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PurposeAdverse drug events are related to negative outcomes in healthcare, including hospitalization, increased duration of hospital stay and death. The aim of this study was to conduct a systematic review to evaluate hospitalizations and deaths related to adverse drug events worldwide, reported in studies with national coverage.MethodsThe protocol was registered in PROSPERO (CRD42020157008). We performed a systematic search on Medline, Embase, CINAHL, LILACS, and the Cochrane Library (until March 2020) using pre-specified terms. We included published studies that reported data on hospitalizations and/or deaths related to adverse drug events from a national perspective and the use of secondary data as a source of information. Two reviewers independently extracted and synthesized data. The quality of the studies was assessed using an adapted version of the Joanna Briggs Institute critical appraisal checklist for prevalence studies. Narrative summaries of findings were undertaken.ResultsAmong 59,336 citations, 62 studies were included for data extraction and synthesis. Among these studies, 41 studies included the outcome of hospitalization, 16 included the death outcome, and five included both outcomes. Administrative databases regarding discharges and registries of vital statistics were the most common sources of information. The relative frequency of hospitalizations ranged from 0.03% to 7.3%, and from 9.7 to 383.0/100,000 population, whereas mortality rate ranged from 0.1 to 7.88/100,000 population.ConclusionOur study highlights information about adverse drug events using large administrative databases in a national scenario and provides an overview of databases and methods implemented to detect adverse drug events.

Phosphate (P) recovery from urban wastewaters is an effective strategy to address environmental protection and resource conservation, aiming at an effective circular economy. Off-grid wastewater treatment systems like urine-diverting toilets (UDT) can contribute to source separation towards nutrient recovery, namely phosphorus recovery. Effectiveness of P precipitation requires a process-based knowledge regarding pH, Mg:PO4, contact time and their interactions in P recovery and crystal morphology. Several studies failed to see the process as a whole and how factors influence both morphology and P recovery for UDT hydrolysed urine. This study addressed the above-mentioned factors and their interactions, and results showed that pH and Mg:PO4 ratio are the key factors for struvite precipitation, whereas contact time is relevant for crystal growth. The recommended set of factors proposed (pH 8.5, Mg:PO4 ratio of 1.2:1 and 30 minutes contact time) not only promotes a high precipitation yield – 99% of P with co-precipitation of at least 21% of ammonium (NH4+) – but also leads to larger crystals with lower water solubility (10% less crystals dissolved in water after 3 days). The obtained outcome facilitates the downstream process and leads to a more efficient slow-release fertiliser, as less P is wasted to receiving waters by leaching, minimising eutrophication processes.

Long-term adherence to medication is of critical importance for the successful management of chronic diseases. Objective tools to track oral medication adherence are either lacking, expensive, difficult to access, or require additional equipment. To improve medication adherence, cheap and easily accessible objective tools able to track compliance levels are necessary. A tool to monitor pill intake that can be implemented in mobile health solutions without the need for additional devices was developed. We propose a pill intake detection tool that uses digital image processing to analyze images of a blister to detect the presence of pills. The tool uses the Circular Hough Transform as a feature extraction technique and is therefore primarily useful for the detection of pills with a round shape. This pill detection tool is composed of two steps. First, the registration of a full blister and storing of reference values in a local database. Second, the detection and classification of taken and remaining pills in similar blisters, to determine the actual number of untaken pills. In the registration of round pills in full blisters, 100% of pills in gray blisters or blisters with a transparent cover were successfully detected. In the counting of untaken pills in partially opened blisters, 95.2% of remaining and 95.1% of taken pills were detected in gray blisters, while 88.2% of remaining and 80.8% of taken pills were detected in blisters with a transparent cover. The proposed tool provides promising results for the detection of round pills. However, the classification of taken and remaining pills needs to be further improved, in particular for the detection of pills with non-oval shapes.

ObjectiveThe A2 score is an eight-question patient-reported outcome measure that has been validated for ruling in (score ≥4) and ruling out (score 0–1) asthma. However, this screening tool has been validated in a cohort similar to the derivation cohort used. This study aims to validate the predictive accuracy of the A2 score in a primary care population against general practitioner (GP) clinical assessment and to determine whether the proposed cut-offs are the most appropriate.DesignThis accuracy study is a secondary analysis of the EPI-ASTHMA population-based study.SettingPrimary care centres in Portugal.ParticipantsRandom adult participants answered the A2 score by phone interview.OutcomesThose with an A2 score ≥1 (plus 5% with an A2 score of 0) were invited to a diagnostic visit carried out by a GP to confirm or not a diagnosis of asthma. Diagnostic accuracy was assessed using receiver operating characteristic (ROC) curves.ResultsA total of 1283 participants (median 54 (p25–p75 43–66) years; 60% women) were analysed. The A2 score showed high discriminatory power in identifying asthma, with an area under the ROC curve of 82.9% (95% CI 80.4% to 85.4%). The proposed cut-off ≥4 was the most appropriate to rule in asthma (specificity 83.1%, positive predictive value 62.4%, accuracy 78%). Similarly, the proposed cut-off<2 was the most suitable for excluding asthma (sensitivity 92.7%, negative predictive value 93.7%, accuracy 60.5%).ConclusionsThe A2 score is a useful tool to identify patients with asthma in a primary care population.Trial registration number NCT0516961.

Most mobile health (mHealth) decision support systems currently available for chronic obstructive respiratory diseases (CORDs) are not supported by clinical evidence or lack clinical validation. The development of the knowledge base that will feed the clinical decision support system is a crucial step that involves the collection and systematization of clinical knowledge from relevant scientific sources and its representation in a human-understandable and computer-interpretable way. This work describes the development and initial validation of a clinical knowledge base that can be integrated into mHealth decision support systems developed for patients with CORDs. A multidisciplinary team of health care professionals with clinical experience in respiratory diseases, together with data science and IT professionals, defined a new framework that can be used in other evidence-based systems. The knowledge base development began with a thorough review of the relevant scientific sources (eg, disease guidelines) to identify the recommendations to be implemented in the decision support system based on a consensus process. Recommendations were selected according to predefined inclusion criteria: (1) applicable to individuals with CORDs or to prevent CORDs, (2) directed toward patient self-management, (3) targeting adults, and (4) within the scope of the knowledge domains and subdomains defined. Then, the selected recommendations were prioritized according to (1) a harmonized level of evidence (reconciled from different sources); (2) the scope of the source document (international was preferred); (3) the entity that issued the source document; (4) the operability of the recommendation; and (5) health care professionals’ perceptions of the relevance, potential impact, and reach of the recommendation. A total of 358 recommendations were selected. Next, the variables required to trigger those recommendations were defined (n=116) and operationalized into logical rules using Boolean logical operators (n=405). Finally, the knowledge base was implemented in an intelligent individualized coaching component and pretested with an asthma use case. Initial validation of the knowledge base was conducted internally using data from a population-based observational study of individuals with or without asthma or rhinitis. External validation of the appropriateness of the recommendations with the highest priority level was conducted independently by 4 physicians. In addition, a strategy for knowledge base updates, including an easy-to-use rules editor, was defined. Using this process, based on consensus and iterative improvement, we developed and conducted preliminary validation of a clinical knowledge base for CORDs that translates disease guidelines into personalized patient recommendations. The knowledge base can be used as part of mHealth decision support systems. This process could be replicated in other clinical areas.

Background/Objectives: Helicobacter pylori is the leading cause of chronic gastritis, peptic ulcer, gastric adenocarcinoma, and mucosal-associated lymphoma. Due to the emerging problems with antibiotic treatment against H. pylori in clinical practice, H. pylori vaccination has gained more interest. Oral immunization is considered a promising approach for preventing initial colonization of this bacterium in the gastrointestinal tract, establishing a first line of defense at gastric mucosal surfaces. Chitosan nanoparticles can be exploited effectively for oral vaccine delivery due to their stability, simplicity of target accessibility, and beneficial mucoadhesive and immunogenic properties. Methods: In this study, new multi-epitope pDNA- and recombinant protein-based vaccines incorporating multiple H. pylori antigens were produced and encapsulated in chitosan nanoparticles for oral and intramuscular administration. The induced immune response was assessed through the levels of antigen-specific IgGs, secreted mucosal SIgA, and cytokines (IL-2, IL-10, and IFN-γ) in immunized BALB/C mice. Results: Intramuscular administration of both pDNA and recombinant protein-based vaccines efficiently stimulated the production of specific IgG2a and IgG1, which was supported by cytokines levels. Oral immunizations with either pDNA or recombinant protein vaccines revealed high SIgA levels, suggesting effective gastric mucosal immunization, contrasting with intramuscular immunizations, which did not induce SIgA. Conclusions: These findings indicate that both pDNA and recombinant protein vaccines encapsulated into chitosan nanoparticles are promising candidates for eradicating H. pylori and mitigating associated gastric diseases in humans.

The Control of Allergic Rhinitis and Asthma Test (CARAT) is a patient‐reported outcome measurement (PROM) assessing the control of asthma and allergic rhinitis (AR) at a 4 week interval. This systematic review aimed to evaluate the measurement properties of CARAT. Following PRISMA and COSMIN guidelines, we searched five bibliographic databases and retrieved studies concerning the development, assessment of properties, validation, and/or cultural adaption of CARAT. The studies' methodological quality, the quality of measurement properties, and the overall quality of evidence were assessed. We performed meta‐analysis of CARAT measurement properties. We included 16 studies. Control of Allergic Rhinitis and Asthma Test displayed sufficient content validity and very good consistency (meta‐analytical Cronbach alpha = 0.83; 95% CI = 0.80–0.86;I2 = 62.6%). Control of allergic rhinitis and Asthma Test meta‐analytical intraclass correlation coefficient was 0.91 (95% CI = 0.64–0.98;I2 = 93.7%). It presented good construct validity, especially for correlations with Patient‐reported outcome measures assessing asthma (absolute Spearman correlation coefficients range = 0.67–0.73; moderate quality of evidence), and good responsiveness. Its minimal important difference is 3.5. Overall, CARAT has good internal consistency, reliability, construct validity and responsiveness, despite the heterogeneous quality of evidence. Control of Allergic Rhinitis and Asthma Test can be used to assess the control of asthma and AR. As first of its kind, this meta‐analysis of CARAT measurement properties sets a stronger level of evidence for asthma and/or AR control questionnaires.

Background Blood eosinophil (B‐Eos) count is an emerging biomarker in the management of respiratory disease but determinants of B‐Eos count besides respiratory disease are poorly described. Therefore, we aimed to evaluate the influence of non‐respiratory diseases on B‐Eos count, in comparison to the effect on two other biomarkers: fraction of exhaled nitric oxide (FeNO) and C‐reactive protein (CRP), and to identify individual characteristics associated with B‐Eos count in healthy controls. Methods Children/adolescents (<18 years) and adults with complete B‐Eos data from the US National Health and Nutritional Examination Surveys 2005–2016 were included, and they were divided into having respiratory diseases (n = 3333 and n = 7,894, respectively) or not having respiratory disease (n = 8944 and n = 15,010, respectively). After excluding any respiratory disease, the association between B‐Eos count, FeNO or CRP, and non‐respiratory diseases was analyzed in multivariate models and multicollinearity was tested. After excluding also non‐respiratory diseases independently associated with B‐Eos count (giving healthy controls; 8944 children/adolescents and 5667 adults), the independent association between individual characteristics and B‐Eos count was analyzed. Results In adults, metabolic syndrome, heart disease or stroke was independently associated with higher B‐Eos count (12%, 13%, and 15%, respectively), whereas no associations were found with FeNO or CRP. In healthy controls, male sex or being obese was associated with higher B‐Eos counts, both in children/adolescents (15% and 3% higher, respectively) and adults (14% and 19% higher, respectively) (p < 0.01 all). A significant influence of race/ethnicity was also noted, and current smokers had 17% higher B‐Eos count than never smokers (p < 0.001). Conclusions Non‐respiratory diseases influence B‐Eos count but not FeNO or CRP. Male sex, obesity, certain races/ethnicities, and current smoking are individual characteristics or exposures that are associated with higher B‐Eos counts. All these factors should be considered when using B‐Eos count in the management of respiratory disease.

Background Atherosclerotic Cardiovascular Disease (ASCVD) is a global public health concern. This study aimed to estimate the healthcare resource utilization (HRU) and costs stratified by cardiovascular disease (CVD) risk categories using real-world evidence, in a regional population in Portugal. Methods This is a retrospective observational study, using data from Electronic Health Records between 2017 and 2021. Patients aged ≥ 40 years, and with at least one general practitioner (GP) appointment in the 3 years before 31st of December 2019, were included. CVD risk categories were determined based on 2021 ESC prevention guidelines. HRU encompassed hospital data (hospitalizations, outpatient and emergency room visits) and GP appointments. Total direct costs per patient were calculated based on the reference cost of the Portuguese legislation for payment methodology on Diagnosis-Related Groups (DRGs). Results Analysis of 3 122 695 episodes, revealed consistent HRU and costs across the five years. Very high-risk patients, showed higher HRU, particularly in hospital admissions. Costs tended to rise with higher CVD risk level. Very high-risk patients with ASCVD had higher costs for hospital admissions, while low-to-moderate risk patients had higher costs for GP visits. Despite a smaller proportion, very high-risk patients with prior ASCVD represent the highest costs per patient across healthcare settings (from 115€ in emergency visits to 2 673€ in hospitalizations), followed by very high-risk patients without prior ASCVD (ASCVD-risk equivalents). Conclusion This study revealed a substantial HRU and costs by patients with very high CVD risk, particularly those with prior ASCVD. Moreover, ASCVD-risk equivalents emerge as notable consumers, emphasizing the importance of risk assessment and preventive measures in cost-effective management of these patients.