Sample Testis Data Entry Guide

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Contents

Introduction

This guide was made in order to help new and current RSAs efficiently and precisely enter testis patient information from the clinic or surgery forms into Caisis in a standardized method. This guide is also intended to enable other RSAs who generally enter data for other urological cancers to be able to enter testis patient data as well. In the event testis data accumulates and RSAs responsible for its entry are not able to enter it within four weeks, other RSAs can refer to this guide and assist in entering the data to ensure completion in a timely fashion. It is the goal of this guide to ensure a standard of testis data entry and procedures for issues that may arise due to discrepancies on forms, medical records, et cetera.

General Guidelines

When entering data from Caisis forms it is not always clear what the physician has written especially in the Medications and Comorbidities sections. For these sections a good way to start is entering the first few letters in the data field until a list of possibilities drops down. If the dropdown list does not aid in interpreting the hand writing, there are several tools available to determine what has been written.

One of the most important tools is the Electronic Medical Record (EMR). EMR is where scanned copies of forms and other documentation can be found. Here you can zoom in on forms and try to take a closer look at the writing. Occasionally and depending on the doctor, you can find a dictation of the same form in EMR allowing you to easily understand what is written on the form.

For items written in the Medical & Surgical History and Comorbidities section on the Caisis forms, doing a web search can provide clues to what the doctor wrote if you are not certain. Another great resource is of course your co-workers. Some RSAs are used to an individual doctor's hand writing and may be able to help make out ambiguous items. If you are unable to definitively make out hand writing do not enter what you think it might say. Speak to your RDC or contact the person (ie. Attending or Fellow) who wrote down the items in question to find the answer.

Once you have entered data and want to save the form you need to always enter the Data Quality when it is available. You will have four options to select from. They are as follows:
  • OUT - Occured outside the hospital with no documentation available in EMR; hearsay; patient reported data (ie. Outside Lab Tests); procedures without documentation; E-mail correspondence; telephone conversations, medications without original Rx order.
  • REV - Source documentation reviewed at the hospital available in EMR under "OutsideCorres" folder; official reports such as path reports, lab reports, pathology specimens or slides reviewed at the hospital.
  • STD - All original hospital documentation including dictated initial consults, clinic forms, diagnostic and pathology reports
  • RR – Data reviewed for research by the Attending Pathologist (Only for Testis pathology results).

Patients

Allergies

Under the Patients tab click on Allergies. If "NKA" is checked on the form, then the patient has no known allergies. If the allergy or response listed is illegible on the form look in EMR if there is a dictation for that visit. Also, in the "ACHARTDOC" folder in EMR there will usually be a list of allergies and reactions.

Family History

Under the Patients tab click on Family Members. Only enter in family members who have/had cancer. The Relationship field must have a value entered, so if no relationship is stated use “Unknown”. If a relative has died from any type of cancer make sure to type it in the Notes section and include the age of death (ie. Died at age 72 of colon cancer).

Social History

Under the Patients tab click on Social History. Choose the type of Tobacco Usage from the drop down list. For entering the number of packs per day, use numbers to describe the amount. For example, a patient smokes an average 5 cigarettes a day (20 cigarettes per pack), so enter 0.25 packs per day. If a patient is described as only a social or occasional smoker, type either answer in the Pack per Day field. Sometimes a patient will have a smoking history that is not limited only to cigarettes. For these patients use the Other field (eg. Occasional marijuana use). Enter in the patient’s alcohol usage, carcinogen exposure and any other information that is supplied. The Data Source is always STD for social history.


Comorbidities

Under the Patients tab click on Comorbidities. Enter patient’s past medical histories in this form. It is important to note that past medical procedures are written in the same box on the clinic forms as Comorbidities. Make sure any procedures are entered in Procedures under the Procedure tab with the appropriate data quality entered. If there is no initial date, use “PreTx” meaning before treatment. Enter the Data Quality as OUT if there is no documentation besides the form for the comorbidity or procedure in EMR.

Therapies

Medications

Under the Therapies tab click on Medications. Enter each medication and the date when the patient started taking it from the form, dictation, or medication reconciliation list. For a new visit or initial dictation, if there is no date on any of these documents enter “PreTx”, meaning the patient began taking the medication prior to treatment. If a new medication is listed during a follow up visit, then enter the date of the visit as the start date for that medication. Many times medications are difficult to read so check if there is a dictation for that visit explaining the medications. You can also try entering the first few letters of the medication to generate a drop down list. Another option is to look up possible spellings of the medication on the web. After completing the Date, Medication, Dose, and Schedule fields, select the appropriate Data Source (ie. Data Form / Medical Record / Medication Reconciliation) and Data Quality. If you do not have the original prescription order the Data Quality will be OUT.

Chemotherapy

Under the Therapies tab click on Medical Tx. When available, always include the treatment Start Date, Stop Date, Type (required), Agent, Indication, Intent, Cycle and Institution. If the chemotherapy was administered here, you can open a patient's Pharmacy Profile under Tools in CIS to check dates, agents, and cycles.

Combinations of Chemotherapeutic Agents for Testis Cancer

EP - Etoposide (VP-16), CISplatin
BEP - Bleomycin, Etoposide, CISplatin
TIP - Taxol, Ifosfamide, CISplatin
VIP - Etoposide (VP-16), Ifosfamide, CISplatin
VeIP - Vinblastin, Ifosfamide, CISplatin
TICE - Taxol, Ifosfamide, Carboplatin, Etoposide
ICE - Ifosfamide, Carboplatin, Etoposide
PVB - CISplatin, Vinblastine, Bleomycin
VAB-6 - Vinblastin, Adrianmycin, Bleomycin, CISplatin, Cystoxan (older treatment)

Indication or Risk Category

Indication corresponds to the patient's risk category. The risk category is determined by one of three lab values (serum tumor markers) placing the patient in either Good, Intermediate, or Poor risk. These risk categories also correspond to the patient's S Stage.
Categories are defined in the table below.

S Stage and Risk
Stage (Risk) AFP - HCGN - LDH
S0 (Good) AFP WNL and HCGN WNL and LDH WNL
S1 (Good) AFP < 1000 or HCGN < 5000 or LDH < 1.5 x Normal Value
S2 (Intermediate) AFP 1000-10000 or HCGN 5000-50000 or LDH 1.5-10 x Normal Value
S3 (Poor) AFP >10000 or HCGN > 50000 or LDH >10 x Normal Value

Intent

Intent corresponds to the point in the timeline of cancer treatment that the chemotherapy is given. Potential points are listed below with defining preceding events.
  • Induction
Induction is the most common intent. This point is after orchiectomy and before RPLND.
  • Relapse after surveillance
Surveillance (observation with no treatment) after orchiectomy in which the patient exhibits no evidence of disease for a minimum period of 2 months. Following this period, evidence of disease is identified.
  • Salvage after incomplete RPLND
RPLND fails to remove all disease.
  • Adjuvant after RPLND
After orchiectomy the patient undergoes RPLND with positive pathology.
  • Adjuvant after postChemo RPLND
After orchiectomy the patient receives induction chemotherapy, then RPLND with positive pathology.
  • Relapse after postChemo RPLND
After orchiectomy the patient receives induction chemotherapy, then RPLND with negative pathology. After the patient exhibits no evidence of disease for two months or more, disease is identified.
  • Relapse after RPLND
After orchiectomy the patient undergoes RPLND. After the patient exhibits no evidence of disease for two months or more, disease is identified.
  • Second line
Induction chemotherapy fails to slow progression of disease. Second line chemotherapy is a different combination of agents than the induction chemotherapy.
  • Third line
Induction and second line chemotherapy fail to slow progression of disease. Third line chemotherapy is a different combination of agents than both the induction and second line chemotherapies.
  • Relapse with progression of disease
Equivalent to a second line of chemotherapy after point of relapse.
  • Relapse after Chemo
After orchiectomy the patient receives induction chemotherapy. After the patient exhibits no evidence of disease for two months or more, disease is identified.



Number of Cycles

Chemotherapeutic agents have shown to be most effective when administered over a certain number of cycles and in particular combinations. The number of cycles is either indicated by the clinician or can be calculated by counting the administrations in the patient's pharmacy profile.
Sometimes due to toxicities or adverse events, certain agents are dropped from the patient's chemo regimen. In this case, enter the original scheduled regimen and make a note of the dropped agent. For instance, a patient was scheduled to receive BEP for 4 cycles. Due to pulmonary toxicity, bleomycin was dropped from the last cycle and the patient received only EP for the last cylcle. Enter BEP X 4 cycles and indicate in the Notes field that bleomycin was dropped from the last cycle.
If, however, the entire regimen was discontinued, enter the number of administered cycles. For instance a patient was scheduled to receive BEP for 4 cycles. Due to neutropenia, chemotherapy was stopped after 3 cycles. Enter BEP X 3 cycles and indicate in the Notes field that the patient received 3 of 4 scheduled cycles.

Radiation Therapy

Some testis cancer patients receive external beam radiation treatment. This form is found under Medical Tx. When available, the following fields should be entered: Start Date, Stop Date, Type (required), Intent, Target, Total Dose, # Fractions, Data Source, and Data Quality. The information can be found in outside reports or the Radiation Oncology folder in EMR.
The type is most often External Beam.
The intent is most often Adjuvant. After orchiectomy, some patients with a pure seminoma pathology receive adjuvant external beam radiation.
The target is most often Pelvic/ Paraaortic.

Diagnostics

Lab Tests

Under the Diagnostics tab click on Lab Tests. All lab tests done at the hospital are automatically entered into Caisis. The three main lab tests, also known as markers, for testic cancer patients are AFP (Alpha-Fetoprotein), HCGn (Human Chorionic Gonadotropin) and LDH or LD (Lactate dehydrogenase). All outside lab tests need to be entered from either clinic forms or outside reports in the "OutsideCorres" folder in EMR. Always check EMR if you are unsure whether a lab test is OUT or REV. It will be considered REV if the original outside lab report is in EMR.

Diagnostic Imaging

Imaging technologies are used to diagnose testis cancer and to systematically monitor treated patients. Certain patients are closely observed with imaging technologies with the intent to preempt a disease recurrence. Images obtained for diagnostic purposes unrelated to testis cancer are not entered by the testis RSA (i.e., a CT Urogram to delineate urinary retention). Images that capture a complication of testis cancer treatment (surgery, chemotherapy, radiation therapy) are not entered; however the complication should be entered under Outcomes.
Images are entered in the Diagnostics form. The following fields should always be entered when available: Date, Type (a required field), Target, Result, Data Source, and Data Quality.
  • The Date is the date of the examination, not the date of the imaging report.
  • The Type or modality of images entered for testis cancer are Ultrasound, CT Scan, X-Ray, MRI, and PET Scan.
  • The Target of the image is related to the modality. Targets commonly entered for testis cancer are Scrotum, Abdomen/Pelvis, Chest, Whole Body (reserved for PET Scans), and Brain. The scrotum is usually imaged by ultrasound. The abdomen and pelvis are usually imaged by CT scan. The chest is imaged either by x-ray or CT scan. PET scans image the whole body - sometimes labeled as neck to groin - to detect metabolic activity. The brain is usually imaged by MRI or CT scan.
When more than one target is imaged in a single scan it is important to enter the targets separately according to the above regions. For instance, with a CT scan of the chest/abdomen/pelvis, 2 diagnostic forms would be entered. One for a CT scan of the chest, and one for a CT scan of the abdomen/pelvis.
  • The Result is the extent of testis cancer captured in the image. Primary testicular tumors imaged by ultrasound are entered in the Result field. The most common regions for testis cancer metastasis are the retroperitoneal (RP) lymph nodes, the mediastinal lymph nodes, and the lungs. Metastasis to the RP lymph nodes is entered in the Result field of images of the abdomen/pelvis. Metastasis to the mediastinum and lungs are entered in the Result field of images of the chest. The details are outlined below.

Results for Scrotum

Remember that images of the scrotum are used to diagnose primary testicular tumors.
  • Normal
No germ cell testicular tumor is suspected. Benign testicular pathologies such as microlithiasis, or epididymal cysts are entered in the Notes field.
  • Ipsilateral-Malignant
Germ cell testicular tumor is suspected in one testicle.
  • Bilateral-Malignant
Germ cell testicular tumors are suspected in both testicles simultaneously.
  • Contralateral-Malignant
Germ cell testicular tumor is suspected post orchiectomy in remaining testicle.

Results for Abdomen/Pelvis

Remember that images of the abdomen and pelvis are used to evaluate the extent of retroperitoneal lymph node metastasis. Less commonly, metastasis to other abdominal and/or pelvic tissues are found on these scans. The Result entered for CT scans or MRIs of the abdomen/pelvis is going to be a number (represented here by X) in centimeters or "Normal".
  • Normal
  • No lymph nodes seen
  • Reactive lymph nodes (meaning the lymphadenopathy is due to inflammation resulting from tissue trauma or infection)
  • Mildly enlarged lymph node(s) that has been previously captured and is now stable over time - enter in Notes field.
  • Xcm
The size of the largest metastatic lymph node in centimeters. RP sites commonly reported are para-aortic and interaortocaval. Lymph nodes in the mediastinum or neck would not be entered here.
When the metastatic lymph nodes are identified, an Other Image Findings subform is entered detailing each RP region in which metatastasis is suspected. This is required only for images of the abdomen/pelvis.
Other Image Findings
This subform is primarily entered for RP lymph node metastases detected through imaging. For patients with a known right testis primary tumor, the primary landing zone for lymph node metastasis is the interaortocaval region. For patients with a known left testis primary tumor, the primary landing zone for lymph node metastasis is the para-aortic region. Required fields for this subform are Site, Subsite, Result, and Length.
  • For any non-lymphatic site of metastasis in the abdomen or pelvis enter the required fields with Result = Abnormal Malignant and Length = the maximum recorded dimension for the site. (This is not common.)
  • For lymph nodes, the Site = "Nodes", the Subsite = RP region, Result = "Abnormal Malignant" and the Length = the maximum recorded dimension for the largest node in that region. Do not record multiple nodes of the same region. If the RP region = the landing zone for the tumor laterality, the first record in the subform is entered with Subsite = "PrimaryLandingZone" and Length left blank. Enter the complete record for this node second.
Nodes to be recorded in this subform: precaval, paracaval, para-aortic, pre-aortic, interaortocaval, interiliac (hypogastric), right iliac, left iliac, right hilar, left hilar, right retrocrural, left retrocrural and inguinal. If the region of the node is not mentioned in the report, do not enter it in a subform.

Results for Chest

Remember that images of the chest are used to evaluate the extent of mediastinal lymph node metastasis or pulmonary metastasis. The Result entered will reflect this metastatic involvement.
  • Normal
  • Clear lungs
  • No disease recurrence or metastasis seen in the thorax
  • No evidence of cardiopulmonary disease
  • Previously recorded findings that exhibit stability over time - enter in Notes field
  • Mediastinal mass
  • One lung-one met
  • One lung-mult mets
  • Bilateral-one met
  • Bilateral-mult mets
  • Mediastinum+one lung-one met
  • Mediastinum+one lung-mult mets
  • Mediastinum+bilateral-one met
  • Mediastinum+bilateral-mult mets

These values are mostly self-explanatory. No subform is needed for chest findings.

Results for all other targets

  • Since PET scans are used to detect metabolic activity (an indicator of active metastasis) results are entered as "Normal" when no metastasis is suspected and as "Abnormal Malignant" when metastasis is suspected.
  • Images of the brain are used to detect metastasis. Results are entered as "Normal" when no metastasis is suspected, as "Single met" when one metastasic lesion is suspected and as "Multiple mets" when more than one metastatic lesion is suspected.
  • If metastatic lymph nodes are identified in the neck, a diagnostic form is entered with the Target=Neck and the Result=Xcm.
  • If metastasis is identified in any of the abdominal or pelvic organs, the result defaults to the largest lymph node as outlined in Results for Abdomen/Pelvis. However, if metastasis is identified in any of the abdominal or pelvic organs independent from any lymphadenopathy (such as a recurrence post RPLND), the result is entered as "Abnormal Malignant" and the details are entered in the Other Image Findings subform.

Encounters

Encounters

Under the Encounters tab click on Encounters. Usually vitals are taken at the encounter and should always be entered when available.

Always enter an Encounter record with the Date, Type of visit, Chief Complaint (ie. Prostate Cancer or Bladder Cancer), Physician, Data Source and Data Quality for every data form or dictated visit you enter into Caisis. Usually vitals are taken at the encounter and should always be entered when available, especially Height and Weight.

Initial Diagnostic Testicular Symptoms

This is the first time the patient exhibits signs of testicular cancer. It will usually be mentioned in the New Visit Caisis form, Attending Summary, or Outside Correspondence folder, all can be found in EMR. An exact date will sometimes be given however more often than not a estimated date will be given.
First Enter the date, exact or estimated,then in the Chief Complaint box enter Initial Diagnostic Testicular Symptoms. The actual symptoms will be entered in the Review of Systems subform. Select Genitourinary in the Systems box, then select the appropriate symptom(s). Symptoms can include, but are not limited to; Testis Presenting Mass, Testicle Hardness, Testis Presenting Breast, or Back Pain, to name a few.

Ejaculation

Enter Ejaculation as Chief Complaint if it is noted as so in the Caisis form filled out by the attending. In Review of Systems subform, select "Genitourinary" as the system. Select Ejaculation as the symptom, and in the Result field select Abnormal or Normal.
If Abnormal:
  • Partial = Enter Decreased in notes.
  • Absent = Enter Absent in notes.

Clinical Stage

Under the Encounters tab click on Clinical Stage. Only enter a clinical stage provided by the hospital's physicians. Select "Testis" for Disease, "UICC_02" for Staging System, Stage Group, T, N, M, and S stages, Physician and Date. The clinical stage is based on the pathologic T stage (pT), and the clinical N and M stages. (See also Pathology Stages.) The Date is the date of the orchiectomy. If no orchiectomy was performed, the Date would be the first date of pathologically confirmed germ cell tumor (i.e., biopsy or mass resection). Refer to the following tables for stage details.
T Stage:
  • pTX cannot be assessed
  • pT0 histologic scar or no evidence of primary tumor
  • pTis intratubular germ cell neoplasia (CIS) or intratubular tumor, preinvasive cancer
  • pT1 limited to testis and epididymis without LVI, may invade tunica albuginea but not vaginalis or limited to testis, including rete testis
  • pT2 invades beyond tunical albuginea or into epididymis or limited to testis and epididymis with LVI, or invades beyond tunical albuginea involving vaginalis
  • pT3 invades spermatic cord or invades spermatic cord with or without LVI
  • pT4 invades scrotum or invades scrotum with or without LVI
N Stage:
  • NX cannot be assessed
  • N0 no regional lymph node mets
  • N1 nodes <=2cm
  • N2 single >2cm and <=5cm, multiple <5cm
  • N3 node >5cm
M Stage:
  • MX cannot be assessed
  • M0 no distant mets
  • M1 distant mets
  • M1a non regional lymph nodes or lung
  • M1b other site(s)


Stage Groups
+ I II III
A IA - T1, N0, M0 IIA - Any T, N1, M0 III - Any T, Any N, M1
B IB - T2, N0, M0 IIB - Any T, N2, M0
C IIC - Any T, N3, M0
In addition, there is an IS stage group which is reserved for patients with any T, N0, M0, and rising or persistent elevated serum tumor markers.
S Stage and Risk
Stage (Risk) AFP - HCGN - LDH
S0 (Good) AFP WNL and HCGN WNL and LDH WNL
S1 (Good) AFP < 1000 or HCGN < 5000 or LDH < 1.5 x Normal Value
S2 (Intermediate) AFP 1000-10000 or HCGN 5000-50000 or LDH 1.5-10 x Normal Value
S3 (Poor) AFP >10000 or HCGN > 50000 or LDH >10 x Normal Value

Surveys

Types of surveys:

  • Testis Relapse
  • Testis Fertility

Outcomes

Disease Status

Under the Outcomes tab click on Status. Always include the Date, Data Source and Data Quality along with the Status. The following are different status types:
Stable – Alive
NED – No Evidence of Disease
AWD – Alive with Disease
BCR – Biochemical Recurrence
LCR – Local Recurrence
Mets – Distant Metastasis
Also entered using the Status form is initial diagnosis date. This can usually be found on the new visit form or initial consult dictation. Select Diagnosis Date under the "Status" drop down list. Again, always enter the Date, Disease, Data Source and Data Quality.

Toxicities

Testis Cancer Operations and Procedures

Many cases of testis cancer are diagnosed through an operation to remove the involved testicle called an orchiectomy. Retroperitoneal lymph node dissection (RPLND) is another operation to remove lymphatic tissue involved by testis cancer or germ cell tumor. Biopsies are sometimes performed to obtain a pathologic diagnosis prior to or preemptive to surgery.

Operating Room Details

The OR Details form is a record of the time the patient spent in the operating room. It can be found under the Procedures tab. If the Case Surgeon has already electronically completed an OR Details record you can enter additional data. Biopsies or procedures performed at an outside institution unrelated to testis cancer do not require on OR Details form.
Every OR Detail form will have the following fields entered:
Date
Institution
Case Surgeon
Admit Date and Discharge Date - Found in the D/C Summary under the Discharge folder in EMR.
Operating Time - In minutes. Found in the OR Record under the Surgery folder in EMR.
ASA and Anesthesia Type - Found in the Anesthesia Perioperative Report Part 2 under the Surgery folder in EMR.
Estimated Blood Loss (EBL) and Fluids - In milliliters. Found in the Anesthesia Perioperative Report Part 1 under the Surgery folder in EMR.
Data Source
Data Quality

Procedure

The Procedure form is a record of each procedure performed in the operating room. There can be multiple procedures during one operation (multiple Procedure forms linked to one OR Details form).
Every Procedure form will have the following fields entered:
Date
Procedure - Found on the OP Report under the Surgery folder.
Institution
Surgeon
Surgeon Type
Data Source
Data Quality

Pathology

The pathology form is a record of the histological diagnosis of each specimen submitted from each procedure. Not every procedure will require a pathology form; however every pathology form requires a parent procedure form.
Every Pathology form will have the following fields entered when available:
From Operation On
Source Procedure
Path Report Date
Path #
Specimen Type - This is the name of the Procedure to which the pathology corresponds.
Histology - Refer to the specific details for orchiectomy and RPLND to enter this field.
Institution
Pathologist
Data Source
Data Quality

Retroperitoneal Lymph Node Dissection (RPLND)

Procedure

In the procedure record the Approach will coincide with the Template that was used by the attending surgeon. RPLNDs involve removing lymph nodes, the Template depends on which lymph nodes are taken.
Templates
Templates Full Bilateral/Suprahilar Dissection Mod Bilateral Right Modified Left Modified
Lymph nodes
Left/Right SuprahilarX
Paracaval X X X X
Precaval X X X X
Para-aortic X X XX
Pre-aortic X XX X
Interaortocaval X X X X
Right/Left RetrocruralX
Gonadal VeinX X X X
Right Iliac X X X
Left Iliac X X X

Pathology

Pathology Node Findings

Side
Site
Max Dim
Extension
Positive Nodes
Total Nodes
Histology


Pathology Stages

Disease
Staging System - "UICC_02"
N Stage

Orchiectomy

Operating Room Details

Procedure

Pathology

Orchiectomy Histology

Pure Histologies

  • Pure Embryonal, enter as: EC Pure(total), Embryonal
  • Pure Yolk Sac enter as: YS Pure(total), Yolk Sac
  • Pure Seminoma (sometimes called Classic) enter as: Seminoma Pure(total), Seminoma
  • Pure Choriocarcinoma enter as: Chorio Pure(total), Chorio
  • Pure (Mature)Teratoma enter as: Teratoma Pure(total), Teratoma
  • Pure Immature Teratoma enter as: Immature Teratoma(total), Immature Teratoma
    • Only (Mature)Teratoma and Immature Teratoma enter as: Teratoma Pure(total), Teratoma, Immature Teratoma

Mixed Histologies Can be Mixed or one histology can be Predominate, meaning that 50% or more of the tumor consists of this histology.

Mixed:
  • Mixed(total), Embryonal, Yolk Sac, Chorio, etc., etc.,
Predominately (50% or more):
  • Predominately Embryonal enter as: EC Predominately(total),Embryonal, etc., etc.,
  • Predominately Yolk Sac enter as: YS Predominately(total), Yolk Sac, etc., etc.,
  • Predominately Seminoma enter as: Seminoma Predominately(total), Seminoma, etc., etc.,

Burn Out Scar enter as: BurnOutScar

Benign enter as: Benign

Pathology Stages

Disease
Staging System - "UICC_02"
N Stage
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