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Form Revision and Development

This article outlines the process of revising and developing forms, the importance of revisions, and how to get involved in the process. It also highlights upcoming revisions for core forms and specific changes made during the Pre-TED form revision.

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Form Revision and Development

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  1. Form Revision and Development Tiffany Hunt, CCRP Rachael Latchana, MPH Stephanie Meyers February 20, 2019

  2. Objectives

  3. The Form Revision Process The Form Revision Process

  4. The form revision process

  5. Plan Why revise a form? • Time since last revision • Upcoming studies • Updates or resolving issues • Updates from WHO • Requests from staff or centers

  6. Plan Create a Roadmap • Form Revision Core Team • Draft proposed schedule • Obtain approval • Scientific directors and senior leaders review and approve • Be flexible! • allow wiggle room for critical revisions, or new priority forms

  7. The form revision process

  8. Prepare • Announce revisions to the network • Includes scientific directors and centers • Volunteer! • Send form change suggestions • Meet with scientific director of working committee

  9. The form revision process

  10. Revise Initial Review Committee (IRC) • Consists of field expert physicians, subject matter experts (SME), data managers, CIBMTR staff and other individuals • Weekly Meetings (4 weeks, 2 hours) • review the form(s) top to bottom, question by question • remove outdated questions, add new questions based on new technology/treatments, clarify problematic sections • Q&A Meeting • allow for data managers to pilot the forms • ensure source documents exist for requested data

  11. The form revision process

  12. Review Internal Review • CIT review • Statistical review • Database review • Develop validations, identify potential problem areas, and discuss form development

  13. Approve • Scientific Director(s) • Review form drafts and change summaries • Review occurs at standing weekly meeting • Request volunteers for time studies • Assess form completion burdens

  14. Approve OMB Approval • Form 2400, 2402, 2004, 2005, 2006, and 2450 • Long process (6+ months) • Post to the Federal Register: 60 day notice, 30 day notice • OMB review and approval

  15. Post- Approval • FormsNet3 Process • Build new forms • Write/test validations • Define Events and Actions (logic for how forms come due) • Metadata work • AGNIS • Mappings

  16. Release • New Forms • Announce to Network • Release forms prior to “Go Live” date • Forms Instruction Manual • Announce to Network • Release updated manuals prior to “Go Live” date • Update / develop eLearnings

  17. Finally…How can YOU help? • Submit form change suggestions • Submit at any time • Send to your CRC • Suggestions reviewed during the next revision • Volunteer • Participate on a form revision committee! • Important to have data managers involved

  18. Finally…How can YOU help? • Time studies • We need your input on the length of time it takes to complete the forms • Important information for OMB process but also any revised forms

  19. Upcoming Revisions

  20. The Core Forms • 2400, 2402, 2000, 2004, 2005, 2006, 2450, 2804 • Revision committees met May – July 2018 for 2400/2000, 2006 • Internal review July – October 2018 • Requires OMB approval (in process) • Scheduled for release in Summer 2019 • Will be posted 2 months in advance for preview

  21. Pre-TED (Form 2400) Revision Highlights*not a complete list Fun Fact: Decreased total number of questions (357 to 142) • ‘Check all that apply’ capability: • Race, race detail, country of residence, comorbidities, planned post-HCT therapy • Recipient Information section • Ethnicity, race, race detail • Collected on CRID assignment (Form 2804) • Auto-populated on Pre-TED

  22. Pre-TED (Form 2400) Revision Highlights (cont.) • Hematopoietic Cellular Transplant (HCT) section • New cellular therapy (CT) history questions • Previous history of CT • All prior CT reported to CIBMTR • Place of prior CT • Does not require completion of a F4000

  23. Pre-TED (Form 2400) Revision Highlights (cont.) • Donor Information section • Donor ID • Collect only on Pre-TED • Auto populate Forms 2004/2005/2006 • Specify donor list condensed • Autologous, allogeneic related / unrelated • Product • NMDP • Genetically modified HCT products • Consolidated all donor-related questions from this and other forms

  24. Pre-TED (Form 2400) Revision Highlights (cont.) • Pre-HCT Preparative Regimen (Conditioning) section • Chemotherapy Drugs • Added ‘multiple’ capability to eliminate Yes/No for each drug • Updated drug list • Additional Drugs Given in Peri-Transplant Period section • NEW SECTION TO FORM • Used to report drugs given for both the preparative regimen and GVHD prophylaxis

  25. Disease classification (F2402) Revision Highlights *not a complete list • New indications • “Tolerance induction associated with solid organ transplant” • “Recessive Dystrophic Epidermolysis Bullosa” • Cytogenetic results • Added a place holder question to allow for future submission of results • Cytogenetic abnormality list has been made ‘check all that apply’ (MDS/MPN, PCD)

  26. Disease classification (F2402) Revision Highlights cont. • Inherited Abnormalities of Erythrocyte Differentiation or Function section • New questions added to capture beta thalassemia and sickle cell

  27. Baseline (F2000) Revision Highlights*not a complete list Fun Fact: Decreased total number of questions (264 to 118) • Recipient Demographics / Race / Clinical status • Moved country of primary residence, ethnicity, race, race detail, recipient blood type and Rh factor to pre-TED • Infection • Collect infections in 6 months prior to infusion • Pre-HCT Preparative Regimen (Conditioning) section • Chemotherapy Drugs • Added ‘multiple’ capability to eliminate Yes/No for each drug • Updated drug list

  28. Baseline (F2000) Revision Highlights (cont.) • Additional Drugs Given in Peri-Transplant Period section • NEW SECTION TO FORM • Used to report drugs given for both the preparative regimen and GVHD prophylaxis • Socioeconomic Information • Will collect most recent works status • Updated insurance list

  29. Infusion (F2006) Revision Highlights*not a complete list Fun Fact: Decreased total number of questions (285 to 170) • Donor/cord blood unit identification • Donor Identification to be auto-populated on form in key fields • Product processing and manipulation • Consolidated questions from pre-TED to here • Removed whole section for Autologous products

  30. Infusion (F2006) Revision Highlights (cont.) • Product analysis • Consolidated timepoints to “pre-cryopreservation” and “post thaw” • Expanded cell types (TNC, CD34, CD3/4/8) and • collect viability per cell type instead of overall viability • Product infusion • Clarified question “was the entire volume of received product infused”

  31. Infusion (F2006) Revision Highlights (cont.) • Donor/Infant demographic information • Donor blood type/Rh factor moved to pre-TED • Biological relationship of donor to recipient • Removed and consolidated to the pre-TED • Transferable genetic or clonal abnormalities • Expanded option list

  32. IDM and HLA (F2004 / F2005) Revision Highlights *not a complete list • Donor/cord blood unit identification • Donor Identification to be auto-populated on form in key fields • Form 2004 • New question added to capture NAT testing for HBV • NAT testing for HIV-1 and HCV split • Removed questions for Anti-HTLV1, syphyllis, CMV, WNV, toxoplasmosis • Form 2005 • Form will be collected for recipient and final donor only

  33. Post-TED (F2450) Revision Highlights*not a complete list • ‘Check all that apply’ capability: • Liver toxicity prophylaxis, post-HCT therapy, relapse or progression post-HCT therapy • GVHD • Added questions to capture organ staging since the date of the last report • Chimerism studies • Collecting chimerism data for beta thalassemia and sickle cell recipients

  34. Post-TED (F2450) Revision Highlights (cont.) • Relapse or progression post-HCT • The intent of the F2450 has always been to capture the first relapse only • Updated question text to say “was the date of the first clinical/hematologic relapse or progression previously reported” • Removed “decreased chimerism” from the intervention given for relapse question

  35. CRID Assignment Form (F2804) Revision Highlights • Demographics • Added recipient ethnicity, race and race detail • Will be auto-populated on pre-TED • Race will be ‘check all that apply’ • Race detail list will automatically filter based on race selection

  36. Plasma Cell Disorder Revision Highlights • Revising the forms 2016/2116 and the PCD section of the 2402 • Capturing biclonal/triclonal scenarios • Capturing information on monoclonal gammopathy of renal significance (MRGS) and POEMS • Updated Amyloidosis sections • Fall release

  37. Contact form (F2820) • Form will collect recipient contact details for use in: • CIBMTR observational research database: permission to contact for future CIBMTR research studies • BMT CTN studies for direct patient follow up • Additional future studies • Includes: • name • address • phone number • email

  38. Questions

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