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Journal Club. Alcohol, Other Drugs, and Health: Current Evidence September –October 2010. Featured Article. Association Between Substance Use Disorder Status and Pain-Related Function Following 12 Months of Treatment in Primary Care Patients with Musculoskeletal Pain
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Journal Club Alcohol, Other Drugs, and Health: Current Evidence September–October 2010 www.aodhealth.org
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]. www.aodhealth.org
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). www.aodhealth.org
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. www.aodhealth.org
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. www.aodhealth.org
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.aodhealth.org
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.aodhealth.org
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? www.aodhealth.org
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. www.aodhealth.org
Was randomization concealed? • Yes. • Neither clinicians nor patients knew which group they were randomized to prior to the start of the study. www.aodhealth.org
Were patients analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org
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). www.aodhealth.org
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). www.aodhealth.org
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). www.aodhealth.org
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. www.aodhealth.org
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. www.aodhealth.org
What Are the Results? • How large was the treatment effect? www.aodhealth.org
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). www.aodhealth.org
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). www.aodhealth.org
How Can I Apply the Results to Patient Care? • Were the study patients similar to the patients in my practice? www.aodhealth.org
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. www.aodhealth.org