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Principal Investigators: 
Mrs. M.J. Roobol, Prof. Dr.
+31 10 70 33 271
Mr. C.H. Bangma, Prof. Dr. M.D.
+31 10 70 33 607
Database management:
Mr. Henk Luiting M.D.
+31 10 70 33 571
Site management:
Mr. W. Roobol
Frequently Asked Questions
  Sun 27 May 2007 (2526 )
FAQ PRIAS-study and website
Version 1.0

Contents:

1. General questions
2. Questions on patient inclusion
3. Questions on inclusion biopsies
4. Questions on follow-up
5. Questions on extra repeat biopsies

1: GENERAL QUESTIONS

Q: I am interested in including my future patients suitable for active surveillance in the PRIAS-study, how can I obtain an account for using the website?

A: Send an email with your request to F.Drost@erasmusmc.nl. You will be contacted on the possibilities of your participation in the study.



Q: There is no patient ID (of my hospital) visible on the PRIAS-website, solely a PRIAS-study number, how can I trace back my patients?

A: When including a patient, both the patient ID and the PRIAS-study number are printed on the informed consent, which is presented after the inclusion screen has been entered and saved. The informed consent should be put in the patient status, so that the link between PRIAS-number and patient ID is always present in the patient status. Due to reasons of patient privacy, the link between these two numbers is not saved online on the website. The PRIAS-number is also printed on the visit plan, of which one copy should be put in the patient status.


2: QUESTIONS ON PATIENT INCLUSION

Q: I want to enter a patient into the PRIAS-study, what actions do I have bear in mind?

A: Action-points when including a patient can be summarized as follows:

1) login onto website (with a computer from which can be printed),

2) insert patient inclusion data (patient-ID, date of birth, date of diagnosis, PSA, prostatic volume, DRE, number of biopsy cores invaded with cancer, and Gleason-score)

3) print consent (put in status later),

4) print patient information,

5) print visit plan twice (one for patient, put one in patient status),

6) plan future visits (this is very essential for the study) according to the personalized visit plan according to timetable (always plan two visits ahead; the first visit is a lab-visit for PSA-measurement, 3 months after inclusion; during the second follow-up visit PSA should be measured and clinical stage should be evaluated)


Q: I want to enter patients retrospectively (patients who have been on active surveillance for a certain amount of time, but outside of the PRIAS-study), is this possible?

A: Yes, the dates of all the previous visits can be entered retrospectively. It should however be kept in mind that it is an essential part of the protocol that the PRIAS-timetable is followed in a patient when follow-up visits are planned. If the follow-up visits of a patient do not conform to the PRIAS-timetable, this patient cannot be entered into the website.

Example 1: A patient is on active surveillance for 2 years now. His PSA has been evaluated every 3 months, his clinical stage every 6 months. Standard repeat biopsies after one year were however not performed.

- The patient data is not suitable to be retrospectively entered into the PRIAS-study; repeat biopsies after one year are required.

Example 2: A patient has been diagnosed with prostate cancer 4 months ago and an active surveillance-policy has been chosen. One month ago his PSA has been checked.

-This patient until now conforms to the PRIAS-timetable and can be included into the study at this moment. The timetable should be followed from then on. This means that the next visit (which will be follow-up visit 2, standard planned after 6 months) has to be planned after 2 months and should consist of a PSA-measurement and clinical evaluation. Three months after that visit the PSA should be measured again, another three months later a complete check including repeat biopsies should be performed, and so on.

Example 3: A patient is on active surveillance for just over one year now. Clinical evaluation and PSA-measurements were performed every 3 months. No repeat biopsies have been performed until this  day.

- This patient could be entered into the database, but repeat biopsies should be planned as soon as possible, to collect all the necessary data. After this has been done and all the data is entered, this patient continues to visit 5, which has to be planned 15 months after the inclusion date and should consist of a lab-visit (PSA-measurement).


Q: When including a patient, what should be considered as date of diagnosis or ‘t=0’?

A: The date the first biopsies (in which prostate cancer was first found) were performed should always be considered as the starting point of the study. All follow-up visits (after 3, 6, 9, 12 months etc.) are based on this date. 


3: QUESTIONS ON INCLUSION-BIOPSIES

Q: Another pathologist has revised the biopsies, where should I enter the new data?

A: The inclusion data should be changed to conform to this new evaluation of the biopsies. This is done using the ‘edit’ option of the inclusion visit (visit 0).


Q: This patient underwent a new series of biopsies within 8 weeks after inclusion, because during the first biopsy an inadequate number of cores was taken (the PRIAS-biopsy-guideline was not followed: 8 in <40cc, 10 in 40-60cc, and 12 in >60 cc). Where can this data be entered?

A: The initial inclusion biopsy (in which the PC was detected) information should remain the basis of the inclusion, so this should not be changed. All the relevant information on the repeat biopsies (date, number of invaded cores, Gleason-score) should be mentioned in the comments section. It is possible that with the new biopsy data, this patient is no longer suitable for active surveillance (e.g. Gleason-score is >6 or >2 cores are invaded with cancer on the new biopsies). Another possibility is that in the new biopsies no cancer is found; patient should then remain on the active surveillance protocol, as cancer has been found previously.


4: QUESTIONS ON FOLLOW-UP

Q: When should the data of a follow-up visit be entered into the website?

A: It is advised to fill in the data of a certain (type of) follow-up visit as soon as all the data required for this visit is collected.

Option 1: One very practical option is to perform PSA-measurements and re-biopsies some time before a patient has his appointment with the urologist for the evaluation of his active surveillance. The resulting data can then be entered into the website during the actual visit of a patient to the outpatient clinic and also the recommendation of the website and future visits can then be discussed.  

Option 2: Another option is to see a patient and have his PSA-measured at the same day. The result of the test should then later be reviewed, entered into the database, and discussed with this patient.


Q: I want to enter patient follow-up data into the PRIAS-website, how does this work?

A: After a patient has performed a follow-up visit to the outpatient clinic or lab, or during his visit (when PSA and/or biopsy data was collected previously), the following actions should be undertaken:  


1) login onto website,
2) search for this patient using PRIAS-number,
3) enter new follow-up visit,
4) insert data for this visit,
5) check if future visits are planned according to the timetable (conforming to the recommendation of the website)


Q: Is it necessary to see a patient on the outpatient clinic when only a lab-visit is planned?

A: No, the patient should only have his PSA-measured. The results of this test and the possible consequences (enter PSA into the website) should of course be checked when the results are known.

Q: A lab visit was planned, but I did see this patient on the outpatient clinic and also performed a DRE. How can I still enter this additional data into the website?

A: The entry-screen of a follow-up visit is adapted to the planned visit according to the timetable. When a lab visit is planned, only PSA-data can be entered. Additional data (such as a DRE) or comments on that particular visit should be entered in the comments section.


Q: After entering the follow-up data, a recommendation on the future policy is presented in a patient, but I do not agree with this recommendation! What to do?

A: The recommendation presented by the website is merely an advice, but should never replace the clinical view of the treating physician. Active surveillance can be discontinued at every single moment during follow-up, even though the recommendation is to continue. At the other hand, a recommendation to discontinue active surveillance can also be ignored. The follow-up timetable should be followed in this case, as if the recommendation was to continue active surveillance. It is of course possible that after another follow-up visit of the same patient, a future recommendation based on the new available data is to continue active surveillance.


5: QUESTIONS ON EXTRA REPEAT-BIOPSIES

Q: Repeat-biopsies (additional to the standard biopsies according to the timetable) are recommended, when should these be performed?

A: The recommendation to perform repeat biopsies means that at thisparticular point during follow-up, based on all the data available, itseems that a re-evaluation of the current pathological status ofthe tumor is required. Depending on when the last biopsies wereperformed the repeat biopsies should be planned. The results should beevaluated (entered into the website) to check if thenew pathological characteristics are still suitable for activesurveillance. No more than one series of biopsies should be performedper year in a patient in the PRIAS-study. 

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