Transcript Related Journal Club Presentation

Journal Club
Alcohol, Other Drugs, and Health: Current Evidence
November–December 2014
Featured Articles
A. Brief intervention for problem drug
use in safety-net primary care settings
B. Screening and brief intervention for
drug use in primary care: the ASPIRE
randomized clinical trial
A: Roy-Byrne P, et al. JAMA. 2014;312(5):492–501.
B: Saitz, et al. JAMA. 2014;312(5):502–513.
Study Objectives
• A: To determine whether a single-session
brief intervention (BI) decreases unhealthy
drug use, compared with no BI.
• B: To determine whether 2 kinds of BI
decrease unhealthy drug use (a brief
negotiated interview [BI] or a modified
motivational interview [MOTIV]), compared
with no BI.
www.aodhealth.org
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Study Designs
• A: 2-arm randomized clinical trial of 868 patients with drug
use on screening. The intervention group received a single
motivational interview from a clinic social worker, a 10minute telephone booster 2 weeks later, an illustrated
handout indicating their score on the drug screen, and a list
of substance use resources. The comparison group
received just the handout and resource list.
– Follow-up was at 3, 6, 9, and 12 months.
• B: Randomized clinical trial of 528 adults who screened
positive for unhealthy drug use. Randomization was to 1 of
3 conditions: a 10–15 minute structured brief negotiated
interview (BI) with a health educator, a 30–40 minute
motivational interview plus a 20–30-minute booster
session, or no BI.
– Follow-up was at 1.5 and 6 months.
www.aodhealth.org
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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.
– A: 1:1 randomization using permuted
blocks stratified by clinic and by 3 factors
known to affect outcome:
• drug use severity, comorbid mental illness, and readiness
to change.
– B: 1:1:1 randomization using secure
website using random permuted blocks of
size 3 and 6 stratified by drug dependence
and main drug used.
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Was randomization concealed?
– A: Group “allocation was concealed in
sequentially numbered opaque
envelopes opened by the research
assistant at randomization.”
– B: Patients were randomized by “data
coordinating center.”
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Were patients analyzed in the groups
to which they were randomized?
• A: Yes.
• B: Yes.
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Were the patients in the treatment
and control groups similar?
• A: Yes.
• B: Yes.
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Were patients aware of group
allocation?
• A: Yes.
• B: Yes.
www.aodhealth.org
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Were clinicians aware of group
allocation?
• A: Yes.
• B: Yes.
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Were outcome assessors aware of
group allocation?
• A: No.
• B: No.
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Was follow-up complete?
• A: Follow-up was >87% at all points.
• B: Follow-up was 98% at 6 months.
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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?
•
A:
•
B:
Only 47% of the intervention group could be reached for the booster call.
– No differences were found between the groups in the number of days in a
month for use of the primary drug, even when adjusted for baseline drug use
severity, psychiatric comorbidity, or motivation to change.
– No effects were found on drug use severity; medical, psychiatric, employment,
social, or legal consequences; acceptance of referral to chemical dependency
treatment; or medical care use. Arrests and deaths also did not differ between
groups.
Only 31% of participants in the MI arm received the booster session.
– No differences were found between the groups in the number of days in a
month for use of the primary drug, even when stratified by primary drug and
risk of drug dependence, or as detected by hair analysis.
– No effects were found on drug use consequences; injection drug use; unsafe
sex; health care utilization (hospitalizations and emergency department visits,
overall or for substance use or mental health reasons); or mutual help group
attendance.
– Drug use remained high (>90%) in all groups and did not decrease over 6
months.
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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?
– A: The mean age was 48 years in both
groups. Participants were 30% female, 45%
white, and 30% were homeless.
– B: The mean age was 41 years in all 3
groups. Participants were 30% female, 20%
white, and 70% were a high school graduate
or equivalent.
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Were all clinically important
outcomes considered?
• A: Yes.
• B: Yes.
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Are the likely treatment benefits
worth the potential harm and costs?
• A: No benefits were demonstrated and
costs were not reported.
• B: No benefits were demonstrated and
costs were not reported.
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