Psychometric testing and validation of the Chronic Pain Sleep Inventory.

BACKGROUND: Patients with chronic pain often experience significant disruptions in sleep. A potential benefit of treatment aimed at pain relief is improved quality of sleep in patients with chronic pain. OBJECTIVE: The goal of this study was to evaluate the psychometric properties of the Chronic Pain Sleep Inventory (CPSI) and provide preliminary evidence of its construct validity in assessing sleep problems among patients with chronic pain. METHODS: Data came from four 12-week, multi-center, double-blind, randomized, placebo-controlled clinical trials of chronic low back pain and osteo-arthritis of the hip or knee. CPSI data were collected at baseline and 12 weeks. The 5 CPSI items measured trouble falling asleep (CPSI1), needing sleep medication (CPSI2), awakened by pain during the night (CPSI3) and in the morning (CPSI4), and overall quality of sleep (CPSI5) on a 100-mm visual analog scale. Exploratory and confirmatory factor analyses were conducted to evaluate the underlying dimensionality and structure of the CPSI scales. The known-groups method was used to assess validity by comparing CPSI item scores across groups of patients known to differ in the presence and severity of sleep problems as measured by the Physical Dependence Questionnaire. RESULTS: A total of 2674 patients were included in the study (mean age, 57.6 years; 61.0% female; 80.2% white). The majority of the patients were treated for chronic pain related to osteoarthritis of the hip or knee (n=2294). Findings revealed a single sleep problems index can be scored from 3 of the 5 CPSI items (CPSI1, CPSI3, and CPSI4). All 3 items attributed sleep problems to pain, with high factor loadings (>0.80) and a high internal consistency (>0.90). Moderate to high correlations (r >or= 0.50) between CPSI items demonstrated convergent validity, and weak correlations (r<0.50) with other health-related scales (the Western Ontario and McMaster Universities Osteo-arthritis Index and the 36-item Short-Form Health Survey) demonstrated discriminant validity. All CPSI items showed greater ability to discriminate and respond to changes in the presence and severity of sleep problems than the other health-related scales. CONCLUSIONS: CPSI items showed good construct validity, and the results support the scoring of a reliable single index from 3 of the 5 CPSI items that all attributed sleep problems to pain.

Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: This study evaluated the efficacy and safety of tramadol extended-release (tramadol ER) tablets once daily in subjects with osteoarthritis pain. METHODS: This 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial included 1020 adults with osteoarthritis of the knee or hip and baseline pain intensity >or= 40 on a 100-mm pain visual analog scale (0 = no pain, 100 = extreme pain). Subjects took placebo or were titrated to a target dose of tramadol ER 100, 200, 300, or 400 mg once daily. MAIN OUTCOME MEASURES: The co-primary efficacy variables were pain and physical function subscales of the WOMAC Osteoarthritis Index and subject global assessment of disease activity. RESULTS: Mean changes in WOMAC Osteoarthritis Index pain and physical function subscales were significantly different between tramadol ER and placebo, overall (p

Risperidone versus Conventional Antipsychotics for Schizophrenia and Schizoaffective Disorder : Symptoms, Quality of Life and Resource Use under Customary Clinical Care.

OBJECTIVE: To prospectively compare risperidone with conventional antipsychotic agents among schizophrenia patients treated under usual practice conditions. DESIGN: One-year, multicentre, open-label, randomised trial carried out in 21 centres in 17 states of the US. PATIENTS: 684 patients were followed from 1995 to 1997, and must have experienced a symptom relapse at study start. INTERVENTIONS: Patients were randomly assigned to risperidone therapy or their physician's 'best choice' of any one of the 13 conventional antipsychotic medications approved in the US. MAIN OUTCOME MEASURES AND RESULTS: Outcomes measured were changes in psychiatric symptoms, side effects, satisfaction with drug therapy, quality of life (including health-related quality of life [HRQOL]) and resource utilisation. A subgroup analysis of the non-switchers was also conducted. Irrespective of treatment group, treatment switching and days with no drug therapy were observed. Compared with patients on conventional antipsychotics, those in the risperidone group achieved statistically superior scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [PANSS total score improved from 83.32 to 61.80 vs 81.42 to 66.99 in the risperidone and conventional groups, respectively), Barnes Akathisia Scale (scores improved from 0.89 to 0.55 vs 0.87 to 0.81 in the risperidone and conventional groups, respectively), and 36-Item Short Form Health Survey (SF-36) scale (scores improved from 32.83 to 39.92 vs 32.55 to 37.22 in the risperidone and conventional groups, respectively) during the 1-year treatment period. A significantly higher percentage of risperidone- treated patients had a 60% improvement in PANSS scores at 12 months (20.9% of patients compared with 10.7% in the risperidone and conventional groups, respectively). There was no statistically significant difference in resource utilisation between the two groups. Among non-switchers, patients in the risperidone group had lower total costs and more clinical benefits. CONCLUSIONS: Conditions of usual practice resulted in a high degree of non-treatment, treatment changing and multi-antipsychotic drug therapy. Patients in the risperidone group had better clinical outcomes (e.g. reduced psychiatric symptoms and side effects) and improved HRQOL. There were no significant differences in healthcare utilisation between the two study groups.