NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #7: NCRA /23/17 Eileen Tonner, MS

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1 NCDB Special Study: Post-Active Treatment Surveillance in Prostate Cancer Webinar #7: NCRA /23/17 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? 5 years is required for a patient to be eligible, once eligible we ask for 8 years of follow up

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 Patient Eligibility If any eligibility question is answered No and is submitted, a new patient should automatically be added to the list once the page is refreshed. Please wait at least 2 weeks to hear back from outside offices for records. If the patient does not have a PCP, then the patient is eligible. If you do not know if the patient has a PCP, or if the patient has a PCP but you are not able to get records, then this patient is not eligible. A complete record is needed for patients to be eligible. However, it is possible that some patients did not have PSAs every year. Patients receiving care at the VA for prostate cancer or prostate cancer follow-up are not eligible. If any eligibility question is answered No and is submitted, a new patient should automatically be added to the list once the page is refreshed.

6 Ineligible Patients Our goal was to have each site complete 12 patients for the Special Study Monitoring for this study so far have shown a higher than expected rate of ineligible patients, so our sample size seems to be much lower than initially projected We are in the process of considering study modifications which are necessary to reach the projected sample size

7 PSA Enter PSAs until time of distant recurrence or death or until the end of the surveillance period (not at biochemical recurrence) Please round results to the nearest tenth 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. Except: When a patient has a result of <0.03 or <0.01 or <0.2 ( less than some number), please 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.

8 Scans 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 Example: Patient developed second cancer of the urethra and found lung lesions and upon biopsy they were from prostate. Please enter all lung scans, biopsies, and treatments since they were from prostate cancer.

9 Recurrence When the doctor indicates possible recurrence and a treatment starts, this should be considered recurrence Date of recurrence should be the date of the doctor s note The term salvage radiotherapy indicates a recurrence

10 Additional Clinical Information If the pathology report states suspicious for LVI enter as No There is no response for suspicious for the study so please categorize as No

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 Patient Data Form The Patient Data Form has been added to the study website and the CAnswer forum. This can be used to aid in data collection The Instructions document is still the main resource for the study

13 Web form If error messages appear when using the Datalinks credentials when logging in to the web form, please use a lowercase if there is a capital in the password. If there are any errors on a submitted case, specialstudy@facs.org and the patient will be back on the Patient Data to be Submitted section If there are any errors in the Patient Data section, specialstudy@facs.org with the updates Include Special Study IDs in communication

14 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 EITHER send an through the Contact form of the website OR the address. Please do not send both as all s go to the same account. Include FINs in all communication

15 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: ,

16 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 Webinar #6: NCRA ; 1.0CE 5/16/17 Webinar #7 : NCRA ; 1.0CE 5/23/17

17 Questions Updated Instructions Document will be available soon 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 Source:

18 Review of FAQs from Previous Webinars

19 Data Collection Q: Is the entire medical needed or just the records of PSAs and Scans? A: It may be easiest to ask for the entire medical record. However, the only records required to complete data collection are those that are asked on the web form. Note: Only information during the surveillance period is required.

20 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

21 PSA Q: What should PSA of 7.96 be coded as? A: Please follow the FORDS manual for this particular situation. The FORDS rounds PSA to one decimal point. For example, 7.96 rounds to 8.0, you should enter 80 (eighty).

22 Testosterone Q: Study directions state normal testosterone levels are (this is for ng/dl). How should 2.69 ng/ml be coded? A: The units ng/ml should be converted to ng/dl. This answer should be 269 ng/dl.

23 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.

24 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.

25 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. Never disease free can be noted as progression of disease or persistent disease after treatment

26 Radiation Dose Q: What does 7027 cgy convert to in Gy? A: This would convert to 70.2 Gy and then rounding to the nearest whole number is 70 Gy.