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OBJECTIVE: To study medication adherence and persistence among heart failure patients, assess the methods utilised for estimating medication adherence, and identify optimal adherence thresholds and their impact on clinical outcomes. METHODS: A systematic search will be conducted in PubMed, Embase, CINAHL, Web of Science, and Scopus databases. Observational studies assessing medication adherence or persistence among heart failure patients via electronic healthcare databases will be included. A narrative synthesis will describe medication adherence and persistence reported and methods used to measure it. A meta-analysis will be attempted to evaluate the impact of secondary medication adherence (multiple and by drug class) on clinical outcomes, including hospitalisation, emergency visits, and mortality. The I2 statistic will be employed to study heterogeneity and the GRADE framework to evaluate evidence certainty. This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and is registered with the Prospective Register of Ongoing Systematic Reviews CRD42024509542. DISCUSSION: This study aims to evaluate medication adherence and persistence in heart failure management through electronic health databases, intending to explore widely used measurement methods and their limitations, and to identify adherence thresholds associated with improved clinical outcomes. By examining these aspects, we anticipate proposing enhancements for future research and establishing desired adherence goals. This approach highlights the expected significance of our findings in advancing patient care and research methodologies.
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INTRODUCTION: This systematic review, adhering to PRISMA guidelines, aimed to evaluate the efficacy and safety of antiemetic prophylaxis in haematological patients undergoing high-dose chemotherapy as part of their hematopoietic stem cell transplantation (HSCT) conditioning regimens. METHODS: We performed a comprehensive search in PubMed, EMBASE, ClinicalTrials.gov and the Cochrane database to identify randomised controlled trials (RCTs) and systematic reviews of antiemetic prophylaxis. Studies in English, French, Italian or Spanish were included. This review is registered with PROSPERO, ID CRD42023406380. RESULTS: Eight RCTs were analysed. The antiemetic regimens evaluated ranged from monotherapy with 5-Hydroxytryptamine Receptor 3 antagonists (5-HT3RAs) to complex combinations including olanzapine, neurokinin-1 receptor antagonists, 5-HT3RAs and corticosteroids. Complete response rates for triplet or quadruple regimens varied between 23.5% and 81.9%. Although no significant adverse effects were observed, minor symptoms such as diarrhoea, constipation, sedation and headaches were reported. CONCLUSION: Existing evidence on HSCT antiemetic therapy highlights its benefits but fails to provide clear clinical directions. The choice between triplet and quadruplet therapies for different patient scenarios is still uncertain. Until more detailed research is available, healthcare providers must rely on the latest guidelines and their judgement to customise antiemetic care for each patient's specific needs and risks.
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Heart failure is a prevalent syndrome with high mortality rates, representing a significant economic burden in terms of healthcare. The lack of systematic information about the treatment and adherence of patients with heart failure limits the understanding of these aspects and potentially the improvement of clinical outcomes. OBJECTIVE: To describe the clinical characteristics, therapeutic management, adherence, persistence, and clinical results, as well as the association between these variables, in a cohort of patients with heart failure in Andalusia. DESIGN: This study will be an observational, population-based, retrospective cohort study. Data of patients discharged from an Andalusian hospital with a diagnosis of heart failure between 2014 and 2023 will be extracted from the Andalusian population health database. ANALYSIS: The statistical analysis will incorporate the following strategies: (1) Descriptive analysis of the characteristics of the population cohort, adherence measures, and clinical outcomes. (2) Bivariate analyses to study the association of covariates with adherence, persistence, and clinical results. (3) Multivariate logistic regression and Cox regression analysis including relevant covariates. (4) To evaluate changes over time, multivariate Poisson regression models will be used. By conducting this comprehensive study, we aim to gain valuable insights into the clinical characteristics, treatment management, and adherence of heart failure patients in Andalusia, as well as to identify factors that may influence clinical outcomes. These findings could be critical both for the development of optimised strategies that improve medical care and quality of life of patients and for mitigating the health burden of HF in the region.
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Heart failure is a prevalent syndrome with high mortality rates, representing a significant economic burden in terms of healthcare. The lack of systematic information about the treatment and adherence of patients with heart failure limits the understanding of these aspects and potentially the improvement of clinical outcomes. OBJECTIVE: To describe the clinical characteristics, therapeutic management, adherence, persistence and clinical results, as well as the association between these variables, in a cohort of patients with heart failure in Andalusia. DESIGN: This study will be an observational, population-based, retrospective cohort study. Data of patients discharged from an Andalusian hospital with a diagnosis of heart failure between 2014 and 2023 will be extracted from the Andalusian population health database. ANALYSIS: The statistical analysis will incorporate the following strategies: 1) Descriptive analysis of the characteristics of the population cohort, adherence measures, and clinical outcomes. 2) Bivariate analyses to study the association of covariates with adherence, persistence and clinical results. 3) Multivariate logistic regression and Cox regression analysis including relevant covariates. 4) To evaluate changes over time, multivariate Poisson regression models will be used. By conducting this comprehensive study, we aim to gain valuable insights into the clinical characteristics, treatment management, and adherence of heart failure patients in Andalusia, as well as to identify factors that may influence clinical outcomes. These findings could be critical both for the development of optimized strategies that improve medical care and quality of life of patients and for mitigating the health burden of HF in the region.
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OBJECTIVES: To describe the extent, characteristics, and knowledge gaps regarding explicit decision criteria for deprescribing drugs with anticholinergic or sedative properties (Ach/Sed) in older adults. DESIGN: Scoping review. SETTING AND PARTICIPANTS: Original studies, clinical trial protocols, grey literature, and Summaries of Product Characteristics. METHODS: Searches targeting explicit decision criteria for deprescribing Ach/Sed were performed across MEDLINE, EMBASE, CINAHL, and Web of Science, including trial registries (clinicaltrials.gov, ICTRP, EU-CTR, ANZCTR) for pertinent articles, study protocols. Additionally, to encompass non-traditional or 'grey literature' sources, Google searches and relevant agency websites were explored, alongside the summary of product characteristics for Ach/Sed. RESULTS: The initial literature search identified 8,192 unique data sources. After review, 188 original articles or books, 79 internet sources, and 127 SmPCs were included. Examining these sources for explicit criteria for 154 Ach/Sed, overall, 1,271 explicit criteria guidance for identifying clinical scenarios warranting deprescription of Ach/Sed across 145/154 Ach/Sed were identified. These criteria were identified mainly from qualitative research and Summaries of Product Characteristics. Additionally, 455 criteria-based recommendations suggesting approaches for tapering implementation across 76/154 Ach/Sed were identified, mostly from sources classified as expert opinions. Significant heterogeneity was found across the approaches for tapering Ach/Sed. CONCLUSIONS: This scoping review provides a comprehensive overview of the literature providing guidance for clinical scenarios where Ach/Sed should be deprescribed and highlights the existing knowledge gaps regarding comprehensive guidance on tapering these drugs which warranties future research and development.
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Antagonistas Colinérgicos , Hipnóticos e Sedativos , Humanos , Idoso , Hipnóticos e Sedativos/uso terapêutico , Pesquisa Qualitativa , Antagonistas Colinérgicos/uso terapêuticoRESUMO
OBJECTIVE: Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS: A systematic review will be conducted using MEDLINE via PubMed, EMBASE, ClinicalTrials.gov., and Cochrane databases. Studies written in English, French, Italian or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, two independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION: Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them includes specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.
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Antieméticos , Antineoplásicos , Neoplasias Hematológicas , Transplante de Células-Tronco Hematopoéticas , Humanos , Antieméticos/uso terapêutico , Qualidade de Vida , Revisões Sistemáticas como Assunto , Metanálise como Assunto , Vômito/induzido quimicamente , Vômito/prevenção & controle , Náusea/induzido quimicamente , Náusea/prevenção & controle , Neoplasias Hematológicas/complicações , Neoplasias Hematológicas/terapia , Antineoplásicos/efeitos adversosRESUMO
OBJECTIVE: Chemotherapy-induced nausea and vomiting continue to pose a significant challenge for patients undergoing hematopoietic stem cell transplantation. This study aims to synthesize available evidence on antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation, in order to identify the best standard of care. METHODS: A systematic review will be conducted using MEDLINE via PubMed, EMBASE, Clinical-Trials.gov., and Cochrane databases. Studies written in English, French, Italian, or Spanish will be considered. After screening the literature according to the inclusion and exclusion criteria, 2 independent reviewers will extract data and assess the risk of bias in eligible articles. This protocol has been prepared according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. This protocol is registered in the Prospective Register of Ongoing Systematic Reviews (PROSPERO) CRD42023406380. DISCUSSION: Chemotherapy-induced nausea and vomiting is a debilitating side effect that presents a significant challenge for patients with hematologic malignancies. Despite the publication of various guidelines, none of them include specific recommendations for each chemotherapy regimen. Therefore, analyzing the primary antiemetic prophylaxis regimens in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation would be valuable in enhancing patients' quality of life.
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Antieméticos , Antineoplásicos , Neoplasias Hematológicas , Transplante de Células-Tronco Hematopoéticas , Humanos , Antieméticos/uso terapêutico , Qualidade de Vida , Revisões Sistemáticas como Assunto , Metanálise como Assunto , Vômito/induzido quimicamente , Vômito/prevenção & controle , Náusea/induzido quimicamente , Náusea/prevenção & controle , Neoplasias Hematológicas/tratamento farmacológico , Antineoplásicos/efeitos adversosRESUMO
INTRODUCTION: Randomized controlled trials (RCTs) that conduct subgroup analyses have the potential to provide information on treatment decisions in specific groups of patients from heterogeneous populations. Although we understand several factors can modify the incidence of venous thromboembolism (VTE) and the benefit/risk ratio of anticoagulation treatments, further evidence is warranted to show the heterogeneity of treatment effects in different subgroups of patients. AIMS: The primary purpose was to evaluate the appropriateness and interpretation of subgroup analysis performed on VTE RCTs reporting pharmacological interventions. MATERIALS AND METHODS: A systematic review of RCTs published between January 2017 and January 2022 was conducted. Claims of subgroup effects were evaluated with predefined criteria. High-quality claims of subgroup effect were further analyzed and discussed. RESULTS: Overall, 28 RCTs with a generally low bias risk were included. The purposes of the treatments included pharmacologic thromboprophylaxis (17), therapeutic dose anticoagulation (9), and catheter-directed pharmacologic thrombolysis (2). The evaluated subgroup analyses generally presented: a high number of subgroup analyses reported, a lack of prespecification, and a lack of usage of statistical tests for interaction. The authors reported 13 claims of subgroup effect; only two were considered potentially reliable to represent heterogeneity in the direction or magnitude of treatment effect. CONCLUSIONS: Subgroup analyses of VTE RCTs reporting pharmacologic interventions are generally methodologically poor. Most claims of subgroup effect did not meet critical criteria and lacked credibility. Clinicians in this field may proceed with scepticism when assessing claims of subgroup effects due to methodological concerns and misleading interpretations.
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Tromboembolia Venosa , Humanos , Tromboembolia Venosa/etiologia , Anticoagulantes/uso terapêuticoRESUMO
West syndrome is a severe epilepsy syndrome characterised by the appearance of drug-resistant epileptic disorders associated with hypsarrhythmia and intellectual disability. Among non-pharmacological treatments, the ketogenic diet, which consists of low carbohydrate intake and a rich lipid intake, stands out. This treatment induces a state of ketosis, which has been related to a decrease in the number of seizures. It is essential to control the carbohydrate intake within drug treatment for these patients since many pharmaceutical forms, specifically liquid oral medication, may contain carbohydrates in the form of mono/polysaccharides or polyols. We describe the case report of an infant with drug-resistant West syndrome, treated with a ketogenic diet, whose antiseizure liquid medication impeded a proper response to the diet. After the substitution of these medications, the patient showed a remarkable decrease in the number of seizures.
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Dieta Cetogênica , Espasmos Infantis , Lactente , Humanos , Convulsões/tratamento farmacológico , Carboidratos/uso terapêutico , Preparações FarmacêuticasRESUMO
[This corrects the article DOI: 10.2196/35851.].
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BACKGROUND: Hematological malignancies (HMs) are a heterogeneous group of cancers representing a significant cause of morbidity and mortality. The chronification of HMs and the increasing use of smartphones may lead patients to seek their current unmet needs through mobile health apps. OBJECTIVE: The goal of this review was to identify and assess the quality of smartphone apps aimed at patients diagnosed with HMs. METHODS: A systematic search of apps that were aimed at patients diagnosed with HMs, accessed from a Spain IP address, and were available on the iOS (App Store) and Android (Google Play) platforms was conducted in November 2021. The search terms used were "hematology," "blood cancer," "leukemia," "lymphoma," and "myeloma" apps in English, Spanish, or both languages. The identified apps were downloaded and analyzed independently by 2 reviewers. Information about general app characteristics was collected. The Mobile Application Rating Scale (MARS) was used to assess quality. The resulting parameter of the analyses, the mean score of the apps, was compared by Student t test. RESULTS: Overall, 18 apps were identified; 7 were available on Android, 5 were available on iOS, and 6 were available on both platforms. All included apps were free; 3 were published in 2021, and among the apps published before 2021, only 6 were updated in 2021. Most (16/18, 89%) of the apps were aimed at patients with leukemia or lymphoma (16). The primary purposes of the apps were to provide general information about the condition (16/18, 89%) and monitor symptoms and clinical parameters (11/18, 61%). Health care professionals contributed to the development of 50% (9/18) of apps; 6 were owned and supported by scientific societies, and 3 were developed with the participation of health care professionals. The mean MARS score for the overall quality of the apps was 3.1 (SD 1.0). The engagement and aesthetics subscales were the lowest rated subscales, with only 44% (8/18) and 67% (12/18), respectively, of the apps obtaining acceptable scores. None of the included apps proved clinical efficacy through clinical trials in patients with HMs. Statistically significant differences were found in the MARS scores between operating systems (+1.0, P=.003) in favor of iOS apps. The participation of health care professionals in the development of the apps did not have a statistically significant impact on the MARS scores. CONCLUSIONS: This systematic search and evaluation identified few acceptable quality mobile apps for patients with HMs. Current and future apps for patients with HMs should provide evidence-based valuable information, improve user engagement, incorporate functions according to patient preferences, and generate evidence regarding the efficacy of app use by patients with HMs.
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Neoplasias Hematológicas , Leucemia , Linfoma , Aplicativos Móveis , Neoplasias Hematológicas/terapia , Humanos , SmartphoneRESUMO
Pulmonary hypertension (PH) treatment decisions are driven by the results of randomized controlled trials (RCTs). Subgroup analyses are often performed to assess whether the intervention effect will change due to the patient's characteristics, thus allowing for individualized decisions. This review aimed to evaluate the appropriateness and interpretation of subgroup analyses performed in PH-specific therapy RCTs published between 2000 and 2020. Claims of subgroup effects were evaluated with prespecified criteria. Overall, 30 RCTs were included. Subgroup analyses presented: a high number of subgroup analyses reported, lack of prespecification, and lack of interaction tests. The trial protocol was not available for most RCTs; significant differences were found in those articles that published the protocol. Authors reported 13 claims of subgroup effect, with 12 claims meeting four or fewer of Sun's criteria. Even when most RCTs were generally at low risk of bias and were published in high-impact journals, the credibility and general quality of subgroup analyses and subgroup claims were low due to methodological flaws. Clinicians should be skeptical of claims of subgroup effects and interpret subgroup analyses with caution, as due to their poor quality, these analyses may not serve as guidance for personalized care.
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In recent years, one of the most successful advances in treating acute myeloid leukaemia (AML) has been the combination of the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax with hypomethylating agents (decitabine or azacytidine). This combination treatment has an accelerated approval by the Food and Drug Administration for newly diagnosed AML adults who are 75 years of age or older or who have comorbidities and are not eligible to receive intensive induction chemotherapy. AML is the most common form of acute leukaemia in adults, with a median age at diagnosis of 68 years. Consequently, most of the patients included in the studies are elderly. Traditionally, young patients achieve higher remission rates compared with the elderly AML population. Although venetoclax combination therapy could become a treatment option for treating young patients with relapsed/refractory AML, this regimen has not been systematically tested in this setting. In this study, we summarize the currently available evidence on the treatment of venetoclax in combination with hypomethylating agents for the treatment of young relapsed/refractory AML patients, in addition to our experience in clinical practice with two case reports. Venetoclax, combined with hypomethylating agents, seems to be an effective option for young relapsed/refractory AML patients. However, due to the poor quality of the evidence, additional well-designed studies with greater numbers of patients are needed to confirm the effectiveness and safety of venetoclax combination regimens for this population.
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Candidíase/epidemiologia , Interleucina-17/antagonistas & inibidores , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/efeitos adversos , Candidíase/induzido quimicamente , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Obesidade , Estudos Retrospectivos , Fatores de Risco , Espanha/epidemiologia , Adulto JovemRESUMO
The association between anticholinergic burden and constipation is not well defined and documented; for this reason, a systematic review was carried out in five databases (Medline, Embase, Cochrane Central Register of Controlled Trials, CINAHL, and Scopus), including studies assessing the correlation between anticholinergic burden, and constipation between January 2006 and December 2020. Data extraction was conducted independently by two researchers. Abstracts and titles were reviewed to determine eligibility for review with eligible articles read in full. From 2507 identified articles, 11 were selected for this review: six cross-sectional studies, four retrospective cohort studies, and a post hoc analysis of a randomized clinical trial. Overall, nine studies reported at least one statistical association between anticholinergic burden and constipation, finding 13 positive results out of 24 association measurements. A total of 211,921 patients were studied. The association between constipation and anticholinergic burden could be demonstrated in studies including 207,795 patients. Most studies were not designed to find differences in constipation prevalence and did not adjust the results by confounding factors. Our findings suggest that a correlation between anticholinergic burden and constipation exists. Higher quality-evidence studies are needed, including analysis that considers confounding factors, such as other non-pharmacological causes of constipation.
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AIMS: To assess the appropriateness of the use and interpretation of subgroup analysis in haematology randomized clinical trials (RCTs). METHOD: A systematic review of Medline, including haematology phase III RCTs published between January 2013 and October 2019, was carried out to identify reported subgroup analysis. Information related to trial characteristics, subgroup analysis and claims of subgroup difference were collected. RESULTS: The initial search identified 1622 studies. A total of 98 studies reporting subgroup analyses were identified. Of those, 24 RCT reported 46 claims of subgroup difference. Among them, 44 were claims for the primary outcome, of which 25 were considered strong claims and 17 were considered suggestions of a possible effect. Authors included subgroup variables for the primary outcome measured at baseline for 38 claims (n = 86.36%), used a subgroup variable as a stratification factor at randomization for 15 (34.09%), clearly prespecified their hypothesis for 11 (25%), the subgroup effect was one of a small number of hypothesised effects tested (≤ 5) for 17 (38.64%), carried out a test of interaction that provide statistically significant for 18 (40.91%), documented replication of a subgroup effect with previously related studies for 11 (25%), identified the consistency of a subgroup effect across related outcome for 10 (22.72%) and provided a biological rationale for the effect for 8 (18.18%). Of the 44 claims for the primary outcome, 34 (77.27%) met four or fewer of the 10 credibility criteria. CONCLUSION: The subgroup claims reported in haematology RCTs lack credibility, even when the claims are strong. Information about subgroup difference should be interpreted cautiously.
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Neoplasias Hematológicas , Neoplasias Hematológicas/tratamento farmacológico , HumanosRESUMO
INTRODUCTION: Outpatient parenteral antimicrobial therapy (OPAT) has been recognised as a useful, cost-effective and safe alternative to inpatient treatment. Nevertheless, the most common antimicrobials used are antibiotics, and there is less information about the use of antifungal therapy (AT). The aim of this study is to analyse a cohort of patients treated with AT administered via OPAT and to compare them with patients from the rest of the cohort (RC) treated with antibiotics. METHODS: Prospective observational study with post hoc (or retrospective) analysis of a cohort of patients treated in the OPAT program. We selected the patients treated with antifungals between July 2012 and December 2018. We recorded demographic and clinical data to analyse the validity of the treatment and to compare the differences between the AT and the RC. RESULTS: Of the 1101 patients included in the OPAT program, 24 (2.18%) were treated with AT, 12 Liposomal Amphotericin B, 6 echinocandins and 6 fluconazole. This result is similar to other cohorts. There were differences between the AT vs RC in the number of patients with neoplasia (58.3% vs 28%; p=0.001), IC Charlson>2 (58.3% vs 38.8; p=0.053), duration of treatment (15 days vs 10.39 days; p=0.001) and patients with central catheters (54.2% vs 21.7%; p=0.0001). These differences are justified because there were more hematologic patients included in the AT group. Nevertheless, there were no differences in adverse reactions (25% vs 32.3%; p=0.45) or re-admissions (12.5% vs 10%; p=0.686) and OPAT with AT was successful in 21/24 patients (87.5%). CONCLUSIONS: AT can be successfully administered in OPAT programs in selected patients, that are clinically stable and monitored by an infectious disease physician.