Wednesday, December 17, 2003
April 14. 2005
Infection in central line vs. in blood?
On pg 30: in regards to organism site-we draw blood cultures from central line and peripheral. Do we use code 60 if it is positive (not culturing the actual line but the blood) or do we use code 1 if positive? And what do we do if it is positive for peripheral site do we use code 1?
Answer from Diane
Thank you for asking about the distinction between 'blood' and the 'central line'. Have you discovered the Data Management Manual (www.ibmtr.org)? In Section 3-Appendix G there is a table with some extra text to help you sort out sites of infection. The distinction between the site 'blood' (code 1) and the 'catheter' (code 60) is whether the infection is really in the patient's blood stream - that of course is quite serious. So, sometimes you have to correlate the MD's notes stating what is going on with a patient - you can't just read the microbiology reports to figure it out. Determine what you can tell from the MD's notes. If they aren't clear, then ask them about it (in the context of - you just want to be really accurate with your reporting.)
Note - try not to use the general infection site codes (which mostly end in zero). If the infection is really from the catheter - try to distinguish between the insertion/exit site, the skin or "wound" (code 61) vs. the catheter tip (code 62). While subtle differences - these, too, are important.
Diane Knutson
Sr Research Associate
CIBMTR
January 17. 2005
ANC dropping in relaiton to the DCI form
Hello, I have not had too much experience with the DCI form, (since it was not on stemsoft until the latest release) so I have found I need clarification regarding DCI Q.# 85-87 duration of aplasia post DCI.
To record the date of ANC dropping below 500, would the drop reported be the first day of three consecutive values, or should I put the first drop below 500 even if it is only for 1-2 days??
Thank you in advance for your assistance.
Carol
Answer from Diane
No "three day rule" for ANC drop on DCI. If there was, I would have made sure it was printed on the Form.
Thanks for asking for clarification!
Diane Knutson
Sr Research Associate
CIBMTR
October 22 2004
Question regarding multiple DCIs or transplants
We have a young boy, first allo standard transplant with an unrelated donor earlier this summer, then he develops a poor marrow function and low donor chimerism... this in interpret as poor marrow function and the physicians decide to correct this with a DCI infusion October 13th 2004. At the same date a bone marrow biopsy shows relapse. The physicians decide to go a head with the original plan...and he gets the DCI infusion. Because of the new relapse information they decide he needs treatment: conditioning with fludarabine and stem cells form the donor on October 22nd 2004. My question: the DCI and the re-transplant is with in 14 days of each other, so if I should follow the general rules then the stem cell infusion given on OCT 22nd should not be reported on a pre-registration form, but since he is treated with fludarabine before the second transplant then I not so sure anymore, so I just want to know how you want this reported. Should I send a new pre-registration form for the transplant on October 22nd even though it’s within the 14 days of the DCI infusion and regard this as 2 separate situations? or should I count the DCI on OCT 13th and the infusion on October 22nd as one?
Answer from Diane
The answer to your Q is revealed on p75 of the Manual, a little more than half way down, "any time conditioning is used, that HSCT must be reported separately, regardless of how much time has lapsed. "There is no day rule 14, 28 or otherwise, once conditioning is used.
Diane Knutson
Sr Research Associate
CIBMTR
Juli 1 2004
Myeloma insert
I need help with a myeloma follow-up disease insert. My report period is up to the day before conditioning for a 2nd transplant(11/02/03).
The patient was in complete remission then relapsed 08/05/03. We started thalidomide and serum ig dropped :
8/05/03 .69; 09/02/03 .5 ; 10/9/03 .2 - I do not have a 6 week period. What is the best response for this report period? no lesions, no bm to compare-need more info? let me know and thank you for your help.
How is a relapse from CR the best response? (does this mean that the patient started off in relapse and then the disease progressed, so the best response for the period would be-relapse from CR?
Answer from Diane
The Registry's position on disease status is that the physician overseeing the patient's care should be documenting their response to therapy and disease status. You should not have to be doing this, which is likely very time consuming.
PreTransplant (TX) we do "forgive" the six weeks rule if there is not 6 weeks between the end of therapy and transplant, but not postTX. In the case you describe it may very well be that the disease response is unknown based on the criteria in the Disease Insert, although in the next Day-100 Report Form you could indicate the patient's disease was at least "sensitive to chemo" prior to conditioning.
If the patient was CR preTX and started out the reporting period in CR, their 'best' response to transplant for that reporting period is still CR, even if they relapsed. The status prior to the subsequent TX would be whatever the response to therapy was. If CR was not attained, then their current response would be 'relapse' or 'relapse from CR' - if that is an option and there is not a more appropriate tick box to indicate the true response. In the next reporting period, if the patient is still in relapse, that's when 'relapse from CR' would be their 'best' response to transplant. Best response is always to TX, not to therapy after the relapse.
I hope this explanation helps to clear up some of the terminology.
Best regards,
Diane Knutson
Sr Research Associate
CIBMTR
June 12 2004
DCI or HSCT?
I have a question.
We have a patient that had a HSCT on 4/7/03 for which a Day-100 Report Form was completed.
She then had a DCI on 9/24/03 for progressive disease. A Follow-up Report Form for the HSCT was completed and a DCI Report Form for the DCI was completed.
She progressed again and was given Chemotherapy. A few weeks later, her marrow "died". She was infused with mobilized cells from the original donor on 1/21/04. Which insert do I submit for this 3rd infusion? The donor was mobilized, but the recipient had no pre-conditioning?
Answer from Diane
Good questions. Thank you for asking. I think this may be covered in the Data Management Manual, but briefly - the 21Jan04 infusion is another HSCT. It sounds like you are making the connection of no conditioning to DCI and that is true **most** of the time, but not in this situation. DCI's don't contain enough stem cells to support engraftment. In a DCI (aka DLI), T-cells of the lymphocytes are given to create an immune effect to get rid of malignant cells, remaining host cells (mixed chimerism), etc. If there is no graft (so to speak) you don't have any stem cells. Giving DLI won't change that. But there is also no recipient immune system to "take down" with conditioning. So that is why they can infuse stem cells with no conditioning and it is an HSCT.
Diane Knutson
Sr Research Associate
IBMTR/ABMTR
March 10 2004
Question: Validation of data?
Are there any data managers out there that have set up a system for data validation of their StemSoft/Transplant Database on a regular basis? If so I would be interested in any ideas as to how this is set up, how they validate, what points you validate etc.
Thanks for your help.
Shaunna
Do you have an answer to Shaunna then send an e-mail to Hanne: rh07604@rh.dk
Answer from Pam:
At one time we had a demographics database that was created in Access - this database maintained just the basic information and key points such as: BMTdate, conditioning regimen, patient demographics (DOB, Race etc.) Relapse date, donor demographics.
Whenever, I needed to run BMTstats or any type of patient information - I would run a list from what is called the legacy database and match up those key points - so this was how I would validate my data to BMTbase TED and Reports, as well as BMTsrv.
But, now that the legacy database in no longer in place, the only way to validate your data is to do internal audits choosing key points and checking those key points every 3 to 6 months. Set an error percentage rate and see where your high's and low's are. Just like when we get audit by the IBMTR or NMDP.
Start by writing your SOP take the criteria from there and start at some point actually doing your internal audits. This is the new system we are putting in place - especially now that it is a FDA regulation.
Pam
Answer from Irving:
We do not have any sort of validation system set up at our institution either. I think that would be an interesting question for a questionnaire or survey for the data managers. Maybe we could come up with some sort of instrument that we could distribute via a link from the website? We could gather data on a whole array of issues. Just a thought, -IRV-
Frequent ask question to Diane Knutson (IBMTR):
The postTX section of the registration forms (TED/TEDFU) has wording that is very confusing to a lot of people. Think of the questions in this way:
Post HSCT/DLI:
Was there any evidence of disease during this reporting period?
Yes or No
By what methods was the patient's disease monitored, during this reporting period?
Tick applicable methods. At the very least "clinical" should be ticked - we assume the patient is seen somewhere by some doctor, it doesn't have to be your transplant center.
Was disease found by this method in the reporting period?
If yes, list the first date evidence of disease was found by this method in the reporting period.
If no, list the latest date assessed in the reporting period.
It may seem redundant to repeat the phrase "in this reporting period" for each questions, but that is what we are asking about - what did you do in the assessment period. Prior information would already have been collected, no need to re-report.
Top 10 misconceptions.
Authors: Sarah Anderson, Sharon Nell and Amie Lalor, IBMTR/ABMTR
Misconception 1
Every patient must be pre-registered
Answer:
Research teams:
Must pre-register all patients with in 2 weeks prior to start of high dose conditioning (including day one of conditioning), using the IBMTR/ABMTR pre-registration form.
Registering teams:
Must register all patients using the Transplant Essential Data form (TED-01) at 100 days post transplant. Registering teams do not submit pre-registration forms.
Misconception 2
Each transplant receives a different IUBMID number.
Answer:
Every patient transplanted at your institution should be assigned only one IUBMID number. This includes all Allo and Auto cases, subsequent transplants and DCI´s.
Misconception 3
All data submitted to the registry is evaluated equally.
Answer:
All data submitted to the registry is not evaluated equally. We prioritize which forms are entered first based on
1. Studies
2. Complete forms
3. Incomplete forms
Misconception 4
Who is responsible for patients transplanted/follow-up by another institution?
Answer:
Your team is only responsible for reporting data on patients that are seen by your institution. If a patient has a transplant at another institution, then you are no longer responsible for that patient. If a patient has follow-up by another institution, you are still responsible for them.
Misconception 5
The IBMTR/ABMTR requests information on patients that have been reported “lost to follow-up”.
Answer:
Patients that have been reported “lost to follow-up” will continue to appear on the request for patient data reports. You do not have to submit data on “lost to follow-up” patients unless they are seen again by your institution.
Misconception 6
What does a Day 100 report form consist of?
Answer:
Day 100 Report form consists of: Core insert, Graft insert and Disease specific insert.
Follow-up report form consists of: Core follow-up insert and Disease follow-up insert.
Misconception 7
A Complete report form is due for every patient.
Answer:
Research teams:
Please look at the bottom of the first page of the pre-registration form faxed to you by the IBMTR/ABMTR registry. If you see an X in the tick off box saying “Form due”, then you have to submit a day 100 report form (Core insert, Graft insert and Disease specific insert). If you see an X in the tick off box saying “No Form due”, then you have to submit a Modified Transplant Essential Data form (MTED) 100 days post transplant.
Misconception 8
Which forms will be reimbursed?
Answer:
Pre-registration forms - $10.00
Report forms - $120.00
Subsequent or DCI forms - $60.00
Follow-up forms - $40.00
Registering teams do not receive reimbursement.
Misconception 9
Who should be contacted?
Answer:
Bernardo Mayorga: Pre-registration
Kavita Bhavsar: Disk/E-mail forms
Sharon Nell: Reimbursement
Sarah Anderson: Form Question/Studies
Diane Knutson: Medical related questions
Sherry Fisher: Studies/HIPPA
StemSoft Helpline: 1-800-671-3234
Misconception 10
We are not psychic.
Answer:
Update any changes with the IBMTR/ABMTR staff.
- Personnel changes.
- Fax, phone, e-mail.
- Write legibly (visibly clear letters and numbers on forms).
- Before submitting data, check to see if form(s) are filled out correctly (IUBMID, Centre, Transplant date etc.).
Infection in central line vs. in blood?
On pg 30: in regards to organism site-we draw blood cultures from central line and peripheral. Do we use code 60 if it is positive (not culturing the actual line but the blood) or do we use code 1 if positive? And what do we do if it is positive for peripheral site do we use code 1?
Answer from Diane
Thank you for asking about the distinction between 'blood' and the 'central line'. Have you discovered the Data Management Manual (www.ibmtr.org)? In Section 3-Appendix G there is a table with some extra text to help you sort out sites of infection. The distinction between the site 'blood' (code 1) and the 'catheter' (code 60) is whether the infection is really in the patient's blood stream - that of course is quite serious. So, sometimes you have to correlate the MD's notes stating what is going on with a patient - you can't just read the microbiology reports to figure it out. Determine what you can tell from the MD's notes. If they aren't clear, then ask them about it (in the context of - you just want to be really accurate with your reporting.)
Note - try not to use the general infection site codes (which mostly end in zero). If the infection is really from the catheter - try to distinguish between the insertion/exit site, the skin or "wound" (code 61) vs. the catheter tip (code 62). While subtle differences - these, too, are important.
Diane Knutson
Sr Research Associate
CIBMTR
January 17. 2005
ANC dropping in relaiton to the DCI form
Hello, I have not had too much experience with the DCI form, (since it was not on stemsoft until the latest release) so I have found I need clarification regarding DCI Q.# 85-87 duration of aplasia post DCI.
To record the date of ANC dropping below 500, would the drop reported be the first day of three consecutive values, or should I put the first drop below 500 even if it is only for 1-2 days??
Thank you in advance for your assistance.
Carol
Answer from Diane
No "three day rule" for ANC drop on DCI. If there was, I would have made sure it was printed on the Form.
Thanks for asking for clarification!
Diane Knutson
Sr Research Associate
CIBMTR
October 22 2004
Question regarding multiple DCIs or transplants
We have a young boy, first allo standard transplant with an unrelated donor earlier this summer, then he develops a poor marrow function and low donor chimerism... this in interpret as poor marrow function and the physicians decide to correct this with a DCI infusion October 13th 2004. At the same date a bone marrow biopsy shows relapse. The physicians decide to go a head with the original plan...and he gets the DCI infusion. Because of the new relapse information they decide he needs treatment: conditioning with fludarabine and stem cells form the donor on October 22nd 2004. My question: the DCI and the re-transplant is with in 14 days of each other, so if I should follow the general rules then the stem cell infusion given on OCT 22nd should not be reported on a pre-registration form, but since he is treated with fludarabine before the second transplant then I not so sure anymore, so I just want to know how you want this reported. Should I send a new pre-registration form for the transplant on October 22nd even though it’s within the 14 days of the DCI infusion and regard this as 2 separate situations? or should I count the DCI on OCT 13th and the infusion on October 22nd as one?
Answer from Diane
The answer to your Q is revealed on p75 of the Manual, a little more than half way down, "any time conditioning is used, that HSCT must be reported separately, regardless of how much time has lapsed. "There is no day rule 14, 28 or otherwise, once conditioning is used.
Diane Knutson
Sr Research Associate
CIBMTR
Juli 1 2004
Myeloma insert
I need help with a myeloma follow-up disease insert. My report period is up to the day before conditioning for a 2nd transplant(11/02/03).
The patient was in complete remission then relapsed 08/05/03. We started thalidomide and serum ig dropped :
8/05/03 .69; 09/02/03 .5 ; 10/9/03 .2 - I do not have a 6 week period. What is the best response for this report period? no lesions, no bm to compare-need more info? let me know and thank you for your help.
How is a relapse from CR the best response? (does this mean that the patient started off in relapse and then the disease progressed, so the best response for the period would be-relapse from CR?
Answer from Diane
The Registry's position on disease status is that the physician overseeing the patient's care should be documenting their response to therapy and disease status. You should not have to be doing this, which is likely very time consuming.
PreTransplant (TX) we do "forgive" the six weeks rule if there is not 6 weeks between the end of therapy and transplant, but not postTX. In the case you describe it may very well be that the disease response is unknown based on the criteria in the Disease Insert, although in the next Day-100 Report Form you could indicate the patient's disease was at least "sensitive to chemo" prior to conditioning.
If the patient was CR preTX and started out the reporting period in CR, their 'best' response to transplant for that reporting period is still CR, even if they relapsed. The status prior to the subsequent TX would be whatever the response to therapy was. If CR was not attained, then their current response would be 'relapse' or 'relapse from CR' - if that is an option and there is not a more appropriate tick box to indicate the true response. In the next reporting period, if the patient is still in relapse, that's when 'relapse from CR' would be their 'best' response to transplant. Best response is always to TX, not to therapy after the relapse.
I hope this explanation helps to clear up some of the terminology.
Best regards,
Diane Knutson
Sr Research Associate
CIBMTR
June 12 2004
DCI or HSCT?
I have a question.
We have a patient that had a HSCT on 4/7/03 for which a Day-100 Report Form was completed.
She then had a DCI on 9/24/03 for progressive disease. A Follow-up Report Form for the HSCT was completed and a DCI Report Form for the DCI was completed.
She progressed again and was given Chemotherapy. A few weeks later, her marrow "died". She was infused with mobilized cells from the original donor on 1/21/04. Which insert do I submit for this 3rd infusion? The donor was mobilized, but the recipient had no pre-conditioning?
Answer from Diane
Good questions. Thank you for asking. I think this may be covered in the Data Management Manual, but briefly - the 21Jan04 infusion is another HSCT. It sounds like you are making the connection of no conditioning to DCI and that is true **most** of the time, but not in this situation. DCI's don't contain enough stem cells to support engraftment. In a DCI (aka DLI), T-cells of the lymphocytes are given to create an immune effect to get rid of malignant cells, remaining host cells (mixed chimerism), etc. If there is no graft (so to speak) you don't have any stem cells. Giving DLI won't change that. But there is also no recipient immune system to "take down" with conditioning. So that is why they can infuse stem cells with no conditioning and it is an HSCT.
Diane Knutson
Sr Research Associate
IBMTR/ABMTR
March 10 2004
Question: Validation of data?
Are there any data managers out there that have set up a system for data validation of their StemSoft/Transplant Database on a regular basis? If so I would be interested in any ideas as to how this is set up, how they validate, what points you validate etc.
Thanks for your help.
Shaunna
Do you have an answer to Shaunna then send an e-mail to Hanne: rh07604@rh.dk
Answer from Pam:
At one time we had a demographics database that was created in Access - this database maintained just the basic information and key points such as: BMTdate, conditioning regimen, patient demographics (DOB, Race etc.) Relapse date, donor demographics.
Whenever, I needed to run BMTstats or any type of patient information - I would run a list from what is called the legacy database and match up those key points - so this was how I would validate my data to BMTbase TED and Reports, as well as BMTsrv.
But, now that the legacy database in no longer in place, the only way to validate your data is to do internal audits choosing key points and checking those key points every 3 to 6 months. Set an error percentage rate and see where your high's and low's are. Just like when we get audit by the IBMTR or NMDP.
Start by writing your SOP take the criteria from there and start at some point actually doing your internal audits. This is the new system we are putting in place - especially now that it is a FDA regulation.
Pam
Answer from Irving:
We do not have any sort of validation system set up at our institution either. I think that would be an interesting question for a questionnaire or survey for the data managers. Maybe we could come up with some sort of instrument that we could distribute via a link from the website? We could gather data on a whole array of issues. Just a thought, -IRV-
Frequent ask question to Diane Knutson (IBMTR):
The postTX section of the registration forms (TED/TEDFU) has wording that is very confusing to a lot of people. Think of the questions in this way:
Post HSCT/DLI:
Was there any evidence of disease during this reporting period?
Yes or No
By what methods was the patient's disease monitored, during this reporting period?
Tick applicable methods. At the very least "clinical" should be ticked - we assume the patient is seen somewhere by some doctor, it doesn't have to be your transplant center.
Was disease found by this method in the reporting period?
If yes, list the first date evidence of disease was found by this method in the reporting period.
If no, list the latest date assessed in the reporting period.
It may seem redundant to repeat the phrase "in this reporting period" for each questions, but that is what we are asking about - what did you do in the assessment period. Prior information would already have been collected, no need to re-report.
Top 10 misconceptions.
Authors: Sarah Anderson, Sharon Nell and Amie Lalor, IBMTR/ABMTR
Misconception 1
Every patient must be pre-registered
Answer:
Research teams:
Must pre-register all patients with in 2 weeks prior to start of high dose conditioning (including day one of conditioning), using the IBMTR/ABMTR pre-registration form.
Registering teams:
Must register all patients using the Transplant Essential Data form (TED-01) at 100 days post transplant. Registering teams do not submit pre-registration forms.
Misconception 2
Each transplant receives a different IUBMID number.
Answer:
Every patient transplanted at your institution should be assigned only one IUBMID number. This includes all Allo and Auto cases, subsequent transplants and DCI´s.
Misconception 3
All data submitted to the registry is evaluated equally.
Answer:
All data submitted to the registry is not evaluated equally. We prioritize which forms are entered first based on
1. Studies
2. Complete forms
3. Incomplete forms
Misconception 4
Who is responsible for patients transplanted/follow-up by another institution?
Answer:
Your team is only responsible for reporting data on patients that are seen by your institution. If a patient has a transplant at another institution, then you are no longer responsible for that patient. If a patient has follow-up by another institution, you are still responsible for them.
Misconception 5
The IBMTR/ABMTR requests information on patients that have been reported “lost to follow-up”.
Answer:
Patients that have been reported “lost to follow-up” will continue to appear on the request for patient data reports. You do not have to submit data on “lost to follow-up” patients unless they are seen again by your institution.
Misconception 6
What does a Day 100 report form consist of?
Answer:
Day 100 Report form consists of: Core insert, Graft insert and Disease specific insert.
Follow-up report form consists of: Core follow-up insert and Disease follow-up insert.
Misconception 7
A Complete report form is due for every patient.
Answer:
Research teams:
Please look at the bottom of the first page of the pre-registration form faxed to you by the IBMTR/ABMTR registry. If you see an X in the tick off box saying “Form due”, then you have to submit a day 100 report form (Core insert, Graft insert and Disease specific insert). If you see an X in the tick off box saying “No Form due”, then you have to submit a Modified Transplant Essential Data form (MTED) 100 days post transplant.
Misconception 8
Which forms will be reimbursed?
Answer:
Pre-registration forms - $10.00
Report forms - $120.00
Subsequent or DCI forms - $60.00
Follow-up forms - $40.00
Registering teams do not receive reimbursement.
Misconception 9
Who should be contacted?
Answer:
Bernardo Mayorga: Pre-registration
Kavita Bhavsar: Disk/E-mail forms
Sharon Nell: Reimbursement
Sarah Anderson: Form Question/Studies
Diane Knutson: Medical related questions
Sherry Fisher: Studies/HIPPA
StemSoft Helpline: 1-800-671-3234
Misconception 10
We are not psychic.
Answer:
Update any changes with the IBMTR/ABMTR staff.
- Personnel changes.
- Fax, phone, e-mail.
- Write legibly (visibly clear letters and numbers on forms).
- Before submitting data, check to see if form(s) are filled out correctly (IUBMID, Centre, Transplant date etc.).
