PMID- 23347125
OWN - NLM
STAT- MEDLINE
DCOM- 20140410
LR  - 20151119
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Linking)
VI  - 23
IP  - 1
DP  - 2013 Feb
TI  - Two different solicitation methods for obtaining information on adverse events 
      associated with methylphenidate in adolescents: a 12-week multicenter, open-label 
      study.
PG  - 22-7
LID - 10.1089/cap.2012.0018 [doi]
AB  - OBJECTIVE: We explored two different methods of determining adverse events (AEs) 
      among methylphenidate (MPH)-treated adolescents with 
      attention-deficit/hyperactivity disorder (ADHD). METHODS: We performed a 12-week 
      open label study of osmotic-release oral system (OROS) MPH in adolescents with 
      ADHD who were recruited from four child and adolescent psychiatric outpatient 
      clinics. The AEs were evaluated via a two-step procedure at weeks 1, 3, 6, and 
      12. The first step was to ask a general question to subjects and their parents 
      regarding AEs. The second step included an AE evaluation process by the 
      investigators, which was performed using a drug-specific checklist. One-way 
      repeated measures ANOVA were used to compare the number of AEs reported by 
      patients and their parents compared with the number reported by clinicians. This 
      statistical technique was also used to compare the number of AEs reported by 
      various sources (i.e., patients, parents, and clinicians) at weeks 1, 3, 6, and 
      12. RESULTS: Of the 55 participants (43 males, 12 females) between the ages of 12 
      and 18 enrolled in this study, 47 participants completed the trial. When the 
      number of AEs reported by patients, parents and clinicians were compared, there 
      were no statistically significant differences. When the numbers of AEs obtained 
      from the three different information sources at each study visit were compared, 
      we noted differences. At week 6, the number of AEs evaluated by clinical 
      investigators was higher than those reported by patients and their parents 
      (p=0.003). Although the results did not reach statistical significance, the 
      number of AEs reported by clinical investigators appeared to be greater than 
      those obtained from patients or parents at weeks 3 and 12. The number of AEs 
      reported by patients and their parents were similar at every visit. There were 
      some differences in the pattern of AEs reported between patients and their 
      parents. CONCLUSIONS: Clinicians should supplement the subjective report on AEs 
      from patients or their parents with a more drug-specific checklist to obtain drug 
      side effects more effectively. As there are some differences in the pattern of 
      AEs reported by patients and their parents, it is generally recommended that 
      clinicians obtain information from both parties when possible.
FAU - Lee, Moon-Soo
AU  - Lee MS
AD  - Department of Psychiatry, Korea University Medical Center, Seoul, Republic of 
      Korea.
FAU - Lee, Soyoung I
AU  - Lee SI
FAU - Hong, Sungdo D
AU  - Hong SD
FAU - Kim, Ji-Hoon
AU  - Kim JH
FAU - Choi, Jeewook
AU  - Choi J
FAU - Joung, Yoo-Sook
AU  - Joung YS
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130124
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - Adolescent
MH  - Adolescent Behavior/drug effects
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Checklist
MH  - Child
MH  - Data Collection/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylphenidate/*adverse effects
MH  - Surveys and Questionnaires
EDAT- 2013/01/26 06:00
MHDA- 2014/04/11 06:00
CRDT- 2013/01/26 06:00
PHST- 2013/01/26 06:00 [entrez]
PHST- 2013/01/26 06:00 [pubmed]
PHST- 2014/04/11 06:00 [medline]
AID - 10.1089/cap.2012.0018 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2013 Feb;23(1):22-7. doi: 10.1089/cap.2012.0018. 
      Epub 2013 Jan 24.