Journal Club Alcohol and Health: Current Evidence September–October 2004

Featured Article A Randomized Effectiveness Trial of Stepped Collaborative Care for Acutely Injured Trauma Survivors Zatzick D, et al. Arch Gen Psychiatry. 2004;61(5):498–506.

Study Objective To assess the effectiveness of a multifaceted collaborative care intervention for posttraumatic stress disorder (PTSD) and alcohol abuse

Study Design A randomized controlled trial comparing collaborative care with usual care in injured surgical inpatients

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.) 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, patients were randomized. Randomization was stratified by –PTSD symptom severity; –depressive symptom severity; and –alcohol and stimulant toxicology results (on admission).

Was randomization concealed? It is not clear whether randomization was concealed. Patients were randomized after they completed an initial detailed research interview.

Were patients analyzed in the groups to which they were randomized? Yes, analyses were done on an intention-to-treat sample.

Were the patients in the treatment and control groups similar? Age Sex Education Income Race Marital status Intentional injury Injury severity Number of prior traumas PTSD and depressive symptom severity Admission blood alcohol Presence of medical comorbidity Inpatient length of stay Days on the surgical ward before enrollment Groups did not differ significantly on the following: There was a non-significant trend toward more alcohol abuse or dependence in the collaborative care group.

Were patients aware of group allocation? Yes: –They provided informed consent for the research. –They knew if they had received case management, counseling, and/or pharmacotherapy. Subjects were not blinded to the content of the interventions.

Were clinicians aware of group allocation? Yes, clinicians were aware of group allocation in order to provide the intervention.

Were outcome assessors aware of group allocation? Outcome assessors may have been aware of group allocation. –There was no blinding.

Was follow-up complete? One subject in the intervention group dropped out after randomization, but before intervention (a post-randomization dropout). 83%–88% of subjects completed the 1-, 3-, 6-, and/or 12-month follow-up.

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? Collaborative CareUsual Care % of patients with PTSD Decreased by 0.07% (95% CI, -4.2% to 4.3%) Increased by 6% (95% CI, 3.1% to 9.3%) % of patients with alcohol abuse or dependence Decreased by 24.2% (95% CI, -19.9% to -28.6%) Increased by 12.9% (95% CI, 8.2% to 17.7%) Results Over a Year of Follow-up

How precise was the estimate of the treatment effect? Precision is reflected in the confidence intervals. –The results were statistically significant.

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? Patients with impaired cognition, self-inflicted injuries or psychosis, incarceration, or recent history of violence were excluded. They also had to have significant PTSD or depressive symptoms to be in the study. Almost 70% were men, and most had previous trauma.

Were all clinically important outcomes considered? The following were not assessed: –recurrent injury –alcohol problems/symptoms alcohol consequences were assessed with a diagnostic interview –PTSD diagnosis diagnosis was assessed with a symptom checklist, not a gold standard diagnostic interview –functional status outcomes –costs

Are the likely treatment benefits worth the potential harm and costs? The treatment benefits may be worth the potential harm and costs. –However, determining so will require additional study.

Summary A collaborative care intervention, compared with usual care including community referrals, –prevented a small increase in the prevalence of PTSD; and –decreased the prevalence of alcohol abuse or dependence at 12 months.

Summary (cont.) The study had some threats to validity. –The collaborative care group had a higher proportion of patients with alcohol abuse or dependence (a non-significant trend). However, this imbalance should not have been an issue as it would have biased the study against finding an effect of the intervention. –Unconcealed randomization, loss to follow-up, and lack of blinding could have introduced biases favoring the intervention of unknown magnitude.

Summary (cont.) Additional study of the findings’ clinical importance and the costs involved will be needed before such interventions are implemented widely.