4 Attachment C2 - Medical_Record_Astraction_short.xlsm

Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP) Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health Services (Non-OAHS)

Attachment C2 - Medical_Record_Astraction_short.xlsm

Medical Record Abstraction

OMB: 0906-0046

Document [xlsx]
Download: xlsx | pdf

Overview

Instructions
List of HIV Medicines
Data Abstraction Tool - SHORT


Sheet 1: Instructions


Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-xxxx. Public reporting burden for this collection of information is estimated to average xx hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857.


DATA TYPE SUMMARY DATA TYPE INSTRUCTIONS
Abstractor and Site Information Name The name of the person doing chart abstraction/data collection
Date The date of data collection/medical chart abstraction
Type 1 Site ID The Type 1 provider side ID
Type 2 Site ID The Type 2 provider side ID
Demographic information Client Identifier Client's eUCI or encrypted client identifier*
Age Client's current age*
Gender Client's current gender*
Initial HIV diagnosis Month and year of initial HIV diagnosis Enter month and year, if known, of initial HIV diagnosis
Medical visit frequency Number of medical visits in 2018 Enter number of client's medical visits in 2018. Medical visits are defined as the provision of professional diagnostic and therapeutic services rendered by a licensed physician, physician's assistant, clinical nurse specialist, or nurse practitioner in an outpatient setting (not a hospital, hospital emergency room, or any other type of inpatient treatment center), consistent with HHS guidelines and including access to antiretroviral and other drug therapies, including prophylaxis and treatment of opportunistic infections and combination antiretroviral therapies. Allowable services include: Diagnostic testing • Early intervention and risk assessment, • Preventive care and screening • Practitioner examination, medical history taking, diagnosis and treatment of common physical and mental conditions • Prescribing and managing of medication therapy • Education and counseling on health issues • Well-baby care • Continuing care and management of chronic conditions • Referral to and provision of HIV-related specialty care (includes all medical subspecialties even ophthalmic and optometric services)
At least one outpatient medical visit during first 9 months of 2018 Answer yes, no, or unknown if the client had at least one outpatient medical visit in 2018.
Second outpatient medical visit at least 90 days after any previous visit in first 9 months of 2018 Answer yes, no, or unknown if the client had a second outpatient medical visit at least 90 days after any previous medical visit in first 9 months of 2018.
Medical visit data source Indicate whether the information found in the medical record regarding the client's medical visits is a primary or secondary source
Prescription of ART Any ART prescription during 2018 Answer yes, no, or unknown if the client had an ART prescribed in 2018. See list of HIV medicines approved by FDA.
ART prescription data source Indicate whether the information found in the medical record regarding the client's ART prescription is a primary or secondary source
Viral load suppression At least one viral load test in 2018 Answer yes, no, or unknown if the client had at least one viral load test in 2018.
Most recent viral load test result in 2018 Answer <200 copies/ml, ≥200 copies/ml, or unknown to record the client's last viral test load result in 2018.
Viral load data source Indicate whether the information found in the client's medical record regarding the viral load test is a primary or secondary source




* This value will be pre-populated from the 2017 RSR.



Sheet 2: List of HIV Medicines

Drug Class Generic Name Brand Name FDA Approval Date
(Other names and acronyms)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (N = 5)
NRTIs block reverse transcriptase, an enzyme HIV needs to make copies of itself. abacavir  Ziagen 17-Dec-98
(abacavir sulfate, ABC)
emtricitabine Emtriva 2-Jul-03
(FTC)
lamivudine  Epivir 17-Nov-95
(3TC)
tenofovir disoproxil  Viread 26-Oct-01
fumarate
(tenofovir DF, TDF)
zidovudine Retrovir 19-Mar-87
(azidothymidine, AZT, ZDV)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (N = 5)
NNRTIs bind to and later alter reverse transcriptase, an enzyme HIV needs to make copies of itself. doravirine  Pifeltro 30-Aug-18
(DOR)
efavirenz  Sustiva 17-Sep-98
(EFV)
etravirine  Intelence 18-Jan-08
(ETR)
nevirapine  Viramune 21-Jun-96
(extended-release nevirapine, NVP) Viramune XR (extended release) 25-Mar-11
rilpivirine Edurant 20-May-11
(rilpivirine hydrochloride, RPV)
Protease Inhibitors (PIs) (N = 6)
PIs block HIV protease, an enzyme HIV needs to make copies of itself. atazanavir Reyataz 20-Jun-03
(atazanavir sulfate, ATV)
darunavir Prezista  23-Jun-06
(darunavir ethanolate, DRV)
fosamprenavir Lexiva 20-Oct-03
(fosamprenavir calcium, FOS-APV, FPV)
ritonavir Norvir 1-Mar-96
(RTV)
*Although ritonavir is a PI, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
saquinavir Invirase 6-Dec-95
(saquinavir mesylate, SQV)
tipranavir Aptivus 22-Jun-05
(TPV)
Fusion Inhibitors (N 1)
Fusion inhibitors block HIV from entering the CD4 cells of the immune system. enfuvirtide Fuzeon 13-Mar-03
(T-20)
CCR5 Antagonists (N=1)
CCR5 antagonists block CCR5 coreceptors on the surface of certain immune cells that HIV needs to enter the cells. maraviroc Selzentry 6-Aug-07
(MVC)
Integrase Inhibitors (N= 2)
Integrase inhibitors block HIV integrase, an enzyme HIV needs to make copies of itself. dolutegravir Tivicay  August 13, 2013 
(DTG, dolutegravir sodium) 
raltegravir Isentress 12-Oct-07
(raltegravir potassium, RAL) Isentress HD  May 26, 2017 
Post-Attachment Inhibitors (N = 1)
Post-attachment inhibitors block CD4 receptors on the surface of certain immune cells that HIV needs to enter the cells. ibalizumab Trogarzo 6-Mar-18
(Hu5A8, IBA, Ibalizumab-uiyk, TMB-355, TNX-355)

Pharmacokinetic Enhancers (N = 1)
Pharmacokinetic enhancers are used in HIV treatment to increase the effectiveness of an HIV medicine included in an HIV regimen. cobicistat  Tybost 24-Sep-14
(COBI)
Combination HIV Medicines (N = 21)
Combination HIV medicines contain two or more HIV medicines from one or more drug classes. abacavir and lamivudine  Epzicom 2-Aug-04
(abacavir sulfate / lamivudine, ABC / 3TC)
abacavir, dolutegravir, and lamivudine Triumeq  22-Aug-14
(abacavir sulfate / dolutegravir sodium / lamivudine, ABC / DTG / 3TC) 
abacavir, lamivudine, and zidovudine Trizivir 14-Nov-00
(abacavir sulfate / lamivudine / zidovudine, ABC / 3TC / ZDV)
atazanavir and cobicistat Evotaz 29-Jan-15
(atazanavir sulfate / cobicistat, ATV / COBI)
bictegravir, emtricitabine, and tenofovir alafenamide  Biktarvy 7-Feb-18
(bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate, BIC / FTC / TAF)
darunavir and cobicistat Prezcobix 29-Jan-15
(darunavir ethanolate / cobicistat, DRV / COBI)
darunavir, cobicistat, emtricitabine, and tenofovir alafenamide Symtuza  July 17, 2018 
(darunavir ethanolate / cobicistat / emtricitabine / tenofovir AF, darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide, darunavir / cobicistat / emtricitabine / tenofovir AF, darunavir / cobicistat / emtricitabine / tenofovir alafenamide fumarate,  DRV / COBI / FTC / TAF) 
dolutegravir and rilpivirine Juluca 21-Nov-17
(dolutegravir sodium / rilpivirine hydrochloride, DTG / RPV)
doravirine, lamivudine, and tenofovir disoproxil fumarate Delstrigo 30-Aug-18
(doravirine / lamivudine / TDF, doravirine / lamivudine / tenofovir DF, DOR / 3TC / TDF)
efavirenz, emtricitabine, and tenofovir disoproxil fumarate Atripla 12-Jul-06
(efavirenz / emtricitabine / tenofovir DF, EFV / FTC / TDF)
efavirenz, lamivudine, and tenofovir disoproxil fumarate Symfi 22-Mar-18
(EFV / 3TC / TDF)
efavirenz, lamivudine, and tenofovir disoproxil fumarate Symfi Lo 5-Feb-18
(EFV / 3TC / TDF)
elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Genvoya 5-Nov-15
(elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide fumarate, EVG / COBI / FTC / TAF)
elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate Stribild 27-Aug-12
(QUAD, EVG / COBI / FTC / TDF)
emtricitabine, rilpivirine, and tenofovir alafenamide Odefsey 1-Mar-16
(emtricitabine / rilpivirine / tenofovir AF, emtricitabine / rilpivirine / tenofovir alafenamide fumarate, emtricitabine / rilpivirine hydrochloride / tenofovir AF, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide, emtricitabine / rilpivirine hydrochloride / tenofovir alafenamide fumarate, FTC / RPV / TAF)
emtricitabine, rilpivirine, and tenofovir disoproxil fumarate Complera 10-Aug-11
(emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate, emtricitabine / rilpivirine / tenofovir, FTC / RPV / TDF)
emtricitabine and tenofovir alafenamide Descovy  4-Apr-16
(emtricitabine / tenofovir AF, emtricitabine / tenofovir alafenamide fumarate, FTC / TAF)
emtricitabine and tenofovir disoproxil fumarate Truvada 2-Aug-04
(emtricitabine / tenofovir DF, FTC / TDF)
lamivudine and tenofovir disoproxil fumarate Cimduo 28-Feb-18
(Temixys, 3TC / TDF)
lamivudine and zidovudine Combivir 27-Sep-97
(3TC / ZDV)
lopinavir and ritonavir Kaletra 15-Sep-00
(ritonavir-boosted lopinavir, LPV/r, LPV / RTV)




https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-approved-hiv-medicines/



Sheet 3: Data Abstraction Tool - SHORT


Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-xxxx. Public reporting burden for this collection of information is estimated to average xx hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857.
OMB Number: 0915-XXXX
Expiration date: XX/XX/20XX






















Abstractor and provider information Demograhic information
(for validation of record)
Initial HIV diagnosis HIV medical visit frequency
(HRSA)
Prescription of ART
(NQF #2083)
Viral load suppression
(NQF #2082)
Notes
Abstractor name Abstraction date Type 1 provider
encrypted ID
Type 2 provider
encrypted ID
Client
encrypted ID
(eUCI)
Client age Client gender Month and year of initial HIV diagnosis Number of outpatient medical visits in 2018 (see defintion) At least one outpatient medical visit in 2018 Second outpatient medical visit at least 90 days after any previous visit in first 9 months of 2018 Medical visit
data source
Any ART prescription in 2018 (see list of HIV medicines) ART prescription data source At least one viral load test in 2018 Last viral load test result in 2018 Viral load data source Additional Information from the Abstractor


















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