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Journal Club

Journal Club. Alcohol, Other Drugs, and Health: Current Evidence September –October 2011. Featured Article. A Randomized Controlled Trial of an Integrated Care Intervention to Increase Eligibility for Chronic Hepatitis C Treatment Evon DM, et al. Am J Gastroenterol. 2011;106(10):1777–1786.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence September–October 2011 www.aodhealth.org

  2. Featured Article A Randomized Controlled Trial of an Integrated Care Intervention to Increase Eligibility for Chronic Hepatitis C Treatment Evon DM, et al. Am J Gastroenterol. 2011;106(10):1777–1786. www.aodhealth.org

  3. Study Objective • To determine whether an integrated care intervention for patients with chronic hepatitis C virus (HCV) deferred from pegylated interferon (pegIFN) therapy because of mental-health and substance-abuse comorbidities could improve subsequent HCV treatment eligibility rates. www.aodhealth.org

  4. Study Design • Randomized single-blind controlled trial. • Participants included 101 patients with HCV evaluated at 2 hepatology centers and deferred from PegIFN therapy due to mental-health/substance-abuse (MH/SA) comorbidities. • Participants were randomized to 1 of 2 groups: • integrated care intervention* (INT) (n=50). • standard care† (SC) (n=51). • All participants were re-evaluated for treatment eligibility at 3, 6, and 9 months by a hepatology clinician masked to group assignment. *Standard care + counseling and case management for up to 9 months. †Screening + receipt of a handout addressing MH/SA concerns + a book on HCV. 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. www.aodhealth.org

  9. Was randomization concealed? • Yes. • Participants were assigned to groups via a computer-generated random numbers. www.aodhealth.org

  10. Were patients analyzed in the groups to which they were randomized? • Yes (intention-to-treat analysis). www.aodhealth.org

  11. Were the patients in the treatment and control groups similar? • Some differences existed between groups on baseline demographic and reason-for-deferral data. These differences were adjusted for in multivariable models. www.aodhealth.org

  12. Were patients aware of group allocation? • Yes. • Blinding procedures and their importance were reviewed with participants at each follow-up visit. Participants were asked not to divulge any information that could identify group assignment to the hepatology clinician. • At no time during the study did a patient report comprising the masking requirements. www.aodhealth.org

  13. Were clinicians aware of group allocation? • Clinicians conducting the intervention were aware of group allocation. The hepatologists determining HCV treatment eligibility were not aware of group allocation. www.aodhealth.org

  14. Were outcome assessors aware of group allocation? • No. • The hepatologist, who was blinded to group allocation, assessed the primary outcome (i.e., eligibility for PegIFN treatment). www.aodhealth.org

  15. Was follow-up complete? • No. • At 9 months, 9 of 50 patients withdrew or were lost to follow-up in the INT group, and 8 of 51 patients withdrew or were lost to follow-up in the SC group. 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? • Patients in the INT group, compared with those in the SC group, were more likely to be deemed eligible for PegIFN treatment by 9 months (42% versus 18%, respectively; p=0.009). www.aodhealth.org

  18. How precise was the estimate of the treatment effect? • Participants in the INT group, compared with those in the SC group, were 2.4 times more likely to be deemed eligible for PegIFN treatment by 9 months (95% CIs=1.2 and 4.7, respectively). 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? • All participants were HCV positive; 77% had HCV genotype 1. • The mean age of participants was 48 years; 50% were men, and 61% were Caucasian. www.aodhealth.org

  21. Were all clinically important outcomes considered? • PegIFN retention and the proportion of participants who had a sustained virologic response were not reported. www.aodhealth.org

  22. Are the likely treatment benefits worth the potential harm and costs? • Few harms would be expected to be associated with the observed benefits. • No cost data were provided. www.aodhealth.org

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