ID

31092

Description

LOW BACK PAIN DATA COLLECTION REFERENCE GUIDE Version 2.0.3 Revised August 24th, 2017 www.ichom.org Conditions: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains Outcome Variables to be assessed at different timepoints: During the index hospitalization, Within 30 days of the index hospitalization, 6 months after index hospitalization, 3*, 6 months, 1, 2, 5* year after index event or when occurs (*recommended, but not essential). With use of the following Scores: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/

Link

www.ichom.org

Keywords

  1. 7/20/18 7/20/18 - Sarah Riepenhausen
  2. 8/23/18 8/23/18 - Sarah Riepenhausen
  3. 8/30/18 8/30/18 - Sarah Riepenhausen
  4. 8/31/18 8/31/18 - Sarah Riepenhausen
  5. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

ICHOM

Uploaded on

July 20, 2018

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ICHOM Low Back Pain

ICHOM Low Back Pain - Outcomes

Acute Complications of Treatment
Description

Acute Complications of Treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0009566
Indicate if patient died in-hospital following procedure (all-cause mortality)
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1]
C0277608
Surgically treated patients
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Indicate if there was iatrogenic nerve root damage (including cauda equina) due to the intervention
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0007458
UMLS CUI [1,2]
C1708460
UMLS CUI [2,1]
C0037940
UMLS CUI [2,2]
C1708460
Indicate if there was unintentional surgery on the wrong level/site, not on level of main pathology
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0741419
UMLS CUI [1,2]
C0037949
UMLS CUI [1,3]
C3845811
Indicate if there was relevant iatrogenous damage to a vessel
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0005847
UMLS CUI [1,2]
C1708460
Indicate if there was iatrogenous damage of a dura with liquor emission
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C1707833
UMLS CUI [1,2]
C0439669
UMLS CUI [1,3]
C0023182
Indicate if there were other complications (e.g. superficial hematoma, malpositioned implant, donor-site pain, DVT without PE, and/or device failure)
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: During the index hospitalization REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0741419
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0205394
Indicate if patient died within 30 days following procedure (all-cause mortality)
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: Within 30 days of the index hospitalization REPORTING SOURCE: Administrative (where available) TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C3887296
Indicate date of death
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: Within 30 days of the index hospitalization REPORTING SOURCE: Administrative (where available)

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C3887296
DD/MM/YYYY
Indicate if the patient was admitted to an acute care facility as an inpatient within 30 days from the date of index intervention for ANY reason
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: Within 30 days of the index hospitalization REPORTING SOURCE: Administrative (where available) TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0679878
UMLS CUI [1,2]
C0030700
UMLS CUI [1,3]
C3887296
Indicate date of rehospitalization(s)
Description

Do not include admissions to rehabilitation hospital or nursing home INCLUSION CRITERIA: Surgically treated patients TIMING: Within 30 days of the index hospitalization REPORTING SOURCE: Administrative (where available)

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0600290
UMLS CUI [1,2]
C3887296
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
The following questions refer to your low back surgery that occurred roughly 6 months ago: Were you treated with antibiotics (penicillins or similar) for 6 weeks or longer for a deep infection in the surgical site within 3 months after surgery?
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: 6 months after index hospitalization REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0406103
UMLS CUI [1,2]
C1442461
UMLS CUI [1,3]
C0241311
Were you diagnosed with and treated for pulmonary emboli (blood clot in the lung) within 3 months after surgery?
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: 6 months after index hospitalization REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C1442461
UMLS CUI [1,3]
C0241311
Were you admitted overnight in the hospital (excluding emergency room visits) for ANY reason during the 30 days after you underwent your back surgery?
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: 6 months after index hospitalization REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0600290
UMLS CUI [1,2]
C3887296
Disease Recurrence
Description

Disease Recurrence

Alias
UMLS CUI-1
C0679254
Have you had any additional low back surgery at the same level?
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0558347
UMLS CUI [1,2]
C0741423
If yes, when did you have you surgery?
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0558347
UMLS CUI [1,2]
C0741423
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate if the current surgery is a reoperation at the same level because the prior surgery at the same level did not reach its technical or clinical goals
Description

INCLUSION CRITERIA: Surgically treated patients TIMING: when occurs REPORTING SOURCE: Clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0558347
UMLS CUI [1,2]
C0741419
UMLS CUI [1,3]
C0037949
UMLS CUI [1,4]
C2946261
UMLS CUI [1,5]
C0445247
Indicate the type of reoperation
Description

Hardware removal: removal of implants (For example, screws, rods) Non-union: failure of bony consolidation of bridge/union at minimum 12 months after surgery Neuro-compression: compression of neural structures with or without neurological deficits (select recurrent disc herniation or other neuro- compression) Post-op infection: superficial or deep (subfascial) wound/tissue infection after surgery Implant malposition: incorrect position of the implant Implant failure: problem due to an implant (For example, loosening, breakage) Wrong level: procedure mistakenly performed at wrong vertebral level Sagittal imbalance: sagittal malalignment of the spine (select lumbar flatback deformity or junctional kyphosis) Cerebrospinal fluid leakage: includes CSF fistula, seudomeningocele, etc. Epidural hematoma: collection of blood adjacent to dura, potentially creating compression INCLUSION CRITERIA: Surgically treated patients TIMING: when occurs REPORTING SOURCE: clinical TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0558347
UMLS CUI [1,2]
C0741419
UMLS CUI [1,3]
C0332307
Patient-Reported Health Status
Description

Patient-Reported Health Status

Alias
UMLS CUI-1
C0018759
UMLS CUI-2
C2987124
What is your work status?
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0014003
UMLS CUI [1,2]
C0449438
How long after you received treatment for Low Back Pain did you return to work (where applicable)?
Description

Time to return to work

Data type

integer

Alias
UMLS CUI [1,1]
C0425105
UMLS CUI [1,2]
C0449238
Are you working at a physically less demanding job now because of your leg or back pain?
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C4540969
UMLS CUI [1,2]
C0392756
Do you take non-narcotic pain relievers (For example NSAIDs, acetaminophen)?
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0242937
UMLS CUI [1,2]
C0549178
Do you take narcotics, also known as opioids (For example morphine, codeine, dextropropoxyphene)?
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: Single Answer

Data type

integer

Alias
UMLS CUI [1,1]
C0027409
UMLS CUI [1,2]
C0549178
Oswestry Disability Index - Total Score
Description

For use of ODI a licence is needed. Therefore only a single item for the total score for ODI is given here, while in the original ICHOM the separate questions of the score appear (ODI_Q01 to ODI_Q10).INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported

Data type

integer

Alias
UMLS CUI [1,1]
C4288568
UMLS CUI [1,2]
C2964552
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, please indicate your average back pain over the last 7 days
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported RESPONSE OPTIONS: Ordinal values from 0 to 10, with 'No pain' marked at '0' and 'Worst pain imaginable' marked at '10'

Data type

integer

Alias
UMLS CUI [1,1]
C1518471
UMLS CUI [1,2]
C0004604
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, please indicate your average leg pain over the last 7 days
Description

INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported RESPONSE OPTIONS: Ordinal values from 0 to 10, with 'No pain' marked at '0' and 'Worst pain imaginable' marked at '10'

Data type

integer

Alias
UMLS CUI [1,1]
C1518471
UMLS CUI [1,2]
C0023222
EQ-5D-3L Score
Description

For use of EQ-5D-3L a licence is needed. Therefore only two items for the EQ-5D-3L are given here, while in the original ICHOM the separate questions of the score appear (EQ5D_Q01 to EQ5D_Q06). This item is for the calculated Score of the 5 questions. INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported

Data type

float

Alias
UMLS CUI [1,1]
C1880594
UMLS CUI [1,2]
C0449820
EQ-5D-3L VAS
Description

For use of EQ-5D-3L a licence is needed. Therefore only two items for the EQ-5D-3L are given here, while in the original ICHOM the separate questions of the score appear (EQ5D_Q01 to EQ5D_Q06). This item is for the result of the VAS. INCLUSION CRITERIA: All patients TIMING: 3*, 6 months, 1, 2, 5* year after index event REPORTING SOURCE: Patient-reported TYPE: VAS

Data type

float

Alias
UMLS CUI [1]
C3639380

Similar models

ICHOM Low Back Pain - Outcomes

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Acute Complications of Treatment
C0087111 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
Item
Indicate if patient died in-hospital following procedure (all-cause mortality)
integer
C0277608 (UMLS CUI [1])
Code List
Indicate if patient died in-hospital following procedure (all-cause mortality)
CL Item
No (0)
CL Item
Yes (1)
Date of death
Item
Surgically treated patients
date
C1148348 (UMLS CUI [1])
Item
Indicate if there was iatrogenic nerve root damage (including cauda equina) due to the intervention
integer
C0007458 (UMLS CUI [1,1])
C1708460 (UMLS CUI [1,2])
C0037940 (UMLS CUI [2,1])
C1708460 (UMLS CUI [2,2])
Code List
Indicate if there was iatrogenic nerve root damage (including cauda equina) due to the intervention
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate if there was unintentional surgery on the wrong level/site, not on level of main pathology
integer
C0741419 (UMLS CUI [1,1])
C0037949 (UMLS CUI [1,2])
C3845811 (UMLS CUI [1,3])
Code List
Indicate if there was unintentional surgery on the wrong level/site, not on level of main pathology
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate if there was relevant iatrogenous damage to a vessel
integer
C0005847 (UMLS CUI [1,1])
C1708460 (UMLS CUI [1,2])
Code List
Indicate if there was relevant iatrogenous damage to a vessel
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate if there was iatrogenous damage of a dura with liquor emission
integer
C1707833 (UMLS CUI [1,1])
C0439669 (UMLS CUI [1,2])
C0023182 (UMLS CUI [1,3])
Code List
Indicate if there was iatrogenous damage of a dura with liquor emission
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate if there were other complications (e.g. superficial hematoma, malpositioned implant, donor-site pain, DVT without PE, and/or device failure)
integer
C0741419 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Code List
Indicate if there were other complications (e.g. superficial hematoma, malpositioned implant, donor-site pain, DVT without PE, and/or device failure)
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate if patient died within 30 days following procedure (all-cause mortality)
integer
C0011065 (UMLS CUI [1,1])
C3887296 (UMLS CUI [1,2])
Code List
Indicate if patient died within 30 days following procedure (all-cause mortality)
CL Item
No (0)
CL Item
Yes (1)
Date of death
Item
Indicate date of death
date
C1148348 (UMLS CUI [1,1])
C3887296 (UMLS CUI [1,2])
Item
Indicate if the patient was admitted to an acute care facility as an inpatient within 30 days from the date of index intervention for ANY reason
integer
C0679878 (UMLS CUI [1,1])
C0030700 (UMLS CUI [1,2])
C3887296 (UMLS CUI [1,3])
Code List
Indicate if the patient was admitted to an acute care facility as an inpatient within 30 days from the date of index intervention for ANY reason
CL Item
No (0)
CL Item
Yes (1)
Date of rehospitalization
Item
Indicate date of rehospitalization(s)
date
C0600290 (UMLS CUI [1,1])
C3887296 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
The following questions refer to your low back surgery that occurred roughly 6 months ago: Were you treated with antibiotics (penicillins or similar) for 6 weeks or longer for a deep infection in the surgical site within 3 months after surgery?
integer
C0406103 (UMLS CUI [1,1])
C1442461 (UMLS CUI [1,2])
C0241311 (UMLS CUI [1,3])
Code List
The following questions refer to your low back surgery that occurred roughly 6 months ago: Were you treated with antibiotics (penicillins or similar) for 6 weeks or longer for a deep infection in the surgical site within 3 months after surgery?
CL Item
No (0)
CL Item
Yes (1)
Item
Were you diagnosed with and treated for pulmonary emboli (blood clot in the lung) within 3 months after surgery?
integer
C0034065 (UMLS CUI [1,1])
C1442461 (UMLS CUI [1,2])
C0241311 (UMLS CUI [1,3])
Code List
Were you diagnosed with and treated for pulmonary emboli (blood clot in the lung) within 3 months after surgery?
CL Item
No (0)
CL Item
Yes (1)
Item
Were you admitted overnight in the hospital (excluding emergency room visits) for ANY reason during the 30 days after you underwent your back surgery?
integer
C0600290 (UMLS CUI [1,1])
C3887296 (UMLS CUI [1,2])
Code List
Were you admitted overnight in the hospital (excluding emergency room visits) for ANY reason during the 30 days after you underwent your back surgery?
CL Item
No (0)
CL Item
Yes (1)
Item Group
Disease Recurrence
C0679254 (UMLS CUI-1)
Item
Have you had any additional low back surgery at the same level?
integer
C0558347 (UMLS CUI [1,1])
C0741423 (UMLS CUI [1,2])
Code List
Have you had any additional low back surgery at the same level?
CL Item
No (0)
CL Item
Yes (1)
Date of reoperation
Item
If yes, when did you have you surgery?
date
C0558347 (UMLS CUI [1,1])
C0741423 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate if the current surgery is a reoperation at the same level because the prior surgery at the same level did not reach its technical or clinical goals
integer
C0558347 (UMLS CUI [1,1])
C0741419 (UMLS CUI [1,2])
C0037949 (UMLS CUI [1,3])
C2946261 (UMLS CUI [1,4])
C0445247 (UMLS CUI [1,5])
Code List
Indicate if the current surgery is a reoperation at the same level because the prior surgery at the same level did not reach its technical or clinical goals
CL Item
No (0)
CL Item
Yes (1)
Item
Indicate the type of reoperation
integer
C0558347 (UMLS CUI [1,1])
C0741419 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Indicate the type of reoperation
CL Item
Hardware removal (1)
CL Item
Non-union (2)
CL Item
Neuro-compression (3)
CL Item
Post-op infection (4)
CL Item
Implant malposition (5)
CL Item
Implant failure (6)
CL Item
Wrong level (7)
CL Item
Sagittal imbalance (8)
CL Item
Cerebrospinal fluid leakage (9)
CL Item
Epidural hematoma (10)
Item Group
Patient-Reported Health Status
C0018759 (UMLS CUI-1)
C2987124 (UMLS CUI-2)
Item
What is your work status?
integer
C0014003 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
What is your work status?
CL Item
Unable to work due to a condition other than back or leg pain (0)
CL Item
Unable to work due to back or leg pain (1)
CL Item
Not working by choice (student, retired, homemaker) (2)
CL Item
Seeking employment (I consider myself able to work but cannot find a job)  (3)
CL Item
Working part-time (4)
CL Item
Working full-time (5)
Item
How long after you received treatment for Low Back Pain did you return to work (where applicable)?
integer
C0425105 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Code List
How long after you received treatment for Low Back Pain did you return to work (where applicable)?
CL Item
Less than 3 months  (1)
CL Item
3-6 months (2)
CL Item
6-9 months (3)
CL Item
9-12 months (4)
CL Item
1-2 years (5)
CL Item
More than 2 years  (6)
Item
Are you working at a physically less demanding job now because of your leg or back pain?
integer
C4540969 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
Code List
Are you working at a physically less demanding job now because of your leg or back pain?
CL Item
No (0)
CL Item
Yes (1)
Item
Do you take non-narcotic pain relievers (For example NSAIDs, acetaminophen)?
integer
C0242937 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Do you take non-narcotic pain relievers (For example NSAIDs, acetaminophen)?
CL Item
No (0)
CL Item
Yes, regularly (1)
CL Item
Yes, sometimes (2)
Item
Do you take narcotics, also known as opioids (For example morphine, codeine, dextropropoxyphene)?
integer
C0027409 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Do you take narcotics, also known as opioids (For example morphine, codeine, dextropropoxyphene)?
CL Item
No (0)
CL Item
Yes, regularly (1)
CL Item
Yes, sometimes (2)
ODI Total Score
Item
Oswestry Disability Index - Total Score
integer
C4288568 (UMLS CUI [1,1])
C2964552 (UMLS CUI [1,2])
Question 1 of NPRS
Item
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, please indicate your average back pain over the last 7 days
integer
C1518471 (UMLS CUI [1,1])
C0004604 (UMLS CUI [1,2])
Question 2 of NPRS
Item
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable, please indicate your average leg pain over the last 7 days
integer
C1518471 (UMLS CUI [1,1])
C0023222 (UMLS CUI [1,2])
EQ-5D-3L Score
Item
EQ-5D-3L Score
float
C1880594 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
undefined item
Item
EQ-5D-3L VAS
float
C3639380 (UMLS CUI [1])

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