Lustman - Adherence to Medical Regimes Flashcards
Aim
To assess the effectiveness of fluoxetine as a treatment for depression in patients with diabetes.
Fluoxetine controls depression, and study measures effect it would have in control of diabetes.
Method
Lab experiment
Double blind technique and placebo control.
Sample
60 patients
volunteer - responded to advertisements for type 1 or 2 diabetes + major depressive disorder
21-60
Procedure
All screened for depression (Becks Depression Inventory)
Randomly assigned to two groups
one: Fluoxetine for depression.
one: placebo
Given daily doses of medication for 8 weeks.
Patients and doctors did not know which group they had been assigned to (double blind).
Follow a normal medical regime for diabetes eg. special diet and inject insulin.
After 8 weeks - re-assessed for depression using DBI & HAMD.
All blood sugar levels measured (GHb) to assess adherence to their normal medical regime. USE OF PHYSICAL METHOD.
Findings
- Reduction in depression symptoms significantly greater in patients treatment with fluoxetine compared to those receiving the placebo.
- Nearer normal blood sugar levels which indicated improved adherence to medical regime eg. new diet and self-injection insulin.
Conclusions
- Measuring blood sugar in patient with diabetes is a good way of measuring adherence to medical regime.
- Those on fluoxetine more likely to follow diabetes regime as depression drug was working, therefore effective drug for treating depression in diabetic patients.
- Patients whose depression was reduced showed better control of their blood sugar - also not significant difference p>0.13.
A
Choo - Track cap
- Specially designed pill bottle which records how often it is opened. Hence measures drug taking behaviour.
- Choo compared self reports with track cap results for patients with hypertension
Choo - Findings/Conclusions/EV
- 21% admitted missing a day, mechanical measure showed to be 42%
SHOWS DEMAND CHARACTERISTICS and self report = not accurate measure of adherence. - Although, mechanical measures had validity problem, to what extent does it measure drug taking behaviour. Track cap only measures how often the bottle is opened but not whether pills are actually taken. Hypertension is also not a major disorder.
- Not reliable
Validity 1
Physiological measures can get around issue of self report (Choo) and people not understanding what regimen is (Kent).
+ve: Double blind therefore avoid demand characteristics.
Diabetes:
Blood sugar levels: Diabetics take drug then depression would be lower, therefore means they would be taking their insulin to treat diabetes, therefore blood sugar levels close to normal. Physiological measure = blood sugar levels show how well they are adhering to their diabetic medication.
Depression is a frequent condition in patients with diabetes. Associated with poor control of patients blood sugar levels.
Drop out
54 completed… 3 dropped out of each group.
Validity 2
-ve: 8 weeks not long enough to measure adherence to medical regime. Gab test usual span = 120 days.
Behaviour of patients some weeks before trail may have effected blood sugar level results.
Validity 3
-ve: Blood sugar levels are an operationalisation of adherence, they do not measure the drug adherence itself. Therefore may not be testing what he aimed to.
Use of placebo group was to avoid demand characteristics. Placebo group aims to measure adherence to regime for antidepressants as placebo not working. Therefore don’t follow diabetes medical regime, however that is not measuring regime adherence its measuring the biological effect of antidepressant therefore not valid. MEASURE EFFECTIVENESS OF ANTI-DEPRESSANT NOT ADHERENCE.
- Those who took the placebo drug blood pressure was not reduced. This meant they were recorded as “not adherent participants” however that is only happening as placebo not effecting depression, which leads them to not follow normal diabetes regime.
Relaibility
Small sample, therefore biased and difficult to generalise.
