Assessment of hemostatic profile in patients with mild to advanced liver cirrhosis.

BACKGROUND: Hemostasis of patients suffering from liver cirrhosis is challenging due to both, pro- and anticoagulatory disorders leading to hemostatic alterations with distinct abnormalities of coagulation. Pathological changes in conventional coagulation analysis and platelet count are common manifestations of decreased liver synthesis of coagulation factors and reduced platelet count in these patients. However, conventional coagulation analysis and platelet count do not reflect in-vivo coagulation status or platelet function. The purpose of this present observational study was therefore to assess the haemostatic profile including plasmatic coagulation using thrombelastometry and impedance aggregometry for platelet function in patients suffering from liver cirrhosis. AIM: To assess the hemostatic profile of cirrhotic patients according to model for end-stage liver disease (MELD) score. METHODS: Our study included both in- and outpatients suffering from liver cirrhosis attending the out- and inpatient care of the department of hepatology. Demographic and biochemical data as well as medical history including cause of liver cirrhosis, end stage kidney failure and medication with anticoagulants were recorded. To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate® (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM® (EXTEM, INTEM, FIBTEM). Data were compared using Mann-Whitney U- or χ 2-test. Spearman correlation was performed to analyze the association between MELD Score and results of thrombelastometry and MEA. RESULTS: A total of 68 patients attending the out- and inpatient care suffering from liver cirrhosis were screened. Of these, 50 patients were included and assigned to groups according to MELD score 6 to 11 (n = 25) or ≥ 17 (n = 25). Baseline patient characteristics revealed significant differences for MELD score (8 vs 22, P < 0.0001) and underlying laboratory parameters (international normalized ratio, bilirubine, creatinine) as well as fibrinogen level (275 mg/dL vs 209 mg/dL, P = 0.006) and aPTT (30 s vs 35 s, P = 0.047). MEA showed a moderately impaired platelet function (medians: AUCADP = 43U, AUCASPI = 71U, AUCTRAP = 92U) but no significant differences between both groups. Thrombelastometry using ROTEM® (EXTEM, INTEM, FIBTEM) revealed values within normal range in both groups. No significant correlation was observed between MELD score and results of MEA/thrombelastometry. CONCLUSION: Our data demonstrate a partially impaired hemostatic profile in liver cirrhosis patients unrelated to MELD score. An individual assessment of a potential coagulopathy should therefore be considered.

Healthcare provision in amyotrophic lateral sclerosis: procedures, queries and pitfalls in Germany and Poland.

There are a number of physical restrictions that develop in the course of amyotrophic lateral sclerosis (ALS). While loss of speech and motor control may be partially compensated by the support of assistive devices, swallowing difficulty and respiratory insufficiency require medical interventions (percutaneous endoscopic gastrostomy, noninvasive, and invasive ventilation). Based on the data collected within the NEEDSinALS study, we found major differences in personal satisfaction with the financing, healthcare provision, medical infrastructure, and regulations of German and Polish ALS patients, despite minor differences in economic burden caused by the disease. In order to explain this phenomenon, we thoroughly reviewed the legal basis, structure and organization of the healthcare systems in Germany and Poland to determine the range of obstacles in the everyday lives of patients and their caregivers that are attempting to attain an assistive device or care after the start of medical interventions.

Low-volume solubility assessment during high-concentration protein formulation development.

OBJECTIVE: Solubility is often one of the limiting factors for high-concentration protein formulation (HCF) development. Determination of protein solubility is challenging and requires high amount of material. Therefore, low-volume and predictive approaches are desired. METHODS: This work presents a simple and material-saving approach using static light scattering to describe non-ideal solution behaviour of HCF. Non-ideality can be related to protein-protein interactions in solution. The type and strength of these interactions indicate maximum protein solubility at actual formulation compositions. Interactions of four therapeutic model proteins at multiple formulation compositions were investigated, and deduced solubility was compared to apparent solubility behaviour determined by ether turbidity or content measurements. KEY FINDINGS: Protein-protein interactions and deduced solubilities matched actual solubility data for all tested formulations. Protein solubility was found to be lowest at pH values near the isoelectric point of each model protein. Buffer salts and ionic strength were also found to strongly influence protein solubility. In addition, sucrose and a combination of arginine and glycine enhanced protein solubility, whereas surfactants such as polysorbate 20 did not influence protein solubility. CONCLUSIONS: The introduced screening procedure is a powerful tool during (early) protein formulation development. It meets several requirements of HCF development and enables reliable prediction of protein solubility based on determination of protein interactions. In addition, rare data about the influence of several common excipients on apparent solubility of therapeutic proteins were shown.

Cost-Effectiveness of POC Coagulation Testing Using Multiple Electrode Aggregometry.

BACKGROUND: The economic effects of Point-of-Care (POC) coagulation testing including Multiple Electrode Aggregometry (MEA) with the Multiplate device have not been examined. METHODS: A health economic model with associated clinical endpoints was developed to calculate the effectiveness and estimated costs of coagulation analyses based on standard laboratory testing (SLT) or POC testing offering the possibility to assess platelet dysfunction using aggregometric measures. Cost estimates included pre- and perioperative costs of hemotherapy, intra- and post-operative coagulation testing costs, and hospitalization costs, including the costs of transfusion-related complications. RESULTS: Our model calculation using a simulated true-to-life cohort of 10,000 cardiac surgery patients assigned to each testing alternative demonstrated that there were 950 fewer patients in the POC branch who required any transfusion of red blood cells. The subsequent numbers of massive transfusions and patients with transfusion-related complications were reduced with the POC testing by 284 and 126, respectively. The average expected total cost in the POC branch was 288 Euro lower for every treated patient than that in the SLT branch. CONCLUSIONS: Incorporating aggregometric analyses using MEA into hemotherapy algorithms improved medical outcomes in cardiac surgery patients in the presented health economic model. There was an overall better economic outcome associated with POC testing compared with SLT testing despite the higher costs of testing.

Assessment of hemostatic changes after initiation of continuous venovenous hemodialysis.

BACKGROUND: Continuous renal replacement therapy (CRRT) is a standard therapy in critically ill patients suffering from acute kidney injury (AKI). Extracorporeal circulation and exposure to foreign surfaces during CRRT may induce disturbances in hemostasis, particularly in platelet function. The present study described the hemostatic changes associated with CRRT and aimed to identify the independent predictors of premature clotting of the circuit. METHODS: In a prospective cohort mono-center study, patients were assessed for eligibility if they were i) diagnosed with AKI and ii) assigned to receive CRRT for the first time. Patients were included in the study if their platelet count was greater than 100/nL prior to inclusion in the study. After initiation of CRRT, aggregometric [Multiplate, Roche, Grenzach, Germany: Arachidonic acid (ASPItest)-, ADP (ADPtest)- and Thrombin (TRAPtest)-induced platelet aggregation] and viscoelastic (ROTEM; TEM International, Munich, Germany) analyses were performed immediately before (Baseline, T1) and 6 hours (T2), 12 hours (T3), 24 hours (T4), and 48 hours (T5) after initiation of CRRT. Conventional laboratory coagulation analyses were routinely performed twice a day. Arachidonic acid- and ADP-induced platelet aggregations were defined as primary endpoints. RESULTS: A total of 127 patients were screened for eligibility, and 50 patients were enrolled in this study. Aggregometric analyses showed that arachidonic acid-induced platelet aggregation was significantly reduced at T2 [532 (210/1105) median (25th/75th percentile) AU*min] compared to the Baseline at T1 [780 (297/1156), p = 0.007] and remained unchanged from T2 onward. Platelet aggregation in the ADPtest and TRAPtest remained unchanged during the study period. Viscoelastic and conventional coagulation analyses indicated a progredient increase of clot firmness. In total, 76 filter sets (an average of 1.5 per patient) were used, and 26 filter sets occluded prematurely after an average treatment time of 17 ± 12 hours. No predictors for premature clotting of the circuit were identified. CONCLUSIONS: The results of the present study indicate that CRRT may lead to impaired primary hemostasis as shown by a decrease in ex vivo arachidonic acid-induced platelet aggregation. Moreover, viscoelastic measure indicate a fibrinogen-associated trend of increasing clot firmness during the study period. Further studies are needed to analyze whether these findings are of hemostatic relevance.

Optical imaging innovations for atherosclerosis research: multiphoton microscopy and optical nanoscopy.

Cardiovascular disease is the leading cause of death and morbidity worldwide. Improving vascular prevention and therapy based on a refined mechanistic pervasion of atherosclerosis as the underlying pathology could limit the effect of vascular disease in aging societies. During the past decades, microscopy has contributed greatly to a better understanding of vascular physiology and pathology by allowing imaging of living specimen with subcellular resolution and high specificity. An important advance has been accomplished through the application of multiphoton microscopy in the vascular domain, a technological development that enabled multidimensional and dynamic imaging deep into the cellular architecture of intact tissue under physiological conditions. To identify and validate new targets for treating atherosclerosis, novel imaging strategies with nanoscale resolution will be essential to visualize molecular processes in intracellular and extracellular compartments. This review will discuss the current use of 2-photon microscopy and will provide an overview and outlook on options for introducing nanoscopic optical imaging modalities in atherosclerosis research.

Fermentation and Cost-Effective 13C/15N Labeling of the Nonribosomal Peptide Gramicidin S for Nuclear Magnetic Resonance Structure Analysis.

Gramicidin S (GS) is a nonribosomally synthesized decapeptide from Aneurinibacillus migulanus. Its pronounced antibiotic activity is attributed to amphiphilic structure and enables GS interaction with bacterial membranes. Despite its medical use for over 70 years, the peptide-lipid interactions of GS and its molecular mechanism of action are still not fully understood. Therefore, a comprehensive structural analysis of isotope-labeled GS needs to be performed in its biologically relevant membrane-bound state, using advanced solid-state nuclear magnetic resonance (NMR) spectroscopy. Here, we describe an efficient method for producing the uniformly (13)C/(15)N-labeled peptide in a minimal medium supplemented by selected amino acids. As GS is an intracellular product of A. migulanus, we characterized the producer strain DSM 5759 (rough-convex phenotype) and examined its biosynthetic activity in terms of absolute and biomass-dependent peptide accumulation. We found that the addition of either arginine or ornithine increases the yield only at very high supplementing concentrations (1% and 0.4%, respectively) of these expensive (13)C/(15)N-labeled amino acids. The most cost-effective production of (13)C/(15)N-GS, giving up to 90 mg per gram of dry cell weight, was achieved in a minimal medium containing 1% (13)C-glycerol and 0.5% (15)N-ammonium sulfate, supplemented with only 0.025% of (13)C/(15)N-phenylalanine. The 100% efficiency of labeling is corroborated by mass spectrometry and preliminary solid-state NMR structure analysis of the labeled peptide in the membrane-bound state.

Multiple electrode aggregometry for the assessment of acquired platelet dysfunctions during extracorporeal circulation.

BACKGROUND: There have been many reports on how the usage of extracorporeal circulation (ECC) is independently associated with the induction of platelet dysfunctions. The aim of the present investigation was to study the capability of the multiple electrode aggregometry (MEA) using the Multiplate (Roche AG, Grenzach, Germany) device to reflect the extent of ECC-associated platelet dysfunctions. PATIENTS AND METHODS: The study population consisted of patients who were treated with either hypothermic (cardiopulmonary bypass [CPB]) or normothermic (extracorporeal membrane oxygenation) ECC. Hemostatic analyses included conventional laboratory coagulation tests and aggregometric measures following stimulation with different agonists using MEA. The area under the aggregation curve in the ADPtest (ex vivo adenosine diphosphate induced platelet aggregation) of the MEA was defined as the primary end point. The analyses were performed before the usage of ECC (baseline) and 90 minutes (T1), 120 minutes (T2), 150 minutes (T3), and 180 minutes (T4) after the usage of ECC. In the hypothermic ECC group, additional hemostatic analyses were performed after the patient's postoperative admission to the intensive care unit (T5). Periprocedural data and results of other hemostatic testing were defined as secondary end points. RESULTS: A total of n = 40 patients were assessed for eligibility and n = 25 patients were finally enrolled into the study (hypothermic ECC group: n = 20; normothermic ECC group: n = 5). The extent of ADP-induced platelet aggregation decreased significantly between baseline and consecutive measuring points during hypothermic ECC and remained unchanged between T4 and T5. In the normothermic ECC group, ADP-induced aggregability was significantly lower at T1 compared with baseline and remained unchanged from T1 onward. CONCLUSION: Data from the present study indicate that ex vivo ADP-induced platelet aggregation in MEA reflects the time-dependent extent of ECC-induced platelet dysfunction.

Aggregometric assessment of clonidine's impact on the efficacy of dual platelet inhibition.

BACKGROUND: Clonidine is commonly used as a calmative and antihypertensive agent in perioperative care. Due to the drug's alpha-2-agonistic effects, it has recently been hypothesised that clonidine may affect platelet aggregability. The present investigation aimed to study the potential impact of clonidine on the efficacy of dual antiplatelet therapy. METHODS: In this prospective, observational, single-centre study, patients treated with dual antiplatelet therapy were screened for eligibility. The patients were enrolled in the study if ex vivo thrombin-induced (TRAPtest), arachidonic acid-induced (ASPItest) and adenosine diphosphate-induced (ADPtest) platelet aggregation, as measured using multiple electrode aggregometry (MEA; Multiplate, Roche AG, Grenzach, Germany), confirmed efficient dual platelet inhibition. Ex vivo induced platelet aggregation was assessed before (baseline) and 3 minutes after (T1) spiking blood samples with either 1 ng/mL clonidine or sodium chloride 0.9% (control group). RESULTS: In total, 34 patients were finally enrolled in the study. Compared with baseline, platelet aggregation in the ASPItest and ADPtest was significantly increased at T1 in both groups. Platelet aggregation in the TRAPtest remained unchanged between baseline and T1 in both groups. Comparing platelet aggregation at T1, we detected no differences between blood samples that were spiked with clonidine and blood samples that were spiked with sodium chloride 0.9% in the TRAPtest, the ASPItest, or the ADPtest. CONCLUSIONS: The results of this study indicate that clonidine does not affect platelet aggregability in patients treated with dual antiplatelet therapy. The findings of the study also indicate that ex vivo induced platelet aggregation in the ASPItest and ADPtest increases with the duration between blood drawing and MEA analyses.

Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial.

BACKGROUND: Preoperative and hospital-acquired anaemia is common among surgical patients. It is associated with an increased risk of morbidity and mortality and a strong risk factor for allogeneic blood transfusions with their own inherent risks. Patient Blood Management (PBM) concepts aim to increase and preserve autologous erythrocyte volume and to optimise haemotherapy. They thus have great potential to benefit patients. METHODS/DESIGN: This prospective, multi-centre clinical trial tests the hypothesis that PBM programs are safe and effective in the care of adult surgical patients. Primary outcome is a composite endpoint of adverse events and in-hospital mortality. DISCUSSION: This trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort. This trial is registered at www.clinicaltrials.gov (NCT01820949).

Challenges in funding diabetes care: a health economic perspective.

Diabetes mellitus - especially Type 2 diabetes - represents a major threat to public health in nearly all countries worldwide. The number of patients with diabetes is expected to rise to over 438 million by the year 2030. As healthcare resources are considered limited, there is a need for prioritization among the different, existing therapeutic options available for treating or preventing diseases in a given healthcare system. This article will highlight five particular challenges for evaluating complex therapeutic approaches in diabetes care, introducing the health economic fundamentals of cost-effectiveness assessment and the different concepts to determine a cost-effectiveness threshold, with a special focus on the situation in low- and middle-income countries.

A point-of-care assessment of the effects of desmopressin on impaired platelet function using multiple electrode whole-blood aggregometry in patients after cardiac surgery.

BACKGROUND: Blood loss after cardiac surgery can be caused by acquired platelet dysfunction after cardiopulmonary bypass. Monitoring of platelet function is clinically important for the identification of patients experiencing such platelet dysfunction. 1-Deamino-8-D-arginine vasopressin (desmopressin acetate, DDAVP) has been shown to augment platelet function and to reduce blood loss in patients with platelet dysfunction. In this study, we examined the feasibility of whole blood multiple electrode aggregometry (MEA) for the detection of cardiopulmonary bypass-induced platelet dysfunction and investigated its ability to monitor DDAVP treatment. METHODS: Fifty-eight consecutive patients with blood loss exceeding 150 mL/h in the first 2 consecutive hours after cardiac surgery were screened for suspected isolated platelet dysfunction. Twenty-two patients had suspected isolated platelet dysfunction and were enrolled in the study. Platelet dysfunction was assumed if conventional coagulation analyses (platelet count, activated partial thromboplastin time, international normalized ratio, and fibrinogen) did not show abnormal values as defined for transfusion of allogenic blood products, and no surgical cause of bleeding was suspected. Eleven patients received 0.3 microg/kg DDAVP, and 11 patients received no therapy in a nonrandomized manner. MEA was performed after stimulation with thrombin receptor-activating peptide (TRAPtest, 32 microM), adenosine diphosphate (ADPtest, 6.4 microM), and arachidonic acid (ASPItest, 0.5 mM) before and 2 hours after intervention. Conventional laboratory variables were recorded. The Mann-Whitney test was used to detect differences between the groups, and the Wilcoxon test was used to detect differences before and after intervention. RESULTS: All enrolled patients showed platelet dysfunction that manifested as impaired platelet aggregation in MEA before intervention. After the intervention, platelet function improved in the DDAVP group (49 U [30/72 U], median [25th/75th percentile] postintervention vs 15 U [8/21 U] preintervention for the ASPItest [P < 0.001]; 35 U [24/54 U] vs 14 U [7/28 U] for the ADPtest [P = 0.002]; and 85 U [66/115 U] vs 64 U [26/88 U] for the TRAPtest [P = 0.007]). In contrast, MEA remained unchanged in the control group (22 U [10/50 U] postintervention vs 33 U [14/57 U] preintervention for the ASPItest [P = 0.175]; 17 U [12/20 U] vs 14 U [10/28 U] for the ADPtest [P = 0.147]; and 65 U [41/89 U] vs 57 U [30/91 U] for the TRAPtest [P = 0.123]). CONCLUSIONS: Impaired platelet function after cardiac surgery can be assessed at the bedside using MEA. The effect of DDAVP on impaired platelet function can also be detected as significant improvement in platelet aggregation to all activators. This device might be helpful for the identification of patients who may benefit from DDAVP therapy.

Impact of self-measurement of blood glucose on complications of type 2 diabetes: economic analysis from a Czech perspective.

OBJECTIVE: A growing body of evidence indicates that self-measurement of blood glucose (SMBG) also has beneficial effects in people with type 2 diabetes, irrespective of the type of therapy. The objective of this analysis was to determine the economic impact of SMBG by comparing the cost share of self-monitoring and the direct costs of diabetes-related complications in users and non-users. RESEARCH DESIGN AND METHODS: A matched-pair analysis based on the cohorts of a large retrospective study of patients with type 2 diabetes (ROSSO) was conducted. The average annual direct costs of diabetes monitoring, treatment-related services, complications and follow-up costs of the disease for SMBG users versus non-users were calculated from the perspective of the Czech statutory health insurance system. Univariate sensitivity analysis was performed to determine the main cost drivers. Limitations of this study are: (1) differences in medical facilities/practice between Germany and the Czech Republic, (2) causal relationship between SMBG and health outcomes is missing, (3) ROSSO underestimated the number of test strips used, (4) Czech cost data are scarce. RESULTS: In patients treated with oral antidiabetic drugs (OAD) only, total annual costs in Czech koruna (CZK) were CZK 16 476 for SMBG users and CZK 19 440 for non-users. In patients treated with OAD + insulin, total annual costs were CZK 32 590 and CZK 48 600, respectively. The main cost drivers were stroke and myocardial infarction in patients treated with OAD only, and stroke, dialysis and myocardial infarction in patients treated with OAD + insulin. CONCLUSION: Cost analysis indicated that SMBG provides a rapid return on initial investment. By increasing the number of patients using SMBG, the statutory health insurance system in the Czech Republic may save several million CZK annually.

The assessment of glycemic variability and its impact on diabetes-related complications: an overview.

There is a growing body of evidence that the sole use of hemoglobin A1c is insufficient to adequately reflect the metabolic situation of patients with diabetes mellitus. The risk of developing diabetes-related complications apparently not only depends on the long-term stability of glucose values, but also on the presence or occurrence of short-term glycemic peaks and nadirs lasting for minutes or hours during a day. This leads to the phenomenon of glycemic variability. This article reviews the existing evidence for the clinical relevance of short-term glucose variations and the currently available different means of measuring glycemic variability.

Cost impact of self-measurement of blood glucose on complications of type 2 diabetes: the Spanish perspective.

BACKGROUND: Despite the increasing prevalence of type 2 diabetes, its financial burden on the Spanish healthcare system remains unclear. This study was conducted to determine the cost share of self-measurement of blood glucose (SMBG) by comparing the direct costs of reduced complications of diabetes in SMBG users versus nonusers in the Spanish statutory health insurance system. METHODS: Matched-pair analysis was done of the average annual total direct cost of diabetes monitoring, treatment-related services, complications, and follow-up in the RetrOlective Study Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (ROSSO) study cohort, updated to 2008 from the year of occurrence or diagnosis of diabetes. RESULTS: In patients treated with oral antidiabetes drugs (OADs) only, total annual costs were euro1,934 in SMBG users and euro1,982 in nonusers. In those treated with OADs plus insulin, total annual costs were euro3,451 and euro4,167, respectively. By increasing the number of patients using SMBG, the Spanish statutory health insurance system might save several million Euros annually. CONCLUSIONS: The analysis showed that the promotion of SMBG in patients with type 2 diabetes is associated with considerable cost savings for the Spanish healthcare system.

Multitask electrical stimulation for cortical language mapping: hints for necessity and economic mode of application.

PURPOSE: Electrical stimulation mapping (ESM) is the gold standard for identifying language-relevant cortex prior to neurosurgical resections near the eloquent cortex. However, its application mode is not standardized, as some procedures rely on a single task, whereas others depend on task batteries. In this study, we examine whether multitask ESM is necessary, quantify the information loss that occurs from restricting the number of applied tasks, and search for a procedure that allows for time-efficient, multitask ESM. METHODS: Thirty-eight epilepsy and 11 brain tumor patients with subdural grid electrodes receive extraoperative ESM for language cortex at 1,890 stimulation sites. The applied test battery includes counting, naming, repeating, reading, Token Test, and body commands. Correlation analysis and principal component analysis are used to identify the functional overlap between tasks. Sensitivity analysis is the basis for determining the optimal task order, which requires a minimum number of stimulations for identifying language loci. RESULTS: Correlation coefficients between tasks are -0.17 to 0.63; frontal and temporoparietal language cortex are organized differently. Naming is the most sensitive task, but 31% (temporoparietal) to 43% (frontal) of language sites remained undetected after naming alone. The optimal procedure starts with naming and the Token Test and differs thereafter between frontal and temporoparietal cortex. Omitting the Token Test and body commands from the battery results in up to 26% information loss. DISCUSSION: Despite considerable overlap between different tasks, multitask ESM appears necessary to avoid missing language relevant cortex. Applying the tasks in an optimal order allows economizing the procedure.

Cost impact of blood glucose self-monitoring on complications of type 2 diabetes: a Swiss perspective (ROSSO study No.11).

QUESTION UNDER STUDY: despite the increasing prevalence of type 2 diabetes, its financial burden on the Swiss healthcare system remains unclear. Our aim was to determine the cost of self-monitoring of blood glucose (SMBG) in reducing diabetic complications by comparing the direct costs to the Swiss statutory health insurance system of diabetic complications in SMBG users vs. nonusers. METHOD: matched pair analysis of the average annual total cost of diabetes monitoring, treatment-related services, complications and followup in the RetrOlective Study Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (ROSSO) study cohort, updated to 2005 from the year of occurrence or diagnosis of diabetes, applying an annual inflation rate of 5%. RESULTS: in those patients treated with oral antidiabetic drugs only, total annual costs were CHF 5,140 in SMBG users and CHF 5,654 in non - users. In those patients treated with oral antidiabetic drugs plus insulin, total annual costs were CHF 8,254 and CHF 11,776, respectively. SMBG accounted for 1.6% to 1.7% of total costs. CONCLUSION: cost analysis indicates that SMBG provides a rapid return on initial investment.

Self-measurement of blood glucose in patients with type 2 diabetes: a health economic assessment.

BACKGROUND: The clinical role and the potential benefit of self-measurement of blood glucose (SMBG) for patients with type 2 diabetes are still under discussion. Even less information is available on the cost-effectiveness of performing SMBG by this patient group. The goal of this study was to establish cost-effectiveness ratios of performing SMBG by patients afflicted by this disease. METHODS: We assessed the benefit and cost-effectiveness of SMBG in type 2 diabetes from a third-party payer perspective based on results of both a large epidemiologic cohort study reflecting the reality of care, and a Markov model calculation. RESULTS: Analysis of cohort study data revealed that total costs cumulated over the observation period of 8 years were lower in the SMBG group than in the non-SMBG group according to savings of euro 1'714 [oral antidiabetic drugs (OAD) only] and euro 13'815 (OAD + insulin) per patient. Several scenarios were considered in the model-based calculation. The cost-effectiveness ratio varied from euro 20'768/life year gained to domination of SMBG use compared to nonusers in OAD treated patients and from euro 59'057/life year gained to domination of SMBG use compared to nonusers in OAD + insulin treated patients. CONCLUSION: Results indicate that SMBG in type 2 diabetes offers an excellent opportunity to get a high investment-outcome ratio in the treatment of this pandemic disease.

Using individualized predictive disease modeling to identify patients with the potential to benefit from a disease management program for diabetes mellitus.

Diabetes is an increasing health problem, but efforts to handle this pandemic by disease management programs (DMP) have shown conflicting results. Our hypothesis is that, in addition to a program's content and setting, the choice of the right patients is crucial to a program's efficacy and effectiveness. We used individualized predictive disease modeling (IPDM) on a cohort of 918 patients with type 2 diabetes to identify those patients with the greatest potential to benefit from inclusion in a DMP. A portion of the patients (4.7%) did not have even a theoretical potential for an increase in life expectancy and would therefore be unlikely to benefit from a DMP. Approximately 16.1% had an increase in life expectancy of less than half a year. Stratification of the entire cohort by surrogate parameters like preventable 10-year costs or gain in life expectancy was much more effective than stratification by classical clinical parameters such as high HbA1c level. Preventable costs increased up to 50.6% (or 1,010 per patient (1 = US dollars 1.28), p < 0.01) and life expectancy increased up to 54.8% (or 2.3 years, p < 0.01). IPDM is a valuable strategy to identify those patients with the greatest potential to avoid diabetes-related complications and thus can improve the overall effectiveness and efficacy of DMPs for diabetes mellitus.