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
A2 - Lundgren, Jens D.
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.
KW - Cardiovascular Diseases/diagnosis
KW - Diagnostic Techniques and Procedures
KW - Endpoint Determination
KW - HIV/growth & development
KW - HIV Infections/complications
KW - Humans
KW - Kidney Diseases/diagnosis
KW - Liver Diseases/diagnosis
KW - Randomized Controlled Trials as Topic/methods
KW - Retrospective Studies
U2 - 10.1310/hct1104-205
DO - 10.1310/hct1104-205
M3 - Journal article
C2 - 20974576
SN - 1528-4336
VL - 11
SP - 205
EP - 219
JO - HIV Clinical Trials
JF - HIV Clinical Trials
IS - 4
ER -