NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #5: NCRA /9/17 Eileen Tonner, MS

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1 NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #5: NCRA /9/17 Eileen Tonner, MS

2 Purpose of the Study For patients who have received curative-intent prostate cancer treatment Determine whether more frequent PSA testing leads to better survival or more harm for the patient In order to answer this question, it is important to know every PSA test the patient had To know exactly how frequently a patient is having PSA tests To know if the patient has had a recurrence

3 Thank you for Asking Questions Many questions relate to is this patient eligible? What if I can only get some records for a patient, but not all the records? What if the PCP s office responds but the urologist s office will not respond? The key question is: do you feel you are able to record all the PSAs a patient has had after treatment?

4 Eligibility Criteria 1) Evidence that medical records are available for the patient for 5 consecutive years or until distant recurrence or death- whichever is first 2) For patients who received primary radical prostatectomy: the patient s urologist and primary care physician can be identified For patients who received primary radiotherapy: the patient s radiation oncologist and urologist and primary care physician can be identified 3) The patients has at least 1 PSA test result within 2 years after end of primary treatment and registrar is confident in capturing PSA information for 2 years after primary treatment completion

5 Eligibility Questions If No is selected on the first question, the second question will not show up If No is selected on the second question, the third question will not show up All three questions have to be answered yes for a patient to be eligible

6 PSA We need the patient to have 5 years of complete information on PSA It is possible that the patient did not have a PSA checked every year Registrars should follow the FORDS manual Example: For PSA of 1.2, the registrar can enter 012 or 12. Numerically, these are identical numbers and will not affect the study or data analysis. When a patient has a result of <0.03 or <0.01 or <0.2 ( less than some number), we would prefer that you enter the result "0" for this special study. In this sole instance we differ from the FORDS manual, and the example was given in the instructions to specifically show this.

7 Scan Scans that are clearly not related to prostate cancer or prostate cancer recurrence anywhere in the body do not need to be entered. If not sure about whether a scan should be entered, please err on the side of entering For radiation planning scans (CT usually), enter the radiation planning CT scans as Other for Indication for Study

8 Recurrence Local recurrence is defined as recurrence in the prostate or prostate bed. This is defined by biopsy of the prostate or prostate bed, and pathology from this biopsy showing recurrent prostate cancer. Date of local recurrence = date of this biopsy. Alternatively, if biopsy is not done or information not available, local recurrence in the prostate or prostate bed can be defined using imaging (date of local recurrence = date of imaging scan) Regional nodes are nodes of the true pelvis, which essentially are the pelvic nodes below the bifurcation of the common iliac arteries. They include the following groups: pelvic NOS, hypogastric, obturator, iliac (internal, external, NOS), sacral (lateral, presacral, promontory [Gerota s] or NOS) Distant recurrence/metastasis is recurrence that is not local and not regional.

9 Radiation Dosage Please remember radiation dose is collected in units of Gy, not cgy Example: Patient received 6660 cgy- converts to 66.6 Gy Please round to the nearest whole number (67 Gy) Page 82 of the Instructions document states the allowable values are Gy and 0s, 7s, and 9s options for No/Unknown

10 NCDB Radiation Therapy Code Label Definition 0 None Radiation not administered Please use the following to code 1 Beam radiation Xray, cobalt, linear accelerator, neutron beam, betatron, spray radiation, intraoperative radiation and stereotactic radiosurgery (gamma knife and proton beam). 2 Radioactive implants Brachytherapy, interstitial implants, molds, seeds, needles, or intracavitary applicators of radioactive materials (cesium, radium, radon, and radioactive gold). 3 Radioisotopes Internal use of radioactive isotopes (iodine131, phosphorus32, strontium 89 and 90). Can be administered orally, intracavitary, or by intravenous injection. 4 Combination of beam radiation with radioactive implants or radioisotopes Combination of code 1 with codes 2 and/or 3. 5 Radiation therapy, NOS Radiation was administered, but the method or source is not documented. 9 Unknown. Unknown if radiation therapy recommended or administered; death certificate only.

11 Instructions: Special Study vs. FORDS All instructions in the Special Study Instructions Document are for the Special Study only FORDS should be used for routine data collection for the NCDB Specifically the instructions for coding biochemical recurrence and patients who are never disease free instructions differ from FORDS definitions and are only for the Special Study Do not update the NCDB with recurrence differences. We realize this is different from FORDS. If you find a patient has had a recurrence by FORDS definitions and that recurrence was not previously recorded in the NCDB, please update the patient s NCDB record with that information

12 Web form Some registrars were having issues with the display of the Additional Clinical Information Tab This issue should be resolved now. If the problem persists, please We do not have the capabilities to allow for printing or sorting patient lists. We suggest taking screenshots.

13 Study Communication Special Study Website: CAnswer Forum and Standards Resource Library: Please send all study-related questions to Study related questions sent to personal FACS accounts will be forwarded to the Special Study address and a ticket will be created. EITHER send an through the Contact form of the website OR the specialstudy@facs.org address. Please do not send both as all s go to the same account. Include FINs in all communication

14 Issues s for the special study are being sent from the address through an outside server If you have not been receiving these s, send the following information to your IT department and ask them to put us on the whitelist: IP address: ,

15 NCRA Program Recognition Information Webinar #1: NCRA ; 1.0CE 4/11/17 Webinar #2: NCRA ; 1.0CE 4/18/17 Webinar #3: NCRA ; 1.0CE 4/25/17 Webinar #4: NCRA ; 1.0CE 5/02/17 Webinar #5: NCRA ; 1.0CE 5/09/17

16 Questions Questions from previous webinars and the Canswer Forum will be included on all webinars Frequently Asked Questions (FAQ) document will be posted on the website, CAnswer Forum, and the web form

17 Review of FAQs from Previous Webinars

18 Gleason Score vs. Pattern Q: When you are asking for the primary biopsy Gleason score and the secondary biopsy Gleason score, are you really referring to the primary and secondary pattern? My patient had primary biopsy Gleason score already populated with a 4. Secondary biopsy Gleason score populated with a 3. The score, to me, is the combination of the primary/secondary pattern. A: Both score and pattern are used and are meant to describe the same thing. In this case, Primary Biopsy Gleason Score is 4 and Secondary Biopsy Gleason Score is 3.

19 Recurrence What should be documented when a physician states a biochemical recurrence? Please mark this as the date of first recurrence by any method. Local, regional, and distant recurrences have specific definitions in the manual (as described on a prior slide)

20 What should I do if a physician s office does not respond to record requests? If the record request form was faxed, call the office directly to request the records Make sure to send the letter template for patient information from the CoC so the office is aware this data is required for CoC accreditation

21 Additional Clinical Information Q: Perineural invasion was reported on the prostatectomy biopsy pathology report but not mentioned in the surgical (prostatectomy) pathology report A: Please code perinerual invasion as NO. Only the surgical prostatectomy pathology report should be used.

22 What if the urologist and PCP are retired? Please see if possible to collect records from their offices. Often, physicians may have retired but records are still available All NPIs are required for each provider If the NPI on the Surveillance tab is unknown: if there is no provider if they have the provider, but the NPI is completely unknown if it is unknown whether they have this provider.

23 NCDB Data Q: Comparing what information the NCDB tab has for a patient to what the medical record contains, there is more information available in the medical record than was initially abstracted. (i.e. Gleason on Prostatectomy and Date of Last Contact). A: Please select No and fill in the updated information. We are looking for the most current data.

24 Recurrence 1. What PSA level should be used to classify a patient as having recurrence? We are not asking registrars to interpret PSA results Please record recurrence if clinical notes indicate recurrence, and/or if patient receives treatment for recurrence 2. Does the patient have recurrence if he was never disease free after treatment? Yes. Please record the date of first PSA test after primary treatment as date of recurrence.

25 Biopsy Q: Should biopsies/polypectomies from surveillance colonoscopies be coded? A: No, as previously stated for imaging scans, please only include biopsies related to prostate cancer or prostate cancer recurrence anywhere in the body. Note: we will be updating the instructions with these changes.

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