[Translated article] Therapeutic management, adherence, and clinical outcomes of heart failure in Andalucía. ANDALIC Protocol.

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.

Therapeutic management, adherence, and clinical outcomes of heart failure in Andalucía. ANDALIC Protocol. / Manejo terapéutico, adherencia y resultados clínicos de la insuficiencia cardiaca en Andalucía. Protocolo ANDALIC.

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.

Reducing the drug burden of sedative and anticholinergic medications in older adults: a scoping review of explicit decision criteria.

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.

Choice of pharmaceutical form as a key factor during ketogenic diet: a case report.

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.

Subgroup analyses in venous thromboembolism trials reporting pharmacological interventions: A systematic review.

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.

Correction: Smartphone Apps for Patients With Hematologic Malignancies: Systematic Review and Evaluation of Content.

[This corrects the article DOI: 10.2196/35851.].

Smartphone Apps for Patients With Hematologic Malignancies: Systematic Review and Evaluation of Content.

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.

Subgroup Analysis in Pulmonary Hypertension-Specific Therapy Clinical Trials: A Systematic Review.

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.

Venetoclax combination therapy with hypomethylating agents in young adults with relapsed/refractory acute myeloid leukaemia.

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.

Association between Anticholinergic Burden and Constipation: A Systematic Review.

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.

Subgroup analysis in haematologic malignancies phase III clinical trials: A systematic review.

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.

Nuestra experiencia de ocho años en nutrición parenteral domiciliaria de pacientes adultos / Our eight-year experience in home parenteral nutrition for adult patients

INTRODUCCIÓN: la nutrición parenteral domiciliaria (NPD) es una técnica que permite incrementar la supervivencia de los pacientes con fallo intestinal. OBJETIVOS: estudiar la evolución de la NPD en los últimos 8 años en nuestro centro. MÉTODOS: estudio retrospectivo de pacientes adultos con NPD entre 2011 y 2019. Las variables se expresan como frecuencias y media ± DE (rango). Se realizaron pruebas paramétricas, no paramétricas y análisis de la supervivencia (p < 0,05). RESULTADOS: el uso de NPD mostró un sustancial incremento (hasta un 154 %). Un total de 76 pacientes recibieron NPD, el 76,32 % tenían patología oncológica y, en consecuencia, la principal indicación fue la obstrucción intestinal (56,58 %). La duración media fue de 11,12 ± 23,38 meses (0,17-139,17). El 44,74 % experimentaron una o varias complicaciones, siendo las principales la bacteriemia relacionada con el catéter (BRC) (27,63 %) y las metabólicas (40,79 %), fundamentalmente de tipo hepático. La tasa de BRC fue de 2,25/1000 días de NPD. La principal causa de muerte fue la enfermedad de base. La supervivencia global en caso de patología benigna a los 1, 3 y 5 años fue del 65,5 %, 53,6 % y 40,2 %, respectivamente. En caso de patología maligna, la supervivencia global a los 3 meses fue del 55,1 %, a los 6 meses del 28,7 %, y al año del 19,1 %. CONCLUSIONES: la enfermedad oncológica fue la principal patología que motivó la indicación en nuestro centro. Es la patología de base la que determina el pronóstico, lo que debe tenerse en cuenta en la selección de pacientes. La tasa de BRC obtenida es susceptible de mejora, por lo que es fundamental reforzar la educación sanitaria y la técnica correcta

BACKGROUND: home parenteral nutrition (HPN) is a technique that allows increasing the survival of patients with intestinal failure. AIM: to study the evolution of home parenteral nutrition over the last 8 years in our center. METHODS: a retrospective study of adult patients receiving HPN between 2011 and 2019. Study variables are expressed as frequency and mean ± SD (range). Parametric, non-parametric tests, and a survival analysis (p < 0.05) were applied. RESULTS: the use of HPN showed a substantial increase (up to 154 %). A total of 76 patients received HPN, 76.32 % had an oncological pathology, and consequently the main indication was intestinal obstruction (56.58 %). Average duration was 11.12 ± 23.38 months (0.17-139.17). In all, 44.74 % experienced one or several complications, primarily catheter-related bacteremia (CRB) (27.63 %), and metabolic disorders (40.79 %), mainly of hepatic type. CRB rate was 2.25/1,000 days of HPN. The main cause of death was the underlying disease. Overall survival in case of benign conditions at 1, 3, and 5 years was 65.5 %, 53.6 %, and 40.2 %, respectively. In case of malignancy overall survival at 3 months was 55.1 %, at 6 months 28.7 %, and at 1 years 19.1 %. CONCLUSIONS: oncological disease was the primary condition that led to an indication in our center. It is the underlying pathology what determines prognosis, which must be taken into account at the time of selecting patients. The BRC rate obtained is susceptible to improvement, so it is essential that health education and a correct technique be encouraged

[Our eight-year experience in home parenteral nutrition for adult patients]. / Nuestra experiencia de ocho años en nutrición parenteral domiciliaria de pacientes adultos.

INTRODUCTION: Background: home parenteral nutrition (HPN) is a technique that allows increasing the survival of patients with intestinal failure. Aim: to study the evolution of home parenteral nutrition over the last 8 years in our center. Methods: a retrospective study of adult patients receiving HPN between 2011 and 2019. Study variables are expressed as frequency and mean ± SD (range). Parametric, non-parametric tests, and a survival analysis (p < 0.05) were applied. Results: the use of HPN showed a substantial increase (up to 154 %). A total of 76 patients received HPN, 76.32 % had an oncological pathology, and consequently the main indication was intestinal obstruction (56.58 %). Average duration was 11.12 ± 23.38 months (0.17-139.17). In all, 44.74 % experienced one or several complications, primarily catheter-related bacteremia (CRB) (27.63 %), and metabolic disorders (40.79 %), mainly of hepatic type. CRB rate was 2.25/1,000 days of HPN. The main cause of death was the underlying disease. Overall survival in case of benign conditions at 1, 3, and 5 years was 65.5 %, 53.6 %, and 40.2 %, respectively. In case of malignancy overall survival at 3 months was 55.1 %, at 6 months 28.7 %, and at 1 years 19.1 %. Conclusions: oncological disease was the primary condition that led to an indication in our center. It is the underlying pathology what determines prognosis, which must be taken into account at the time of selecting patients. The BRC rate obtained is susceptible to improvement, so it is essential that health education and a correct technique be encouraged.

INTRODUCCIÓN: Introducción: la nutrición parenteral domiciliaria (NPD) es una técnica que permite incrementar la supervivencia de los pacientes con fallo intestinal. Objetivos: estudiar la evolución de la NPD en los últimos 8 años en nuestro centro. Métodos: estudio retrospectivo de pacientes adultos con NPD entre 2011 y 2019. Las variables se expresan como frecuencias y media ± DE (rango). Se realizaron pruebas paramétricas, no paramétricas y análisis de la supervivencia (p < 0,05). Resultados: el uso de NPD mostró un sustancial incremento (hasta un 154 %). Un total de 76 pacientes recibieron NPD, el 76,32 % tenían patología oncológica y, en consecuencia, la principal indicación fue la obstrucción intestinal (56,58 %). La duración media fue de 11,12 ± 23,38 meses (0,17-139,17). El 44,74 % experimentaron una o varias complicaciones, siendo las principales la bacteriemia relacionada con el catéter (BRC) (27,63 %) y las metabólicas (40,79 %), fundamentalmente de tipo hepático. La tasa de BRC fue de 2,25/1000 días de NPD. La principal causa de muerte fue la enfermedad de base. La supervivencia global en caso de patología benigna a los 1, 3 y 5 años fue del 65,5 %, 53,6 % y 40,2 %, respectivamente. En caso de patología maligna, la supervivencia global a los 3 meses fue del 55,1 %, a los 6 meses del 28,7 %, y al año del 19,1 %. Conclusiones: la enfermedad oncológica fue la principal patología que motivó la indicación en nuestro centro. Es la patología de base la que determina el pronóstico, lo que debe tenerse en cuenta en la selección de pacientes. La tasa de BRC obtenida es susceptible de mejora, por lo que es fundamental reforzar la educación sanitaria y la técnica correcta.

Evolución de los pacientes con nutrición parenteral domiciliaria: una revisión sistemática de los estudios disponibles / Evolution of patients with home parenteral nutrition: a systematic review of available studies

INTRODUCCIÓN: la nutrición parenteral domiciliaria (NPD) constituye el tratamiento de elección para pacientes con fallo intestinal que no requieren ingreso hospitalario. En esta revisión sistemática, nuestro objetivo fue realizar un análisis epidemiológico y de práctica clínica en NPD. MÉTODOS: la revisión se realizó siguiendo la guía PRISMA. Para ello, se hizo una búsqueda bibliográfica en PubMed® y EMBASE® de los estudios publicados entre 2009 y 2019 en inglés o español que realizaran el seguimiento de pacientes con NPD durante al menos 5 años. Esta búsqueda se completó manualmente. Se excluyeron los artículos centrados únicamente en pacientes oncológicos, una patología específica o embarazadas o bien en complicaciones. RESULTADOS: se identificaron 267 artículos, de los que cumplieron los criterios 9 (3 de población pediátrica y 6 de adultos). En adultos, la principal diferencia entre los estudios fue la patología de base. La indicación mayoritaria fue el síndrome de intestino corto y la causa de exitus, la enfermedad primaria. La mayor parte de la población pediátrica recibió este apoyo en los primeros meses de vida. Además, destaca el mayor porcentaje de conversión a vía oral y el menor número de fallecimientos frente a población adulta. CONCLUSIONES: la utilización de la NPD en patología oncológica está sometida a una amplia variabilidad geográfica. Sería recomendable establecer directrices de uso en enfermos oncológicos y la realización de estudios de calidad que aporten información rigurosa y homogénea

INTRODUCTION: home parenteral nutrition (HPN) is a fundamental treatment for patients with intestinal failure who do not require hospitalization. We aimed to conduct an epidemiological and clinical practice analysis of HPN through a systematic review. METHODS: the systematic review was conducted according to the PRISMA guidelines. A search was performed using the Healthcare Databases Advanced Search of PubMed® and EMBASE®, to identify articles which followed patients treated with HPN for at least 5 years, published between 2009 and 2019 in English or Spanish language. In addition, we manually retrieved other publications of interest. We excluded articles about subgroups of patients with a specific pathology, cancer or pregnant patients. We excluded studies collecting exclusively HPN complications. RESULTS: a total of 267 references were identified, of which 9 met criteria (3 of pediatric population and 6 of adults). In adults, the main difference found between publications was the underlying pathologies. The most common indication was short bowel syndrome and the main cause of exitus was the underlying pathology. Most of the pediatric patients received this support in the first months of life. In addition, children showed a higher conversion rate to oral intake and a lower number of deaths when compared to adults. CONCLUSIONS: the use of HPN in cancer pathology is subject to wide geographic variability. It would be advisable to establish indication guidelines in patients with cancer and conduct quality studies, which provide rigorous and homogeneous information