New-onset diabetes and antihypertensive treatment

Introduction: Chronic diseases substantially contribute to the continuous increase in health care expenditures, including type-2 diabetes mellitus as one of the most expensive chronic diseases. Arterial hypertension presents a risk factor for the development of type-2 diabetes mellitus. Numerous analyses have demonstrated that antihypertensive therapies promote the development of type-2-diabetes mellitus. Studies indicate, that the application of angiotensin converting enzyme (ACE) inhibitors and angiotensin-receptor-blockers (ARB) lead to less new-onset diabetes compared to beta-blockers, diuretics and placebo. Given that beta-blockers and diuretics impair the glucose metabolism, the metabolic effects of different antihypertensive drugs should be regarded; otherwise not only the disease itself, but also antihypertensive therapies may promote the development of new-onset diabetes. Even though, the cost of ACE inhibitors and ARB are higher, the use in patients with metabolic disorders could be cost-effective in the long-term if new-onset diabetes is avoided. Objectives: To evaluate which class of antihypertensive agents promote the development or the manifestation of type-2 diabetes mellitus. How high is the incidence of new-onset diabetes during antihypertensive therapy and how is treatment-induced type-2 diabetes mellitus evaluated clinically? Which agents are therefore cost-effective in the long term? Which ethical, social or legal aspects should be regarded?MethodsA systematic literature review was conducted including clinical trials with at least ten participants which reported new-onset diabetes in the course of antihypertensive treatment. The trials had to be published after 1966 (after 2003 for economic publications) in English or German. Results: A total of 34 clinical publications meet the inclusion criteria. Of these, eight publications focus on the development of diabetes mellitus under treatment with diuretic and/or beta-blockers, six publications focused on ACE inhibitors alone or in combination with calcium-channel-blockers, ten publications on ARB and/or ACE inhibitors with respect to their effects on new-onset diabetes or their preventive aspects. Furthermore, five publications investigate the role of calcium-channel-antagonists in the development of diabetes, and five publications indicate the development of new-onset diabetes with different antihypertensive agents amongst each other or in comparison to no antihypertensive treatment. The clinical trials show a significant difference in the development of new-onset diabetes. Therapies with diuretics and/or beta-blockers result in a higher incidence of new-onset diabetes. ARB as well as ACE inhibitors have a preventive effect and calcium-channel-blockers show a neutral position regarding the development of new-onset diabetes. Two publications report on economic results. The first one evaluates the cost-effectiveness of ARB alone or in combination with calcium-channel-blockers in comparison to diuretics alone or in combination with beta-blockers. The second publication compares economic outcomes of calcium-channel-blockers and beta-blockers considering the development of new-onset diabetes. Treatment with the ARB candesartan lead to savings in total costs of 549 US-Dollar per patient and in incremental costs of 30,000 US-Dollar per diabetes mellitus avoided. In the second publication, costs to the amount of 18,965 Euro in Great Britain and 13,210 Euro in Sweden are quoted for an avoided event. The treatment with calcium-channel-blockers compared to beta-blockers is proven to be more cost-effective. No publications were identified regarding ethical, social and legal aspects. Discussion: The available meta-analyses allow for a high clinical evidence level. A few studies vary in terms of diabetes definition and study duration. In most of the trials, the incidence of new-onset diabetes is not an endpoint. The evaluation of treatment-induced diabetes mellitus cannot be conducted, due to the lack of sufficient results in the identified literature. The two economic studies do not address all the objectives sufficiently. Ethical, social and legal aspects are discussed but not analysed systematically. Conclusion: Based on these studies, sufficient evidence to confirm the presumption that diuretics and/or beta-blockers promote the development of new-onset diabetes compared to other antihypertensive agents, especially in patients who are predisposed, is presented with this report. Trials reflecting the clinical relevance of treatment-induced diabetes mellitus compared to existing diabetes mellitus regarding cardiovascular outcomes are required. Also health economic evaluations considering the development of new-onset diabetes should be conducted for the different classes of antihypertensive agents

Effect of an interprofessional care concept on the hospitalization of nursing home residents : study protocol for a cluster-randomized controlled trial

Background: The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated. Methods: The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model. Conclusion: A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial

BackgroundStress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention “mindfulHeart” in terms of reducing stress in patients with IHD.Methods and analysisThis randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants’ pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses.EthicsThe Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22–11,015-BO).Trial registrationClinicalTrials NCT05846334. Release 26.04.2023

The Effectiveness of Levocetirizine in Comparison with Loratadine in Treatment of Allergic Rhinitis —A Meta-Analysis

Background: Oral antihistamines are considered the gold standard therapy for allergic rhinitis to date. The goal of this investigation is to make an indirect comparison between loratadine, an oral antihistamine available over-the-counter (OTC) in the USA, and the more modern antihistamine levocetirizine. Only double-blind, placebo-controlled (DBPC) studies involving monotherapy with the active substances levocetirizine and loratadine were included in the meta-analysis. Methods: The medical databases EMBASE and Medline were searched systematically for all relevant studies completed by the end of 2009. Only DBPC studies conducted in normal environmental settings were included. Furthermore, the Jadad scale was used to guarantee the quality of the studies involved. The “standardized mean difference” (SMD) method was applied for calculating the study-specific effects to neutralize the variability between studies. Results: The results of a total of seven published DBPC studies met all criteria for inclusion in meta-analysis. The meta-analysis showed that levocetirizine was significantly more effective than loratadine in improving the total symptom score (TSS) (p < 0.01). The effect sizes were calculated as −0.59 (95% confidence interval −0.89, −0.29) for levocetirizine and −0.21 (95% confidence interval −0.31, −0.1) for loratadine when compared to placebo. Conclusions: The results of this meta-analysis illustrate greater effectiveness for treatment with the active substance levocetirizine as monotherapy in reducing allergic symptoms when compared to treatment with loratadine

Factors Influencing the Acceptability, Acceptance, and Adoption of Conversational Agents in Health Care: Integrative Review

BackgroundConversational agents (CAs), also known as chatbots, are digital dialog systems that enable people to have a text-based, speech-based, or nonverbal conversation with a computer or another machine based on natural language via an interface. The use of CAs offers new opportunities and various benefits for health care. However, they are not yet ubiquitous in daily practice. Nevertheless, research regarding the implementation of CAs in health care has grown tremendously in recent years. ObjectiveThis review aims to present a synthesis of the factors that facilitate or hinder the implementation of CAs from the perspectives of patients and health care professionals. Specifically, it focuses on the early implementation outcomes of acceptability, acceptance, and adoption as cornerstones of later implementation success. MethodsWe performed an integrative review. To identify relevant literature, a broad literature search was conducted in June 2021 with no date limits and using all fields in PubMed, Cochrane Library, Web of Science, LIVIVO, and PsycINFO. To keep the review current, another search was conducted in March 2022. To identify as many eligible primary sources as possible, we used a snowballing approach by searching reference lists and conducted a hand search. Factors influencing the acceptability, acceptance, and adoption of CAs in health care were coded through parallel deductive and inductive approaches, which were informed by current technology acceptance and adoption models. Finally, the factors were synthesized in a thematic map. ResultsOverall, 76 studies were included in this review. We identified influencing factors related to 4 core Unified Theory of Acceptance and Use of Technology (UTAUT) and Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) factors (performance expectancy, effort expectancy, facilitating conditions, and hedonic motivation), with most studies underlining the relevance of performance and effort expectancy. To meet the particularities of the health care context, we redefined the UTAUT2 factors social influence, habit, and price value. We identified 6 other influencing factors: perceived risk, trust, anthropomorphism, health issue, working alliance, and user characteristics. Overall, we identified 10 factors influencing acceptability, acceptance, and adoption among health care professionals (performance expectancy, effort expectancy, facilitating conditions, social influence, price value, perceived risk, trust, anthropomorphism, working alliance, and user characteristics) and 13 factors influencing acceptability, acceptance, and adoption among patients (additionally hedonic motivation, habit, and health issue). ConclusionsThis review shows manifold factors influencing the acceptability, acceptance, and adoption of CAs in health care. Knowledge of these factors is fundamental for implementation planning. Therefore, the findings of this review can serve as a basis for future studies to develop appropriate implementation strategies. Furthermore, this review provides an empirical test of current technology acceptance and adoption models and identifies areas where additional research is necessary. Trial RegistrationPROSPERO CRD42022343690; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=34369

On the Sustainability of Guideline Implementation

Background Allergic rhinitis (AR) is a disorder associated with a high financial burden and is considered an important risk factor for the development of asthma. The ARIA guideline (Allergic Rhinitis and its Impact on Asthma) addresses this problem and provides recommendations for treating allergic rhinitis. The objective of the present analysis was to estimate the compliance with guidelines among ear, nose and throat (ENT) specialists and general practitioners.Methods The data of 121,593 patients collected during 9 prospective observational studies carried out from 1998 to 2005 were examined using individual patient data meta-analysis method.Results Only 14.8% of patients with allergic rhinitis were treated according to the recommendations. Of the others, 73.8% received insufficient treatment. In addition, 36.1% of the patients who were treated by ENT specialists received therapy according to guidelines, whereas only 16% of the general practitioners heeded the recommendations. Patients suffering from rhinitis and asthma were treated by ENT specialists according to the ARIA guideline in 50% of cases. It could be observed that the rate of guideline compliance was highest in the year of publication.Conclusion The results are evidence of the successful implementation process of the ARIA guidelines. However, they have not yet found their way into the daily routine of general practitioners. Keywords: allergic rhinitis, treatment, guidelines, compliance, ARIA, ENT specialist