Lipohypertrophy in China: Prevalence, Risk Factors, Insulin Consumption, and Clinical Impact.

BACKGROUND: Lipohypertrophy (LH) is a complication of insulin therapy. We assessed LH prevalence, risk factors, insulin usage, and clinical and health economic effects in China. METHODS: In four cities, 401 adult patients injecting insulin ≥1 year were surveyed for diabetes/insulin injection history and practices, pen needle reimbursement (PNR), and health resource utilization, followed by structured examination and HbA1c testing. Differences between those with and without LH were evaluated by Student's t-test or the Wilcoxon rank sum test. Insulin costs were calculated. RESULTS: Patients were 59.6 ± 11.5 years old; 50% male; 93.5% type 2 diabetes. LH prevalence was 53.1%. Compared to those without LH, patients with LH had higher body mass index (BMI; 26 vs. 24.8 kg/m2) and HbA1c (8.2% vs. 7.7% [66 vs. 61 mmol/mol]), took 11 IU (0.13 IU/kg or 31.7%) more insulin costing $1.4 versus $1.0 (RMB 9.5 vs. 6.8) daily, reused PNs more times, and had less PNR (all P ≤ 0.003). LH patients correctly rotated injection sites less often (67.6% vs. 92.3%, P < 0.0001). By stepwise logistic regression, BMI, needle reuse frequency, and PNR remained modestly associated with LH prevalence (odds ratios [OR] <1.9; P ≤ 0.03); weight-adjusted insulin dose and incorrect site rotation showed ORs of nearly 7 and 8.4, respectively (P ≤ 0.001). Extrapolated to 9 million insulin-injecting patients in China and adjusted for therapy adherence, LH-related excess annual insulin consumption cost is estimated at nearly $297 million (RMB 2 billion). CONCLUSIONS: LH is common in China and associated with worse glycemic control, despite nearly one-third greater insulin consumption, with large cost implications. Proper injection technique education may reduce LH prevalence.

The Comparative Burden of Chronic Widespread Pain and Fibromyalgia in the United States.

BACKGROUND/PURPOSE: Little information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States. METHODS: This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP-), with CWP but without FM (CWP+), and with confirmed FM were identified. RESULTS: Disease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP- to CWP+ to FM (P = 0.0044, P < 0.0001, respectively). From CWP- to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P < 0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP- to CWP+ to FM (all P < 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP- subjects (32.8%; P < 0.0001). Significant differences in total direct and indirect costs across the three groups (both P < 0.0001) were observed, with highest costs among FM subjects. CONCLUSION: Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs.

Societal and individual burden of illness among fibromyalgia patients in France: association between disease severity and OMERACT core domains.

BACKGROUND: Patients with fibromyalgia (FM) report widespread pain, fatigue, and other functional limitations. This study aimed to provide an assessment of the burden of illness associated with FM in France and its association with disease severity and core domains as defined by Outcome Measures in Rheumatology Clinical Trials (OMERACT) for FM. METHODS: This cross-sectional, observational study recruited patients with a prior diagnosis of FM from 18 community-based physician offices in France. Patients completed questions about FM impact (Fibromyalgia-Impact Questionnaire [FIQ]), core symptoms (defined by OMERACT), health-related quality of life (EQ-5D), current overall health status (rated on a scale from 0 to 100), productivity, treatment satisfaction, and out-of-pocket expenses related to FM. Site staff recorded patients' treatment and health resource use based on medical record review. Costs were extrapolated from 4-week patient-reported data and 3-month clinical case report form data and calculated in 2008 Euros using a societal perspective. Tests of significance used the Kruskal-Wallis test or Fisher's Exact test where P < 0.05 was considered significant. RESULTS: Eighty-eight patients (mean 55.2 y; female:male 74:14) were recruited. The majority of patients (84.1%) were prescribed medications for FM. Patients mainly described medications as a little/not at all effective (40.0%) or somewhat effective (52.9%). Current Overall Health rating was 52.9 (± 17.8) and FIQ total score was 54.8 (± 17.3). FIQ total score was used to define FM severity, and 17 patients scored 0- < 39 (mild FM), 33 patients 39- < 59 (moderate FM), and 38 scored 59-100 (severe FM). As FM severity level worsened, patients had poorer overall health status and perceived their prescription medications to be less effective. Average cost/FM patient was higher for severe (€10,087) vs. moderate (€6,633) or mild FM (€5,473); however, the difference was not significant. CONCLUSIONS: In a sample of 88 patients with FM from France, we found that FM poses a substantial economic and human burden on patients and society. FM severity level was significantly associated with patients' health status and core symptom domains.

The impact of 'best-practice' patient care in fibromyalgia on practice economics.

OBJECTIVE: The office time required for primary care physicians (PCPs) to diagnose, treat and manage fibromyalgia (FM) patients can be extensive. The study objective was to determine if PCPs can positively impact practice economics by requiring fewer patient visits and less office time, while still achieving an acceptable quality of life, as reported by the physician. STUDY DESIGN: Survey of PCPs who diagnose, manage and treat FM patients. METHODS: Surveys were administered to US private practice PCPs, obtaining information on the number of office visits, and time spent with FM patients. PCPs were allotted into two groups: FM-efficient (FME; n = 40) and FM usual care (FMUC; n = 54), based on their reported ability to achieve an acceptable quality of life for ≥50% of their FM patients in less than four office visits post FM diagnosis. An economic model estimated the monetary value of each PCP cohorts' time spent with a newly diagnosed FM patient over a 2-year timeframe. RESULTS: Significant office time cost differences across 2 years exist between FME PCPs and FMUC PCPs ($840 vs. $1117, P < 0.05). FME PCPs had a significantly lower cost of scheduled time to confirm diagnosis ($243 vs. $339, P < 0.05) and time to find right treatment ($264 vs. $365, P < 0.05) than FMUC PCPs. Both groups incurred costs related to excess visit time, but it was less for FME PCPs ($119, 29 minutes) than FMUC PCPs ($182, 44 minutes, P < 0.01), driven by quicker diagnosis confirmation (P < 0.01) and treatment initiation (P < 0.01). CONCLUSIONS: Research suggests that efficient FM care delivery during diagnosis and treatment can be associated with improved practice economics.