Critical Appraisal Therapy Study
(Randomized Controlled Trial)
SCREENING
Does the study question match your question? Yes it does. My question is whether topical
lidocaine-prilocaine cream is effective for the
management of post episiotomy pain
Was the study design appropriate?
The study design appropriate because RCT
was used to evaluate the effectiveness of
therapy given
VALIDITY
F: Patient Follow-Up
Were all patients who entered the trial Yes, they were. All patient reached the end of
properly accounted for at its conclusion? the follow-up period
Losses to follow-up should be less than
20% and reasons for drop-out given.
Yes, it was. The follow up was long enough till
Was follow-up long enough? 5-day post-partum
R: Randomization
Were the recruited patients representative Yes, they were. The target population is
of the target population? postpartum primigravidae
Was the allocation (assignment) of patients Yes, the patients were randomized to the
to treatment randomized and concealed? therapy given. But the research was not
concealed, it was an opened RCT
I: Intention to Treat Analysis
Were patients analyzed in the groups Yes, they were. All of the randomized patient
to which they were randomized? were analyzed. Qualitative data were expressed
Were all randomized patient data as frequencies and percentage. Chi-square (x2)
analyzed? If not, was a sensitivity or and independent t-test were used to compare
“worst case scenario” analysis done? both groups
S: Similar Baseline Characteristics of Patients
Were groups similar at the start of the trial? Yes, they were. The patients included in the
study were all primigravidae met inclusion and
exclusion criteria, after that randomized to
enter whether the LP group or meloxicam
suppository group
B: Blinding
Were patients, health workers, and No, they were not.
study personnel “blind” to treatment?
If blinding was impossible, were Neither the women nor the investigators
blinded raters and/or objective outcome could be blinded to the purpose of the study
measures used?
E: Equal Treatment
Aside from the experimental intervention, Yes they were. Either the cream or the rectal
were the groups treated equally? suppository was given by the same obstetrician
who delivered all the study participants.
The women in both groups asked to receive
oral paracetamol 500 mg on need if there is
severe intolerable pain with recording the
frequency of intake
Conflict of Interest
Are the sources of support and other No they were not. There were no conflict of
potential conflicts of interest acknowledged interest in this study
and addressed?
Summary of Article’s Validity The strength of this study :
Notable study strengths or weaknesses The random assignment of the participants to the
or concerns? study groups
How serious are the threats to validity The ability to follow the patients and assess their
and in what direction could they bias the pain intensity at five days post-partum
study outcomes?
The weakness of this study :
Small sample size
CLINICAL IMPORTANCE
Out come present Outcome absent
Treated/Exposed a = 45 b = 50 a+b
Control (Not c = 20 d = 75 c+d
exposed)
CER *Control event rate)=c/(c+d) 20 / 20 + 75 = 0.210
EER (experimenal event rate) =a/(a+b) 45 / 95 = 0.473
RR (Relative Risik)=(a+b)/(c+d) 95 / 95 = 1
RRR (relative Risk reduction)/RBI (relative 0.21 / 0.473 = 0.556
Benefit Increase)=(EER-CER)/EER
ARR (Absolute Risk Reduction)/ABI (Absolut 0.263
Benefit Increase) = EER-CER
NNT (Number Needed to Treat) 1/RRR 1.799
Results OF IMPORTANCY The p value was <0.01
RRR was 0.556, the LP cream group can reduce
the usage of additional analgesics by 55,6%
APPLICABILITY
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Similar patient
1. Are your patients similar to those in the From the sociodemographic characteristics, our
study? patient in daily practice and the research were
similar
2. Are they so different that the results can’t No. The research drugs are available in this
help you country, so the research is applicable for our
setting
3. How much of the study effect can you Because of the benefit of local treatment (LP
expect for your patients cream) in reducing post episiotomy pain
Apakah pasien dan keluarga dapat menerima compared with other preparation, I expect with
pemberian obat/pengobatan atas dasar nilai good advocacy, our patient can accept this study
nilai sosial, budaya dan agama?
Realistic Interventions
4. Is the intervention realistic in your setting? Yes, it is. the intervention is realistic
5. Does the comparison intervention reflect Yes, because with this result, we may have more
your current practice? option beside oral analgesic drugs. Oral
preparation may have more side effects
6. What alternatives are available We can use oral and rectal preparation of
analgesic drugs
Right Outcomes
7. Are the outcomes appropriate to your Yes, they are. we can apply the outcomes to our
patient? patient
8. Does the intervention meet their values and Yes, it does. The intervention can be applied to
preferences? our patient and the drugs are available in our
country.
Overall conclusion This research is important. Methodology was
valid, it was clinically important, and could be
applied to our patient.
