BURDEN OF LIPOHYPERTROPHY AMONG INSULIN DEPENDENT DIABETES MELLITUS PATIENTS IN CHINA: AN ANALYSIS OF OUTCOMES AND IMPACT OF PEN NEEDLE REIMBURSEMENT POLICY

Background Diabetes is a global epidemic and with an aging population accompanied by rapid urbanization China ranks highest in disease prevalence and associated burden. Independent of diabetes type, insulin is an eventual and costly requirement for disease management. The consequences of insulin administration however are poorly understood. Lipohypertrophy (LH) is one such consequence. It is hypothesized that method of insulin delivery and poor delivery technique are significant risk factors for this condition which is believed to alter insulin pharmacodynamics. Subsequently, insulin pen needles are a critical component of care however access to pen needles varies across China. Objective The objective of this study is to characterize the insulin injecting population in China, determine the prevalence of LH and highlight attributable risk factors. This research is also intended to explore the relationship between pen needle reimbursement policy, injection practices, clinical outcomes and direct costs among insulin injecting diabetics in China. Methods A cross-sectional examination was conducted among 401 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Eligible participants were between the ages of 18-80 and taking insulin for a duration of greater than 1 year. Demographics, medical history including HbA1c, healthcare resource utilization (HRU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. LH prevalence was clinically confirmed at the time of examination. Differences between those with and without LH were evaluated by Student’s t-test or Wilcoxon rank sum. Unit costs were assigned to insulin and healthcare HRU and compared using descriptive statistics and multivariate regression models. Results A total of 403 patients provided informed consent of which 401 completed the clinical module of the survey and 400 completed the HRU section. Half the study population was male (49.9%) with an average age of 59.6 year and BMI of 25.4 kg/m2. Most patients in this study were diagnosed with Type 2 diabetes (93%) and had diabetes for an average duration of 11.8 years and using insulin for 5.8 years (range 1-29.3 years). Prevalence of LH in this population was established to be 53.1%. More than half the study population reported at least one diabetes related outpatient (OP) visit (62.7%) and 14.4% of the sample had at least one hospital stay in the past 6 months. The average number of diabetes related OP visits and hospital stays per patient was 2.55 (SD 2.55) and 0.177 (SD 0.516) respectively. The average daily insulin dose was 33.95 (SD 18.41) with patients reporting a range from 6 -118 units per day. Nearly 100% of study participants had some health insurance coverage (98%) and 35.5% had coverage for insulin pen needles. LH prevalence was observed to be 18.6% higher in those without PN reimbursement (59.3% vs. 40.7%, p=0.0007). LH patients also exhibited higher HbA1c (8.2 vs 7.7%), insulin consumption (11U), median PN reuse (12 vs. 7 times per needle, p\u3c0.0001), and costs (6-month insulin costs 1591 vs. 1328 RMB, p=0.0025; 6-month total HRU 6433 vs. 4432 RMB, p\u3c0.0001). Injection site rotation and PN reuse frequency were both identified as risk factors for LH along with BMI and reimbursement. Incorrect injection site rotation had an odds ratio of 8.4 (p≤0.001). Total cost of excess insulin consumption adjusted for adherence was estimated to be $313 million 2015 USD. Conclusions LH widespread complication among the insulin injecting diabetic population in China. LH is associated with higher insulin consumption and worse glycemic control. Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Injection site rotation and reduction in needle reuse may limit the development and impact of this complication. Furthermore, broader coverage for PN may reduce clinical and economic burden on the patient and healthcare system while improving quality of care

Evaluation of the impact of fibromyalgia on patients' sleep and the content validity of two sleep scales

<p>Abstract</p> <p>Background</p> <p>Disturbed sleep is commonly reported in fibromyalgia (FM). Both the Sleep Quality Numeric Rating Scale (NRS) and the Medical Outcomes Study Sleep Scale (MOS-Sleep) have demonstrated positive psychometric properties in patients with FM. However, these assessments were developed prior to the current recommendation to include patient input during the concept elicitation or item generation phases. Therefore, the objective of this study was to evaluate the impact of FM on participants, including their sleep, and to test the content validity of these two sleep measures in FM patients.</p> <p>Methods</p> <p>Qualitative interviews were conducted in Raleigh, North Carolina and Detroit, Michigan with 20 adults who reported a physician diagnosis of FM. Sixteen participants were female, 13 were white, and the average age was 50 years. Two researchers conducted all interviews using a structured guide.</p> <p>Results</p> <p>Participants consistently reported that FM had a debilitating impact on their lives and their sleep, particularly getting to sleep and staying asleep. Participants responded positively to the Sleep Quality NRS as an assessment of their sleep. The majority of participants stated that they would not change the response numbering or wording of the item's anchors. Participants also responded positively to the 24-hour recall period of the Sleep Quality NRS. Participants found the 12-item MOS-Sleep to be appropriate and relevant; 19 participants indicated the measure captured all of their sleep-related symptoms. However, areas for potential modification were identified, such as the need to separate the item regarding awakening short of breath and awakening with a headache into two separate questions. Participants also questioned the relevance of the snoring and awakening short of breath items to FM. Half of participants expressed a preference for a daily rather than a weekly recall period.</p> <p>Conclusion</p> <p>This study demonstrates the significant impact that FM has on patients' lives, particularly sleep. While patients with FM were not part of the development of the generic sleep assessments that were evaluated, this study provides evidence of their content validity, supporting their use in FM studies. Modifications to the MOS-Sleep may improve the psychometric properties and relevance to patients with FM.</p

The comparative burden of mild, moderate and severe Fibromyalgia: results from a cross-sectional survey in the United States

<p>Abstract</p> <p>Background</p> <p>Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States.</p> <p>Methods</p> <p>203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level.</p> <p>Results</p> <p>Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03).</p> <p>Conclusions</p> <p>FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.</p

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

Abstract 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 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- 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.</p

Primary Care Physicians’ Perceptions of the Challenges and Barriers in the Timely Diagnosis, Treatment and Management of Fibromyalgia

OBJECTIVES: To describe beliefs and practice patterns of primary care physicians (PCPs) providing fibromyalgia (FM) care, and to characterize differences between PCPs who report being able to provide timely and beneficial care versus the remaining PCPs

Financial and Clinical Characteristics of Fibromyalgia: A Case-Control Comparison

Objective: To compare healthcare utilization and costs between subjects with and without fibromyalgia (FM) using claims data from a large health benefits company in the United States. Study Design: Retrospective cohort. Methods: We analyzed 24 months of medical and pharmacy claims data comparing healthcare utilization and costs among Humana members diagnosed with FM to a propensity score matched control group without a diagnosis for FM. FM cases were identified as members aged 18 years and older, with at least 2 medical claims for International Classification of Diseases, Ninth Revision, Clinical Modification codes 729.0 and/or 729.1. The first medical claim for FM was utilized as the index date. Results: A total of 9988 FM cases and 9988 controls were included in the analysis. Compared with controls, the use of pain-related medications by FM cases was approximately 2 times higher with opioids being used most commonly. FM cases utilized a mean (SD) of 22.5 (23.9) and 31.1 (26.6) outpatient services per year in the prediagnosis and postdiagnosis periods, respectively, compared with 14.8 (20.5) and 16.3 (24.5) among controls (P < .01). Office visits, tests, and procedures represented the majority of utilization. During the postdiagnosis period, the mean per-patient per-month costs for outpatient services among FM cases was $377 ($760) and $217 ($740.87) among controls (P < .01). Conclusion: FM cases had significantly higher utilization and costs compared with controls. Office visits, tests and procedures, and the use of pain-related medications accounted for the largest absolute differences between the 2 groups. (Am J Manag Care. 2010; 16: S118-S125

The association between insurance coverage for insulin pen needles and healthcare resource utilization among insulin-dependent patients with diabetes in China

Abstract Background Pen needles are an important component of insulin delivery among patients with diabetes, but are not universally covered in China. We compared clinical and economic characteristics of insulin-dependent patients in China who have some level of pen needle (PN) reimbursement to those with no PN reimbursement. Methods A cross-sectional study was conducted among 400 insulin users with Type 1 or Type 2 diabetes treated in outpatient endocrinology units of four large tertiary care hospitals in Nanjing, Chongqing, Beijing and Zhengzhou. Demographics, medical history, healthcare resource utilization (RU), out-of-pocket costs, insurance and PN reimbursement status were surveyed. Unit costs were assigned to healthcare RU and compared using descriptive statistics and multivariate regression models. Results A total of 400 patients were analyzed; 142 (35.5%) with some level of PN coverage/reimbursement and 258 (64.5%) without. Patients without PN reimbursement had a higher prevalence of lipohypertrophy (59.3% vs. 40.7%, p = 0.0007), greater median PN reuse (12 vs. 7 times per needle, p < 0.0001), greater 6-month insulin costs (1591 vs. 1328 Renminbi [RMB], p = 0.0025) and total unadjusted 6-month expenditures (6433 vs. 4432 RMB, p < 0.0001), respectively. After controlling for clinical and demographic characteristics, patients without PN reimbursement had 4.6 times greater odds of high costs compared to those with PN reimbursement. Conclusions Insulin users without PN reimbursement may pose a greater economic burden to China compared to those with PN reimbursement. Expansion of insurance coverage for insulin PNs can improve the quality of care and potentially help reduce the economic burden in this population