Post 5-Year Liver Follow-up Changes

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

A post 5 year follow-up, a subset of the
data, will be developed to provide
further data reduction for adult and
pediatric recipients.
All Adult

Recipient
Information

Provider
Information

Name

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of Birth

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

SSN

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Gender

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

HIC

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Transplant date

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Previous follow-up

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Previous patient
status date

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Transplant discharge This data will be populated from
date
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

State of permanent
residence

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Zip code

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recipient center

This data will be populated from
previously entered data.
Page 1 of 19
4/2/2007

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

Donor
Information

Patient Status

Kidney Adult

Pancreas Adult

Clinical
Information

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Follow-up center

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

UNOS donor ID

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor type

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date last seen,
retransplanted or
death

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Patient status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
death

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 2 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

Kidney/Pancreas Clinical
Adult
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Contributory cause:
graft/vascular
thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
bleeding

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
anastomotic leak

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
biopsy proven
isletitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
pancreatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
patient
noncompliance

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Contributory cause:
other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Kidney graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 3 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Kidney date of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Kidney primary
cause of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas date of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas primary
cause of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
graft/vascular
thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
bleeding

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
anastomotic leak

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 4 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Liver Adult

SECTION

Clinical
information

FIELD

MODIFICATION/ADDITION

RATIONALE

Pancreas
contributory cause:
chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
biopsy proven
isletitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
pancreatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
patient
noncompliance

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Primary graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Vascular thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 5 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Cause of failure:
Biliary tract
complication

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Denovo hepatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Recurrent hepatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Recurrent disease

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 6 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Intestine Adult

Thoracic Adult

SECTION

Clinical
Information

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
disease for heart
recipients

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Bronchiolities
obliterans syndrome
for lung recipients

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Renal dysfunction

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Creatinine > 2.5
mg/dl

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 7 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

All Pediatric

SECTION

Recipient
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Chronic dialysis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Renal transplant
since thoracic
transplant

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Name

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of Birth

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

SSN

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Gender

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

HIC

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Transplant date

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Previous follow-up

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Previous patient
status date

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Transplant discharge This data will be populated from
date
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

State of permanent
residence

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 8 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

Zip code
Provider
Information

Donor
Information

Patient Status

Clinical
Information

RATIONALE
To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recipient center

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Follow-up center

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

UNOS donor ID

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor type

This data will be populated from
previously entered data.

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date last seen,
retransplanted or
death

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Patient status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
death

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Functional Status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cognitive
development

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Motor development

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of measure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Height

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 9 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Kidney Pediatric

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Weight

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Diabetes onset
during the follow-up
period

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
disease since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 10 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Pancreas
Pediatric

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
graft/vascular
thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
bleeding

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
anastomotic leak

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 11 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Pancreas
contributory cause:
biopsy proven
isletitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
pancreatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
patient
noncompliance

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Diabetes onset
during the follow-up
period

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
disease since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 12 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

Kidney/Pancreas Clinical
Pediatric
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Kidney graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Kidney primary
cause of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Kidney date of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas date of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas primary
cause of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
graft/vascular
thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 13 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Pancreas
contributory cause:
bleeding

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
anastomotic leak

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
biopsy proven
isletitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
pancreatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
patient
noncompliance

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Pancreas
contributory cause:
other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 14 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Liver Pediatric

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Diabetes onset
during the follow-up
period

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
disease since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Primary graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 15 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Cause of failure:
Vascular thrombosis
• Hepatic arterial
thrombosis
• Hepatic outflow
obstruction
• Portal vein
thrombosis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Biliary tract
complication

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Denovo hepatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Recurrent hepatitis

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
Recurrent disease

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
acute rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
chronic rejection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
infection

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Cause of failure:
other, specify

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 16 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Intestine
Pediatric

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Diabetes onset
during the follow-up
period

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
diseases since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.
Page 17 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Thoracic
Pediatric

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Diabetes onset
during the follow-uperiod

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Coronary artery
disease since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Graft status

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Primary cause of
graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Date of graft failure

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 18 of 19
4/2/2007

2007 Post 5 year Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Coronary artery
disease since last
follow-up

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Most recent serum
creatinine

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Diabetes onset
during the follow-up
period

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Insulin dependent

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Post transplant
malignancy

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Donor related

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Recurrence of
pretransplant tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo solid tumor

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

De novo
lymphoproliferative
disease and
lymphoma

To further reduce data collection burden for patients
followed longer than 5 years post transplant.

Page 19 of 19
4/2/2007