Validation of the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) chronic kidney disease risk score in HIV‐infected patients in the USA

Objectives The aim of the study was to assess the validity of an easy‐to‐calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. Methods PLW...

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Veröffentlicht in:HIV medicine 2020-05, Vol.21 (5), p.299-308
Hauptverfasser: Mills, AM, Schulman, KL, Fusco, JS, Brunet, L, Hsu, R, Beyer, A, Prajapati, G, Mounzer, K, Fusco, GP
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container_end_page 308
container_issue 5
container_start_page 299
container_title HIV medicine
container_volume 21
creator Mills, AM
Schulman, KL
Fusco, JS
Brunet, L
Hsu, R
Beyer, A
Prajapati, G
Mounzer, K
Fusco, GP
description Objectives The aim of the study was to assess the validity of an easy‐to‐calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. Methods PLWH (2002–2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco‐Epidemiology Research and Analysis (OPERA®) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft–Gault (C‐G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to < 60 mL/min/1.73 m2 (stages 3–5). Poisson models estimated the association between CKD incidence and a one‐point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. Results There were 19 444, 22 727 and 22 748 PLWH in the OPERA C‐G, CKD‐EPI and MDRD samples, respectively. The median (minimum–maximum) follow‐up duration was 6.1 (0.3–9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2–15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person‐years [95% confidence interval (CI) 6.8, 7.9 per 1000 person‐years] in OPERA C‐G to 11.0 (95% CI 10.4, 11.6 per 1000 person‐years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c‐statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. Conclusions The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3–5) probability in an exclusively USA‐based sample regardless of eGFR method.
doi_str_mv 10.1111/hiv.12826
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Methods PLWH (2002–2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco‐Epidemiology Research and Analysis (OPERA®) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft–Gault (C‐G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to &lt; 60 mL/min/1.73 m2 (stages 3–5). Poisson models estimated the association between CKD incidence and a one‐point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. Results There were 19 444, 22 727 and 22 748 PLWH in the OPERA C‐G, CKD‐EPI and MDRD samples, respectively. The median (minimum–maximum) follow‐up duration was 6.1 (0.3–9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2–15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person‐years [95% confidence interval (CI) 6.8, 7.9 per 1000 person‐years] in OPERA C‐G to 11.0 (95% CI 10.4, 11.6 per 1000 person‐years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c‐statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. Conclusions The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3–5) probability in an exclusively USA‐based sample regardless of eGFR method.</description><identifier>ISSN: 1464-2662</identifier><identifier>EISSN: 1468-1293</identifier><identifier>DOI: 10.1111/hiv.12826</identifier><identifier>PMID: 31985887</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Antiretroviral agents ; chronic kidney disease ; Confidence intervals ; Data collection ; Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) risk score ; Derivation ; Drugs ; Epidemiology ; Epidermal growth factor receptors ; Glomerular filtration rate ; Health risks ; HIV ; Human immunodeficiency virus ; Kidney diseases ; Kidneys ; Original Research ; renal impairment ; Risk ; Risk assessment ; Samples ; Statistical analysis ; Statistical methods ; validation ; Validity</subject><ispartof>HIV medicine, 2020-05, Vol.21 (5), p.299-308</ispartof><rights>2020 The Authors. published by John Wiley &amp; Sons Ltd on behalf of British HIV Association</rights><rights>2020 The Authors. HIV Medicine published by John Wiley &amp; Sons Ltd on behalf of British HIV Association.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4436-add1deb85856184bc8d5b98161a4dfa1e7108d68dda39115215023433d74c7183</citedby><cites>FETCH-LOGICAL-c4436-add1deb85856184bc8d5b98161a4dfa1e7108d68dda39115215023433d74c7183</cites><orcidid>0000-0003-1556-811X ; 0000-0001-8467-4835 ; 0000-0001-6168-9356</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhiv.12826$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhiv.12826$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31985887$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mills, AM</creatorcontrib><creatorcontrib>Schulman, KL</creatorcontrib><creatorcontrib>Fusco, JS</creatorcontrib><creatorcontrib>Brunet, L</creatorcontrib><creatorcontrib>Hsu, R</creatorcontrib><creatorcontrib>Beyer, A</creatorcontrib><creatorcontrib>Prajapati, G</creatorcontrib><creatorcontrib>Mounzer, K</creatorcontrib><creatorcontrib>Fusco, GP</creatorcontrib><title>Validation of the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) chronic kidney disease risk score in HIV‐infected patients in the USA</title><title>HIV medicine</title><addtitle>HIV Med</addtitle><description>Objectives The aim of the study was to assess the validity of an easy‐to‐calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. Methods PLWH (2002–2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco‐Epidemiology Research and Analysis (OPERA®) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft–Gault (C‐G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to &lt; 60 mL/min/1.73 m2 (stages 3–5). Poisson models estimated the association between CKD incidence and a one‐point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. Results There were 19 444, 22 727 and 22 748 PLWH in the OPERA C‐G, CKD‐EPI and MDRD samples, respectively. The median (minimum–maximum) follow‐up duration was 6.1 (0.3–9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2–15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person‐years [95% confidence interval (CI) 6.8, 7.9 per 1000 person‐years] in OPERA C‐G to 11.0 (95% CI 10.4, 11.6 per 1000 person‐years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c‐statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. Conclusions The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3–5) probability in an exclusively USA‐based sample regardless of eGFR method.</description><subject>Antiretroviral agents</subject><subject>chronic kidney disease</subject><subject>Confidence intervals</subject><subject>Data collection</subject><subject>Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) risk score</subject><subject>Derivation</subject><subject>Drugs</subject><subject>Epidemiology</subject><subject>Epidermal growth factor receptors</subject><subject>Glomerular filtration rate</subject><subject>Health risks</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Kidney diseases</subject><subject>Kidneys</subject><subject>Original Research</subject><subject>renal impairment</subject><subject>Risk</subject><subject>Risk assessment</subject><subject>Samples</subject><subject>Statistical analysis</subject><subject>Statistical methods</subject><subject>validation</subject><subject>Validity</subject><issn>1464-2662</issn><issn>1468-1293</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kUFPHCEYhknTplrbQ_9AQ9KLHkbnA4ZhPDSZ7NpqYuKh1SthgXHREbYwu2Zv_Qne_H_9JWV3rGkPcoHwPd_7vfAi9BHKQ8jraO5Wh0AE4a_QLjAuCiANfb09s4JwTnbQu5RuyhJq2pRv0Q6FRlRC1Lvo8Ur1zqjBBY9Dh4e5xVM1KDwJfW_1eO1xa1Y2JotPVtYPaQO2fnC_fz2cnl3haVxeJ7w_PW6PpwdYz2PwTuNbZ7xdY-OSVbkzunSLkw7RYudxbsvNznd5hDV4kedvhXNp4-Dye_sevelUn-yHp30PXX49-TE5Lc4vvp1N2vNCM0Z5oYwBY2f5MRUHwWZamGrWCOCgmOkU2BpKYbgwRtEGoCJQlYQySk3NdA2C7qEvo-5iObuzRmcbUfVyEd2dimsZlJP_V7yby-uwkjWBGmqWBT4_CcTwc2nTIG_CMvrsWRLaECDARZOpg5HSMaQUbfc8AUq5yVDmDOU2w8x--tfSM_k3tAwcjcC96-36ZSWZv3mU_AMMR6fk</recordid><startdate>202005</startdate><enddate>202005</enddate><creator>Mills, AM</creator><creator>Schulman, KL</creator><creator>Fusco, JS</creator><creator>Brunet, L</creator><creator>Hsu, R</creator><creator>Beyer, A</creator><creator>Prajapati, G</creator><creator>Mounzer, K</creator><creator>Fusco, GP</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-1556-811X</orcidid><orcidid>https://orcid.org/0000-0001-8467-4835</orcidid><orcidid>https://orcid.org/0000-0001-6168-9356</orcidid></search><sort><creationdate>202005</creationdate><title>Validation of the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) chronic kidney disease risk score in HIV‐infected patients in the USA</title><author>Mills, AM ; Schulman, KL ; Fusco, JS ; Brunet, L ; Hsu, R ; Beyer, A ; Prajapati, G ; Mounzer, K ; Fusco, GP</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4436-add1deb85856184bc8d5b98161a4dfa1e7108d68dda39115215023433d74c7183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antiretroviral agents</topic><topic>chronic kidney disease</topic><topic>Confidence intervals</topic><topic>Data collection</topic><topic>Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) risk score</topic><topic>Derivation</topic><topic>Drugs</topic><topic>Epidemiology</topic><topic>Epidermal growth factor receptors</topic><topic>Glomerular filtration rate</topic><topic>Health risks</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Kidney diseases</topic><topic>Kidneys</topic><topic>Original Research</topic><topic>renal impairment</topic><topic>Risk</topic><topic>Risk assessment</topic><topic>Samples</topic><topic>Statistical analysis</topic><topic>Statistical methods</topic><topic>validation</topic><topic>Validity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mills, AM</creatorcontrib><creatorcontrib>Schulman, KL</creatorcontrib><creatorcontrib>Fusco, JS</creatorcontrib><creatorcontrib>Brunet, L</creatorcontrib><creatorcontrib>Hsu, R</creatorcontrib><creatorcontrib>Beyer, A</creatorcontrib><creatorcontrib>Prajapati, G</creatorcontrib><creatorcontrib>Mounzer, K</creatorcontrib><creatorcontrib>Fusco, GP</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>HIV medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mills, AM</au><au>Schulman, KL</au><au>Fusco, JS</au><au>Brunet, L</au><au>Hsu, R</au><au>Beyer, A</au><au>Prajapati, G</au><au>Mounzer, K</au><au>Fusco, GP</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validation of the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) chronic kidney disease risk score in HIV‐infected patients in the USA</atitle><jtitle>HIV medicine</jtitle><addtitle>HIV Med</addtitle><date>2020-05</date><risdate>2020</risdate><volume>21</volume><issue>5</issue><spage>299</spage><epage>308</epage><pages>299-308</pages><issn>1464-2662</issn><eissn>1468-1293</eissn><abstract>Objectives The aim of the study was to assess the validity of an easy‐to‐calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. Methods PLWH (2002–2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco‐Epidemiology Research and Analysis (OPERA®) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft–Gault (C‐G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to &lt; 60 mL/min/1.73 m2 (stages 3–5). Poisson models estimated the association between CKD incidence and a one‐point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. Results There were 19 444, 22 727 and 22 748 PLWH in the OPERA C‐G, CKD‐EPI and MDRD samples, respectively. The median (minimum–maximum) follow‐up duration was 6.1 (0.3–9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2–15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person‐years [95% confidence interval (CI) 6.8, 7.9 per 1000 person‐years] in OPERA C‐G to 11.0 (95% CI 10.4, 11.6 per 1000 person‐years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c‐statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. Conclusions The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3–5) probability in an exclusively USA‐based sample regardless of eGFR method.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>31985887</pmid><doi>10.1111/hiv.12826</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-1556-811X</orcidid><orcidid>https://orcid.org/0000-0001-8467-4835</orcidid><orcidid>https://orcid.org/0000-0001-6168-9356</orcidid><oa>free_for_read</oa></addata></record>
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subjects Antiretroviral agents
chronic kidney disease
Confidence intervals
Data collection
Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) risk score
Derivation
Drugs
Epidemiology
Epidermal growth factor receptors
Glomerular filtration rate
Health risks
HIV
Human immunodeficiency virus
Kidney diseases
Kidneys
Original Research
renal impairment
Risk
Risk assessment
Samples
Statistical analysis
Statistical methods
validation
Validity
title Validation of the Data Collection on Adverse Events of Anti‐HIV Drugs (D:A:D) chronic kidney disease risk score in HIV‐infected patients in the USA
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