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

• Population– Patients with Type 2

Diabetes mellitus

• Intervention– Daily VS Weekly blood

glucose monitoring

• Outcome– Compliance to

medications

• Methodology– Case-control studies

Article

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 drop-outs 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.