CRITICAL APPRAISAL CHECKLIST FOR AN ARTICLE ON TREATMENT OR

PREVENTION.

Study Design: Randomised Controlled Trial

Adapted from:

Critical Appraisal Skills Programme (CASP), Public Health Resource Unit,

Institute of Health Science, Oxford.

Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature. II.
How to use an article about therapy or prevention. A. Are the results of the
study valid? JAMA 1993; 270: 2598-2601.

Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature. II.
How to use an article about therapy or prevention. B. What were the results
and will they help me in caring for my patients? JAMA 1993; 271: 59-63.
 DOES THIS STUDY ADDRESS A CLEAR QUESTION?

1. Were the following clearly

stated: Yes Can’t tell No

 Patients √
√
 Intervention
√
 Comparison Intervention
√
 Outcome(s)

ARE THE RESULTS OF THIS SINGLE TRIAL VALID?

A. The main questions to answer:

Yes Can’t tell No

Patients with informed
2. Was the assignment of consent were randomized
patients to treatments to treatment with
randomised prescription Motrin or
ibuprofen-PC, 800 mg of
active ingredient three
times a day (2400 mg of
ibuprofen ⁄ day).

3. Was the randomisation list Patients with

concealed? Can you tell? informed
consent were
randomized to
treatment.

4. Were all subjects who A total of 125

entered the trial accounted patients were
for at it’s conclusion? enrolled in
the study, and
108 patients
completed the
study.

5. Were they analysed in the In this study, three analysis

groups to which they were
randomised, i.e. intention-to-
treat analysis
populations were utilized:
intent to treat (ITT),
evaluable for efficacy and
evaluable for GI toxicity.
All patients who received
at least one treatment were
included in the ITT
population.
 B. Some finer points to address:
6. Were subjects and clinicians
‘blind’ to which treatment was
being received, i.e. could they
tell?
7. Aside from the experimental
treatment, were the
groups treated equally?
8. Were the groups similar at the
start of the trial?
Can’t
Yes tell No
Baseline endoscopy was
performed no more than 7
days before initiating the
study medication and the
findings were compared with
the endoscopic score after 6
weeks on treatment. All
endoscopists were blinded to
the treatment group.
At pre-enrolment, all patients
underwent a physical exam,
laboratory evaluation of
haematology, blood chemistry
and, if relevant, a pregnancy
test. The medical history and
use of any concomitant
medications were collected.
Endoscopies were performed
at baseline and after 6 weeks.
Every 2 weeks on protocol,
patients were evaluated for
pain and inflammation using
the WOMAC and VAS scores
and, to monitor compliance
pill counts were assessed.
Inclusion criteria: Patients
≥18 years of age who had OA
of the knee and ⁄ or hip
requiring NSAID therapy.
 WHAT WERE THE RESULTS?

Outcome event Total

Yes No

Experimental group a b a+b

Control group c d c+d

Experimental event rate = risk of outcome event in experimental group = EER=a/(a+b)

Control event rate = risk of outcome event in control group = CER = c/(c+d)
Relative risk (RR) = EER/CER Odds ratio (OR) = ad/bc

Relative risk reduction (RRR) = (CER - EER)/CER or 1 - RR

Absolute risk reduction (ARR) = CER - EER

Number needed to treat (NNT) = 1/ARR = 1/(CER - EER)

Gastric or duodenal score (lanza score >2)

Present Absent Total

10 39 49
Ibuprofen-PC
Use of
18 40 58
Ibuprofen

Total 26 99 107

9. How large was the treatment effect? RRR= 35.5%

Consider ARR= 11%

 How were the results expressed (RRR, NNT, etc). NNT= 9.09

10. How precise were the results?

95% CI
Were the results presented with confidence intervals?
CAN I APPLY THESE VALID, IMPORTANT RESULTS TO MY PATIENT?

Yes Can’t Tell No

11. Do these results apply to my patient? √

 Is my patient so different from those in √
the trial that the results don’t apply?
 
 How great would the benefit of
therapy be for my particular patient?

Answer:
“Phosphatidylcholine is the major
surfactant phospholipid that confers
surface hydrophobic characteristics to the
gastric mucosa. It is possible that with
age, surface phospholipid levels decrease
below a critical threshold and this
reduction contributes to age-related
NSAID intolerance.”

12. Are my patient’s values and √

preferences satisfied by the
intervention offered?

 Do I have a clear assessment of my √

patient’s values and preferences?
 
 Are they met by this regimen and its √
potential consequences?

The mechanism of age-related NSAID-
induced GI toxicity remains unknown.
However, age associated decreases in
surface hydrophobicity, prostaglandin
levels and impaired healing may
contribute to the deterioration of the
barrier property of the mucosa.

Phosphatidylcholine is the major

surfactant phospholipid that confers
surface hydrophobic characteristics to
the gastric mucosa. It is possible that
with age, surface phospholipid levels
decrease below a critical threshold and
this reduction contributes to age-
related NSAID intolerance.
JARGON BUSTER.

Randomised Clinical trial where at least two treatment groups are

controlled trial compared. One must be a control group, e.g. receiving
(RCT) standard care or a placebo treatment. Allocation to a group
must be random and unbiased.

Randomisation Process of allocating individuals to the alternative

treatments in a clinical trial, avoiding bias. Should produce
groups which are similar, except for the treatment of
interest.

Blinding The process of ensuring that participants or researchers

(single-blind) or participants and researchers (double-blind)
are unaware of which treatment group participants have
been randomised to, reducing the possibility of bias in the
results.

Intention-to- All patients allocated to one arm of a RCT are analysed in

treat analysis that arm, whether or not they completed the prescribed
(ITT) treatment/regimen.

Experimental event Risk (or chance) of outcome event in experimental group.

rate (EER)

Control event rate Risk (or chance) of outcome event in control group.
(CER)

Relative risk A measure of the chance of the event occurring in the

(RR) experimental group relative to it occurring in the control
group.

Relative risk The difference in the proportion of events between the

reduction (RRR) control and experimental groups, relative to the proportion
of events in the control group. Can also be calculated as 1-
RR.

Absolute risk The absolute difference between the risk of the event in the
reduction (ARR) control and experimental groups.

Number needed to The number of patients who needed to be treated to

treat (NNT) prevent the occurrence of one adverse event (e.g.
complication, death) or promote the occurrence of one
beneficial event (e.g. cessation of smoking).

Confidence For whatever effect being measures (e.g. RR, RRR, ARR,
interval NTT) the confidence interval is the range of values within
which the “true” value in the population is found. Generally
expressed as a 95% confidence interval, i.e. you can be
95% confident that the population value lies within those
limits.