Compliance, clinical outcome, and quality of life of patients with stable angina pectoris receiving once-daily betaxolol versus twice daily metoprolol: a randomized controlled trial

Przemyslaw KardasThe First Department of Family Medicine, Medical University of LodzBackground: A randomized, controlled trial was conducted in an outpatient setting to examine the effect of beta-blocker dosing frequency on patient compliance, clinical outcome, and health-related quality of life in patients with stable angina pectoris.Methods: One hundred and twelve beta-blockers-naive outpatients with stable angina pectoris were randomized to receive betaxolol, 20 mg once daily or metoprolol tartrate, 50 mg twice daily for 8 weeks. The principal outcome measure was overall compliance measured electronically, whereas secondary outcome measures were drug effectiveness and health-related quality of life.Results: The overall compliance was 86.5 ± 21.3% in the betaxolol group versus 76.1 ± 26.3% in the metoprolol group (p < 0.01), and the correct number of doses was taken on 84.4 ± 21.6% and 64.0 ± 31.7% of treatment days, respectively (p < 0.0001). The percentage of missed doses was 14.5 ± 21.5% in the once-daily group and 24.8 ± 26.4% in the twice-daily group (p < 0.01). The percentage of doses taken in the correct time window (58.6% vs 42.0%, p = 0.01), correct interdose intervals (77.4% v 53.1%, p < 0.0001), and therapeutic coverage (85.6% vs 73.7%, p < 0.001) were significantly higher in the once-daily group. Both studied drugs had similar antianginal effectiveness. Health-related quality of life improved in both groups, but this increase was more pronounced in the betaxolol arm in some dimensions.Conclusions: The study demonstrates that patient compliance with once-daily betaxolol is significantly better than with twice daily metoprolol. Similarly, this treatment provides better quality of life. These results demonstrate possible therapeutic advantages of once-daily over twice-daily beta-blockers in the treatment of stable angina pectoris.Keywords: patient compliance, quality of life, stable angina pectoris, randomized controlled trial, betaxolol, metoprolol, beta-blocker

Multivariate relationships between international normalized ratio and vitamin K-dependent coagulation-derived parameters in normal healthy donors and oral anticoagulant therapy patients

BACKGROUND AND OBJECTIVES: International Normalized Ratio (INR) is a world-wide routinely used factor in the monitoring of oral anticoagulation treatment (OAT). However, it was reported that other factors, e. g. factor II, may even better reflect therapeutic efficacy of OAT and, therefore, may be potentialy useful for OAT monitoring. The primary purpose of this study was to characterize the associations of INR with other vitamin K-dependent plasma proteins in a heterogenous group of individuals, including healthy donors, patients on OAT and patients not receiving OAT. The study aimed also at establishing the influence of co-morbid conditions (incl. accompanying diseases) and co-medications (incl. different intensity of OAT) on INR. DESIGN AND METHODS: Two hundred and three subjects were involved in the study. Of these, 35 were normal healthy donors (group I), 73 were patients on medication different than OAT (group II) and 95 were patients on stable oral anticoagulant (acenocoumarol) therapy lasting for at least half a year prior to the study. The values of INR and activated partial thromboplastin time (APTT) ratio, as well as activities of FII, FVII, FX, protein C, and concentration of prothrombin F1+2 fragments and fibrinogen were obtained for all subjects. In statistical evaluation, the uni- and multivariate analyses were employed and the regression equations describing the obtained associations were estimated. RESULTS: Of the studied parameters, three (factors II, VII and X) appeared as very strong modulators of INR, protein C and prothrombin fragments F1+2 had moderate influence, whereas both APTT ratio and fibrinogen had no significant impact on INR variability. Due to collinearity and low tolerance of independent variables included in the multiple regression models, we routinely employed a ridge multiple regression model which compromises the minimal number of independent variables with the maximal overall determination coefficient. The best-fitted two-component model included FII and FVII activities and explained 90% of INR variability (compared to 93% in the 5-component model including all vitamin K-dependent proteins). Neither the presence of accompanying diseases nor the use of OAT nor any other medication (acetylsalicylic acid, statins, steroids, thyroxin) biased significantly these associations. CONCLUSION: Among various vitamin K-dependent plasma proteins, the coagulation factors II, VII and X showed the most significant associations with INR. Of these variables, the two-component model, including factors II and VII, deserves special attention, as it largely explains the overall variability observed in INR estimates. The statistical power of this model is validated on virtue of the estimation that the revealed associations are rather universal and remain essentially unbiased by other compounding variables, including clinical status and medical treatment. Further, much broader population studies are needed to verify clinical usefulness of methods alternate or compounding to INR monitoring of OAT

Reasons for low influenza vaccination coverage – a cross-sectional survey in Poland

Aim To assess the reasons for low influenza vaccination coverage in Poland, including knowledge of influenza and attitudes toward influenza vaccination. Methods This was a cross-sectional, anonymous, selfadministered survey in primary care patients in Lodzkie voivodship (central Poland). The study participants were adults who visited their primary care physicians for various reasons from January 1 to April 30, 2007. Results Six hundred and forty participants completed the survey. In 12 months before the study, 20.8% participants had received influenza vaccination. The most common reasons listed by those who had not been vaccinated were good health (27.6%), lack of trust in vaccination effectiveness (16.8%), and the cost of vaccination (9.7%). The most common source of information about influenza vaccination were primary care physicians (46.6%). Despite reasonably good knowledge of influenza, as many as approximately 20% of participants could not point out any differences between influenza and other viral respiratory tract infections. Conclusions The main reasons for low influenza vaccination coverage in Poland were patients’ misconceptions and the cost of vaccination. Therefore, free-of-charge vaccination and more effective informational campaigns are needed, with special focus on high-risk groups

Adherence to Medication in Older Adults as a Way to Improve Health Outcomes and Reduce Healthcare System Spending

Medications are used as the primary approach to prevent and effectively manage the chronic conditions. Non-adherence to medication is recognized as a worldwide public health problem with important implications for the management of chronic diseases, which affects every level of the population, particularly older adults due to the high number of coexisting diseases and consequent polypharmacy. Estimated rates of adherence to long-term medication regimen are of about 50%, and there is no evidence for significant changes in the past 50 years. The consequences of non-adherence include poor clinical outcomes, increased morbidity and mortality and unnecessary healthcare costs. Factors contributing to non-adherence are multifaceted and embrace those that are related to patients, to physicians and to healthcare systems. Cognitive, sensorial and functional decline, poor social support, anxiety, depression symptomatology and reduced health literacy have been linked to medication non-adherence in the elderly patients. Many interventions to improve medication adherence have been described in the study for different clinical conditions; however, most interventions seem to fail in their aims. In this chapter, a revision of the implications of poor adherence as well as its predictors and available tools to improve adherence is performed

A Cross-Sectional Survey on Medication Management Practices for Noncommunicable Diseases in Europe During the Second Wave of the COVID-19 Pandemic

Maintaining healthcare for noncommunicable diseases (NCDs) is particularly important during the COVID-19 pandemic; however, diversion of resources to acute care, and physical distancing restrictions markedly affected management of NCDs. We aimed to assess the medication management practices in place for NCDs during the second wave of the COVID-19 pandemic across European countries. In December 2020, the European Network to Advance Best practices & technoLogy on medication adherencE (ENABLE) conducted a cross-sectional, web-based survey in 38 European and one non-European countries. Besides descriptive statistics of responses, nonparametric tests and generalized linear models were used to evaluate the impact on available NCD services of the number of COVID-19 cases and deaths per 100,000 inhabitants, and gross domestic product (GDP) per capita. Fifty-three collaborators from 39 countries completed the survey. In 35 (90%) countries face-to-face primary-care, and out-patient consultations were reduced during the COVID-19 pandemic. The mean ± SD number of available forms of teleconsultation services in the public healthcare system was 3 ± 1.3. Electronic prescriptions were available in 36 (92%) countries. Online ordering and home delivery of prescription medication (avoiding pharmacy visits) were available in 18 (46%) and 26 (67%) countries, respectively. In 20 (51%) countries our respondents were unaware of any national guidelines regarding maintaining medication availability for NCDs, nor advice for patients on how to ensure access to medication and adherence during the pandemic. Our results point to an urgent need for a paradigm shift in NCD-related healthcare services to assure the maintenance of chronic pharmacological treatments during COVID-19 outbreaks, as well as possible future disasters

Processing Diabetes mellitus composite events in MAGPIE

The focus of this research is in the definition of programmable expert Personal Health Systems (PHS) to monitor patients affected by chronic diseases using agent oriented programming and mobile computing to represent the interactions happening amongst the components of the system. The paper also discusses issues of knowledge representation within the medical domain when dealing with temporal patterns concerning the physiological values of the patient. In the presented agent based PHS the doctors can personalize for each patient monitoring rules that can be defined in a graphical way. Furthermore, to achieve better scalability, the computations for monitoring the patients are distributed among their devices rather than being performed in a centralized server. The system is evaluated using data of 21 diabetic patients to detect temporal patterns according to a set of monitoring rules defined. The system’s scalability is evaluated by comparing it with a centralized approach. The evaluation concerning the detection of temporal patterns highlights the system’s ability to monitor chronic patients affected by diabetes. Regarding the scalability, the results show the fact that an approach exploiting the use of mobile computing is more scalable than a centralized approach. Therefore, more likely to satisfy the needs of next generation PHSs. PHSs are becoming an adopted technology to deal with the surge of patients affected by chronic illnesses. This paper discusses architectural choices to make an agent based PHS more scalable by using a distributed mobile computing approach. It also discusses how to model the medical knowledge in the PHS in such a way that it is modifiable at run time. The evaluation highlights the necessity of distributing the reasoning to the mobile part of the system and that modifiable rules are able to deal with the change in lifestyle of the patients affected by chronic illnesses.Peer ReviewedPostprint (author's final draft

Adding Healthy Life to Years

publishersversionpublishe

The need for patient adherence standard measures for Big Data

Despite half a century of dedicated studies, medication adherence remains far from perfect, with many patients not taking their medications as prescribed. The magnitude of this problem is rising, jeopardizing the effectiveness of evidence-based therapies. An important reason for this is the unprecedented demographic change at the beginning of 21st century. Ageing leads to multimorbidity and complex therapeutic regimens that create fertile ground for non-adherence. As this scenario is a global problem, it needs a worldwide answer. Might this answer be provided, given the new opportunities created by the digitization of healthcare? Day by day health-related information is collected in electronic health records, pharmacy dispensing databases, health insurance systems and national health system records. These Big Data repositories offer a unique chance to study adherence both retrospectively and prospectively, at population level, as well as its related factors. In order to make the full use of this opportunity, there is a need to develop standardised measures of adherence, which can be applied globally to Big Data and will inform scientific research, clinical practice and public health. These standardized measures may also enable a better understanding of the relationship between adherence and clinical outcomes, and allow for fair benchmarking of effectiveness and cost-effectiveness of adherence-targeting interventions. Unfortunately, despite this obvious need, such standards are still lacking. Therefore, the aim of this paper is to call for producing a consensus on global standards for measuring adherence with Big Data. More specifically, sound standards of formatting, and analysing Big Data are needed in order to assess, uniformly present and compare patterns of medication adherence across studies. Wide use of these standards may improve adherence, and make healthcare systems more effective and sustainable

Unapređenje prakse i upotrebe tehnologija za unapređenje adherence

Medication non-adherence is recognized as a global problem associated with financial burden for patients and healthcare funds. At the European level, different Medication Adherence Technologies (MATech) are in use. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) was launched to: 1) identify current practices for Medication Adherence (MA) support by healthcare professionals; 2) create a structure for the repository of existing MATech that could be used by different stakeholders; and to 3) prepare guidance for sustainable implementation of MATech across European healthcare settings. ENABLE gathered different healthcare professionals and academics from 39 countries, to achieve the set of goals during a four-year period. Several cross-European studies were conducted employing stakeholder consultation (Delphi) and survey methods, including analysis of current practices for assessing and supporting MA in routine care, as well as barriers and facilitators to managing MA, work on medication management during COVID pandemic, reimbursement pathways of adherence interventions and protocols to identify the best practices and technologies. The MATech repository was designed by ENABLE members, and consultation of different stakeholders is currently in progress. The repository structure includes information about the MATech product and provider, goals and content related to managing MA, and information about the scientific evaluation and implementation. A cross-European expert survey identified a limited number of MA enhancing interventions that are currently subject to reimbursement. ENABLE identified the need for collaboration, infrastructure, and reimbursement to enhance the uptake of MATech in daily practice.Neadherenca pacijenata prema terapiji prepoznata je kao globalni problem udružen sa finansijskim opterećenjem pojedinaca i zdravstvenih sistema. Na nivou Evrope koriste se različite tehnologije za unapređenje adherence (Medication Adherence Technologies - MATech). Evropska mreža za razvoj najboljih praksi i tehnologija za unapređenje adherence (ENABLE, COST Action 19132) pokrenuta je sa ciljem da se: 1) identifikuju trenutne prakse unapređenja adherence (medication adhrerence – MA) od strane zdravstvenih profesionalaca; 2) kreira struktura repozitorijuma postojećih MATech koju mogu da koriste različiti stejkholderi; 3) da se pripreme vodiči za održivu implementaciju MATech širom Evrope. ENABLE okuplja zdravstvene profesionalce različitih profesija iz 39 zemalja kako bi se postigli ciljevi tokom četvorogodišnjeg perioda. Nekoliko studija u više zemalja Evrope pokrenuto je kako bi se izvršilo ispitivanje 1) stavova različitih stejkholdera delfi metodom i upitnicima, uključujući analizu trenutnih praksi u vezi analize i podrške MA u rutinskoj praksi, kao i barijere i facilitatore koji utiču na MA, 2) menadžment lekovima tokom COVID pandemije, 3) načine refundacije intervencija u vezi sa MA i 4) protokola koji identifikuju nabolje prakse i tehnologije. Kreirana je struktura MATech repozitorijuma, dok je usaglašavanje sa različitim stejkholderima u toku. Struktura repozitorijuma zasniva se na informacijama o MATech, ciljevima i sadržajima u vezi MA, i informacijama o naučnim procenama i implementaciji MATech. Na području Evrope istraživanje je identifikovalo ograničeni broj intervencija za unapređenje MA koje podležu refundaciji. ENABLE ukazuje na potrebu za kolaboracijom, razvojem infrastrukture i politike refundacije kako bi se unapredila upotreba MATech u rutinskoj praksi.VIII Kongres farmaceuta Srbije sa međunarodnim učešćem, 12-15.10.2022. Beogra

A case study of polypharmacy management in nine European countries: Implications for change management and implementation

BackgroundMultimorbidity and its associated polypharmacy contribute to an increase in adverse drug events, hospitalizations, and healthcare spending. This study aimed to address: what exists regarding polypharmacy management in the European Union (EU); why programs were, or were not, developed; and, how identified initiatives were developed, implemented, and sustained.MethodsChange management principles (Kotter) and normalization process theory (NPT) informed data collection and analysis. Nine case studies were conducted in eight EU countries: Germany (Lower Saxony), Greece, Italy (Campania), Poland, Portugal, Spain (Catalonia), Sweden (Uppsala), and the United Kingdom (Northern Ireland and Scotland). The workflow included a review of country/region specific polypharmacy policies, key informant interviews with stakeholders involved in policy development and implementation and, focus groups of clinicians and managers. Data were analyzed using thematic analysis of individual cases and framework analysis across cases.ResultsPolypharmacy initiatives were identified in five regions (Catalonia, Lower Saxony, Northern Ireland, Scotland, and Uppsala) and included all care settings. There was agreement, even in cases without initiatives, that polypharmacy is a significant issue to address. Common themes regarding the development and implementation of polypharmacy management initiatives were: locally adapted solutions, organizational culture supporting innovation and teamwork, adequate workforce training, multidisciplinary teams, changes in workflow, redefinition of roles and responsibilities of professionals, policies and legislation supporting the initiative, and data management and information and communication systems to assist development and implementation. Depending on the setting, these were considered either facilitators or barriers to implementation.ConclusionWithin the studied EU countries, polypharmacy management was not widely addressed. These results highlight the importance of change management and theory-based implementation strategies, and provide examples of polypharmacy management initiatives that can assist managers and policymakers in developing new programs or scaling up existing ones, particularly in places currently lacking such initiatives