FROM: Serban Negoita (NCI SEER): Co-chair NAACCR Mid-Level Tactical Group
Manxia Wu (NPCR): Co-chair NAACCR Mid-Level Tactical Group
SUBJECT: 2019 Field Testing
DATE: October 1, 2019
Hello,
The NAACCR Mid-Level Tactical Group, which includes representations from all standard setters (CoC, NAACCR, NCRA, NPCR, and SEER/IMS) now requires that field testing be done for proposed new data items, or major changes, before implementation in the registry field. This process will help standard setters to evaluate the feasibility of collecting new data items and clarify codes and coding instructions before implementation. The MLTG strongly encourages participation in this effort, which we believe will facilitate better communication with the registrars in the field and provide critical information to the groups working on these data items.
The Field Test will be implemented using the same software used for SEER Reliability Studies, with some modifications. Participation in the Field Test will not be required by any of the standard setters, but is strongly encouraged. This is your chance to comment on data items prior to implementation. This is the first time a field test like this has been done, and based on how well it goes, this could become standard operations for implementation of proposed new data items.
There are 12 new SSDIs that are being proposed for implementation in 2021.
· Breast and Colon: Treatment Effect (Primary Tumor)
· Breast: Treatment Effect (Lymph Nodes)
· Colon and Rectum: NRAS Mutational Analysis
· Colon and Rectum: BRAF Mutational Analysis
· Lung: EGRF Mutational Analysis
· Lung: ALK Rearrangement by Molecular Methods
· Pancreas: CA 19-9 Pre Tx-Lab Value
· Neuroendocrine Tumors: Ki-67 (Ampulla of Vater, Appendix, Colon and Rectum, Pancreas, Small Intestine, Stomach)
· Corpus Carcinoma and Carcinosarcoma: ER and PR
· Esophagus and Stomach: HER2 Overall Summary
Each of these SSDIs has clinical significance for their cancers. The field testing will provide information to the NAACCR SSDI workgroup for
- Clarification of codes and coding instructions
- Needed revisions and/or modifications
- How often the information is available
- Feasibility of implementing the new SSDI
In addition to new SSDIs being tested, there will also be testing on changes to how the registry collects Neoadjuvant therapy. These changes will include a new data item that asks, "was neoadjuvant therapy given." This new data item will provide clear instructions on what is neoadjuvant therapy, along with codes determining if patient had neoadjuvant therapy or not.
Another new proposed data item is "Reason for No Surgery After Neoadjuvant Therapy." This data item records the surgery status of a patient who had neoadjuvant therapy. It records scenarios such as: surgery done, surgery cancelled due to complete clinical response or neoadjuvant therapy failed, or other reasons surgery not done.
Related to the Neoadjuvant Data Items are the AJCC posttherapy clinical staging (yc) data items. These data items are very similar to the posttherapy pathological staging (yp) data items, except they are used to evaluate a clinical stage after a patient has completed their neoadjuvant therapy.
The Neoadjuvant data items and the posttherapy clinical staging (yc) data items will be implemented in 2021; however, we want to use this opportunity to get a better understanding of what registrars will need to code these data items correctly when they are released.
For the Field Testing, registrars will have available the proposed documentation for the Neoadjuvant and posttherapy clinical staging (yc) data items and will be given opportunity to comment on the content and structure. Mini case scenarios will be given with multiple choice questions.
For all data items in the study, participants will be provided the preferred answer and rationale after each question, along with an opportunity to comment on the preferred answer and rationale. In addition, there will be questions regarding the Field Test process and recommendations for future improvements.
Continuing Educate (CE) credits will be available.
The field testing will take place from 8 a.m. EDT, November 1, 2019 to 12:00 a.m. EDT, December 15, 2019. Participants must have access to the SEER reliability studies site (https://reliability.seer.cancer.gov) during this period.
- Registration for Field Testing will open on October 15, 2019
Note that since the objectives of this field testing are to determine how well the new data items are understood, individual results will remain confidential and not released. Results will be de-identified before analysis.
Now is the time to recruit facility reporters and your registry staff to participate. All participants will be using the SEER Reliability software. If you have participated in a previous reliability study (2014 or later), use your same login. If you have not participated in a previous reliability study, you will need to create an account. To create a new account please follow the Create an Account link on the sign-in page (https://reliability.seer.cancer.gov).
Please email reliability@imsweb.com for technical questions and Jennifer Ruhl (ruhlj@mail.nih.gov), co-chair of the SSDI work group, for related questions.
We look forward to your participation and feedback.