HIV Surveillance Programs HIV Case Report Form Revisions Suzanne Whitmore DrPH CSTE Webinar October 2 2012 National Center for HIVAIDS Viral Hepatitis STD and TB Prevention HIV Incidence and Case Surveillance Branch ID: 931976
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Technical Guidance for HIV Surveillance ProgramsHIV Case Report Form Revisions
Suzanne Whitmore, DrPH
CSTE WebinarOctober 2, 2012
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
HIV Incidence and Case Surveillance Branch
Slide2Objectives/GoalsReview major Adult and Pediatric HIV confidential case report forms revisions from 2011 and 2012
Slide3ContentsAdult Form
Slide4Patient Identification
Change / New
Change: Patient Identifier Information is not transmitted to CDC to *Information NOT transmitted to CDC
New: Asterisks added before field name for fields not transmitted to CDC
Change: Name order previously last, first, middle now first, middle, last
New: Alternate name type added
New: Address type added
Change: Medical Record No moved from HARS form Section VII
New: Additional ID field added
Title:
HIV/AIDS was changed to HIV
Any section that included dates had next to the header:
(record all dates as mm/
dd
/
yyyy
)
Section I
:
Notes: Section
1. State/Local Use Only
on HARS form now
Patient
Identification
section on
new
form
.
Slide5Health Department Use Only & Facility Providing Information
Changes / New
New: Date Received at Health Department added
New: eHARS Document UID added
New: State Patient No. from HARS form changed to State Number on new form
Change: Reporting Health Department State on HARS form not on current form (auto completed in eHARS); retained city/county on new form
Change: Report source on HARS form now Document Source
Change: Report Status on HARS form not on current form
New: Surveillance Method added
New: Did this Report Initiate a New Case Investigation added
New: Report Medium added
New: Facility Providing Information section added, with facility name, street address, city, county, state/county and zip code. Additional options were added to indicate facility type
Change: Person Completing the Form & Phone number moved from HARS form Section VII
Change: Facility setting removed
Section II:
Notes:
Section II. Health Department Use
only on HARS form now
Health
Department Use Only & Facility Providing Information
sections on new form.
Slide6Patient Demographics (1)
Changes / New
Change: Order of variables changed to match eHARS
Change: Diagnostic status removed
Change: Age at diagnosis removed
Change: Sex from HARS form changed to Sex assigned at Birth
Change: Country of Birth changed from four options to two
New: Alias Date of Birth added
Change: Name changed from Current Status to Vital Status; Unknown removed as option for Vital Status
Change: State/Territory of Death changed to State of Death
Section III:
Notes:
Section III. Demographic Information
on HARS form now
Patient Demographics
section on new form.
Slide7Patient Demographics (2)
Changes / New
New: Current Gender Identity added (categories different from current
eHARS
New: Extended Ethnicity field added
Change: Race (select one or more) to Race (check all that apply)
New: Extended race field added
New: (add additional addresses in Comments) added next to Residence at Diagnosis
New: Diagnosis Type added to qualify Residence of Diagnosis; Check if SAME as Current Address added as an option
New: Added under residence at diagnosis for address type (check all that apply to the address below)
New: Street Address included with Residence of Diagnosis
Slide8Facility of Diagnosis
Changes / New
Change: Diagnosis Type added to qualify Facility of Diagnosis; Check if SAME as Facility Providing Information added as an option; Added (add additional facilities in Comments)
New: Added under diagnosis type (check all that apply to the facility below)
New: address field added
New: Phone Number added
New: Zip code added
Change: Included additional options to indicate facility type
Change: Provider Name added
Change Provider Phone added
Change: Provider Specialty added
Change: Facility setting removed
Section IV:
Notes: Section IV Facility of Diagnosis on HARS form is also Facility of Diagnosis
section on
new
form
Slide9Patient History (1)
Changes / New
New: Option to indicate Pediatric Risk factors included in Section header
Change: Sub Header on HARS form “After 1977 and Preceding First Positive Antibody test or AIDS Diagnosis, this Patient Had” has been replaced with “After 1977 and before the earliest known diagnosis of HIV infection, this patient had”
Change: Clotting factors on HARS form specified- on eHARS form users just asked to specify with a write in and date received
Change: Heterosexual risk section highlighted
Change: Heterosexual risk section capitalization of HETEROSEXUAL for emphasis
Change: Heterosexual risk section variable “heterosexual contact with person with hemophilia coagulation disorder” updated to include at end “with documented HIV infection”
Section V:
Notes:
Section V. Patient History
on HARS form is also
Patient History
section on
new
form
Slide10Patient History (2)
Change: day for mm/
dd/
yyyy added for Received transfusion of blood/blood components (other than clotting factor); added (document reason in Comments section) for this field
Change: (specify occupation) under “Worked in a health-care or clinical laboratory setting” changed to “If occupational exposure is being investigated or considered as primary mode of exposure, specify occupation and setting”
Change: Other Documented Risk added
Change: No Risk Reported added with shaded row and qualifier “Health Department Use Only”
Slide11Laboratory Data (1)
Changes / New
New: The Laboratory Data header was updated with “record additional tests in Comments section”
Change: The lab section was revised to allow users to record multiple tests of the same test type
Change: The “HIV Antibody Tests at Diagnosis” header was changed to HIV Antibody Tests (Non-type differentiating) and (Type differentiating)
Change: “Indicate first test” and “Record earliest test” were removed from the HIV Antibody Tests at Diagnosis and HIV Detection Tests sections
Change: “Positive” and ”Negative” were changed to “Positive/Reactive” “Negative/Nonreactive”, respectively
Change: “Not Done” was removed as response option under the “HIV Antibody Tests at Diagnosis” section
Change: “Test Date” was changed to “Collection Date”
New: A place holder for day was added to all collection dates.
Change: The list of lab tests was ordered to match eHARS
Change: HIV-1 IFA and HIV-1 Western blot are now separate Antibody tests
Section VI:
Notes:
Section VI. Laboratory Data on
HARS form is also
Laboratory Data
section on
new
form.
Slide12Laboratory Data (2)
Changes / New
New: Additional HIV antibody tests (non-type differentiating) were added: HIV-1/2 Ag/
Ab
, HIV-2 EIA, and HIV-2 Western Blot.
New: Added a check box to capture rapid tests in the “HIV Antibody Tests (non-type differentiating)” section.
New: Additional HIV antibody tests (type differentiating) were added: HIV-1/2 Differentiating (e.g. Multispot) along with the results. Result can be captured as: HIV-1, HIV-2, both (undifferentiated), or neither (negative).
Change: The “Positive HIV Detection Test” section was split into two sections: “HIV Detection Tests (Qualitative)” and “HIV Detection Tests (Qualitative viral load)”.
Change: Changed the “Positive HIV Detection Test” section (culture, antigen, and PCR, DNA or RNA probe) to “HIV Detection Tests (Qualitative)” and changed tests to: HIV-1 RNA/DNA NAAT (
Qual
), HIV-1 P24 Antigen, HIV-1 Culture, HIV-2 RNA/DNA NAAT (
Qual
) and HIV-2 Culture. Removed the “Other, specify” option.
Slide13Laboratory Data (3)
Changes / New
Change: The “Detectable Viral Load test (Record earliest test)” was changed to “HIV Detection tests (Quantitative viral load)”. Added: “RNA/DNA NAAT (Quantitative viral load)” to differentiate from the qualitative RNA/DNA NAAT.
New: Added detectable and undetectable results and the log field in the “HIV Detection tests (Quantitative viral load)” section.
Change: Removed the two digit test type response in the “HIV Detection tests (Quantitative viral load)” section.
Change: “Note: include earliest test after diagnosis” was added to the “HIV Detection Tests (Quantitative viral load)” section.
Change: The “Immunologic lab tests” header was changed to “Immunologic Tests (CD4 count and percentage)”
New: Added a header for the “Documentation of Tests” section
Slide14State/Local Use Only (former)
Changes / New
Change: Physician name now included with Facility of Diagnosis
Change: Physician phone now included with Facility of Diagnosis
Change: Medical Record number now included with Patient Identification
Change: Hospital / Facility now included with Facility Providing Information
Change: Person Completing the Form and Phone Number now included with Facility Providing Information
Section VII:
Notes: Section VII State / Local use only on HARS form does not
exist on
new
form.
Slide15Clinical
Changes / New
Change:
Removed
Clinical Record Reviewed
Change:
Removed
Date Patient was Diagnosed “Asymptomatic” and “Symptomatic”
Change: Remove
d“If
HIV tests were not positive or were not done, does this patient have an immunodeficiency that would disqualify him/her from the AIDS case definition?”
Section VIII:
Notes:
Section VIII. Clinical Status
on HARS form is now
Clinical
section on
the new f
orm.
Slide16Treatments/Services Referrals
Changes / New
Change: Removed “This patient has been enrolled at Clinical Trial / Clinic”
Change: Removed HARS field “This patient’s medical treatment primarily reimbursed by:”
Change: Removed HARS field “ This patient received or is receiving”
Change: Removed HARS field “This patient is receiving or has been referred for”
Change: Child’s state Patient No. is now Child’s state number
Change: Added street address, county, phone number and zip code to hospital of birth
New: Added Child’s Name
New: Added Child’s Coded ID
New: Added “born at home enter “home birth” for hospital name
Section IX:
Notes:
Section IX.
Treatments/Services Referrals
on HARS form is also
Treatments/Services Referrals
section on new form.
Slide17Incidence Testing and Treatment History New Section: Incidence Testing and Treatment History Including questions on previous testing and medications.
Slide18ContentsPediatric Form (sections not covered in the adult form revisions)
Slide19Patient Demographics
Changes / New
Change: Diagnostic status options changed to match
eHARS
Change: Removed age at HIV diagnosis and age at AIDS diagnosis
Change: Date of Birth italicized to indicate required field in
eHARS
New: Date of Last Medical Evaluation field added
Change: Was reason for initial HIV evaluation field removed
Section III:
Notes:
Section III. Demographic Information
on HARS form now
Patient Demographics
section on the new form.
Slide20Patient History (1)
Changes / New
Change: Sub Header on HARS form “After 1977 and Preceding First Positive Antibody test or AIDS Diagnosis, this Patient Had” was replaced with “After 1977 and before the earliest known diagnosis of HIV infection, this child’s biological mother had”
New: Perinatally acquired HIV infection added as risk option
Change: Child’s biologic mother’s HIV infection status (check one) to child’s biological mother’s HIV infection status (select one)
Change: Clotting factors on HARS form specified for child- on eHARS form users just asked to specify with a write in and date received
Change: Heterosexual risk section highlighted
Change: Heterosexual risk section capitalization of HETEROSEXUAL for emphasis
New: Added “biological mother had” next to HETEROSEXUAL relations
Section V:
Notes
: Section V. Patient History/Maternal History
on HARS form is now
Patient History
section on
new
form
Slide21Patient History (2)
Change: Heterosexual risk section variable “heterosexual contact with person with hemophilia coagulation disorder” updated to include at end “with documented HIV infection”
Change: day for mm/dd/yyyy added for Received transfusion of blood/blood components (other than clotting factor); added (document reason in Comments section) for this field
Change: Order for child risks changed to match eHARS
Change: Other Documented Risk added; (please include detail in Comments section) added replacing (Alert State/City NIR Coordinator)
Change: No Risk Reported added with shaded row and qualifier “Health Department Use Only”
Slide22Laboratory Data
Change: “If HIV tests were not positive or were not done, or the patient is less than 18 months of age, does this patient have an immunodeficiency that would disqualify him/her from the AIDS case definition” field was removed
Change: Documentation of Tests header added to the “If laboratory tests were not document, is patient confirmed by a physician as”
Slide23Birth History and Treatment/Services Referral
Changes / New
Change: Unknown option included for neonatal status field
New: Street address added for residence of birth
New: added “Check if SAME as Facility of Diagnosis” for Hospital of Birth; added street address and phone number to hospital of birth
New: Additional maternal ID type field added
Change: maternal state patient no to maternal
stateno
Change: birthplace of biologic mother to country of birth
Changes / New
Change: Removed HARS field “This child has been enrolled at” Clinical trial / Clinic
Change: Removed HARS field “This child’s medical treatment primarily reimbursed by:”
Section IX:
Notes:
Section IX. Birth History
on HARS form is also
Birth History
section on
new form.
Section X:
Notes:
Section X. Treatments/Services Referrals
on HARS form is also
Treatments/Services Referrals
section on
new
form.
Slide242012 Changes (1)Changes that were made to both the ACRF and the PCRF forms:Added “Manufacturer” for each test in the HIV Antibody (Non-type differentiating) section. We will provide a space for sites to capture the manufacturer of the immunoassays on the CRF. There will be a drop down list of all of the known manufacturers + other (for future manufactures) in eHARS v4.0.
Added another row for TEST 3 to the HIV Antibody (Non-type differentiating) section on the ACRF. This will be very helpful as the number of immunoassays being reported may increase with the new algorithms.
Slide252012 Changes (2)Added another row to the Immunologic Tests section to capture CD4 results that don’t fall under one of the two categories currently listedOther CD4 result: CD4 count: cells/µL CD4 percentage: % Collection Date: /
/ Added another row to the Documentation of Tests section to capture persons diagnosed through one of the new
algorithms
Slide262012 Changes (3)Complete only if none of the following was positive: HIV-1 Western blot, IFA, culture, p24 Ag test, viral load, or qualitative NAAT [RNA or DNA]: Did documented laboratory test results meet approved HIV diagnostic algorithm criteria? Yes □ No □ Unknown
If YES, provide date (specimen collection date if known) of earliest positive test: / /
Re-ordered the rows in the Documentation of Tests section (adult). Added New algorithm question
and Physician diagnosis question Changed Date of last documented negative HIV test to Date of last documented negative HIV test (before HIV diagnosis date)
___/___/____ (adults)
Slide272012 Changes (4) To both forms:Removed phone number for person completing form for State/local use only section Under Patient History section removed AIDS from PERSON WITH AIDS OR DOCUMENTED HIV INFECTION, RISK NOT SPECIFIED Added to Laboratory section header : (record all dates as
mmddyyyy)Removed Definitive and Presumptive distinction from Clinical
Slide282012 Changes (5)Changes made to the PCRF:Under Birth History:Changed Neonatal Status Weeks to Neonatal Gestational Age in Weeks Changed Prenatal Care- Month of Pregnancy Prenatal Care Began to Gestational Month Prenatal Care Began Did the mother receive zidovudine
(ZDV, AZT) prior to this pregnancy to Did mother receive any Anti-retrovirals (ARVs) prior to this pregnancy?Added if yes, specify
all
Slide292012 Changes (6)Did the mother receive zidovudine (ZDV, AZT) during pregnancy to Did mother receive any ARVs) during pregnancy?Added all to if yes, specifyDid the mother receive zidovudine (ZDV, AZT) during labor/delivery to Did mother receive any ARVs during labor/delivery?
Added all to if yes, specifyUnder Services ReferralsChanged Neonatal zidovudine
(ZDV, AZT) for HIV prevention to Neonatal ARVs for HIV prevention
Slide302012 Changes (7)To the PHER form (approx. 20 questions):The critical variables were identified as:1. If information on the mother is not available, was the child adopted, or in foster care?2. Records abstracted
3. Weeks’ gestation at first prenatal care visit (changed from: month of pregnancy during which prenatal care began (mos) (99 = unknown) or (in weeks if month is not noted in chart)
4. Was the mother screened for any of the following during pregnancy?5. Diagnosis (for the mother) of the following conditions during this pregnancy or at the time of labor and delivery
Slide312012 Changes (8)6. Mother's reproductive history7. Complete the chart for all siblings.8. Was substance use during pregnancy noted in the medical or social work records? 8a. If yes, indicate which substances were used during pregnancy.8b. If substances used, were any injected?
9. Was a toxicology screen done on the mother (either during pregnancy or at the time of delivery)?
10. Was a toxicology screen done on the infant at birth? 11. Was the mother's HIV serostatus noted in her prenatal care medical records?
Slide322012 Changes (9) 12. Were antiretroviral drugs prescribed for the mother during this pregnancy? 12a. If no antiretroviral drug was prescribed during pregnancy, check reason. 13. Was mother's HIV
serostatus noted in her labor and delivery records? 14. Did mother receive antiretroviral drugs during labor and delivery? (added: £ Treatment not indicated)
14a. If no antiretroviral drug was received during labor and delivery, check reason. (added: Hospital did not have ARVs available and Prescribed but not administered)15. Was mother referred for HIV care after delivery?
Slide332012 Changes (10)16. If yes, indicate first CD4 result or first viral load after discharge from hospital 16a. CD4 result 16b. Viral load 17. Birth information 18. If Cesarean delivery, mark all the following indications that apply.
19. Was mother's HIV serostatus noted on the child's birth record?
20. Were antiretroviral drugs prescribed for the child during the first 6 weeks of life? 20a. If no antiretroviral drug was prescribed during the first 6 weeks of life, indicate reason.
Slide34Main Takeaway PointsRemoved the word AIDSExpanded the lab data sectionRemoved Definitive and Presumptive distinction from ClinicalNew Section: Incidence Testing and Treatment History Including questions on previous testing and
medicationsReferences to ZDV, AZT changed to ARTsPHER form: critical variables
added (approx. 20 questions)
Slide35Questions will be taken at the end
Slide36Thank you!For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Place Division name here