Clinical Characteristics, Pharmacotherapy and Healthcare Resource Use among Patients with Fibromyalgia Newly Prescribed Gabapentin or Pregabalin

Objective:  To characterize comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with fibromyalgia (FM) newly prescribed pregabalin or gabapentin in clinical practice. Methods and design:  Using the PharMetrics ® Database, FM patients (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) newly prescribed pregabalin ( n  = 1,606; mean age 49.9 ± 9.6 years; 87.9% female) and gabapentin ( n  = 930; mean age 49.5 ± 9.6 years; 86.6% female) on/after July 1, 2007 were identified. Prevalence of comorbidities, pharmacotherapy, and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 6 months preceding (preindex) and following (postindex) the date of their first pregabalin or gabapentin (index) prescription. Results:  Patients in both cohorts had a variety of comorbidities and used multiple medications. There were significant decreases ( P values < 0.05) in the use of nonsteroidal anti-inflammatory drugs (32.1% vs. 29.5%), anticonvulsants (27.0% vs. 22.0%), and combination therapies in the pregabalin cohort in the postindex period. There were significant increases (all P values < 0.05) in use of short-acting opioids (58.8% vs. 63.7%), any opioids (61.5% vs. 65.6%), serotonin–norepinephrine reuptake inhibitors (22.5% vs. 24.5%), anticonvulsants (16.3% vs. 26.2%), benzodiazepines (33.2% vs. 36.6%), topical agents (6.6% vs. 9.0%), and combination therapies in the gabapentin cohort. Although there were no changes in units of healthcare resources used, there were increases in the postindex period in hospitalization, medications, and total costs for pregabalin, and office visits and medication costs for gabapentin (all P values < 0.05). Conclusions:  Results suggest a high comorbidity and medication use burden in FM patients in this study. Further evaluation is warranted to clarify differences in resource utilization/costs observed with these two anticonvulsants.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/73737/1/j.1533-2500.2009.00292.x.pd

Measurement properties of painDETECT: Rasch analysis of responses from community-dwelling adults with neuropathic pain

© 2017 The Author(s). Background: painDETECT (PD-Q) is a self-reported assessment of pain qualities developed as a screening tool for pain of neuropathic origin. Rasch analysis is a strategy for examining the measurement characteristics of a scale using a form of item response theory. We conducted a Rasch analysis to consider if the scoring and measurement properties of PD-Q would support its use as an outcome measure. Methods: Rasch analysis was conducted on PD-Q scores drawn from a cross-sectional study of the burden and costs of NeP. The analysis followed an iterative process based on recommendations in the literature, including examination of sequential scoring categories, unidimensionality, reliability and differential item function. Data from 624 persons with a diagnosis of painful diabetic polyneuropathy, small fibre neuropathy, and neuropathic pain associated with chronic low back pain, spinal cord injury, HIV-related pain, or chronic post-surgical pain was used for this analysis. Results: PD-Q demonstrated fit to the Rasch model after adjustments of scoring categories for four items, and omission of the time course and radiating questions. The resulting seven-item scale of pain qualities demonstrated good reliability with a person-separation index of 0.79. No scoring bias (differential item functioning) was found for this version. Conclusions: Rasch modelling suggests the seven pain-qualities items from PD-Q may be used as an outcome measure. Further research is required to confirm validity and responsiveness in a clinical setting

Impact of self-rated osteoarthritis severity in an employed population: Cross-sectional analysis of data from the national health and wellness survey

<p>Abstract</p> <p>Background</p> <p>Although osteoarthritis (OA) often affects older persons, it has a profound effect on individuals actively employed. Despite reports of reduced productivity among workers with OA, data are limited regarding the impact of OA among workers. The objective of this study was to evaluate the impact of self-rated OA severity on quality of life, healthcare resource utilization, productivity and costs in an employed population relative to employed individuals without OA.</p> <p>Methods</p> <p>This cross-sectional analysis used data derived from the 2009 National Health and Wellness Survey (NHWS). Multivariable analyses characterized outcomes and costs (direct medical costs and indirect) among workers (full-time, part-time, or self-employed) ≥ 20 years of age who were diagnosed with OA and who self-rated their OA severity as mild, moderate, or severe relative to workers without OA. Evaluated outcomes included productivity, assessed using the Work Productivity and Impairment (WPAI) scale; health-related quality of life, using the SF-12v2 Health Survey; and healthcare resource utilization.</p> <p>Results</p> <p>4,876 workers reported being diagnosed with OA (45.0% mild, 45.9% moderate, and 9.1% severe); 34,896 workers comprised the non-OA comparator cohort. There was a greater proportion of females in the OA cohort (55.5% vs 45.6%; <it>P </it>< 0.0001) and more individuals in the 40-64 year and ≥ 65 year age ranges (<it>P </it>< 0.0001). As OA severity increased, workers reported more frequent pain, poorer quality of life, greater use of specific healthcare resources (hospitalizations) and reduced productivity. All outcomes indicated a significantly greater burden among workers with OA relative to those without OA (<it>P </it>< 0.0001). Estimated total annual costs per worker were $9,801 for mild OA,$14,761 for moderate OA, $22,111 for severe OA compared with$7,901 for workers without OA (<it>P </it>< 0.0001).</p> <p>Conclusions</p> <p>Workers with OA were characterized by significant disease and economic burdens relative to workers without OA that substantially increased with greater self-rated OA severity. Greater levels of OA severity were associated with reductions in quality of life and productivity, and increases in healthcare resource utilization and costs.</p

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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).</p> <p>Conclusion</p> <p>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.</p

Burden of Illness Associated with Peripheral and Central Neuropathic Pain among Adults Seeking Treatment in the U nited S tates: A Patient‐Centered Evaluation

Objective The aim of this study was to evaluate patient‐reported burden associated with peripheral and central neuropathic pain ( NeP ) by pain severity and NeP condition. Design Six hundred twenty‐four subjects with one of six NeP conditions were recruited during routine office visits. Subjects consented to retrospective chart review and completed a one‐time questionnaire (including E uro Q ol‐5 dimensions, 12‐item S hort‐ F orm H ealth S urvey, B rief P ain I nventory‐ S hort F orm, M edical O utcomes S tudy S leep S cale, H ospital A nxiety and D epression S cale, and demographic and clinical characteristics). Pain severity scores were used to stratify subjects by mild, moderate, and severe pain. Summary statistics and frequency distributions were calculated. Differences by severity level were compared using K ruskal– W allis (continuous variables) and chi‐square or F isher's exact test (categorical variables). Effect size was computed with C ohen's d (mild vs severe). Results Subjects' mean age was 55.5. The majority (80.8%) had moderate or severe pain. Patient‐reported outcomes (health status, physical and mental health, pain interference with function, sleep, anxiety, and depression) were significantly worse among subjects with greater pain severity (all P  0.95) for all others. The observed burden was most substantial among chronic low back pain‐ NeP , although the pattern of disease burden was similar across the six NeP conditions. Conclusions Subjects across NeP conditions exhibited high pain levels, which were significantly associated with poor function, compromised health status and sleep, and increased anxiety and depression. Results indicate substantial patient burden across broad NeP , particularly among subjects with severe pain.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/109996/1/pme12502.pd

Priority strategies to improve gender equity in Canadian emergency medicine: proceedings from the CAEP 2021 Academic Symposium on leadership

Objectives: Gender inequities are deeply rooted in our society and have significant negative consequences. Female physicians experience numerous gender-related inequities (e.g., microaggressions, harassment, violence). These inequities have far-reaching consequences on health, well-being and career longevity and may result in the devaluing of various strengths that female emergency physicians bring to the table. This, in turn, has an impact on patient healthcare experience and outcomes. During the 2021 Canadian Association of Emergency Physicians (CAEP) Academic Symposium, a national collaborative sought to understand gender inequities in emergency medicine in Canada. Methods: We used a multistep stakeholder-engagement-based approach (harnessing both quantitative and qualitative methods) to identify and prioritize problems with gender equity in emergency medicine in Canada. Based on expert consultation and literature review, we developed recommendations to effect change for the higher priority problems. We then conducted a nationwide consultation with the Canadian emergency medicine community via online engagement and the CAEP Academic Symposium to ensure that these priority problems and solutions were appropriate for the Canadian context. Conclusion: Via the above process, 15 recommendations were developed to address five unique problem areas. There is a dearth of research in this important area and we hope this preliminary work will serve as a starting point to fuel further research. To facilitate these scholarly endeavors, we have appended additional documents identifying other key problems with gender equity in emergency medicine in Canada as well as proposed next steps for future research

Randomized phase 2 trial and open-label extension of domagrozumab in Duchenne muscular dystrophy.

We report results from a phase 2, randomized, double-blind, 2-period trial (48 weeks each) of domagrozumab and its open-label extension in patients with Duchenne muscular dystrophy (DMD). Of 120 ambulatory boys (aged 6 to \u3c16 \u3eyears) with DMD, 80 were treated with multiple ascending doses (5, 20, and 40 mg/kg) of domagrozumab and 40 treated with placebo. The primary endpoints were safety and mean change in 4-stair climb (4SC) time at week 49. Secondary endpoints included other functional tests, pharmacokinetics, and pharmacodynamics. Mean (SD) age was 8.4 (1.7) and 9.3 (2.3) years in domagrozumab- and placebo-treated patients, respectively. Difference in mean (95% CI) change from baseline in 4SC at week 49 for domagrozumab vs placebo was 0.27 (-7.4 to 7.9) seconds (p = 0.94). There were no significant between-group differences in any secondary clinical endpoints. Most patients had ≥1 adverse event in the first 48 weeks; most were mild and not treatment-related. Median serum concentrations of domagrozumab increased with administered dose within each dose level. Non-significant increases in muscle volume were observed in domagrozumab- vs placebo-treated patients. Domagrozumab was generally safe and well tolerated in patients with DMD. Efficacy measures did not support a significant treatment effect. Clinicaltrials.gov identifiers: NCT02310763 and NCT02907619

Resource utilization and costs before and after total joint arthroplasty

<p>Abstract</p> <p>Background</p> <p>The purpose of this study was to compare pre- and post-surgical healthcare costs in commercially insured total joint arthroplasty (TJA) patients with osteoarthritis (OA) in the United States (U.S.).</p> <p>Methods</p> <p>Using a large healthcare claims database, we identified patients over age 39 with hip or knee OA who underwent unilateral primary TJA (hip or knee) between 1/1/2006 and 9/30/2007. Utilization of healthcare services and costs were aggregated into three periods: 12 months "pre-surgery," 91 days "peri-operative," and 3 to 15 month "follow-up," Mean total pre-surgery costs were compared with follow-up costs using Wilcoxon signed-rank test.</p> <p>Results</p> <p>14,912 patients met inclusion criteria for the study. The mean total number of outpatient visits declined from pre-surgery to follow-up (18.0 visits vs 17.1), while the percentage of patients hospitalized increased (from 7.5% to 9.8%) (both <it>p </it>< 0.01). Mean total costs during the follow-up period were 18% higher than during pre-surgery ($11,043 vs.$9,632, <it>p </it>< 0.01), largely due to an increase in the costs of inpatient care associated with hospital readmissions ($3,300 vs.$1,817, p < 0.01). Pharmacotherapy costs were similar for both periods ($2013 [follow-up] vs.$1922 [pre-surgery], p = 0.33); outpatient care costs were slightly lower in the follow-up period ($4338 vs.$4571, <it>p </it>< 0.01). Mean total costs for the peri-operative period were $36,553.</p> <p>Conclusions</p> <p>Mean total utilization of outpatient healthcare services declined slightly in the first year following TJA (exclusive of the peri-operative period), while mean total healthcare costs increased during the same time period, largely due to increased costs associated with hospital readmissions. Further study is necessary to determine whether healthcare costs decrease in subsequent years.</p