Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient

population: protocol for a feasibility randomised controlled trial

Catherine M Pound,1 Jaime McDonald,2 Ken Tang,3 Gillian Seidman,1 Radha Jetty,1 Sarah Zaidi,3 Amy C
Plint4

Received 25 July 2018; Revised 9 October 2018; Accepted 19 October 2018

Pound CM, et al. BMJ Open 2018;8:e025630. doi:10.1136/bmjopen-2018-025630

I. Directness
Does the study provide a direct enough answer to your clinical question in terms of patients
(P), exposure (E), and clinical outcome (O)?

Patients: Children 18 months to 17 years Population

admitted to a Canadian tertiary care center Intervention
Exposure: Short course dexamethasone Comparator
Comparator: Longer course Outcome
prednisone/prednisolone Method
Outcome: (-) Readmission to hospital,
repeat ED visits or unplanned visits to PHC
providers for asthma symptoms within 4
weeks of hospital discharge
Method: Comparative treatment regimen
for inpatients

II. Validity
Were the patients randomly assigned to treatment groups?

Children randomised to the dexamethasone

group will receive the approximate
pharmacological equivalent of two doses
(days) of dexamethasone 0.6 mg/kg/dose
(maximum dose 16 mg per dose) as current
evidence supports the use of this dose for the
inpatient population.

Children randomised to the

prednisone/prednisolone group will receive
four doses (days) of prednisone/
prednisolone 1 mg/kg/dose once daily
(maximum single dose 50 mg) following the
initial dose of CS received in the ED.

Was allocation concealed?

 Treatment assignments will be written on a
piece of paper and concealed in sequentially
numbered opaque envelopes kept in a
secure locked location in the study research
office.

Were baseline characteristics similar at the start of the trial?

Both patients randomized to the study

medication (dexamethasone) and standard of
care (prednisone/prednisolone) were
subjected to the same inclusion and exclusion
criteria.

Were patients blinded to the treatment assignment?

Blinding of the participants and members of

the healthcare team is not undertaken in
the study. Since the palatability of the CS is
likely to affect compliance, making the taste
of the CS similar to ensure blinding would
decrease ability to detect a difference in
compliance due to taste.

Were caregivers blinded to treatment assignment?

Blinding of the participants and members of

the healthcare team is not undertaken in
the study. Since the palatability of the CS is
likely to affect compliance, making the taste
of the CS similar to ensure blinding would
decrease ability to detect a difference in
compliance due to taste.

Were outcome assessors blinded to the treatment assignment?

Investigators, data analysts and research

assistant completing patient assessment at
the follow-up visit will however be blinded
to group assignment.

Were all patients analyzed in the group to which they were originally randomized?

To help inform the design of main trial (ie,

expected effect sizes), we will apply
 intention-to-treat principles and estimate
the treatment effect (and 95% CI) by
comparing outcomes (proposed for the
main trial) between intervention groups
using statistical techniques appropriate to
the type and distribution of the various
outcomes (eg, continuous, binary, count
data).

Was follow-up rate adequate?

III. Results
How large was the effect of treatment?

How precise was the estimate of the treatment?

IV. Applicability
Are there any biologic issues that may affect applicability of estimates of treatment
effectiveness?

Are there socio-economic issues that may affect applicability of estimates of treatment
effectiveness?

V. Individualizing Results
What is the likely effect of the treatment on your individual patient?

AR (absolute risk) = the number of events (good or bad) in treated or control groups, divided by the no. of people in that group
ARC = the AR of events in the control group
ART = the AR of events in the treatment group
ARR (absolute risk reduction) = ARC – ART
RR (relative risk) = ART / ARC
RRR (relative risk reduction) = (ARC – ART) / ARC
RRR = 1 – RR
NNT (number needed to treat) = 1 / ARR