www.ebmt.org #EBMT2015
Data Reporting Problems
Shelley Hewerdine & Khrystyna Valkiv
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Format of this session
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Recent EBMT Registry work
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Improving Data Quality
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Data reporting Quiz
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How the data is used
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The Registry provides a pool of data to perform
retrospective studies, assess epidemiological trends, or
prepare prospective trials. Collected data on >500,000
transplants since they began in the 1970s.
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For basic and clinical Research
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Standardisation and Quality Control
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Accreditation (JACIE)
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Requirements - Health Authorities and Commissioners
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EBMT Membership requirements: MED-A for every
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Importance of good data
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Data as accurate and complete as possible for research
and quality management
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Missing data and missing follow ups can skew data or
lead to a statistical bias
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Follow up: very important part of the Registry, research
helping to improve quality of life, long term. Example of
centre reporting follow up only when something
happens (Centre A) and a centre systematically reporting
follow ups (Centre B):
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Overall survival for Centres A and B
0 10 20 30 0.00 0.25 0.50 0.75 1.00 Years Centre B Centre A
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Length of follow up
Centres with same outcome may look worse when follow up is shorter
Years 0 20 40 60 0.00 0.25 0.50 0.75 1.00 >10 years >5 and =<10 years =< 5 years
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Working to improve the data
“Tidy Up Your Data” campaign. Have run a full list of
data quality queries and sent to centres. (ProMISe users
encouraged to run them to check data)
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Tidy Up Your Data: list of report queries
• Diagnosis labelled as other or unknown (Main Classification only) • Diagnosis sub classification labelled as other or unknown
• Best Response_Status after HSCT is Null and_or Unknown • Disease status at HSCT is Null and_or Unknown
• Missing number of Disease status at HSCT • No relapse prior to 2nd or subsequent HSCT • Cause of death is GvHD but no GvHD recorded • Cause of death is relapse but no relapse recorded • Last assessment is HSCT assessment
• Patient alive with a cause of death
• Hospital or Unit unique patient number (UPN) missing
• Hospital unique patient number (UPN) shared by two patient records • Patient date of birth missing
• Possible duplicate entry of same patient • Allogeneic HSCT without a donor
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Working to improve the data:
further requests
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Emailed all centres with a list of patients that have not
had a follow up reported for 5 years or more. Aim to
send these more regularly: twice a year
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Missing MED-A: requests sent to centres sending in data
forms. Aim to widen requests to target more ProMISe
users
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Duplicate registrations: many emails have been sent to
query possible duplicates in centres and clean up the
doubles
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Quiz
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Quiz handouts – 8 questions. Have a look in pairs or
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Quiz: Solutions
1. Which of the following should NOT be reported as a transplant registration?
Answer b) Autologous reinfusion after graft failure
• This is not considered as a transplant. Check transplant definitions at the beginning of the MED-AB manual. Ask clinician or registry helpdesk if unsure.
• A boost is an infusion of cells from the same donor without conditioning, with the same donor being present in a proportion higher than 10%
• If cells are not from same donor OR there is conditioning OR donor cells are present at a lower proportion than 10%, then it is a genuine
transplant.
• Please also report patients who die between conditioning and transplant. We enter the day 0 info and put the planned HSCT date as the date of death
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Quiz: Solutions
2. A patient received Rituximab as a treatment for EBV or CMV reactivation, but you can’t find this in the MED-A form, what should you do?
• This treatment is not part of the EBMT data collection. Can be entered in the database by advanced users, but unlikely to be analysed. Centres can record data for own use if preferred
• Recommendation: keep to MED-AB. And if you report MED-A but find you want to record MED-B items, report MED-B!
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Quiz: Solutions
3. A patient has a rare diagnosis and you cannot find the right disease classification sheet or code. What do you do?
• Answer: b) Check the disease classifications list on the EBMT website If cannot find or unsure, answer c) Contact the registry helpdesk
• Answer a) Enter it in the database as “uncoded” is a no-no. It is very rare for diseases to be uncoded. Only enter an uncoded diagnosis if we
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Quiz: Solutions
4. In 2005 the percentage of transplant registrations with the best response at 100 days missing or unknown was 12%. Do you think this percentage has increased or decreased for recent registrations (2013 transplants)?
• Answer: decreased. The number of registrations with this item missing/unknown in 2013 was 7%
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Missing data items - average per HSCT Med-A submission
0 50 100 150 200 250 300 350 400 2011 2012 2013 2014 < 5 missing items 5-10 missing items >10 missing items 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 2011 2012 2013 2014 < 5 missing items 5-10 missing items >10 missing items Number of centres Percentage of centres
EBMT Registry
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Quiz: Solutions
Remember you can run a report on the best response missing item, plus display records without disease status at transplant (and number of the status) properly filled.
Crucial data quality reports on identifiers: • Unique UPN per patient per centre
• Possible duplicates: all transplants need to go in one single patient record, no matter where performed or the number of transplants (Request form to access original transplant in other centre)
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Quiz: Solutions
5. If a patient has more than one transplant, when should follow up be reported?
Answer: b) Between transplants, then annually after the most recent transplant
We will try to improve our data forms to help capture the follow up between transplants. Again a DQ report: “No relapse prior to 2nd or subsequent HSCT”
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Quiz: Solutions
6. Donor Lymphocyte Infusions (DLI): Must all the infusions of the same regimen (given for the same indication within 10 weeks) be recorded separately, or must only the 1st infusion of the regimen be recorded with the total number of infusion in this regimen (without entering details for each infusion)?
Answer: only the 1st infusion of each 10 week cycle needs to be reported,
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Quiz: Solutions
7. What is the best way to send electronic data files to EBMT? E.g. scanned forms, HLA reports, Excel files with study or data queries
• Correct answer: b) send by email with password protection or c) use
secure download facility in Promise. c) ideally best, available Promise 3. • Answer ‘a) Just send by email’ is a no-no for files containing identifiers,
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Quiz: Solutions
8. MED-A follow up form: discrepancies
• Cause of death is relapse, but relapse data not recorded. (Also may happen with gvhd). DQ reports available for both
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Conclusions
• Positive response to “Tidy Up Your Data” and “5 Year follow up” • Decrease in number of missing items in MED-A
• Cleaning the duplicate registrations and shared UPNs. <400 possible doubles. Shared UPNs halved.
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Your Questions
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Related Sessions EBMT 2015
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then join us for a drink!
Data Managers’ Reception
Room 3B10
Tuesday
09:00 – 09:40
Changes to MED-A
10:00 – 12:00 (computer room)
HLA Data Entry
11.45 – 13:00
Introduction to HSCT and the MED-A form
14:00 – 15:30 (computer room)
Avoiding & solving problems in ProMISe
14:45 – 15:25
