No abstract

There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

The Decisional Balance Sheet of Incentives has been proposed by Janis and Mann (1977) as a general schema for representing both the cognitive and motivational aspects of human decision making. In this study, a brief 24-item paper and pencil measure was constructed to study the decision-making process in smoking cessation. Two scales were identified and labeled the Pros of Smoking and the Cons of Smoking. These scales were successful in differentiating between five groups representing stages of change in the quitting process. The two scales were also successful when employed as predictors of smoking status at a 6-month follow-up. The Decisional Balance Scale appears to be a powerful construct of potentially wide application in behavior change.

This paper investigates comorbidity between chronic back and neck pain and other physical and mental disorders in the US population, and assesses the contributions of chronic spinal pain and comorbid conditions to role disability. A probability sample of US adults (n=5692) was interviewed. Chronic spinal pain, other chronic pain conditions and selected chronic physical conditions were ascertained by self-report. Mood, anxiety and substance use disorders were ascertained with the Composite International Diagnostic Interview (CIDI). Role disability was assessed with questions about days out of role and with impaired role functioning. The 1 year prevalence of chronic spinal pain was 19.0%. The vast majority (87.1%) of people with chronic spinal pain reported at least one other comorbid condition, including other chronic pain conditions (68.6%), chronic physical conditions (55.3%), and mental disorders (35.0%). Anxiety disorders showed as strong an association with chronic spinal pain as did mood disorders. Common conditions not significantly comorbid with chronic spinal pain were diabetes, heart disease, cancer, and drug abuse. Chronic spinal pain was significantly associated with role disability after controlling for demographic variables and for comorbidities. However, comorbid conditions explained about one-third of the gross association of chronic spinal pain with role disability. We conclude that chronic spinal pain is highly comorbid with other pain conditions, chronic diseases, and mental disorders, and that comorbidity plays a significant role in role disability associated with chronic spinal pain. The societal burdens of chronic spinal pain need to be understood and managed within the context of comorbid conditions.

Our goal was to evaluate pain severity, pain-related interference with function, sleep impairment, symptom levels of anxiety and depression, and quality of life among patients with painful diabetic peripheral neuropathy (DPN). Participants in a burden of illness survey (n = 255) completed the modified Brief Pain Inventory-DPN (BPI-DPN), MOS Sleep Scale, Hospital Anxiety and Depression Scale (HADS), Short Form Health Survey-12v2 (SF-12v2), and the EuroQoL (EQ-5D). Patients were 61 +/- 12.8 years old (51.4% female), had diabetes for 12 +/- 10.3 years and painful DPN for 6.4 +/- 6.4 years. Average and Worst Pain scores (BPI-DPN, 0-10 scales) were 5.0 +/- 2.5 and 5.6 +/- 2.8. Pain substantially interfered (>or=4 on 0-10 scales) with walking ability, normal work, sleep, enjoyment of life, mood, and general activity. Moderate to severe symptom levels of anxiety and depression (HADS-A and HADS-D scores >or=11 on 0-21 scales) occurred in 35% and 28% of patients, respectively. Patients reported greater sleep problems compared with the general U.S. population and significant impairment in both physical and mental functioning (SF-12v2) compared with subjects with diabetes. The mean EQ-5D utility score was 0.5 +/- 0.3. Greater pain levels in DPN (mild to moderate to severe) corresponded with higher symptom levels of anxiety and depression, more sleep problems, and lower utility ratings and physical and mental functioning, (all Ps < 0.01). Painful DPN is associated with decrements in many aspects of patients' lives: physical and emotional functioning, affective symptoms, and sleep problems. The negative impact is higher in patients with greater pain severity.