CERVIX MEASURE SPECIFICATIONS

Size: px

Start display at page:

Download "CERVIX MEASURE SPECIFICATIONS"

Lydia McDaniel
6 years ago
Views:

1 Cancer Programs Practice Profile Reports (CP 3 R) CERVIX MEASURE SPECIFICATIONS Introduction The Commission on Cancer s (CoC) National Cancer Data Base (NCDB) staff has undertaken an effort to improve the transparency with which the measures in the CP 3 R and RQRS reporting systems are calculated. To this end, for each measure, supporting information, three tables and a flow-diagram are provided: The measure type, clinical rationale and references are provided. The Measure Item List table provides each cancer registy data item used in the assessment of the indicated measure. This includes the FORDS data item name, the North American Association of Central Cancer Registry (NAACCR) item number and a brief description of each item. The Case Eligibility Criteria table itemizes the steps taken to determine whether cases belong in the measure denominator for cases diagnosed 2010 and later. Each condition is described and is accompanied by the data item and code values used in the assesment. The Numerator Criteria table illustrates how cases are assessed to determine whether they qualify for the numerator of the measure, in other words are concordant for the standard of care. A flow-diagram is provided to illustrate the steps through which cases pass as they are evaluted for the indicated measure. The number appearing in each flow-diagram element corresponds to the assessment criteria appearing in the Case Eligibility Criteria and Numerator Criteria tables. Note: Newly adopted measures will be integrated into CP 3 R prior to their release in RQRS. Measure Definitions This document provides specifications for the following measures: Measure Use of brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) Measure Abbreviation CBRRT CERRT CERCT Measure Type Surveillance Surveillance Surveillance These measures were developed in conjunction with the Society of Gynecologic Oncology. 1

2 Measure Type There are several types of measures approved by the CoC. Evidence-based measures or accountability measures promote improvements in care delivery and are the highest standard for measurement. These measures demonstrate provider accountability, influence payment for services and promote transparency. The quality improvement measure function is to monitor the need for quality improvement or remediation. Generally, these measures are for individual program use. Surveillance measures are used to identify the status quo, generate information for decision making, and/or to monitor patterns and trends of care. The following Table summarizes the purposes and use of these measures: Measure Type Accountability Quality Improvement Surveillance Measure definition and use High level of evidence supports the measure, including multiple randomized control trials. These measures can be used for such purposes as public reporting, payment incentive programs, and the selection of providers by consumers, health plans, or purchasers. Evidence from experimental studies, not randomized control trials supports the measure. These are intended for internal monitoring of performance within an organization. Limited evidence exist that supports the measure or the measure is used for informative purposes to accredited programs. These measures can be used for to identify the status quo as well as monitor patterns and trends of care in order to guide decision-making and resource allocation. 2

3 CBRRT Cervix - Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer Measure Type: Surveillance Rationale: Although not fully documented in the literature, it is clear that radiation oncologists are using IMRT as a replacement for brachytherapy. Experts in cervical cancer routinely state that intracavitary brachytherapy for the treatment of locally advanced cervical cancer is perhaps the most important component of treatment and local disease control. Substituting IMRT for brachytherapy or omitting it entirely puts the patient at substantial risk of local recurrence and failure. CBRRT Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer 3

4 Note: This measure applies to cases diagnosed in 2010 and later. Measure Item List FORDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at dx Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Surgical Procedure of the Primary Site 1290 Surgical procedure of the primary site performed at any facility Location of Radiation 1550 Location of the facility where radiation therapy was administered as the first course of treatment Radiation Treatment Volume 1540 Volume or anatomic target of the most clinically significant radiation therapy Palliative Care 3270 Any care provided to palliate or alleviate symptoms Regional Treatment Modality 1570 The dominant modality of radiation therapy used to deliver the most clinically significant regional dose to the primary volume Boost Treatment Modality 3200 Exclusion (This is a user field in CP 3 R, it is not a FORDS item) N/A of interest during the first course of treatment The dominant modality of radiation therapy used to deliver the most clinically significant boost dose to the primary volume of interest during the first course of treatment Field used to manually exclude cases CBRRT Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer 4

5 Diagram Reference Case Eligibility Criteria Assessment FORDS Item FORDS Codes 1 Primary Site - Cervix Primary Site C530, C531, C538, C539 2 Exclude manually censored cases Exclusion (This is a user field in CP 3 R, it is not a FORDS item) Exclude: 80 - Patient enrolled in a clinical trial that directly impacts delivery of the standard of care 3 Female Sex 2 4 Adult patient over the age of 17 at diagnosis Age at Diagnosis First or only diagnosis of malignant neoplasm Sequence Number 00 or 01 6 Stageable Cervix Histologies, excludes sarcoma and lymphoma listed in AJCC 7 th ed. Histology Invasive tumors Behavior Code 3 8 All or part of the first course of treatment was performed at the reporting facility 9 Exclude Hysterectomy 10 Radiation (regional and/or boost) was provided at this facility Class of Case 10, 11, 12, 13, 14, 20, 21, or 22 Surgical Procedure of the Primary Site Location of Radiation Uterus and cervix, or pelvis NOS Radiation Treatment Volume 29, Exclude palliative radiation Palliative Care 2, 5, 6 CBRRT Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer 5

6 Numerator Criteria Diagram Reference Assess ment FORDS Item FORDS Codes 13 Brachytherapy administered: 1. Regional brachytherapy with no Boost or other Boost modality OR 2. Boost brachytherapy with other Regional modality OR 3. Both Regional and Boost brachytherapy Regional Treatment Modality Boost Treatment Modality Regional Treatment Modality and Boost Treatment Modality 00 or Regional Treatment Modality and Boost Treatment Modality not (00, 50-54) OR Boost Treatment Modality and Regional Treatment Modality not (00, 50-54) OR Regional Treatment Modality and Boost Treatment Modality Note: 1) March 2015 CP3R release: CBRRT measure was introduced. 2) September 2015 CP3R release: no changes to the CBRRT measure. 3) November 2015 CP3R release updates: a. Allow for manual exclusion with censor 80 4) August 2016: No updates for NAACCRv16 (no TNM staging in this measure) CBRRT Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer 6

7 CBRRT Use of Brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer 7

8 CERRT Cervix - Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer Measure Type: Surveillance Rationale: Prolonged treatment times are associated with negative outcomes. It has been reported that pelvic control drops 1% per day for treatment that extends beyond 55 days. CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 8

9 Note: This measure applies to cases diagnosed in 2010 and later. Measure Item List FORDS Data Item NAACCR # Description Primary Site 400 Organ of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Surgical Procedure of the Primary Site 1290 Surgical procedure of the primary site performed at any facility Location of Radiation 1550 Location of the facility where radiation therapy was administered as the first course of treatment Radiation Treatment Volume 1540 Volume or anatomic target of the most clinically significant radiation therapy Regional Treatment Modality 1570 The dominant modality of radiation therapy used to deliver the most clinically significant regional dose to the primary volume of interest during the first course of treatment Date Radiation Started 1210 Date on which radiation therapy began at any facility Date Radiation Ended 3220 Date on which the patient receives the last radiation treatment at any facility Vital Status 1760 Vital Status of the patient as of the date entered in Date of Last Contact Date of Last Contact or Death 1750 Date of last contact with the patient or the date of death Exclusion (This is a user field in CP 3 R, it is not a FORDS item) N/A Field used to manually exclude cases CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 9

10 Diagram Reference Case Eligibility Criteria Assessment FORDS Item FORDS Codes 1 Primary Site - Cervix Primary Site C530, C531, C538, C539 2 Exclude manually censored cases Exclusion (This is a user field in CP 3 R, it is not a FORDS item) Exclude: 80 - Patient enrolled in a clinical trial that directly impacts delivery of the standard of care 3 Female Sex 2 4 Adult patient over the age of 17 at diagnosis Age at Diagnosis First or only diagnosis of malignant neoplasm Sequence Number 00 or 01 6 Stageable Cervix Histologies, excludes sarcoma and lymphoma listed in AJCC 7 th ed. Histology Invasive tumors Behavior Code 3 8 All or part of the first course of treatment was performed at the reporting facility Class of Case 10, 11, 12, 13, 14, 20, 21, or 22 9 Regional Radiation was provided at this facility Location of Radiation 1, 2 CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 10

11 10 Uterus and cervix, or pelvis NOS Radiation Treatment Volume 29, Beam; including IMRT, stereotactic varieties Regional Treatment Modality Patient completed radiation or was reported living within 60 days from start of radiation (exclude cases who died < 60 days from radiation start before completing the radiation) Vital Status Vital Status = 1 Date of Last Contact or Death Date Radiation Started Date Radiation Ended OR (Date Radiation Ended is non-blank) OR (#Elapsed days between Date Radiation Started and last contact > 60) CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 11

12 Numerator Criteria Diagram Reference Assessment FORDS Item FORDS Codes days or less between start of radiation and end of all radiation (including boost radiation, if any) Date Radiation Started Date Radiation Ended Date Radiation Ended - Date Radiation Started <= 60 days Note: 1) March 2015 CP3R release: CERRT measure was introduced. 2) November 2015 CP3R release updates: a. Allow for manual exclusion with censor 80 b. Exclude cases as non-eligible if there is no radiation end date and patient died <60 days from radiation start. These cases were previously excluded as incomplete (they will now be NE). 3) August 2016 release: There are no for NAACCRv16 (no TNM staging in this rule) CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 12

13 CERRT Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer 13

CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive

14 CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) Measure Type: Surveillance Rationale: In 1999, five randomized clinical trials clearly demonstrated that adding cisplatin based chemotherapy to radiation therapy (I.e., chemoradiation) improves overall survival compared to treatment with radiation therapy alone. This lead to a clinical alert from the NCI and is now considered to be standard of care. A Phase III randomized trial by Peters et al demonstrated a PFS and OS benefit in women receiving chemoradiation who have positive pelvic nodes, a positive surgical margin, and/or positive parametrium 14 CERCT Cervical Measure: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2)

15 Note: This measure applies to cases diagnosed in 2010 and later. Measure Item List FORDS Data Item NAACCR # Description Primary Site 40 Organ of origin of the cancer Sex 220 Sex of patient Age at Diagnosis 230 Age of patient at diagnosis Sequence Number 560 Sequence of malignant and nonmalignant neoplasms over the lifetime Histology 522 Microscopic or cellular anatomy of the cancer Behavior Code 523 Neoplastic behavior of the cancer Class of Case 610 Indicates the reporting facility s role in managing the cancer Radiation Treatment Volume 1540 Identifies the volume or anatomic target of the most clinically significant radiation therapy CS Site-Specific Factor FIGO Stage Clinical T 940 AJCC Clinical T Clinical N 950 AJCC Clinical N Clinical M 960 AJCC Clinical M Pathologic T 880 AJCC Pathologic T Pathologic N 890 AJCC Pathologic N Pathologic M 900 AJCC Pathologic M Surgical Procedure of the Primary Site 1290 Surgical procedure of the primary site performed at any facility Surgical Margins of the Primary Site 1320 The final status of the surgical margins after resection of the primary tumor Regional Lymph Nodes Positive 820 Number of regional lymph nodes examined and found to contain metastases CS Site-Specific Factor Pelvic Nodal Status Chemotherapy 1390 The type of chemotherapy administered as first course of treatment at any facility Exclusion (This is a user field in CP 3 R, it is not a FORDS item) N/A Field used to manually exclude cases CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 15

16 Diagram Reference Case Eligibility Criteria Assessment FORDS Item FORDS Codes 1 Diagnosis of Cervix cancer Primary Site C530, C531, C538, C539 2 Exclude manually censored cases Exclusion Exclude: (This is a user field in CP 3 R, 80 - Patient enrolled in a clinical trial that directly impacts it is not a FORDS item) delivery of the standard of care 3 Female Sex Adult patient over the age of 17 at diagnosis First or only diagnosis of malignant neoplasm Age at Diagnosis Sequence Number 00 or 01 6 Stageable Cervix Histologies listed in AJCC 7 th ed. (exclude sarcoma and lymphoma) Histology Histology = Invasive tumors Behavior Code 3 8 All or part of the first course of treatment was performed at the reporting facility Class of Case 10, 11, 12, 13, 14, 20, 21, or 22 9 Uterus and cervix, and pelvis NOS Radiation Treatment Volume 29, 36 CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 16

17 Group 1 or Group 2 Selection 10 Group 1 Stage IB2-IV (FIGO stage, substituted with clinical TNM where missing, followed by pathologic TNM) CS Site-Specific Factor 1 (FIGO) Clinical T Clinical N Clinical M Pathologic T Pathologic N Pathologic M FIGO: 122, 200, 210, 211, 212, 220, 300, 310, 320, 400, 410, 420 OR AJCC clinical TNM (if FIGO is missing or unknown): T=(c1B2,c2,c2A,c2A1,c2A2,c2B,c3,c3A), N=c0, M (c1,p1); or T=c3B, any N, M (c1,p1); or T=(pIS,c1,c1A,c1A1,c1A2,c1B,c1B1,c1B2,c2,c2A,c2A1,c2A2,c2B,c 3,c3A), N=c1, M (c1,p1); or T=c4, any N, M (c1,p1); or any T, any N, M=(c1,p1) OR AJCC pathologic TNM (if FIGO and clinical stage is missing or unknown): T=(p1B2,p2,p2A,p2A1,p2A2,p2B,p3,p3A), N=(c0,p0), M (c1,p1); or T=p3B, any N, M (c1,p1); or T=(pIS,p1,p1A,p1A1,p1A2,p1B,p1B1,p1B2,p2,p2A,p2A1,p2A2,p2B,p3,p3A), N=p1, M (c1,p1); or T=p4,any N, M (c1,p1), or any T, any N, M=(c1,p1) OR OR (if not selected in Group 1) CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 17

18 11 OR OR (if not selected in Group 1) Group 2 (if not selected in Group 1) Hysterectomy and positive pelvic nodes, positive surgical margins, and/or positive parametrium Surgical Procedure of the Primary Site Surgical Margins of the Primary Site Pathologic N CS Site-Specific Factor 1 (FIGO) Regional Lymph Nodes Positive CS Site-Specific Factor 2 (Pelvic Nodal Status) Pathologic T Clinical T Surgical Procedure AND (Positive surgical margins 1-3 or Any number of regional nodes positive: Pathologic N=p1 or FIGO Stage IIIB: ssf1 = 320 or One or more positive nodes or Positive pelvic lymph nodes: ssf2 = 010 or Involves the parametrium Pathologic T=(p2B,p3B) or Clinical T=(c2B,c3B) CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 18

19 Numerator Criteria Diagram Reference Assessment FORDS Item FORDS Codes 12 Any chemotherapy administered: singleagent, multiagent, or type and number of agents unknown (This measure calculates the percentage of only chemotherapy administered. No chemo, chemo recommended, missing or unknown is not administered in this measure) Chemotherapy 01, 02, 03 Notes: 1) September 2015 CP3R release: CERCT was introduced. 2) November 2015 CP3R release updates: a) Allow for manual exclusion with censor 80 b) Edit Histology regardless of FIGO. 3) August 2016 update: a. NAACCRv16 add c or p prefix to TNM. CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 19

20 CERCT Cervix: Chemotherapy administered to cervical cancer patients who received radiation for stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) 20

OVARY MEASURE SPECIFICATIONS

Cancer Programs Practice Profile Reports (CP 3 R) OVARY MEASURE SPECIFICATIONS Introduction The Commission on Cancer s (CoC) National Cancer Data Base (NCDB) staff has undertaken an effort to improve the