APPRAISAL GUIDE FOR ARTICLE ON TREATMENT

Name of Student (Surname/First Name/M.I.)

Bugayong, Maria Lorraine
Guce, Joyce Roleen
Muyco, Alexie Corelle
Pedro, Carolyn Tan-chi
VALIDITY: ARE THE RESULTS VALID?
YES
1. Was the assignment of patients to
treatment randomized?
X
2. Were all patients who entered the trial
properly accounted for and attributed at its
conclusion?
X

a) Was follow-up complete?

X

b) Were patients analyzed in the

groups to which they were
randomized?

3. Were patients, their clinicians, and

study personnel "blind" to treatment?
4. Were the groups similar at the start of
the trial?

X
X

5.
Aside from the experimental
intervention, were the groups treated
equally?
X

RELIABILITY: WHAT WERE THE

RESULTS
1. How large is the treatment effect?

Date of Activity:
November 3, 2014

NO

EXPLANATION
Households were randomly assigned in a 4:4:1 ratio to
1 of 3 treatment groups using a master household
randomization schedule and kit number assignment
form, blinded for treatment condition and generated
using permuted blocks.
A total of 949 subjects out of 1038 enrolled completed
the studies. In study 1, 511 subjects completed while
47 discontinued. In study 2, 438 subjects completed
while 42 discontinued.
Reasons for discontinuation (withdrawal of consent,
lost to follow-up, and protocol violations like missing a
visit, getting a haircut, using prohibited medication,
failure to apply medication as instructed, or failure to
conduct day 21 visit) were noted.
Participants returned to the clinic on day 1 for a safety
assessment and on days 7 and 14 for efficacy and
safety assessments. For participants who were
retreated on day 7, they returned to the clinic on day 8
for safety assessment and on day 21 for a final efficacy
and safety assessment.
Patients were evaluated for drug safety in both groups
and efficacy of each product were analyzed and
discussed. All patients were also reassessed after day
7 for possible recurrence of head lice.
An individual with no other role in the study assigned
the households to treatments and kit numbers to each
participant.
Study participants were healthy males and females
(within a household) >/6 months of age with active
cases of head lice.
Only the first 25 qualifying pediatric participants had
clinical laboratory assessments (hematology and serum
chemistry) on day 0 (screening) and day 14 due to the
extremely clean safety profile exhibited in phase-1 and
phase-2 studies of spinosad.
Safety
evaluations
(adverse
events
and
scalp/cutaneous and ocular irritation evalutaions) were
conducted on all participants who had >/1 on-therapy
follow-up visit.
All of the participants within an individual household
were treated with the same study medication.
ANSWERS & COMPUTATIONS

Relative risk: 0.058/ 0.318= 0.182

Absolute relative risk: .318-0.058=
26
Number needed to treat: 1/.26= 3.8

Treatment with spinosad has a

lesser risk of not eradicating head
lice than permethrin.
The absolute benefit of treatment is
26% when treated with spinosad
compared
to
treatment
with
permethrin.
With spinosad, we need to treat at
least 4 people in order to prevent
one bad outcome.

APPRAISAL GUIDE FOR ARTICLE ON TREATMENT

2. How precise was the estimate of
treatment effect?
APPLICABILITY: WILL THE RESULTS
HELP ME IN CARING FOR MY
PATIENTS?
1. Can the results be applied to my
patient care?
2. Were all clinically important outcomes
considered?
3. Are the likely treatment benefits worth
the potential harm and costs?
RESOLUTION OF THE SCENARIO:

The study implemented a 99% confidence interval and the results were
statistically significant at P <0.001.
YES
X

NO

EXPLANATION
Head lice infestation is common in the Philippines.

The primary end point which was to determine the

number of participants who were lice free was noted.
X
Adverse effects, scalp/cutaneous and ocular irritation
were considered.
Yes since spinosad had a good safety profile. There is
X
no mention however of the cost.
If available, spinosad can be used over permetrhin since it was found to
be more effective against head lice.