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.

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.

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.

Assessing Validity of an Article about Therapy Are the results valid? What are the results? How can I apply the results to patient care?

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?

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?

Were patients randomized? Yes.

Was randomization concealed? Yes. –Participants were assigned to groups via a computer-generated random numbers.

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

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.

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.

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.

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).

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.

What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?

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).

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).

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?

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.

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

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.