critical appraisal of a randomized controlled trail by annerie hattingh 07 january 2009

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)