051611 Site Abstracting Manual-FINA-v16.1 091911 · 9/19/2011 · UCSF Department of Urology G-CEPS Program, San Francisco, CA Revised September 19, 2011 S:\Outcomes\CaPSURE\Administrative\Manuals\Sites\Abs

$Page 1: 051611 Site Abstracting Manual-FINA-v16.1 091911 · 9/19/2011 · UCSF Department of Urology G-CEPS Program, San Francisco, CA Revised September 19, 2011 S:\Outcomes\CaPSURE\Administrative\Manuals\Sites\Abs$
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Version 16.1 © 2011 – All Rights Reserved - Regents of the University of California UCSF Department of Urology G-CEPS Program, San Francisco, CA Revised September 19, 2011

S:\Outcomes\CaPSURE\Administrative\Manuals\Sites\Abs Manual V16 2011\FINAL\051611_Site Abstracting Manual-FINA-v16.1_091911.doc

CaPSURE™: Cancer of the Prostate Strategic Urologic

Research Endeavor

ABSTRACTING MANUAL

Prepared by:

Department of Urology Genitourinary Cancer Epidemiology & Population Science

(G-CEPS) Program University of California, San Francisco (UCSF)

Release date: September 19, 2011

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CaPSURE™ Secure Website: https://www.capsure.ucsf.edu/

Project Contact Information:

University of California, San Francisco (UCSF) Department of Urology 3333 California Street,

Suite 282 San Francisco, California 94118

Telephone: (415) 514-0201 Facsimile: (415) 514-0210 Toll Free: (800) 526-4433

Clinical Project Staff

Jenny Broering, R.N., M.S., M.P.H. Director Data Quality Assurance 415-514-0203 [email protected]

Ali Zargham, B.A. Research Analyst IV 415-514-0204 [email protected]

Ada Sanchez, B.A. Research Analyst II 415-514-0206 [email protected]

Tatyana Noller Research Analyst I

[email protected]

Alex Ignatov, B.S. Research Analyst I 415-5140-0201 [email protected]

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TTAABBLLEE OOFF CCOONNTTEENNTTSS

SSEECCTTIIOONN II.. SSTTUUDDYY PPUURRPPOOSSEE ............................................................................................................................................................................................................................ 99

A. Purpose .............................................................................................................................................................. 9

B. What is CaPSURE™? ...................................................................................................................................... 9

SSEECCTTIIOONN IIII.. CCOOMMMMUUNNIICCAATTIIOONN WWIITTHH CCAAPPSSUURREE SSTTAAFFFF .................................................................................................................. 1111

A. CaPSURE Telephone ................................................................................................................................. 11

B. CaPSURE Fax .............................................................................................................................................. 11

C. CaPSURE Address ..................................................................................................................................... 11

D. Project Staff (Clinical) ................................................................................................................................... 11

E. Secure Email at UCSF ................................................................................................................................... 12 1. Accessing UCSF Secure Messenger email ............................................................................................ 12 2. Responding to emails from UCSF Research Associates ..................................................................... 13

F. Email Request for Copy of Surgical Pathology Reports ..................................................................... 14 2. The ‘Pathology Request’ Reports: Pending Reports ............................................................................ 14 3. Unobtainable Surgical Pathology Reports .............................................................................................. 15 4. The ‘Pathology Request’ Reports: Statistics ......................................................................................... 15 5. Instructions for Submitting Copies of Pathology Reports ..................................................................... 16

G. Email Request for HIPAA/Consent Forms .............................................................................................. 16

H. ‘Support’ on CaPSURE .............................................................................................................................. 18 1. Technical Support ....................................................................................................................................... 18 2. Clinical Support ........................................................................................................................................... 18

I. Requesting Additional Study Supplies .................................................................................................... 19

SSEECCTTIIOONN IIIIII.. RREECCRRUUIITTMMEENNTT PPRROOCCEESSSS:: NNEEWW RREESSEEAARRCCHH SSUUBBJJEECCTT .................................................................... 2200

A. Figure 1: New Patient Recruitment Process Flow Chart .................................................................... 20

B. New Patient Enrollment ................................................................................................................................ 21 1. Process of inviting patients to participate ................................................................................................ 21

C. Inclusion / Exclusion Criteria ...................................................................................................................... 22 1. Inclusion Criteria ......................................................................................................................................... 22 2. Exclusion Criteria ........................................................................................................................................ 22

D. Patients Who Decline Participation........................................................................................................... 22 1. Decline Form ............................................................................................................................................... 23 2. Decline Patients Report ............................................................................................................................. 24

E. Consenting The Research Subject ............................................................................................................ 24 1. Consenting procedures .............................................................................................................................. 24 2. Consenting research subjects: Additional resources ............................................................................ 25

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F. Medical Release of Information Form ....................................................................................................... 25

G. New Patient Packet ....................................................................................................................................... 26 1. Description ................................................................................................................................................... 26 2. Instructions for the Patient ......................................................................................................................... 26

H. Creating a New Patient File / Registration Form .................................................................................... 27 1. Verifying Patient is Not Already in Database .......................................................................................... 27 3. Entering the New Patient/Completing the Registration Form .............................................................. 28 4. Deleting a Registration Form .................................................................................................................... 29 5. Patient Study ID .......................................................................................................................................... 29 6. New Enrollment Report .............................................................................................................................. 30

SSEECCTTIIOONN IIVV.. AABBSSTTRRAACCTTIINNGG AANNDD EENNTTEERRIINNGG DDAATTAA:: NNEEWW RREESSEEAARRCCHH SSUUBBJJEECCTT ...................... 3311

A. FIGURE 2: Abstracting & Entering Data for New Research Subject – Flowchart ......................... 31

B. Information to be Abstracted and Entered for New Research Subject ............................................ 32 1. Overview ...................................................................................................................................................... 32 2. General Rules ............................................................................................................................................. 32 3. Key Events for all New Research Subjects ............................................................................................ 32 4. Reporting of Relevant Office Visit ............................................................................................................ 33 5. Clinical Examination by Digital Rectal Examination (DRE) .................................................................. 33 6. Tumor Markers – Prostate Specific Antigen (PSA) ............................................................................... 34 7. Diagnostic Biopsy ....................................................................................................................................... 36 8. Clinical TNM Stage ..................................................................................................................................... 38 9. Initial Treatment .......................................................................................................................................... 39 10.Clinical Trial Participant ............................................................................................................................. 39

C. New Patient Abstraction Detail Report ..................................................................................................... 39

D. General Guidelines for Completing and Tracking Data ....................................................................... 39 1. Completing the Enrollment Visit ............................................................................................................... 40 2. Tracking Scheduled Visits ......................................................................................................................... 40 3. Tracking Clinical Form Completion .......................................................................................................... 40 4. Sending Completed Forms via Overnight Mail ....................................................................................... 40

SSEECCTTIIOONN VV.. AABBSSTTRRAACCTTIINNGG AANNDD EENNTTEERRIINNGG DDAATTAA:: CCOONNTTIINNUUIINNGG PPAATTIIEENNTTSS .................................... 4422

A. Figure 3: Abstracting & Entering Data: Continuing Pts. – Flowchart ............................................. 42

B. Accessing a Patient’s Records .................................................................................................................. 43 1. Finding an Existing Patient ........................................................................................................................ 43 2. Patient Summary Page .............................................................................................................................. 43

C. Enter a NEW Form ......................................................................................................................................... 44

D. View / Modify an Existing Form .................................................................................................................. 45

E. Tab Out of Form With ‘No Changes’ ......................................................................................................... 45

F. Deleting a Patient Form ................................................................................................................................ 46

G. Saving Data: “Submit” ................................................................................................................................ 46

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H. Printing Capabilities ...................................................................................................................................... 46

I. Abstracting and Entering Data: Continuing Patients .......................................................................... 47 1. Overview ...................................................................................................................................................... 47 2. General Rules ............................................................................................................................................. 47

J. Clinic Visit Form (Scannable Hybrid Form) ............................................................................................ 49 1. Overview of Form ....................................................................................................................................... 49 2. Corrections .................................................................................................................................................. 49 3. Abstracting Data to the Hybrid Clinic Visit Form .................................................................................... 51 4. Type of Visit ................................................................................................................................................. 51 5. Current Disease Stage............................................................................................................................... 52 6. Procedures at This Visit ............................................................................................................................. 53 7. Karnofsky Score .......................................................................................................................................... 54 8. New Diagnoses ........................................................................................................................................... 54 9. Signs and Symptoms ................................................................................................................................. 55 10. IPSS ............................................................................................................................................................ 55 11. “Lab Portion” — Hybrid Clinic Visit Form ............................................................................................... 56 12. “Medication Portion” — Hybrid Clinic Visit Form .................................................................................. 59 13. Next Visit Date — Hybrid Clinic Visit Form ............................................................................................ 59

K. Labs and Imaging Form ............................................................................................................................... 60 1. PSA, PAP, and Free PSA ......................................................................................................................... 60 2. PSA Manufacturers—Total PSA and Free PSA .................................................................................... 60 3. Hematology/CBC ........................................................................................................................................ 60 4. Blood Chemistry Panel .............................................................................................................................. 61 5. Urine ............................................................................................................................................................. 61 6. Imaging Tests .............................................................................................................................................. 62 7. Imaging Tests: TRUS ................................................................................................................................. 62 8. Other Tests .................................................................................................................................................. 62

L. Scan Enabled Multiple PSA Form .............................................................................................................. 64 1. General guidelines for using the form ...................................................................................................... 64 2. Filling out the form and making corrections ............................................................................................ 64 3. Duplicate PSA’s .......................................................................................................................................... 65

M. Multiple PSA Form – Upload History ....................................................................................................... 66

N. Electronic Multiple PSA Form .................................................................................................................... 67 1. Automated Data Quality Assurance (QA) Checks ................................................................................. 68

O. Medications Form ......................................................................................................................................... 70 1. General Coding Rules for all Sections of the Medication Form ........................................................... 70 2. LHRH Agonists/Antagonists ...................................................................................................................... 70 3. Antiandrogens ............................................................................................................................................. 71 4. Hormone Refractory and Related Antineoplastic Therapies ................................................................ 71 5. Treatment for Hot Flashes ......................................................................................................................... 71 6. Other Medications ...................................................................................................................................... 72

P. Erectile Dysfunction Form ........................................................................................................................... 73 1. Medication ................................................................................................................................................... 73 2. Management ............................................................................................................................................... 73

Q. Prostate Biopsy Pathology Form .............................................................................................................. 74

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1. General Coding Rules ................................................................................................................................ 74 2. Digital-Rectal Exam Findings at Time of Biopsy .................................................................................... 74 3. Biopsy Type ................................................................................................................................................. 74 4. Biopsy Results — Mapped ........................................................................................................................ 74 5. Biopsy Results — Non-Mapped ............................................................................................................... 75 6. Biopsy Results — TURP ........................................................................................................................... 75 7. Clinical Stage of Disease (TNM) .............................................................................................................. 76

R. Surgeries and Treatment Form .................................................................................................................. 76 1. Watchful Waiting ......................................................................................................................................... 76 2. Radical Prostatectomy ............................................................................................................................... 76 3. Lymphadenectomy ..................................................................................................................................... 77 4. Radiation Treatment ................................................................................................................................... 77 5. Brachytherapy ............................................................................................................................................. 78 6. Other Treatments or Procedures .............................................................................................................. 78

S. Clinical Trial Form ......................................................................................................................................... 78

T. Status Form ..................................................................................................................................................... 80 1. Reason for Study Status Change ............................................................................................................. 80 2. Deceased Patient ....................................................................................................................................... 81 3. Study Status List ......................................................................................................................................... 81

SSEECCTTIIOONN VVII.. UUSSIINNGG CCAAPPSSUURREE™™ WWEEBB--SSIITTEE FFOORR DDAATTAA CCOOLLLLEECCTTIIOONN .................................................................. 8822

A. Security and Confidentiality Safeguards ................................................................................................. 82 1. Understanding a ‘Secure Site’ .................................................................................................................. 82 2. Personal Identification Name and Password .......................................................................................... 82 3. User Identification – Login History ........................................................................................................... 82 4. Log Out Function ........................................................................................................................................ 83 5. Auto Log Out Function ............................................................................................................................... 83

B. Finding an Existing Patient ......................................................................................................................... 83

C. Patient Summary Page ................................................................................................................................. 84

D. Deleting a Patient Form ................................................................................................................................ 84

E. Saving Data: “Submit” ................................................................................................................................ 85

F. Tab Out of Form With ‘No Changes’ ......................................................................................................... 85

G. Printing Capabilities ..................................................................................................................................... 85

H. Shortcut Keys: Alternatives to Using the Mouse ................................................................................. 86 1. HTML code .................................................................................................................................................. 86 2. Option Buttons ............................................................................................................................................ 86 3. Hyperlinks .................................................................................................................................................... 86 4. Pull-Down Menus ........................................................................................................................................ 86

I. Public Site ........................................................................................................................................................ 87

SSEECCTTIIOONN VVIIII.. GGRRAAPPHHSS,, RREEPPOORRTTSS AANNDD EEXXTTRRAACCTT FFIILLEESS .................................................................................................................... 8888

A. Patient Graphs ................................................................................................................................................ 88

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B. Clinic Graphs .................................................................................................................................................. 89

C. Research .......................................................................................................................................................... 90 1. Data Extract Tab ......................................................................................................................................... 90 2. Reports Tab: Study Status Report for Your Site ................................................................................... 92 3. Reports Tab: Generating a Count of Patients’ Ethnicity ...................................................................... 93 4. Reports Tab: Archive ................................................................................................................................ 93

D. Site Management ........................................................................................................................................... 93 1. Quality of Life Response Rate .................................................................................................................. 93 2. Enrollment: New Enrollment Report ....................................................................................................... 94 3. Enrollment: Status Change Report .......................................................................................................... 94 4. Enrollment: Decline Patients Report ........................................................................................................ 95 5. Enrollment: Deleted Patients Report ....................................................................................................... 95

E. Site Statistics Reports .................................................................................................................................. 97 1. New Patient Abstraction Detail Report .................................................................................................... 97 2. Patient Abstraction Notes Screen ............................................................................................................ 99 3. Data Activity Report .................................................................................................................................. 100 4. Monthly Clinic Visit Schedule .................................................................................................................. 102 5. HIPAA Compliance Report ...................................................................................................................... 103

SSEECCTTIIOONN VVIIIIII.. ’’WWHHEERREE DDOOEESS DDAATTAA GGOO??’’:: WWHHEERREE TTOO RREEPPOORRTT YYOOUURR DDAATTAA ................................ 110077

SSEECCTTIIOONN IIXX.. AAPPPPEENNDDIICCEESS.............................................................................................................................................................................................................................. 111122

A. Site ID Number for Participating Clinical Investigators ..................................................................... 112

B. CaPSURE™ Quick Reference Guide for Recruiting Subjects .......................................................... 113

C. CaPSURE™ Definitions of Patient Study Status ................................................................................. 115 1. Defining Subject Study Status ................................................................................................................ 115 2. Active Status ............................................................................................................................................. 115 3. Inactive Status ........................................................................................................................................... 115

D. TNM Staging Guidelines: Understanding the TNM Classification System & its Application ... 116 1. Why TNM? ................................................................................................................................................. 116 2. General Rules of the TNM System ........................................................................................................ 116 3. Four Classifications of TNM .................................................................................................................... 116 4. Grouping the TNM .................................................................................................................................... 117 5. References ................................................................................................................................................ 118

E. Comparison of Staging Classifications for Prostate Cancer ........................................................... 119

F. The Karnofsky Performance Status (KPS) ............................................................................................ 121 1. About Karnofsky Scoring ......................................................................................................................... 121 2. Karnofsky Performance Status Scale - Definitions Rating (%) Criteria ............................................ 121 3. Assessing Patients’ Karnofsky Scores .................................................................................................. 122 4. Limitations of the Karnofsky Scale ......................................................................................................... 122 5. References ................................................................................................................................................ 122

G. International Prostate Symptom Score (I-PSS) .................................................................................... 124 1. About the I-PSS ........................................................................................................................................ 124 2. I-PSS Questions ....................................................................................................................................... 124 3. Reference .................................................................................................................................................. 125

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H. Glossary ......................................................................................................................................................... 126 1. Computer Terminology ............................................................................................................................ 126 2. Symbols ..................................................................................................................................................... 127 3. Abbreviations ............................................................................................................................................. 128

I. Clinical Form Downloads ........................................................................................................................... 130

J. ICD-9 Diagnosis Codes for Use with the Clinic Visit Form ............................................................... 131

Page 9 of 138 CaPSURE Observational Database Section I. Study Purpose



SECTION I. STUDY PURPOSE

A. Purpose

The CaPSURE Observational Database is designed to learn more about how prostate cancer affects patients’ lives and the type of health care that is required to manage the disease. This manual serves as a guide to standardized methods for abstracting information from participating patients’ medical records for consistent and quality data recording.

B. What is CaPSURE™?

CaPSURE™ (Cancer of the Prostate Strategic Urologic Research Endeavor) is a longitudinal observational study of prostate cancer patients nationwide. Created in 1995, the database has enrolled 4,459 patients during the first wave of patient enrollment into CaPSURE™. Recruitment for the second cohort began in March of 1999 and is continuing. Physicians provide a comprehensive clinical assessment of their prostate cancer patients over the course of their treatment, including their method of diagnosis, patients’ clinical and, when relevant, pathological staging, and the results of all procedures and lab tests. All participating sites also provide copies of the surgical pathology reports to University of California, San Francisco (UCSF) for all patients undergoing a prostatectomy. UCSF project staff abstracts and records the information from each pathology report. The data coordinating center would also like to obtain any key source documents such as:

Prostate biopsy reports; Treatment summary reports of operative events such as radical

prostatectomy, cryosurgery, brachytherapy or external beam treatment summary reports; and

Finally any imaging reports that document regional or distant spread of the cancer i.e., positive bone scan.

Receipt of these key events will be digitally scanned into our electronic archives for future review about quality assurance questions or re-reading of events when future data fields are added. Patients are asked to report their quality of life, health care resource use, productivity and satisfaction with care using a standardized questionnaire (RAND-UCLA Prostate Cancer (UCLA_PCI) Questionnaire or the Expanded Prostate Cancer Index Composite (EPIC) 26-item short form version) upon entry into the study. For participants in the Comparative Effectiveness of Surgery and Radiation of prostate cancer study (CEASAR) the UCSF staff will be mailing a follow-up survey at six and twelve months after enrollment. After the end of the CEASAR study all active participants will receive a CaPSURE questionnaire annually in January of

Page 10 of 138 CaPSURE Observational Database Section I. Study Purpose



each year. From information provided by the patient, the project research staff requests discharge summary reports on hospitalizations and emergency room visits for abstraction and inclusion into the database. In the event of death, a death certificate is requested to abstract information regarding the cause of death. The CaPSURE™ database is funded by UCSF, Department of Urology and is managed by the Quality Assurance group within the Genitourinary Cancer Epidemiology and Population Science (G-CEPS) Group of the University of California, San Francisco Department of Urology. The CaPSURE database is hosted at and maintained by UCSF, School of Medicine - Information Services Unit. Specific sub-study projects maybe funded by other external sources such as the National Cancer Institute (NCI) or the AHRQ – The Agency for Healthcare Research and Quality. The CEASAR project began on September 1, 2010 and is funded through August 31, 2013.

Page 11 of 138 CaPSURE Observational Database Section II. Communication With CaPSURE Staff



SECTION II. COMMUNICATION WITH CAPSURE STAFF

A. CaPSURE Telephone

Telephone Number: (415) 514-0201 Toll-Free Number: (800) 526-4433

B. CaPSURE Fax

Facsimile Number (415) 514-0210

C. CaPSURE Address

University of California, San Francisco (UCSF) Department of Urology 3333 California Street; Suite 282 San Francisco, California 94118-1944

D. Project Staff (Clinical)

Jenny Broering, R.N., M.S., M.P.H.Project Director,

Director Data Quality Assurance415-514-0203

[email protected]

Ali Zargham, B.A.Research Analyst IV

[email protected]

Ada Sanchez, B.A. Research Analyst II

[email protected]

Alex Igntov, B.S.Research Analyst I

[email protected]

Tatyana NollerResearch Analyst I

415-685-4778

[email protected] Note: Remember that to send or receive messages that have patient names or other private health information, you need to use the secure UCSF Secure Messenger portal email account described on the next page.




E. Secure Email at UCSF

Information about study patients can be securely exchanged between UCSF data coordinating center and participating sites using the ‘UCSF Secure Email system’. We will be using the following email account to send you requests that contain personal health information (PHI): [email protected]. In the subject line our staff will use the following key words of ‘Secure:’, ‘PHI:’ or ‘ePHI:’ to indicate that this email needs to be sent in a secure or encrypted format. This information will be held on our UCSF secure web site in a coded format until it is retrieved by someone at the site. Given that this system is secure, we are able to send information about individual patients to research staff at your site.

UCSF Secure e-mail will be sent to your email account at your practice where you will be asked to log-in to the ‘UCSF Secure Email system’ where you will find the contents of the full message.

1. Accessing UCSF Secure Messenger email

a. You will receive a UCSF-branded email notifying you that a containing notification or a secure email message is waiting for you in the UCSF Secure Message portal. The notification will contain:

i. The subject line without the trigger word

ii. A ‘VIEW MESSAGE’ link

b. By clicking on the ‘VIEW MESSAGE’ link, your Internet browser will link you to the UCSF Secure Messenger website. Registration in the ‘UCSF Secure Email system’ message portal is required for new recipients and for accounts that have expired due to inactivity. Registration includes:

i. First Name

ii. Last Name

iii. New password

iv. New password re-entered

v. Password hint phrase (to be used to retrieve forgotten passwords)

c. Users who have already completed the registration will be required to enter only their password when signing onto the UCSF Secure Messenger. Your automatically created UCSF Secure Messenger account will remain active indefinitely.

d. Once you have logged on, your emails will be displayed.




i. To reply to a message, click on the tab labeled “Reply.” The “To:” field will automatically be filled with the recipient’s address. Compose your email and then click “Send Message.” When you respond through the UCSF Secure Messenger portal your return e-mail will be encrypted as well.

ii. If you have problems using this site please call the CaPSURE™ research team at 1-800-526-4433. We will contact UCSF Customer support on your behalf to remedy any access problems that you may have with the UCSF Secure Messenger.

2. Responding to emails from UCSF Research Associates

a. The Research Associate assigned to your site will use the email account on a regular basis to request clarification or additional information on patients and clinical forms submitted. Some important information that may be requested includes:

Consent Forms: missing forms, incomplete forms Registration: missing/changed information, i.e., change of

address/telephone number Clinical Data Corrections: missing information/clarification.

b. Please discuss procedures for responding to these emails with your assigned UCSF Research Associate, and reply in a timely manner to any requests.




F. Email Request for Copy of Surgical Pathology Reports

We would like a hard copy of the surgical pathology report for every subject from your site who underwent a radical prostatectomy (RP). Once a subject’s radical prostatectomy information is entered on the “Treatment Form” the web application will generate an electronic request for a copy of the surgical pathology report. UCSF will generate and send a request email for RP using the UCSF Secure Email system. The request will come in the form of an email from the UCSF Secure Email system.

Each site coordinator will be asked to sign up to access the UCSF Secure Messenger email account. This will keep sites up to date with requests from UCSF research staff, as well as with any requests for pathology reports.

Note: You do not need to wait for an email request to send in a report; if you have it in hand when abstracting the patient’s treatment, make a copy and send it in with clinical forms.

2. The ‘Pathology Request’ Reports: Pending Reports

The Pathology Requests Pending report allows you to view a list of all your patients with outstanding pathology reports. To access this list and view your outstanding reports:

a. Click on link within the email message, or

b. Go to “Site Mgmt” button, click on the “Pathology” tab and then click “Pending”.

c. This report can be printed; click on the ‘Print’ button on the top-right of the screen.

Print report

RP date Date pathology rpt. requested




3. Unobtainable Surgical Pathology Reports

a. If a pathology report is unobtainable, make a note within the Pathology Requests Pending report so that UCSF will not generate additional requests for this document.

b. The far-right column in the “Pending” report is “Unobtainable,” and when selected will open a box where you can note the report is not available. Once you “Submit” the information, you will be returned to the Pathology Requests Pending report.

4. The ‘Pathology Request’ Reports: Statistics

a. Click on the “Statistics” tab to view the status of the pathology reports for all of your RP patients. There are four categories of status which are recorded in the column labeled ‘Notes’:

i. Pending: Report not received by UCSF and not indicated as unobtainable.

ii. Received: Report received and logged in system (moved from Pending category).

iii. Completed: UCSF abstracted report and data entered into system (moved from the Received category). Click on the word Complete to access a read-only version of the abstracted report.

iv. Unobtainable: Report not available; no further requests will be made.

b. This report can be printed; click on the ‘Print’ button on the top-right of the screen.




5. Instructions for Submitting Copies of Pathology Reports

Send all copies of pathology reports to UCSF, using the following guidelines to facilitate rapid processing:

a. Important: Record Subject Study ID # on the bottom center of each page.

b. Important: Attach report where it will be easily seen, such as on the top of each subject packet, or collate together as a batch.

c. Once UCSF receives copy of report, patient will be removed from the pending list.

d. If you have any questions, you can contact your UCSF staff research associate at (800) 526-4433.

G. Email Request for HIPAA/Consent Forms

When a subject is recruited into the CaPSURE™ study, he will be required to sign both a “Consent to be a Research Subject” form and a “Permission to use Personal Health Information” (Health Insurance Portability and Accountability Act or HIPAA) form. More information on these forms can be found in Section III. Once these forms are signed they are sent to UCSF. If UCSF staff does not receive these forms within 30 days of a patient’s enrollment, a reminder e-mail will be sent to the site coordinator.

This e-mail will always have one of two subjects:

“UCSF CaPSURE HIPAA forms needed” OR

“UCSF CaPSURE HIPAA/consent forms needed”

Print report

Overall pathology rpt status numbers

Notes column: status of all pathology reports for RP patients at your site




Click on the link within this e-mail to view your site’s list of outstanding Consent/HIPAA reports. When you are in the secure web application a report is available to show which subjects need consent and/or HIPAA forms sent to UCSF. This can be viewed by mousing over the the ‘Site Statistics’ tab and clicking on the ‘HIPAA Compliance’ text. This tab has a print function as well. Only those participants’ whose regulatory documents are still outstanding will appear on this report. For more information, please see Section VII.E.5, “HIPAA Compliance Report.”

Link to ‘HIPAA Compliance’ report




H. ‘Support’ on CaPSURE

The “SUPPORT” button is located in the upper right of the main menu. This section can be used to access contact information for technical and clinical support, information about system requirements, and access to demonstration slides and links to copies of clinical forms to download and print out for your site.

1. Technical Support

Please contact the research team at UCSF with any technical issues. Issues may include:

Web site use, suggestions for improvement

Hardware/software needs

System requirements

2. Clinical Support

Contact the research team at UCSF with any research questions and use the Support Site/Clinical Support page for the following:

UCSF Research Associate list Clinical data collection support

Clinical Form downloads Access to CaPSURE public web site

UCSF TECHNICAL AND RESEARCH SUPPORT




I. Requesting Additional Study Supplies

Complete and fax a “Material Request Form” (example below) to request additional study supplies. Please allow 3-4 working days for your supplies to arrive. If you need additional Material Request Forms, please contact a Research Associate toll-free at 800-526-4433.

Page 20 of 138 CaPSURE Observational Database Section III. Recruitment Process: New Research Subject



SECTION III. RECRUITMENT PROCESS: NEW RESEARCH SUBJECT

A. Figure 1: New Patient Recruitment Process Flow Chart

Approach thepatient

to consent?

Does thepatientwish to

participate?

CompleteDecline Form

Patient signs and dates:1. Informed Consent2. HIPAA Authorization

1. Enter into CaPSURE.net2. Write 7- digit Subject ID on ALL forms

Send allforms toUCSF viaFederalExpress

Yes

No

No

Yes

Provide patient with:1. New Patient Packet (English or Spanish)2. Instructions for completing & returning BASELINE (Phase 0) questionnaire to UCSF

CompletePaper & ElectronicRegistration Form




B. New Patient Enrollment

1. Process of inviting patients to participate

a. Identify study patients based on the study inclusion/exclusion criteria (see next page). The CaPSURE™ study has a waiver of consent/authorization for screening and recruitment purposes only. This allows us to continue our current method of identifying patients with a positive biopsy for prostate cancer in order to invite them to participate in the study. (Note: The study continues to require individual consent and authorization at the time of enrollment into the study.)

b. Invite all individuals who meet the study criteria to join the study in order to avoid clinician selection bias, and to ensure that all eligible patients are invited to participate in the study.

c. Recruit patients using either of the following IRB-approved methods:

i. Eligible patients are enrolled in the study after speaking to the participating investigator, co-investigator or research staff at the investigator’s site.

ii. Eligible subjects may first receive a “Dear Patient” letter from their treating physician (the PI or a colleague of the PI) describing the study and asking them to contact the Principal Investigator if interested in participating. Please see “NOTES” section for a sample “Dear Patient” letter.

d. Provide an overview of the study to each potential study patient and give him an opportunity to ask questions.

It is important that each patient fully understand what he is agreeing to before participation can begin. If he agrees to participate, he will be asked to:

Complete a baseline quality-of-life questionnaire upon entry into the study.

Complete follow-up questionnaires once a year. The follow-up questionnaire asks questions about quality of life, satisfaction, and use of health care during the previous twelve months. Because the purpose of the questionnaire is to track change over the time, the follow-up questionnaire will always ask the same questions.

The follow-up questionnaire is available in both an on-line and a paper version. Subjects can choose to complete whichever version they prefer.

Answer occasional questions by phone from UCSF research staff about questions related to their use of health care especially if responses are unclear, illegible, or left blank.




Patients may use a proxy (e.g., wife or other relative willing to facilitate participation) if he is incapable of filling out questionnaires or taking phone calls due to physical limitations.

C. Inclusion / Exclusion Criteria

1. Inclusion Criteria

In phase II of the study that started in March 1999, the enrollment criteria were changed. a. Enrollment criteria in Phase II includes:

i. Selection of men that are “newly diagnosed” with biopsy confirmed prostate cancer. We define a “newly diagnosed” patient as someone who is within 6 months of his date of first positive biopsy.

ii. We would prefer to enroll patients prior to the administration of their first treatment to insure that we obtain an assessment of their quality of life at baseline.

iii. The person will need to be able to read and understand either English or Spanish.

2. Exclusion Criteria

a. Persons who cannot be in the study include patients who:

i. Do not have prostate cancer.

ii. Are seeing the participating physician for a second opinion only.

iii. Do not want to be in the study. D. Patients Who Decline Participation

If a subject decides not to sign the informed consent, you will complete the Decline Form. This information is very important to the research group because it helps identify if there are particular types of patients that decline to participate. Abstracting may be done on the paper form before entering them into the electronic web-based capsure.net system. *Note: On August 15, 2003, we received approval to continue data collection on patients who Decline participation in the CaPSURE™ study (“Decliners”). The approval was received from UCSF’s Committee on Human Research (Approval #H5664-11911-10A), and on-line and paper versions of the Decline form have been revised in order to de-identify dates and to adhere to HIPAA and IRB regulations.




As a result, when filling out Decline forms, please report dates as Month/Year only. 1. Decline Form

a. To enter a decline subject into the database, first log-on, click “Data Entry,” then click the tab labeled “Decline”. After you click, a data entry screen will appear that lists all previously declining patients. To enter a new decline patient, click on the button NEW. This will bring up a blank data entry screen.

b. In the Decline Summary you will see a list of all patients at your practice that have declined. Click on the blue highlighted Decline ID to bring up the previously entered Decline Form. To return to the Decline Summary after viewing the form without making changes, click on the Decline tab.

c. Note: if for any reason you need to delete the form after entering the information, click on the “Delete” button (or you can also move out of the form before submitting, and not save the information). By doing this, a unique ID number will NOT be assigned to this patient.

d. After entering the information on the Decline Form and clicking on “Submit”, you will note the patient name and his unique study ID number now appear at the top of the “Patient Summary” page.

Click on to enter a NEW form

Click on to view entered forms

Click here to save this form after completing entry. This will assign a unique ID number for this patient.




2. Decline Patients Report

a. You can view and print a list of all patients who have declined to participate in the study so that you will not approach them again in the future. Please refer to ‘Section VII.D.4. Decline Patients Report’ for further information.

Please note that the Decline Patients Report is organized by CaPSURE ID and date of birth since information for these patients has been “de-identified” and does not include patient names. You may want to keep a separate list for your own records that includes the names of men who have previously declined to participate.

E. Consenting The Research Subject

When the patient agrees to join the study, the consent form must be read and then fully explained to the individual. Give the patient an opportunity to ask questions.

1. Consenting procedures

a. Once the patient agrees to participate and all questions are answered, the patient must sign and date both the consent and HIPAA authorization forms. After the patient has signed the consent and HIPAA forms, the person who explained and received the consent/HIPAA needs to sign the consent as the witness (either the study coordinator or the physician). After the consent form has been signed, the study coordinator should separate the forms. The white copy is sent to UCSF, the yellow copy is filed

Click here to return to the full list of decline patients from your site.

Click this button to delete an entry (you can also move out of the form before submitting, and not save information). By doing this, a unique ID number will NOT be assigned to this patient.




in the patient chart, and the pink copy is given to the patient to keep for their files. This format applies unless the site’s own institutional review board mandates otherwise. **Note: the HIPAA Authorization form is NOT in 3-part NCR form. Sites may choose to have the patient sign one form and then make three copies of the form, or photocopy the form beforehand and have the patient sign all three copies, whichever is most convenient for the site. Either way, one copy goes to UCSF, one copy stays at the site for the patient’s chart, and one copy is given to the patient to keep for his records.

2. Consenting research subjects: Additional resources

Additional information about consenting a research subject can be found at the following websites (hyperlinks last updated May 16, 2011):

a. UCSF Committee on Human Research: http://research.ucsf.edu/chr/

b. UCSF CHR Consent guidance: http://research.ucsf.edu/chr/Recruit/chrRC.asp#Consent

c. Nuremberg Code: http://ohsr.od.nih.gov/guidelines/nuremberg.html

d. World Medical Association Declaration of Helsinki: http://www.wma.net/en/30publications/10policies/b3/

e. Belmont Report-Ethical Principals and Guidelines for the Protection of Human Research Subjects: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

f. NCI website for Human Participant Protections Education for Research Teams: http://phrp.nihtraining.com/users/login.php .

g. Collaborative Institutional Training Initiative (CITI) – mandatory training for

human subjects starting in 2010: https://www.citiprogram.org/default.asp?language=english.

F. Medical Release of Information Form

In addition to signing the consent and HIPAA forms, the patient needs to read and sign the Medical Release of Information Form. This form is used by UCSF staff to request information about hospitalizations and emergency room visits as they occur, and to obtain death certificates if necessary. Because hospitals require updated forms to release information, the form is located on the back of every questionnaire the patient receives throughout the study. The Medical Release of Information form must be read and signed whenever the patient fills out a study questionnaire. Please point out the form on the back of the patient’s Phase 0 (Baseline) questionnaire and answer any questions the patient may have regarding the release of medical information.




G. New Patient Packet

1. Description

When the patient agrees to join the CaPSURE™ study, and has read and signed the Informed Consent Form and HIPAA Authorization form, he is given the Patient Packet. There are two different patient packets: one for the patient receiving materials in English and one for the patient receiving materials in Spanish. These packets consist of a letter describing the study, a Background (Baseline, or Phase 0) Quality-of-Life Questionnaire with a return envelope, and instructions for registering to complete follow-up questionnaires on-line (rather than receiving them in the mail). (Additional supplies of Patient Packets are available upon request; use the Materials Request Form).

2. Instructions for the Patient

When you provide the patient with the packet, please provide some instructions about the questionnaire.

a. Explain that the purpose of the questionnaire is to find out how their prostate

cancer and any treatments for prostate cancer impact their well-being and quality-of-life.

b. For the baseline (first questionnaire) it is preferred that the participant complete the questionnaire prior to the start of their first treatment for prostate cancer. This insures that the research project understands the patient’s functioning before the effects of treatment.

c. Let the patient know that many of the questions are sensitive and personal, but he can be assured that all patient data will be kept strictly confidential.

d. He should be encouraged to complete all questions, but he can choose not to complete any questions. He should also complete the questionnaire without assistance from others (unless he is physically unable to, in which he can use a Proxy; see Section III.B for more information).

e. Advise the patient to return the completed questionnaire to UCSF in the envelope provided; no postage is necessary.

f. If the patient has any questions about how to complete the questionnaire, tell him that he can speak with a Research Analyst at the Genitourinary Cancer Epidemiology and Population Science (G-CEPS) group toll-free at 1-800-526-4433.

g. Remind him that he will be asked to complete a follow-up questionnaire annually in January of each year. The follow-up questionnaire is used to track how quality-of-life changes over time and to record any use of health care resources (i.e., hospitalizations, emergency room visits, etc.). To do this we must ask the same questions each time. An EXCEPTION to this rule is




for the CEASAR participant who will be asked to complete a questionnaire at baseline, 6-months and 12-months later.

h. Subjects may elect to complete the follow-up questionnaire on-line, otherwise a paper version of the questionnaire will be sent to each subject. A mode of questionnaire preference form is included in the packet (EXCEPTION: The CEASAR study does not have an online offering of the baseline, 6, and 12-month questionnaires).

H. Creating a New Patient File / Registration Form

NOTE: Please send the completed Consent Form, HIPAA Authorization Form, and paper Registration Form for your new patient as soon as possible to UCSF. We will not make a research chart for a patient, or edit and enter his quality-of-life questionnaires, until we receive his Consent and HIPAA Forms. It is very important that you send these forms in on a regular basis.

1. Verifying Patient is Not Already in Database

Before generating a new patient registration form, please verify that the patient is not already entered. This quick check will help avoid duplicate entries of patients into the database. a. After you have logged on with your personal user name and password, and

have clicked on the “Data Entry” button, the first screen that will open is the “Find Patient” screen.

b. In the ‘Find Patient’ screen, type the patient’s last name into the ‘Last Name’

field and the computer will search for all the subjects with that last name. If you only remember the first one or two letters of the last name, you can search by typing only those one or two letters, and the computer will list all subjects whose last name begins with those two letters.




c. Please refer to ‘Section VI.D. Finding an Existing Patient’ for more detail regarding searching for patients.

3. Entering the New Patient/Completing the Registration Form

a. To enter a new patient, Click on the tab labeled “New Patient.”

b. Once you have clicked on the “New Patient” tab, the Registration Form will

appear. It is mandatory to complete this form for every new patient in order to generate his unique study ID number and to document contact and background information. Some of this information is used for creation of the mailing list.

c. On the top of the form, please complete: Visit Date, Patient Name, Medical

Record Number, Date of Consent, Date of HIPAA, Primary Urologist, and Date of Birth. The medical record # is an optional field on the Registration Form. If your site uses medical record numbers, please record it on this form. The number can be alpha numeric and up to 9 characters in length.

d. The addresses provided in the next section of the Registration form will be used to mail follow-up patient questionnaires. The form allows you to enter two different mailing addresses for each patient. The follow-up questionnaires will be mailed to patients once a year in January. Please indicate whether the address(es) provided is “Year round”, “January only”, or “July only”.




e. Under “Ethnicity” and “Insurance Type”, please check all that apply. Additionally, please let us know whether the patient would prefer to receive English or Spanish versions of the questionnaire.

4. Deleting a Registration Form

a. Before clicking on “Submit”, if you discover an error is made you have the option of clicking on the “Delete” button and your entry will be erased without a number being assigned.

b. If you clicked on “Submit” before you realized that this patient should not be enrolled, please notify one of the UCSF CaPSURE staff members at 1-800-526-4433. The assigned ID number will be recorded as either a Deleted patient or a Declined patient, based on the reason for ineligibility.

5. Patient Study ID

a. After entering the information for your new patient on the Registration Form and clicking on “Submit”, you will note the patient name and his unique study ID number now appear at the top of the “Patient Summary” page.

b. The study ID number is seven digits in length. It is a combination of your site ID and 5 additional numbers. For example, if you are site #50, your numbers will appear as 50-XXXXX. Please record this ID number on each form that you send to UCSF.




6. New Enrollment Report

a. Each site has the ability to view the number and details of the patients they have enrolled into the study. Please refer to ‘Section VII.D.2. Enrollment: New Enrollment Report’ for further information.

Unique patient identifier (ID)

Page 31 of 138 CaPSURE Observational Database Section IV. Abstracting and Entering Data: New Research Subject



SECTION IV. ABSTRACTING AND ENTERING DATA: NEW RESEARCH SUBJECT

A. FIGURE 2: Abstracting & Entering Data for New Research Subject – Flowchart

Labs & Imaging Form1. TRUS2. Bone Scan3. CT of abdomen &/or pelvis4. Any other labs or imaging

relevant to Prostate Cancer evaluation

Medication Form1. Report any Medications

related to Prostate Cancer2. If Lupron or Zoladex injection

was administered, be sure to report it on the Clinic Visit Form as a procedure under "Other"

Clinic Visit Form1. Disease Stage:

Newly Diagnosed, Pre-Tx2. Ordered at this Visit:

Labs and Imaging, Biopsies 3. New Diagnoses:

Prostate Cancer (185)4. Prior medical history in New

Diagnoses, Unrelated to PCa5. Schedule Next Visit

Enter all forms into CaPSURE (fax in

Multiple PSA Form) and write Subject ID

on ALL forms

Prostate Biopsy Pathology Form1. DRE – choose DRE that is

closest to time of diagnosis2. Biopsy date and results,

including Gleason score for each biopsy

3. Stage using 2002 TNM Staging Conventions

4. Send copy of biopsy report

Surgeries and Treatments Form1. Report type of treatment2. Send copy of Surgical

Pathology Report for all Prostatectomies

3. Report pre-treatment hormone therapy on Medication form

Erectile Dysfunction Form

1. Report any Erectile Dysfunction Management or Medications

Send all forms to UCSF via Federal Express

Patient agrees to participate in CaPSURE

Clinical Trial Form1. Is the patient part of a clinical trial?2. If yes, record sponsor, device/drug and start/stop dates.

Recruitment Visit

Multiple PSA Form1. PSA at Diagnosis2. All prior PSA results

available. If only month and year are known, default to 15th

for the day.




B. Information to be Abstracted and Entered for New Research Subject

1. Overview

In this section, we will review the types of information that should be abstracted and entered for the new research subject. Once a patient has decided to participate in the CaPSURE™ study, the research coordinator will need to abstract the relevant data. In ‘Section V. Abstracting and Entering Data: Continuing Patients’, each data form is reviewed in further detail with coding rules for reference.

2. General Rules

a. A “newly diagnosed” patient is defined as being within six months, or 182 days, from date of first positive biopsy for adenocarcinoma of the prostate.

b. Report all events that are relevant to the diagnosis and staging of prostate cancer and that contribute to the cost of total urologic health care.

c. Each form includes a Notes/Comments Section at the bottom of the page. Use this section to document any information that does not fit into the existing form, or to communicate any additional comments regarding the visit or patient to USCF staff.

d. Use the New Patient Abstraction report to review status of abstraction process. Refer to ‘Section VII.E.1. New Patient Abstraction Detail Report’.

e. If required information is unobtainable, record details in the ‘Notes’ section of the New Patient Abstraction Details report to explain why data is missing from patient’s electronic chart. Refer to ‘Section VII.E.2. Patient Abstraction Notes Screen’ for further instruction.

f. Abstract on paper forms before entering the data into the electronic web-based capsure.net system.

g. Most sites error on the side of reporting too little information. If you have specific questions while abstracting, please feel free to contact the UCSF research staff.

3. Key Events for all New Research Subjects

There are a total of nine key events that need to be reported for all new research subjects, or an indication made that the information is unobtainable. Administrative Key Events:

Registration into CaPSURE™ study. Completion of Consent and HIPAA Forms.

Clinical Key Events:




Office Visit associated with recruitment into study. DRE result from initial evaluation. PSA value at time of diagnosis. Diagnostic biopsy results. Transrectal ultrasound (TRUS) results from initial positive biopsy. Clinical staging for tumor, node and metastases (TNM staging). Initial treatment.

If required information is unobtainable, this information should be recorded in the ‘Notes’ section of the New Patient Abstraction Details report. This record will explain to UCSF why certain information is missing from the patient’s electronic chart. Refer to ‘Section VII.E.2. Patient Abstraction Notes Screen’ for further instruction. The following sections describe in detail the Clinical Key Events to be reported.

4. Reporting of Relevant Office Visit

The Clinic Visit Form is designed to report all billable office visits to the urologist or nurse. Usually there is an office visit associated with the recruitment into CaPSURE™. The recruitment visit, and every other office visit that would be billed to an insurance carrier, should be reported to the database while the subject remains active in the study.

a. Report the recruitment visit on the Clinical Visit Form (yellow paper form).

5. Clinical Examination by Digital Rectal Examination (DRE)

A physical examination that includes a digital rectal examination (DRE) is usually done as part of routine clinical practice. Report the date and results of the DRE that was done during the initial evaluation. This date may precede the biopsy date or may occur on the same day that the diagnostic biopsy was obtained. The DRE is important element for assessing the clinical stage for TNM (tumor node metastases staging) prior to first treatment selection.

a. The initial evaluation DRE result is reported on the Biopsy Form (blue paper

form). You may check all options that best describe the subject. If you click on the option “negative”, both left and right lobes will be noted. If the DRE is “positive”, click on those options that best describe the clinical exam such as nodular or the DRE indicates that the cancer is outside of the capsule or invaded the seminal vesicle/s.




b. If the DRE was done elsewhere and the results are unknown, leave this section blank or report the amount of detail that is available such as the date and leave the results section blank. Record details in the ‘Notes’ section of the New Patient Abstraction Details report to explain why data is missing from patient’s electronic chart. Refer to ‘Section VII.H.3. Patient Abstraction Notes Screen’ for further instruction. You may also make a notation in the Comments Section at the bottom of the page.

6. Tumor Markers – Prostate Specific Antigen (PSA)

The use of serum PSA has revolutionized when and how patients are evaluated for prostate cancer. Onset of early screening has lead to earlier diagnosis when prostate cancer is more likely to be organ confined. Patients may differ with regards to the number of PSA tests, the manufacturer and the type of test obtained (free and/or total PSA). We would like a complete PSA history when available; please report all total and free PSA values that are known at the time of diagnosis. By reporting all PSA values, we will be able to understand the PSA velocity or rate of change over time. The Multiple PSA Form, which has space to report from 1 – 15 PSA results, is an ideal way to report the PSA history for new subjects. a. Individual PSA results can be reported on the Labs and Imaging Form (yellow

paper form) and then entered manually into the lab form in the database (shown below). Report the date of the test, the result and the manufacturer if known. There is an “unknown” option for manufacturer.

To a lesser extent, prostatic acid phosphatase (PAP) may be collected at the time of initial evaluation. The PAP should also be reported on this form.




b. If several PSA results need to be reported for one patient, a Multiple PSA Form can be used to report from 1 to 15 separate PSA results. This form is especially useful when entering data for new patients as it is an efficient way to capture PSA history. PSA tests reported on the Multiple PSA Form are entered into the database by faxing the form to UCSF or by entering the results manually. Once a Multiple PSA form is scanned in, we recommend checking the upload history the following day to confirm the PSA results were uploaded to the correct patient in the database without any errors. The upload history is found under the Multiple PSA Tab.

Number of PSA results entered for each subject.

UCSF Staff member who performed the data upload

Date PSA form was uploaded to CaPSURE database




Multiple PSA results for a single patient can also be entered manually by using the PSA Form on the Multiple PSA Tab.

7. Diagnostic Biopsy

Systematic sextant core needle biopsy by the transrectal approach under ultrasound guidance is the most common method to confirm the diagnosis of prostate cancer. Other anatomic approaches are acceptable and can be written in using the other option (e.g., perineal). Report the initial positive biopsy on the Biopsy Form (blue paper form) using either the mapped or non-mapped grid. This is the most critical event since it is necessary to calculate the age of diagnosis (used in the benchmarking graph) and to estimate the onset of prostate cancer. To the extent possible, report the number of biopsies obtained and the number that were read as positive for adenocarcinoma. This is helpful in estimating the extent or amount of tumor volume. Report the first biopsy performed that confirmed cancer of the prostate, whether or not the site performed the biopsy and/or first treatment. Please send a copy of the biopsy report, together with this form, to UCSF. a. Mapped Biopsy: This grid illustrates the two choices for reporting biopsy

information. The mapped grid allows for reporting by anatomic location within each lobe of the prostate.




b. Non-Mapped Biopsy: The non-mapped grid allows for reporting the number

of biopsies in each lobe of the prostate or if the lobe is unknown.

c. TRUS Reporting: When reporting biopsy results, do not forget to report the transrectal ultrasound results on the Labs and Imaging Form (yellow paper form). Record the date, volume in cubic centimeters (cc), and the result as negative (isoechoic), abnormal (such as image suggests stones) or positive (hypoechoic lesions present). If the result is positive, you may record it if it is within the capsule (left or right side), extends outside the capsule, or invades the seminal vesicle. Report to the highest level of detail possible.




d. Transurethral Resection of the Prostate (TURP): Some patients are diagnosed with prostate cancer through incidental findings on the pathology report from the transurethral resection of the prostate (TURP). Patients that are diagnosed with this pathology method should have their results reported in the biopsy results – TURP section only.

8. Clinical TNM Stage

Once you have reported all of the relevant clinical and diagnostic tests associated with the initial diagnosis of prostate cancer, the final critical information is to provide the clinical staging for tumor, node and metastases. Report the TNM Staging on the Surgeries and Treatments Form (blue paper form). The TNM Stage stands for the Tumor, Node, and Metastasis Stage of the cancer. The clinical stage is the complete staging after biopsy, but before treatment. This is the culmination of the tests and imaging studies ordered by the urologist. The clinical stage is determined prior to the application of a definitive treatment.

a. Tx (tumor not assessed) and T0 (no cancer) are not valid options for this section.

b. As of July 2002 CaPSURE™ uses the 2002 TNM staging conventions. Information on how to code the TNM and a table that provides the 2002 TNM convention is contained in Appendices D and E. Please read this section thoroughly before affixing the TNM stage.

c. Imaging: Imaging may be performed for the purposes of clinical TNM staging at diagnosis. Report all imaging diagnostics on the Labs and Imaging Form (yellow paper form) such as:

Bone scan CT or MRI – specify anatomic location ProstaScint® Cystoscopy or Intravenous Pyleogram




9. Initial Treatment

a. We prefer patients are recruited at the time of diagnosis and prior to first treatment. However, we will accept those patients that are newly diagnosed (within six months of diagnosis), but have received initial treatment.

b. Report the patient’s treatment history on the Surgeries and Treatment Form (blue paper form), once the information becomes available. The treatment page allows for reporting of watchful waiting, radical prostatectomy and staging lymphadenectomy, radiation treatment, brachytherapy, orchiectomy, cryosurgery and other treatments.

i. Note: If the patient has initiated hormonal therapy, report this information on the Medication Form (pink paper form).

c. If treatment was done elsewhere, report the amount of detail that is available. Record details in the ‘Notes’ section of the New Patient Abstraction Details report to explain why data is missing from patient’s electronic chart. Refer to ‘Section VII.H.3. Patient Abstraction Notes Screen’ for further instruction. You may also make a notation in the Comments Section at the bottom of the page.

10.Clinical Trial Participant

a. Report Clinical Trial Participation on the Clinical Trial Form (lime green paper form). At enrollment we request that you report participation in any clinical trials since that may affect resource use of diagnostic test or office visits. If the patient is not enrolled in a clinical trial, please check “NO” on the form.

b. You do not need to use this form again unless the subject is enrolled in a trial in the future. Also, once the subject has completed or terminated participation in a trial, it is important to report the trial Stop Date.

C. New Patient Abstraction Detail Report

To make sure that all of the key elements are reported for each of your new research subjects, we recommend using the color-coded (green = complete and red = not complete) New Patient Abstraction report to review the status of each patient’s abstraction process. With this report, you can review whether all required forms for a new patient have been completed. Refer to ‘Section VII.E.1. New Patient Abstraction Detail Report’ for more information.

D. General Guidelines for Completing and Tracking Data

Detailed below are guidelines for tracking patients enrolled at the site and the completion of their data. These suggestions are important and will ensure that all appropriate information is recorded and sent to UCSF G-CEPS Group.




1. Completing the Enrollment Visit

a. Patient fills out Consent and HIPAA Authorization Form to enroll in the study; site files yellow copy of Informed Consent and site copy of HIPAA in patient’s chart.

b. Complete the Registration Form and assign study ID number.

c. Abstract and enter data for the new research subject using appropriate clinical forms (Clinic Visit, Labs and Imaging, Treatments, Biopsy Pathology, etc.).

d. Review whether all required forms for a new patient have been completed. Use the New Patient Abstraction report to quickly see the status of new patients’ abstraction process on one screen. Refer to ‘Section VII.E.1. New Patient Abstraction Detail Report’ for more information.

2. Tracking Scheduled Visits

a. If a computer is used for scheduling, attach an identifier to participant name in database. Then review the daily schedule - if a participant is making an office visit, place the appropriate forms in the chart for the physician to complete.

b. Use the Visit Schedule report to view and print your patient visits per month. Refer to ‘Section VII.E.4. Monthly Clinic Visit Schedule’ for more information.

c. If a computer is not used, attach a label to the front of the patient chart to alert to the fact that a study participant is scheduled for a visit.

3. Tracking Clinical Form Completion

a. Use the New Patient Abstraction report to review the status of new patients’ abstraction process on one screen. Refer to ‘Section VII.E.12. New Patient Abstraction Detail Report’ for more information.

b. Use the “Data Activity Report” to review your patients' most recent Clinic Visit date and most recent PSA date. Refer to ‘Section VII.E.3. Data Activity Report’ for more information.

c. Create a Study Status List to review which of your patients continue to participate and which ones have withdrawn. Refer to ‘Section VII.C.2. Reports Tab: Study Status Report for Your Site’ for more information.

4. Sending Completed Forms via Overnight Mail

a. Send completed forms to UCSF as demand requires using Express Saver (if not available from your area, please use most conservative option, such as 2-day shipment).




b. Use provided paper airbills with shipping address and billing information pre-printed.

c. Airbills can be provided on short notice and sent as a .pdf file by email.

d. Communicate with UCSF staff if you need to request additional materials. Refer to ‘Section II. Communication with CaPSURE Staff’ for contact options.

Page 42 of 138 CaPSURE Observational Database Section V. Abstracting and Entering Data: Continuing Patients



SECTION V. ABSTRACTING AND ENTERING DATA: CONTINUING PATIENTS

A. Figure 3: Abstracting & Entering Data: Continuing Pts. – Flowchart

Multiple PSA Form

o FAX 1- 10 PSA’s

o Do not send in faxed PSA forms




B. Accessing a Patient’s Records

1. Finding an Existing Patient

a. To find a patient and his entered data, select the “Data Entry” button, and the “Find Patient” tab. You can select the patient by name from the list, or locate the patient by using the search options.

b. Refer to ‘Section VI.D. Finding an Existing Patient’ for further information on search options.

c. When you click on the blue highlighted patient name, the “Patient Summary” page will open.

2. Patient Summary Page

a. The Patient Summary page will appear once you select the patient by name from the “Find Patient” page.

b. The Patient Summary page can be printed for the physician to review with the patient or to send to a referring physician. The Print button is located in the title bar, at the top upper- right corner of the report. After clicking on the print button, the page will reload with printable graphics, and open the browser’s Print window.

c. This page provides a brief overview of the patient’s status, visit/form dates and summary information, patient’s quality of life questionnaire response and links to enter NEW forms for that patient.




d. Form tabs: at the top of the screen, you will see tabs labeled with each

clinical data entry form. You can click on any tab and you will be provided with a list of all previously completed forms by date (if previous forms have been entered).

e. Modifications Summary: click on the blue highlighted text in the right-hand column to view when a form was created and by whom, and the last date and time of any modifications for that patient’s data, if applicable.

f. Patient Graphs: Click on the blue highlighted text in the right-hand column to create individual patient graphs. Refer to “Section VII. A. Creating Patient and Clinic Graphs” for more information.

g. Partin Nomogram: Click on the blue highlighted text in the right-hand column to access the clinical tool that looks at the combination of prostate-specific antigen, clinical stage, and Gleason score to predict pathological stage of localized prostate cancer.

C. Enter a NEW Form

A NEW form can be entered in two ways:

a. Select the patient by name from the “Find Patient” page. Within the Patient Summary page, select the NEW form link in the Visit/Form Date column (refer to Patient Summary page description). A blank form will appear to enter data.

Click to enter a NEW form

Click to view or modify an existing form

List of QoL questionnaires completed by patient

Form Tabs

Print button

History of form creation and modifications

Individual patient graphs

Clinical tool to predict stage of PCa




b. Select the patient by name from the “Find Patient” page. To go to a specific form, select the appropriate Form Tab to view the form summary and to access the NEW form link within that page. A blank form will appear to enter data.

D. View / Modify an Existing Form

An existing form can be identified by the blue highlighted date in the Visit/Form Date column in the Patient Summary or Form Summary pages, and viewed or modified in two ways:

a. Select the patient by name from the “Find Patient” page. Within the Patient Summary page, select the blue highlighted Visit/Form Date under the appropriate form section (refer to Patient Summary page description).

b. Select the patient by name from the “Find Patient” page. To go to a specific form, select the appropriate Form Tab to view the form summary, and to select the date of interest within that page.

c. To return to the Patient Summary page after viewing the form without making changes, click on the “Patient” tab

E. Tab Out of Form With ‘No Changes’

To exit a form without saving any changes, select any “Form” Tab, or the “Patient” Tab (to go to the Patient Summary page). A prompt will appear instructing that you

Click to enter a NEW form

Click to view or modify an existing form

Form Tabs

Form Tab: Click here to return to the full list of visits for the particular form.

Patient Tab: Click here to return to the Patient Summary page.




will lose your changes. If there are no changes to save, select ‘OK’. If you do want to save changes, select ‘Cancel’ and save your data by selecting ‘Submit’.

F. Deleting a Patient Form

If for any reason you need to delete a patient form, such as the form was double entered, select the form and click the ”Delete” button on the top right of the form. A prompt will appear to verify that you do in fact want to delete the form. Please be aware that once you have deleted a form it is impossible to undo the action.

G. Saving Data: “Submit”

a. Use the ‘Submit’ button - found at both the top and the bottom of the form - to save your data.

b. If you try to move to another form without saving what was just entered, you will see a prompt that reminds you about saving your data. However, if you leave the computer for too long, you may miss this kind of prompt, and your Internet session may close, causing the data you just entered to be lost.

c. Get in the habit of always clicking the “Submit” button. All data once saved stays available whenever the user logs onto the CaPSURE site.

H. Printing Capabilities

a. Some pages have a ‘Print’ button located at the top right of the form (e.g., Patient Summary Page). If available, select this button to print. After clicking on the print button, the page will reload with printable graphics, and open the browser’s Print window.

b. If there is no ‘Print’ button, use the “File” menu in the top gray toolbar and click on “Print” in the pull down menu. A screen will appear that allows you to choose how much of the form you wish to print. You can click on: as laid out on screen, only the selected frame, or all frames individually. Choose the one you want, and click “ok” button.




I. Abstracting and Entering Data: Continuing Patients

1. Overview

In this section, we will review each data form and their coding rules for reference. The following is a brief summary of the forms you may use for continuing patients to report:

a. Office visits, Tests and Medications: Hybrid Clnic Visit Form (white scannable form)

b. Office visits: Clinical Visit Form (yellow paper form)

c. Test results:

1. Labs/Imaging Form (yellow paper form)

2. Multiple PSA form (white paper form with scannable fields)

d. New/Modifications to medication: Medications Form (pink paper form)

e. Management for erectile dysfunction: Erectile Dysfunction Form (pink paper form)

f. Additional Biopsies, DRE’s and Clinical Staging: Biopsy Form (blue paper form)

g. Additional Treatments: Surgeries/Treatments Form (blue paper form)

h. Enrollment in trial since recruitment: Clinical Trial Form (lime green paper form)

i. Changes in subject’s participation since recruitment: Status Form (lavender paper form)

2. General Rules

a. A “continuing” patient is defined as any patient enrolled in CaPSURE who is post initial biopsy and, potentially, post initial treatment.

b. We assume that active study patients will be seen at least annually (once every 365 days), and will have their PSA assessed.

i. Use the “Data Activity Report” to review your patients' most recent Clinic Visit date and most recent PSA date. Refer to ‘Section VII.H.3. Data Activity Report’ for more information.

c. Every office visit that would be billed to an insurance carrier should be reported while the subject remains active in the study. This includes visits for medication administration by a nurse.

d. Each form includes a Notes/Comments Section at the bottom of the page. Use this section to document why certain information is unobtainable, to




report information that does not fit into the existing form, and to communicate any additional comments regarding the visit or patient to USCF staff.

e. If required information is unobtainable, record details in the ‘Notes’ section of the New Patient Abstraction Details report to explain why data is missing from patient’s electronic chart. Refer to ‘Section VII.E.2. Patient Abstraction Notes Screen’ for further instruction.

f. Abstract on scannable forms where possible: Multiple PSA is faxed in; Hybrid Clinic Visit is returned to be scanned and uploaded by UCSF.

g. Abstract all data that does not go on scannable forms onto the colored paper forms and enter into the electronic web-based capsure.net system.

h. Most sites error on the side of reporting too little information. If you have specific questions while abstracting, please feel free to contact the UCSF research staff.




J. Clinic Visit Form (Scannable Hybrid Form)

1. Overview of Form

a. Scanned by UCSF at their office location (no data entry by site required). Batch all scannable Clinic Visit forms, sorted by ID (make sure the Patient

ID is written on each form) and send to UCSF. Do not staple, paper clip together.

b. Captures any and all billable office visits to the urologist or nurse c. Mixture (hybrid) of the clinic visit, lab and medication forms:

Office visit details PSA Urine culture/UA TRUS PVR LHRH Agonists/Antagonists, Antiandrogens

d. Use a black or blue BALLPOINT PEN (felt tip pens leak through the page

and can be read by the scanner as a response on the back side). Avoid making stray marks and/or writing close to any check box. Use the

Comments section on the back side of the form for any pertinent notes. Print clearly and within the boxes. Mark the box/bubble with or . Don’t circle or mark outside the

box/bubble. e. Don’t make copies for extra forms – blank forms must be requested

from UCSF.

2. Corrections

a. If you make a mistake with a number make a tight horizontal wavy line through the error (the horizontal wavy line makes the error unrecognizable by the scanner); rewrite correct value close to the box so it’s easily read and associated with the correction.

b. If you make a mistake with a bubble or check box, cross out wrong response then mark and circle correct bubble or box.

The same is true if None or Not Assessed are erroneously marked: fill in the correct response and circle; cross out ‘None’ or ‘N/A’ to clearly mark as an error.

098 0

X X X




X

X




3. Abstracting Data to the Hybrid Clinic Visit Form

The Clinic Visit Form is designed to collect each billable office visit that occurs. The purpose of this form is to capture the cost of care and the clinical elements that make up a patient’s prostate cancer and urologic care. The majority of clinic visits will be Routine follow-up visit to Urologists. Some other frequently reported visits include Medication Administration visits to a Nurse or MD, or Acute visits and their follow-up to an MD because of retention or incontinence. Clinic visits to outside providers such as Radiation Oncologists, Medical Oncologists or outside Urologists should only be reported if the patient is no longer attending the practice and the only method by which to report on the patient’s clinical progress is to abstract from reports and/or letters sent to the practice.

4. Type of Visit

Report the type of office visit by selecting one of the categories. Use the ‘Other’ category if type of visit is not included in the pre-typed options.

If patient comes in with acute problem (i.e., retention), or for follow-up of acute problem, mark the visit as Acute Problem and specify reason. Also report condition under New Diagnoses and report relevant symptoms under Signs/Symptoms.

If patient comes in for hormone injection

only, mark Med. Admin. Only. If injection is part of a routine visit with exam, mark Routine.

If patient comes in for ED counseling or

medication trials, mark ED Mgmt. Only.

Please fill in ID and date boxes, writing numbers clearly and within the lines.

Format MD Name as: LAST; FIRST (DO NOT USE A COMMA – please use a semicolon or dash ) Providers other than MD can be listed by name or as: ‘Nurse Practitioner’, ‘Nurse’, ‘Resident’, etc. Providers outside of practice* should be listed by role: ‘Outside Urologist’, ‘Rad/Onc’, ‘Med/Onc’, etc.

ABSTRACTION TIPS




5. Current Disease Stage

Report the patient’s current disease stage in all applicable categories. If ‘Not Assessed,’ select the box at the top of the section.

Newly diagnosed – pre-treatment Distant progression – lymph node

- For a new patient at their recruitment visit or prior to treatment

- Definitive metastases; non-regional lymph node involvement

No evidence of progression or recurrence - Results reported on Lab/Imaging form

- Indicates a stable condition post therapy - Classify patient as M1a on Biopsy form

Rising PSA - Send in copy of positive lab/imaging

- Biochemical evidence of recurrence Distant progression – bone

- Significant rise in PSA after treatment - Definitive bone metastases

Local recurrence – clinically assessed - Imaging results reported on Lab form

- Defined as progressing disease - Classify patient as M1b on Biopsy form

- Patient had positive DRE or - Send in copy of positive imaging report

ProstaScint after treatment Distant progression – other

- DRE reported on Clinic Visit form - Distant metastases to other sites

- ProstaScint reported on Lab form - State location of metastases

Local recurrence – biopsy and T stage - Results reported on Lab/Imaging form

- Patient had + biopsy after treatment - Classify patient as M1c on Biopsy form

- Reported on Biopsy Form with T stage - Send in copy of positive lab/imaging

Other

- Report any disease staging not listed

Rising PSA should be marked for any significant rise in PSA after treatment.

When patient has local recurrence or distant progression, report:

o How recurrence/progression was identified (e.g., imaging, biopsy, DRE)

o The new T (+ biopsy) or M (+ bone scan or other imaging) staging.

o Adjuvant treatment and/or medications

Send in copies of positive biopsy and imaging results (source documentation)

ABSTRACTION TIPS

CODING RULES for reporting Current Disease Stage




6. Procedures at This Visit

Report any clinic procedures related to the visit in the applicable categories. If None, select the box at the top of the section.

Bladder irrig./install. of antineoplastic agent DRE - Result

Catheter placement - Initial DRE with biopsy is reported on Bx form

Catheter removal Med. Admin. (specify)

- Check both boxes if placement and removal - Report office medication injections & insertions

occur at same visit (i.e., straight catheter - Report any start/change/stop of hormones on back

in/out; removal/reinsertion of catheter) or, if not included, on a Medication form

Collagen injection - Report any start/change/stop of ED medications

Cystoscopy - Result on an ED form

- Report diagnostic cystoscopy with results - Report hormones as: Drug/Frequency

when occurred during the clinic visit - Report ED medication as: Drug/Dose

- Occurring outside of clinic visit; use Lab form Staples removed

- Cystoscopy w/ procedure @ visit -> report Transrectal biopsy

procedure only; do not check cystoscopy box - Report biopsy results on the Biopsy form.

- Procedure outside of clinic visit; use Tx form - Report date, volume and result of TRUS on back

Dilation Uroflow/Urodynamics

- Report cystoscopy with dilation by checking - Report PVR volume and result on back

this box; do not check the box for cystoscopy Other

- Report any procedures not listed.

When a diagnostic cystoscopy occurs during the clinic visit, check ‘Cystoscopy’ box & report results. Visit date will = cystoscopy date. You don’t need to also report on a Lab form once reported on the clinic visit.

o When a diagnostic cystoscopy occurs outside of the clinic visit -> report on the Lab form.

Cystoscopy with procedure at time of visit (e.g., cysto with dilation) -> check the ‘Dilation’ box; don’t also check the cystoscopy box on the form. Visit date will = procedure date.

o Procedures that occur outside of the clinic visit -> report on the Treatment form.

Use standard terminology for reporting medications in the Med. Admin. write-in section.

o Report hormones as: Drug/Frequency - E.g., Lupron QM, Q3M or Q4M

o Report ED med as: Drug/Dose - E.g., Caverject 20 mcg

Report PVR results for Uroflow/Urodynamics on back side of form. Results will appear on the Lab/Imaging form under Ultrasound - Bladder. The PVR field should also be used to report of BladderScan results.

ABSTRACTION TIPS

CODING RULES for reporting Procedures At This Visit




7. Karnofsky Score

- Report a Karnofsky rating based on the physician’s assessment of the patient

at the time of examination. - The score is assessed in increments of 10 only, from zero to 100 (100 being

normal functioning, zero being dead). - If not assessed or unclear from physician’s notes, select Not Assessed.- Refer to Appendix, Section F for further instruction for rating patients using

the Karnofsky Scale.

8. New Diagnoses

Report in this section any new diagnoses related or unrelated to prostate cancer that are noted in the progress note. Remember, if signs/symptoms are reviewed at the visit, they are reported in the Signs and Symptoms section. If there were no new diagnoses noted, select None at the top of the section.

CODING RULES for reporting Karnofsky Scale




9. Signs and Symptoms

10. IPSS

Report in the first clinic visit form you abstract all existing medical conditions (patient’s medical history) as new diagnoses.

For example: report pre-treatment erectile dysfunction and urological conditions, other cancers, cardiac disease or conditions such as Parkinson’s disease and diabetes.

Enter ICD-9 code ‘185’ to report a new diagnosis of prostate cancer in the clinic visit that occurs after positive biopsy.

ABSTRACTION TIPS CODING RULES for New Diagnoses

- Write in the diagnosis and assign an ICD-9 code:

o Use Appendix, Sect. K to code the diagnosis.

o Write in the text only if the specificity of the condition is not included on the list or if the condition is not listed. A UCSF staff member will fill in the corresponding ICD-9 code.

- Use the next clinic visit or Comments section to report any diagnoses that do not fit in the allocated spaces on the form.

Only report ‘0’ for symptoms that were discussed and the patient indicated ‘None’.

Write in ‘Other’ symptoms beginning from left (#1) to right.

If >3 ‘Other’ symptoms are reported, make a notation in the Comments section at the end of the form.

Examples of ‘Other’ symptoms to report include, but are not limited to, hesitancy, split stream, depression, constipation, etc.

ABSTRACTION TIPS CODING RULES for Signs and Symptoms

- If the patient complains of any symptoms, select the number corresponding to the degree of severity.

- If a symptom is positive and the severity is not evident, default to ‘1-mild’.

- Write in any signs or symptoms not included in list under “Other.”

- Only report ‘0’ for symptoms that were discussed and patient indicates ‘None.’

- If not assessed, select Not Assessed in the upper right hand corner.




- Report an I-PSS rating based on the patient’s self-report at the time of the office visit. To be assessed as 0 = Not at all, 3 = Half the time and 5 = Almost always.

- If not assessed, select Not Assessed in the upper right hand corner.

- Refer to Appendix, Section G for further instruction on using the I-PSS Scale.

11. “Lab Portion” — Hybrid Clinic Visit Form

Note: There must be a clinic visit reported for the database to accept the Lab and/or Medication portion of the form.

a. Total PSA, Free PSA, Urine Culture and Urinalysis

Individual total PSA, free PSA, UA and urine culture results can be reported on the back side of the hybrid clinic visit form. To report one or more total PSA’s per participant, we suggest using the fax-back Multiple PSA Form. Go to pg. 19 in this section for further instruction. For overall instruction on the full Lab and Imaging Form, refer to ‘Section V.K. Labs and Imaging Form.’

Mark an “X” through the Quality of Life Due to Urinary Symptoms box.

CODING RULES for New Diagnoses




- Do not repeat any values that have been already entered into the database. This will cause the system to error and we will need to deal with the error manually.

o Verify two PSA’s are not the same event if they have the same result and are dated 1-30 days apart.

- Use the fax-back Multiple PSA form to report one or more total PSAs per participant on a single form.

- Translate text to numbers to report microscopic RBC/WBS (refer to the legend on the form).

- Report the date the PSA and/or urine was drawn as the test date. This date can differ from the Clinic Visit date.

- Information entered on this portion of the Hybrid Clinic Visit form will be reported in the electronic database under “labs”.

ABSTRACTION TIPS

CODING RULES for PSA, Urine culture & Urinalysis

- Prostate Specific Antigen (PSA): Record results as reported by the lab. If the lab reported PSA results as: <0.05 ng/mL or >100.0 ng/mL, write value exactly as reported on the laboratory report. - To report a PSA value, fill in the circle before the symbol to represent:

o < is “less than” (e.g., PSA is < 0.01) o > is “greater than” (e.g., PSA is >100) o = is “equal to” (e.g., PSA is 4.5)

- Free PSA: If the lab only reports free PSA as a percent, indicate that on the form - Call your lab to determine who manufactures their PSA tests Report the PSA

Manufacture by filling in the circle that corresponds with the company: o A = Abbott, B = Bayer, D = DPC-Immulite, H = Hybritech (Beckman), T = Tosoh and

U = Unknown - If PSA Manufacturer is “Other’, fill in the circle next to Other/specify and clearly print the

name on the line. - Urinalysis: If results of microscopic analysis are written in text, report results as a number

(i.e., Occasional = 5). Refer to the legend on the form for the translation.




b. TRUS/PVR

Individual TRUS and PVR results can be reported on the back side of the hybrid clinic visit form. For overall instruction on the full Lab and Imaging Form, refer to ‘Section V.K. Labs and Imaging Form.’

- If TRUS is done as volume study prior to radiation therapy, report date and volume but code result as unknown.

- Use the PVR field to report the volume of residual urine found with ultrasound, BladderScan and other Urodynamic tests.

- If the patient is positive for retention, report this as a New Diagnosis on the front side of the form.

- Information entered on this portion of the hybrid clinic visit form will be reported in the electronic database under ‘labs’. The PVR volume and result will be reported in the Ultrasound-bladder field.

- The TRUS and/or PVR procedure date can differ from the Clinic Visit date.

ABSTRACTION TIPS

CODING RULES for TRUS and PVR

- TRUS: Record the date, volume in cubic centimeters (cc), and the result asnegative (isoechoic), abnormal (such as image suggests stones) or positive (hypoechoic lesions present). - If the result is positive, you may record it if it is within the capsule (left or

right side), extends outside the capsule, or invades the seminal vesicle. Report to the highest level of detail possible. If the TRUS show extra-capsular involvement, report that as well - PVR: Use the PVR field to report the volume of residual urine found with

ultrasound, BladderScan, Uroflow and/or Urodynamic tests. - Assign a PVR result as Neg, Abn or Pos by using the following guidelines:

o Normal = 50 mL or less o Abnormal = >100 mL o Positive (definite sign of problem) = 200 mL or greater

- The PVR volume and result will be reported in the Ultrasound-bladder field of the Labs/Imaging form.




12. “Medication Portion” — Hybrid Clinic Visit Form

The start, change or end of a limited list of LHRH Agonists/Antagonists and Antiandrogens can be reported on the back side of the hybrid clinic visit form. For overall instruction on the full Medication Form, refer to ‘Section V.M. Medication Form.’

13. Next Visit Date — Hybrid Clinic Visit Form

Refer to ‘Section VII. Graphs, Reports and Extract Files’ for further description of the ‘Monthly Clinic Visit Schedule’ report.

- Report the return date (month/year) for next scheduled visit in the “Next Visit Date” option at the bottom of the page.

- This information can be viewed for all patients scheduled to return for an office visit during the month chosen on the “Monthly Clinic Visit Schedule” report.

- Complete this section to report a start, change or discontinue of a medication for prostate cancer. Report when the injection occurs under “Procedures at this Visit” in Med Admin (specify) on the front side of the form. - Standard Drug Dosage:

Lupron = 7.5 mg (QMO), 22.5 mg (Q3MO), 30 mg (Q4MO) Eligard = 7.5 mg (QMO), 22.5 (Q3MO), 30 mg (Q4MO) Zoladex = 3.6 QMO, 10.8 mg (Q3MO)

- Information entered on this portion of the hybrid clinic visit form will be reported in the electronic database under ‘medications’.

- Use a separate pink Medication form to report medications not listed on this hybrid form.

ABSTRACTION TIPS

CODING RULES for Next Visit Date




K. Labs and Imaging Form

1. PSA, PAP, and Free PSA

Report results of PSA, PAP or Free PSA and record the test date.

a. Prostate Specific Antigen (PSA): Record results as reported by the lab. If the lab reported PSA results as: < 0.05 ng/mL or >100.0 ng/mL, write the value exactly as reported on the laboratory report.

b. Prostatic Acid Phosphatase (PAP): Report as ng/mL.

c. Free PSA: Report as ng/mL. Remember to include the PSA results, as well. If the lab only reports free PSA as a percent, indicate that on the form.

2. PSA Manufacturers—Total PSA and Free PSA

a. Call your lab to determine who manufactures their PSA tests.

b. If manufacturer is not included on list, select “Other” and write in name.

c. If you cannot determine the PSA manufacturer, select “Unknown”.

3. Hematology/CBC

a. Report any results for WBC, Hemoglobin and Hematocrit and record the test date.

b. Be sure to double check entry in these fields after saving. Particularly verify numbers with decimal places, as some fields don’t permit them, making it easy to enter incorrect information (i.e., 9 being entered instead of 0.9). Round-up values to the appropriate number of digits (i.e., 0.9 changes to 1 for single digit field).




4. Blood Chemistry Panel

a. Report any of the test results requested/received and record the test date.

b. Acid Phosphatase or Alkaline Phosphatase: write in the numeric result and record if the laboratory reports a Low, Normal or High result.

c. Testosterone: write in the numeric result, select the appropriate units (either ng/mL or ng/dL) and record if the laboratory reports a Low, Normal or High result.

d. Be sure to double check entry in these fields after saving. Particularly verify numbers with decimal places, as some fields don’t permit them, making it easy to enter incorrect information (i.e., 9 being entered instead of 0.9). Round-up values to the appropriate number of digits (i.e., 0.9 changes to 1 for single digit field).

5. Urine

a. Record test date and report urine test results.

b. If there are multiple urine tests to report, fill out one form per test, submit information and return to new form. Continue to report multiple tests on new forms, as needed.

c. If results of microscopic analysis are written in text, report results as a number (i.e., Occasional = 5).

d. If Urine Cytology is performed, write in text results and findings.

e. Report other urine tests (i.e., sugar, glycosuria) in “Other Tests” at bottom of page.




6. Imaging Tests

a. Record each imaging test date and report the result for each.

b. Where applicable, report type of test (i.e., MRI of ______).

7. Imaging Tests: TRUS

a. Record the date, volume in cubic centimeters (cc), and the result as negative (isoechoic), abnormal (such as image suggests stones) or positive (hypoechoic lesions present).

b. If the result is positive, you may record it if it is within the capsule (left or right side), extends outside the capsule, or invades the seminal vesicle. Report to the highest level of detail possible. If the TRUS show extra-capsular involvement, report that as well.

c. If TRUS is done as volume study prior to radiation therapy, report date and volume but code result as unknown.

8. Other Tests

a. Record any other tests ordered, the dates, and the results.




b. Examples of other tests to report are Bladder Scan/post-void residual urine (PVR), estrogen and progesterone. For PVR, record the residual number of cc’s in Result.

c. If there are more than two Other Tests to report, fill out one form for the first two tests, submit information and return to new form. Continue to report additional tests on new forms, as needed.




L. Scan Enabled Multiple PSA Form

PSA results can also be reported using the Multiple PSA Form that you can send via FedEx to our data coordinating center. The scan enabled multiple PSA form will negate the need to enter this data manually. 1. General guidelines for using the form

Do not repeat any values that have been already entered. This will cause the system to error and we will need to deal with the error manually. Please refer to the instructions below for full definition of ‘duplicate’ events and detailed instructions on correctly filling out the form.

Use black or blue ink and print clearly within the boxes.

2. Filling out the form and making corrections

Please print numbers clearly 0 1 2 3 4 5 6 7 8 9 . International numbers (e.g., Ø) do not scan properly. See example 1.

Example 1: Good Printing

For the boxes , write numbers carefully within the lines. Be aware of numbers touching or crossing over boundaries of the boxes, and of slanted 2's and 0’s. See Example 2.

Example 2: Poorly Completed

If you make a mistake with a number you must cross out the whole line and mark at least two bubbles so the computer picks up the error. Please complete the following three steps (as given in example 3 on the next page):

a. Make a tight vertical or horizontal wavy line through the error (the wavy line makes the error unrecognizable by the scanner).

b. Mark two bubbles with ink and cross both out (this forces the UCSF staff to delete both marks).

c. Rewrite the correct value on the next line.




Example 3: Correcting Number Mistakes

If you make a mistake with a bubble only (numbers are still okay), cross out the wrong response and fill in the correct bubble and circle. See example 4.

Example 4: Correcting Bubble Mistakes

3. Duplicate PSA’s

A duplicate is defined as:

o Same date and same PSA result; or

o Dates within 1-30 days and same PSA result.

UCSF uses quality assurance (QA) checks to identify and resolve duplicates in the following way:

o Entries with same date and same PSA result. The later reported PSA is deleted.

o Entries with dates within 1-5 days and the same PSA value. This is a common duplicate and the PSA with the later date is deleted. An assumption is made that the same PSA is reported with drawn date & again with reported date. Default to the earlier date when reporting; i.e., the date PSA was drawn.

o Entries with dates within 6-30 days and the same PSA value. A PSA will be deleted if the PSA result is undetectable and therefore not likely repeated within a short time period. The validity of other duplicates in this category will be verified with sites before adding to the database.

Please check against the database and within the form for PSA’s that meet the duplicate definitions above. Report on the form if the data was verified and not a duplicate event.

Notify your UCSF Analyst if there are trends that occur at your practice where ‘duplicate’ PSA’s are true and should not be excluded.




M. Multiple PSA Form – Upload History

Upload PSA History page displays the monthly history of data transferred (uploaded) to the CaPSURE™ database from scannable Multiple PSA forms sent in from your site. This page can be used to reconcile what UCSF uploaded against the original paper copy of the form. The information on this page is organized by individual patient form and includes:

Patient ID = unique study ID (hyperlink field – select to access Upload PSA Details).

Upload Date = date the information was transferred to the database by UCSF.

User = UCSF staff person who uploaded the data.

Records = number of records (PSA’s) uploaded from the individual form.

If the number of records uploaded does not match the number reported on your paper form, select Pt ID from this page to access the Upload PSA Details page (shows which values were included in the transfer). An example of this page is shown below.

Please note: UCSF staff removes PSA record(s) from the transfer file if a record errors as a duplicate. (Refer to the previous page for our definition of Duplicate




PSA.) Sites will be notified via the secure email system if PSA record(s) were removed from the transfer file. When a ‘duplicate’ record is verified by the site or internally as valid, the record is manually entered into the database by UCSF staff (separately from the transfer file). This manual entry is required in order to bypass the automated error checks.

N. Electronic Multiple PSA Form

The Electronic Multiple PSA form is another method offered to capture multiple PSA values per patient and can be used as an alternative to the fax-back multiple PSA paper form. Select the Multiple PSA and PSA form tabs to open the Multiple PSA Summary page (as shown below). This page displays a monthly record of PSA’s entered using the Electronic Multiple PSA Form. It will also display if any errors were detected when the form was submitted. Refer to Automated Data Quality Assurance (QA) Checks on the next page.

Select ‘New’ to create a form




1. Automated Data Quality Assurance (QA) Checks

The same data QA checks that apply to the fax-back PSA data upload, also apply to the electronic multiple PSA form. Once you select the ‘Submit’ button on the electronic form, you will be taken back to the Multiple PSA Summary page. If there were any errors with the form, they will appear at the top of the Summary page as displayed below: Select the Patient ID field in the Mulitple PSA Summary page to access the form and modify or delete your entry:

Enter up to 15 PSA’s per patient




Once changes are made to the form, select the Submit button. An exception to this approach is if a PSA errors as a duplicate. If you determine the PSA is not truly a duplicate (should be entered into the database), then the record(s) must be removed from the electronic form and entered manually into the database in order to bypass the automated QA check.




O. Medications Form

Complete this form any time a patient starts, changes, or stops taking a medication for prostate cancer. It’s common for a site to complete the Medications Form when a patient starts a medication and forget to complete another form once the patient completes the medication. Please be sure that a new form is completed each time there is a new medication, a change, or a discontinuation of a medication. 1. General Coding Rules for all Sections of the Medication Form

The following coding rules are applicable to all sections of the Medication Form:

a. Use additional Medication Forms (submit and return to new form) to record multiple events, such as start and stop dates of the same drug and multiple types of 'Other' medications.

b. If there is only a dose and/or frequency change, do not enter start and stop dates. Record new dose and/or frequency and select ‘Change’ as the

Medication Action.

c. All appropriate dosages, frequencies, dates and medication actions are to be reported. If unknown, please indicate with “unknown” in the Comments Section at the bottom of the page.

2. LHRH Agonists/Antagonists




3. Antiandrogens

4. Hormone Refractory and Related Antineoplastic Therapies

5. Treatment for Hot Flashes




6. Other Medications

a. Use a second Medication Form (submit and return to new form) if more than two “Other” drugs will be reported.

b. For short-term medications reported in the ‘Other’ section, you can use this section of the Medication form to report both the start and stop of the medication.




P. Erectile Dysfunction Form

1. Medication

a. Record dose, date and medication action (start, stop, change) for any medications prescribed for erectile dysfunction. Specify type of medication if “Other” is selected.

b. If patient is receiving a pharmacologic therapy, fill in dosing information and start date.

c. Just as with other medications, don’t forget to enter stop dates when patients discontinue erectile dysfunction medications.

2. Management

a. Select the type(s) of management and record the date. Check all options pertaining to the patient’s care. Specify type of management if “Other” is selected. If dates are unknown, indicate by writing "unknown” in the Comments Section at the bottom of the page.

b. Select a response (yes/no) for each of the three questions at the bottom of the page regarding any counseling, including discussion only, and any ‘trial runs’ of medications in the office at this visit.




Q. Prostate Biopsy Pathology Form

1. General Coding Rules

a. For continuing patients, report any follow-up biopsy that is performed to evaluate disease recurrence. A DRE may be reported preceding the event. Re-stage patient’s TNM staging.

b. When reporting biopsy results, do not forget to report any transrectal ultrasound results on the Labs and Imaging Form (yellow paper form).

2. Digital-Rectal Exam Findings at Time of Biopsy

a. If the DRE was performed, check the findings and the date the exam was performed.

b. If positive, complete findings for both right and left sides.

3. Biopsy Type

a. Select the biopsy type (core needle biopsy – transrectal, TURP or Other) and report the date performed. If biopsy type is 'Other', specify type.

4. Biopsy Results — Mapped

The mapped grid allows for reporting by anatomic location within each lobe of the prostate.




a. If cores taken from each section are positive, report for both the right and left sides.

b. Report primary, secondary and total Gleason Scores.

c. Report total number of mapped biopsies and total number of positives.

5. Biopsy Results — Non-Mapped

The non-mapped grid allows for reporting the number of biopsies in each lobe of the prostate or if the lobe is unknown.

a. Record the number of positive cores taken from the right and the left. If which

lobe is unknown, default to “Unknown”.

b. If the exact number is not detailed in the pathology report, it is appropriate to write in a descriptor for example, “many” or “multiple” in the Comments Section at the bottom of the page. Translate the descriptor into a value. Call the staff at UCSF if you don’t know what value to assign and we will make the decision.

c. Include total number of non-mapped biopsies done and total number of positives.

6. Biopsy Results — TURP

a. If a TURP was done, complete this section including the percentage involved and the Gleason scores.




7. Clinical Stage of Disease (TNM)

a. For continuing patients, restage only if a follow-up biopsy is performed to evaluate disease recurrence.

b. Because continuing patients rarely need to be restaged, please consult with UCSF before any re-staging is done.

c. As of July 2002 CaPSURE™ uses the 2002 TNM staging conventions. Information on how to code the TNM and a table that provides the 2002 TNM convention is contained in Appendices D and E. Please read this section thoroughly before affixing the TNM stage.

d. Imaging may be performed for the purposes of clinical TNM staging. Report all imaging diagnostics on the Labs and Imaging Form (yellow paper form) such as: Bone scan CT or MRI – specify anatomic location ProstaScint® Cystoscopy or Intravenous Pyleogram

R. Surgeries and Treatment Form

1. Watchful Waiting

a. If the patient elects for watchful waiting or active surveillance, check the box indicating this and report the decision date.

2. Radical Prostatectomy

a. If the patient undergoes a radical prostatectomy, select the type and report the procedure date. Pre-specified types include: retropubic, perineal,




transcoccygeal, laparoscopic (with or with-out robot), and ‘other’. Please specify type if “Other” is selected.

b. Select whether the procedure was nerve sparing. If you are not certain about nerve sparing, send a copy of the operation report to UCSF with a note and we will try to code this field for you.

c. Report the Primary, Secondary and Total Gleason scores. If Gleason score is unknown, select the “Unknown” box. Use the Comments Section at the bottom of the page to report any relevant comments as to why score is unobtainable.

d. Report the Pathologic T Stage using both the 2002 and 1997 staging convention.

e. Please indicate if the patient did or did not undergo pre-operative hormonal therapy.

f. Remember to send a copy of the surgical pathology form to UCSF. Requests for pending surgical pathology forms will be sent by UCSF via the secure email system.

3. Lymphadenectomy

a. Select type, procedure date, report the Pathologic N Stage and Primary, Secondary and Total Gleason scores. If Gleason score is unknown, select the “Unknown” box. Use the Comments Section at the bottom of the page to report any relevant comments as to why score is unobtainable.

4. Radiation Treatment

a. Select type and anatomic location. Specify type if “Other” is selected.

b. Report the start date, stop date, and the total dose received.

c. Select whether the patient received pre-radiation hormone therapy.




5. Brachytherapy

a. Select seed type and date inserted. Specify type if “Other” is selected.

b. Report pre- and post-implant volumes, dose, number of seeds, total implant activity and post implant dosimetry.

c. Select whether the patient had pre-brachytherapy hormone therapy.

d. Select whether the patient had pre-brachytherapy XRT.

6. Other Treatments or Procedures

a. Specify type of treatment or procedure if “Other” is selected.

b. Record the procedure date for each reported treatment or procedure.

c. Do not report hormone therapy in “Other”. Report any new or changed prescription in the Medications Form.

d. Examples of other treatment may include: cystoscopy with dilation, transurethral resection of the bladder, and circumcision.

S. Clinical Trial Form




a. Complete the Clinical Trial Form only when a patient starts a trial, and when a patient completes or terminates participation in a trial. This form does not need to be filled out if there is no change.

b. Report the Stop Date once the subject has completed or terminated participation in a trial.

c. Do not include the CaPSURE™ study on this form; it is not a clinical trial.




T. Status Form

This form is to be completed any time a patient changes status or dies (see Appendix C for Study Status categories). Unlike the other forms discussed, please do not enter this form. Instead, please fill it out and send to UCSF for entry. 1. Reason for Study Status Change

A participant can stop his affiliation with the CaPSURE study at any time. This is usually communicated in three different methods:

a. Patient tells his physician or study contact at time of a clinic visit that he

no longer wishes to participate.

i. Ask the patient if he will give permission to continue collecting clinical information for the study. If yes, select “Clinical Only”. Clinical Only means that the patient will not be sent questionnaires, but the study site will continue to document office visits and report information to UCSF.

ii. If the patient is moving to another practice, ask the patient whether they would still like to complete the questionnaires in January and July. If yes, select “Questionnaire Only”.

b. Patient communicates to UCSF staff that he is no longer interested in

participating.

i. A participant may contact the staff at UCSF and communicate his desire to withdraw from the study. He is asked to make a decision as to whether or not to allow continued collection of clinical data and/or questionnaire data (see above).

ii. UCSF staff will communicate this information to the site. The site is not required to complete and submit a Status form, but is responsible for making sure that all of the patient’s data has been reported up to the date of status change.

c. Staff at UCSF removes patient from study due to a history of

nonparticipation.




i. We remove patients from the study who have not communicated with UCSF by returning their questionnaire. If there has been no questionnaire returned in over two years and the patient cannot be reached by phone, the individual is removed from the study. His patient status would be, “Lost to Follow-up”. The site will no longer send UCSF clinical data regarding this patient.

ii. UCSF staff will communicate this information to the site. The site is not required to complete and submit a Status form, but is responsible for making sure that all of the patient’s data has been reported up to the date of status change.

2. Deceased Patient

a. Please obtain exact date of death. If only approximate month and year is known, please report as such.

b. Since we are interested in knowing the cause of death, any and all information that is available will be helpful to us in obtaining official documentation (death certificate).

3. Study Status List

a. Generate a Study Status List for your site to quickly see which of your patients have had a status change and when this changed occurred.

b. Create a Study Status List to review which of your patients continue to participate and which ones have withdrawn. Refer to ‘Section VII.C.2. Reports Tab: Study Status List for Your Site’ for more information.

Page 82 of 138 CaPSURE Observational Database Section VI. Using CaPSURE Web-Site for Data Collection



SECTION VI. USING CaPSURE™ WEB-SITE FOR DATA COLLECTION

A. Security and Confidentiality Safeguards

1. Understanding a ‘Secure Site’

a. When you log onto the CaPSURE website at https://www.capsure.ucsf.edu/, you are accessing the secure site where you enter data for your site. This secure site is restricted by passwords to ensure the security of subject data. It is important that CaPSURE remain secure and that only authorized study personnel have access to the database. If you need to add new users, assign or change passwords, or delete users that are no longer involved with the CaPSURE study, you must contact UCSF.

b. In addition to unique user names and passwords, data on the site remains secure through several additional security features. All data that is passed to and from the secure site are encrypted. Additionally, the data resides on a physically secure server. All data are backed up daily in the event that data are lost.

2. Personal Identification Name and Password

Specified personnel at your office have been assigned a personal “log-on” user name and password in order to identify the person accessing the research database. It is important not to share the passwords with outside personnel. If your office would like another staff member to be able to enter data, please contact the CaPSURE office at the University of California, San Francisco with a request for an additional user name and password.

3. User Identification – Login History

Each time a user logs in, it is recorded in the system. To view how many times an individual user has logged on, click on “Site Mgmt” and “Security”, and then go to the Login History Summary. A list will be displayed which includes the user name, number of log-ins, and the date of the last log in.




4. Log Out Function

a. To further protect the site, we ask that you log off after you have completed entering data or if you need to leave your computer to attend to another matter. To log off, click on the button labeled “Log Out” in the upper right hand corner.

5. Auto Log Out Function

When your computer remains idle for over sixty minutes, it will automatically log you off. However, it is recommended that if you need to leave your computer that you log off yourself by clicking “Log Off” in the upper right hand corner of your screen.

B. Finding an Existing Patient

When you click on the “Date Entry” button and then the “Find Patient” tab you will go to the Find screen. From here you: Can locate a subject who is already enrolled to see what data has been entered, Begin data entry from a recent office visit, and View up to 100 subjects on one screen from your site in alphabetical order. Your site number and the main site physician’s name will appear at the top. A record count is displayed to the right of the physician name after you have entered your patient search.




a. Five data entry fields are listed to search for a patient. You may choose to enter data into only one field (such as patient name) to pull up the record on your patient.

b. You can type in the unique Patient ID number and then click the “Find” button. You must enter the site number with 2 digits, type a hyphen, and then the patient ID number with 5 digits

c. If you only know the subject’s last name, type that into the open field and the computer will search for all the subjects with that last name. If you only remember the first one or two letters of the last name, you can search by typing only those one or two letters, and the computer will list all subjects whose last name begins with those two letters.

d. If you click on “Find” with no information typed in any of the entry fields, the computer will list the first 100 subjects, alphabetically, and you can scroll down the list until you locate the name you want. This is not the most efficient way to search for a subject’s file, but it is a way for you to locate a subject with little information. Since it lists only the first 100 subjects, at this time, it is not a way to print your total patient enrollment list.

C. Patient Summary Page

Once you find and select the patient’s name, a Patient Summary page will open. This page can be printed for the physician to review with the patient or to send to a referring physician. The summary provides a brief overview of the patient’s status, visit/form dates and summary information, patient’s quality of life questionnaire response and links to enter NEW forms for that patient or to view/modify existing forms. Please refer to ‘Section V.B.2. Patient Summary Page’ for more information.

D. Deleting a Patient Form

If for any reason you need to delete a patient form, such as the form was double entered, click on the form and click the “Delete” button. A prompt will appear to




verify that you do in fact want to delete the form. Please be aware that once you have deleted a form it is impossible to undo the action.

E. Saving Data: “Submit”

a. Use the ‘Submit’ button - found at both the top and the bottom of the form - to save your data.

b. It is recommended that you always click the “Submit” button in these two cases to save your data: after a data entry form is complete, or if you must leave the computer for some other office matter and are not sure

how long you may be gone.

c. If you try to move to another form without saving what was just entered, you will see a prompt that reminds you about saving your data. However, if you leave the computer for too long, you may miss this kind of prompt, and your Internet session may close, causing the data you just entered to be lost.

d. NOTE: Get in the habit of always clicking the “Submit” button.

Because this program uses the Internet, your data entry, once saved, goes directly to a “server farm” that will securely store everything entered at your site. For this reason, this study does not require the user to insert a “back-up” disc before you close from the data entry session. All data once saved stays available whenever the user logs onto the CaPSURE site.

F. Tab Out of Form With ‘No Changes’

To exit a form without saving any changes, select any Form Tab, or the Patient Tab (to go to the Patient Summary page). A prompt will appear instructing that you will lose your changes. If there are no changes to save, select ‘OK’. If you do want to save changes, select ‘Cancel’ and save your data by selecting ‘Submit’.

G. Printing Capabilities

a. The laptop provided does not come with a printer. You will need to have someone connect the laptop to a printer in the office, and configure the laptop for that printer.




b. Some pages have a ‘Print’ button located at the top right of the form (e.g., Patient Summary Page). If available, select this button to print. After clicking on the print button, the page will reload with printable graphics, and open the browser’s Print window.

c. If there is no ‘Print’ button, use the “File” menu in the top gray toolbar and click on “Print” in the pull down menu. A screen will appear that allows you to choose how much of the form you wish to print. You can click on: as laid out on screen, only the selected frame, or all frames individually. Choose the one you want, and click “ok” button.

H. Shortcut Keys: Alternatives to Using the Mouse

1. HTML code

HTML code allows for movement across, but not up and down.

a. To SAVE CTRL + S

b. To PRINT CTRL + P

c. To complete a cell entry ENTER

d. To cancel a cell entry: ESC

e. To skip a cell: TAB

f. To complete a cell entry and move to the right: TAB or ENTER

g. To complete a cell entry and move to the left or to go back to the previous cell: SHIFT + TAB

h. To add or remove a √ in checkboxes: SPACE BAR

2. Option Buttons

a. Only one choice or option can be checked.

b. To select an option in a button (e.g., Yes, No):SPACE BAR

c. To move the selection between answer options, use or arrow keys.

3. Hyperlinks

a. Hyperlinks are identified by blue text and underline.

b. Example of hyperlinks are ICD-9; 0 1 2 3; Karnofsky scores; I-PSS

4. Pull-Down Menus

a. Pull-down menus ________________ are found on all forms and are used to select an answer instead of typing text into an open field.




b. Type in the first letter of your response to quickly select results, e.g., Imaging Test Results: N for Negative, A for Abnormal and P for Positive.

I. Public Site

There is a public CaPSURE website in the UCSF, Urology Department’s website http://urology.ucsf.edu/clinicalRes/CRuroOnc_gceps_capsure.html. The public site provides information about CaPSURE that can be accessed by any Internet user, including your patients who may want more information about the project. The site provides a description of the project, contact information about faculty involved, a list of publications, patient newsletters, information for urologists who would like to participate in CaPSURE or have access to the dataset, and information about the CaPSURE Scholar’s program.

Page 88 of 138 CaPSURE Observational Database Section VII. Graphs, Reports and Extract Files



SECTION VII. GRAPHS, REPORTS AND EXTRACT FILES

A. Patient Graphs

a. You have the option of creating graphs for individual patients or for your site.

b. To view patient graphs, click on the blue highlighted patient name under “Find.” After you have clicked on the name, look to right column for Patient Graphs.

c. Graphs can be viewed in different time increments by selecting a time frame from the pull down menu directly to the left of the screen.

d. There is also a pull down box to select to view other graphs. Graphs can be viewed for Serum PSA, Sexual, Urinary and Bowel Function, Physical Component Summary, Mental Component Summary, Satisfaction with Treatment, and Fear of Recurrence scales.

Patient NameSelect time frame here

Select here to view other graphs




B. Clinic Graphs

a. To view your patients’ data and compare them with the national data set, click on “Clinic Graphs”.

b. Select what data you want to view (Clinic only; National data only; or Clinic & National data) from the “Display” menu on the upper left corner of the screen.

c. Directly below this menu, you can click on which “Grouped Patient Analyses” you would like to view. Clicking on each selection will display all the graphs available under each section. For example, by clicking on Demographics, you have three choices: “Age at Initial Diagnosis”, “Insurance Type”, or “Ethnicity.” Select the graph that you wish to view and it will be displayed.

d. You also have the option of viewing data on all patients or a subset of patients. You will see four buttons directly above the graphs, which allow you to select the criteria of the population you would like to view. Options include Ethnicity, Gleason score, TNM stage, or Age at diagnosis. Each time criteria is changed the graph will automatically update.

e. To print a graph or a screen, select File, then Print. You must then select one of the following print options: As laid out on screen, only the selected frame, or all frames individually.

Select your clinic or national data, or both

Select Grouped Patient Analyses

Select subset by criteria




C. Research

1. Data Extract Tab

a. You have the ability to download patient data from your individual site. In order to create data extract reports, click on the tab labeled “Research”, then click on the tab labeled “Data Extract”, and finally click on the button NEW.

b. You can search for all patients or narrow the search for patients with a particular PSA, age, treatment, etc.

c. Label your search in “Query Name”. To clear the search and begin a new one, click “Cancel”. To save the search, click “Save”.

Select for a new query

Define your search criteria

Label your query

Once you have selected all your criteria, click “Save”




d. After the data extract query has completed running, this screen will appear. You have three options. You can Download, Archive, or Delete. Under Status, you may see “Waiting…” or “Running…”—this means that your data query is still running and may take a few minutes to be completed.

e. To download the data extract, click on Download. Another window will appear. Follow instructions and data will be displayed in an Excel table.

f. The data can be downloaded to Excel or you can choose to leave it on the website.

Click here first to download your data.

This screen will appear after you have selected Download. Follow directions to display file.




2. Reports Tab: Study Status Report for Your Site

a. To create a list or a count of all your patients and their study status, click on “Research”. When you see the next screen, click on “Reports.”

b. Type in a title for your report under “Report Name.” For example, “Study Status Report 9/19/00.”

c. Select from a report of Enrollment, simple count and column % or Enrollment, ID list of subject by name.

d. Select whether you would like the report generated using Phase I subjects, Phase I and Phase II, or Phase II subjects. Phase I subjects include all patients enrolled from May 1995 through October 1997. Phase II subjects include all patients enrolled between February 1999 and the present.

e. Select your site number and name for a list of patients from your site only.

f. Once you have selected the type of report you would like to run, press the button labeled “Save”. Your report will appear on the screen. If you would like to print the report, select File and then Print. To return to the previous screen, press the Back button. All previously generated reports will be catalogued on the “Report” page. You have the option to View, Delete, or Archive previously generated reports.




3. Reports Tab: Generating a Count of Patients’ Ethnicity

a. To generate a count of your patients’ reported ethnicity, follow the instructions from Section B above for Study Status Report.

b. Select report type from a report of Ethnicity, simple count and column %.

c. Select your site number and name for a count of patients from your site only, or select all sites for a count of all patients enrolled in the study.

4. Reports Tab: Archive

Your saved (or archived) queries will appear on the Archive screen. These saved queries are a ‘snap shot’ of the data from the time created (Date Created). In order to view updated information, you must create a new query. Refer to C.1. Data Extract Tab for instructions on creating a new query.

D. Site Management

1. Quality of Life Response Rate

a. The Questionnaire Response Report details the percentage of patients who return questionnaires. To access this report, click on “Site Mgmt” and “QoL”.

b. Using the pull-down menus, select which Phase to view (e.g., Phase 21 – Jan.’02, Phase 22 - July ‘02), to show numbers or percentages, and patient status (all patients, questionnaire only or full participant).

c. Once you have selected the criteria, click “Update.” A report will be displayed.




2. Enrollment: New Enrollment Report

a. This report details how many patients you have enrolled in the study. To access this report, click on “Site Mgmt”, “Enrollment”, and “New Patients.”

b. Choose to search by year and by quarter. Once your search criteria are selected, click “Update Report.” A summary report will be provided and can be printed.

c. If you want a more detailed report with the patient names, ID’s, medical record numbers and enrollment dates, click on the highlighted numbers under the Year.

d. The report can be printed by selecting the “Print” button on the top right of the screen.

3. Enrollment: Status Change Report

a. The Status Change Report lists any patient with a status change by phase. The report includes patient ID number, date status was changed, status, and reason for change.

Select which phase to view.

Select numbers or percentages.

Select all patients, quest. only or full participant

Select year; select to show by year or by quarter.

Click here for a more detailed report of year.

Click here to print the report.




b. To access this report, click on “Site Mgmt”, “Enrollment”, and “Status Change.”

c. You can search all patients by phase. Once you have selected which phase you would like to view, click “Run Report”. A report will be provided and can be printed.

d. The report can be printed by selecting the “Print” button on the top right of the screen.

4. Enrollment: Decline Patients Report

a. The Decline Patients Report lists patients who have declined to participate in the study. To access this report, click on “Site Mgmt”, “Enrollment”, and “Decline”.

b. A list will appear with subject ID, creation date, created by and reason the patient declined to participate.

c. Click on the blue underlined Decline ID number to go to the Decline Form for the individual subject.

5. Enrollment: Deleted Patients Report

a. The Deleted Patients Report lists patients at your site that have been deleted from the database. Patients are typically deleted if it was determined they are

Click here to print the report.

Click here to go to the Decline Form for this subject.




in violation of inclusion/exclusion criteria or if they were assigned an ID number without consenting to participate.

b. To access a list of deleted patients, click on “Site Mgmt”, “Enrollment”, and “Deleted”. A list for your site will appear with patient ID and reason patient was deleted from the study. This summary also displays when the patient was deleted and by whom.




E. Site Statistics Reports

The Site Statistics tab includes four new features: New Patient Abstraction report, Data Activity Report, Clinical Visit Scheduling, and HIPAA Compliance report. To access the New Patient Abstraction report, click on the “Data Entry” button, and then move your mouse pointer to the “Site Statistics” tab.

A menu will pop up over “Site Statistics,” with four new options. Click on “Abstraction.”

1. New Patient Abstraction Detail Report

a. Abstraction for a new patient is discussed in “Section IV. Abstracting and Entering Data: New Research Subject”. This report allows the research coordinator to quickly see the status of new patients’ abstraction process on one screen.

b. This report focuses on Phase II patient abstraction only. Phase II includes all patients enrolled since February 1999. All subjects are included in this report irrespective of active or inactive study status.

c. Each patient is listed by his CaPSURE Patient ID, as assigned when the registration form was completed. The required clinical abstraction items include:

Item Description (Location)

Registration Registration form

Consent Consent form received by UCSF

HIPAA HIPAA Authorization form received by UCSF

Clinic Visit Clinical Visit form

PSA at Dx PSA taken within 270 days before positive biopsy

TRUS Transrectal Ultrasound (Labs & Imaging form)

Biopsy Prostate Biopsy Pathology form

Staging TNM staging (Prostate Biopsy Pathology form)

DRE Prostate Biopsy Pathology form

Treatment Treatment 270 days post positive biopsy; Surgeries and Treatments form/Medication form




d. Patients who have all of the clinical abstraction forms completed have a green square in the ‘Complete’ column. Those who are missing a form have a red square and red dash marks (--) in the column(s) that are missing information.

e. If a category has been completed, either the date of the event or a green ‘X’ value is displayed. The Consent Form column displays an ‘X’ value for ‘Yes’ because it is based on whether a consent form has been received at UCSF, rather than the Date of Consent. The HIPAA Form column may also contain an ‘OK.’ This means that the patient was consented before April 14, 2003 and does not require a HIPAA form. See this section, #5. “HIPAA Compliance Report” for more information.

f. The third column is for Notes. Notes can be added for each patient using the ‘Add’ link. When missing information is addressed/resolved with notes, a Notes Caption “N/A” will appear.

Notes link: Add notes or View existing notes

Totals

Color coding: Red square = incomplete; Green square = complete




g. Totals are displayed at the bottom of the page. The first row of the “Completed” section shows the number of completed forms in each category. The second row shows the number of completed forms as a percentage of the number of registered patients in each category.

h. This report can be printed. The Print button is located in the title bar, at the top upper- right corner of the report. After clicking on the print button, the page will reload with printable graphics, and open a Print window, where user’s individual preferences can be selected.

2. Patient Abstraction Notes Screen

a. From the “New Patient Abstraction Details” report, notes can be added to a patient’s record to explain why a data element is missing from the electronic research chart. To enter notes, click on the ‘Add’ link in the Notes column.

b. If the PSA at diagnosis, TRUS, Biopsy, Staging, DRE, or Treatment form cannot be obtained for a patient or is otherwise irrelevant to that patient’s abstraction. After completing the Notes form, click the ‘Submit’ button in the upper right side of the title bar. If no changes are made, click the ‘Back’ button. Both actions will return you to the Abstraction Details report.

c. On the Abstraction Details report, forms that were checked on the notes screen will display as ‘OK’, and will be considered complete. After notes have been entered for a particular patient, the Notes link will change from ‘Add’ to ‘View’.

d. Notes previously entered are displayed at the bottom of the notes screen in reverse chronological order.




3. Data Activity Report

Continuing patients are expected to have a clinical visit and a PSA test at least annually. This report displays patients' most recent Clinic Visit date and most recent PSA date. Dates within the last 12 months are displayed in green, and dates more than 12 months ago are displayed in red. Patients with a status of 'Full Participation' (F) or 'Clinical Only' (C) are included in this summary.

Patients identified as greater than 18 months delinquent for a clinic visit need to be prioritized and their continued attendance at your practice should be verified.

a. To access the Data Activity Report, click on the “Data Entry” button, then move your mouse pointer to the “Site Statistics” tab, and select “Visit/PSA Data” from the pop-up menu.

b. When the display option of “All” is chosen, the “Last Visit Date” and “Last PSA Date” are displayed for all of a site’s Full Participation and Clinical Only patients. If the date falls within the last year, it is displayed in green.

Explanation Box

Close/ Back Button

Submit Button




Otherwise, the date is displayed in red. “None” is displayed if no visit or PSA records exist.

c. When the display option of ‘Delinquent Visit’ is chosen, only the patients who do not have a clinical visit reported within the last year are displayed. The count of these ‘delinquent’ records is displayed at the bottom of the report.

d. When the display option of ‘Delinquent PSA’ is chosen, only the patients who do not have a PSA value reported within the last year are displayed. The count of these ‘delinquent’ records is displayed at the bottom of the report.

e. When the display option of ‘Visit/PSA >19 or more months is chosen, only the patients who do not have either a PSA value OR a clinic visit reported within the last year are displayed. The count of these ‘delinquent’ records is displayed at the bottom of the report.

a. As of 2011 there are three pull down options for time:

i. 19-24 months

ii. 25-36 months

iii. > 36 months

Display Option

Sort Function

Print button

Add or view ‘notes’

Status: F = full participation or C = Clinical Only




View of the Data Activity Report with ‘Visit/PSA >18months’ selected; only patients who have not had a PSA or clinic visit reported in the last 18 months will be displayed in this view

e. Notes can be added to a patient’s record to explain why a data element is missing from the electronic research chart. To enter notes, click on the ‘Add’ link in the ‘Notes’ column.

f. The data can be sorted by clicking on a column header (e.g., Patient ID, Name or Last Visit Date).

g. The number of forms completed within the last year is displayed at the bottom of the page.

h. This report can be printed. The Print button is located in the title bar, at the top upper- right corner of the report. After clicking on the print button, the page will reload with printable graphics, and open the browser’s Print window.

4. Monthly Clinic Visit Schedule

a. The Monthly Clinic Visit Schedule provides a listing of all patients that have been scheduled to return for an office visit during the month chosen. The listing is based on the return dates selected on the patients’ ‘Clinical Visit’ forms. Patients for whom a visit date is either unscheduled or has elapsed can be viewed by selecting the ‘View Unscheduled’ option.

b. Using the ‘View Unscheduled’ option, the month and year of a patient’s

expected return date can be entered. After entering the dates, click on the ‘Submit’ button at the top of the page.




5. HIPAA Compliance Report

a. About HIPAA

As of April 14, 2003, all human subjects’ researchers must be in compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule. For more information on HIPAA, move your mouse pointer over the question mark, located in the upper-right corner of the CaPSURE™ website. Click on “HIPAA Reference” from the pop-up menu that appears.

Print button

Last visit date

Phone number




A new “HIPAA Reference” window will pop-up. Navigate through the sections to find the information that you are looking for.

b. Accessing and Using the HIPAA Compliance Report

From the original CaPSURE.net screen, click on “Data Entry.” Move your mouse pointer to “Site Statistics,” and click on “HIPAA Compliance” in the pop-up menu that appears.




The HIPAA Compliance report can be used to identify patients who are pending HIPAA and/or consent (not yet received by UCSF).

The legend at the bottom of the screen indicates the symbols for the status of each

HIPAA or Consent form. Most patients will have either a green ‘X’ (form received, patient compliant) or red dash marks (--) (form not received by UCSF, patient non-compliant). Patients who were enrolled into the study before April 14, 2003 are considered “Grandfathered in” and do not require a HIPAA form (OK).

UCSF will change to Decline any non-compliant patients. This is defined as patients

who are pending a HIPAA or consent form for greater than 30 days from date of consent. All clinical and patient-reported data received for non-compliant patients will be deleted. Before Declining, UCSF will send a reminder e-mail to the site with a link to the above report. Please see SectionII.G “Email Request for HIPAA Consent Forms” for more information.

Click to Add notes to patient record for UCSF to view.

Total # of non-compliant patients

Legend to table




Use the “Notes” Column of the report to communicate any special circumstances to

UCSF. Click on “add” to use this feature. The following window opens:

Enter information for UCSF to view

Prior notes can be read here also.

Click to submit for UCSF staff to view.

Page 107 of 138 CaPSURE Observational Database Section VIII. ‘Where Does Data Go?’



SECTION VIII. ’WHERE DOES DATA GO?’: WHERE TO REPORT YOUR DATA

The following is a list in alphabetic order of the most common tests, procedures, medications, treatments, status changes, diagnoses, etc. with instruction regarding in which ‘form’ the information is to be reported.

Abarelix (Plenaxis) Medications Form

Acute problem Clinic Visit Form

Aminoglutethimide Medications Form

Anandron Medications Form

Aneurysm resection Surgeries and Treatment Form

Antiandrogens Medications Form

Artificial urinary sphincter repair Surgeries and Treatment Form

Biopsy Prostate Biopsy Pathology Form

Biopsy to evaluate disease recurrence Prostate Biopsy Pathology Form

Bladder irrigation/installation of antineoplastic agent (BCG)

Medications Form and Clinic Visit Form (procedures section)

Bladder neck contracture Surgeries and Treatment Form

Blood Chemistry Panel Labs and Imaging Form

Blood tests Labs and Imaging Form

Bone scan Labs and Imaging Form

Brachytherapy Surgeries and Treatment Form

Casodex Medications Form

Catheter placement Clinic Visit Form

Catheter removal Clinic Visit Form

Caverject Erectile Dysfunction Form

CBC Labs and Imaging Form Clinical stage of disease Prostate Biopsy Pathology Form

Clinical trial completion/termination Clinical Trial Form

Clinical trial participation Clinical Trial Form

Clonidine Medications Form

Collagen injection (Contigen implant) Medications Form and Clinic Visit Form (procedures section)

Collect clinical information only Status Summary Form

Collect patient questionnaire only Status Summary Form

Coronary artery bypass graph (CABG) Surgeries and Treatment Form

Corticosteroids Medications Form

Cryoablation Surgeries and Treatment Form

Cryosurgery Surgeries and Treatment Form




CT Labs and Imaging Form

Cystoscopy Clinic Visit Form and Labs and Imaging Form

Cystoscopy Labs and Imaging Form

Death of patient, Death Form Status Summary Form

Decline form Decline Summary

Decline patients Decline Summary

Degarelix (FIRMAGON®) Medications Form

DES Medications Form

Diagnostic biopsy result Prostate Biopsy Pathology Form

Digital Rectal Exam (DRE) Clinic Visit Form and Prostate Biopsy Pathology Form

Dilation Clinic Visit Form

Dip stick/blood Labs and Imaging Form

Edex Erectile Dysfunction Form

Emcyt Medications Form

Erectile dysfunction (ED) Erectile Dysfunction Form

Erectile dysfunction (ED) medications Erectile Dysfunction Form

Erectile dysfunction counseling Erectile Dysfunction Form

Erectile dysfunction management Erectile Dysfunction Form

Eulexin Medications Form

Free PSA Labs and Imaging Form

Gleason score – Biopsy results Prostate Biopsy Pathology Form

Hematology Labs and Imaging Form

Histrelin (Vantas) Medications Form

Hormonal therapy Medications Form Hormone injection at office (new or

changed) Medications Form and Clinic Visit Form

Hormone injection at office (no change) Clinic Visit Form

Hormone Refractory and Related Antineoplastic therapies

Medications Form

Hot flashes treatment Medications Form

ICD-9 diagnosis code Clinic Visit Form

Imaging tests Labs and Imaging Form

Initial positive biopsy Prostate Biopsy Pathology Form

Initial treatment Surgeries and Treatment Form

Intravenous pyleogram Labs and Imaging Form

I-PSS Clinic Visit Form




Karnofsky Clinic Visit Form

Latest clinical visit date Patient Summary Form

Latest hospitalization date Patient Summary Form

Latest lab PSA date Patient Summary Form

LHRH Agonists/Antagonists Medications Form

Lupron Medications Form

Lymphadenectomy Surgeries and Treatment Form

Megace Medications Form

Megace Medications Form

Metastron Medications Form

MRI Labs and Imaging Form

MUSE Erectile Dysfunction Form

New diagnoses, not related to prostate cancer

Clinic Visit Form

New diagnoses, related to prostate cancer

Clinic Visit Form

Nizoral Medications Form

No progression of disease Clinic Visit Form

No recurrence of disease Clinic Visit Form

Novantrone Medications Form

Office visit Clinic Visit Form

Orchiectomy Surgeries and Treatment Form

PAP Labs and Imaging Form

Pathologic N Stage Surgeries and Treatment Form: Lymphadenectomy

Pathologic T Stage Surgeries and Treatment Form: Radical Prostatectomy

Patient contact information Registration Form

Patient death, Death Form Status Summary Form

Patient mailing address Registration Form

Patient moving to another practice/no longer patient of study physician

Status Summary Form

Patient phone number Registration Form

Patient registration information Registration Form

Patient study status change/reason Status Summary Form

Patient withdrawal from study Status Summary Form

Penile implant Erectile Dysfunction Form

Post-op visit Clinic Visit Form: Type of Visit




Pre-op visit Clinic Visit Form: Type of Visit

Pre-operative hormone therapy Surgeries and Treatment Form

ProstaScint Labs and Imaging Form

PSA manufacturer Labs and Imaging Form/Multiple PSA Form

PSA post treatment Labs and Imaging Form/Multiple PSA Form

PSA value at time of diagnosis Labs and Imaging Form/Multiple PSA Form

Radiation treatment Surgeries and Treatment Form

Radical prostatectomy Surgeries and Treatment Form

Recruitment visit Clinic Visit Form

Recurrence/progression of disease Clinic Visit Form and Prostate Biopsy Pathology Form

Rising PSA Clinic Visit Form and Labs and Imaging Form or Clinic Visit Form and Multiple PSA Form

Schedule next visit Clinic Visit Form: Schedule Next Visit

Stable condition post therapy Clinic Visit Form

Staging for tumor, node and metastases Prostate Biopsy Pathology Form

Study status Status Summary Form

Surgical therapies Surgeries and Treatment Form

Symptoms, symptom complaints Clinic Visit Form

Testosterone Labs and Imaging Form

TNM staging Prostate Biopsy Pathology Form

Transrectal ultrasound Labs and Imaging Form Transurethral resection of the prostate Prostate Biopsy Pathology Form

Treatment related to prostate cancer Surgeries and Treatment Form

Treatment unrelated to prostate cancer Surgeries and Treatment Form

Triptorelin pamoate (Trelstar) Medications Form

TRUS Labs and Imaging Form

TRUS results from initial positive biopsy Labs and Imaging Form

Tumor staging Prostate Biopsy Pathology Form

TURP Prostate Biopsy Pathology Form

Ultrasound Labs and Imaging Form

Urinalysis Labs and Imaging Form

Urine culture Labs and Imaging Form

Urine cytology Labs and Imaging Form

Urine tests Labs and Imaging Form




Uroflow Clinic Visit Form and Labs and Imaging Form

Uroflow Labs and Imaging Form

Vacuum device Erectile Dysfunction Form

Velban Medications Form

Viadur Medications Form

Viagra Erectile Dysfunction Form

Watchful waiting Surgeries and Treatment Form

Withdrawal of patient from study Status Summary Form

X-ray Labs and Imaging Form

Yohimbine Erectile Dysfunction Form

Zoladex Medications Form

Page 112 of 138 CaPSURE Observational Database Appendices Page A-112



SECTION IX. APPENDICES

A. Site ID Number for Participating Clinical Investigators

The table below reports the SITE ID and Clinical Investigator for each core CaPSURE™ research site.

Site Number and Name

Site Number and Name

01 Carroll UCSF-Mount Zion Cancer Center, San Francisco, CA

25 Ray (Inactive) Cook County Hospital, Chicago, IL

02 Cochran (Inactive) Urology Clinics of North Texas, Dallas, TX

26 Noyes (Inactive) Berkshire Physicians & Surgeons, Pittsfield, MA

03 Cooperberg VA Medical Center, San Francisco, CA

27 Mostafavi (Inactive) Urology Group of W. New England, Springfield, MA

04 Finnerty (Inactive) PAPP Clinic, Newnan, GA

28 Keeler, III (Inactive) Center for Urologic Care, Haddon Heights, NJ

05 Forrest (Inactive) Urologic Specialists of Oklahoma, Tulsa, OK

29 Gottesman (Inactive) Seattle Urological, Seattle, WA

06 Kramolowsky The Virginia Urology Center, Richmond, VA

30 Tolia (Inactive) Assoc. Adv. Adult & Pediatric Urology, Bronx, NY

07 Cohen (Inactive) Urology Associates of West Broward, Sunrise, FL

31 Daily (Inactive) Mississippi Urology, Jackson, MI

08 Sieber Urological Associates of Lancaster, Lancaster, PA

32 Katz (Inactive) Medical College of Virginia, Richmond, VA

09 Schmied (Inactive) Metro Urology, Jeffersonville, IN

33 Katz (Inactive) Veterans Administration, Richmond, VA

10 Young (Inactive) S. Coast Urological Medical Group, Laguna Hills, CA

34 Wells (Inactive) Alabama Urology Associates, Birmingham, AL

11 Brosman (Inactive) Urology Associates, Santa Monica, CA

35 Kahnoski Michigan Medical, P.C., Grand Rapids, MI

12 Conrad (Inactive) Memphis Urology Specialists, Memphis, TN

36 Childs (Inactive) Cheyenne Urology, Cheyenne, WY

13 Chee-Awai (Inactive) Urologic Institute of New Orleans, Gretna, LA

37 Tomera (Inactive) Alaska Urological Associates, Anchorage, AK

14 Flanagan (Inactive) Urology Specialists, Waterbury, CT

38 Freedman (Inactive) Sheldon J. Freedman, M.D., Ltd., Las Vegas, NV

15 Cohen Triangle Urological Group, Pittsburgh, PA

39 Clark (Inactive) North Idaho Urology, Coeur D’Alene, ID

16 Sharkey (Inactive) Urology Health Center, New Port Richey, FL

40 Lin (Inactive) VA Puget Sound/University of WA, Seattle, WA

17 Not used. 41 Austenfeld (Inactive) Kansan City Urology Care, Kansas City, MO

18 Not used. 42 Lanctin Adult & Pediatric Urology, St. Cloud, MN

19 Coleman (Inactive) Bay Urology Services, Mobile, AL

43 Thrasher (Inactive) University of Kansas, Kansas City, KS

20 Not used.

44 Bowyer (Inactive) Twin Falls Clinic & Hospital, Twin Falls, ID

21 Hudnall (Inactive) Urology San Antonio, San Antonio, TX

45 Karsh The Urology Center of Colorado (TUCC), Denver, CO

22 Not used. 46 Concepcion Urology Associates, P.C., Nashville, TN

23 Silbar (Inactive) Clinic of Urology, S.C., Milwaukee, WI

47 Tutrone Chesapeake Urology Associates, PA , Towson, MD

24 Brunk (Inactive) Central Indiana Urology, Indianapolis, IN

o Indicates active sites

Page 113 of 138 CaPSURE Observational Database Appendices Page B-113



B. CaPSURE™ Quick Reference Guide for Recruiting Subjects

Study Purpose: The purpose of this study is to learn more about how prostate cancer affects the patient’s life and the type of health care needed. More specifically, the study will:

Determine which treatments result in the best clinical outcomes for the patient

Describe which factors affect patient quality of life Identify patterns of clinical care Identify what health care services are used by this group Describe costs associated with the treatment of prostate

cancer and effects on work productivity. Information is collected from a large group of men from diverse practice settings. More specifically we collect the following information: The urologist reports all office visits The patient completes a questionnaire at enrollment and

annually in January of each year. The UCSF research project team requests hospital

audits and official death certificates when appropriate. Who CAN be in the study? Persons who can be a part of the study include patients whom:

Are male

Have prostate cancer diagnosis confirmed by biopsy

Are newly diagnosed (6 months or less from date of initial positive biopsy)

Preferably before the start of any definitive treatment

Can read and understand English or Spanish Who CANNOT be in this study? Persons who cannot be in this study include patients whom:

Do not have prostate cancer

Are seeing the participating physician for a second opinion only

Do not want to be in the study Who should ask patients to be in the study and how do you explain it?

Develop a system for identifying eligible study patients. For example, look every day to see who is eligible from the patient appointment log

The urologist or onsite research coordinator may choose to approach the patient about participating

Approach the patient to be in the study during their regular office visit, or use “Dear Patient” letter

Talk about the study purpose to the patient.

Review the specific information contained on the patient informed consent

What if the patient says NO? We understand that some patients, for a number of reasons, may not wish to participate. We would still like to know some basic information about all patients who could be in the study but choose not to. Fill out the patient Decline Form. This form asks for

some basic information about their background and their reasons for choosing not to participate in the study.

If patient is interested in being a study participant: 1) Obtain patient Informed Consent and HIPAA

authorization:

Patient reads, signs and dates Consent and HIPAA

Study coordinator or physician signs as witness

Patient returns signed forms to the study coordinator

Return the white Consent: Study coordinator separates the form and:

Sends white copy to UCSF Files yellow copy in patient chart Gives pink copy to the patient (remind patient

that this is their copy to keep) HIPAA: The site may choose to have the patient

sign three copies, or sign one copy and then make copies of the signed document. Forms are dispositioned with the Informed Consent.

2) Patient Packet (take-home materials):

Give the patient the materials to take home, complete and send back to UCSF. The patient packet includes:

An invitation letter from UCSF explaining the study

A Phase 0 - Baseline questionnaire

Point out Release of Medical Information form on back of Phase 0. DO NOT TEAR OFF; patient can fill it out when he completes questionnaire. Explain that UCSF staff will use this form only as indicated. *It is preferable that the patient sign this form but a decision not to sign this medical release form will not preclude them from participating in the study.

A third class business reply envelope to send the questionnaire back to UCSF.

3) Registration Form:

Complete all of the necessary information on the Registration Form. More detailed instruction is included in the abstracting manual.

4) Other Clinical Forms:

At enrollment, report information about patient’s initial diagnosis, staging and treatment (if available). Use scannable clinic visit form(s), a prostate biopsy/treatment form, and lab/imaging form (review back of scannable clinic visit form for commonly reported labs and medications; you may need to fill out only one form).

Make a copy of ‘source’ documents to send to UCSF with data collection forms including positive biopsy pathology report, staging imaging (positive only) and treatment (surgical pathology report, radiation treatment notes, etc.).

Page 114 of 138 CaPSURE Observational Database Appendices Page B-114



Enter new patient into the database and assign study ID number. Data enter any non-scannable forms and send all (including not yet entered scannable) to the UCSF research project team by FedEx.

Use 3-day express saver for FedEx to forward all completed forms to UCSF. Airbills are provided by UCSF.

What needs to be done on the RETURN visit?

Clinic Visit Form and any other relevant Forms:

There are no mandated visits or a set frequency of visits.

Complete a scannable Clinic Visit Form each time a patient returns to the office for regularly scheduled visits. Information about laboratory tests, imaging, medications and treatments should be recorded on the appropriate form (review back of scannable clinic visit form for commonly reported labs and medications; you may need to fill out only one form).

Make a copy of ‘source’ documents to send to UCSF with data collection forms including positive biopsy pathology report, staging imaging (positive only) and treatment (surgical pathology report, radiation treatment notes, etc.).

Use 3-day express saver for FedEx to forward all completed forms to UCSF. Airbills are provided by UCSF.

What do I do if I have questions about the research project, filling out the forms or technical issues (e.g., logging on)?

A member of our research project team will gladly answer any questions that may arise. Staff are available during normal business hours (8:00 a.m. to 5:00 p.m., Pacific Time);

o Jenny Broering, RN, MS, MPH — Project Director, CaPSURE™ Data Quality Assurance

o Ali Zargham – Analyst IV/Supervisor

o Ada Sanchez – Analyst II

o Tatyana Noller – Analyst I

o Alex Ignatove – Analyst I If you call outside of business hours, please leave a message and a research project team member will return your call.

Our contact information is:

University of California, San Francisco Department of Urology

3333 California Street, Suite 282 San Francisco, CA 94118-1944

1 (415) 514-0210 - FAX 1 (800) 526-4433 - Toll Free

The CaPSURE™ web site address is: https://www.capsure.ucsf.edu/

Page 115 of 138 CaPSURE Observational Database Appendices Page C-1



C. CaPSURE™ Definitions of Patient Study Status

1. Defining Subject Study Status

The subjects’ study status is an indicator of patients’ current level of participation in the CaPSURE™ Database. This information is used to track subjects to learn if they are still participating in the study and determine the amount and type of information available for use with analyses such as benchmarking.

2. Active Status

a. ONGOING OR FULL PARTICIPANT: Used for both new patients who agree to participate in the study and continuing patients from phase I (1995-97 enrollment period) who have returned a signed informed consent. They will receive a questionnaire at the designated time (June and January of each year until the termination of the study). Subjects who are full participants are contributing patient and clinical data to the CaPSURE™ database.

b. CLINICAL ONLY: Used when a study participant (either verbally or by mail) requests to be removed from the “full participation” study status but has agreed to allow clinical information to be collected. Reasons for change in status may be when a study participant (or their relative) asks to be removed from the study because he is too sick to complete a questionnaire.

c. QUESTIONNAIRE ONLY: Used when a study participant is no longer visiting the CaPSURE site, but agrees to continue completing the questionnaire at the designated time (June and January of each year). They may also have hospital audits and death certificate entered into the database.

3. Inactive Status

a. WITHDRAWN: Used when a "Full participant” asks to be removed entirely from the study (either verbally or by mail).

Note that such a request for withdrawn status should be followed by an attempt to obtain permission for continued abstraction of clinical data.

b. LOST (TO FOLLOW-UP) (LTF): Used for patients who cannot be located or traced by both the UCSF project team and the clinical staff at the participating urologist’s office. The participant will receive no further study materials. This code can only be used for participants that have returned at least one questionnaire.

c. DECEASED: Used when a) a study participant has died, or b) when a person who agreed to join the study died before completing his/her first questionnaire.

Page 116 of 138 CaPSURE Observational Database Appendices Page D-116



D. TNM Staging Guidelines: Understanding the TNM Classification System & its Application

1. Why TNM?

a. Clinical classification - pretreatment - is the basis for treatment choice. b. Pathologic classification is the basis for prognostic assessment i.e.,

epidemiological end surveillance for survival analysis.

2. General Rules of the TNM System

a. The TNM system for describing the anatomic extent of disease is based on the assessment of three components:

T The extent of the primary tumor N The absence or presence and extent of regional lymph node

metastasis M The absence or presence and extent of distant metastasis

b. The addition of numbers to these three components indicates the extent of

malignant disease, thus showing progressive increase in tumor size or involvement:

T0, T1, T2, T3, T4 N0, N1, N2, N3 M0, M1

a. In the CaPSURETM study for the tumor classification, all cases should be

confirmed microscopically. Any cases not confirmed must be reported separately using the following descriptors:

TX Primary tumor cannot be assessed NX Regional lymph node cannot be assessed MX Presence of distant metastasis cannot be assessed

3. Four Classifications of TNM

a. Pre-treatment designated as TNM or cTNM - Clinical Classification

Clinical classification is based on evidence acquired before primary treatment. Such evidence arises from: Physical examination (i.e., digital rectal exam [DRE]); Imaging (bone scan, CT scan or MRI); Biopsy (transrectal biopsy); and Other relevant findings

(i.e., laboratory tests such as serum prostate-specific antigen testing [PSA]).




In other words, all information available prior to first definitive treatment is used.

b. Post-surgical histopathological designated pTNM - Pathologic Classification

Pathologic staging is based on evidence acquired before treatment, supplemented or modified by the additional evidence acquired from surgery and from pathologic examination.

pT entails a resection of the primary tumor or biopsy adequate to evaluate the highest pT category.

pN entails removal of the regional lymph nodes adequate to evaluate the absence of (pN0) regional lymph node metastasis and sufficient to evaluate the highest pN category.

pM implies microscopic examination of distant lesions.

c. Retreatment Classification designated rTNM

Retreatment classification is used after a disease-free interval and when further definitive treatment is planned. All information at the time of retreatment should be used in determining the stage of the recurrent tumor (rTNM). Biopsy confirmation of the tumor is required.

d. Autopsy Classification designated aTNM If classification of a cancer is done after the death of a patient and a postmortem examination has been done, all pathologic information should be used. This classification does not apply in the CaPSURETM study.

4. Grouping the TNM

a. After assigning T, N, and M and/or pT, pN, and pM categories, these may be grouped into stages. The TNM staging and stage grouping, once established, must remain unchanged in the medical records. The clinical stage is essential to select and evaluate therapy, and the pathologic stage provides the most precise data to estimate prognosis and calculate end results.

b. If there is doubt concerning the correct T, N, and M category to which a

particular case is allotted, then the lower (less advanced) category is chosen. This will also be reflected in the stage grouping.

c. Definitions of TNM categories and stage grouping may be telescoped or

expanded for clinical or research purposes as long as basic definitions as recommended are not changed. For instance, any T, N, or M can be divided into subgroups.




5. References

a. AJCC Cancer Staging Manual. Fleming ID, Cooper JS, Henson DE, Hutter RVP, Kennedy BJ, Murphy GP, O’Sullivan B, Sobin LH, Yarbro JW (eds). J.B. Lippincott – Raven Publishers. Philadelphia, PA. 1997; 5th Edition.

b. AJCC Cancer Staging Manual. Greene FL, Page DL, Fleming, ID, Fritz AG, Balch CM, Haller DG, Morrow M (eds). Lippincott Raven Publishers. Philadelphia, PA. 2002; 6th Edition.

c. American Joint Committee on Cancer web site for information on TNM staging: www.cancerstaging.org.

d. TNM Supplement 1993. A commentary on uniform use. Hermanek P, Henson DE, Hutter RVP, Sobin LH, Eds. Springer-Verlag Berlin. Heidelberg, Germany. 1993.

Page 119 of 138 CaPSURE Observational Database Appendices Page E-119



E. Comparison of Staging Classifications for Prostate Cancer

1. Please remember to fill in all three parameters: Tumor, Node, and Metastases. Use the designation of Tx, Nx or Mx when any of these parameters cannot be assessed.

2. Be as specific as possible about the cancer substage (e.g., ‘M1a’ rather than just ‘M1’).

3. In some cases you may be unable to specify the substage because you do not have enough information. In this case, then you may simply fill in the stage - e.g., with T3 lesions the pathology report may not state whether the extracapsular extension is unilateral/ bilateral (T3a) or seminal vesicle invasion (T3b).

TNM

2002 NONPALPABLE CANCER

Primary Tumor cannot be assessed Tx No evidence of primary tumor T0 ≤ 5% of TURP tissue T1a > 5% of TURP tissue T1b Cancer detected by biopsy (e.g., because of elevated PSA) T1c

PALPABLE OR VISIBLE CANCER CLINICALLY CONFINED WITHIN THE CAPSULE

Tumor confined with prostate (tumor found in one or both lobes by needle biopsy, but not palpable or reliably visible by imaging, is classified as T1c)

T2

Unilateral, one-half of one lobe or less T2a Unilateral, involving more than one-half of lobe but not both lobes T2b Bilateral disease – tumor involves both lobes T2c

CANCER WITH LOCAL EXTRACAPSULAR EXTENSION Tumor extends through the prostate capsule (invasion into the prostatic apex or into – but not beyond – the prostatic capsule is classified not as T3, but as T2)

T3

Extracapsular extension (unilateral or bilateral) T3a Tumor invades seminal vesicle(s) T3b Tumor is fixed or invades adjacent structures other than seminal vesicles: bladder neck, external sphincter, rectum, levator muscles and/or pelvic wall

T4

METASTATIC CANCER Regional lymph nodes cannot be assessed Nx No regional lymph node metastasis N0 Metastasis in regional lymph node or nodes N1

Page 120 of 138 CaPSURE Observational Database Appendices Page E-120



DISTANT METASTASIS Distant metastasis cannot be assessed Mx No distant metastasis M0 Distant metastasis M1

Nonregional lymph node(s) M1a Bone(s) M1b Other site(s) M1c

a. Manual for the staging of cancer. Beahrs OH, Henson DE, Hutter RVP, and

Kennedy BJ (eds). Philadelphia: J.B. Lippincott Company; 1992; Fourth Edition.

b. AJCC Cancer Staging Manual. Fleming ID, Cooper JS, Henson DE, Hutter RVP, Kennedy BJ, Murphy GP, O’Sullivan B, Sobin LH, Yarbro JW (eds). J.B. Lippincott – Raven Publishers. Philadelphia, PA. 1997; 5th Edition.

c. AJCC Cancer Staging Manual. Greene FL, Page DL, Fleming, ID, Fritz AG, Balch CM, Haller DG, Morrow M (eds). Lippincott Raven Publishers. Philadelphia, PA. 2002; 6th Edition.

Page 121 of 138 CaPSURE Observational Database Appendices Page F -121



F. The Karnofsky Performance Status (KPS)

1. About Karnofsky Scoring

a. The Karnofsky Performance Status (KPS) is a numeric scale 0 to 100 (dead to normal) originally designed as a measure of physical function performance in evaluating the efficacy of palliative chemotherapeutic treatments for patients with lung cancer (Karnofsky and Burchenal, 1949). Its validity has been robustly replicated as a predictor of longevity in the population of terminally ill cancer patients (Grieco and Long, 1984) as well as a negative correlate to patients’ self-ratings of pain (Yates, et al., 1980). In turn, the KPS has been recognized as an indicator of quality of life, since a better quality of life or level of functioning should be associated with a lower level of pain. It is now the most widely used instrument in the assessment of medical patients’ quality of life.

b. In the context of the CaPSURE study, the investigator should use the scale to describe the overall functional performance (global health status) of the patient, it should not be used to describe how his functional performance is affected specifically by prostate cancer. Standardized instructions for scoring patients using the KPS have, apparently, never been published, making scores less precise or replicable among different observers. Therefore, the reliability of KPS ratings can be improved when observers use the same data (Grieco and Long, 1984).

2. Karnofsky Performance Status Scale - Definitions Rating (%) Criteria

100 Normal no complaints; no evidence of disease.

90 Able to carry on normal activity; minor signs or symptoms of disease.

80 Normal activity with effort; some signs or symptoms of disease.

70 Cares for self; unable to carry on normal activity or to do active work.

60 Requires occasional assistance, but is able to care for most of his personal needs.

50 Requires considerable assistance and frequent medical care.

40 Disabled; requires special care and assistance.

30 Severely disabled; hospital admission is indicated although death not imminent.

20 Very sick; hospital admission necessary; active supportive treatment necessary.

10 Moribund; fatal processes progressing rapidly.

0 Dead




3. Assessing Patients’ Karnofsky Scores

It is recommended that the following data be considered while assessing patients’ scores:

a. A review of the patients’ medical chart for vital life functions (i.e., pulmonary, gastrointestinal, cardiovascular, endocrine, sleep, and sexual). disease diagnoses medications activity restrictions need for assistance with ambulating or self-care psychiatric syndromes institutional dependence

b. Interview with the patient. level of consciousness (alertness, orientation) sensory (vision, audition) memory (attention, recent, remote) motor, (strength, mobility, control) cognitive (judgment, reasoning, abstract thinking, ideation) language functions (speech, comprehension) pain complaints/behaviors, or discomfort.

4. Limitations of the Karnofsky Scale

Despite its widespread use, the Karnofsky Performance Status has its limitations as a method of rating a patient’s quality of life for the following reasons:

Scoring involves a subjective categorization of a patient by another individual, which may differ significantly.

Ratings are often reported as mean scores, yet there is no evidence that the intervals between the ten functional categories represent the same degree of dysfunction (Bowling, 1991).

Scoring is primarily based upon physical function and dependency, so the assumption that a patient with a low score due to immobility has a lower quality of life than a patient with a higher score may be misguided.

Broader quality of life, such as social or emotional well being, is not measured.

5. References

a. Bowling A. Measuring Health. Open University Press. Bristol, Pennsylvania. 1991.

b. Grieco A, and Long CJ. Investigation of the Karnofsky Performance Status as a measure of quality of life. Health Psychology. 1984; 3(2):129-142.




c. Karnofsky DA, and Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In Evaluation of chemotherapeutic agents. MacLeod CM, Ed. Columbia Press. New York. 1949.

d. Yates JW, Chalmer B, and McKegney FP. Evaluation of patients with advanced cancer using the Karnofsky Performance Status. Cancer. 1980; 45:2220-222.

Page 124 of 138 CaPSURE Observational Database Appendices Page G-124



G. International Prostate Symptom Score (I-PSS)

1. About the I-PSS

The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). For the CaPSURE study, sites will report the I-PSS based on their patient’s self report at the time of the office visit.

2. I-PSS Questions

The questions refer to the following urinary symptoms:

#1 Incomplete emptying #2 Frequency #3 Intermittency #4 Urgency #5 Weak stream #6 Straining #7 Nocturia

Question eight refers to the patient’s perceived quality of life. The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows:

Mild (symptom score less than or equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35)

The International Scientific Committee (SCI), under the patronage of the World Health Organization (WHO) and the International Union Against Cancer (UICC), recommends the use of only a single question to assess the quality of life. The answers to this question range from ‘delighted’ to ‘terrible’ or 0 to 6. Although this single question may or may not capture the global impact of benign prostatic hyperplasia (BPH) symptoms or quality of life, it may serve as a valuable starting point for a doctor-patient conversation.

Page 125 of 138 CaPSURE Observational Database Appendices Page G-125



The SCI has agreed to use the symptom index for BPH, which has been developed by the AUA Measurement Committee, as the official worldwide symptoms assessment tool for patients suffering from prostatism. The SCI recommends that physicians consider the following components for a basic diagnostic workup: history; symptoms; physical exam; appropriate labs, such as U/A, creatinine, etc.; and DRE or other evaluation to rule out prostate cancer.

3. Reference

a. Adapted from: Recommendations of the International Scientific Committee. The evaluation and treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction. Proceedings of the 4th International Consultation on BPH. Paris; July 2-5, 1997:3-6.

Page 126 of 138 CaPSURE Observational Database Appendices Page H-126



H. Glossary

1. Computer Terminology

Analog: Computer information is stored digitally, whereas information transmitted over telephone lines is transmitted in the form of analog waves. A modem converts between these two forms.

Browser: Short for Web browser, a software application used to locate and display Web pages. The two most popular browsers are Netscape Navigator and Microsoft Internet Explorer.

Data Encryption: The translation of data into a secret code. Encryption is the most effective way to achieve data security. To read an encrypted file, you must have access to a secret password.

Database: A collection of information organized in such a way that a computer program can quickly select desired pieces of data. You can think of a database as an electronic filing system.

Desktop: A desktop is the metaphor used to portray file systems. Such a desktop consists of pictures, called icons that show cabinets, files, folders and various types of documents (that is, letters, reports, pictures). You can arrange the icons on the electronic desktop just as you can arrange real objects on a real desktop -- moving them around, putting one on top of another, reshuffling them, and throwing them away.

Digital: Describes any system based on discontinuous data or events. Computers are digital machines because at their most basic level they can distinguish between just two values, 0 and 1, or off and on.

HTML: Short for HyperText Markup Language, the authoring language used to create documents on the World Wide Web.

Hyperlink: An element in an electronic document that links to another place in the same document or to an entirely different document. Typically, you click on the hyperlink to follow the link. Hyperlink text is usually in blue and underlined.

Icon: A small picture that represents an object or program. Icons are very useful in applications that use windows, because with the click of a mouse button you can shrink an entire window into a small icon. (This is sometimes called minimizing.) To redisplay the window, you merely move the pointer to the icon and click a mouse button. (This is sometimes called restoring or maximizing.)

Internet Service Provider (ISP): A company that provides access to the Internet. For a monthly fee, the service provider gives you a software package, username, password and access phone number. Equipped with a modem, you can then log on to the Internet.

Log on: To make a computer system or network recognize you so that you can begin a computer session. Most personal computers have no log-on procedure --




you just turn the machine on and begin working. For larger systems and networks, however, you usually need to enter a username and password before the computer system will allow you to start programs.

Modem: Short for modulator-demodulator. A modem is a device or program that enables a computer to transmit data over telephone lines.

Network: A group of two or more computer systems linked together.

Password: A password is a secret word or phrase that gives a user access to a particular program or system.

Query: A request for information from a database.

Option buttons: Groups of buttons, of which only one can be on at a time (e.g., Yes or No). When you select one button, all the others are automatically deselected.

Security: Refers to techniques for ensuring that data stored in a computer cannot be read or compromised. Most security measures involve data encryption and passwords. Data encryption is the translation of data into a form that is unintelligible without a deciphering mechanism.

Server: A computer or device on a network that manages network resources. For example, a file server is a computer and storage device dedicated to storing files. Any user on the network can store files on the server.

URL: Abbreviation of Uniform Resource Locator, the global address of documents and other resources on the World Wide Web.

2. Symbols

Description Description a� before, pre- � above, elevated, enlarged, up p after � below, decreased, down � negative, none, subtract due to, followed by � positive, present, add caused by, derived from � equals change(s) ± more or less, with or without � and =/ not equal to @ at greater than or equal to of, per, and, divided by � greater than number, pounds less than or equal to � percent � less than foot, feet, minutes � about, approximate inch, seconds approximately equals therefore minimum is to , ratio there exists no data (in a given category) such that � first degree, one hour, primary � micron (common term for micrometer) � secondary to, secondary degree, two hrs. �g microgram prescription




3. Abbreviations

A ...........................assessment/impression ABD ......................abdominal active bs ...............active bowel sounds AF .........................anterior flexion AHCPR .................Agency for Health Care Policy

Research ALT .......................alanine aminotransferase (also

SGPT) ARD ......................acid-related disorders AST ......................aspartate aminotransferase

(also SGOT) bi ...........................two bid .........................twice a day bin .........................twice a night BUN ......................blood urea nitrogen Ca .........................calcium cbc ........................complete blood count cc ..........................unit of liquid measurement

equiv. to milliliters c/c .........................current complaint CK or CPK ............creatine phosphokinase clear to P&A .........clear to percussion and

auscultation cns ........................central nervous system c/o .........................complains of COPD ...................Chronic obstructive pulmonary

disease cor ........................cardiac exam creat .....................creatinine CT .........................computed tomography (also

known as CAT) ctx .........................cytoxan CV ........................cardiovascular cvs ........................cardiovascular system CXR ......................chest x-ray DES ......................diethylstilbestrol, synthetic

estrogen hormone DRE ......................digital-rectal exam d/c .........................discontinued D/C .......................discharged doe .......................dyspnea on exertion dpca ......................dpenicillamine Dx .........................diagnosis ECG......................Electrocardiogram (also known

as EKG) EGD......................esophagogastroduodenoscopy emerg ...................emergency emg ......................electromyelogram EOM's ...................extraocular movements E/R .......................emergency room ESR ......................sedimentation rate fh ..........................family history fhx .........................family history FNA ......................fine needle aspiration FROM ...................full range of motion f/u .........................follow-up fx ...........................effects g ...........................gram GER......................gastroesophageal reflux GERD ...................gastroesophageal reflux disease GI ..........................gastrointestinal

gr .......................... grain H2 RA ................... histamine - 2 receptor

antagonists H/A ....................... headache HCT ...................... hematocrit (also PCV) hctz ....................... thiazide (diuretic) HEENT ................. head, eyes, ears, nose and

throat HGB ..................... hemoglobin HMO ..................... Health Maintenance

Organization h/o ........................ history of hs ......................... bedtime ht .......................... height Hx ......................... history im ......................... intramuscular imp ....................... impression INH ....................... isoniazid iv ........................... intravenous IVP ....................... intravenous pyelogram K ........................... potassium kg ......................... kilograms (1 kg = 2.2 lb) lb .......................... pound LD, LDH ............... lactic dehydrogenase LES ...................... lower esophageal sphincter LFT's .................... liver function tests LHRH ................... luteinizing hormone releasing

hormone LLF ....................... left lateral flexion LLL ....................... left lower lobe of lung LSKK .................... liver, spleen, kidneys LUL....................... left upper lobe of lung lytes ...................... 1) electrolytes, 2) sodium (Na+),

potassium (K+), chloride (Cl-) MCV ..................... mean corpuscular volume mEq/L .................. milliequivalents per liter mg ........................ milligram mg/dL ................... milligrams per deciliter Mg ........................ magnesium MRI....................... magnetic resonance imaging

(also known as MR) ms ........................ morphine sulfate nl .......................... normal npo ....................... nothing by mouth NSAID .................. non-steroidal anti-inflammatory

drug N&V ...................... nausea and vomiting NV ........................ nausea and vomiting o ........................... no, negative, normal O .......................... objective / signs / physical oDorRT ................ no direct or rebound tenderness o/e ........................ on exam OI ......................... opportunistic infections O&P ..................... ova & parasites P ........................... plan pan ....................... polyarteritis nodosa P.C. ...................... phone call PCV ...................... packed cell volume (also HCT) PERRLA............... pupils = round, reactive to light &

accommodation




pgl .........................persistent general lymphadenopathy

pmh ......................past medical history po .........................by mouth poqhs....................by mouth every bedtime prn ........................as needed prn1 ......................as needed 1 tablet prn2 ......................as needed 2 tablets poqhs....................by mouth every bedtime PPI ........................proton pump inhibitor PPO ......................Preferred Provider Organization prn ........................as needed prn1 ......................as needed 1 tablet prn2 ......................as needed 2 tablets pt ..........................patient PUD ......................peptic ulcer disease Px .........................physician PSA ......................prostate-specific antigen qam ......................every morning qd .........................every day q7d .......................once a week qh .........................every hour q2h .......................every 2 hours q4h .......................every 4 hours qhs ........................every evening qid .........................four times a day qn .........................every night qo .........................every day qod .......................every other day quad .....................four times a day q4wq .....................every four hours when awake RBC ......................red blood cells RLF .......................right lateral flexion RLL .......................right lower lobe of lung RML ......................right middle lobe of lung r/o .........................rule out rom .......................range of motion ros ........................review of systems rtc; rto ...................return to clinic; return to office RUL ......................right upper lobe of lung Rx .........................prescription/therapy s or /s ....................without S ...........................subjective/symptoms/history sero - ...................seronegative sero + ..................seropositive SGOT ...................serum glutamic - oxaloacetic

transaminase SGPT ...................serum glutamic - pyruvic

transaminase sl ...........................slight SLR ......................straight leg raising sob ........................short of breath s/p .........................status post sq ..........................subcutaneous sr ..........................slow release st ...........................sore throat sub cu ...................subcutaneous Sx .........................symptoms tr ...........................trace tri...........................three times a day UA ........................uric acid, also urinalysis UGI .......................upper gastrointestinal u/L ........................units per liter

ung ....................... ointment VA ........................ Veterans Administration WBC ..................... white blood cells (also

leukocytes) wt .......................... weight w/u ........................ work up

Page 130 of 138 CaPSURE Observational Database Appendices Page I -130



I. Clinical Form Downloads

The CaPSURE Observational Database is designed to allow the user access to all of the clinical data collection forms for saving on their own computer or for printing. The access the clinical forms in the CaPSURE website, log-on, click on the ‘Support Site’ button, and then click on ‘Clinical Support’. The user will need the program Adobe Acrobat Reader to open and print any of the files. You can put this program on your computer from this screen if you do not already have it. To open the form, click on the blue, underlined text name of the form you would like. When the form opens, use ‘save’ or ‘print’ functions. If you choose to save, you will need to choose a directory on your computer. Clinical support and support with the clinical forms is available from UCSF research associates at (800) 526-4433.

Page 131 of 138 CaPSURE Observational Database Appendices Page J -131



J. ICD-9 Diagnosis Codes for Use with the Clinic Visit Form

a. Sorted by Topic

ICD-9 CODE

DIAGNOSIS NAME (Sorted by Disease Topic)

Prostate 185 Prostate cancer

600.00 Prostate, hypertrophy (benign) (BPH) without mention of urinary obstruction

600.01 Prostate, hypertrophy (benign) (BPH) with mention of urinary obstruction 600.10 Prostate, nodular

601.0 Prostatitis, acute 601.1 Prostatitis, chronic 601.9 Prostatitis, unspecified 602.0 Prostate, calculus

790.93 Prostate specific antigen (PSA) elevation Urinary

188.9 Bladder, Malignant neoplasm of, part unspecified 198.1 Urinary Organs, Secondary malignant neoplasm 233.7 Bladder, Carcinoma in situ 239.4 Bladder, Neoplasm of unspecified nature of bladder 592.1 Ureter, calculus 594.1 Bladder, other calculus

595.82 Cystitis, irradiation 595.9 Cystitis, unspecified 596.0 Bladder neck obstruction

596.51 Bladder, hypertonicity 596.59 Bladder, other functional disorder

596.8 Bladder, other specified disorder 598.2 Urethral stricture, postoperative 598.9 Urethral stricture, unspecified 599.0 Urinary tract infection, site not specified 599.6 Urinary obstruction, unspecified 599.7 Hematuria 599.9 Lower Urinary Tract Symptoms (LUTS) 788.1 Dysuria

788.20 Urine retention, unspecified 788.21 Bladder emptying incomplete 788.29 Urine retention, specified other 788.30 Urinary incontinence, unspecified 788.31 Incontinence, urge




ICD-9 CODE


788.32 Incontinence, stress, male 788.41 Urinary frequency 788.43 Nocturia 788.62 Urinary stream slowing

788.9 Urinary system, other symptoms involving 791.9 Urine examination, other nonspecific findings

Erectile Dysfunction 607.84 Erectile dysfunction 302.72 Psychosexual dysfunction with inhibited sexual excitement

Genital Organs 603.9 Hydrocele, unspecified

604.90 Orchitis and epididymitis, unspecified 605 Prepuce and phimosis, redundant

607.1 Balanoposthitis 607.85 Peyronie's Disease 607.89 Penis, other specified disorder

608.1 Spermatocele 608.3 Testis, atrophy of

608.86 Genital organs, edema (male) 608.89 Genital organs, other specified disorder (male)

608.9 Genital organs, unspecified disorder (male) Other Cancers

188.9 Bladder, Malignant neoplasm, part unspecified 198.5 Bone and bone marrow, Secondary malignant neoplasm 211.3 Colon, Benign neoplasm 239.4 Bladder, Neoplasm of unspecified nature of bladder

Abdomen/Digestion 441.4 Abdominal aneurysm without mention of rupture

530.81 Esophageal reflux 562.11 Diverticulosis of colon (without mention of hemorrhage) 564.00 Constipation, unspecified 789.00 Abdominal pain, unspecified site

Circulatory System/Cardiac 401.1 Hypertension, essential, benign 401.9 Hypertension, unspecified essential (etiology unknown)

414.00 Coronary atherosclerosis of unspecified type of vessel, native or graft (CAD)

414.01 Coronary atherosclerosis of native coronary artery




ICD-9 CODE


414.9 Chronic ischemic heart disease, unspecified 427.31 Atrial fibrillation

427.9 Cardiac dysrhythmia, unspecified 428.0 Congestive heart failure (CHF) (not due to hypertension) 435.9 Cerebral ischemia, transient, unspecified

436 Cerebrovascular disease, acute but ill-defined, Bones/Spine

716.90 Arthropathy, unspecified, both acute and chronic 274.9 Gout, unspecified

715.90 Osteoarthrosis, unspecified whether generalized or localized, unspecified site

715.90 Degenerative joint disease 716.60 Monoarthritis, unspecified, site unspecified

722.6 Degenerative disk disease 724.2 Lumbago 724.3 Sciatica 724.5 Backache, unspecified

733.90 Bone and cartilage disorder, unspecified Miscellaneous

285.9 Anemia, unspecified anemia 278.00 Obesity, unspecified

366.9 Cataract, unspecified 486 Pneumonia, organism unspecified

611.1 Gynecomastia, hypertrophy of breast 692.9 Dermatitis (contact) and other eczema, due to unspecified cause

990 Radiation effects, unspecified Kidney

586 Renal failure, unspecified 591 Hydronephrosis

590.3 Renal insufficiency, acute 585.9 Renal insufficiency, chronic 592.0 Kidney, calculus 593.2 Kidney, acquired cyst of

593.89 Kidney and ureter, other specified disorder 593.9 Kidney and ureter, unspecified disorder - unspecified kidney disease

General Symptoms 300.4 Depression, neurotic and/or depression with anxiety

311 Depressive disorder, not elsewhere classified




ICD-9 CODE


782.3 Edema 782.62 Flushing (hot flashes) 787.91 Diarrhea

Other Commorbidities 272.0 Hypercholesterolemia, pure 244.9 Hypothyroidism, unspecified

250.00 Diabetes mellitus w/o mention of complication, type II/unspecified., not stated as controlled

250.01 Diabetes mellitus w/o mention of complication, type I, not stated as controlled

250.02 Diabetes mellitus w/o mention of complication, type II/ unspecified, uncontrolled

272.4 Hyperlipidemia, other and unspecified 331.0 Alzheimer's Disease 332.0 Parkinson's Disease

496 Chronic airway obstruction, not elsewhere classified (COPD) 550.90 Hernia, inguinal , without mention of obstruction or gangrene, unilateral or

unspecified 553.3 Hernia, diaphragmatic (hiatal) without mention of obstruction or gangrene

780.57 Sleep apnea unspecified 354.0 Carpal Tunnel syndrome

Rectum/Anus 569.3 Hemorrhage of rectum and anus 455.6 Hemorrhoids, unspecified, without mention of complication

569.49 Rectum and anus, other specified disorder




b. Sorted Alphabetically by Diagnosis Name

ICD-9 CODE DIAGNOSIS NAME (Sorted Alphabetically by Name)

441.4 Abdominal aneurysm without mention of rupture 789.00 Abdominal pain, unspecified site 285.9 Anemia, unspecified anemia 716.90 Arthropathy, unspecified, both acute and chronic 427.31 Atrial fibrillation 724.5 Backache, unspecified 607.1 Balanoposthitis 600.00 Benign Prostate Hyperplasia (BPH) w/no mention of obstruction or

unspecified 600.01 Benign Prostate Hyperplasia (BPH) with mention of urinary obstruction 788.21 Bladder emptying incomplete 596.0 Bladder neck obstruction 233.7 Bladder, Carcinoma in situ 596.51 Bladder, hypertonicity 188.9 Bladder, Malignant neoplasm of, part unspecified 239.4 Bladder, Neoplasm of unspecified nature of bladder 594.1 Bladder, other calculus 596.59 Bladder, other functional disorder 596.8 Bladder, other specified disorder 198.5 Bone and bone marrow, Secondary malignant neoplasm 733.90 Bone and cartilage disorder, unspecified 427.9 Cardiac dysrhythmia, unspecified 354.0 Carpal Tunnel Syndrome 366.9 Cataract, unspecified 435.9 Cerebral ischemia, transient, unspecified 436 Cerebrovascular disease, acute but ill-defined, 496 Chronic airway obstruction, not elsewhere classified (COPD) 414.9 Chronic ischemic heart disease, unspecified 211.3 Colon, Benign neoplasm 428.0 Congestive heart failure (not due to hypertension) 564.00 Constipation, unspecified 414.01 Coronary atherosclerosis of native coronary artery 414.00 Coronary atherosclerosis of unspecified type of vessel, native or graft

(CAD) 595.82 Cystitis, irradiation 595.9 Cystitis, unspecified 722.6 Degenerative disk disease





300.4 Depression, neurotic and/or depression with anxiety 311 Depressive disorder, not elsewhere classified 692.9 Dermatitis (contact) and other eczema, due to unspecified cause 250.00 Diabetes mellitus w/o mention of complication, type II/unspec., not stated

as controlled 250.01 Diabetes mellitus w/o mention of complication, type I, not stated as

controlled 250.02 Diabetes mellitus w/o mention of complication, type II/unspec.,

uncontrolled 787.91 Diarrhea 562.11 Diverticulosis of colon (without mention of hemorrhage) 788.1 Dysuria 782.3 Edema 607.84 Erectile dysfunction 530.81 Esophageal reflux 782.62 Flushing (hot flashes) 608.86 Genital organs, edema (male) 608.89 Genital organs, other specified disorder (male) 608.9 Genital organs, unspecified disorder (male) 274.9 Gout, unspecified 611.1 Gynecomastia, hypertrophy of breast 599.7 Hematuria 569.3 Hemorrhage of rectum and anus 455.6 Hemorrhoids, unspecified, without mention of complication 553.3 Hernia, diaphragmatic (hiatal) without mention of obstruction or gangrene 550.90 Hernia, inguinal , without mention of obstruction or gangrene, unilateral or

unspecified 782.62 Hot Flashes 603.9 Hydrocele, unspecified 591 Hydronephrosis 272.0 Hypercholesterolemia, pure 272.4 Hyperlipidemia, other and unspecified 401.1 Hypertension, essential, benign 401.9 Hypertension, unspecified essential (etiology unknown) 244.9 Hypothyroidism, unspecified 788.32 Incontinence, stress, male 788.31 Incontinence, urge 593.89 Kidney and ureter, other specified disorder





593.9 Kidney and ureter, unspecified disorder 593.2 Kidney, acquired cyst of 592.0 Kidney, calculus 599.9 LUTS Lower Urinary Tract Symptoms 724.2 Lumbago 716.60 Monoarthritis, unspecified, site unspecified 788.43 Nocturia 278.00 Obesity, unspecified 604.90 Orchitis and epididymitis, unspecified 715.90 Osteoarthrosis, unspecified whether generalized or localized, unspecified

site 332.0 Parkinson's disease 607.89 Penis, other specified disorder 607.85 Peyronie's Disease 486 Pneumonia, organism unspecified 605 Prepuce and phimosis, redundant 185 Prostate cancer 790.93 Prostate specific antigen (PSA) elevation 602.0 Prostate, calculus 600.10 Prostate, nodular 601.0 Prostatitis, acute 601.1 Prostatitis, chronic 601.9 Prostatitis, unspecified 302.72 Psychosexual dysfunction with inhibited sexual excitement 990 Radiation effects, unspecified 569.49 Rectum and anus, other specified disorder 586 Renal failure, unspecified 724.3 Sciatica 780.57 Sleep apnea unspecified 608.1 Spermatocele 608.3 Testis, atrophy of 592.1 Ureter, calculus 599.9 Urethra and urinary tract, other disorders of 598.9 Urethral stricture, unspecified 598.2 Urethral stricture, postoperative 598.9 Urethral stricture, unspecified 788.41 Urinary frequency 788.30 Urinary incontinence, unspecified





599.6 Urinary obstruction, unspecified 198.1 Urinary Organs, Secondary malignant neoplasm 788.62 Urinary stream slowing 788.9 Urinary system, other symptoms involving 599.0 Urinary tract infection (UTI), site not specified 791.9 Urine examination, other nonspecific findings 788.29 Urine retention, specified other 788.20 Urine retention, unspecified

Documents

051611 Site Abstracting Manual-FINA-v16.1 091911 · 9/19/2011 · UCSF Department of Urology G-CEPS Program, San Francisco, CA Revised September 19, 2011 S:\Outcomes\CaPSURE\Administrative\Manuals\Sites\Abs