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Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
March–April 2009
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Featured Article
Randomized Controlled Trial of a Brief
Intervention for Problematic
Prescription Drug Use in
Non-Treatment-Seeking Patients
Zahradnik A, et al. Addiction. 2009;104(1):109–117.
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Study Objective
• To determine whether brief intervention
delivered in general hospitals promotes
discontinuation or reduction of
problematic prescription drug use.
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Study Design
• Randomized controlled trial of 126 patients admitted to
the internal, surgical, or gynecological ward of a general
and university hospital in Germany.
• Inclusion criteria:
– Consumption of prescription drugs (PD) with addiction potential (>60
days within the last 3 months); or
– DSM criteria for PD abuse or dependence.
• Participants were randomly allocated to either:
– 2 motivational-interviewing (MI) sessions (intervention); or
– receipt of a booklet about PD generally (control).
• Outcomes measured were >25% reduction or
discontinuation of daily PD intake.
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Assessing Validity of an Article
about Therapy
• Are the results valid?
• What are the results?
• How can I apply the results to patient
care?
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Are the Results Valid?
• Were patients randomized?
• Was randomization concealed?
• Were patients analyzed in the groups to
which they were randomized?
• Were patients in the treatment and control
groups similar with respect to known
prognostic variables?
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Are the Results Valid? (cont‘d)
• Were patients aware of group allocation?
• Were clinicians aware of group allocation?
• Were outcome assessors aware of group
allocation?
• Was follow-up complete?
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Were patients randomized?
• Yes.
– Patients were randomized by ward.
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Was randomization concealed?
• Unknown.
– Data on the method of randomization are
not provided.
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Were patients analyzed in the groups
to which they were randomized?
• Yes
– Outcome measures were analyzed on the
basis of intention-to-treat.
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Were the patients in the treatment
and control groups similar?
• Yes.
– Groups were similar on most
demographic and clinical variables.
– PD dependence was less common in
the control group (35.7%) compared
with the intervention group (53.6%)
(p=0.049).
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Were patients aware of group
allocation?
• Yes.
– Patients were aware of group allocation.
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Were clinicians aware of group
allocation?
• Yes.
– Clinicians were aware of group allocation.
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Were outcome assessors aware of
group allocation?
• No.
– Follow-up interviews were conducted by
staff who had no prior contact with the
patient.
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Was follow-up complete?
• Eight patients in the control group (n=70)
did not complete follow-up:
– 1 had died.
– 3 were too ill to answer questions.
– 4 could not be contacted.
• One patient in the intervention group
(n=56) did not complete follow-up:
– he or she could not be contacted.
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What Are the Results?
• How large was the treatment effect?
• How precise was the estimate of the
treatment effect?
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How large was the treatment
effect?
Differences in Control Group (CG) and Intervention Group
(IG) Prescription Drug use at 3-Month Follow-up
All
participants
CG
IG
p value
Effect
size
Difference in
defined daily
dosage*
(SD**)
0.26 (2.1)
0.12 (1.4)
0.42 (2.7)
0.08
0.14
Discontinued
use (%)
16 (12.7)
6 (8.6)
10 (17.9)
0.17
0.28
Reduced use by
>25% (%)
50 (39.7)
21 (30)
29 (51.8)
0.02†
0.45
*Follow-up minus baseline; **standard deviation; †significant (p<0.05).
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How precise was the estimate of
the treatment effect?
• The primary hypothesis—that the discontinuation
rate would be greater in the intervention group—
was not confirmed.
• No confidence intervals around the proportion of
subjects with >25% reduction in dose were
provided.
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How Can I Apply the Results to
Patient Care?
• Were the study patients similar to the
patients in my practice?
• Were all clinically important outcomes
considered?
• Are the likely treatment benefits worth
the potential harm and costs?
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Were the study patients similar to
those in my practice?
• Of the final sample,
– 61.9% were women.
– mean age was 55 years (range, 30–69 years, with
69% age 50 or older).
– more than half were married (56.4%).
– the majority were retired (69.1%).
• The study took place in Germany.
• No data on race/ethnicity are provided.
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Were all clinically important
outcomes considered?
• No information was provided about the
indications for the use of the medications with
“addictive potential.”
• It is possible that some patients received these
medications for pain, anxiety, or insomnia.
• Subjective outcomes from the patients were
not reported.
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Are the likely treatment benefits
worth the potential harm and costs?
• This is not clear due to the lack of
information about the prescribed medications,
their indications, and patients’ subjective
experiences.
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