PMID- 19025852
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20170123
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 9
IP  - 6
DP  - 2000 Nov
TI  - Development and evaluation of a standardized questionnaire for identifying 
      adverse events in vaccine clinical trials.
PG  - 457-71
LID - 10.1002/1099-1557(200011)9:6<457::AID-PDS529>3.0.CO;2-R [doi]
AB  - In vaccine trials, diary questionnaires or vaccination report cards (VRCs) are 
      used extensively to collect complaints reported by subjects or guardians 
      following vaccination. These have not been evaluated for accuracy or standardized 
      to facilitate tolerability comparisons among vaccines.Objectives -(1) Develop 
      standardized, age-specific VRCs for collecting self-reported adverse events (AEs) 
      in trials; (2) Evaluate whether complaints elicited by nurse examinations or 
      telephone interviews were missed by VRCs.Methods -Vaccine-trial databases, focus 
      groups, experts and experienced nurses were used to develop paediatric and 
      adolescent/adult VRCs. VRCs were evaluated at four sites. The primary outcome was 
      subjects with AEs missed on the VRC and reported in nurse examinations (for 
      injection-site reactions) or telephone interviews (for systemic 
      complaints).Results -Of 855 subjects, 96.5% completed VRCs. For systemic 
      complaints, 1.5% (12/812) reported both no complaint on VRCs and at least one 
      complaint in telephone interviews. For injection-site reactions, 5.1% (53/1030) 
      of injection sites had both no reaction reported on VRCs and had reactions noted 
      by nurse examination. No missed AEs were rated as severe.Conclusion -The data 
      suggest VRCs provide a practical and reasonably complete method of eliciting 
      complaints following vaccination. Copyright (c) 2000 John Wiley & Sons, Ltd.
FAU - Coplan, P
AU  - Coplan P
AD  - Merck Research Laboratories, West Point, PA, USA.
FAU - Chiacchierini, L
AU  - Chiacchierini L
FAU - Nikas, A
AU  - Nikas A
FAU - Shea, J
AU  - Shea J
FAU - Baumritter, A
AU  - Baumritter A
FAU - Beutner, K
AU  - Beutner K
FAU - Cassidy, W
AU  - Cassidy W
FAU - Sawyer, M
AU  - Sawyer M
FAU - Watson, B
AU  - Watson B
FAU - Heyse, J
AU  - Heyse J
FAU - Guess, H
AU  - Guess H
LA  - eng
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
EDAT- 2008/11/26 09:00
MHDA- 2008/11/26 09:01
CRDT- 2008/11/26 09:00
PHST- 2008/11/26 09:00 [pubmed]
PHST- 2008/11/26 09:01 [medline]
PHST- 2008/11/26 09:00 [entrez]
AID - 10.1002/1099-1557(200011)9:6<457::AID-PDS529>3.0.CO;2-R [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2000 Nov;9(6):457-71. doi: 
      10.1002/1099-1557(200011)9:6<457::AID-PDS529>3.0.CO;2-R.