Docstoc

Form Physical Exam

Document Sample
Form Physical Exam Powered By Docstoc
					             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

                                  FORM CHANGES
Abbreviated Visit-ABRV-1001a:
  • In first and third prompts of Section B, F22 changed to F22HX and F22MED.
  • Reference to FHX in removed from first and third prompts of Section B.

ACSR Acertainment Tracking Checklist-ACSR-ATC-0499b:
  • Changed the name of the Form and any ACSB references to ACSR: AIDS and Cancer
     Specimen Resource to reflect the institutions October 2002 name changes.
  • Changed footer reference of ACSB to ACSR and version date of 04/01/99a to 04/01/99b.

Anthropometry Training Form-ANTHRO-1002a:
   • Footer added to form.

Clinical Outcomes Reporting Form-CORE-0403:
   • Change version date from 04/01/01a to 04/01/03.
   • Add question B1a: Name of diagnosing facility. Enter the name of the facility or institution at
       which the participant received her diagnosis.
   • Add question B1b: Address of diagnosing facility. Enter the address of the facility named in
       question B1a.
   • Question B3: Change instructions to read “See Manual of Operations, Section 12, for list of
       disease codes.”
   • QxQs: Change all references to “Ascertainment Control Sheet” or “ACS” to “Ascertainment
       Tracking Checklist” or “ATC.”
   • QxQs: Change all references to “Manual of Operations, Section 11,” to “Manual of
       Operations, Section 12.”

Disenrollment Form-DENR-0403:
   • Added "WIHS Anal Substudy" to question 1, disenrollment type. This is now the 6th option
      for this question.
   • Changed version date of form in footer and on the first page.
   • Inserted a page break after question 4g Specify.
   • Deleted instructions that the form should be faxed to WDMAC prior to Data Entry.

Antiretroviral Medications-DRUG1-0403:
   • Change version date from 10/01/02 to 04/01/03.
   • Medication list, page 1: Reorder antiretroviral medications to match data entry screen – 1)
       NRTI, 2) NNRTI, 3) PI, 4) Entry Inhibitors, 5) other.
   • Medication list, page 1: Add NRTI 239 Coviracil (emtricitabine, FTC). Add PI 238
       Tipranavir (PNU-140690).
   • Medication list, page 1: Reword “Fusion” Inhibitors to “Entry” Inhibitors.
   • Medication list, page 1: Reword “T-20 (pentafuside)” to “Fuzeon (T-20, enfuviratide).”
   • Question 1C: Add response category “My CD4 level went down.” Please note that, for data
       coding consistency, response #6 (my CD4 level went down) precedes response #5 (other
       reason) on the form.
   • Question 5B: Add response category “Injection/IV.”

                              Final Form and Protocol Changes Page 1 of 19
                                               3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

Non-antiviral Medications-DRUG2-1000c:
  • Change version date from 10/01/00b to 10/01/00c.
  • Change all references on form and in QxQs to question numbers “F9.A – F9.C” to “C1A –
      C1C.”
  • Change all references on form and in QxQs to form “F22” to “F22Med.”
  • QxQs general instruction #8: Change reference to question number “F10B” to “F1B.”
  • QxQs general instruction #8: Change reference to question number “F14” to “E10.”

Antiviral Medications-DRUG3-0403:
   • Change version date from 10/01/02 to 04/01/03.
   • Change reference to question number on F22MED about hepatitis medication use: from
       “B11” to “D1A.”
   • Drug code 239: correct spelling of medication; change order in which different names are
       listed to match F22MED.
   • Question 2b: add response categories: “I had other blood test abnormalities,” “It required too
       many visits,” “It was too expensive/my insurance didn’t cover treatment,” and “I was not
       able to keep all the appointments.” Please note that, for data coding consistency, responses
       #9–12 (listed above) precede response #8 (other reason) on the form.

Physical Exam-F07-0403:
   • Add a space for the clinician’s initials at the end of the body measure, skinfold measure, and
      BIA sections. The spaces for recording initials were placed after questions A12b, A16a#3,
      and A21.
   • The definitions of mild, moderate and severe for questions A5a-j, visual assessment, were
      changed to the following:
                                 o Mild – Only seen if looked for.
                                 o Moderate – Easily seen.
                                 o Severe – Obvious immediately.
   • The Q x Q’s for questions A5b and c were reworded to further clarify how to assess the
      shape of the participant’s abdomen versus her waist.

Medical and Health History-F22HX-0403:
  • Change version date from 10/01/02 to 04/01/03.
  • Delete reference to medication history in “Introduction to participant.”
  • Question B8a-j: Change definitions of “mild,” “moderate” and “severe” change in body
      shape.
  • QxQs, question B8a-j: Add definitions of “mild,” “moderate” and “severe” change in body
      shape.
  • Question C32: Change question from “ever” to “since your (MONTH) study visit.”
  • Delete question C32a: “In what year?”
  • Add question C32b.i: “Did your overactive thyroid get better without any treatment?”
  • Question C32d: Reword from “Other (e.g., cancer, goiter)” to “Was it another type of thyroid
      disease, for example cancer or goiter?”
  • Question C33: Change question from “ever” to “since your (MONTH) study visit.”
  • Delete question C33a.1: “How old were you?”
  • Delete question C33b.1: “How old were you?”

                              Final Form and Protocol Changes Page 2 of 19
                                               3/21/2003
          FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
•   Delete question C33c.1: “How old were you?”
•   QxQs, question C33c: Add note indicating that a broken tailbone should not be recorded as a
    spinal fracture.
•   Move and renumber old question C34a to C35.
•   Add question C35a: “Have you ever been told by a health care provider that you have
    hepatitis C?” This question will be asked only of those women who report no diagnosis of
    hepatitis C since last visit. NOTE: question will be deleted for visit 19.
•   Add question C35b: “Who first told you?”
•   Add question C36: “Are you aware that there are treatment options for hepatitis C?”
•   Add question C36a: “How did you first learn about treatment options for hepatitis C?”
•   Add question C36b: “Which of the following best describes your opinion of how well
    hepatitis treatment works?”
•   Add question C36c: “Has anyone ever offered you treatment for hepatitis C?” NOTE:
    question will be deleted for visit 19.
•   Add question C36d: “Were you offered this treatment since your (MONTH) study visit or
    prior to your (MONTH) study visit?” NOTE: question will be deleted for visit 19.
•   Add question C36e: “Did you agree to be treated for hepatitis C?” NOTE: question will be
    deleted for visit 19 as this information “since your (MONTH) study visit” will be captured on
    F22MED.
•   Add question C36f: “Did you complete the treatment?” NOTE: question will be deleted for
    visit 19 as this information “since your (MONTH) study visit” will be captured on DRUG3.
•   Add question C36g: “What was the main reason or reasons you stopped treatment?” NOTE:
    question will be deleted for visit 19 as this information “since your (MONTH) study visit”
    will be captured on DRUG3.
•   Add question C37: “Have you ever been referred to a special provider or clinic for patients
    with hepatitis C?” NOTE: question will be changed from “ever” to “since your (MONTH)
    study visit” at visit 19.
•   Add question C37a: “Have you ever gone to a special provider or clinic for patients with
    hepatitis C?” NOTE: question will be changed from “ever” to “since your (MONTH) study
    visit” at visit 19.
•   Renumber old question C35a to C38.
•   Add question C38a: “Has a health care provider ever recommended you have a liver
    biopsy?” This question will be asked only of those women who report no recommendation
    for liver biopsy since last visit. NOTE: question will be deleted for visit 19.
•   Add question C38b: “Why was the liver biopsy recommended?”
•   Add question C38c: “Did you have the liver biopsy?” NOTE: a “YES” answer to this
    question will not result in generation of an ATC event.
•   Add question C38d: “Why did you choose not to have the biopsy? (circle all that apply).”
•   Add question C39: “Have you ever been told by a health care provider that you needed a
    liver transplant?” NOTE: question will be changed from “ever” to “since your (MONTH)
    study visit” for visit 19.
•   Add question C40: “Have you ever had a liver transplant?” NOTE: question will be changed
    from “ever” to “since your (MONTH) study visit” for visit 19.
•   Add question C40a: “In what year?” NOTE: question will be deleted at visit 19.
•   Add question C41: “Are you currently on a waiting list for a liver transplant?”



                           Final Form and Protocol Changes Page 3 of 19
                                            3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
   •   Prompt after question C41a: Change question numbers that trigger hepatitis/liver disease
       abstraction.
   •   Renumber old questions C36a-d to C42a-d.
   •   Renumber old question C37 to C43.
   •   Prompt after question C43: Change question numbers that trigger heart disease abstraction.
   •   Prompt after question E22a-g: Change “AIDS and Cancer Specimen Bank” to “AIDS and
       Cancer Specimen Resource.”
   •   QxQs, question E24: Add instructions to record time module ended and proceed to form
       F22MED.
   •   Update QxQs for all added, deleted or changed questions listed above.
   •   Correct formatting errors in QxQs.

Medical and Health History-F22MED-0403:
  • Change version date from 10/01/02 to 04/01/03.
  • QxQs general instruction #1: indicate that interviewer should also have copies of Drug Form
      3 available prior to initiation of interview.
  • Rename old “Section B. Medication History” to “Section B. Antiretroviral History.”
  • Question B2A: Reorder antiretroviral medications to match data entry screen – 1) NRTI, 2)
      NNRTI, 3) PI, 4) Entry Inhibitors, 5) other.
  • Question B2A: Add NRTI 239 Coviracil (emtricitabine, FTC). Add PI 238 Tipranavir (PNU-
      140690).
  • Question B2A: Reword “Fusion” Inhibitors to “Entry” Inhibitors.
  • Question B2A: Reword “T-20 (pentafuside)” to “Fuzeon (T-20, enfuviratide).”
  • Add new section division to form: “Section C. OI Medication History.”
  • Renumber old questions B9A-C to C1A-C.
  • Add new section division to form: “Section D. Hepatitis Medication History.”
  • Renumber old question B11 to D1A-B.
  • Question D1A: Reword from “ever” to “since your (MONTH) study visit.”
  • Question D1A: Reword “FTC (Entricitabine, Corviracil)” to “Coviracil (emtricitabine,
      FTC).”
  • Question D1B: Change from “if the participant has never…” to “if the participant has not…”
  • Add new section division to form: “Section E. Other Prescription Medication Use.”
  • Move old question B10 to Section E and renumber as E1.
  • Question E1: Change from “ever” to “since your (MONTH) study visit.”
  • Question E1a-f: Stop asking for the year of last vaccination.
  • Renumber old questions B12-B18 to E2-8.
  • Question E5: Reword from “medication for osteoporosis” to “medication to prevent or treat
      osteoporosis.”
  • Add question E5f: “Forteo (teriparatide)” use for osteoporosis.
  • QxQs question E8B: add “Do not include medications the participant reports taking solely
      for birth control as their use will be captured on WIHS Form F23 Obstetric, Gynecologic and
      Contraceptive History.”
  • Add question E9: “Have you ever been treated with radioactive iodine or any other
      medication for an overactive thyroid (hyperthyroidism)?” This question will be changed to
      “since your (MONTH) study visit” at visit 19.


                             Final Form and Protocol Changes Page 4 of 19
                                              3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
   •   Add questions E9a-d: “Propylthiouracil (PTU),” “Beta blockers (propranolol, Inderal),”
       “Methimazole (Tapazole),” “Radioactive iodine (RAI).”
   •   Move question old B23 to Section E and renumber as E10.
   •   Add new section division to form: “Section F. Alternative/Complementary Medication Use.”
   •   Renumber old questions B19-B22 to F1-F4.
   •   Add new section division to form: “Section G. Symptoms.”
   •   Renumber old questions B24-B26 to G1-G3.
   •   Update QxQs for all added, deleted or changed questions listed above.

OB/GYN History-F23-0403:
  • After question C4, added new question C5 “Ortho Evra, the once-a-week birth control
     patch?” (page 7)
  • Renumber questions C5-C12 to C6-C13 to adjust for #1.
  • (pages 7-9)
  • Adjust skip pattern to skip to question C6 for women who’ve had a hysterectomy or tubal
     ligation to adjust for #1. (page 6)
  • Changed page breaks to account for #1.
  • Changed interviewer skip instructions for NO and DECLINED for C5-C12.
  • Changed form version date on first page and footer version dates on all pages. 10/01/02 to
     4/01/03.

Alcohol, Drugs & Sexual Behavior-F24-0403:
   • Questions C12a-c regarding lifetime use of injection drugs were removed.
   • Question D1 (English version only), “pertain” was changed to “pertains.”
   • Question D5b reworded to capture both female and male condom use. It now reads as
      follows:
          o “During this time, how often did you and/or (PARTNER ID) wear a rubber or
             condom when you had vaginal sex?
   • The following questions were added to Section C regarding lifetime and recent use of Rave
      drugs:
C12.   Have you ever taken any form of amphetamine that was not prescribed for you by a medical
       provider? (Sometimes called MDMA, ecstasy, XTC, Adam, Essence, speed, crystal meth, or
       meth-amphetamine.)
                              YES.................................................1
                              NO ..................................................2 (C13)

       a.     Have you taken any in the last month?

                              YES.................................................. 1
                              NO .....................................................2

C13.   Have you ever taken any form of GHB? (Sometimes called liquid ecstasy, grievous bodily
       harm, or G.)

                              YES.................................................1
                              NO ..................................................2 (C14)

       a.     Have you taken any in the last month?


                               Final Form and Protocol Changes Page 5 of 19
                                                3/21/2003
              FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

                               YES.................................................. 1
                               NO .....................................................2

C14.   Have you ever taken any form of ketamine? (Sometimes called special K or kit kat.)

                               YES.................................................1
                               NO ..................................................2 (C15)

       a.      Have you taken any in the last month?

                               YES.................................................. 1
                               NO .....................................................2

C15.   Have you ever taken any form of PCP? (Sometimes called angel dust, rocket fuel, or killer
       weed.)

                               YES.................................................1
                               NO ..................................................2 (C16)

       a.      Have you taken any in the last month?

                               YES.................................................. 1
                               NO .....................................................2

C16.   Have you ever taken any form of LSD? (Sometimes called acid or blotters.)

                               YES.................................................1
                               NO ..................................................2 (D1)

       a.      Have you taken any in the last month?

                               YES.................................................. 1
                               NO ................................................ 2

Antiviral Usage Assessment for Blood Draw-F29a-0403:
   • Change version date from 10/01/02 to 04/01/03.
   • Revise introduction to question 1A.
   • Reorder antiretroviral medications to match data entry screen – 1) NRTI, 2) NNRTI, 3) PI, 4)
       Entry Inhibitors, 5) Other.
   • Question 1A: Add NRTI – 239, Coviracil (emtricitabine, FTC).
   • Question 1A: Add PI – 238, Tipranavir (PNU-140690).
   • Question 1A: Change “Fusion Inhibitors” to “Entry Inhibitors.”
   • Question 1A: Change “T-20 (pentafuside)” to “Fuzeon (T-20, enfuviratide).”
   • QxQs: Add instructions on how to record if participant reports taking more than one
       “unknown” antiretroviral in the past three days.




                                Final Form and Protocol Changes Page 6 of 19
                                                 3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Specimens collected during PE-F31-0403:
   • Changed:
             C1.a.)    IF YES, then specify location from where the sample was taken:



                                                         Specify
       To:
         C1.a.) If YES, from where was the
         sample taken:
                Occipital region of the scalp (preferred)          1
                Other region of the scalp                          2 (SPECIFY)

                          Specify


   •   Changed version date on first page and version date in footer from 10/010/2 to 04/01/03.
   •   Changed interviewer instructions on first page in the single asterisk: “Required for every
       women…” to “Required for every woman…”

Liver/Renal Function Tests-L05-0403:
   • Removed PT testing results (seconds and INR).
   • Changed version date on first page and version date on footer from 10/01/02 to 04/01/03.

Colposcopy Results-L14-1002a:
   • Changed pagination due to picture files for those listed in #2. The reference page 9 was
      deleted. Clinicians can refer to the same pictures on pages 10 and 11. Codes and pictures for
      the Perineum view of the vagina and the vaginal wall were separated onto two pages.
   • Indicated the change in pagination for form instructions on page 7 – “Location codes are
      located on page 10 and 11.”
   • Enlarge and import into file pictures for:
          o Quadrants of the cervix (page 4)
          o Perineum view of vagina (pages 10)
          o Anterior and Posterior vaginal wall (page 11)
          o Detail of the anus (page 14).
   • A1c, changed “ACSB” to “ACSR.”
   • Changed footer from 10/01/02 to 10/01/02a.
   • Changed interviewer instructions on page 7, “Complete Section B on pages 12-14”, since
      pagination has changed.

Biopsy Histopathology Pelvic Exam-L15-0403:
   • Remove question A7, Predominant Grade of Biopsy.
   • Renumber questions A8 – A10 to A7 – A9, respectively.
   • Questions A8 b and c, now A7 a and b.




                              Final Form and Protocol Changes Page 7 of 19
                                               3/21/2003
               FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Oral Research Interview-OP02-0403:
   • Added the following questions to account for community dental treatment between WIHS
      visits:
20.     (READ RESPONSE CATEGORIES)
        How often do you usually brush your teeth?

                      Don’t brush ................................... 1
                      Less than once a day ..................... 2
                      Between 1 and 3 times a day…… 3
                      Other ............................................. 4

                      ___________________________
                              SPECIFY

21.    (DO NOT READ RESPONSE CATEGORIES)
       Do you usually use dental floss?

                      YES ............................................... 1
                      NO................................................. 2 (22)

      a. (READ RESPONSE CATEGORIES)
          How often do you do usually do this?

                      Daily.............................................. 1
                      Weekly .......................................... 2
                      Less than weekly........................... 3

22.     (DO NOT READ RESPONSE CATEGORIES)
        Do you usually use an Antibacterial prescription mouthwash?

                      YES ............................................... 1
                      NO................................................. 2 (23)

      a. (READ RESPONSE CATEGORIES)
          How often do you do usually do this?

                      Daily.............................................. 1
                      Weekly .......................................... 2
                      Less than weekly........................... 3

23.     Approximately how many times altogether have you visited the dentist in the past year?
        (NOT COUNTING YOUR WIHS STUDY VISITS)

        RECORD THE NUMBER OF TIMES:                      ________
For each of the following dental procedures or treatment, Tell me after I read each one whether or not you
received such a procedure or treatment in the past year.




                                      Final Form and Protocol Changes Page 8 of 19
                                                       3/21/2003
               FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
24.     (DO NOT READ RESPONSE CATEGORIES)
        Have you had your teeth or mouth examined in the past year?

                      YES ............................................... 1
                      NO................................................. 2 (25)

        a. If yes, how many times?               ___________

25.     (DO NOT READ RESPONSE CATEGORIES)
        Have you had your teeth cleaned in the past?

                      YES ............................................... 1
                      NO................................................. 2 (26)

        a. If yes, how many times?               ____________

26.     (DO NOT READ RESPONSE CATEGORIES)
        Have you had X-rays of your teeth in the past year?

                      YES ............................................... 1
                      NO................................................. 2

27.    (DO NOT READ RESPONSE CATEGORIES)
       Have you had a gum treatment in the past year?

                      YES ............................................... 1
                      NO................................................. 2 (28)

        a. If yes, how many times? ____________

28. (DO NOT READ RESPONSE CATEGORIES)
       Have you had a tooth or teeth pulled in the past year?

                      YES ............................................... 1
                      NO................................................. 2 (END)


        a. Why?
                      Gum disease .................................. 1
                      Cavities ......................................... 2
                      Other ............................................. 3

                      ___________________________
                              SPECIFY

Oral Gingival Banding Score-OP08-0403:
   • Updated form to indicate that subgingival plaque samples should now be taken from both
      facial and lingual sites exhibiting positive scores. The “NOTE” now reads:
            “Take subgingival plaque samples from areas exhibiting positive scores on facial and
            lingual sites (the shaded items), as described in procedures for form OP10.”



                                      Final Form and Protocol Changes Page 9 of 19
                                                       3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Oral Papillary Assessment-OP09-0403:
   • Updated form to indicate that subgingival plaque samples should be taken from distal sites of
      teeth with codes 1, 2, 3, and 5. The “NOTE” now reads:
       “Take subgingival plaque samples from distal sites of teeth with codes 1, 2, 3, or 5 (the
      shaded items).” {Rows 1 and 2 are now shaded to indicate that the samples should be taken.}

Oral Subgingival Plaque-OP10-0403:
   • Question 2 now reads: “Sample(s) from site(s) exhibiting positive gingival banding scores on
      facial and lingual?”
   • Questions 2a and 2b now have a space to record both the facial and lingual tooth number.
   • Question 3 now reads: “Sample(s) from site(s) receiving Papillary Assessment scores of 1, 2,
      3, or 5:
   • Question 3b, Papillary score, now has options of 1, 2, 3, and 5.
   • Question 4 now reads: “Samples from site(s) exhibiting a 2 mm or greater change in
      attachment level since prior to last visit.”

Transfer Form-TRANS-1001a:
   • Updated prompt at end of Section C and Q x Q’s to indictate that the new site should forward
      the participant’s new ID to WDMAC via email or phone to: gspringe@jhsph.edu or 410-614-
      6923.




                             Final Form and Protocol Changes Page 10 of 19
                                               3/21/2003
             FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

                                    QxQ CHANGES
Pregnancy Form-PR01-QxQ-0499c:
   • Updated the first section regarding visit number to indicate that forms should now be sent to
      WDMAC for data entry, as there is no longer a separate database for pregnancy forms.
      Forms can be faxed or mailed to Johanna Goderre at 410-614-7125 or:

       Johanna Goderre
       Johns Hopkins Bloomberg School of Public Health
       Department of Epidemiology
       615 North Wolfe Street
       Room E7009
       Baltimore, MD 21205

Post-partum Form-PR02-QxQ-0499d:

   •   Updated the first section regarding visit number to indicate that forms should now be sent to
       WDMAC for data entry, as there is no longer a separate database for pregnancy forms.
       Forms can be faxed or mailed to Johanna Goderre at 410-614-7125 or:

       Johanna Goderre
       Johns Hopkins Bloomberg School of Public Health
       Department of Epidemiology
       615 North Wolfe Street
       Room E7009
       Baltimore, MD 21205




                             Final Form and Protocol Changes Page 11 of 19
                                               3/21/2003
              FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

                              PROTOCOL CHANGES
Referral Checklist-0403:
   • Change version date from 04/01/02 to 04/01/03.
   • Delete all referrals for F20, New Recruit Baseline History, as form is no longer used.
   • Delete referrals for F24, questions E3b and E4b, as questions are no longer asked.
   • Delete referral for F07, question D1, as exam is no longer done.
   • Delete all referrals for F07r, Physical Exam Addendum, as form is no longer used.
   • Delete referral for L08, Mantoux Skin Test Result, as form is no longer used.
   • Add referrals to F24 for new questions:
   • Used amphetamines in last month
   • Used GHB in last month
   • Used ketamine in last month
   • Used PCP in last month
   • Used LSD in last month
   • Add referral to F07 for blood pressure <90/60 or >140/90.

General:
Changed footer date to reflect current version date for those sections that have changed.

Section 1:
Added WIHS-III Core and Platform Aims and Hypotheses as they were revised at the Reverse Site
Visit. WIHS-III objectives were added at the beginning and previous objectives were renumbered.

Section 2:
Revised NIH Program Officers and WDMAC staff list. Updated and added information regarding
the Steering Committee, Administrative Working Groups, and the Scientific Advisory Board (Parts
F through H). Updated information on the restricted WIHS Administrative web site. Updated
Appendix A-WIHS Organizational Structure.

Section 3:
Updated information on the process of submitting and approving Concept Sheets and Manuscripts.
Updated information on the formation and objectives of writing committees. Revised expected
timelines for manuscript development. Appendix A was merged with the section into one document
in the PDF version.

Section 4:
Updated new recruit enrollment table with actual vs. projected enrollment. Added total recruit
enrollment table.

Section 5:
No changes.

Section 6:
Made minor typographical changes.

Section 7:
Changed procedures for data entry of TRANS form. PPD discontinued at visit 17.

                              Final Form and Protocol Changes Page 12 of 19
                                                3/21/2003
              FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

Section 8:
Revised Interviewer Evaluation Instrument. Added Basic Interviewer Training Module that should
be completed and logged within the first 3 months of employment. Sites should send the logs of
completed Evaluations and Modules at the end of every even numbered visit. Replaced the example
question for pre-coded “Mentioned/Not Mentioned” questions with F22MED, B19.B.

Section 9:
Updated various typographical errors. Updated footer of all Appendices for date and page number.
Updated WDMAC contact information in Appendix A. This section has several attachments. All
attachments have been merged into one document in the PDF version.

Section 10:
Part I.B: Add S-code to all labels for proper specimen identification. Part II.B.2: Add directions on
aliquoting serum and plasma for the national repository. “It is preferred that when aliquoting serum
or plasma for shipment to the national repository, vials are filled to the stated volumes. In the event
that all aliquoted vials will not have the full volume, do not distribute the volume evenly among all
vials. Fill as many vials as a possible to the stated volume. It is more important to have correct
volumes in fewer vials than to have less volume in more vials.” Part II.D – Venous Blood
Collection procedures: Add patient care, re-stick policy and safe handling instructions. Add
instructions to record s-codes on labels after venipuncture. Add instructions to notify ChemTel
regarding shipments to BBI as stated in Communication Memo #341. Changed passive voice to
active voice as necessary throughout Section 10. Changed “CPT tubes” or “CPT tube” to “CPTs” or
“CPT” respectively. Insert picture of CPT before and after centrifuging. Add Part X. How to
request specimens from the national repository. Add Part X.D. How to find specimen locations at
the national repository.

Section 11:
Section A: Removed references to the WDMS in the introduction. Added paragraph on scheduled
Apollo downtime. A.3: Navigation menu - added items to reflect the current menu. A.4: Change in
wording, no content changes. A.5 Updated information on View and modifying data with the new
"View" function. A.7: Reports - updated list to include the current reports. A.9: Outcomes: Added
information on ATC generation through the reports option. Section C Forms: Revised information
on WIHSIDS (change of wording, no new content.) Section E: updated to include all new forms.
Section F: Deleted Database Structure for Historical Data, as this is no longer part of our data
management system. All sections beyond this need to be renumbered. Old Section G: Offline edit -
removed reference to duplicate record edits. Revised Visit 17 date schedule to reflect the new dates.
Form versions list is no longer in this section but is distributed in separate file.

Section 12:
Clarified what forms must be completed for NDI notifications of death. Deleted references to ACS
(Ascertainment Control Sheet) as this has been merged with the ATC (Ascertainment Tracking
Checklist). Deleted disease code #330 (heart disease, non-specified) from Appendix B.

Section 13:
Updated number of participants enrolled in substudy during the expansion. Updated Section IV, J
(subgingival plaque sample procedure, OP10) to indicate that samples should be obtained for both


                              Final Form and Protocol Changes Page 13 of 19
                                                3/21/2003
              FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
facial and lingual sites with a positive gingival banding score, a papillary assessment score of 1,2,3
or 5, or loss of attachment of at least 2 mm since the previous oral visit (additions are underlined).

Section 14:
No changes.

Section 15:
No changes. Merged Appendix B into section in PDF version.

Section 16:
Updated procedures for inclusion of new recruits.

Section 17:
No changes.

Section 18:
Updated protocol regarding form processing for extra 3rd trimester visit.

Section 19:
Changed all references from AIDS and Cancer Specimen Bank (ACSB) to AIDS and Cancer
Specimen Resource (ACSR).

Section 20:
Updated NDI data transmission procedures. Clarified what forms must be completed for NDI
notifications of death. Include updated ACSR forms after page 14.

Section 21:
Deleted Section III H. ADVERSE EVENTS. The genotyping test is now FDA approved and no
longer subject to additional reporting. Added section “Core Random PK Visit”
   a. A core Random PK visit should be done when a Core 2 hour PK visit is indicated, but cannot
       be completed due to logistical problems. This will most likely be the case when a participant
       switches to a PI or NNRTI, which is only taken once a day, and they take their dose at night
       (i.e., Efavirenz). Core random PK visits may be combined with Core Visits.
   b. Collect one 8ml EDTA (purple top) tube on ice. Record date and time of this 0 minute blood
       sampling on VRS29 specimen collection form. No other blood samples need to be collected
       at time 00 as all other tests will or can be run on blood collected at the core visit.
   c. Administer questionnaires (VRS03, VRS04).
   d. Obtain a signed release for release of medication records and contact the participant’s
       medical provider in order to complete VRS06.

Section 22:
Made minor typographical changes.

Section 23:
Made minor typographical changes.




                               Final Form and Protocol Changes Page 14 of 19
                                                 3/21/2003
              FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Section 24:
Added hair clips to list of supplies. In Section G, switched instructions 3 and 4. Updated storage
and shipping procedures according to Communications Memo 335

Section 25:
Metabolic Substudy (Prospective) – New protocol; to be distributed when complete.

Section 26:
Intensive PK Substudy – New protocol; to be distributed when complete.

Section 27:
Sex Steroid Substudy – New protocol; to be distributed when complete.

Section 28:
Pap Smear Re-read Protocol – New protocol; to be distributed when complete.




                              Final Form and Protocol Changes Page 15 of 19
                                                3/21/2003
           FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL

                              VRS FORM CHANGES
Form     Visit #       Form Version    Changes from previous version.
VRS 1    13            10/01/00        NA

VRS 1R   15,16,17,     01/01/02        NA
         18
VRS 2    13            10/01/00        NA

VRS 3    13, 14, 15,   10/01/00        NA
         16
VRS 3    17, 18        10/01/02        Deleted questions Deleted questions D2, D2a, D3, D3a, D4 and D4a.
                                       Deleted question D5 and D5a except for “St. John’s Wort”.
                                       Renumbered the following questions accordingly
VRS 4    13, 14        10/01/00        NA

VRS 4    15            (10/01/00a)*    Added medications to match Drug Form 1.
                       10/01/00b       Changed sequence of medication names to match Drug Form 1.

VRS 4    15.1          (01/01/02)*     Changed instruction in B3 to enter dosage of solutions in mg/ml instead of
                       01/01/02a       #cc per dose. Changed designation from “mg or cc” to “mg” only.

                                       Changed “(pills/packs/cc)” in question B4. to “(pills/packs/ml)”

                                       Added variable at the end of B4a to indicate whether this was an observed
                                       dose.

                                       Added variable B5: When did you start (DRUG)

VRS 4    16,17         01/01/02b       Added Viread as a name for drug code 234 to match Drug Form 1.
                                       Revised QbyQs to specify that the last time participant took her medication
                                       is the last time she took it before her blood was drawn. (5/30/02)
VRS 4    18            01/01/02c       Added 239 Coviracil (emtricitabine, FTC) and 238 Tipranavir (PNU-
                                       140690 to match Drug Form 1. Changed "Fusion" inhibitors to "Entry"
                                       inhibitors, and changed "T-20 (pentafuside)" to "Fuzeon (T-20,
                                       enfuviratide)" to match Drug Form 1.
VRS 5    13            10/01/00        NA

VRS 5    14            04/01/01        Moved A2 and A2a (WIHS Study Visit and Core vs 3 month VRS visit) to
                                       below A5.

                                       Changed medication list in A6 to check list.

                                       Replaced A7 through A11 with A8 through A14.
VRS 5    15            (04/01/01a)*    Added medications to match Drug Form 1.
                       04/01/01b
                                       Changed sequence of medication names to match Drug Form 1.

VRS 5    15.1          04/01/01c       Moved A2 and A2a (WIHS Study Visit and Core vs 3 month VRS visit) to
                                       below A5.

                                       Changed medication list in A6 to check list.

                                       Replaced A7 through A11 with A8 through A14.

VRS 5    16,17         04/01/01d       Added Viread as a name for drug code 234 to match Drug Form 1.
VRS 5    18            04/01/03        Added 239 Coviracil (emtricitabine, FTC) and 238 Tipranavir (PNU-


                              Final Form and Protocol Changes Page 16 of 19
                                                3/21/2003
           FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Form     Visit #   Form Version Changes from previous version.
                                140690 to match Drug Form 1. Changed "Fusion" inhibitors to "Entry"
                                inhibitors, and changed "T-20 (pentafuside)" to "Fuzeon (T-20,
                                enfuviratide)" to match Drug Form 1.

                                       Question A11 will be data entered as well.
VRS 6    13            10/01/00        NA

VRS 6    13.1, 14      10/01/00a       In question B2c – B9c, dropped “cc”.

                                       In question B2c – B9c, moved “*LEAVE BLANK FOR MEDS
                                       COMBINING TWO OR MORE SUBSTANCES” from bottom of cell to
                                       middle of cell.

VRS 6    15, 16,17,    10/01/00b       In question 4e, corrected spacing.
         18
VRS 6r   16, 17, 18    06/01/02        NA
VRS 29   13            10/01/00        none

VRS 29   13.1, 14,     10/01/00a       Corrected Header from “WOMEN’S INTERAGENCY HIV STUDY” to
         15                            “WIHS VIROLOGIC REBOUND AND RESISTANCE STUDY”.

                                       Changed version date and footer
VRS 29   15.1          (01/01/02)*     Added variable to differentiate type of blood draw. (A2)
                       01/01/02a
                                       Change A3 to read “time of first (0 min) or only blood draw” from “time of
                                       first (0 min) blood draw”
                                       Added skip instruction after A4.

                                       Added skip instruction after B1.

                                       Added skip instruction after B4.
VRS 29   16            01/01/02b       Corrected skip pattern in A2 for core and 3 month 2 hour PK visits. Skip
                                       now reads “COMPLETE A3-A11”; instead of A3-A9.
VRS 29   17            10/01/02        Corrected skip pattern in A2.

                                       Changed prompt before A6 to read “COLLECT 2ND SAMPLE 120
                                       MINUTES AFTER PATIENT TAKES MEDICATION” instead of
                                       “COLLECT 2ND SAMPLE 30 MINUTES AFTER PATIENT TAKES
                                       MEDICATION”

                                       Deleted A8-A11.

                                       Changed prompt before B5 to read “IF A2 EQUALS 3 OR 4 (RANDOM
                                       OR NON PK) CIRCLE “3” (NA) FOR B5” instead of IF A2 EQUALS 3
                                       OR 4 (RANDOM OR NON PK) CIRCLE “3” (NA) FOR B5, B6 and B7”.

                                       Changed B5 to “120 minute PK sample”

                                       Deleted B6 and B7.
VRS 29   18            04/01/03        In A2., added “Core Random PK”
VRS 10   13, 14, 15,   01/12/01        NA
         16
VRS 10   17, 18        10/01/02        In section B., changed “30 minute sample” to “120 minute sample”.

                                       Deleted sections C and D.



                              Final Form and Protocol Changes Page 17 of 19
                                                3/21/2003
                FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL
Form          Visit #   Form Version Changes from previous version.
                                     Changed version date at top and in footer.
VRS NOTI      13,       10/01/00     NA
              15,16,17,
              18


*not implemented

VRS visit types

       CORE VISITS
        Administer VRS 5 after completion of the core interview.

Core Non – PK Visit (No change in ART or patient not currently on any PI/NNRTI)
   - Administer VRS 3 and VRS 4 at core visit.

Core 2 hour PK visit (Change in Art and participant currently on PI or NNRTI)
   - Schedule core 2 hour PK visit within 2 weeks of core visit
   - Schedule participant within 2 hours of when she usually takes her ART. If participant takes her medications at
        different times, schedule according to when she takes her PI. If she doesn’t take a PI, schedule according to the
        NNRTI.
   - Collect one 8ml EDTA tube on ice (B2 on VRS 29)
   - Have participant take her HAART medication.
   - Collect one 8ml EDTA tube on ice at 120 minutes after participant takes medication (B5 on VRS 29)
   - Administer VRS 3 and VRS 4, complete VRS 29.
   - Obtain medication record release and contact participant’s physician to complete VRS 6.

       3 MONTH VISITS
        Administer VRS 5 when scheduling 3 month visit or at the beginning of the visit.

3 month random PK visit (No change in ART and participant currently on a PI and/or NNRTI)
   - Collect one 8ml CPT tube, one 8ml EDTA (purple top) on ice for random PK, and one 8ml or two 5 ml purple
       tops for CBC/Diff and T-cell subsets. (B1-B4 on VRS 29)
   - Administer F22MED, F22HX, Drug Form 1, Drug Form 2, VRS 3 and VRS 4. Complete VRS 29.

3 month 2 hour PK visit (Change in ART and participant currently on a PI and/or NNRTI)
   - Schedule participant within 2 hours of when she usually takes her ART. If participant takes her medications at
       different times, schedule according to when she takes her PI. If she doesn’t take a PI, schedule according to the
       NNRTI.
   - Collect one 8ml CPT tube, one 8ml EDTA (purple top) on ice for random PK, and one 8ml or two 5 ml purple
       tops for CBC/Diff and T-cell subsets. (B1-B4 on VRS 29)
   - Have participant take her HAART medication.
   - Collect onw 8ml EDTA tube on ice at 120 minutes after participant takes medication (B5 on VRS 29)
   - Administer F22MED, F22HX, Drug Form 1, Drug Form 2, VRS 3 and VRS 4. Complete VRS 29.
   - Obtain medication record release and contact participant’s physician to complete VRS 6.

3 month non PK visit (Participant not currently on a PI or NNRTI)
   - Collect one 8ml CPT tube, and one 8ml or two 5 ml purple tops for CBC/Diff and T-cell subsets. (B1, B3 and
       B4 on VRS 29)
   - Administer F22MED, F22HX, Drug Form 1, Drug Form 2, VRS 3 and VRS 4. Complete VRS 29.
   - If participant had a change in ART, obtain medication record release and contact participant’s physician to
       complete VRS 6.




                                    Final Form and Protocol Changes Page 18 of 19
                                                      3/21/2003
            FINAL FORM AND PROTOCOL CHANGES FOR VISIT 18 TRAINING CALL


                        VRS PROTOCOL CHANGES
1.    Page 7: added section “Core Random PK Visit:”
         a. A core Random PK visit should be done when a Core 2 hour PK visit is indicated, but
             cannot be completed due to logistical problems. This will most likely be the case
             when a participant switches to a PI or NNRTI which is only taken once a day and
             they take their dose at night (i.e. Efavirenz). Core random PK visits may be
             combined with Core Visits.
         b. collect one 8ml EDTA (purple top) tube on ice. Record date and time of this 0
             minute blood sampling on VRS 29 specimen collection form. No other blood
             samples need to be collected at time 00 as all other tests will or can be run on
             blood collected at the core visit.
         c. Administer questionnaires (VRS 3, VRS 4).
         d. Obtain a signed release for release of medication records and contact the participant’s
             medical provider in order to complete VRS 6.

2. Deleted Section III H. ADVERSE EVENTS. The genotyping test is now FDA approved an no
longer subject to additional reporting.




                            Final Form and Protocol Changes Page 19 of 19
                                              3/21/2003

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:40
posted:10/28/2011
language:English
pages:19