PMID- 22561389
OWN - NLM
STAT- MEDLINE
DCOM- 20121217
LR  - 20191210
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Linking)
VI  - 33
IP  - 5
DP  - 2012 Sep
TI  - The measurement of symptoms and side effects in clinical trials of chronic pain.
PG  - 903-11
LID - 10.1016/j.cct.2012.04.008 [doi]
AB  - Clinical trials in chronic pain have used various methods to assess the effect of 
      medications. In addition to measuring symptom relief, researchers must also 
      address adverse events (AEs) associated with the medication to evaluate overall 
      therapeutic results. This paper reviews methods of measuring symptoms and AEs, 
      including passive capture, scripted prompting, prospective assessments of side 
      effects of interest, and prospective comprehensive symptom checklists. Methods of 
      measuring therapeutic results have advantages and disadvantages. Although passive 
      AE capture (unscripted, open-ended questions about symptoms) is not constrained 
      by preconceptions of potential AEs, it sometimes fails to capture clinically 
      significant AEs. Scripted prompting (prespecified, scripted, open-ended questions 
      about symptoms) is likely to address the latter problem but preclude consistency 
      across trials. Prospective assessments (prespecified symptom inventories) can 
      offer greater sensitivity and consistency in detecting side effects of specific 
      treatments. Comprehensive symptom distress inventories can be more sensitive 
      measures of overall treatment benefit, which may be important when efficacy, 
      passive AE capture, and comprehensive quality of life (QOL) batteries fail to 
      differentiate between treatments. In cancer populations these inventories have 
      been statistically correlated with survival and other important clinical 
      outcomes, even after controlling for disease status, global QOL, psychological 
      state, and performance status. Other important considerations are patient 
      perceptions of the importance of symptoms, the correlations between QOL and 
      symptom distress, and the usefulness of global ratings, in which patients 
      integrate any perceived benefits of the medication with tolerability and other 
      factors, such as convenience and cost.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Katz, Nathaniel P
AU  - Katz NP
AD  - Program on Opioid Risk Management, Tufts University School of Medicine, Boston, 
      MA 02111, USA. nkatz@analgesicsolutions.com
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20120425
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
SB  - IM
MH  - Chronic Pain/*drug therapy
MH  - Clinical Trials as Topic/*methods
MH  - Data Collection/methods
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Outcome Assessment, Health Care/*methods
MH  - Quality of Life
MH  - Survival Analysis
EDAT- 2012/05/09 06:00
MHDA- 2012/12/18 06:00
CRDT- 2012/05/08 06:00
PHST- 2012/01/10 00:00 [received]
PHST- 2012/03/29 00:00 [revised]
PHST- 2012/04/13 00:00 [accepted]
PHST- 2012/05/08 06:00 [entrez]
PHST- 2012/05/09 06:00 [pubmed]
PHST- 2012/12/18 06:00 [medline]
AID - S1551-7144(12)00102-4 [pii]
AID - 10.1016/j.cct.2012.04.008 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2012 Sep;33(5):903-11. doi: 10.1016/j.cct.2012.04.008. Epub 
      2012 Apr 25.