Effective methods of Bone Marrow Transplantation data collection Filipi, C.F.; Simione, A.J; Testa, L.H.A.; Colturato, V.A.R.; Souza, M.P.; Machado, C.M.; Azevedo, W.M.; Mattos, E.R.; Mauad, M.A. – Serviço de Transplante de Medula Óssea do Hospital Amaral Carvalho
z 1996: first transplant z 1996: began to report to ABMT z 2008: began to report to Eurocord z 2009: began to report to CIBMTR
2009: 009 C CIBMTR,, a new e routine out e of o data collection co ect o
z 163 transplantations z 100% enrollment z 3 doctors z 1 nurse z 2 data managers
2009: 009 C CIBMTR,, a new e routine out e of o data collection co ect o z 1996: Mother Worksheet
2009: 009 C CIBMTR,, a new e routine out e of o data collection co ect o z Input Summary
2009: 009 C CIBMTR,, a new e routine out e of o data collection co ect o z Output Summary
2009: 009 C CIBMTR,, a new e routine out e of o data collection co ect o z Control spreadsheet
Effective methods of Bone Marrow Transplantation data collection Filipi, C.F.; Simione, A.J; Testa, L.H.A.; Colturato, V.A.R.; Souza, M.P.; Machado, C.M.; Azevedo, W.M.; Mattos, E.R.; Mauad, M.A. – Serviço de Transplante de Medula Óssea do Hospital Amaral Carvalho
Our Bone Marrow Transplantation Service has reported data to CIBMTR since January 2009, and has been reporting to ABTO since 1999 and 2008 to Eurocord. In 2009 we performed 163 transplants, with 100% enrollment in CIBMTR. To have a comprehensive and continuous database it was needed to adapt our routine supply of information. So it can happen we have a multidisciplinary team of physicians, nurses, social workers and data managers. Since we became Researcher Center our mission is to send information before the deadline is due and based on medical reports and clinic visits. Before the CIBMTR, we kept our data on the "General Worksheet," which is a spreadsheet in Excel where all patients since 1996 were catalogued and separated by 4 colors (transplantations allogeneic related, allogenic unrelated, autologous and retransplantation). This worksheet is our main reference for both studies and statistics to support data collection to report to ABTO and Eurocord because in it we can find about patient personal data, the illness details of each patient, about the transplant and its complications. It was the "General Worsheet" that kicked off our database and remains strong until today, being monthly supplied with new transplants and its clinical events. Since we started with the CIBMTR, we feel the need to create ways to better capture accurate information. In addition to accuracy, this information should be continuous and have a chronological follow-up. We recreate the forms called Input Summary and Output Summary. These forms were already in the patients’ charts, what we've done is add more complete information, such as detailed dates, medications and treatments. This way, the data managers have the information easily accessible and always reliably, because these Summaries are supplied in accordance with the evolution and medical requirements by trained nurses. Both the Input and Output Summary are done during the patient’s hospitalization. For follow-ups we use a mini and smaller version of the CIBMTR forms in Portuguese which are filled with dates, diagnoses and treatments by a nurse who reviews medical records, checks the information and take questions to the medical staff. To be always up to date, we have created a spreadsheet to control the dates, which shows exactly when the transplants complete 100, 180 days, 1 year, 2 years and so on, that way we can manage important dates, prioritize the patients who are coming to due date and don’t get lost . We are about to complete 1 year of data report to CIBMTR and now the work of social assistants will be very helpful in the search for lost patients who are not following-up in our Transplant Center, even though it’s a rare situation. Mostly lost to follow-up are autologous post-transplants patients who have distant return dates to our Center, and sometimes do not return to our Hospital by the CIBMTR specified date. When that happens, the social assistants get into direct contact with the patient and their physicians to record the condition of the patient's general health, recent exams and medications, so we have basic reference for filling in whatever is due and update our database. We believe that the records produced by our data collect routine is the key to our evolution as a Research Center, it serves as reference to what is actually being done about the patient and how they respond to treatment. The aid of the multidisciplinary team is essential to fulfill the deadline with efficiency, excellence and functionality.
HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
==================================================================
Input Summary Name: ____________________________________________________ Age: ______________ RGP: ______________ RA: ____________ Gender: ( ) Masculino ( ) Feminino Date of Birth: _____/_____/______ Race: _________________ Medical Director: ___________________________________________________ RECIPIENT Height: __________ m Body Surface: _________ m2 State: ____ Karnofsky ( ) /Lansky ( ) _______
Weight: ________ kg City: ____________________ Nº of pregnancies:______ Blood Type: Rh factor:
( (
Normal Labor : _____
)A ) Negative
( (
)B ( ) Positive
C-section: _____ ) AB
(
Abort: _____
)O
Occupation: _________________________________________________ Remarkable History: _________________________________________________________ Comments: _________________________________________________________________ ____________________________________________________________________________ Comorbidities ( ) Arrhythmia ( ) Cardiac: ____________________________ ( ) Cerebrovascular disease ( ) Diabetes ( ) Heart valve disease ( ) Hepatic: _______________________ ( ) Solid Tumor ( ) Infection (treatment afetr Day 0) ( ) Inflamatory bowel disease ( ) Obesity ( ) Peptic ulcer ( ) Psychiatric disturbance ( ) Pulmonary ( ) Renal ( ) Rheumatologic ( ) Other _________________________________________________________________
DOENÇA Diagnóstico: ( ) AML - Fab: ________________ ( ) MM - ________________ ( ) ALL - Fab: ________________ ( ) NHL - Classif: ____________________ ( ) CML - ____________________ ( ) Hodgkin - Classif : _________________ ( ) SMD - Classif:______________ ( ) Germ cell tumor - __________ ( ) CLL - Classif: ______________ ( ) Other: ___________________________ ( ) SAA - ____________ _____________________________________ Date of diagnosis: ______/_____/_______ City of diagnosis: _________________________ Status at transplantation: ( ) CR ( ) Parcial Response ( ) Relapse ( ) Chronic Phase ( ) Accelerate Phase ( ) Blast Crisis
( ( (
) 1ª ) 2ª ) ≥ 3ª
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HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
================================================================== IF complete remission, Cytogenetic remission? Molecular remission?
( (
) Yes ( ) Yes (
Central Nervous System (CNS):
(
) No ( ) No (
) Yes (
) Unknown ) Unknown ) No
Last Marrow Biopsy and/or Flow Citometry : Date: _____/_____/_____ Result: _____________________________________________ Karyotype: ( ) Not done ( ) Abnormal: If abnormal: ( ) t(9,22) ( ( ) hyperploid>50 ( ( ) inv 16 ( ( ) t (14;18) (
(
) Not assessed
(
) Normal
) t(4,11) ( ) t(1,19) ( ) 11q23 ) hypoploid ( ) t(8,14) ( ) t(15,17) ) t(8,21) ( ) Monosomy 7 ( ) Monosomy 5 ) Other: ____________________________________________
Important informations: _____________________________________________________________________________ _____________________________________________________________________________
DONOR Donor Type: ( ) Autologous
(
) Related allogeneic
(
) Unrelated allogeneic
Name/Code: __________________________________________________________________ Gender: ( ) Male ( ) Female Relationship: ____________________________________ Age: ______ Date of birth: ___/___/___ Height: ________ kg Nº of pregnancies:______ Normal Labor : _____ C-section: _____ Abort: _____ Blood Type: Rh factor:
( (
)A ) Negative
( (
)B ( ) Positive
) AB
(
)O
Occupation: _________________________________________________ Remarkable History: _________________________________________________________ Comments: _________________________________________________________________ ____________________________________________________________________________ Cell source: ( ) Bone marrow
(
) PBSC
Compatibilidade HLA ( ) HLA identical sibling ( ) Identical relative ( ) Non-identical relative Donor Recipient Multiple UCB
A _____ ; _____ _____ ; _____ _____ ; _____
(
) UBC
(
( ( (
) Monozygotic twin ) Identical non-related ) Non-identical
B _____ ; _____ _____ ; _____ _____ ; _____
) Multiple SCUP
C _____ ; _____ _____ ; _____ _____ ; _____
DRB1 _____ ; _____ _____ ; _____ _____ ; _____
DQB1 _____ ; _____ _____ ; _____ _____ ; _____
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HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
==================================================================
Output Summary Name: ____________________________________________________ Age: ______________ RGP: ______________ RA: ____________ Gender: ( ) Masculino ( ) Feminino Date of Birth: _____/_____/______ Race: _________________ Medical Director: ___________________________________________________ Discharge date: _____/_____/_______
D+ __________
PREPARATIVE REGIMEN Preparative regimem myeloablative: ( ) Yes ( ) No IF no: ( ) Age of recipient ( ) Comorbidities
(
) Per protocol
Preparative Regimen ( ) Cyclo ___________________ ( ) Melphalan _______________________ ( ) Busulfan ____________( ) Oral ( )IV ( ) VP16 ___________________________ ( ) Fludarabine _____________________ ( ) Ara-C _________________________ ( ) BCNU (Carmustine) _______________ ( ) Ifosfamide ______________________ ( ) Mitoxantrone ____________________ ( ) Thiotepa ________________________ ( ) Other: __________________________________________________________________ ____________________________________________________________________________ ATG
(
) No
(
) Yes
Dose: _____________
TBI TLI
( (
) No ) No
( (
) Yes ) Yes
Total dose (cGy): __________ Total dose (cGy): __________
Did the recipient had any growth factor: ( ) No ( ) G-CSF ( ) GM-CSF Start Day: D+ ____________
(
) EPO
(
) Other: ________
TRANSPLANTATION Donor Type ( ) Related (
) Non-related
(
) Autologous
( ) BM Bag 1 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x108) ____________ Bag 2 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x108) ____________
Rua: Dona Silvéria, 150 Vila Assis Cep: 17.210.120 Jaú / SP Fone/Fax: (0xx14) 3602-1381
E-mail:
[email protected]
1
HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
================================================================== ( ) PBSC Bag 1 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x106) ____________ Bag 2 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x106) ____________ ( ) UCB ( ) Multiple UCB Bag 1 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x107) ____________ Cell viability: _________ Bag 2 Time of thaw: _________ Infusion time: __________ to _________ Volume: ______ ml Total of nucleated cells (x107) ____________ Cell viability: _________ Informations: _____________________________________________________________________________ _____________________________________________________________________________
HEMATOLOGIC PROFILE Neutrophil Recovery: ( ) Yes ( ) No ( ) Not assessed Neutrophils > 500 mm3: _____/_____/_______ Nº transfusions: ____________ Last transfusion date: _____/_____/_____ Platelet recovery: ( ) Yes ( ) No ( ) Not assessed Platelets > 20.000 mm3: _____/_____/_______ Platelets > 50.000 mm3: _____/_____/_______ Nº of platelets transfuisons: ____________ Last transfusion date: _____/_____/_____ * platelets recovery must be 7 days after the last transfusion
Chimerism: _____/_____/______ ( ) Not done ( ) Unknown ( ) Complete (100% Donor) ( ) Mixed ( ) 100% Recepient Method: ______________________________________________________
Rua: Dona Silvéria, 150 Vila Assis Cep: 17.210.120 Jaú / SP Fone/Fax: (0xx14) 3602-1381
E-mail:
[email protected]
2
HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
==================================================================
ACUTE GVHD GVHD Profilaxy (* enter all the options) ( ) None ( ) CSA ( ) Corticosteroids ( ) ATG (after D0) ( ) Tacrolimus ( ) MMF ( ) Outro: _____________________________________ GVHD Date of diagnosis: _____/_____/______ Maximum overall grade: ( )I ( ) II ( ) III
(
( (
) MTX ) Monoclonal Antibody
) IV
Skin: _________ Lower intestinal tract: ________
Upper intestinal tract: _________
Staging of the GVHD (Glucksberg) GRADE
STAGING
I
+ até + + skin rash; without gut involvement; and with no more than + liver involvement + até + + + skin rash; plus either + to +++ GI involvement, or + to ++ liver involvement or both + + até + + + + skin rash with + + até + + ++ GI involvement with or without ++ to ++++ liver involvement Similar to Grade III plus extreme symptoms
II III IV
STAGING + ++ +++ ++++
Acute GVHD (Grade by Thomas) SKIN: maculopapular rash LIVER: BILIRUBIN < 25% of body surface 25-50% of body surface General erythrodermia General erythrodermia with blisters and scaling
Diagnosis based on: ( ) Histology evidence
(
GUT: DIARRHEA > 500 ml > 1000 ml > 1500 ml Severe abdominal pain
2 – 3 mg/gl (34-50µ/L) 3 – 6 mg/dl (51-102µ/L) 6 – 15 mg/dl (103-255µ/L) 15 mg/dl (> 255 µ/L)
) Clinical Evidence
Tratamento: ( ) None ( ) Corticosteroids ( ) Simulect ( ) ATG (after D0) ( ) Tacrolimus ( ) MMF ( ) Other: _____________________________________
( (
) Sirolimus ) Monoclonal antibody
INFECTION Infection profilaxy Drugs ( ) Acyclovir ( ) Ganciclovir ( ) Immunoglobulins ( ) Bactrim ( ) Fluconazole Other: __________________
Start date ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____
End date ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____ ____/____/_____
Dose ______________ ______________ ______________ ______________ ______________ ______________
Rua: Dona Silvéria, 150 Vila Assis Cep: 17.210.120 Jaú / SP Fone/Fax: (0xx14) 3602-1381
E-mail:
[email protected]
3
HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
================================================================== Gut decontamination ( ) Albendazol
____/____/_____
____/____/_____
______________
Bacterial Infection Microbiologically documented bacterial infection: ( ) Yes ( ) No Date Type* Organism _____/_____/_____ __________________ _______________________________ _____/_____/_____ __________________ _______________________________ _____/_____/_____ __________________ _______________________________ _____/_____/_____ __________________ _______________________________ * Septicemia; penumonia, ITU, septic shock, infection catheter Antibiotics Drugs Dose Via Start date End date ( ) Cefepine ______ ______ ____/____/_____ ____/____/_____ ( ) Vancomycine ______ ______ ____/____/_____ ____/____/_____ ( ) Metronidazole ______ ______ ____/____/_____ ____/____/_____ ( ) Meropenem ______ ______ ____/____/_____ ____/____/_____ ( ) Imipinem ______ ______ ____/____/_____ ____/____/_____ ( ) Piperacillin ______ ______ ____/____/_____ ____/____/_____ ( ) Clindamycin ______ ______ ____/____/_____ ____/____/_____ ( ) Levofloxacin ______ ______ ____/____/_____ ____/____/_____ ( ) Ciprofloxacin ______ ______ ____/____/_____ ____/____/_____ ( ) Other: _____________________________________________________________ Fungal Infections Candidemia (1 or + positive hemoculture): ( ) Yes ( ) No Diagnosis date: _____/_____/______ Etiology: ____________________________ Diagnosis date: _____/_____/______ Etiology: ____________________________ Aspergillosis: ( ) No Diagnosis date: _____/_____/______ Diagnosis date: _____/_____/______
( ) Probably ( ) Definitive Etiology: ____________________________ Etiology: ____________________________
Diagnóstico microbiológico: ( ) Cultura ( Local da infecção: ( ) Pulmão ( ) SNC
) Galactomanana ( ( ) Seios da face (
) PCR ) Outro: _________
Other fungal infections: ( ) No ( ) Yes Date Type* Organism _____/_____/_____ __________________ _______________________________ _____/_____/_____ __________________ _______________________________ * Blood, urine, bronchoalveolar lavage; TGI; Feces; Other Use of empirical amphotericin: (
) No
Viral Infection Diagnosis date: _____/_____/______ Diagnosis date: _____/_____/______
(
) Yes, dose: ______________________
Etiology: ____________________________ Etiology: ____________________________
Rua: Dona Silvéria, 150 Vila Assis Cep: 17.210.120 Jaú / SP Fone/Fax: (0xx14) 3602-1381
E-mail:
[email protected]
4
HEMONÚCLEO REGIONAL DE JAÚ SERVIÇO DE TRANSPLANTE DE MEDULA ÓSSEA AMBULATÓRIO
================================================================== Others complications: Idiopathic Interstitial Pneumonia ( ) No ( ) Yes ARDS ( ) No ( ) Yes VOD ( ) No ( ) Yes Hemorrhagic cystitis ( ) No ( ) Yes Intubation ( ) No ( ) Yes Other: _____________________________________________
Date: _____/_____/______ Date: _____/_____/______ Date: _____/_____/______ Date: _____/_____/______ Date: _____/_____/______ Date: _____/_____/______
METABOLIC AND NUTRICIONAL METABOLIC ( ( ( ( ( (
) Renal ) Hypertension ) Diabetes ) Hemorrhagic cystitis ) Liver VOD ) Thrombotic microangiopathy
TPN: ( ) Yes ( ) No Start date: _____/_____/____ Mucositis: ( )I ( ) II ( ) III ( ) IV
Creat Max:__________ Date Creat Max: ____/___/___ Trat: ___________________________ Trat: ___________________________ Trat: ___________________________ Trat: ___________________________ Trat: ___________________________
D+ _____
Date: _____/_____/_____ Date: _____/_____/_____ Date: _____/_____/_____ Date: _____/_____/_____
End date: _____/____/____ D+ _____
D+ _______ D+ _______ D+ _______ D+ _______
OTHER COMPLICATIONS _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________
Rua: Dona Silvéria, 150 Vila Assis Cep: 17.210.120 Jaú / SP Fone/Fax: (0xx14) 3602-1381
E-mail:
[email protected]
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