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Journal Club

Randomized trial assessing the effectiveness of a brief intervention for problematic prescription drug use in non-treatment patients admitted to a general hospital in Germany. Results analysis and implications for patient care included.

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Journal Club

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

  2. 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. www.aodhealth.org

  3. Study Objective • To determine whether brief intervention delivered in general hospitals promotes discontinuation or reduction of problematic prescription drug use. www.aodhealth.org

  4. 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. www.aodhealth.org

  5. Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org

  6. 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? www.aodhealth.org

  7. 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? www.aodhealth.org

  8. Were patients randomized? • Yes. • Patients were randomized by ward. www.aodhealth.org

  9. Was randomization concealed? • Unknown. • Data on the method of randomization are not provided. www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes • Outcome measures were analyzed on the basis of intention-to-treat. www.aodhealth.org

  11. 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). www.aodhealth.org

  12. Were patients aware of group allocation? • Yes. • Patients were aware of group allocation. www.aodhealth.org

  13. Were clinicians aware of group allocation? • Yes. • Clinicians were aware of group allocation. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • No. • Follow-up interviews were conducted by staff who had no prior contact with the patient. www.aodhealth.org

  15. 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. www.aodhealth.org

  16. What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org

  17. How large was the treatment effect? Differences in Control Group (CG) and Intervention Group (IG) Prescription Drug use at 3-Month Follow-up *Follow-up minus baseline; **standard deviation; †significant (p<0.05). www.aodhealth.org

  18. 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. www.aodhealth.org

  19. 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? www.aodhealth.org

  20. 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. www.aodhealth.org

  21. 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. www.aodhealth.org

  22. 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. www.aodhealth.org

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