Download All analyses were performed according to intention-to

Journal Appraisal
Martin Ongkeko
The Dilemma…
• Population
– Patients with Type 2 Diabetes mellitus
• Intervention
– Daily VS Weekly blood glucose monitoring
• Outcome
– Compliance to medications
• Methodology
– Case-control studies
THE SEARCH
Hmmm…
Dilemma
• Population
– Patients with Type 2 Diabetes
Mellitus treated with oral
anti-diabetic drugs
• Intervention
– Frequency of self-monitoring
(once weekly vs four times
weekly)
• Outcome
– HbA1c level after 6 months
• Methodology
– -RCT
Article
• Population
– Patients with Type 2
Diabetes mellitus
• Intervention
– Daily VS Weekly blood
glucose monitoring
• Outcome
– Compliance to
medications
• Methodology
– Case-control studies
Primary Validity Guides
Was the assignment of patients to
treatment randomized?
• Yes, it’s a randomized controlled trial.
Were all patients who entered the trial
properly accounted for and attributed
at its conclusion?
• Was follow-up complete?
– Follow-up was incomplete because there were
drop-outs in each of the treatment groups. 12
drop-outs in the low SMBG group and 11 dropouts in the high SMBG group. Also, the reasons
for the dropping-out of the subjects were not
mentioned in the article.
Were patients analyzed in the groups
to which they were randomized?
• The subjects belonging to each group at the
onset of the study were analyzed in the same
grouping. However, the dropouts were not
included in the analysis after 6 months.
“All analyses were performed according to
intention-to-treat and included all randomized
patients excluding the drop-outs.”
Secondary Validity Guides
Were patients, their clinicians and
study personnel “blind” to treatment?
• Due to the nature of the intervention, the
patients and the clinicians know how many
blood glucose monitoring the patient carries
out. However, the outcome assessors were
blinded in the study.
Were the groups similar at the start of
the trial?
• The baseline characteristics in the two groups
were similar. Based on age, sex, duration of
diabetes, level of HbA1c before the study,
types of OHA used for treatment and other
demographics (nationality, level of education,
marital status).
Aside from the experimental
intervention, were the groups treated
equally?
• Other co-interventions or confounding factors
could have affected the study other than the
frequency of self-monitoring of blood glucose
(SMBG). This might include the diet and
exercise habits of the subjects and dietary or
herbal supplements used both of which may
affect the outcome.
Overall, is the study valid?
What are the results?
How large was the treatment effect?
In other words…
• There is no statistically significant difference
between the average HbA1c values of the low
and high frequency SMBG groups after 3, 6
and 12 months.
Other outcomes
• Secondary outcomes were also considered
which includes number and type of
hypoglycemic and hyperglycemic events and
compliance with interventions (SMBG).
• There were no significant differences between
the two groups with respect to compliance to
frequency of SMBG, health care utilization,
changes in diabetes treatment and adverse
events.
Can the results be applied to my
patient?
• Inclusion criteria for the study includes: type 2
DM patients with one or more OAD (without
insulin and stable oral medications for the last
three months), age between 35-80 years
• Exclusion criteria: Type 1 DM, 2 episodes of
hypoglycemia requiring external support
within the previous 3 months, one or more
severe metabolic events, pregnancy
Were all clinically important outcomes
considered ?
• Mortality, morbidity and quality of life were
not included in the study which are important
endpoints for consideration.
Are the likely benefits worth the
potential harm and costs?
• Yes, because less frequent SMBG is not
associated with higher levels of HbA1C (less
glycemic control) but will afford the patient
relief from periodic pricking and the cost of
SMBG.
What would you advise the
patient?
THE END.