The clinical and economic burden of illness in the first two years after ostomy creation: a nationwide Danish cohort study.

BACKGROUND: Living with an ostomy is often associated with costly complications. This study examined the burden of illness the first two years after ostomy creation. METHODS: Data from Danish national registries included all adult Danes with an ostomy created between 2002 and 2014. RESULTS: Four cohorts consisted, respectively, of 11,385 subjects with a colostomy and 4,574 with an ileostomy, of which 1,663 subjects had inflammatory bowel disease (IBD) and 1,270 colorectal cancer as cause of their ileostomy. The healthcare cost was significantly higher for cases versus matched controls for all cohorts. In the first year, the total healthcare cost per person-year was €27,962 versus €4,200 for subjects with colostomy, €29,392 versus €3,308 for subjects with ileostomy, €15,947 versus €2,216 when IBD was the underlying cause, and €32,438 versus €4,196 when it was colorectal cancer. Healthcare costs decreased in the second year but remained significantly higher than controls. Hospitalization and outpatient services were primary cost drivers, with ostomy-related complications comprising 8-16% of hospitalization expenses. CONCLUSION: Compared to controls, subjects with an ostomy bear a significant health and financial burden attributable to ostomy-related complications, in addition to the underlying disease, emphasizing the importance of better ostomy care to enhance well-being and reduce economic strain.

Short- and long-term direct and indirect costs of illness after ostomy creation - a Swedish nationwide registry study.

BACKGROUND: Despite advance in care of people with an ostomy, related complications remain prevalent. The objective of this study was to examine short- and long-term healthcare resource utilization and associated costs after ostomy creation. METHODS: This observational study was based on retrospectively collected data from national and regional Swedish registries. The population consisted of people living in Sweden, who had an ostomy created. The earliest index date was 1 January 2006, and people were followed for ten years, until death, reversal of temporary ostomy, termination of purchases of ostomy products, or end of study, which was 31 December 2019. Each person with an ostomy was matched with two controls from the general population based on age, gender, and region. RESULTS: In total, 40,988 persons were included: 19,645 with colostomy, 16,408 with ileostomy, and 4,935 with urostomy. The underlying diseases for colostomy and ileostomy creations were primarily bowel cancer, 50.0% and 55.8% respectively, and additionally inflammatory bowel disease for 20.6% of ileostomies. The underlying cause for urostomy creation was mainly bladder cancer (85.0%). In the first year after ostomy creation (excl. index admission), the total mean healthcare cost was 329,200 SEK per person with colostomy, 330,800 SEK for ileostomy, and 254,100 SEK for urostomy (100 SEK was equivalent to 9.58 EUR). Although the annual mean healthcare cost decreased over time, it remained significantly elevated compared to controls, even after 10 years, with hospitalization being the main cost driver. The artificial opening was responsible for 19.3-22.8% of 30-day readmissions after ostomy creation and for 19.7-21.4% of hospitalizations during the entire study period. For the ileostomy group, dehydration was responsible for 13.0% of 30-day readmissions and 4.5% of hospitalization during the study period. CONCLUSIONS: This study reported a high disease burden for persons with an ostomy. This had a substantial impact on the healthcare cost for at least ten years after ostomy creation. Working ability seemed to be negatively impacted, indicated by increased cost of sickness absence and early retirement. This calls for improved management and support of ostomy care for the benefit of the affected persons and for the cost of society.

Using peristomal body profile assessment to improve leakage-related quality of life for individuals with an ostomy.

BACKGROUND: Improper fitting between peristomal body profile and ostomy product(s) is one of the main reasons for leakage among individuals with an ostomy. AIM: To evaluate clinical usability of the Body Assessment Tool developed by Coloplast that is available free of charge. The aim was also to study how changing to product(s) that were best suited to an individual, guided by peristomal body profile, affected the number of leakages and individuals' quality of life. METHODS: The study consisted of questionnaires administered before and after the study, which spanned 4-5 weeks. A total of 22 nurses and 68 individuals with an ostomy participated in four Nordic countries. FINDINGS: Of the 22 nurses, 21 recommended use of the tool. A shift to best fitting ostomy product(s) resulted in a significant decrease in the number of leakages (from 5.9 to 1.8 per 7 days) and a substantial improvement in quality of life. CONCLUSION: The findings support the use of the Body Assessment Tool in clinical practice and the results showed that optimally fitting ostomy product(s) reduced the number of leakages and increased individuals' quality of life.

Burden of illness among intermittent catheter users with non-neurogenic urinary retention in Denmark.

BACKGROUND: Urinary retention (UR) caused by non-neurogenic conditions is a frequent disorder often requiring the use of intermittent catheterization (IC). This study examines the burden of illness among subjects with an IC indication due to non-neurogenic UR. METHODS: Health-care utilization and costs were extracted from Danish registers (2002-2016) related to the first year after IC training and compared to matched controls. RESULTS: A total of 4,758 subjects with UR due to benign prostatic hyperplasia (BPH) and 3,618 subjects with UR due to other non-neurological conditions were identified. Total health-care utilization and costs per patient-year were significantly higher compared to matched controls (BPH: 12,406 EUR vs 4,363, p < 0.000; other non-neurogenic causes: 12,497 EUR vs 3,920, p < 0.000) and driven mainly by hospitalizations. Urinary tract infections (UTIs) were the most frequent bladder complications often requiring hospitalization. The inpatient costs per patient-year for UTIs were significantly higher for cases than controls (BPH: 479 EUR vs 31, p < 0.000; other non-neurogenic causes: 434 EUR vs 25, p < 0.000). CONCLUSIONS: The burden of illness caused by non-neurogenic UR with need for IC was high and essentially driven by hospitalizations. Further research should clarify if additional treatment measures may reduce the burden of illness in subjects suffering from non-neurogenic UR using IC.

Burden of illness the first year after diagnosed bladder dysfunction among people with spinal cord injury or multiple sclerosis - a Danish register study.

BACKGROUND: People with spinal cord injury (SCI) or multiple sclerosis (MS) are often living with some degree of bladder and/or bowel dysfunction due to acquired neurogenic damage. The objective was to estimate the burden of illness of SCI and MS the first year after diagnosed bladder dysfunction. METHODS: Data were extracted from registers covering all Danish citizens. People with SCI or MS were indexed at diagnosis of bladder dysfunction. Inclusion period was 2002-2015 and cases and matched controls were followed for one year. RESULTS: A total of 2,132 subjects with SCI and 1,887 subjects with MS were identified. Healthcare utilization and societal costs per patient-year were significantly higher for cases compared to controls driven primarily by inpatient care. Cases with urinary tract infection had significantly higher inpatient costs per patient-year compared to controls (SCI: 544 EUR vs 23, p < 0.05; MS: 497 EUR vs 6, p< 0.05) and medication for constipation was significantly more costly per patient-year (SCI: 178 EUR vs 3, p < 0.05; MS: 78 vs 1, p < 0.05). CONCLUSIONS: The study demonstrates heavy societal and personal costs in the first year after bladder dysfunction in people with SCI or MS. This emphasizes the need for medical and social interventions to reduce the burden of illness.

The Humanistic Burden of Type 1 Diabetes Mellitus in Europe: Examining Health Outcomes and the Role of Complications.

AIMS: Diagnoses of Type 1 Diabetes Mellitus (T1DM) in Europe appear to be on the rise. Therefore it is imperative that researchers understand the potential impact that increases in prevalence could have on the affected individuals as well as on society as a whole. Accordingly this study examined the humanistic and economic burden of T1DM in patients relative to those without the condition across a number of health outcomes including health status, work productivity loss, activity impairment, and healthcare resource use. METHODS: Survey data from a large, representative sample of EU adults (The EU National Health and Wellness Survey) were examined. RESULTS: Results suggest that overall burden is higher for those diagnosed with T1DM than respondents without diabetes and that burden increases as complications associated with T1DM increase. CONCLUSIONS: Taken together, these results suggest that treatment strategies for T1DM should balance clinical, humanistic, and economic burden and patients should be educated on the role of complications in disease outcomes.

Association Between Weight Change, Clinical Outcomes, and Health Care Costs in Patients with Type 2 Diabetes.

BACKGROUND: Previous research suggests that weight loss is associated with decreases in health care costs among individuals with type 2 diabetes mellitus (T2DM) and that weight change can affect clinical measures, including hemoglobin A1c (A1c), low-density lipoprotein cholesterol (LDLC), and blood pressure. Previous research has also demonstrated more pronounced impact of weight change among patients with T2DM who are obese and have no evidence of cardiovascular disease (CVD). OBJECTIVES: To (a) examine the association between weight change and all-cause and diabetes-related health care costs among patients with T2DM; (b) examine the association between weight change and select clinical measures among patients with T2DM; and (c) analyze a subgroup of obese patients with no previous CVD. METHODS: This retrospective, observational cohort study used U.S. insurance claims linked to laboratory and electronic medical records. This study included patients with T2DM aged 18 years or older who added or switched to a nonmetformin antidiabetes medication after metformin monotherapy between January 1, 2007, and June 30, 2012 (date of add/switch was the index date). The primary predictor was percentage weight change (PWC) between a weight measurement at index and a follow-up measurement 6 months later; PWC ranged from negative (weight loss) to positive (weight gain). Outcomes, measured in the 12-month period beginning at the time of follow-up weight measurement, included all-cause and diabetes-related health care costs and achievement of thresholds for A1c, blood pressure, and LDL-C. Multivariable models quantified the association between PWC (linear effect) and study outcomes. RESULTS: A total of 1,520 patients (mean age 55 years; 47% female) were included, with 780 patients (mean age 53 years; 51% female) in the subgroup sample. Mean (SD) index weight and PWC were 224.6 (52.8) lbs and +0.2% (4.7%) in the primary analysis, and 241.3 (47.3) lbs and -0.2% (4.6%) in the subgroup sample. In adjusted analyses, decreasing PWC was associated with decreasing diabetes-specific pharmacy costs (P < 0.001) in the primary analysis sample and with decreasing all-cause pharmacy costs (P = 0.018), diabetes-specific total costs (P = 0.039), diabetes-specific medical costs (P = 0.002), and diabetes-specific pharmacy costs (P < 0.001) in the subgroup sample. PWC was not associated with all-cause total health care costs or all-cause medical costs in either sample. In adjusted analyses, decreasing PWC was also associated with increasing odds of attaining the A1c goals of < 6.5% (P < 0.001) and < 7.0% (P < 0.001) in the primary analysis sample and increasing odds of attaining the A1c goals of < 6.5% (P < 0.001), < 7.0% (P < 0.001), and < 8.0% (P = 0.010) in the subgroup sample. PWC was not associated with any of the other clinical measures in either of the study samples. CONCLUSIONS: This real-world study suggests that among patients with T2DM, weight loss over a short-term (6-month) period is associated with positive impact on attainment of A1c goals and decreased diabetes-specific pharmacy costs over the subsequent 12 months. In the subset of patients who were obese and had no previus CVD, weight loss over the 6-month period was also associated with decreased all-cause pharmacy costs, diabetes-specific medical costs, and diabetes-specific total health care costs. Future research is warranted to examine whether these associations change over longer-term periods of follow-up. DISCLOSURES: This study was sponsored by AstraZeneca and Bristol-Myers Squibb. Truven Health Analytics received funding from Bristol-Myers Squibb and AstraZeneca to conduct this study. Mukherjee is an employee of Bristol-Myers Squibb. Bell and Sternhufvud are employees of AstraZeneca. Johnston, Stott-Miller, and McMorrow are employees of Truven Health Analytics. Nancy Smith is a consultant to Bristol-Myers Squibb and is employed by GreenKey Resources. Study concept was created by Mukherjee, Sternhufvud, Bell, and Johnston. Stott-Miller and McMorrow took the lead in data collection, along with Johnston, with data interpretation performed by Mukherjee, Sternhufvud, Smith, Stott-Miller, and Johnston. The manuscript was written by Mukherjee, Johnston, and Stott-Miller, along with Sternhufvud and Smith, and revised by Mukherjee, Smith, and Johnston, along with Sternhufvud and Stott-Miller.

A Systematic Review of Cost-Effectiveness Models in Type 1 Diabetes Mellitus.

BACKGROUND: Critiques of cost-effectiveness modelling in type 1 diabetes mellitus (T1DM) are scarce and are often undertaken in combination with type 2 diabetes mellitus (T2DM) models. However, T1DM is a separate disease, and it is therefore important to appraise modelling methods in T1DM. OBJECTIVES: This review identified published economic models in T1DM and provided an overview of the characteristics and capabilities of available models, thus enabling a discussion of best-practice modelling approaches in T1DM. METHODS: A systematic review of Embase(®), MEDLINE(®), MEDLINE(®) In-Process, and NHS EED was conducted to identify available models in T1DM. Key conferences and health technology assessment (HTA) websites were also reviewed. The characteristics of each model (e.g. model structure, simulation method, handling of uncertainty, incorporation of treatment effect, data for risk equations, and validation procedures, based on information in the primary publication) were extracted, with a focus on model capabilities. RESULTS: We identified 13 unique models. Overall, the included studies varied greatly in scope as well as in the quality and quantity of information reported, but six of the models (Archimedes, CDM [Core Diabetes Model], CRC DES [Cardiff Research Consortium Discrete Event Simulation], DCCT [Diabetes Control and Complications Trial], Sheffield, and EAGLE [Economic Assessment of Glycaemic control and Long-term Effects of diabetes]) were the most rigorous and thoroughly reported. Most models were Markov based, and cohort and microsimulation methods were equally common. All of the more comprehensive models employed microsimulation methods. Model structure varied widely, with the more holistic models providing a comprehensive approach to microvascular and macrovascular events, as well as including adverse events. The majority of studies reported a lifetime horizon, used a payer perspective, and had the capability for sensitivity analysis. CONCLUSIONS: Several models have been developed that provide useful insight into T1DM modelling. Based on a review of the models identified in this study, we identified a set of 'best in class' methods for the different technical aspects of T1DM modelling.

A retrospective study of persistence, adherence, and health economic outcomes of fixed-dose combination vs. loose-dose combination of oral anti-diabetes drugs.

OBJECTIVE: To compare outcomes between patients with type 2 diabetes mellitus (T2DM) using fixed-dose combination (FDC) and loose-dose combination (LDC) products. METHODS: This retrospective cohort study used MarketScan Commercial and Medicare Supplemental data from January 1, 2009-December 31, 2013. The identified population included patients with T2DM and ≥1 additional oral anti-diabetic prescription (of the same regimen [FDC/LDC] as the index prescription) within 12 months following the fill date. Persistence (no ≥30-day gap) and adherence (medication possession ratio [MPR] ≥0.8) were assessed as primary end-points; secondary end-points included hypoglycemia, healthcare resource utilization, and costs. RESULTS: Of 23,361 patients identified, 12,590 (53.9%) were on FDC therapy and 10,771 (46.1%) were on LDC therapy. FDC patients had a significantly lower rate of non-persistence (67.9% vs. 73.4%, p < 0.0001) and a significantly higher rate of adherence to therapy (57.0% vs. 50.7%, p < 0.0001) when compared to LDC patients. Average time to non-persistence was significantly longer among FDC vs. LDC patients (207.1 vs. 186.3 days, p < 0.0001). After adjusting for baseline characteristics, the odds of non-persistence were 21% lower with FDC vs. LDC therapy (OR = 0.79, 95% CI = 0.74-0.85, p < 0.0001), with a 28% higher odds of adherence (OR = 1.28, 95% CI = 1.20-1.36, p < 0.0001). Differences in most secondary outcomes significantly favored FDC therapy, including total predicted monthly all-cause costs ($1008 vs. $1053; p = 0.006) and T2DM-related costs ($142 vs. $155; p < 0.001). LIMITATIONS: Cohort classification was based on prescription claims data. The lack of clinical data limits assessment of potential influencers of FDC vs. LDC decisions, residual confounding was possible, and diabetes-related medical costs only captured claims with a primary diagnosis for diabetes. The results may not be generalizable to populations such as Medicaid. CONCLUSION: Management of T2DM using FDC therapies provides a compliance benefit relative to LDC therapies that may translate to reductions in healthcare utilization and costs.

Impact of treatment with rosuvastatin and atorvastatin on cardiovascular outcomes: evidence from the Archimedes-simulated clinical trials.

OBJECTIVE: No clinical trials have been conducted to directly compare the effect of the two high-intensity statins, rosuvastatin and atorvastatin, on cardiovascular outcomes. However, three such trials have been computer-simulated using the Archimedes model, an individual-based simulation of human physiology and behaviors, treatment interventions, and health care systems. The results are reviewed here. METHODS: The first simulated trial assessed clinical outcomes in patients receiving available doses of the two drugs. The second assessed the impact of initial treatment decisions, while the third assessed the effect of switching from rosuvastatin to atorvastatin. RESULTS: In the first simulated trial, treatment with rosuvastatin was estimated to result in greater reductions than treatment with atorvastatin in major adverse cardiac event (MACE) rates at 5 years and 20 years at all doses examined (relative risk [RR]: 0.897, 0.888, and 0.930 at 5 years for rosuvastatin 20 mg vs atorvastatin 40 mg, rosuvastatin 40 mg vs atorvastatin 80 mg, and rosuvastatin 20 mg vs atorvastatin 80 mg, respectively; all P<0.05). In the second simulated trial, outcomes were significantly better in patients initially prescribed rosuvastatin than in those initially prescribed atorvastatin (RR of MACE at 5 years: 0.918; P<0.001). In the third simulated trial, risk of MACE was significantly greater in patients switching from rosuvastatin to atorvastatin than in those remaining on rosuvastatin (RR at 5 years: 1.109; P<0.001). CONCLUSION: The results of these simulated clinical trials suggest improved outcomes among patients receiving rosuvastatin relative to patients receiving atorvastatin in various clinical settings.

Impact of switching treatment from rosuvastatin to atorvastatin on rates of cardiovascular events.

BACKGROUND: Now that generic atorvastatin has become available, a process of switching from rosuvastatin to atorvastatin may occur and could persist until the patent on branded rosuvastatin expires. It is important to understand the impact that such therapy may have on patients' cardiovascular (CV) health. OBJECTIVES: This simulated study estimates the impact of switching patients treated with rosuvastatin to atorvastatin on rates of CV events over a 5-year period. METHODS: A study of 50,038 virtual dyslipidemic patients aged 45 to 70 years was conducted using the Archimedes model. Virtual patients were created based on the profiles of patients in the National Health and Nutrition Examination Survey (NHANES). Statin treatment models were constructed based on data from published studies, including STELLAR, JUPITER, CARDS, ASCOT, and TNT. Patients were started on a dose of rosuvastatin based on their ATP III low-density lipoprotein cholesterol (LDL-C) goal and the distributions of statin use observed in US pharmacy claims data. Patients were monitored for 5 years, during which time they received regular visits with the opportunity to increase their dosage if they were above their LDL-C goal. In the experimental arm, patients were switched from rosuvastatin to atorvastatin at the first clinic visit 6 weeks after initiating rosuvastatin (using an atorvastatin dose twice the rosuvastatin milligram-dose). No switching occurred in the control arm, and patients were titrated as necessary per ATP III cholesterol management guidelines. The rate of first occurrence of a major adverse cardiovascular event (MACE; myocardial infarction, stroke, and/or cardiovascular-related death) over the 5-year period was estimated for each study arm. RESULTS: After 5 years, in the atorvastatin-switched arm compared with continuing rosuvastatin, 4.8% fewer patients reached goal (87% vs 91%, respectively). The 5-year relative risk for MACE with switching was 1.109 (95% CI, 1.092-1.127), and the number needed to harm (NNH) to incur 1 additional MACE over 5 years was 262, favoring treatment with rosuvastatin. In diabetic individuals who were switched to atorvastatin, the 5-year relative risk for MACE was 1.121 (95% CI, 1.091-1.151), and the NNH over 5 years was 195, indicating greater risk in diabetic individuals. The results were insensitive to adherence rates and LDL-C goal values. CONCLUSIONS: This study found that switching from rosuvastatin to atorvastatin led to fewer patients attaining LDL-C goal and a greater risk for MACE.