Follow-up Fields

See ISHLT_Followup_Data Elements for technical details for the follow-up fields.

Click here to view a sample of the Follow-up Record.

The follow-up period, patient's name and transplant ID will display.

The following Tier I fields are required:

Follow-up Hospital Name and Provider Number: Select the Name of the hospital and Provider Number following this patient.

Patient Status: Select the appropriate status for this recipient. This is a required field.

Living: Select only if the recipient is living during this follow-up period.
Dead: Select only if the recipient died during this follow-up period.

Primary Cause of Death: If the Patient Status is Dead, enter the patient's primary cause of death. If an Other code is selected, specify the other cause of death in the space provided.

Retransplanted: Select only if the recipient received another heart, lung or heart/lung from a different donor since the last follow-up was submitted to OPTN/UNOS.

Date: Last Seen, Retransplanted or Death: Enter the date the patient was last seen or the date of, death or retransplant for this patient, using the standard 8-digit numeric format of MM/DD/YYYY.

Contributory Cause of Death: If the Patient Status is Dead, enter the patient's contributory cause of death. If an Other code is selected, specify the other cause of death in the space provided.

Contributory Cause of Death: If the Patient Status is Dead, enter the patient's contributory cause of death. If an Other code is selected, specify the other cause of death in the space provided.

Note: The remaining fields are optional.

Has the patient been hospitalized since the last patient status date: If the patient has been hospitalized since the last patient status report, regardless of patient status (living, dead, or retransplanted), select YES. If not, select NO. If unknown, select UNK.

Number hospitalizations: If the patient was hospitalized, enter the number of hospitalizations.

Hospitalized for rejection: Select YES, NO or UNK (Unknown) to indicate if the patient was hospitalized for rejection since the last follow-up.

Hospitalized for infection: Select YES, NO or UNK (Unknown) to indicate if the patient was hospitalized for infection since the last follow-up.

Was there evidence of noncompliance with immunosuppression medication during this follow-up period that compromised the patient's recovery: Select YES or NO to indicate if the patient was noncompliant during this follow-up period. If unknown, select UNK.

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Functional Status: Select the choice that best describes the recipient's functional status just prior to the time of transplant.

Cognitive Development: Select the choice that best describes the candidate's cognitive development at the time of listing.

Definite Cognitive Delay/Impairment (verified by IQ score <70 or unambiguous behavioral observation)

Probable Cognitive Delay/Impairment (not verified or unambiguous but more likely than not, based on behavioral observation or other evidence)

Questionable Cognitive Delay/Impairment (not judged to be more likely than not, but with some indication of cognitive delay/impairment such as expressive/receptive language and/or learning difficulties)

No Cognitive Delay/Impairment (no obvious indicators of cognitive delay/impairment)

Not Assessed

Motor Development: Select the choice that best describes the candidate's motor development at the time of listing.

Definite Motor Delay/Impairment (verified by physical exam or unambiguous behavioral observation)

Probable Motor Delay/Impairment (not verified or unambiguous but more likely than not, based on behavioral observation or other evidence)

Questionable Motor Delay/Impairment (not judged to be more likely than not, but with some indication of motor delay/impairment)

No Motor Delay/Impairment (no obvious indicators of motor delay/impairment)

Not Assessed

Physical Capacity: (Complete for recipients older than 18 years of age.) Select the choice that best describes the recipient's physical capacity just prior to the time of transplant. If the recipient's Medical Condition indicates they are hospitalized, select Not Applicable (hospitalized). (This field is optional for adult recipients only.)

No Limitations

Limited Mobility

Wheelchair bound or more limited

Not Applicable (<1 year="" old="" or="" hospitalized)

Unknown

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Working for income: (Complete for patients 19 years of age or older) Indicate whether the patient was working for income at the time of follow-up by selecting YES, NO or UNK.

If No, Not Working Due To: If NO is selected, indicate the reason why the patient was not working.

If Yes: If Yes is selected, indicate the patient's working status.

Academic Progress: (Complete for patients 18 years of age or younger) Select as appropriate to indicate the patient's academic progress at the time of follow-up.

Academic Activity Level: Select as appropriate to indicate the patient's academic activity level at the time of follow-up.

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Date of Measurement: Enter the date, using the 8-digit format of MM/DD/YYYY, the patient’s height and weight were measured.

Height: If the patient is 18 years of age or younger, enter the height of the patient at time of follow-up in centimeters.

Weight: Provide the weight of the patient at time of follow-up in kilograms.

BMI (Body Mass Index): For recipients 18 years old or younger during the follow-up period, calculated percentiles will display based on the 2000 CDC growth charts.

Percentiles are the most commonly used clinical indicator to assess the size and growth patterns of individual children in the United States. Percentiles rank the position of an individual by indicating what percent of the reference population the individual would equal or exceed (i.e. on the weight-for-age growth charts, a 5 year-old girl whose weight is at the 25th percentile, weighs the same or more than 25 percent of the reference population of 5-year-old girls, and weighs less than 75 percent of the 5-year-old girls in the reference population).

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Graft Status: If the graft is functioning, select Functioning. If the graft is not functioning at the time of hospital discharge or time of report, select Failed. If Failed, complete the remainder of this section.

Note: If death is indicated for the recipient, and the death was a result of some other factor unrelated to graft failure, select Functioning.

If Failed, provide the following information:

Primary Cause of Graft Failure: Select the cause of graft failure.

Primary Non-Function
Acute Rejection
Chronic Rejection/Atherosclerosis
Other, Specify

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Heart:

Ejection Fraction: Enter the most recent ejection fraction available for the patient.

Pacemaker: Select YES if the patient has had a permanent pacemaker inserted since the last follow-up. If not, select NO. If unknown, select UNK.

Coronary Artery Disease: Select YES if the patient has experienced new signs and symptoms of coronary artery disease at the time of follow-up. If not, select NO. If unknown, select UNK.

Clinically Significant Events If the patient had coronary artery disease: Select YES if the recipient has exhibited clinically significant events related to coronary artery disease (e.g. myocardial infarction, heart catheterization, angioplasty, unstable angina). If not, select NO. If unknown, select UNK.

Lung:

FeV1: Enter the most recent value available for forced expiratory volume at one second. Provide FeV1 values in percentages only.

O2 Requirement at Rest: Enter the patient's oxygen requirement at rest in L/min. at the time of follow-up. If the patient does not require oxygen at rest, enter 0 (zero).

Bronchiolitis Obliterans Syndrome: Select YES if the patient has been diagnosed with bronchiolitis obliterans since the last follow-up and indicate the Grade. If not, select NO. If unknown, select UNK.

Bronchial Stricture (Since last follow-up): Select YES if the patient has been diagnosed with a bronchial stricture since the last follow-up. If not, select NO. If unknown, select UNK.

If YES, Stent: If the recipient has been diagnosed with a bronchial stricture, indicate if stents have been inserted. If not, select NO. If unknown, select UNK.

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Did patient have any acute rejection episodes during the follow-up period: Select Yes if the patient experienced at least one episode treated with anti-rejection agent or if the patient experienced at least one episode but none were treated with additional anti-rejection agent during this follow-up period. If not, select NO. Select Unknown if unknown.

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Have any of the following viruses ever been tested for: Indicate whether the patient was tested for HIV, CMV, HBV, HCV, EBV by selecting YES or NO. If Yes was selected for any of the viruses listed below, indicate whether there was clinical disease by selecting YES or NO for the viruses listed below.

HIV (Human Immunodeficiency Virus)- Any of several retroviruses and especially HIV-1 that infect and destroy helper T cells of the immune system causing the marked reduction in their numbers that is diagnostic of AIDS. Indicate if there was any clinical disease. If yes, indicate the results of the Antibody and RNA tests.

CMV (Cytomegalovirus) - A herpesvirus (genus Cytomegalovirus) that causes cellular enlargement and formation of eosinophilic inclusion bodies especially in the nucleus and that acts as an opportunistic infectious agent in immunosuppressed conditions (as AIDS). Indicate if there was any clinical disease. If yes, indicate the results of the IgG, IgM, Nucleic Acid Testing and Culture tests.

HBV (Hepatitis B Virus) - A sometimes fatal hepatitis caused by a double-stranded DNA virus (genus Orthohepadnavirus of the family Hepadnaviridae) that tends to persist in the blood serum and is transmitted especially by contact with infected blood (as by transfusion or by sharing contaminated needles in illicit intravenous drug use) or by contact with other infected bodily fluids (as during sexual intercourse) -- called also serum hepatitis. Indicate if there was any clinical disease. If yes, indicate the results of the Liver Histology, Core Antibody, Surface Antigen, HBV DNA and HDV (Hepatitis Delta Virus) tests.

HCV (Hepatitis C Virus) - A disease caused by a flavivirus that is usually transmitted by parenteral means (as injection of an illicit drug, blood transfusion, or exposure to blood or blood products) and that accounts for most cases of non-A, non-B hepatitis. Indicate if there was any clinical disease. If yes, indicate the results of the Liver Histology, Antibody, RIBA and HCV RNA tests.

EBV (Epstein-Barr Virus) - A herpesvirus (genus Lymphocryptovirus) that causes infectious mononucleosis and is associated with Burkitt's lymphoma and nasopharyngeal carcinoma -- abbreviation EBV; called also EB virus. Indicate if there was any clinical disease. If yes, indicate the results of the IgG, IgM and EBV DNA tests.

EBV (Epstein-Barr Virus) - A herpesvirus (genus Lymphocryptovirus) that causes infectious mononucleosis and is associated with Burkitt's lymphoma and nasopharyngeal carcinoma -- abbreviation EBV; called also EB virus. If there was a clinical disease, indicate the results of the IgG, IgM and EBV DNA tests.

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Drug Treated Hyperlipidemia: Select YES if the patient has had any medication newly prescribed for the purpose of lowering serum lipid levels. If not, select NO. If unknown, select UNK. If the patient has hyperlipidemia but is not taking medication, answer NO to this question. If the patient was taken off of medication but was then put back on the medication during the follow-up period, answer Yes to this question.

Bone Disease (Symptomatic): Select Yes if the patient has exhibited new signs and symptoms of bone disease since the last follow-up. If not, select NO. If unknown, select UNK.

Chronic Liver Disease: Select YES if the patient has exhibited new signs and symptoms of chronic liver disease since the last follow-up. If not, select NO. If unknown, select UNK.

Cataracts: Select YES if the patient has been newly diagnosed as having cataracts since the last follow-up. If not, select NO. If unknown, select UNK.

Diabetes: Select Yes if the patient has been newly diagnosed as having diabetes since the last follow-up. If not, select NO. If unknown, select UNK. If the patient is not newly diagnosed with diabetes but has newly become insulin dependent for their diabetes, then answer Yes to this question.

If Diabetes yes, Insulin Dependent: If Yes is selected for Diabetes, indicate if the patient has started insulin since the last follow-up. If not, select NO. If unknown, select UNK.

Renal Dysfunction: Select YES if the patient has been newly diagnosed or developed signs and symptoms of renal dysfunction since the last follow-up. If not, select NO. If unknown, select UNK.

If Yes, Creatinine > 2.5 mg/dl: Indicate if the patient's creatinine level is greater than 2.5 mg/dl.

Chronic Dialysis: Indicate if the patient is on chronic peritoneal or hemodialysis

Renal Tx since Thoracic Tx: Indicate if the patient has received a renal transplant since the thoracic transplant.

Stroke: Select Yes if the patient experienced a stroke (CVA) since the last follow-up. If not, select NO. If unknown, select UNK.

Drug Treated Hypertension: Select YES if the patient has had any medication newly prescribed for the purpose of hypertension control since the last follow-up. If not, select NO. If unknown, select UNK. If the patient has hypertension, but is not taking medication, answer NO to this question. If the patient was taken off of hypertension medication but was then put back on the medication during the follow-up period, answer YES to this question.

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Post Transplant Malignancy: Select YES if the patient has been diagnosed with any record of malignant cancer since the last follow-up. If not, select NO. If unknown, select UNK. If Yes is selected, at least one of the fields listed below must be completed. A Post Transplant Malignancy record will generate when one or more of the fields listed below is selected.

Donor Related: In most instances the donor does not have a history of cancer and transmission of cancer is unexpected. This occurrence is usually discovered when multiple recipients of organs from a single donor develop the same cancer (e.g. Melanoma). It may also occur when the clinical (not histological) diagnosis of primary brain cancer is made when, in fact, the donor had a metastatic brain cancer from an occult (concealed from observation) primary site. Select YES if the malignancy is donor related. If not, select NO. If unknown, select UNK.
 

Recurrence of pre-tx tumor: The patient has a past history of cancer, and develops the same type of cancer post-transplantation. This does not apply to basal cell or squamous cell carcinoma of the skin, unless it recurs in the original site. The patient has a cancer in an explanted (removed) organ (usually liver or maybe kidney), and later develops a recurrence of the same type of cancer. For example, the patient has a hepatocellular carcinoma of the native liver (hepatoma), which is resected at the time of transplantation, and develops a recurrent hepatocellular carcinoma (at any site, at any time). Select YES if a pre-transplant tumor has recurred. If not, select NO. If unknown, select UNK.
 

Post Tx De Novo solid tumor: Select the type from the drop-down list. This includes all new malignant tumors except Post Transplant Lymphoproliferative Disease. This includes all skin cancers, sarcomas, adeno-carcinomas, hematological malignancies, and many cancers with special names. It does not include benign tumors such as nevi, adenomas, or fibromas. Usually, the description should include the type of cancer (e.g. squamous cell, adenocarcinoma), and the organ involved. Select the one or more tumor types: Select all tumor types that apply to the patient by clicking on the checkbox next to the type.

Post transplant lymphoproliferative disease and lymphoma: Lymphoid growths which occur in organ transplant patients, in which evidence of Epstein-Barr virus (EBV) can be demonstrated. A family of lesions that straddle the border between infection and neoplasia (tumors). The spectrum runs from infectious mononucleosis to clonal proliferation of lymphoid cells to gross tumor formation and malignancy. PTLDs must be distinguished from sporadic lymphomas or non-EBV-associated lymphadenopathies, which may also be seen in the transplant population. Select YES if the cancer was post transplant lymphoproliferative disease and lymphoma. If not, select NO. If unknown, select UNK.

Note: Please report each type of malignancy only once in the follow-up process.

When a patient has a tumor during one follow up period and the tumor continues into the next follow-up period without going away, the tumor should only be reported on that first follow-up record and not reported on the next follow-up record. The tumor should be reported on subsequent follow-up records ONLY if the tumor goes away and then returns in the next follow-up period.

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Biological or Anti-viral Therapy: Select Yes, NO or Unknown/Cannot Disclose if biological or anti-viral therapy is being administered to the patient. If Yes is selected, check all that apply:

Acyclovir (Zovirax)

Cytogam (CMV)

Gamimune

Gammagard

Ganciclovir (Cytovene)

Valgancyclovir (Valcyte)

HBIG (Hepatitis B Immune Globulin)

Flu Vaccine (Influenza Virus)

Lamivudine (Epivir) (for treatment of Hepatitis B)

Other/specify

Other Therapies: Select Yes or NO to indicate if the patient received each of the therapies listed.

Were any medications given during the follow-up period for maintenance: Select Yes same as previous validated report if there have been no changes in medications during this follow-up period. The immunosuppressive medications selected as Current on the previous validated report will automatically be checked off in the Current column of this follow-up record. Select Yes, but different than previous validated report if there have been changes in medications during this follow-up period. Then select the appropriate Immunosuppressive Medications. Select None given if no medications were given during this follow-up period.

Did the physician discontinue all immunosuppressive medications: The purpose of this question is to determine whether the physician stopped the immunosuppressive medications, or whether the patient stopped the medications themselves. Select Yes, if the physician discontinued the medications. Select NO, if the medications were stopped by the patient or for some other reason. Only complete if the answer to the preceding question was NO.

Did the patient participate in any clinical research protocol for immunosuppressive medications: Select Yes to indicate the patient did participate in clinical research for immunosuppressive medications. If not, select NO. If Yes, specify in the space provided.

Immunosuppressive Medications AT Follow-up:

immunosuppressive Medications:

For each of the immunosuppressant medications listed, check Previous Maintenance (Prev Maint), Current Maintenance (Curr Maint) or Anti-rejection (AR) to indicate all medications that were prescribed for the recipient during this follow-up period, and for what reason. If a medication was not given, leave the associated box(es) blank.

Previous Maintenance (Prev Maint) includes all immunosuppressive medications given during the report period, which covers the period from the last clinic visit to the current clinic visit (example: Prednisone, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Azathioprine, or Rapamycin). This does not include any immunosuppressive medications given to treat rejection episodes.

Current Maintenance (Curr Maint) includes all immunosuppressive medications given at the time of the current clinic visit to begin in the next report period with the intention to maintain them long-term (example: Prednisone, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Azathioprine, or Rapamycin). This does not include any immunosuppressive medications given to treat rejection episodes.

Note: On Recipient Death (RD) records, any maintenance medications given during the follow-up period should be noted as Previous, and nothing should be noted in the Current column.

Anti-rejection (AR) immunosuppression includes all immunosuppressive medications given for the purpose of treating an acute rejection episode since the last clinic visit (example: Methylprednisolone, Atgam, OKT3, or Thymoglobulin). When switching maintenance drugs (example: from Tacrolimus to Cyclosporine; or from Mycophenolate Mofetil to Azathioprine) because of rejection, the drugs should not be listed under AR immunosuppression, but should be listed under maintenance immunosuppression.

Note: The Anti-rejection field refers to any anti-rejection medications since the last clinic visit, not just at the time of the current clinic visit.

As further clarification, drugs that are used with the intention to maintain recipients long-term are medications such as Tacrolimus, Cyclosporine, Azathioprine, Mycophenolate Mofetil and Prednisone. These maintenance medications should not be listed as AR medications to treat acute rejection. When patients have a true acute rejection, they are given anti-rejection medication such as steroids, OKT3, ATG, Simulect and Zenapax, in addition to the maintenance medications. These are the medications that should be selected as anti-rejection.

If an immunosuppressive medication other than those listed is being administered (e.g., new monoclonal antibodies), select Previous Maint, or Current Maint, or AR next to Other Immunosuppressive Medication field, and enter the full name of the medication in the space provided. Do not list non-immunosuppressive medications.