Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials

Alan R Lifson, INSIGHT Cause of Death Writing Group, Waldo H Belloso, Cate Carey, Richard T Davey, Daniel Duprez, Wafaa M El-Sadr, Jose M Gatell, Daniela C Gey, Jennifer F Hoy, Eric A Krum, Ray Nelson, Daniel E Nixon, Nick Paton, Court Pedersen, George Perez, Richard W Price, Ronald J Prineas, Frank S Rhame, James Sampson & 1 andre John Worley

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: May-June
OriginalsprogEngelsk
TidsskriftHIV Clinical Trials
Vol/bind9
Udgave nummer3
Sider (fra-til)177-85
Antal sider8
ISSN1528-4336
DOI
StatusUdgivet - 1. maj 2008

Fingeraftryk

Cause of Death
Advisory Committees
Clinical Trials
HIV
Documentation
Acquired Immunodeficiency Syndrome
Committee Membership
Drug Overdose
Accidents
Interleukin-2
Liver Diseases
Consensus
Research Personnel
Neoplasms

Citer dette

Lifson, A. R., Cause of Death Writing Group, INSIGHT., Belloso, W. H., Carey, C., Davey, R. T., Duprez, D., ... Worley, J. (2008). Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials. HIV Clinical Trials, 9(3), 177-85. https://doi.org/10.1310/hct0903-177
Lifson, Alan R ; Cause of Death Writing Group, INSIGHT ; Belloso, Waldo H ; Carey, Cate ; Davey, Richard T ; Duprez, Daniel ; El-Sadr, Wafaa M ; Gatell, Jose M ; Gey, Daniela C ; Hoy, Jennifer F ; Krum, Eric A ; Nelson, Ray ; Nixon, Daniel E ; Paton, Nick ; Pedersen, Court ; Perez, George ; Price, Richard W ; Prineas, Ronald J ; Rhame, Frank S ; Sampson, James ; Worley, John. / Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials. I: HIV Clinical Trials. 2008 ; Bind 9, Nr. 3. s. 177-85.
@article{e81b1aa0422011dd9fbe000ea68e967b,
title = "Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials",
abstract = "Purpose: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. Method: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated. Results: Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10{\%} AIDS-defining diseases, 21{\%} non-AIDS malignancies, 9{\%} cardiac diseases, 9{\%} liver disease, 8{\%} non-AIDS-defining infections, 5{\%} suicides, 5{\%} other traumatic events/accidents, 4{\%} drug overdoses/acute intoxications, 11{\%} other causes, and 18{\%} unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51{\%}) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. Conclusion: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.",
author = "Lifson, {Alan R} and {Cause of Death Writing Group}, INSIGHT and Belloso, {Waldo H} and Cate Carey and Davey, {Richard T} and Daniel Duprez and El-Sadr, {Wafaa M} and Gatell, {Jose M} and Gey, {Daniela C} and Hoy, {Jennifer F} and Krum, {Eric A} and Ray Nelson and Nixon, {Daniel E} and Nick Paton and Court Pedersen and George Perez and Price, {Richard W} and Prineas, {Ronald J} and Rhame, {Frank S} and James Sampson and John Worley",
year = "2008",
month = "5",
day = "1",
doi = "10.1310/hct0903-177",
language = "English",
volume = "9",
pages = "177--85",
journal = "HIV Clinical Trials",
issn = "1528-4336",
publisher = "Taylor & Francis",
number = "3",

}

Lifson, AR, Cause of Death Writing Group, INSIGHT, Belloso, WH, Carey, C, Davey, RT, Duprez, D, El-Sadr, WM, Gatell, JM, Gey, DC, Hoy, JF, Krum, EA, Nelson, R, Nixon, DE, Paton, N, Pedersen, C, Perez, G, Price, RW, Prineas, RJ, Rhame, FS, Sampson, J & Worley, J 2008, 'Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials', HIV Clinical Trials, bind 9, nr. 3, s. 177-85. https://doi.org/10.1310/hct0903-177

Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials. / Lifson, Alan R; Cause of Death Writing Group, INSIGHT; Belloso, Waldo H; Carey, Cate; Davey, Richard T; Duprez, Daniel; El-Sadr, Wafaa M; Gatell, Jose M; Gey, Daniela C; Hoy, Jennifer F; Krum, Eric A; Nelson, Ray; Nixon, Daniel E; Paton, Nick; Pedersen, Court; Perez, George; Price, Richard W; Prineas, Ronald J; Rhame, Frank S; Sampson, James; Worley, John.

I: HIV Clinical Trials, Bind 9, Nr. 3, 01.05.2008, s. 177-85.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials

AU - Lifson, Alan R

AU - Cause of Death Writing Group, INSIGHT

AU - Belloso, Waldo H

AU - Carey, Cate

AU - Davey, Richard T

AU - Duprez, Daniel

AU - El-Sadr, Wafaa M

AU - Gatell, Jose M

AU - Gey, Daniela C

AU - Hoy, Jennifer F

AU - Krum, Eric A

AU - Nelson, Ray

AU - Nixon, Daniel E

AU - Paton, Nick

AU - Pedersen, Court

AU - Perez, George

AU - Price, Richard W

AU - Prineas, Ronald J

AU - Rhame, Frank S

AU - Sampson, James

AU - Worley, John

PY - 2008/5/1

Y1 - 2008/5/1

N2 - Purpose: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. Method: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated. Results: Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10% AIDS-defining diseases, 21% non-AIDS malignancies, 9% cardiac diseases, 9% liver disease, 8% non-AIDS-defining infections, 5% suicides, 5% other traumatic events/accidents, 4% drug overdoses/acute intoxications, 11% other causes, and 18% unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. Conclusion: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.

AB - Purpose: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. Method: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated. Results: Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10% AIDS-defining diseases, 21% non-AIDS malignancies, 9% cardiac diseases, 9% liver disease, 8% non-AIDS-defining infections, 5% suicides, 5% other traumatic events/accidents, 4% drug overdoses/acute intoxications, 11% other causes, and 18% unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. Conclusion: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.

U2 - 10.1310/hct0903-177

DO - 10.1310/hct0903-177

M3 - Journal article

VL - 9

SP - 177

EP - 185

JO - HIV Clinical Trials

JF - HIV Clinical Trials

SN - 1528-4336

IS - 3

ER -

Lifson AR, Cause of Death Writing Group INSIGHT, Belloso WH, Carey C, Davey RT, Duprez D et al. Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials. HIV Clinical Trials. 2008 maj 1;9(3):177-85. https://doi.org/10.1310/hct0903-177