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Procedure for Reporting of Stage Information This document provides guidance regarding the reporting of stage for cancer patients in Ontario’s Integrated Cancer Programs (ICPs). This procedure is in accordance with the CCO policy entitled “Guidelines for Staging Patients with Cancer” (November 2005). Documentation of Staging Information: Stage information should be documented in the Databook submission (Chapter 1 of the Activity Level Reporting: Disease Entity) to ensure that the information can be used locally or on a population basis for monitoring purposes, research and planning of cancer services. Procedure for Reporting Staging Information: o All new patients with a diagnosis of cancer (invasive and insitu) should be staged according to the 6th Edition of AJCC Cancer Staging for TNM. Based on the guidelines from AJCC1, the following cases should be excluded from staging as there is no staging schema for them: CNS Myeloma Leukemias Thymomas Primary unknown Kaposis Sarcoma Islets of Langerhans of Pancreas. There are additional histologies within each of the disease sites that cannot be staged. Consult the lists of included histologies in the AJCC manual. Note: Ann Arbor staging system should be applied for Lymphomas as it has been adopted by AJCC. o CCO’s Stage Capture Rate calculates the percentage of ICP cases that reported a valid stage at diagnosis. The methodology for this calculation excludes some additional cases. While CCO encourages all facilities to collect stage at diagnosis on as many cases as possible, the following cases are excluded from the Stage Capture Rate: Non-melanomata skin Paediatric (i.e., < 18 years of age at diagnosis) 1 American Join Committee on Cancer: AJCC Cancer Staging Manual, 6th ed. Greene FL, Page DL, Fleming ID, Gritz AG, Balch CM, Haller, DG, Morrow M (Eds.). Philadephia: LippincottRaven, 2002. Procedure for Reporting of Stage Information (Jan 2007) 1 Non-analytic cases (see Databook: Appendix G for definition) (The identification of analytic cases is still under investigation and will be implemented once reviewed). o The stage of disease at diagnosis at an Integrated Cancer Program is to be recorded. o General rules of the 6th Edition of the UICC TNM Classification or the AJCC Cancer Staging Handbook, sixth edition should apply: o All cases should use the following time guidelines for evaluating stage at diagnosis: through the first course of surgery or 4 months, whichever is longer. All cases should be confirmed microscopically for TNM classification (including clinical classification). Rare cases that do not have biopsy or cytology of the tumour can be staged but should be analyzed separately and should not be included in the survival analysis. Clinical classification (pretreatment clinical classification – designated cTNM) and pathological classification (postsurgical histopathological classification – designated pTNM) should be used to describe each tumour site. After assigning cT,cN and cM and/or pT, pN and pM categories, these may be grouped into stages. An accurate record of the T, N, M categories and the stage group should be recorded in the medical record for every case. The clinical stage is essential to select and evaluate therapy, while the pathological stage provides the most precise data to estimate prognosis and calculate results. If there is doubt concerning the T, N, or M classification to which a particular case should be assigned, then the lower (less advanced) category should be assigned. The same principle applies to the stage grouping. In the case of multiple, simultaneous tumours in one organ, the tumour with the highest T category is the one selected for classification and staging. For simultaneous bilateral cancers in paired organs, the tumours are classified separately as independent tumours in different organs. In the case of tumours of the thyroid, liver, and ovary, multiplicity is a criterion of T classification. When assigning T, N, and M values, an “X” should only be used when the T, N, and M category cannot be assessed given all reasonable clinical or pathologic maneuvers to stage. It should not be used to simply fill in blanks when someone has neglected to apply an N or M designation when a patient was seen, despite the presence of relevant information at the time and before treatment. When a physician decides that it is not clinically necessary to assess N and/or M categories to confirm absence of disease, for low stage tumours, the assumption is N0 and M0. On this assumption a clinical stage grouping can be determined (e.g., Prostate cancer: T2bN0M0 – Procedure for Reporting of Stage Information (Jan 2007) 2 Stage Group II). Sometimes a physician will not assess the full extent of the disease simply because that would not impact on treatment choices. If the highest category can be determined in T,N or M, a stage group can be assigned with “X” in the other two categories (e.g., TxN3Mx assign stage grouping as IV, since the nodes automatically make the case Stage IV). o When staging the pathological TNM, the pM is most often “X”. If the cM is “0”, the Health Record Technician can assume that the pM is “0” and stage accordingly. For final stage grouping clinical and pathological data may be combined when only partial information is available in either the pathological classification or the clinical classification o Patients with metastatic disease being treated with palliative intent should record as much staging information as is available. o Stage should be documented in the Health Record based on standardized AJCC v.6 staging forms (electronic or manual). Modifications to these forms to capture additional information of clinical or prognostic importance could also be considered Accountability/Responsibility for Staging Information: The Regional Vice President is ultimately responsible for ensuring that stage information is properly documented. Cancer Care Ontario will assist RVPs in ensuring that there are effective processes for ensuring the highest level of stage related data quality. It will be the responsibility of each Regional Vice-President to ensure that their centre is compliant with the policy and that procedures are in place to ensure that the stage information is of high quality. Data for TNM are derived from a variety of sources (e.g., the physician’s physical exam, the radiologist’s report(s), the operating surgeon’s notes, the histopathologist report(s)). The final TNM classification and/or stage grouping rest with a designated individual who has access to the most complete data. All ICPs should have a documented policy for the identification, collection and processing of stage related data in their organization. The policy should also include identified responsibility/accountability for assigning stage. Data should be reported as per the Databook requirements. CCO will however, continue to allow stage and disease to be updated at a record level on a continuous basis. The information will only be frozen for reporting purposes after 6 months but updates are still accepted. Procedure for Reporting of Stage Information (Jan 2007) 3 Monitoring CCO will monitor the performance of the Integrated Cancer Programs in documenting complete, accurate and timely stage information and will present data on stage information at regular meetings of the RVPs or their delegates. The Cancer Surgery Agreement requirements identify a 90% completeness target of valid and accurate stage at diagnosis data. Health Records has a responsibility to monitor on an on-going basis completeness and quality of stage data quality capture. Review of incomplete stage cases, audits, validation of stage by Health Record Technicians are identified strategies that should be implemented as a part of this process. Uses of Stage Data Stage information constitutes one of the most important prognostic factors for cancer. The availability of high quality stage data supports providers, administrators, researchers and decision-makers in their planning, evaluation and quality improvement activities in order to continue to improve the quality of patient care. CCO is working to promote the use of stage data and other prognostic factors in the development of cancer system indicators. As part of this, CCO is working towards the development of clinically relevant indicators for prognostically similar groups of cancer cases. This grouping would be done using valid and reliable data on cancer stage and other important prognostic factors. These indicators would support specific actions and strategies aimed at improving the understanding and treatment of cancer. More specifically, this involves: o Identifying, developing, implementing and reporting surveillance indicators for prognostically similar groups of cancer cases. o Identifying, developing, implementing, and reporting treatment pattern and guideline concordance indicators that use stage and other prognostic factors for specific disease sites. o Disseminating and sharing stage based indicators in order to promote uptake of stage related information in decision making processes (and also support stage data quality improvement). Procedure for Reporting of Stage Information (Jan 2007) 4 STAGE: FREQUENTLY ASKED QUESTIONS DRAFT – January 2007 1) How was the stage capture indicator (facility-based) calculated in April 2006? The most recent stage capture indicator results were published in May 2006 and were based on data from the period of July to December 2005. Each Integrated Cancer Program (ICP) received a copy of their results in May 2006. The indicator refers to completeness of stage data at diagnosis for new stageable incident cancer cases (refer to FAQ #2 for further information on stageable and non-stageable cases). A refinement was applied to the stage rate methodology in the May 2006 release to identify non-valid group stage values. The revised methodology now includes a validation step that compares the pathological OR clinical stage group at diagnosis to valid values by disease site according to the AJCC version 6 manual. Stageable ICD-10CA codes were mapped to AJCC site groups and all non-cancer sites and non-stageable cases in the cancer range were excluded from the indicator. Stage values at diagnosis were validated against the AJCC v.6 table of valid values. If either pathological or clinical group stage at diagnosis was valid, the case was counted as staged. Note that non-melanoma skin cancers and paediatric cases were included in the calculation of the stage capture rate released in May 2006. All new incident cases identified by the centre were included in the calculation (Analytic case filter was not applied on the dataset). The currently published stage capture rate (through the Cancer Services Quality Indicators (CSQI)) does not include the validation of stage as identified above. Hence, there will be substantial differences between the published results and those results provided to the sites in May 2006. A more refined approach of the stage capture rate will be released with the CSQI indicators in March 2007 and will be based on fiscal 2005/06 data. Details of this approach are provided later on in the FAQs. Procedure for Reporting of Stage Information (Jan 2007) 5 2) What are non-stageable cancer cases? All cases with diagnoses outside the cancer range are non-stageable (C000 to D0999). There are also sites within the cancer range such as brain and conjunctiva that are not stageable, as per the AJCC v.6 manual. Attached please find the list of ICD-10-CA diagnoses which would be considered stageable by CCO for the stage capture rate indicator (based on the AJCC v.6). Revised AJCC Validation table May,2007 3) What was the timeframe used to capture the stage capture rate indicator (facility-based) published in May 2006? For the stage capture rate published in May 2006, all new cancer cases for the period from July to December 2005 were included. In future, for purposes of the stage capture indicator, a six-month timeframe will be applied to allow hospitals to collect stage over a six-month period. This is defined as sixmonths from the date of the first encounter to the ICP. The rule is guided by the AJCC general rule that all cases should use the following time guidelines for evaluating stage: “through the first course of surgery or 4 months, whichever is longer”.2. Prior to April 1, 2006, stage data updates were not permitted after four months. Currently, there is no limitation on submitting updates to stage data. Hence, ICPs will still have the ability to update staging information indefinitely however (as mentioned above), the stage capture rate will be based on a six-month timeframe. 4) When is it appropriate to use ‘X’? ‘X’ is a valid value for individual stage at diagnosis elements (clinical or pathological) T, N or M only (e.g., ‘TX’). ‘TX’ means you were not able to evaluate the tumour, as compared to ‘T0’ which means no evidence of a primary tumour being found by any method. ‘X’ is not a valid value for stage group. Work is currently underway to remove ‘X’ and other invalid options for group stage in OPIS. 2 Greene FL, Page DL, Fleming ID Fritz, AG, Balch CM, Haller DG, etc al. AJCC Cancer Staging Handbook. New York: Springer, 2002. Procedure for Reporting of Stage Information (Jan 2007) 6 If there is doubt concerning the T, N, or M classification to which a particular case should be assigned, then the lower (less advanced) category should be assigned. The same principle applies to the stage group. When assigning T, N, and M values, an ‘X’ should only be used when the T, N, and M category cannot be assessed given all reasonable clinical or pathologic maneuvers to stage. It should not be used to simply fill in blanks when someone has neglected to apply an N or M designation when a patient was seen, despite the presence of relevant information at the time and before treatment. When a physician decides that it is not clinically necessary to assess N and/or M categories to confirm absence of disease, for low stage tumours, the assumption is N0 and M0. On this assumption a clinical stage grouping can be determined (e.g., Prostate cancer: T2bN0M0 – Stage Group II). Sometimes a physician will not assess the full extent of the disease simply because that would not impact on treatment choices. If the highest category can be determined in T,N or M, a stage group can be assigned with “X” in the other two categories (e.g., TXN3MX assign stage grouping as IV, since the nodes automatically make the case Stage IV) When staging the pathological TNM, the pM is most often “X”. If the cM is “0”, the Health Record Technician can assume that the pM is “0” and stage accordingly. For final stage grouping clinical and pathological data may be combined when only partial information is available in either the pathological classification or the clinical classification Attached is a reference article with further information on the appropriate use of ‘X’. O:\PMO\Stage Capture\Data Quality\On the use and abuse of X in the TNM classification.pdf 5) Are non-TNM staging systems accepted by Databook? CCO’s stage capture vision mandates the submission of stage data through the AJCC v.6 (including Ann Arbor for lymphomas) or using the collaborative staging methodology. The Stage Data Quality Working Group has recommended that hospitals using FIGO in gynecological cancers be allowed to continue submitting with the staging system recorded. Those hospitals submitting using the FIGO staging system should leave the T, N and M elements blank and only complete one stage group (clinical or pathological stage at diagnosis). Other non-AJCC v.6 approved systems are not supported by Databook. Procedure for Reporting of Stage Information (Jan 2007) 7 6) What cases should be excluded from staging? Based on the guidelines from AJCC v.63, the following cases should be excluded from staging as there is no staging schema for them: o CNS o Myeloma o Leukemias o Thymomas o Primary unknown o Kaposis Sarcoma o Islets of Langerhans of Pancreas. o There are additional histologies within each of the disease sites that are not to be staged. Consult the lists of included histologies in the AJCC manual. Note: Ann Arbor staging system should be applied for Lymphomas as it has been adopted by AJCC. 7) When will stage data be available through i-PORT? It is anticipated that stage data and the stage capture rate indicator results will be available through i-Port for ICPs by the end of summer 2007. In the interim, ad-hoc reports will be provided to ICPs as they are produced. Additional data quality stage related indicators are currently under development and will be available in the near future. 8) If I have a question regarding staging, what is the mechanism for obtaining an answer? A new FAQ response process has been implemented and all questions related to staging should be submitted via [email protected]. All questions will be responded within 48 hours. 9) Can data be re-submitted after the month end? CCO will continue to allow stage and disease to be updated at a record level on a continuous basis. The information will only be frozen for purposes of reporting the stage capture rate. Updates to stage information are still accepted after 6 months from first encounter to the facility. 3 American Join Committee on Cancer: AJCC Cancer Staging Manual, 6 th ed. Greene FL, Page DL, Fleming ID, Gritz AG, Balch CM, Haller, DG, Morrow M (Eds.). Philadelphia: Lippincott-Raven, 2002. Procedure for Reporting of Stage Information (Jan 2007) 8 10) How will I submit data on surgical only cases? As of April 1st 2007, ICPs will be required to submit stage related information on surgical only cases at the cancer centre (including the host hospital). Submission of these cases will occur in the Databook (Disease Entity). Two new fields have been added to the Databook to accommodate for this reporting including: o First Definitive Cancer Treatment Flag, and o First Definitive Cancer Treatment Date. More detailed definitions are provided in the Databook. 11) What kind of error reports are available? Error reports are available in the Databook QA Reports available on https://ssl.cancercare.on.ca. There is both a summary and a detailed report available. Please refer to the Databook QA Specs document for specific error description in the Databook document folder: https://ssl.cancercare.on.ca/http/ecco.cancercare.on.ca/databookdocs/databookqaspecs200 6-07.doc 12) What is the methodology for calculating the stage capture rate for the 2005/06 fiscal year data? The stage capture rate for the 2005/06 fiscal year will include the following refinements (from the May 2006 release): o Implementation of six-month staging rule. The stage capture rate will be refined to include the reporting of stage over a period of six-months from the first encounter to the facility (i.e., consult and/or clinic visit and/or surgery). Hence, if the stage capture rate is calculated for April 2005, then stage data for the period of April through October is required to allow hospitals a period of time to submit stage information on new cases. o Exclusion of paediatric cases. All cases where the patient is less than 18 years of age at the time of diagnosis or the first encounter to the facility are to be excluded from the stage capture rate (i.e., only cases greater than or equal to 18 years of age to be included). o Inclusion of stage validation tables in population based stage capture rate. Similar to the facility-based stage capture rate, the stage validation rules (that define valid stage values by disease site) will be applied to the population-based stage capture rate (based on all new incident cancer cases). Procedure for Reporting of Stage Information (Jan 2007) 9 o Exclusion of non-melanoma skin from the stage capture rate. All cases where the disease is identified as non-melanoma skin (as specified below) are to be excluded from the stage capture rate: o C440 Malignant Neoplasm Of Skin Of Lip o C441 Malignant Neoplasm Skin Of Eyelid, Including Canthus Skineyelid o C442 Malignant Neoplasm Skin Of Ear And External Auricular Canal o C443 Malignant Neoplasm Skin Of Other And Unspecified Parts Of Face o C444 Malignant Neoplasm Skin Of Scalp & Neck o C445 Malignant Neoplasm Of Skin Of Trunk o C446 Malignant Neoplasm Skin Of Upper Limb, Including Shoulder o C447 Malignant Neoplasm Skin Of Lower Limb, Including Hip o C448 Overlapping Malignant Lesion Of Skin o C449 Malignant Neoplasm Of Skin, Unspecified. o Stage capture rate to be calculated on Analytic cases only. CCO staging policy (2006/07) identifies that stage data are to be reported only for analytic cases as defined in the American College of Surgeons, FORDS manual (specifically codes 0, 1 or 2). Several ICPs identified challenges to identifying analytic cases upon coding stage; hence, CCO is currently investigating the development of an algorithm to identify analytic cases only. Further information will be provided in the next several months. In the meantime, ICPs are encouraged to send data on all patients. Procedure for Reporting of Stage Information (Jan 2007) 10