ABSTRACT
OBJECTIVES: The aim of this study was to identify the relationship and impact between Real World Evidence (RWE) and experimental evidence (EE) in Polish decision-making processes for the drugs from selected Anatomical Therapeutic Chemical (ATC) groups. STUDY DESIGN: Descriptive study. METHODS: A detailed analysis was performed for 58 processes from five ATC code groups in which RWE for effectiveness, or effectiveness and safety were cited in Agency for Health Technology Assessment and Tariff System's (AOTMiT) documents published between January 2012 and September 2015: Verification Analysis of AOTMiT, Statement of the Transparency Council of AOTMiT, and Recommendation of the President of AOTMiT. RESULTS: In 62% of the cases, RWE supported the EE and confirmed its main conclusions. The majority of studies in the EE group showed to be RCTs (97%), and the RWE group included mainly cohort studies (89%). There were more studies without a control group within RWE compared with the EE group (10% vs 1%). Our results showed that EE are more often assessed using Jadad, NICE or NOS scale by AOTMiT compared with RWE (93% vs 48%). When the best evidence within a given decision-making process is analysed, half of RWE and two-thirds of EE are considered high quality evidence. CONCLUSIONS: RWE plays an important role in the decision-making processes on public funding of drugs in Poland, contributing to nearly half (45%) of all the evidence considered. There exist such processes in which the proportion of RWE is dominant, with one process showing RWE as the only evidence presented.
Subject(s)
Decision Making , Evidence-Based Medicine , Health Care Sector/organization & administration , Reimbursement Mechanisms , Technology Assessment, Biomedical/organization & administration , Health Policy , Humans , Poland , Reproducibility of Results , Technology Assessment, Biomedical/methodsABSTRACT
BACKGROUND: Insulin aspart (IAsp) is one of the three rapid-acting insulin analogues (RAAs) registered for the treatment of diabetes. However, there is an ongoing debate concerning the efficacy and safety of RAAs. For this reason, a systematic review-based study was performed to compare clinical outcomes of treatment with IAsp and regular human insulin (RHI) as well as biphasic insulin aspart and premixed human insulin in type 1 and type 2 diabetes (T1DM, T2DM) patients. METHODS: Relevant articles were identified by a systematic search through the electronic medical databases (MEDLINE, EMBASE, CENTRAL) up to July 2009. RESULTS: A total of 28 trials fulfilled the inclusion criteria, including 17 studies of T1DM, 10 of T2DM and one study of both. For T1DM, pooled data for HbA(1c) (13 studies) demonstrated lower levels with IAsp than with RHI (WMD=-0.11%; 95% CI: -0.16 to -0.06). In addition, meta-analysis revealed statistically significant differences in favour of IAsp for postprandial glucose (PPG) after breakfast, lunch and dinner, but not for fasting glucose (FG). The Diabetes Treatment Satisfaction Questionnaire evaluating treatment flexibility showed IAsp benefits compared with RHI (WMD=0.31; 95% CI: 0.15 to 0.47). Safety analyses (three studies) showed a significant reduction in nocturnal hypoglycaemia risk with IAsp (RR=0.67; 95% CI: 0.54 to 0.83), and no difference in severe hypoglycaemias and a slight increase in any hypoglycaemic episodes with RAAs (RR=1.06; 95% CI: 1.01 to 1.10). For T2DM, a meta-analysis of nine studies revealed no significant differences between IAsp and RHI in HbA(1c) (WMD=-0.04%; 95% CI: -0.10 to 0.03), whereas PPG was significantly lower in the IAsp group (WMD=-1.18 mmol/L; 95% CI: -1.88 to -0.47). No studies of treatment satisfaction or quality of life were identified. CONCLUSION: Analyses based on a systematic review showed that treatment with IAsp in T1DM patients resulted in moderately better metabolic control and treatment satisfaction than RHI. In T2DM patients, meta-analysis showed improvement in PPG, but not in any other outcomes.
Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/analogs & derivatives , Insulin/administration & dosage , Humans , Hypoglycemic Agents/adverse effects , Insulin/adverse effects , Insulin AspartABSTRACT
In this paper the pressure gravidiffusive model equation in a single-membrane osmotic-diffusive cell is elaborated. In this cell the flat, microporous and symmetric polymeric membrane so-called Nephrophane positioned horizontally separated water and binary (aqueous glucose or aqueous ethanol) or ternary (glucose in 0.2 mol.l-1 aqueous ethanol or ethanol in 0.05 mol.l-1 aqueous glucose) non-electrolyte solutions. The calculations of pressure gravidiffusive effects for the configurations A and B of the single-membrane osmotic-diffusive cell were elaborated. In configuration A solution was placed in compartment below membrane and in configuration B--above membrane. The calculated result are interpreted in terms of the convective instability that increases the diffusive permeability coefficient of complex: concentration boundary layer/membrane/concentration boundary layer.
Subject(s)
Membranes, Artificial , Models, Biological , Solutions/chemistry , Cell Membrane/metabolism , Diffusion , Glucose Solution, Hypertonic/chemistry , Gravitation , Osmosis , Permeability , Polymers , Pressure , Water/chemistryABSTRACT
In this paper the results of study flux graviosmotic effect for a double-membrane system, in which two (Ml and M(r)), microporous and symmetrical flat polymeric membranes (Nephrophane and Cellulose IMP-1) separate three compartments (l, m, r) containing the heterogeneous and binary (aqueous glucose or ethanol solutions) or ternary (glucose solutions in 0.75 mole.l-1 aqueous ethanol solution or ethanol solutions in 0.1 mol.l-1 aqueous glucose solution) non-ionic solutions. In this system the solution concentrations fulfill the condition Ckl > Ckm > Ckr. The inter-membrane compartment (m) consists of the infinitesimal layer of solution. The volume of compartment m and external compartment (l and r) fulfill the conditions Vm-->0 and Vl = Vr-->infinity respectively. The calculations of flux graviosmotic effect for configurations A and B of the double-membrane osmotic-diffusive cell were elaborated. In configuration A solution was placed in compartment below membrane M(r) and water above membrane Ml. In configuration B solution was placed in compartment above membrane Ml and water below membrane Ml. These calculated results are interpreted in terms of the convective instability that increases the diffusive permeability coefficients of complexes: concentration boundary layers/membrane Ml or M(r)/concentration boundary layer.
