PMID- 26991481
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181202
IS  - 1399-6576 (Electronic)
IS  - 0001-5172 (Linking)
VI  - 60
IP  - 7
DP  - 2016 Aug
TI  - Adverse event assessment and reporting in trials of newer treatments for 
      post-operative pain.
PG  - 842-51
LID - 10.1111/aas.12721 [doi]
AB  - BACKGROUND: Assessment and reporting of adverse events (AEs) in studies of 
      perioperative interventions is critical given the potential for unintended and 
      preventable iatrogenic morbidity and mortality. This focused review evaluated the 
      quality of AE assessment and reporting in acute post-operative pain treatment 
      trials. Since older analgesics (e.g., opioids, NSAIDs) already have a 
      well-characterized safety profile, we concentrated on trials of pregabalin and 
      gabapentin as a representative sample of studies where the perioperative safety 
      profile was relatively unknown. METHODS: We reviewed primary reports of trials of 
      pregabalin and gabapentin for treatment of acute post-operative pain for: (1) 
      adherence to the 10 recommendations from the 'CONSORT Extension for Harms,' (2) 
      AE assessment method, (3) timing of AE assessment and reporting, and (4) 
      assessment and reporting of AE severity. RESULTS: We identified 31 trials of 
      pregabalin and 59 of gabapentin. The median number of CONSORT harms 
      recommendations that were satisfied was 7 of 10. The most common (41%) method of 
      AE assessment was direct questioning about specific AEs by investigators. 
      However, AE assessment method was not described in 18% of trials. AE assessments 
      were reported for specified perioperative time points in only 24% of trials. Of 
      greatest concern, no AE data were reported whatsoever in 8 of the included 
      publications. CONCLUSIONS: Considerable widespread improvements are needed in AE 
      reporting for post-operative pain treatment trials. In addition to heightened 
      awareness among clinical investigators, mandatory journal editorial policies may 
      further facilitate improvements in safety assessment and reporting.
CI  - (c) 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John 
      Wiley & Sons Ltd.
FAU - Hoffer, D
AU  - Hoffer D
AD  - Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, 
      Canada.
FAU - Smith, S M
AU  - Smith SM
AD  - Anesthesiology, University of Rochester, Rochester, NY, USA.
FAU - Parlow, J
AU  - Parlow J
AD  - Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, 
      Canada.
FAU - Allard, R
AU  - Allard R
AD  - Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, 
      Canada.
FAU - Gilron, I
AU  - Gilron I
AD  - Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, 
      Canada.
LA  - eng
PT  - Comment
PT  - Journal Article
PT  - Review
DEP - 20160316
PL  - England
TA  - Acta Anaesthesiol Scand
JT  - Acta anaesthesiologica Scandinavica
JID - 0370270
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
SB  - IM
CON - Pain. 2005 Jan;113(1-2):191-200. PMID: 15621380
MH  - *Analgesics
MH  - Humans
MH  - Pain/chemically induced
MH  - *Pregabalin
MH  - Research Report
EDAT- 2016/03/19 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/03/19 06:00
PHST- 2016/01/07 00:00 [received]
PHST- 2016/02/09 00:00 [revised]
PHST- 2016/02/16 00:00 [accepted]
PHST- 2016/03/19 06:00 [entrez]
PHST- 2016/03/19 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.1111/aas.12721 [doi]
PST - ppublish
SO  - Acta Anaesthesiol Scand. 2016 Aug;60(7):842-51. doi: 10.1111/aas.12721. Epub 2016 
      Mar 16.