Transcript Related Journal Club Presentation

Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
November–December 2009
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Featured Article
Brief intervention in general
hospital for problematic
prescription drug use:
12-month outcome
Otto C, et al. Drug Alcohol Depend. 2009;105(3):221–226.
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Study Objective
• To determine whether brief intervention
delivered in the general hospital setting
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 either a
general or university hospital in Germany.
• Inclusion criteria:
– Consumption of prescription drugs (PD) with addiction potential (>60
days in the 3 months prior to baseline assessment); 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 at 12 months.
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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 an
intent-to-treat basis.
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Were the patients in the treatment
and control groups similar?
• Yes.
– Groups were similar on 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.*
*Information from a prior published report of 3-month outcomes: Zahradnik A, et al.
Randomized controlled trial of a brief intervention for problematic prescription drug use in
non-treatment-seeking patients. Addiction. 2009;104(1):109–117.
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Was follow-up complete?
• Eight patients in the control group (n=70)
did not complete follow-up:
– 2 had died.
– 2 refused to participate.
– 4 could not be contacted.
• Six patients in the intervention group
(n=56) did not complete follow-up:
– 4 had died.
– 2 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?
How precise was the estimate of the
treatment effect?
Main outcomes at 12 months controlling for significant group
differences in PD dependence and duration of intake
Effect on PD cessation
Intervention
PD dependence
Duration of intake
Effect on reduction of use
Intervention
PD dependence
Duration of intake
rb
OR
CI
p value
0.350
−0.537
−0.002
1.420
0.584
0.998
0.573–3.516
0.230–1.487
0.994–1.002
0.449
0.260
0.317
0.082
0.110
0.001
0.921
1.116
1.001
0.428–1.938
0.518–2.404
0.998–1.004
0.833
0.780
0.478
rb=regression coefficient; OR=odds ratio; CI=95% confidence interval.
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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 was conducted 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?
• Benefits were noted at 3 months in an earlier
publication but not at 12 months in the
current publication.
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