Information without Implementation: A Practical Example for Developing a Best Practice Education Control Group.

This article considers methodology for developing an education-only control group and proposes a simple approach to designing rigorous and well-accepted control groups. This approach is demonstrated in a large randomized trial. The Lifestyles trial (n = 367) compared three group interventions: (a) cognitive-behavioral treatment (CBT) for osteoarthritis pain, (b) CBT for osteoarthritis pain and insomnia, and (c) education-only control (EOC). EOC emulated the interventions excluding hypothesized treatment components and controlling for nonspecific treatment effects. Results showed this approach resulted in a control group that was highly credible and acceptable to patients. This approach can be an effective and practical guide for developing high-quality control groups in trials of behavioral interventions.

Chronic use of symptomatic headache medications.

Chronic use of symptomatic headache medication is believed to be a risk factor for drug-induced chronic headache. This study reports the frequency of chronic use of symptomatic headache medications implicated in drug-induced chronic headache among primary-care headache (PCH) patients and identifies predictors of chronic/frequent use. The design uses a 2-year cohort study of a sample of PCH patients in Group Health Cooperative of Puget Sound, a large health maintenance organization in Seattle, WA. Among 779 PCH patients (aged 18-74 years) interviewed at baseline, 662 (85%) completed both 1- and 2-year follow-up interviews. This study estimates the percent of PCH patients reporting: (1) frequent use of over-the-counter, non-steroidal anti-inflammatory, opioid, sedative-hypnotic, and ergot medications (defined as 14 or more days of use for each class in the prior month), (2) chronic/frequent use of these medications, defined as surpassing criteria for frequent use on at least 2 of the 3 study interviews, and (3) chronic/frequent polypharmacy, defined as chronic/frequent use of 2 or more classes of headache medication. Twenty-one percent of PCH patients were chronic/frequent users of symptomatic headache medications, while 2.6% met study criteria for chronic/frequent polypharmacy. Chronic/frequent use of over-the-counter medications (15.9%) was twice as common as chronic/frequent use of prescription medications (7.7%). Headache days at baseline was the strongest predictor of chronic/frequent medication use. After controlling for baseline persistence and severity, older patients were more likely to be chronic/frequent users of headache medications. The age effect was explained by chronic/frequent use of over-the-counter medications.(ABSTRACT TRUNCATED AT 250 WORDS)

De facto long-term opioid therapy for noncancer pain.

OBJECTIVES: This paper describes characteristics of opioid use episodes for noncancer pain and defines thresholds for de facto long-term opioid therapy. METHODS: CONSORT (CONsortium to Study Opioid Risks and Trends) includes adult members of 2 health plans serving over 1% of the US population. Opioid use episodes beginning in the years 1997 to 2005 were classified as acute, episodic, long-term/lower dose, or long-term/higher dose. RESULTS: On the basis of evaluation of the likelihood of opioid use continuing, long-term opioid therapy was defined by episodes lasting longer than 90 days with 10+ opioid prescriptions or 120+ days supply of opioids dispensed. Long-term/higher dose episodes (<1.5% of all opioid use episodes) were characterized by daily or near daily use, a mean duration of about 1000 days, and an average daily dose of about 55 mg. They accounted for more than half the total morphine equivalents dispensed from the years 1997 to 2006. Short-acting, non-Schedule II opioids (eg, hydrocodone with acetaminophen) were, by far, the most commonly prescribed medications for acute, episodic, and long-term episodes. Long-acting (sustained-release) opioids were the predominately prescribed medication in a minority of long-term episodes (6% to 12%). DISCUSSION: Long-term opioid therapy was characterized by the diversity in medications prescribed, dosage levels, and frequency of use. The proposed threshold for long-term opioid therapy provides a checkpoint for physicians to review whether an explicit decision to sustain opioid therapy has been reached, and to ensure that a documented treatment plan and provisions for monitoring medication use and patient outcomes are in place.