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

Understand the Form Revision Process Objectives Understand the Form Revision Process Review 2019 Revisions Objectives Review the form revision process- there are have been changes since the last form revision talk in 2017 Take a look at the big changes coming in 2019

The Form Revision Process Let’s start with the form revision process and the steps involved Form revision is a complicated process. From the last time form revision was presented here, we completed a process improvement project that reviewed the process from start to finish and streamlined parts where we could. The result took us from a 22+ week process down to 12 weeks. AML/ALL vs LYM

The form revision process Step 1 Plan Prepare Revise Review Approve Release The form revision process The first step is to plan

Plan Why revise a form? Time since last revision Upcoming studies Updates or resolving issues Updates from WHO Requests from staff or centers Every good process starts with planning. To determine which forms should be revised, we look at several factors: how long it’s been since the last revision, which forms may be utilized by upcoming studies, necessary updates of things that we know are out of date or new practices or resolving known issues, if disease classification updates from WHO and we take requests from staff or centers.

Plan Create a Roadmap Form Revision Core Team Obtain approval 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 Our form revision core team then creates a roadmap. The core team consists of the form revision product owners, data ops directors and a scientific director, who meets weekly. At one of those meetings, we will draft the schedule for the next year of form revisions. This roadmap is presented to the scientific directors and senior leaders for review and approval. There is always flexibility built in to allow for unforeseen critical revisions or new form creation that takes priority.

The form revision process Plan Step 2 Prepare Revise Review Approve Release The form revision process

Prepare Announce revisions to the network Volunteer! Includes scientific directors and centers Volunteer! Send form change suggestions Meet with scientific director of working committee After we have the roadmap, the work begins on the next form on the list8. An announcement will be sent to all of CIBMTR and the network announcing that revisions are beginning. We ask for volunteers and suggestions at this time. We also meet with the scientific director of the working committee who will be leading the meetings. Get their input and suggestions.

The form revision process Plan Prepare Step 3 Revise Review Approve Release The form revision process

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 We then assemble and meet with the initial review committee. This group consists of physicians who are experts in the field, other subject matter experts, data managers, and cibmtr staff. The group meets weekly, for 4 weeks, 2 hours each, to review the form top-to-bottom and question-by-question. This group is removing outdated questions, adding new questions based on new technology or treatments, and clarifying problematic issues. After the 4 weeks of meetings, we allow a few weeks for the data managers to pilot the new form. We want to ensure that the questions being asked can be answered or that they make sense. This Q&A session allows data managers to voice concerns, raise issues, and seek clarification with the physicians and CIBMTR staff.

The form revision process Plan Prepare Revise Step 4 Review Approve Release The form revision process

Review Internal Review CIT review Statistical review Database review Develop validations, identify potential problem areas, and discuss form development Once the initial review committee is complete and there is a working draft, we continue the internal review. CIBMTR staff participate on the IRC and can provide input during the revision calls. We then meet with CIT, the statistical group and our database team. We develop validations based on previously known issues or suspected future issues, and identify potential problem areas of the new form.

Plan Prepare Revise Review Step 5 Approve Release

Approve Scientific Director(s) Request volunteers for time studies Review form drafts and change summaries Review occurs at standing weekly meeting Request volunteers for time studies Assess form completion burdens After IRC and internal reviews are done, we will have a working draft that we feel comfortable presenting for approval. The form draft goes to the scientific directors. This group will review the form drafts and change summaries and give feedback. We may have to make changes based on their input.

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 Approval by the Office of Management and Budget, b/c of paperwork reduction act

Post- Approval FormsNet3 Process Build new forms Write/test validations Define Events and Actions (logic for how forms come due) Metadata work AGNIS Mappings We pass it off then, to the next team where

Plan Prepare Revise Review Approval Step 5 Release

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

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

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 Please, please, please volunteer

Upcoming Revisions

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 This was a huge undertaking. We revised the pre-TED, Disease classification, Baseline, IDM, HLA, Infusion and Post-TED forms Let’s take a closer look to what these changes are (a more in depth change summary can and will be provided with the form drafts)

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 We added, removed and moved question around that resulted in the number of questions asked on the form dropping from 357 to 142

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 We added, removed and moved question around that resulted in the number of questions asked on the form dropping from 357 to 142

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 Lots of changes

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

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)

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

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

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

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

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”

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

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

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

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

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

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

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

At this point, I feel like every center has participated in some way to this round of revisions. I’ve lost track of the full list, so thank you to everyone who has participated in any way.

Questions