Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

Alan R Lifson, Waldo H Belloso, Richard T Davey, Daniel Duprez, Jose M Gatell, Jennifer F Hoy, Eric A Krum, Ray Nelson, Court Pedersen, George Perez, Richard W Price, Ronald J Prineas, Frank S Rhame, James H Sampson, John Worley, INSIGHT Study Group, INSIGHT Endpoint Review Committee Writing Group

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). RESULTS: Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.
OriginalsprogEngelsk
TidsskriftHIV Clinical Trials
Vol/bind11
Udgave nummer4
Sider (fra-til)205-19
Antal sider15
ISSN1528-4336
DOI
StatusUdgivet - 2010

Fingeraftryk

Advisory Committees
Clinical Trials
HIV
Liver Diseases
Coronary Artery Disease
Diabetes Mellitus
Referral and Consultation
Pharmaceutical Preparations
Neoplasms

Citer dette

Lifson, A. R., Belloso, W. H., Davey, R. T., Duprez, D., Gatell, J. M., Hoy, J. F., ... INSIGHT Endpoint Review Committee Writing Group (2010). Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials. HIV Clinical Trials, 11(4), 205-19. https://doi.org/10.1310/hct1104-205
Lifson, Alan R ; Belloso, Waldo H ; Davey, Richard T ; Duprez, Daniel ; Gatell, Jose M ; Hoy, Jennifer F ; Krum, Eric A ; Nelson, Ray ; Pedersen, Court ; Perez, George ; Price, Richard W ; Prineas, Ronald J ; Rhame, Frank S ; Sampson, James H ; Worley, John ; INSIGHT Study Group ; INSIGHT Endpoint Review Committee Writing Group. / Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials. I: HIV Clinical Trials. 2010 ; Bind 11, Nr. 4. s. 205-19.
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title = "Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials",
abstract = "PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). RESULTS: Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72{\%} met {"}confirmed{"} and 13{\%} {"}probable{"} criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.",
author = "Lifson, {Alan R} and Belloso, {Waldo H} and Davey, {Richard T} and Daniel Duprez and Gatell, {Jose M} and Hoy, {Jennifer F} and Krum, {Eric A} and Ray Nelson and Court Pedersen and George Perez and Price, {Richard W} and Prineas, {Ronald J} and Rhame, {Frank S} and Sampson, {James H} and John Worley and {INSIGHT Study Group} and {INSIGHT Endpoint Review Committee Writing Group}",
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doi = "10.1310/hct1104-205",
language = "English",
volume = "11",
pages = "205--19",
journal = "HIV Clinical Trials",
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Lifson, AR, Belloso, WH, Davey, RT, Duprez, D, Gatell, JM, Hoy, JF, Krum, EA, Nelson, R, Pedersen, C, Perez, G, Price, RW, Prineas, RJ, Rhame, FS, Sampson, JH, Worley, J, INSIGHT Study Group & INSIGHT Endpoint Review Committee Writing Group 2010, 'Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials', HIV Clinical Trials, bind 11, nr. 4, s. 205-19. https://doi.org/10.1310/hct1104-205

Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials. / Lifson, Alan R; Belloso, Waldo H; Davey, Richard T; Duprez, Daniel; Gatell, Jose M; Hoy, Jennifer F; Krum, Eric A; Nelson, Ray; Pedersen, Court; Perez, George; Price, Richard W; Prineas, Ronald J; Rhame, Frank S; Sampson, James H; Worley, John; INSIGHT Study Group; INSIGHT Endpoint Review Committee Writing Group.

I: HIV Clinical Trials, Bind 11, Nr. 4, 2010, s. 205-19.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

AU - Lifson, Alan R

AU - Belloso, Waldo H

AU - Davey, Richard T

AU - Duprez, Daniel

AU - Gatell, Jose M

AU - Hoy, Jennifer F

AU - Krum, Eric A

AU - Nelson, Ray

AU - Pedersen, Court

AU - Perez, George

AU - Price, Richard W

AU - Prineas, Ronald J

AU - Rhame, Frank S

AU - Sampson, James H

AU - Worley, John

AU - INSIGHT Study Group, null

AU - INSIGHT Endpoint Review Committee Writing Group

PY - 2010

Y1 - 2010

N2 - PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). RESULTS: Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.

AB - PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were developed based upon the following: (1) criteria from a previous trial (SMART), (2) review of published literature, (3) an iterative consultation and review process with the ERC and other content experts, and (4) evaluation of draft SNA criteria using retrospectively collected reports in another trial (ESPRIT). RESULTS: Final criteria are presented for acute myocardial infarction, congestive heart failure, coronary artery disease requiring drug treatment, coronary revascularization, decompensated liver disease, deep vein thrombosis, diabetes mellitus, end-stage renal disease, non-AIDS cancer, peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication.

U2 - 10.1310/hct1104-205

DO - 10.1310/hct1104-205

M3 - Journal article

VL - 11

SP - 205

EP - 219

JO - HIV Clinical Trials

JF - HIV Clinical Trials

SN - 1528-4336

IS - 4

ER -