Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results

Neval Ete Wareham; Caspar Da Cunha-Bang; Álvaro H Borges; Christina Ekenberg; Jan Gerstoft; Finn Gustafsson; Ditte Hansen; Carsten Heilmann; Marie Helleberg; Jens Hillingsø; Paul Suno Krohn; Isabelle Paula Lodding; Thomas Kromann Lund; Louise Lundgren; Amanda Mocroft; Michael Perch; Søren Lykke Petersen; Irma Petruskevicius; Allan Rasmussen; Kasper Rossing; Andreas A Rostved; Henrik Sengeløv; Vibeke Rømming Sørensen; Søren Schwartz Sørensen; Jens D. Lundgren

doi:10.1097/MD.0000000000011564

Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results

Neval Ete Wareham, Caspar Da Cunha-Bang, Álvaro H Borges, Christina Ekenberg, Jan Gerstoft, Finn Gustafsson, Ditte Hansen, Carsten Heilmann, Marie Helleberg, Jens Hillingsø, Paul Suno Krohn, Isabelle Paula Lodding, Thomas Kromann Lund, Louise Lundgren, Amanda Mocroft, Michael Perch, Søren Lykke Petersen, Irma Petruskevicius, Allan Rasmussen, Kasper RossingAndreas A Rostved, Henrik Sengeløv, Vibeke Rømming Sørensen, Søren Schwartz Sørensen, Jens D. Lundgren

Institut for Klinisk Medicin

3 Citationer (Scopus)

31 Downloads (Pure)

Abstract

Correct classification of death causes is an important component of transplant trials.We aimed to develop and validate a system to classify causes of death in hematopoietic stem cell (HSCT) and solid organ (SOT) transplant recipients.Case record forms (CRF) of fatal cases were completed, including investigator-designated cause of death. Deaths occurring in 2010 to 2013 were used for derivation; and were validated by deaths occurring in 2013 to 2015. Underlying cause of death (referred to as recorded underlying cause) was determined through a central adjudication process involving 2 external reviewers, and subsequently compared with the Danish National Death Cause Registry.Three hundred eighty-eight recipients died 2010 to 2015 (196 [51%] SOT and 192 [49%] HSCT). The main recorded underlying causes of death among SOT and HSCT were classified as cancer (20%, 48%), graft rejection/failure/graft-versus-host-disease (35%, 28%), and infections (20%, 11%). Kappa between the investigator-designated and the recorded underlying cause of death was 0.74 (95% CI 0.69-0.80) in derivation and comparable in the validation cohort. Death causes were concordant with the Danish National Death Cause Registry in 37.2% (95% CI 31.5-42.9) and 38.4% (95% CI 28.8-48.0) in the derivation and validation cohorts, respectively.We developed and validated a method to systematically and reliably classify the underlying cause of death among transplant recipients. There was a high degree of discordance between this classification and that in the Danish National Death Cause Registry.

Originalsprog	Engelsk
Artikelnummer	e11564
Tidsskrift	Medicine
Vol/bind	97
Udgave nummer	29
Antal sider	10
ISSN	0025-7974
DOI	https://doi.org/10.1097/MD.0000000000011564
Status	Udgivet - 1 jul. 2018

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10.1097/MD.0000000000011564Licens: CC BY-NC-ND

Classification of death causes after transplantation (CLASS)Forlagets udgivne version, 664 KBLicens: CC BY-NC-ND

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Wareham, N. E., Da Cunha-Bang, C., Borges, Á. H., Ekenberg, C., Gerstoft, J., Gustafsson, F., Hansen, D., Heilmann, C., Helleberg, M., Hillingsø, J., Krohn, P. S., Lodding, I. P., Lund, T. K., Lundgren, L., Mocroft, A., Perch, M., Petersen, S. L., Petruskevicius, I., Rasmussen, A., ... Lundgren, J. D. (2018). Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results. Medicine, 97(29), [e11564]. https://doi.org/10.1097/MD.0000000000011564

Wareham, NE, Da Cunha-Bang, C, Borges, ÁH, Ekenberg, C, Gerstoft, J , Gustafsson, F , Hansen, D, Heilmann, C, Helleberg, M, Hillingsø, J, Krohn, PS, Lodding, IP, Lund, TK, Lundgren, L, Mocroft, A, Perch, M, Petersen, SL, Petruskevicius, I, Rasmussen, A, Rossing, K, Rostved, AA, Sengeløv, H, Sørensen, VR, Sørensen, SS & Lundgren, JD 2018, 'Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results', Medicine, bind 97, nr. 29, e11564. https://doi.org/10.1097/MD.0000000000011564

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title = "Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results",

abstract = "Correct classification of death causes is an important component of transplant trials.We aimed to develop and validate a system to classify causes of death in hematopoietic stem cell (HSCT) and solid organ (SOT) transplant recipients.Case record forms (CRF) of fatal cases were completed, including investigator-designated cause of death. Deaths occurring in 2010 to 2013 were used for derivation; and were validated by deaths occurring in 2013 to 2015. Underlying cause of death (referred to as recorded underlying cause) was determined through a central adjudication process involving 2 external reviewers, and subsequently compared with the Danish National Death Cause Registry.Three hundred eighty-eight recipients died 2010 to 2015 (196 [51%] SOT and 192 [49%] HSCT). The main recorded underlying causes of death among SOT and HSCT were classified as cancer (20%, 48%), graft rejection/failure/graft-versus-host-disease (35%, 28%), and infections (20%, 11%). Kappa between the investigator-designated and the recorded underlying cause of death was 0.74 (95% CI 0.69-0.80) in derivation and comparable in the validation cohort. Death causes were concordant with the Danish National Death Cause Registry in 37.2% (95% CI 31.5-42.9) and 38.4% (95% CI 28.8-48.0) in the derivation and validation cohorts, respectively.We developed and validated a method to systematically and reliably classify the underlying cause of death among transplant recipients. There was a high degree of discordance between this classification and that in the Danish National Death Cause Registry.",

keywords = "Adult, Aged, Cause of Death, Denmark, Female, Humans, Male, Middle Aged, Registries, Transplant Recipients/statistics & numerical data, Transplantation/mortality",

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doi = "10.1097/MD.0000000000011564",

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TY - JOUR

T1 - Classification of death causes after transplantation (CLASS)

T2 - Evaluation of methodology and initial results

AU - Wareham, Neval Ete

AU - Da Cunha-Bang, Caspar

AU - Borges, Álvaro H

AU - Ekenberg, Christina

AU - Gerstoft, Jan

AU - Gustafsson, Finn

AU - Hansen, Ditte

AU - Heilmann, Carsten

AU - Helleberg, Marie

AU - Hillingsø, Jens

AU - Krohn, Paul Suno

AU - Lodding, Isabelle Paula

AU - Lund, Thomas Kromann

AU - Lundgren, Louise

AU - Mocroft, Amanda

AU - Perch, Michael

AU - Petersen, Søren Lykke

AU - Petruskevicius, Irma

AU - Rasmussen, Allan

AU - Rossing, Kasper

AU - Rostved, Andreas A

AU - Sengeløv, Henrik

AU - Sørensen, Vibeke Rømming

AU - Sørensen, Søren Schwartz

AU - Lundgren, Jens D.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Correct classification of death causes is an important component of transplant trials.We aimed to develop and validate a system to classify causes of death in hematopoietic stem cell (HSCT) and solid organ (SOT) transplant recipients.Case record forms (CRF) of fatal cases were completed, including investigator-designated cause of death. Deaths occurring in 2010 to 2013 were used for derivation; and were validated by deaths occurring in 2013 to 2015. Underlying cause of death (referred to as recorded underlying cause) was determined through a central adjudication process involving 2 external reviewers, and subsequently compared with the Danish National Death Cause Registry.Three hundred eighty-eight recipients died 2010 to 2015 (196 [51%] SOT and 192 [49%] HSCT). The main recorded underlying causes of death among SOT and HSCT were classified as cancer (20%, 48%), graft rejection/failure/graft-versus-host-disease (35%, 28%), and infections (20%, 11%). Kappa between the investigator-designated and the recorded underlying cause of death was 0.74 (95% CI 0.69-0.80) in derivation and comparable in the validation cohort. Death causes were concordant with the Danish National Death Cause Registry in 37.2% (95% CI 31.5-42.9) and 38.4% (95% CI 28.8-48.0) in the derivation and validation cohorts, respectively.We developed and validated a method to systematically and reliably classify the underlying cause of death among transplant recipients. There was a high degree of discordance between this classification and that in the Danish National Death Cause Registry.

AB - Correct classification of death causes is an important component of transplant trials.We aimed to develop and validate a system to classify causes of death in hematopoietic stem cell (HSCT) and solid organ (SOT) transplant recipients.Case record forms (CRF) of fatal cases were completed, including investigator-designated cause of death. Deaths occurring in 2010 to 2013 were used for derivation; and were validated by deaths occurring in 2013 to 2015. Underlying cause of death (referred to as recorded underlying cause) was determined through a central adjudication process involving 2 external reviewers, and subsequently compared with the Danish National Death Cause Registry.Three hundred eighty-eight recipients died 2010 to 2015 (196 [51%] SOT and 192 [49%] HSCT). The main recorded underlying causes of death among SOT and HSCT were classified as cancer (20%, 48%), graft rejection/failure/graft-versus-host-disease (35%, 28%), and infections (20%, 11%). Kappa between the investigator-designated and the recorded underlying cause of death was 0.74 (95% CI 0.69-0.80) in derivation and comparable in the validation cohort. Death causes were concordant with the Danish National Death Cause Registry in 37.2% (95% CI 31.5-42.9) and 38.4% (95% CI 28.8-48.0) in the derivation and validation cohorts, respectively.We developed and validated a method to systematically and reliably classify the underlying cause of death among transplant recipients. There was a high degree of discordance between this classification and that in the Danish National Death Cause Registry.

KW - Adult

KW - Aged

KW - Cause of Death

KW - Denmark

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Registries

KW - Transplant Recipients/statistics & numerical data

KW - Transplantation/mortality

U2 - 10.1097/MD.0000000000011564

DO - 10.1097/MD.0000000000011564

M3 - Journal article

C2 - 30024557

SN - 0025-7974

VL - 97

JO - Medicine (Baltimore)

JF - Medicine (Baltimore)

IS - 29

M1 - e11564

ER -

Classification of death causes after transplantation (CLASS): Evaluation of methodology and initial results

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