Factors associated with non-normal birth outcomes for low-risk women in an inner-city hospital.

INTRODUCTION: The purpose of this study was to examine factors associated with normal versus non-normal birth outcomes for low-risk women who were admitted for care in spontaneous labor. METHODS: The birth records of 93 women were reviewed. RESULTS: At the completion of the fourth stage of labor, 61% of births (n = 57) met the criteria for normal, while 39% of births (n = 36) had non-normal outcomes. On bivariate analysis, variables associated with non-normal outcomes included nulliparity (odds ratio [OR], 9.10; 95% confidence interval [CI], 3-28; P < .0001), lower average centimeters of dilation at admission (t-score 4.422; P < .001), use of pharmacologic pain relief, including narcotics and epidural anesthesia (OR, 5.03; 95% CI, 2-16; P = .005), and birth attended by a physician versus a certified nurse-midwife (OR, 3.60; 95% CI, 2-9; P = .004). In a multivariate analysis, nulliparity (OR, 6.07; 95% CI, 2-19; P = .002) and lower average centimeters of dilation at admission (OR, 0.63; 95% CI, 0.5-0.9; P = .005) were independently associated with non-normal outcome. DISCUSSION: The development of clinical guidelines aimed at reducing admissions of women in early labor may reduce non-normal outcomes, particularly for nulliparous women.

Psychometric properties of a single-item scale to assess sleep quality among individuals with fibromyalgia.

BACKGROUND: Sleep disturbances are a common and bothersome symptom of fibromyalgia (FM). This study reports psychometric properties of a single-item scale to assess sleep quality among individuals with FM. METHODS: Analyses were based on data from two randomized, double-blind, placebo-controlled trials of pregabalin (studies 1056 and 1077). In a daily diary, patients reported the quality of their sleep on a numeric rating scale ranging from 0 ("best possible sleep") to 10 ("worst possible sleep"). Test re-test reliability of the Sleep Quality Scale was evaluated by computing intraclass correlation coefficients. Pearson correlation coefficients were computed between baseline Sleep Quality scores and baseline pain diary and Medical Outcomes Study (MOS) Sleep scores. Responsiveness to treatment was evaluated by standardized effect sizes computed as the difference between least squares mean changes in Sleep Quality scores in the pregabalin and placebo groups divided by the standard deviation of Sleep Quality scores across all patients at baseline. RESULTS: Studies 1056 and 1077 included 748 and 745 patients, respectively. Most patients were female (study 1056: 94.4%; study 1077: 94.5%) and white (study 1056: 90.2%; study 1077: 91.0%). Mean ages were 48.8 years (study 1056) and 50.1 years (study 1077). Test re-test reliability coefficients of the Sleep Quality Scale were 0.91 and 0.90 in the 1056 and 1077 studies, respectively. Pearson correlation coefficients between baseline Sleep Quality scores and baseline pain diary scores were 0.64 (p < 0.001) and 0.58 (p < 0.001) in the 1056 and 1077 studies, respectively. Correlations between the Sleep Quality Scale and the MOS Sleep subscales were statistically significant (p < 0.01), except for the MOS Snoring subscale. Across both studies, standardized effect sizes were generally moderate (0.46 to 0.52) for the 300 mg group and moderate (0.59) or moderate-to-large (0.70) for the 450 mg group. In study 1056, the effect size for the 600 mg group was moderate-to-large (0.73). In study 1077, the effect size for the 600 mg group was large (0.82). CONCLUSION: These results provide evidence of the reproducibility, convergent validity, and responsiveness to treatment of the Sleep Quality Scale and provide a foundation for its further use and evaluation in FM patients.

Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia.

OBJECTIVE: Sleep problems are a common symptom of fibromyalgia (FM). The objective of this study was to evaluate the Medical Outcomes Study (MOS) Sleep Scale as a measure of FM-related sleep problems. METHODS: Analyses were based on data from the 1056 and 1077 studies, two randomized, double-blind, placebo-controlled trials of pregabalin for adults with FM. MOS Sleep Scale scores of study patients were compared with United States normative scores using a one-sample Z test. Subscale structure of the MOS was evaluated by confirmatory factor analyses, internal consistency was evaluated using Cronbach's alpha reliability coefficients. Estimated clinically important differences (CID) in MOS Sleep Disturbance subscale scores were evaluated using mixed-effects models of change in subscale scores as a function of the Patient Global Impression of Change (PGIC). RESULTS: 1056 and 1077 included 748 and 745 patients, respectively. Most patients were female (1056: 94.4%, 1077: 94.5%) and white (1056: 90.2%, 1077: 91.0%). Mean ages were 48.8 years (1056) and 50.1 years (1077). Baseline MOS Sleep Scale scores were statistically (P<0.001) and substantially poorer than general population values. The MOS subscale structure was confirmed in both studies at each assessment except at baseline in the 1056 study. Cronbach's alpha coefficients were acceptable, at least 0.70, for all multi-item scales at baseline and end-of-study assessments in both studies, with the exception of the Sleep Adequacy subscale at baseline. The estimated CID for the MOS Sleep Disturbance subscale was 7.9. CONCLUSIONS: The MOS Sleep Scale is an appropriate measure of FM-related sleep problems. These analyses provide the foundation for further use and evaluation of the MOS Sleep Scale in FM patients.

A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions.

Although the burden of neuropathic pain is well-recognized, the descriptive epidemiology of specific neuropathic pain conditions has not been well-described. While painful diabetic peripheral neuropathy and postherpetic neuralgia have been widely evaluated, many other peripheral and central neuropathic pain syndromes have been less frequently studied. This review summarizes incidence and/or prevalence information about two relatively frequent neuropathic pain conditions-painful diabetic peripheral neuropathy and postherpetic neuralgia-and similarly summarizes the more limited epidemiologic information available for other peripheral and central neuropathic pain conditions. The data suggest that while our knowledge is still incomplete, the high frequency of several of these conditions in specific populations should be considered an important impetus for further studies designed to evaluate their contribution to the overall burden of neuropathic pain.

Sleep disturbances reported by refractory partial-onset epilepsy patients receiving polytherapy.

PURPOSE: Although sleep disturbances are common in epilepsy, few studies examined the prevalence and impact of sleep disturbance in epilepsy patients. This study investigates these in a cross-sectional survey. METHODS: We surveyed 201 adult partial-onset epilepsy patients taking stable regimens of two or more antiepileptic medications. Community-based U.S. neurologists recorded patient demographic and clinical information. Patients completed the Medical Outcomes Study (MOS) Sleep Scale, the Quality of Life in Epilepsy-10 instrument (QOLIE-10), and the EuroQol-5D (EQ-5D). We evaluated the associations of sleep with health-related quality of life and clinical and demographic characteristics by using correlation coefficients and analysis of variance. RESULTS: Mean (SD) age was 44.2 (12.5); 34% of patients had diagnosed sleep disturbances; 10% received prescription sleep medications. Patients with sleep disturbance reported poorer mean QOLIE-10 (55.2 vs. 63.7; p = 0.006) and EQ-5D (0.49 vs. 0.71; p < 0.001) scores relative to those without sleep disturbances. The mean (SD) MOS Sleep Problems Index score was 36.2 (20.8), worse than the general population mean of 26. Patients with physician-reported anxiety or depression had more sleep problems than did those without these comorbidities. Higher Sleep Problems Index scores were significantly (p < 0.001) correlated with poorer QOLIE-10 (r=-0.49) and EQ-5D (r=-0.56) scores. Patients experiencing a seizure within the past week reported higher MOS Sleep Problems Index scores than did those with a less-recent seizure (41.5 vs. 32.8; p = 0.003). CONCLUSIONS: Diagnosed and self-reported sleep disturbances in patients with partial-onset epilepsy are frequently overlooked, but are negatively associated with everyday functioning and well-being, and therefore contribute significantly to the burden of epilepsy.

The burden of neuropathic pain: results from a cross-sectional survey.

BACKGROUND: There are few published data on the treatment patterns and burden of neuropathic pain. We have investigated this in a large, observational, cross-sectional survey. METHODS: We surveyed 602 patients with neuropathic pain recruited from general practitioners in six European countries. Physicians recorded demographic and treatment information, including prescription medications. Patients completed Brief Pain Inventory (BPI) severity and interference questions, the EuroQol (EQ-5D), and questions about their productivity, non-prescription treatments, and frequency of physician visits. The BPI Pain Severity score (range: 0-10) is the mean of worst, least, average, and current pain ratings, with scores of 4-6 and 7-10 considered moderate and severe, respectively. We evaluated the impact of pain severity on functioning using analysis of variance models and chi2 tests. RESULTS: Mean (SD) age was 62.9 (14.4) years (50% female). Most patients reported moderate (54%) or severe (25%) pain. Nearly all patients (93%) were prescribed medications for their neuropathic pain: analgesics (71%); anti-epileptics (51%); antidepressants (29%); sedatives/hypnotics (15%). Seventy-six percent visited their physician at least once in the past month. Employment status was affected in 43% of patients; those employed missed a mean (SD) of 5.5 (9.8) workdays during the past month. Pain severity was associated significantly (P<0.001) with poorer EQ-5D scores (mild=0.67, moderate=0.46, severe=0.16), greater disruption of employment status (mild=24%, moderate=48%, severe=54%), and more frequent physician visits (% with one or more visits: mild=66%, moderate=79%, severe=83%). CONCLUSIONS: Patients with neuropathic pain visit their physician frequently and report substantial pain that interferes with daily functioning despite receiving treatment.