Journal Club

Alcohol, Other Drugs, and Health: Current Evidence March–April 2009 www.aodhealth.org

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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**) Discontinued use (%)

0.26 (2.1) 16 (12.7) 0.12 (1.4) 6 (8.6) 0.42 (2.7) 10 (17.9) 0.08

0.17

0.14

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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