PMID- 29059401
OWN - NLM
STAT- MEDLINE
DCOM- 20180531
LR  - 20220330
IS  - 1460-2385 (Electronic)
IS  - 0931-0509 (Linking)
VI  - 32
IP  - 9
DP  - 2017 Sep 1
TI  - Completeness of reporting of adverse events in trials of maintenance 
      immunosuppression in kidney transplantation: a systematic review.
PG  - 1586-1594
LID - 10.1093/ndt/gfx216 [doi]
AB  - BACKGROUND: Decision-making regarding immunosuppression after transplantation 
      relies on robust evidence on the benefits and harms of available drugs. We aimed 
      to evaluate the reporting of adverse events (AEs) in trials of maintenance 
      immunosuppression in kidney transplantation. METHODS: We conducted a systematic 
      review of published randomized controlled trials of maintenance immunosuppression 
      following kidney transplantation in the Cochrane Kidney and Transplant Register 
      (January 2003-December 2015). Appraisal against the 23-item harms extension of 
      the Consolidated Standards of Reporting Trials statement was conducted. RESULTS: 
      Of 233 trials, 163 (69%) reported at least one AE. Only 17 (10%) provided 
      definitions or justified the AEs, 13 (8%) described methods and 27 (17%) measured 
      severity. Forty AE types were reported, with gastrointestinal being the most 
      common [116 (71%)]. The frequency of reporting did not reflect known drug 
      side-effect profiles. For example, of 90 calcineurin inhibitor trials, only 22% 
      reported tremors, 3% paresthesia and none anxiety, aggression or mood swings. 
      Trials that reported at least one adverse effect were more likely to be industry 
      funded adjusted odds ratio [OR] 7.6 [95% confidence interval (CI) 3.4-17.1], 
      multicenter [OR 5.9 (95% CI 1.7-18.7)] and with follow-up time <24 months [OR 3.7 
      (95% CI 1.4-10.2)]. CONCLUSIONS: AEs in kidney transplant immunosuppression 
      trials appear to be selectively reported and may be unreliable for clinical 
      decisions. Adherence to the Consolidated Standards of Reporting Trials harms 
      extension should be mandatory to ensure transparent reporting of AEs that are 
      important to patients and clinicians.
CI  - (c) The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. 
      All rights reserved.
FAU - Howell, Martin
AU  - Howell M
AD  - Centre for Kidney Research, Children's Hospital at Westmead, Westmead, NSW, 
      Australia.
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
FAU - Yeo, Reichelle
AU  - Yeo R
AD  - Centre for Kidney Research, Children's Hospital at Westmead, Westmead, NSW, 
      Australia.
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
FAU - Tong, Allison
AU  - Tong A
AD  - Centre for Kidney Research, Children's Hospital at Westmead, Westmead, NSW, 
      Australia.
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
FAU - Craig, Jonathan C
AU  - Craig JC
AD  - Centre for Kidney Research, Children's Hospital at Westmead, Westmead, NSW, 
      Australia.
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
FAU - Howard, Kirsten
AU  - Howard K
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
FAU - Wong, Germaine
AU  - Wong G
AD  - Centre for Kidney Research, Children's Hospital at Westmead, Westmead, NSW, 
      Australia.
AD  - Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
AD  - Centre for Transplant and Renal Research, Westmead Hospital, Westmead, NSW, 
      Australia.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
PL  - England
TA  - Nephrol Dial Transplant
JT  - Nephrology, dialysis, transplantation : official publication of the European 
      Dialysis and Transplant Association - European Renal Association
JID - 8706402
RN  - 0 (Immunosuppressive Agents)
SB  - IM
MH  - Drug-Related Side Effects and Adverse Reactions/etiology/*prevention & control
MH  - Graft Rejection/*prevention & control
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Kidney Transplantation/*adverse effects
MH  - Maintenance Chemotherapy
MH  - Patient Outcome Assessment
OTO - NOTNLM
OT  - adverse events
OT  - clinical trial
OT  - immunosuppression
OT  - kidney transplantation
OT  - systematic review
EDAT- 2017/10/24 06:00
MHDA- 2018/06/01 06:00
CRDT- 2017/10/24 06:00
PHST- 2017/03/26 00:00 [received]
PHST- 2017/05/16 00:00 [accepted]
PHST- 2017/10/24 06:00 [entrez]
PHST- 2017/10/24 06:00 [pubmed]
PHST- 2018/06/01 06:00 [medline]
AID - 3956645 [pii]
AID - 10.1093/ndt/gfx216 [doi]
PST - ppublish
SO  - Nephrol Dial Transplant. 2017 Sep 1;32(9):1586-1594. doi: 10.1093/ndt/gfx216.