Excessive Hospitalizations and Its Associated Economic Burden among People with Diabetes in the United States

AbstractObjectivesWe conducted this study to estimate the excessive hospital admission among people with diabetes and the associated economic burden in the USA.MethodsThe study was based on the 2005 Nationwide Inpatient Sample (NIS), a nationally representative probability sample conducted annually by the Agency of Health Research and Quality. Nearly 8 million records were sampled from over 1000 community hospitals in the 2005 NIS.ResultsExcluding childbirth-related admissions, the estimated US hospitalizations numbered approximately 30.8 million; individuals with diabetes accounted for over 6.4 million (20.9%) of these admissions. For every 1000 individuals without diabetes, with type 1 diabetes, and with type 2 diabetes, the numbers of hospitalizations were 89, 418, and 303, respectively. The rates of hospitalization increased greatly by the presence of diabetes for all age groups and sex. During 2005, the national bill of hospital charges and costs for individuals with diabetes exceeded US$171 billion and US$90 billion, respectively. If the prevalence of diabetes increases to 7.5% from 7.0%, the total number of hospitalizations made by individuals with diabetes will be 7.5 million in 2015.ConclusionsAlthough approximately 7% of the population had diabetes in the USA, nearly 20.9% of hospitalizations were made by individuals with this condition. Due to the excessive hospitalizations incurred by patients with diabetes, a small increase in the number of people with diabetes will amplify the number of hospitalizations. Health-care communities should anticipate this possible increased demand of hospitalizations and the associated economic burden

The longitudinal link between visual acuity and health-related quality of life in patients with diabetic retinopathy

<p>Abstract</p> <p>Background</p> <p>This study characterized the degree of change in health-related quality of life (HRQL) associated with change in visual acuity among patients with diabetic retinopathy.</p> <p>Methods</p> <p>Data are from a randomized, placebo-controlled trial of ruboxistaurin for vision loss in patients with diabetic retinopathy. Visual acuity was quantified as letters on the ETDRS visual acuity chart. HRQL was assessed with the 25-Item Visual Function Questionnaire (VFQ-25) and the SF-36. Patients were categorized into groups based on visual acuity change from baseline to month 18. HRQL change of these groups was compared using general linear models. Regression analyses examined visual acuity change defined continuously.</p> <p>Results</p> <p>Patients (N = 535) were primarily Caucasian (81.9%) and male (64.1%); mean age = 59.3 years. Compared to patients whose visual acuity did not change, the group with > 10 letters vision loss had significantly greater decreases in all VFQ-25 subscales except ocular pain. SF-36 change scores did not correspond as closely to change in vision. Change in visual acuity defined continuously was significantly associated with change in all VFQ-25 scales except ocular pain (p < 0.0001).</p> <p>Conclusion</p> <p>Change in visual acuity was associated with corresponding changes in HRQL among patients with diabetic retinopathy. Previous research has often defined vision loss as a loss of at least 15 letters on the ETDRS visual acuity chart. In the current study, however, a loss of at least 10 letters was associated with substantial declines in HRQL domains such as driving, dependency, role limitations, and mental health. These findings suggest that patients who experience vision loss of at least 10 letters may be appropriate targets of future research and clinical intervention.</p

Which multi-attribute utility instruments are recommended for use in cost-utility analysis? A review of national health technology assessment (HTA) guidelines.

Kennedy-Martin M, Slaap B, Herdman M, et al. Which multi-attribute utility instruments are recommended for use in cost-utility analysis? A review of national health technology assessment (HTA) guidelines. The European journal of health economics : HEPAC : health economics in prevention and care. 2020.BACKGROUND: Several multi-attribute utility instruments (MAUIs) are available from which utilities can be derived for use in cost-utility analysis (CUA). This study provides a review of recommendations from national health technology assessment (HTA) agencies regarding the choice of MAUIs.; METHODS: A list was compiled of HTA agencies that provide or refer to published official pharmacoeconomic (PE) guidelines for pricing, reimbursement or market access. The guidelines were reviewed for recommendations on the indirect calculation of utilities and categorized as: a preference for a specific MAUI; providing no MAUI preference, but providing examples of suitable MAUIs and/or recommending the use of national value sets; and recommending CUA, but not providing examples of MAUIs.; RESULTS: Thirty-four PE guidelines were included for review. MAUIs named for use in CUA: EQ-5D (n=29 guidelines), the SF-6D (n=11), HUI (n=10), QWB (n=3), AQoL (n=2), CHU9D (n=1). EQ-5D was a preferred MAUI in 15 guidelines. Alongside the EQ-5D, the HUI was a preferred MAUI in one guideline, with DALY disability weights mentioned in another. Fourteen guidelines expressed no preference for a specific MAUI, but provided examples: EQ-5D (n=14), SF-6D (n=11), HUI (n=9), QWB (n=3), AQoL (n=2), CHU9D (n=1). Of those that did not specify a particular MAUI, 12 preferred calculating utilities using national preference weights.; CONCLUSIONS: The EQ-5D, HUI, and SF-6D were the three MAUIs most frequently mentioned in guidelines. The most commonly cited MAUI (in 85% of PE guidelines) was EQ-5D, either as a preferred MAUI or as an example of a suitable MAUI for use in CUA in HTA

Validation of two generic patient-reported outcome measures in patients with type 2 diabetes

<p>Abstract</p> <p>Background</p> <p>Prior to using a generic patient-reported outcome measure (PRO), the measure should be validated within the target population. The purpose of the current study was to validate two generic measures in patients with type 2 diabetes.</p> <p>Methods</p> <p>Patients with type 2 diabetes in Scotland and England completed two generic measures: EQ-5D and Psychological General Well-Being Index (PGWB). Two diabetes-specific measures were administered: ADS and DSC-R. Analyses assessed reliability and validity.</p> <p>Results</p> <p>There were 130 participants (53 Scotland; 77 England; 64% male; mean age = 55.7 years). Responses on the EQ-5D and PGWB reflected moderate impairment consistent with previous diabetes samples: mean EQ-5D Index score, 0.75; EQ-5D VAS, 68.8; PGWB global score, 67.9. All scales of the PGWB demonstrated good internal consistency reliability (Cronbach's alpha = 0.77 to 0.97). The EQ-5D and PGWB demonstrated convergent validity through significant correlations with the ADS (r = 0.48 to 0.61), DSC-R scales (r = 0.33 to 0.81 except ophthalmology subscale), and Body Mass Index (r = 0.15 to 0.38). The EQ-5D and PGWB discriminated between groups of patients known to differ in diabetes-related characteristics (e.g., history of hypoglycemia).</p> <p>Conclusion</p> <p>Results support the use of the EQ-5D and PGWB among patients with type 2 diabetes, possibly in combination with condition-specific measures.</p

Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes

BACKGROUND: Patient-reported measures can be used to examine whether drug differences other than clinical efficacy have an impact on outcomes that may be important to patients. Although exenatide and insulin glargine appear to have similar efficacy for treatment of type 2 diabetes, there are several differences between the two treatments that could influence outcomes from the patient's perspective. The purpose of the current study was to examine whether the two drugs were comparable as assessed by patient-reported outcomes using data from a clinical trial in which these injectable medications were added to pre-existing oral treatment regimens. METHODS: Patients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial. At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist – Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Change from baseline to endpoint was analyzed within each treatment group. Group differences were examined with General linear models (GLMs), controlling for country and baseline scores. RESULTS: A total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine). The sample was primarily Caucasian (79.6%), with slightly more men (55.2%) than women, and with a mean age of 58.5 years. Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale. GLMs found no statistically significant differences between groups in change on the health outcomes instruments. CONCLUSION: This analysis found that both exenatide and insulin glargine were associated with significant improvements in patient-reported outcomes when added to oral medications among patients with type 2 diabetes. Despite an additional daily injection and a higher rate of gastrointestinal adverse events, treatment satisfaction in the exenatide group was comparable to that of the glargine group, possibly because of weight reduction observed in patients treated with exenatide

Development of a patient-reported outcome (PRO) measure to assess patient perceptions of simplicity and complexity of treatment for type 2 diabetes

Abstract Introduction Treatments for type 2 diabetes vary widely in their complexity. The simplicity or complexity of a treatment regimen may have an impact on patient preference, treatment adherence, and health outcomes. The purpose of this qualitative study was to develop two draft patient-reported outcome instruments focusing on patients’ experience with simplicity and complexity of treatment for type 2 diabetes. Methods The instruments were developed in a series of steps: gather information to support development of a concept elicitation interview guide (literature review and expert interviews), concept elicitation interviews with patients (N = 30), cognitive interviews with patients (N = 20), and a translatability assessment. Results In concept elicitation interviews, patients with type 2 diabetes reported a range of treatment attributes that influence their perceptions of treatment simplicity and complexity, such as injection devices, medication preparation, dose timing, dose frequency, ease of taking the correct dose, flexibility of dose schedule, remembering to take medication, and food requirements. Two draft questionnaires were developed based on the literature review, expert interviews, and concept elicitation interviews with patients. Revisions were made to these draft instruments based on qualitative interviews with patients and translatability assessment. Discussion The qualitative research conducted in this study supports the content validity of two newly developed instruments, the Simplicity of Diabetes Treatment Questionnaire (Sim-Q) and the Simplicity of Diabetes Treatment Questionnaire-Comparison (Sim-Q-Comp), designed to assess the simplicity and complexity of diabetes treatment from the patient’s perspective

A Comparison of Costs among Patients with Type 2 Diabetes Mellitus Who Initiated Therapy with Exenatide or Insulin Glargine

Background: Exenatide (Byetta) and insulin glargine (Lantus) are antidiabetic agents that are typically used after lack of response to an oral antidiabetic agent(s). Although previous research has examined the impact of these medications on glycaemic control, there is little information about the relative costs associated with the medications. Objective: To compare costs among patients with type 2 diabetes mellitus treated with exenatide or insulin glargine from a US third-party payer perspective. Methods: Data from a large, national administrative claims database were used in this study. The intent-to-treat (ITT) cohort included adults who were diagnosed with type 2 diabetes and initiated therapy with either exenatide (n - 4090) or insulin glargine (n - 1660). In addition, included patients were required to have no diagnoses of type 1 diabetes, to have received at least two prescriptions for an oral antidiabetic agent in the 6 months prior to first use of either exenatide or insulin glargine and to have continuous insurance coverage from 6 months before, to 12 months after, initiation on ITT medication. Annual total medical costs and total diabetes-related medical costs, in &dollar;US, year 2007 values, were estimated using stepwise multivariate regressions. Major cost components were also examined using either stepwise multivariate regressions or a two-part model that controlled for the probability of using the service. Smearing estimates were used to transform estimated log costs into costs. The analysis controlled for the potential impact of patient demographics, general health, prior resource use, co-morbidities and complications, and timing of treatment initiation. Results: Compared with insulin glargine, initiation of exenatide was associated with significantly lower total direct medical costs (&dollar;US19 293 vs &dollar;US23 782; p < 0.0001), inpatient costs (&dollar;US4121 vs &dollar;US7532; p < 0.0001), outpatient costs (&dollar;US9501 vs &dollar;US12 885; p < 0.0001), emergency department (ED) costs (&dollar;US82 vs &dollar;US131; p < 0.0001), total diabetes-related medical costs (&dollar;US7833 vs &dollar;US8536; p < 0.0001), diabetes-related inpatient costs (&dollar;US2172 vs &dollar;US3538; p < 0.0001) and diabetes-related outpatient costs (&dollar;US2739 vs &dollar;US3249; p < 0.0001). Initiation of exenatide was associated with significantly higher total overall drug costs (&dollar;US6885 vs &dollar;US5936; p < 0.0001) and diabetes-related drug costs (&dollar;US3160 vs &dollar;US2422; p < 0.0001). Conclusions: Compared with the use of insulin glargine, use of exenatide was associated with significantly lower annual total direct medical costs and significantly lower total diabetes-related medical costs, despite higher total drug costs and higher diabetes-related drug costs. In addition, exenatide was associated with significantly lower total inpatient, outpatient, ED, and diabetes-related inpatient and outpatient costs.