Collaborative Stage Transition Newsletter March 18, 2014

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1 Collaborative Stage Transition Newsletter March 18, 2014 Introduction This is a communication update from organizations within the Table of Contents cancer surveillance community to share with their members and other constituents. It addresses the processes and ongoing efforts Introduction to coordinate and effectively transition from the Collaborative Staging v2 system to use of the AJCC TNM staging standard with Agency Updates related biomarkers and prognostic factors. Shortly after the decision was made to transition from Collaborative Stage, a CS CS Q & A Transition Group was formed as an information sharing and planning forum. This group brings together the four data collection agencies/organizations (Statistics Canada/Canadian Council of Cancer Registries, CDC/NPCR, NCI/SEER and CoC), the agency responsible for staging rules (AJCC), the cancer surveillance umbrella organization (NAACCR) and the organization representing cancer registry professionals (NCRA). The CS Transition Group provides a collaborative opportunity to identify the issues involved in the transition and to share the tasks involved in developing best practices for both the overall surveillance community and the individual agencies/organizations in addressing this change. The agencies and organizations participating in this communication recognize that the transition away from CS is a major change and are committed to working with stakeholders to develop appropriate implementation plans and processes. This is a work in progress and there are many questions that have yet to be fully addressed. As answers become available they will be shared and communicated to the surveillance community and opportunities will be provided for members to identify issues and concerns. There are a number of areas of confusion within the surveillance community that this communication will address. The initial change in 2016 for CDC and NCI registries will be focused on the transition to directly assigned TNM stage, but will not eliminate all CS variables. In particular many of the Site Specific Factors (SSFs) will continue to be required as they are a) either a critical component of stage assignment or b) are essential to understanding the cancer (biomarkers). Thus the initial transition will be focused on assignment of T, N, M and the AJCC TNM stage group. As the coordinating bodies, we will clarify which additional variables and SSFs will continue to be required, but our intent is to carefully evaluate which are essential and which are feasible to be collected by the registrar. The methods/studies and processes that will be used to make these determinations are described below. Each participating entity is performing specific and coordinated tasks related to assessing the needs for the transition, determining the impact of the transition and coordinating the logistical components for implementing the changes. 1

2 These are described below with the organization and task leader responsible for that activity. Agency Updates The following is a collection of activity summaries written by the respective agency/organization. We intend to provide regular updates on these activities. In some cases you will note that agencies are working independently on specific issues, while in other cases shared project work is underway. Further, we have received numerous questions and communications from the community regarding this transition. We have identified several common questions and provided responses from NCI/SEER, CDC/NPCR and the COC at the end of the document. Current and planned activities by the partner organization in relation to the CS Transition: A. AJCC Education on TNM The American Joint Committee on Cancer (AJCC) will provide ongoing education around TNM Staging to support the transition to directly coded TNM. The AJCC currently provides an array of educational offerings for free through its website, cancerstaging.org. The educational resources that are available on the website include the Summary of Changes, the Cancer Staging Posters, Staging Moments PowerPoints and Staging Moments as embedded videos. The AJCC also has 13 recorded webinars available for free on the Commpartners Education Portal Page at In addition to these existing educational resources on TNM Staging, the AJCC will develop new educational offerings through the support of the CDC cooperative agreement. The AJCC output will include the following: Production of effective training materials Mechanisms to disseminate training (classroom, on-line, webcasts, etc.) Establishment and maintenance of a mechanism to respond to staging questions Status: Ongoing Contact Person: Martin Madera B. Statistics Canada and the Canadian Council of Cancer Registries The Canadian Council of Cancer Registries (Council) in collaboration with the Canadian Partnership Against Cancer (CPAC) have formed a joint group known as the Canadian Cancer Staging Working Group (CCSWG) to provide advice on a new stage data collection standard for Canada and to assist in guiding a transition away from the use of CS. 2

3 Linkage with CPAC provides Council with access to a wider range of stakeholders (e.g. clinicians, policy makers) and resources to address CS transition. Canada recognizes that US standard setters have a long history of other stage collection standards (e.g. AJCC TNM, Summary Stage) to consider as they address CS transition. The Canadian surveillance community does not have that history. The use of the CS data collection framework was the first stage collection standard tool used by central registries in Canada when it was adopted by Statistics Canada and Council in A background review of potential options for stage data collection was presented to the CCSWG in January. After discussions, the group has recommended the adoption of TNM as the next Canadian Stage Standard with AJCC being the preferred option. This recommendation has been sent to the Canadian Council for formal adoption. The CCSWG has now started work on several fronts: 1. Evaluating the implications (e.g. costs) associated with TNM adoption. 2. Evaluating the level of TNM data element detail that will be recommended for collection. A survey is being planned with key Canadian stakeholders to understand the current use of stage data by agencies and groups and to gather input into future needs. 3. Council and Statistics Canada have initiated discussions on when to discontinue using CS as the Canadian collection standard and will bring forward their recommendations shortly. It may not be possible to consider TNM adoption at any level for 2016 in Canada as is being considered by the US standard setters, and other timelines are being investigated. 4. Council representatives are participating in the CS Transition work group and will continue to share what is happening in Canada through that group as well as in other forums. C. Centers for Disease Control and Prevention 1. CDC-NPCR has formed an internal transition workgroup. The major focus of this workgroup is to implement a smooth, timely staging transition. The NPCR internal workgroup collaborates with partner organizations in the cancer surveillance community and provides NPCR specifics to state cancer registries. 2. Communication CDC-NPCR has scheduled regional calls with NPCR Cancer Registries to provide information on the transition and to answer questions. Status: Ongoing---most recent calls by region occurred on March 6 and 16 Contact Person: Linda Mulvihill, CDC-NPCR CDC has established a specific address for NPCR registries to submit transition questions. Status: Ongoing 3

4 Contact Person: Linda Mulvihill, CDC-NPCR 3. Guidelines for Implementation Purpose: An implementation guide for NPCR required data items through the transition. These guidelines may serve as a foundation for a complete implementation guide. Status: Ongoing Contact Person: Joe Rogers, CDC-NPCR 4. Education Purpose: Provide education and education materials to all cancer reporters. Education will begin in June 2014 at the NCRA Annual Education meeting special track for NPCR registries Education and Training Coordinators. All materials will be available on the NPCR SharePoint and by request to others. Status: Completion date May 2014/ongoing Contact Person: Linda Mulvihill, CDC-NPCR Purpose: CDC-NPCR revised the cooperative agreement with AJCC from support of CS stage to transition activities for AJCC stage. The expanded cooperative agreement with AJCC includes the following: Production of effective training materials Mechanisms to disseminate training (classroom, on-line, webcasts, etc.) Establishment and maintenance of a mechanism to respond to staging questions Status: Ongoing Contact Person: Linda Mulvihill, CDC-NPCR 5. IT Needs CDC staff will be working with grantees and partners to identify the IT needs and timeline for the transition to AJCC TNM and Summary Stage and away from CS v2. This will include a vendor communication plan to assure that the broader IT needs are met. A priority for CDC is providing TNM coding and consolidation assistance. D. Commission on Cancer The Commission on Cancer is embarking on a project to update the data collected by cancer registries in CoC accredited programs and, therefore, by the National Cancer Data Base. The goal is to assure that data collected are clinically relevant, current, available to registrars, and flexible for use. The transition away from CS is one aspect of this major undertaking. As we do this, many other organizations are going through similar exercises. We are seeking to position ourselves to coordinate with existing efforts, and to offer our assistance where it is most needed. 4

5 1. Timing Invitations for an organizing conference call were distributed on March 4 to fifteen subject matter experts and representatives of cancer registry standard-setting organizations. The call, expected to take place at the end of March or in early April, will identify goals and establish work groups with respect to staging, treatment, and other data item questions. Dr. Rick Greene has agreed to coordinate the project work groups. The full project is expected to take at least 2 years. However, by necessity, the timeline for transitioning away from CS is shorter, and will dovetail with transition activities by other organizations. 2. Purpose with respect to staging issues Address ways to improve staging completeness Determine which data currently collected as part of the Collaborative Stage Data Collection System will be collected by CoC as CS is phased out Identify data CoC might request when the AJCC 8 th edition is implemented 3. Related Activities Participate with the other organizations in this announcement through NAACCR and other workgroups to coordinate the transition from CS, and help make that transition as smooth as possible for data-collection, transmission and analysis. 4. Contact Person: Jerri Linn Phillips/Ryan McCabe E. American Cancer Society This project is to directly compare for recent years the stage assigned through Collaborative Stage version 2 versus AJCC pathologic TNM or AJCC clinical TNM stage. This will provide an assessment of CoC hospital registrars consistency in staging across the two systems. Status: ongoing estimated completion April Contact person: Ahmedin Jemal (ACS) - lead/kathy Cronin NCI F. NAACCR NAACCR will continue to work with all of the partner agencies to facilitate a smooth transition to TNM staging by: 1. Providing expertise on central cancer registry operations, data analysis, IT issues etc. by engaging its members in discussions of best practices and feasibility analysis, formulating recommendations and modifying standards if necessary. 5

6 2. As of February 2014, a short term work group has been formed to review the data transmission layout structure to assess the pros and cons of maintaining the current structure of collecting stage related items (including SSFs) within schemas, or whether the collection of these data items would be more efficient outside of a schema structure. The initial report from this group is expected in late March. 3. A second short term work group was also formed to identify major areas that need to be addressed during the transition phase in order to ensure a smooth implementation. The initial report from this group is also expected in late March. 4. NAACCR will identify major milestones that need to be achieved for the transition to be complete and tie these milestones to a time line in order to monitor progress. 5. After review by the Change Management Board, which is composed of the standard setting organizations, the Uniform Data Standards will review proposed new and revised data items and provide feedback concerning the feasibility of data collection, recommendations regarding the standardization and consistency of data items, and finalize coding structures. 6. NAACCR will coordinate the various implementation guidelines and try to incorporate recommendations into standards and a universal implementation guide if feasible. 7. NAACCR will work with partners to ensure that proper edits are in place to maintain the integrity of high quality surveillance data. 8.. NAACCR currently includes and will continue to include TNM and Summary Stage training in site-specific webinars that are part of the Cancer Registry and Surveillance Webinar Series. Training on TNM and Summary Stage will be included in the NAACCR comprehensive training plan that is being developed Contact person: Betsy Kohler G. NCI 1. Assess the perceived availability of the clinical and pathological TNM by hospital and central registrars. This was performed through the NCI SEER Registries, and the results suggested that the pathologic TNM stage was frequently available in the surgical pathology report, but the clinical TNM stage was less frequently available to registrars. This data was presented at an NCRA meeting in Las Vegas to supplement information from a broader NCRA survey described below under NCRA activities. Contact person: Peggy Adamo 2. Evaluation of the frequency of ptnm in the surgical pathology report Purpose: to determine how often the registrar would need to directly assign ptnm if it were not present in the pathology report to direct training efforts. This includes using software with NLP to evaluate the frequency of e-pathology reports including TNM. Status: in process Estimated completion date: October 2014 Contact person: Carol Kosary/Annie Noone 6

7 3. Comparison of cases restaged with AJCC TNM Purpose: this study will ask registrars to re-stage existing cases with known CSv2 stage to compare the agreement between CS and TNM staging. This will provide information to direct training, but will also allow us to understand the potential impact of implementation of TNM stage on incidence trends over time. Status: A call for cases will go out in the near future Timeline: 12 months Contact person: Annie Noone 4. Evaluation of SSFs Purpose: Develop a formal process for assessing whether or not to include/maintain SSFs as part of required data collection. This process will entail a formal review of all SSFs (with a particular emphasis on biomarkers) to determine when they should be required as part of the cancer abstraction process. Components of this assessment will include: evaluation of whether or not there is either evidence or guidelines for the use of factor, whether it is a component necessary to assign stage; when in the cancer course the factor is assessed; and whether or not the registrar has access to the information (i.e. feasibility). This process will be performed for current SSFs that are part of CSv2 and will be used to determine whether or when to add new variables representing biomarkers that characterize cancer. The NCI will serve as the lead on this, however will include participation from clinical experts representing expertise for specific cancer sites and partners from across the cancer surveillance community. In addition to a focus on the biomarkers, there will be a formal evaluation of the SSFs that are not essential for staging or are not biomarkers. This will be led by the Surveillance Systems Branch personnel. Status: The process and format is in development. The project is scheduled to begin in late March. Timeline for completion will be February Prioritization will be given to assessment of SSFs as recommended by collaborating surveillance partners. Contact person: Valentina Petkov 5. NCI coordinating with NPCR and NAACCR to assess needs for changes in algorithms, and other IT needs related to the transition. IMS and NCI SEER staff will be working with partners including CDC, COC and NAACCR subject matter experts to determine the IT needs and timeline that will be required for the change to TNM. In particular they will discuss developing algorithms for best stage calculation. This will include a vendor communication plan to assure that the broader IT needs are met. 7

8 6. Development of training aids to help registrars assign TNM Purpose: Provide materials to assist registrars in directly assigning AJCC ptnm and ctnm. This tool will be used for the study assessing restaging with TNM. Contact Person: Jennifer Ruhl Timeline: June Analysis of the possible reduction in number of schemas. Preliminary investigation as a first step to determine this will results in a simplification that will help data collection. Contact person: Jennifer Ruhl/Leon Sun Timeline: Candidate schemas for combining have been identified focusing on collapsing the schemas to the AJCC chapters. Analysis is ongoing to determine the impact of such a change and the potential benefits. 8. Develop and lead focus groups consisting of hospital and central registrars (who perform abstraction) Purpose: determine the needs as identified by the individuals who are performing the abstraction process. The groups will identify issues, comment on proposed changes and assist in determining the impact and feasibility of what is being proposed at the organizational level. The format will be similar to that used for assessing the MPH rules. Timeline: Next 5 months Contact person: Lois Dickie 9. Development of Summary Stage 2016 Purpose: to develop and test a system that will permit staging over time consistent with the change to TNM staging. This is a preliminary evaluation to create a system that will allow post hoc recoding for the analysis of time trends since NCI SEER is currently thinking that without CS we will not be able to continue to collect older staging systems. We are therefore investigating the idea of a new summary stage that will be based on TNM and will not require a separate stage collection. It is understood that when definitions of TNM change over time this would result in a (hopefully small) discontinuity in SS2016. The initial intent is for post hoc analytic purposes. However if the system is determined to be reliable and valid after review by internal and external review, consideration will be given to creating a user manual for direct assignment of SS2016 for use by NPCR registries. Status: in process of NCI internal evaluation. Timeline for next step for evaluation by external partners May 2014 Contact person: Carol Kosary 10. Coordinating with COC/ACS on the analysis of NCDB Data 8

9 This project is to directly compare for recent years the stage assigned through Collaborative Stage version 2 versus AJCC pathologic TNM or AJCC clinical TNM stage. This will provide an assessment of COC hospital registrars consistency in staging across the two systems. Status: ongoing Timeline: estimated completion April Contact person: Ahmedin Jemal (ACS) - lead/kathy Cronin NCI H. NCRA 1. Survey of registrars to evaluate knowledge and skills in direct assignment of AJCC TNM stage: Purpose: to determine whether registrars will be able to assign TNM correctly and to identify training needs for this process. Status: Complete- report being generated. Results: Report to be provided to AJCC for their further communication out on the results Contact person: Caitlin Irvin (cirvin@ncra-usa.org) 2. Education Development and delivery of educational materials and programs to best prepare registrars for the transition. Contact person: Peggy Meehan (pmeehan@ncra-usa.org) 3. Credentialing Council on Certification is actively monitoring the transition efforts and will post any CTR examination changes related to new content on its website Contact person: Michael Hechter (mhechter@ncra-usa.org) Collaborative Stage Q&A A. TNM Staging Transition 1. What is the timeline for the transition to directly coded stage? CDC/NPCR: All cases diagnosed in 2016 and after are expected to be staged using directly coded AJCC stage, as well as directly coded Summary Stage. NPCR will soon provide additional information regarding a small number of exceptions for particular registries who may limit stage to directly coded Summary Stage. NCI/SEER: All cases diagnosed in 2016 and after are expected to be staged using directly assigned AJCC stage. Both pathologic and clinical TNM will be collected when available. A consolidated "best stage" will be derived from the two staging results as has been done previously. 9

10 CoC: All cases with defined AJCC T, N, M and/or Stage Group will continue to be directly coded using those definitions, both clinically and pathologically. CS coding will remain in effect with no changes in rules for all cases diagnosed through December 31, What staging information will be collected beginning in 2016? CDC/NPCR, NCI/SEER and COC directly assigned, T, N, M clinical and pathological and stage group clinical and pathological; specific SSFs; including: selected specific biomarkers and prognostic factors. NPCR: directly coded Summary Stage Additional data items will be required including but not limited to: tumor size, lymph nodes examined and positive. 3. Will SSFs continue to be collected? CDC/NPCR, NCI/SEER and COC: Yes. Biomarkers and genetic tests are fundamental to cancer diagnosis and staging and will increase in future. Biomarkers and genetic tests will become increasingly important in characterizing cancers and for prognosis and predicting response to therapy. In addition, some SSFs will still be necessary for assigning directly assigned AJCC stage and are therefore essential. CDC/NPCR, NCI/SEER and COC: As you know there are a large number of SSFs in CS v2 and it is not expected that all of those will be collected. A formal review of SSFs will take place over time and the number of biomarkers and prognostic factors refined to those that are collectable and meaningful at a population level or essential to understanding and characterizing the cancer. 4. What variables are being retained from CS? CDC/NPCR and NCI/SEER: Some of the SSFs and their definitions will be retained though they may be collected in new fields. Tumor size will also be retained but it may be collected in new or revised data field. Other fields under evaluation include: margins clear, initial date of treatment for first course for each category of cancer directed treatment (surgery, chemotherapy, radiation etc.). These are currently a component of the data collected by COC hospitals and familiar to registrars. Note that a formal review of SSFs is being performed to evaluate Is the SSF relevant for staging? 10

11 Is there evidence or guidelines for the use of the SSF in assessing either prognosis of predicting response to therapy? This will be particularly relevant for biomarkers. When in the course of the patient s cancer might the variable be available to registrars during the course of cancer treatment (i.e. at initial diagnosis versus metastatic diagnosis)? Will the registrar have access to this information? Is it only available in the physician office medical record? Are there alternative data sources for capturing the SSF such as epath reports, EMR data, clinical laboratory data feeds? Could these feeds be automated to reduce registrar burden? COC : All items are currently under review 5. Will additional data items be developed and collected? CDC/NPCR and NCI/SEER: There will likely be other items collected such as tumor size, lymph nodes examined and positive. However, these additional items are consistent with data already collected by COC hospitals and are existing NAACCR fields. Lymph vascular invasion is also of interest. Inclusion of variables will take into consideration the burden on registrars, the availability of the information to registrars, and prior data collection from COC or other standard setters. 6. Will CTRs directly assign TNM and stage group if they are not in the record? CDC/NPCR, NCI/SEER and COC: Yes, when the data to do so are available in the record. We recognize that this may be a new skill set for some registrars and are working across the cancer surveillance partners to develop and implement training tools to assure that registrars can attain the necessary skills. 7. Will it be necessary to report multiple staging systems during the transition? CDC/NPCR: Yes, however, CS will remain the official source of stage data for cases diagnosed through CoC facilities are already required to directly code clinical TNM, so this will not be a dramatic change for them. Having an overlap in staging systems allows a learning period for all cancer reporters, including hospital registries and central cancer registries. While it is expected that significant effort go into directly coded TNM and Summary Stage in 2014 and 2015, CDC also understands that this is a learning period. We will be working with central registries to improve the directly assigned stage data but we will not be using these data for staging purposes. CDC sees this time period, , as an opportunity to provide 11

12 training, identify problems, and assess the impact of changes in trends in incidence over time and to work together on consolidation and other procedures. CDC/NPCR and NCI/SEER: Yes, CS will remain the active staging system for cases diagnosed through We anticipate that there will be a several year overlap of CS and TNM staging as pre-2016 cases are accessioned. CoC: Yes, registrars will collect clinical and pathologic T, N, M and Stage Group (where they are defined by AJCC) and code CS for patients diagnosed in 2014 and How will CDC and others use the directly assigned pathological TNM and clinical TNM stage before 2016? CDC/NPCR: We will be working with central registries to improve the quality of the directly coded stage data, but we will not use this data for research or analysis purposes or expect the data to meet stringent quality measures. We do hope to monitor the increase in the collection of directly assigned TNM stages and analyze completeness and accuracy. CDC sees this time period, , as an opportunity to provide training, iron out issues, and to work together on consolidation and other procedures. 9. Who will conduct training for directly assigned AJCC staging? Training will come from many sources. We anticipate that training will be conducted in many formats and venues to meet the needs of providers, hospital registries, and central registries. CDC has begun development of training that will focus on the fundamentals of AJCC staging and collection of Summary Stage. This training will be expanded over time. In addition, CDC is providing funding to AJCC to support activities including development of training materials. Any materials developed by CDC will be freely available. NCI will make available the Educate Software to coordinate and focus on areas where training is required based on baseline assessments as described earlier in this document. NAACCR currently includes and will continue to include TNM and Summary Stage training in site-specific webinars that are part of the Cancer Registry and Surveillance Webinar Series. Training on TNM and Summary Stage will be included in the NAACCR comprehensive training plan that is being developed 10. Will education and training address non-coc registrar training? 12

13 CDC/NPCR and NCI/SEER: Yes, it is important that training be developed for all users/coders. This includes physicians, hospital reporters, and central registries. We anticipate that training will be conducted in many formats and venues to meet the needs of providers, hospital registries, and central registries. 11. What about the cost of the AJCC Manuals for training and resources? CDC/NPCR: It is expected that many people will likely want to purchase AJCC Staging manuals. CDC hopes to purchase some manuals and anticipates that NPCR registries may include some of these costs in their budgets. NCI/SEER: It should be anticipated that required materials will be made available. 12. Will training begin with AJCC 7 th Edition? CDC/NPCR: Yes, training will begin in June We will build on the June 2014 AJCC 7 th edition training as we begin training for the AJCC 8 th Edition. In addition, AJCC training webcasts are available now on the ACoS Education Portal. NAACCR: NAACCR currently presents training on AJCC 7 th Edition through its site-specific webinars that are part of the Cancer Registry and Surveillance Webinar Series. 13. Will education and training include Summary Stage? CDC/NPCR: Yes, NPCR education and training will focus on both AJCC and SS. Training will begin and materials will be available in June NCI/SEER: Training for both central and hospital registry personnel for the SEER registries will focus on direct assignment of pathologic and or clinical TNM staging. Tools are being developed by NCI personnel to assist registrars in translating CS into AJCC TNM when the TNM codes are unavailable in the medical record. NAACCR: NAACCR currently presents and will continue to present Summary Stage training in its site-specific webinars that are part of the Cancer Registry and Surveillance Webinar Series. 13