American College of Surgeons 2014 Content cannot be reproduced or repurposed without written permission of the American College of Surgeons.
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1 Revision of the FORDS Manual: A Process Dependent on Registrar and Clinician Input Frederick L. Greene, MD FACS Medical Director, Cancer Data Services, Levine Cancer Institute, Charlotte, NC 1
2 2
3 Disease is very old and nothing about it has changed. It is we who change as we learn what was formerly imperceptible. -- Charcot 3
4 Purpose of Project Realign data collection with Contemporary multidisciplinary medical practice Enable physicians and researchers to analyze entire continuum of care Diagnostic workup Treatment Prognostic factors National quality measures Guidelines 4
5 Key Objectives Seek input from relevant groups physicians (including AJCC Expert Panels), registrars, researchers, quality improvement groups Understand different perspectives from surveillance community and clinical professionals Identify issues with existing data fields Realign data collection with contemporary medical practice Create instructions and code structures Achieve consensus among partners Provide end product to software vendors & training to registrars 5
6 Introduction to FORDS FORDS manual Facility Oncology Registry Data Standards Implemented 2003 Minor clinical revisions Section One General rules and principles Section Two Details majority of data items collected in registries Provides instructions and code structures 6
7 Data Collection and Submissions Hospital Registrar CoC Hospital Registrar State Registry NCDB NPCR SEER 7
8 FORDS FORDS Facility Oncology Registry Data Standards Implemented in 2003, updated annually, 2014 in process Replaced ROADS - Registry Oncology and Data Standards Implemented in 1996 with major changes in 1998 Currently 459 pages, available online in pdf format Identifies rules for coding and codes for all CoC required items Determines what CoC can measure Quality measures used in RQRS, CQIP, CP3R Determines what questions NCDB data can answer Participant User Files (PUF) Determines CoC s relevance and ability to influence quality care 8
9 CoC-Accredited Cancer Programs Around 1500 CoC-accredited cancer programs in the US and Puerto Rico 6 9
10 Cancer Programs in U.S. Hospitals Number of general medical/surgical facilities (including Puerto Rico): ~ 5000 Estimated new cancer patients in 2012: 1,638,910* *American Cancer Society, Cancer Facts and Figures, 2012
11 FORDS Revision Project Steering Committee Rick Greene, MD Project Leader Carla Amato-Martz Project Manager American Cancer Society Ahmedin Jemal, Anna Lin ACS/CoC/NCDB David Winchester Medical Director Cancer Programs Ryan McCabe, Kathleen Thoburn NCDB Daniel McKellar-Chair COC ACS/CoC Quality Integration Committee Larry Shulman 11
12 FORDS Revision Project Steering Committee AJCC Donna Gress 8 th Edition Expert Panel Representatives ASCO Tom Hensing, Bradford Hirsch, Tracey Locklear ASTRO Julia White Canadian Registries Mary Jane King CAP Kay Washington CDC-NPCR Mary Lewis 12
13 FORDS Revision Project Steering Committee Department of Defense Elizabeth Butts NAACCR Lori Havener NCRA Ann Griffin - Representative to CoC NCI-SEER Lynne Penberthy, Carol Kosary Physicians At-large Edward Grendys Registrars Paige Tedder Veterans Administration Kathleen Waller 13
14 FORDS Revision Project Changes affect Other registry standard-setters National Program of Cancer Registries at CDC SEER at NCI Canadian registries Software providers State central registries Hospital registries and non-coc cancer abstractors Changes coordinated by North American Association of Central Cancer Registries committees Input from National Cancer Registrars Association Once accepted by NAACCR committees, implementation can take 1-2 years 14
15 Overview of Data Items Collected for Each Case Patient Identification Accession and Sequence Numbers Medical Record Number and Social Security Number (not collected by NCDB) Patient Name (not collected by NCDB) Patient Address at Diagnosis (NCDB collects city, state, zip, country; not street) Patient Current Address (not collected by NCDB) Telephone Number (not collected by NCDB) Birth Date and Age at Diagnosis Place of Birth (State and Country) Race (up to 6) and Hispanic Ethnicity Sex Primary Payer at Diagnosis ICD-9 or 10-CM Secondary Diagnoses - up to 10 NPI numbers for Managing Physician (not collected by NCDB); Surgical, Radiation, Medical Oncologists 15
16 Overview of Data Items Collected for Each Case Cancer Identification Class of Case NPI Institution Referred To, From (not collected by NCDB) Date of Initial Diagnosis Date of First Contact Primary Site, Laterality, Histology, Behavior, Grade/Differentiation Method of most definitive Diagnostic Confirmation 16
17 Overview of Data Items Collected for Each Case Stage of Disease at Diagnosis Surgical Diagnostic and Staging Procedure, and Date Number of Regional Nodes Examined, Positive Lymph Vascular Invasion AJCC: clinical and pathologic T, N, M and Stage Group Clinical and pathologic staged-by, clinical and pathologic descriptors Input items for Collaborative Stage Data Collection System (CS) Includes 0-25 site-specific factors depending on site characteristics Derived CS output items Coding requires use of AJCC and CS manuals All items above except surgical diagnostic and staging procedures 17
18 Overview of Data Items Collected for Each Case First Course of Treatment Dates of: first treatment, first surgery, most definitive surgery, radiation begin, radiation end, chemotherapy begin, hormone therapy begin, immunotherapy begin, first systemic therapy begin, other treatment begin Treatment Status: treated, not treated, active surveillance Surgery type: primary site, regional lymph node, other regional or distant site (all here, anywhere); reason for no surgery Radiation: location (here, elsewhere), volume, modality, dose, boost modality, boost dose, number treatments to this volume, radiation/surgery sequence, reason for no radiation Systemic types: Chemotherapy, hormone therapy, immunotherapy (biologic modifier), hematologic transplant and endocrine procedures; systemic/surgery sequence; reasons for not giving each of those modalities 18
19 Overview of Data Items Collected for Each Case Outcomes Type of First Recurrence and Date Vital Status Date of Last Contact or Death Cancer Status - at last follow-up NPI of the following registry (Not collected by NCDB) Follow-up source - last, next 19
20 Overview of Data Items Collected for Each Case Case Administration - entered by registry software Abstracted By Facility Identification: Facility ID, Archive FIN, NPI-Archive FIN Date Case Completed-CoC Override items for verified very rare code combinations Current and original code versions for CoC manual Morphology coding ICD-O-2/3 conversion flags AJCC edition number Current treatment coding system CS versioning 20
21 Possible Directions Require more complete clinical and pathologic staging Better recurrence data collection Collect screening and workup methods Specific systemic treatments imatinib, ipilimumab, trastuzumab, paclitaxel, etc. Subsequent treatment - beyond first course CPT and/or ICD-10-PCS treatment codes Pediatric-relevant data Eliminate unimportant data: registrar workload 18 items deleted Add new clinically relevant data to keep up 21
22 Staging: CS sunsets at the end of 2015 Many committees addressing what to retain, add, change in 2016 All standard setters moving to collection of direct-assigned AJCC clinical and pathologic T, N, M and stage group CoC needs changes by summer What Else is Happening Before May meetings for physician input, especially for site-specific factors Histologies: new histologic terms used in hospitals Not implemented by registry community, cannot be added to CS Decisions for handling in progress, little chance CoC will have input at this time EHR and Volume II Harmonization NAACCR group reviewing Methods to implement collection of CPT and/or ICD-10-PCS codes Currently looking at radiation as available at radiation treatment facilities Chemotherapy Comparative Effectiveness Research study by NPCR 22
23 What Else is Happening Development of 8 th Edition AJCC Cancer Staging Manual Expert site panels chosen Complete in Fall 2016 Begin use January 1,
24 FORDS Revision Project Review current data items Do rules and coding options need revision Remove items no longer necessary Explore need for new data items Steering Committee encompasses all partners Subcommittees to review data item details Physician specialties: Surgery, Pathology, Radiology, Medical & Radiation Oncology Disease site specialties: assistance from CoC QIC and AJCC Expert Panel Leaders Surveillance, central, and hospital registrars Request input from physicians and registrars through surveys 24
25 Survey for FORDS Revision Project Survey link available on CoC Web page One suggestion per survey May submit multiple surveys Survey categories for suggestion Change existing data item Add new data item Remove existing data item Questions similar but unique to each category Specifics needed to understand and evaluate suggestion 25
26
27 Survey for FORDS Revision Change Existing Data Item What is the FORDS data field section? Section One: Case Eligibility Section One: Overview of Coding Principles Section Two: Patient Identification Section Two: Cancer Identification Section Two: Stage of Disease at Diagnosis Section Two: First Course of Treatment Section Two: Outcomes Section Two: Case Administration Appendix B: Site-Specific Surgery Codes PUF Data Dictionary What is the name of the data field or item that needs to be changed? Free text 27
28 Survey for FORDS Revision Change Existing Data Item What needs to be changed? (Please check all that apply) Coding options/choices Instructions or rules What coding option or instruction needs to be changed? Free text Please provide an example or scenario that indicates why this change is needed. Be as specific as possible. Free text 28
29 Survey for FORDS Revision Change Existing Data Item Is there a particular disease site affected by this change? (check all that apply) Head & Neck Gastrointestinal Hepatobiliary Thoracic Bone & Soft Tissue Sarcoma Skin Breast Gynecologic Male Genital Kidney & Urinary Tract Ophthalmic Central Nervous System Endocrine Hematologic No particular site/all sites Other, please specify 29
30 Survey for FORDS Revision Change Existing Data Item Is there a particular diagnostic workup affected by this change? Imaging Biopsies Scopes Exploratory procedures Pathology/Cytology Is there a particular treatment type affected by this change? Surgery Immunotherapy Radiation Therapy Hematologic Transplant Chemotherapy Endocrine Procedures Hormone Therapy Other, please specify 30
31 Survey for FORDS Revision Change Existing Data Item Please suggest a solution. Again, be as specific as possible. Free text Are there rules from other sources that affect this data field? No or Yes Please specify the source and rule that affects this data field. Multiple Primary and Histology Rules Hematopoietic and Lymphoid Neoplasm Rules SEER Rx SEER Coding Manual Collaborative Stage AJCC Cancer Staging Manual NCCN Guidelines CAP Protocols Other, please specify 31
32 Survey for FORDS Revision Change Existing Data Item Additional comments? No Yes, free text Please provide your name and address in case further clarification is needed Disclaimer that information will not be used for any other purposes Will not be used to publicly identify the source of this suggestion 32
33 Results of FORDS Survey(800+ Responses) Add Codes:1) Radiology reports are including a term that needs to be added to ambiguous terms --- concerning for 2) In carcinoma of the lung, include biomarkers EGFR, K-ras and ALK so that registrars can code mutations positive or negative 3)When term bland embolization used, there should be separate code since this is not chemoembolization. Change Codes: 1) Need better clarification of descriptors of surgery codes 2)Clarification of biopsy technique when all tumor is removed Delete Codes: 1) Codes regarding readmission to same hospital within 30 days of discharge 2) Code for birthplace (multiple responses!!) 33
34 Collaboration with AJCC Expert Panels Data needed for AJCC staging analysis collected by registrars More than just stage Includes Diagnostic approaches Tumor size Lymph nodes positive and examined Stage elements: T, N, M, stage group Type of treatment: surgery, radiation, systemic Outcomes Prognostic factors & predictive factors 34
35 AJCC Expert Panel Objectives Provide modern multidisciplinary assessment of diagnosis and treatment Consensus on items necessary to evaluate stage Recommendations on Data items change, add new, remove Definitions and rules for collection 35
36 Case Scenarios Data items collected by cancer registries are in red Identify appropriateness of items Future Discussions Method of collection Appropriateness of rules and coding structure 36
37 Breast Case Scenario #1 Pt is 62 yr old woman with non-tender mass in UOQ lt breast. Physical exam reveals firm mobile 4cm mass UOQ with no skin changes and no axillary adenopathy. Mammogram-3.9cm density UOQ lt breast. US-3.8cm hypoechoic area UOQ lt breast, lt axillary nodes negative. US-guided core needle biopsy. Path: infiltrating duct ca, BR grade 3, ER/PR-positive, HER2 negative by IHC. T2 N0 M0 Clinical Stage IIA 37
38 Breast Case Scenario #1 Pt declined neoadjuvant systemic therapy. Lumpectomy UOQ lt breast, sentinel node bx. Op findings: sentinel nodes negative on frozen section. Path: Infiltrating duct ca, 4.1cm with dermal invasion, BR Grade III, margins negative-closest margin inferior at 4mm, 4 sentinel nodes negative by H&E but IHC shows ITCs <0.1mm in size. pt2 pn0(i+) cm0 Pathologic Stage IIA. 38
39 Other Important Issues Coding for patient metrics for COC Standards: (1)patient refusal (2) Rx contraindicated (coexisting disease, co-morbidities) (3) age exclusion (4) delay secondary to patient choice Date of Clinical vs Pathologic diagnosis Coding for clinical trial participation and agents used 39
40 NCDB Research National Quality Measures, Guidelines, Prognostic Factors Clinical Care Cancer Registry Surveillance Community (NPCR, SEER, NAACCR) AJCC 8 th Edition CS Transition to AJCC Staging 40
41 Project Timeline Milestones Seek Input survey tool, physicians, AJCC, registrars, research, QI groups May August 2015 Subcommittee deliberations and recommendations Steering Committee review of recommendations and determination of changes Nov Sept 2016 Submit to NAACCR, end product to software vendors, training for registrars April June 2017 Compilation of issues, surveys; Understand different perspectives September October 2015 Drafts of rules and codes, feedback & consensus Oct 2016 March 2017 Implementation 1/1/
42
43 Change All organizations need to know that virtually no program or activity will perform effectively for a long time without modification and redesign. Eventually every activity becomes obsolete. Peter Drucker
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