Journal Club Alcohol and Health Current Evidence SeptemberOctober

Journal Club Alcohol and Health: Current Evidence September–October 2004 www. alcoholandhealth. org 1

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. www. alcoholandhealth. org 2

Study Objective To assess the effectiveness of a multifaceted collaborative care intervention for posttraumatic stress disorder (PTSD) and alcohol abuse www. alcoholandhealth. org 3

Study Design A randomized controlled trial comparing collaborative care with usual care in injured surgical inpatients www. alcoholandhealth. org 4

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. alcoholandhealth. org 5

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. alcoholandhealth. org 6

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? www. alcoholandhealth. org 7

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). www. alcoholandhealth. org 8

Was randomization concealed? • It is not clear whether randomization was concealed. • Patients were randomized after they completed an initial detailed research interview. www. alcoholandhealth. org 9

Were patients analyzed in the groups to which they were randomized? • Yes, analyses were done on an intention-to-treat sample. www. alcoholandhealth. org 10

Were the patients in the treatment and control groups similar? Groups did not differ significantly on the following: • • 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 There was a non-significant trend toward more alcohol abuse or dependence in the collaborative care group. www. alcoholandhealth. org 11

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. www. alcoholandhealth. org 12

Were clinicians aware of group allocation? • Yes, clinicians were aware of group allocation in order to provide the intervention. www. alcoholandhealth. org 13

Were outcome assessors aware of group allocation? • Outcome assessors may have been aware of group allocation. – There was no blinding. www. alcoholandhealth. org 14

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. www. alcoholandhealth. org 15

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

How large was the treatment effect? Results Over a Year of Follow-up Collaborative Care Usual 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%) www. alcoholandhealth. org 17

How precise was the estimate of the treatment effect? • Precision is reflected in the confidence intervals. – The results were statistically significant. www. alcoholandhealth. org 18

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. alcoholandhealth. org 19

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. www. alcoholandhealth. org 20

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 www. alcoholandhealth. org 21

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. www. alcoholandhealth. org 22

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. www. alcoholandhealth. org 23

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. www. alcoholandhealth. org 24

Summary (cont. ) • Additional study of the findings’ clinical importance and the costs involved will be needed before such interventions are implemented widely. www. alcoholandhealth. org 25