critical appraisal of a randomized controlled trail by annerie hattingh 07 january 2009
TRANSCRIPT
Critical Appraisal of a Randomized Controlled Trail
By ANNERIE HATTINGH
07 January 2009
Paracetamol plus Ibuprofen for the treatment of fever in
children: Randomized Controlled Trail
Alastair D Hay, Ceire Costelloe, Niamh Redmond,
Alan Montgomery, Margaret Fletcher, Sandra
Hollinghurst and Tim J Peters.
BMJ2008;337:1302 – 1311 and at:http://bmj.com/cgi/content/full/337/sep02_2/a1302
Introduction
Ibuprofen, with or without Paracetamol, was more effective than Paracetamol alone for reducing fever
in children aged 6 months to 6 years.
Introduction (Continued)
Advising parents of children with fever is a daily occurrence in emergency departments.
Researchers in England performed a randomized, blinded, controlled trail to compare ibuprofen (10mg/kg), paracetamol (15mg/kg),and combination therapy for relieving fever and discomfort in 156 outpatients aged 6 months to 6 years with axillary temperatures of 37.8`C – 41.0`C.
During the first 4 hours after administration of the first dose,
ibuprofen plus paracetamol was superior to paracetamol alone
for time spend without fever and similar to ibuprofen alone.
During the first 24 hours , children who received combination
therapy had 4.4 more hours without fever than those who
received paracetamol alone and 2.5 more hours without
fever than those treated with ibuprofen alone. Children
who received ibuprofen alone had 1.9 more hours without
fever than those who received paracetamol alone.
Introduction (Continued)
No differences in the proportion of children with discomfort at 48hours or other fever associated symptoms were noted amonggroups.
Side effects were minor and similar in incidence among groups.
Parents exceeded the maximum 24 hour recommended dosesin 6% - 13% of cases.
Introduction (Continued)
Abstract
1. Were treatments randomly allocated?
yes
Screening questions
Screening questions (continued)
2. Were all the patients accounted for?
yes
3. Were outcomes assessed blind?
yes
Screening questions (continued)
Detailed questions (A) Design:
1. Are the aims clearly stated?
yes
Detailed questions (A) Design: (continued)
2. Was the sample size justified ?
yes
3. Are the measurements likely to be reliable and valid?
yes & no
Detailed questions (A) Design: (continued)
4. Could the choice off subjects influence the size of treatment effect?
yes
Detailed questions (A) Design: (continued)
5. Where there any ambiguities in the description of the treatment and its administration?
no
Detailed questions (A) Design: (continued)
6. Are the statistical methods described?
yes
Detailed questions (A) Design: (continued)
7. Could the lack of blinding have introduced bias?
yes
Detailed questions (A) Design: (continued)
8. Are the outcomes clinically relevant?
yes
Detailed questions (A) Design: (continued)
1. How was the randomization carried out?
Detailed questions (B) Conduct:
2. Did any untoward events occur during the study?
Detailed questions (B) Conduct: (continued)
1. Where the treatment group comparable at baseline?
yes
Table 1 (page 4)
Detailed questions (C) Analysis:
2. Where results analyzed by intention to treat?
yes
Detailed questions (C) Analysis: (continued)
3. Was the statistical significance assessed?
yes
Tables 3 & 4 (pages 6 & 7)
Detailed questions (C) Analysis: (continued)
4. Where the basic data adequately described?
yes
Tables 1 & 2 (pages 4 & 5)
Detailed questions (C) Analysis: (continued)
5. Do the numbers add up?
yes
Detailed questions (C) Analysis: (continued)
6. Where side effects reported?
yes
Detailed questions (C) Analysis: (continued)
1. What do the main finding mean?
Detailed questions (D) Interpretation:
2. How are null findings interpreted?
Detailed questions (D) Interpretation: (continued)
3. Are important effects overlooked?
no
Detailed questions (D) Interpretation: (continued)
4. How does the results compare with previous reports?
Detailed questions (D) Interpretation: (continued)
5. What implications does the study have for your practice?
Detailed questions (D) Interpretation: (continued)