survival and Disease Control
Description

Survival and Disease Control

Indicate if there is evidence of anaemia?
Description

Anaemia is defined by the WHO as a haemoglobin (at sea level) of <12.0 g/dl in non-pregnant women, <11.0g/dl in pregnant women and <13.5 g/dl in men INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1]
C0002871
Is the patient clinically in remission?
Description

This could be determined using any recognised assessment or questionnaire. INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0021390
Is the patient in biological remission?
Description

This could be determined using any approach, e.g. endoscopically, radiological, histologically INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0021390
If the patient is in biological remission, how was this determined? 0= Endoscopically (e.g. endoscopy, colonoscopy)
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C2911685
UMLS CUI [1,5]
C0014245
If the patient is in biological remission, how was this determined? 1= Radiologically (e.g. fluoroscopy, CT, MRI)
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C2911685
UMLS CUI [1,5]
C0011923
If the patient is in biological remission, how was this determined? 2= Biochemistry (e.g. CRP, faecal calprotectin)
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C2911685
UMLS CUI [1,5]
C0005477
If the patient is in biological remission, how was this determined? 3=Histologically (tissue analysis)
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Multiple Answer

Data type

boolean

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0205460
UMLS CUI [1,3]
C0021390
UMLS CUI [1,4]
C2911685
UMLS CUI [1,5]
C0205462
In the last 6 months, my disease has been
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Patient reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C2707252
UMLS CUI [1,2]
C0021390
UMLS CUI [1,3]
C0747307
Has colorectal cancer been diagnosed?
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1]
C0009402
If colorectal cancer has been diagnosed, had colorectal dysplasia previously been diagnosed?
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0555952
UMLS CUI [1,2]
C0334044
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0009402
Indicate the date of death
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Numerical

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate if death was attributed to IBD
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0021390
Indicate if death was attributed to an intervention for IBD
Description

INCLUSION CRITERIA: All Patients TIMING: Baseline and Follow-Up REPORTING SOURCE: Clinician reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0021390
UMLS CUI [1,3]
C0184661

Similar models

Outcome (Clinican reported)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Time Relative to Baseline
Item
Time Relative to Baseline (e.g. Baseline, 6 months follow-up, 1 year follow-up, ...)
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Item Group
Disutility of care
C0231185 (UMLS CUI-1)
C0086388 (UMLS CUI-2)
C0021390 (UMLS CUI-3)
Item
Please indicate whether prednisolone has been used in the last 12 months
integer
C0281991 (UMLS CUI [1,1])
C3887293 (UMLS CUI [1,2])
Code List
Please indicate whether prednisolone has been used in the last 12 months
CL Item
No use of prednisolone in the last 12 months (0)
CL Item
Use of prednisolone in the last 12 months of less than 3 months total duration (1)
CL Item
Use of prednisolone in the last 12 months for more than 3 months total duration (2)
Item
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
integer
C0009566 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
Code List
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
CL Item
No complication occurred (0)
CL Item
Yes, complication occurred (1)
Item
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
integer
C0184788 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
Code List
Indicate whether the patient experienced a (unexpected or expected) complication whist during IBD intervention (this can be any type of intervention) or 3 months following intervention
CL Item
No further intervention required (0)
CL Item
Surgical intervention required (1)
CL Item
Radiological intervention required (2)
CL Item
Endoscopic intervention required (3)
CL Item
Medical intervention required (4)
Item
Did the complication lead to prolonged hospitalization
integer
C0184788 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C0745041 (UMLS CUI [1,4])
Code List
Did the complication lead to prolonged hospitalization
CL Item
Yes (0)
CL Item
No (1)
CL Item
Unknown (2)
Outcome of the complication - hospitalization
Item
If the complication lead to prolonged hospitalization, indicate the total number of days the patient was hospitalized for
integer
C0184788 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C0745041 (UMLS CUI [1,4])
C3640790 (UMLS CUI [1,5])
Item
Did the complication lead to an unplanned admission
integer
C0184788 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C0030673 (UMLS CUI [1,4])
C3854240 (UMLS CUI [1,5])
Code List
Did the complication lead to an unplanned admission
CL Item
Yes (0)
CL Item
No (1)
CL Item
Unknown (2)
Outcome of the complication - unplanned admission
Item
If the complication lead to an unplanned admission, indicate the total length of stay for all unplanned admissions due to complication within 1 year
integer
C0184788 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C0030673 (UMLS CUI [1,4])
C3854240 (UMLS CUI [1,5])
C3640790 (UMLS CUI [1,6])
Item Group
Healthcare utilization
C0042153 (UMLS CUI-1)
C0086388 (UMLS CUI-2)
All IBD-related admission to hospitals
Item
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months (IBD-related)?
integer
C0574846 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C3887293 (UMLS CUI [1,4])
All IBD-related planned admissions to hospitals
Item
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months ( IBD-related) for a planned admission?
integer
C0574846 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0021390 (UMLS CUI [1,4])
C3887293 (UMLS CUI [1,5])
All IBD-related unplanned admissions to hospitals
Item
How many times has the patient been admitted (requiring at least an overnight stay) to a hospital/acute care facility in the last 12 months (IBD-related) for a unplanned admission?
integer
C0574846 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,3])
C0021390 (UMLS CUI [1,4])
C3887293 (UMLS CUI [1,5])
Total length of all admissions and readmissions
Item
Total length of all, (all-cause) admissions and readmissions within 1 year
integer
C3640790 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
C3887293 (UMLS CUI [1,3])
Total number of emergency room visits
Item
Total number of emergency room or emergency department visits within 1 year
integer
C0574846 (UMLS CUI [1,1])
C0583237 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C3887293 (UMLS CUI [1,4])
Item Group
Survival and Disease Control
Item
Indicate if there is evidence of anaemia?
integer
C0002871 (UMLS CUI [1])
Code List
Indicate if there is evidence of anaemia?
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Item
Is the patient clinically in remission?
integer
C0544452 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
Code List
Is the patient clinically in remission?
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Item
Is the patient in biological remission?
integer
C0544452 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
Code List
Is the patient in biological remission?
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Disease activity - method of determining biological remission: Endoscopy
Item
If the patient is in biological remission, how was this determined? 0= Endoscopically (e.g. endoscopy, colonoscopy)
boolean
C0544452 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
C0014245 (UMLS CUI [1,5])
Disease activity - method of determining biological remission: Radiological
Item
If the patient is in biological remission, how was this determined? 1= Radiologically (e.g. fluoroscopy, CT, MRI)
boolean
C0544452 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
C0011923 (UMLS CUI [1,5])
Disease activity - method of determining biological remission: Biochemistry
Item
If the patient is in biological remission, how was this determined? 2= Biochemistry (e.g. CRP, faecal calprotectin)
boolean
C0544452 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
C0005477 (UMLS CUI [1,5])
Disease activity - method of determining biological remission: Histologically
Item
If the patient is in biological remission, how was this determined? 3=Histologically (tissue analysis)
boolean
C0544452 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
C0205462 (UMLS CUI [1,5])
Item
In the last 6 months, my disease has been
integer
C2707252 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
C0747307 (UMLS CUI [1,3])
Code List
In the last 6 months, my disease has been
CL Item
Constantly active giving me symptoms every day (0)
CL Item
Often active, giving me symptoms most days (1)
CL Item
Sometimes active, giving me symptoms on some days (for instance 1–2 days/week) (2)
CL Item
Occasionally active, giving me symptoms 1–2 days/month; (3)
CL Item
Rarely active, giving me symptoms on a few days in the past 6 months (4)
CL Item
I was well in the past 6 months, what I consider a remission or absence of symptoms (5)
Item
Has colorectal cancer been diagnosed?
integer
C0009402 (UMLS CUI [1])
Code List
Has colorectal cancer been diagnosed?
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Item
If colorectal cancer has been diagnosed, had colorectal dysplasia previously been diagnosed?
integer
C0555952 (UMLS CUI [1,1])
C0334044 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0009402 (UMLS CUI [1,4])
Code List
If colorectal cancer has been diagnosed, had colorectal dysplasia previously been diagnosed?
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Date of death
Item
Indicate the date of death
date
C1148348 (UMLS CUI [1])
Item
Indicate if death was attributed to IBD
integer
C0007465 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
Code List
Indicate if death was attributed to IBD
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)
Item
Indicate if death was attributed to an intervention for IBD
integer
C0007465 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Code List
Indicate if death was attributed to an intervention for IBD
CL Item
No (0)
CL Item
Yes (1)
CL Item
Unknown (2)

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