PMID- 25123543
OWN - NLM
STAT- MEDLINE
DCOM- 20150925
LR  - 20181202
IS  - 1872-6623 (Electronic)
IS  - 0304-3959 (Linking)
VI  - 155
IP  - 11
DP  - 2014 Nov
TI  - Adverse event reporting in nonpharmacologic, noninterventional pain clinical 
      trials: ACTTION systematic review.
PG  - 2253-62
LID - S0304-3959(14)00348-0 [pii]
LID - 10.1016/j.pain.2014.08.004 [doi]
AB  - Assessment of treatment safety is 1 of the primary goals of clinical trials. 
      Organizations and working groups have created reporting guidelines for adverse 
      events (AEs). Previous research examining AE reporting for pharmacologic clinical 
      trials of analgesics in major pain journals found many reporting inadequacies, 
      suggesting that analgesic trials are not adhering to existing AE reporting 
      guidelines. The present systematic review documented AE reporting in 3 main pain 
      journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain 
      treatments. To broaden our pool of nonpharmacologic trials, we also included 
      trials examining acupuncture, leech therapy, and noninvasive stimulation 
      techniques (eg, transcutaneous electrical nerve stimulation). We documented AE 
      reporting at 2 levels of specificity using coding manuals based on the 
      Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards 
      and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, 
      Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We 
      identified a number of inadequacies in AE reporting across the 3 journals. For 
      example, using the ACTTION coding manual, we found that less than one-half of the 
      trials reported specific AE assessment methods; approximately one-third of the 
      trials reported withdrawals due to AEs for each study arm; and about one-fourth 
      of the trials reported all specific AEs. We also examined differences in AE 
      reporting across several trial characteristics, finding that AE reporting was 
      generally more detailed in trials with patients versus those using healthy 
      volunteers undergoing experimentally evoked pain. These results suggest that 
      investigators conducting and reporting NP/NI clinical trials are not adequately 
      describing the assessment and occurrence of AEs.
CI  - Copyright (c) 2014 International Association for the Study of Pain. All rights 
      reserved.
FAU - Hunsinger, Matthew
AU  - Hunsinger M
AD  - School of Professional Psychology, Pacific University, Hillsboro, OR, USA. 
      Electronic address: matthewh@pacificu.edu.
FAU - Smith, Shannon M
AU  - Smith SM
AD  - Department of Anesthesiology, University of Rochester School of Medicine and 
      Dentistry, Rochester, NY, USA.
FAU - Rothstein, Daniel
AU  - Rothstein D
AD  - Department of Anesthesiology, University of Rochester School of Medicine and 
      Dentistry, Rochester, NY, USA.
FAU - McKeown, Andrew
AU  - McKeown A
AD  - Department of Anesthesiology, University of Rochester School of Medicine and 
      Dentistry, Rochester, NY, USA.
FAU - Parkhurst, Melissa
AU  - Parkhurst M
AD  - Department of Psychiatry, University of Rochester School of Medicine and 
      Dentistry, Rochester, NY, USA.
FAU - Hertz, Sharon
AU  - Hertz S
AD  - United States Food and Drug Administration, Silver Spring, MD, USA.
FAU - Katz, Nathaniel P
AU  - Katz NP
AD  - Analgesic Solutions, Natick, MA, and Tufts University, Boston, MA, USA.
FAU - Lin, Allison H
AU  - Lin AH
AD  - United States Food and Drug Administration, Silver Spring, MD, USA.
FAU - McDermott, Michael P
AU  - McDermott MP
AD  - Department of Biostatistics and Computational Biology, University of Rochester 
      School of Medicine and Dentistry, Rochester, NY, USA.
FAU - Rappaport, Bob A
AU  - Rappaport BA
AD  - United States Food and Drug Administration, Silver Spring, MD, USA.
FAU - Turk, Dennis C
AU  - Turk DC
AD  - Department of Anesthesiology and Pain Medicine, University of Washington, 
      Seattle, WA, USA.
FAU - Dworkin, Robert H
AU  - Dworkin RH
AD  - Department of Anesthesiology, University of Rochester School of Medicine and 
      Dentistry, Rochester, NY, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20140812
PL  - United States
TA  - Pain
JT  - Pain
JID - 7508686
RN  - 0 (Analgesics)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Analgesics/*adverse effects
MH  - Complementary Therapies/*adverse effects
MH  - Humans
MH  - Pain/*drug therapy
MH  - Pain Management/*adverse effects
MH  - Practice Guidelines as Topic
OTO - NOTNLM
OT  - Adverse events
OT  - Complementary and alternative medical treatments
OT  - Harms reporting
OT  - Safety reporting
EDAT- 2014/08/16 06:00
MHDA- 2015/09/26 06:00
CRDT- 2014/08/16 06:00
PHST- 2014/04/16 00:00 [received]
PHST- 2014/07/30 00:00 [revised]
PHST- 2014/08/06 00:00 [accepted]
PHST- 2014/08/16 06:00 [entrez]
PHST- 2014/08/16 06:00 [pubmed]
PHST- 2015/09/26 06:00 [medline]
AID - S0304-3959(14)00348-0 [pii]
AID - 10.1016/j.pain.2014.08.004 [doi]
PST - ppublish
SO  - Pain. 2014 Nov;155(11):2253-62. doi: 10.1016/j.pain.2014.08.004. Epub 2014 Aug 
      12.