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Journal Club

Alcohol, Other Drugs, and Health: Current Evidence

September–October 2010

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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].

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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).

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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.

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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.

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Assessing Validity of an Article about Therapy

• Are the results valid?

• What are the results?

• How can I apply the results to patient care?

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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?

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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?

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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.

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Was randomization concealed?

• Yes.

– Neither clinicians nor patients knew which group they were randomized to prior to the start of the study.

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Were patients analyzed in the groups to which they were

randomized?

• Yes.

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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).

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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).

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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).

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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.

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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.

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What Are the Results?

• How large was the treatment effect?

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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).

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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).

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How Can I Apply the Results to Patient Care?

• Were the study patients similar to the patients in my practice?

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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.