1 Journal Club Alcohol, Other Drugs, and Health: Current Evidence September–October 2010

2 Featured Article Association Between Substance Use Disorder Status and Pain-Related Function Following 12 Months of Treatment in Primary Care Patients with Musculoskeletal Pain Morasco BJ, et al. J Pain. September 16, 2010 [E-pub ahead of print].

3 Study Objective To examine relationships between substance use disorder (SUD) history and 12-month outcomes among primary-care patients with chronic noncancer pain (CNCP) randomized to either a collaborative care intervention (CCI) or treatment as usual (TAU).

4 Study Design The sample (N=362) included patients originally recruited for a cluster randomized trial comparing CCI to TAU for management of CNCP. Randomi- zation was by clinician, with their patients nested within the same group assignment. This subgroup analysis examined the association between comorbid SUD history, baseline charac- teristics, and 12-month treatment outcomes among those patients. Inclusion criteria were as follows: –score >6 on the Roland Morris Disability Questionnaire. –completion of baseline and 12-month follow-up evaluations.

5 Study Design (cont’d) Patients in the CCI group (n=169) received: –stepped-care management. –outcome monitoring. –ongoing feedback for their care providers (including their clinician and a full-time psychologist/care manager). Patients in the TAU group (n=193) received: –access to a referral-based pain clinic. –access to on-site mental-health services and all ancillary services. –follow-up only for outcome measurements. There were no significant differences in demographic or clinical factors between groups.

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

7 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?

8 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?

9 Were patients randomized? Yes. –A statistician randomized clinicians to the CCI or TAU group prior to patient recruitment. Patients were randomized based on their clinician’s group assignment.

10 Was randomization concealed? Yes. –Neither clinicians nor patients knew which group they were randomized to prior to the start of the study.

11 Were patients analyzed in the groups to which they were randomized? Yes.

12 Were the patients in the treatment and control groups similar? Groups were similar in the primary analysis; however, compared with patients with no SUD, patients with a history of SUD in this subgroup analysis (20% of the total sample) were: –younger (57.8 years versus 62.8 years, p=0.001). –less likely to be married or cohabiting (47.2% versus 63.4%, p= 0.012).

13 Were patients aware of group allocation? No (patients weren't aware of group allocation prior to the study; however, some must have become aware once the study began).

14 Were clinicians aware of group allocation? No (clinicians weren't aware of group allocation prior to the study; however, they would have become aware once the study began).

15 Were outcome assessors aware of group allocation? No. –Patient data were collected by research assistants blinded to study group assignment at baseline, 3, 6, and 12 months.

16 Was follow-up complete? Yes. –All 362 patients included in this subanalysis completed baseline and 12-month follow-up assessments. –Thirty-nine patients included in the original analysis (N=401) did not complete 12-month follow-up evaluations. Whether patients lost to follow-up had a history of SUD is not known.

17 What Are the Results? How large was the treatment effect?

18 How large was the treatment effect? There was no difference in the proportion of patients with a history of SUD based on group randomization (CCI 18.3%, TAU 21.2%). At 12 months, patients assigned to CCI were more likely to have improvement in pain- related disability than those assigned to TAU (CCI 21.95%, TAU 14.0%; p<0.05).

19 How large was the treatment effect? (cont’d) Patients with a history of SUD assigned to TAU were less likely to have improvement in pain-related function than those with no history of SUD (adjusted odds ratio [AOR], 0.30; 95% CI, 0.11–0.82). No difference in improvement was detected between patients with and without an SUD in the CCI group; however, the confidence interval was wide (AOR, 1.06; 95% CI, 0.37– 3.01).

20 How Can I Apply the Results to Patient Care? Were the study patients similar to the patients in my practice?

21 Were the study patients similar to those in my practice? The sample consisted of primary-care patients recruited at a Veterans’ Administration medical center. More than 90% were men, and the mean age was 61.1 years.