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.

Improving the quality of publications in and advancing the paradigms of clinical and social Pharmacy Practice Research: The Granada statements. / [Artículo traducido] Mejora de la calidad de las publicaciones y avance en los paradigmas de la investigación en Farmacia Práctica clínica y social: la Declaración de Granada.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work. © 2023 The Author(s) Published by Elsevier Inc, Springer Nature, Brazilian Society of Hospital Pharmacy and Health Services, Elsevier Inc, Royal Pharmaceutical Society, Biomedcentral, Sociedad Española de Farmacia Hospitalaria (S.E.F.H), Pharmaceutical Care España Foundation, European Association of Hospital Pharmacists, Faculty of Pharmacy.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: the Granada statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as 'the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care'. Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other healthcare areas (i.e. medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into 6 topics, namely the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: the Granada Statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: the Granada Statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as 'the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on healthcare systems, medicine use, and patient care'. Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other healthcare areas (ie, medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: The Granada Statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: The Granada Statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: The Granada statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Improving the quality of publications in and advancing the paradigms of clinical and social pharmacy practice research: The Granada statements.

Pharmacy and pharmaceutical sciences embrace a series of different disciplines. Pharmacy practice has been defined as "the scientific discipline that studies the different aspects of the practice of pharmacy and its impact on health care systems, medicine use, and patient care". Thus, pharmacy practice studies embrace both clinical pharmacy and social pharmacy elements. Like any other scientific discipline, clinical and social pharmacy practice disseminates research findings using scientific journals. Clinical pharmacy and social pharmacy journal editors have a role in promoting the discipline by enhancing the quality of the articles published. As has occurred in other health care areas (i.e., medicine and nursing), a group of clinical and social pharmacy practice journal editors gathered in Granada, Spain to discuss how journals could contribute to strengthening pharmacy practice as a discipline. The result of that meeting was compiled in these Granada Statements, which comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors' selection of the most appropriate pharmacy practice journal to submit their work.

Computerized clinical decision support systems for prescribing in primary care: main characteristics and implementation impact-protocol of an evidence and gap map.

BACKGROUND: Computerized clinical decision support systems are used by clinicians at the point of care to improve quality of healthcare processes (prescribing error prevention, adherence to clinical guidelines, etc.) and clinical outcomes (preventive, therapeutic, and diagnostics). Attempts to summarize results of computerized clinical decision support systems to support prescription in primary care have been challenging, and most systematic reviews and meta-analyses failed due to an extremely high degree of heterogeneity present among the included primary studies. The aim of our study will be to synthesize the evidence, considering all methodological factors that could explain these differences, and build an evidence and gap map to identify important remaining research questions. METHODS: A literature search will be conducted from January 2010 onwards in MEDLINE, Embase, the Cochrane Library, and Web of Science databases. Two reviewers will independently screen all citations, full text, and abstract data. The study methodological quality and risk of bias will be appraised using appropriate tools if applicable. A flow diagram with the screened studies will be presented, and all included studies will be displayed using interactive evidence and gap maps. Results will be reported in accordance with recommendations from the Campbell Collaboration on the development of evidence and gap maps. DISCUSSION: Evidence behind computerized clinical decision support systems to support prescription use in primary care has so far been difficult to be synthesized. Evidence and gap maps represent an innovative approach that has emerged and is increasingly being used to address a broader research question, where multiple types of intervention and outcomes reported may be evaluated. Broad inclusion criteria have been chosen with regard to study designs, in order to collect all available information. Regarding the limitations, we will only include English and Spanish language studies from the last 10 years, we will not perform a grey literature search, and we will not carry out a meta-analysis due to the predictable heterogeneity of available studies. SYSTEMATIC REVIEW REGISTRATION: This study is registered in Open Science Framework https://bit.ly/2RqKrWp.

Adaptación transcultural y validación al español del cuestionario de desprescripción en el paciente de edad avanzada / Cross-cultural adaptation and validation into Spanish of the deprescription questionnaire in the elderly patient

Antecedentes y objetivo: En 2017 se desarrolló un cuestionario en italiano que tenía como objetivo determinar las percepciones de los clínicos ante la desprescripción en población de edad avanzada.El objetivo fue traducir y adaptar transculturalmente al español este cuestionario de desprescripción.MétodosTraducción directa y retrotraducción, seguidas de una síntesis y adaptación por un tercer traductor. Desarrollo de un panel de expertos para evaluar la adecuación de la traducción, comprensibilidad de la pregunta traducida y utilidad de cada cuestión. Se realizó un análisis de comprensibilidad a médicos familiarizados con la desprescripción.ResultadosSe obtuvo la versión española del cuestionario, donde el grado de dificultad medio en la traducción directa e inversa fue baja/moderada. En la primera fase del panel de expertos 4 preguntas tuvieron apartados considerados «indeterminados» y una fue «dudosa». Tras la segunda fase, todas las cuestiones fueron «adecuadas» a excepción de una.ConclusionesSe trata de la primera adaptación transcultural al español de este cuestionario, lo que permitirá disponer de una herramienta para valorar la percepción de los clínicos y establecer mejoras en la realización de esta práctica. (AU)

Background and objective: In 2017, a questionnaire was developed in Italian with the aim of determining clinicians’ perceptions of deprescription in the elderly population.The objective was to translate and cross-culturally adapt this deprescription questionnaire to Spanish.MethodsForward and blind-back translations, followed by a synthesis and adaptation by a third translator. Development of an expert panel to evaluate the adequacy of the translation, the understandability of the translated question and the usefulness of each question. A comprehensibility analysis was carried out on physicians familiar with deprescription.ResultsThe Spanish version of the questionnaire was obtained, where the average degree of difficulty in the direct and the back-translation was low/moderate. In the first phase of the panel of experts, 4 questions had sections considered “indeterminate” and one question was “doubtful”. After the second phase, all the questions were considered “adequate” except for one.ConclusionsThis is the first cross-cultural adaptation to Spanish of this questionnaire, which will provide a tool to assess clinicians’ perception of this practice and establish improvements to carry out this activity. (AU)

[Cross-cultural adaptation and validation into Spanish of the deprescription questionnaire in the elderly patient]. / Adaptación transcultural y validación al español del cuestionario de desprescripción en el paciente de edad avanzada.

BACKGROUND AND OBJECTIVE: In 2017, a questionnaire was developed in Italian with the aim of determining clinicians' perceptions of deprescription in the elderly population. The objective was to translate and cross-culturally adapt this deprescription questionnaire to Spanish. METHODS: Forward and blind-back translations, followed by a synthesis and adaptation by a third translator. Development of an expert panel to evaluate the adequacy of the translation, the understandability of the translated question and the usefulness of each question. A comprehensibility analysis was carried out on physicians familiar with deprescription. RESULTS: The Spanish version of the questionnaire was obtained, where the average degree of difficulty in the direct and the back-translation was low/moderate. In the first phase of the panel of experts, 4 questions had sections considered "indeterminate" and one question was "doubtful". After the second phase, all the questions were considered "adequate" except for one. CONCLUSIONS: This is the first cross-cultural adaptation to Spanish of this questionnaire, which will provide a tool to assess clinicians' perception of this practice and establish improvements to carry out this activity.

The Predictive Value of Anticholinergic Burden Measures in Relation to Cognitive Impairment in Older Chronic Complex Patients.

Anticholinergic burden (AB) is related to cognitive impairment (CI) and older complex chronic patients (OCCP) are more susceptible. Our objective was to evaluate the predictive value of ten anticholinergic scales to predict a potential CI due to anticholinergic pharmacotherapy in OCCP. An eight-month longitudinal multicentre study was carried out in a cohort of OCCP, in treatment with at least one anticholinergic drug and whose cognition status had been evaluated by Pfeiffer test twice for a period of 6-15 months. CI was considered when the Pfeiffer test increased 2 or more points. AB was detected using ten scales included on the Anticholinergic Burden Calculator. An ROC curve analysis was performed to assess the discriminative capacity of the scales to predict a potential CI and the cut-off point of AB that obtains better validity indicators. 415 patients were included (60.2% female, median age of 85 years (IQR = 11)). 190 patients (45.8%) manifested CI. Only the DBI (Drug Burden Index) showed statistically significant differences in the median AB between patients without CI and with CI (0.5 (1.00) vs. 0.67 (0.65), p = 0.006). At the ROC curve analysis, statistically significant values were obtained only with the DBI (AUC: 0.578 (0.523-0.633), p = 0.006). The cut-off point with the greatest validity selected for the DBI was an AB of 0.41 (moderate risk) (sensitivity = 81%, specificity = 36%, PPV = 51%). The DBI is the scale with the greatest discriminatory power to detect OCCP at risk of CI and the best cut-off point is a load value of 0.41.

Chronic-pharma: New Platform for Chronic Patients Pharmacotherapy Optimization.

We describe the technological development of a web platform named CHRONIC-PHARMA that integrates three prescription support tools for patients with chronic diseases: Anticholinergic Burden Calculator (ABC), LESS-CHRON criteria and TRIGGER-CHRON. They focus on the optimization and evaluation of pharmacotherapy in patients with chronic diseases, resulting in a useful, single platform that can facilitate the review of pharmacotherapy and improve the safety of chronically ill patients. This is achieved by estimating and reducing the anticholinergic risk (ABC), detecting opportunities for deprescribing drugs and monitoring its success (LESS-CHRON criteria), as well as calculating the risk of adverse drug events (TRIGGER-CHRON). The platform is freely accessible online ( https://chronic-pharma.com/ ) as well as through a mobile application, and therefore easily accessible among the healthcare community.

Concordance Among 10 Different Anticholinergic Burden Scales in At-Risk Older Populations.

OBJECTIVE: The aim of the study was to evaluate the concordance among 10 anticholinergic scales for the measurement of anticholinergic drug exposure in at-risk elderly complex chronic patients in primary care. METHODS: An 8-month cross-sectional, multicenter study was carried out in a cohort of complex chronic patients older than 65 years in treatment with at least 1 drug with anticholinergic activity. Demographic, pharmacological, and clinical data were collected. Anticholinergic burden and risk were detected using the 10 scales included on the anticholinergic burden calculator (http://www.anticholinergicscales.es/). We used κ statistics to evaluated the concordance 2 to 2 (according to risk: high, medium, low or without risk) among the included scales. RESULTS: Four hundred seventy-three patients were recruited (60.3% female, median age of 84 years [interquartile range = 10]). Eighty was the total number of anticholinergic drugs with any scale (1197 prescriptions), with a median of 2 drugs with anticholinergic activity per patient (interquartile range = 2). The κ statistics comparing all the 10 scales ranged from -0.175 (Drug Burden Index versus Chew Scale) to 0.708 (Anticholinergic Activity Scale [AAS] versus Chew Scale). The best concordance was obtained between AAS and Chew Scale (κ = 0.708), followed by Clinician-Rated Anticholinergic Scale and Duran Scale (κ = 0.632) and AAS and Anticholinergic Cognitive Burden Scale (κ = 0.618), being considered substantial strengths of concordance. CONCLUSIONS: The agreement among the 10 scales in elderly patients with complex chronic conditions was highly variable. Great care should be taken when assessing anticholinergic drug exposure using existing scales because of the wide variability among them. The only scales that showed agreement were the AAS-Chew, Clinician-Rated Anticholinergic Scale-Duran, and AAS-Anticholinergic Cognitive Burden Scale pairs. In the rest of the cases, the scales are not interchangeable.

Anticholinergic Exposure in Elderly Complex Chronic Patients: A Cross-Sectional Study.

BACKGROUND: Elderly patients with multiple chronic conditions are closely linked to polymedication, a condition that is also highly associated with the presence of adverse effects, such as those observed by anticholinergic activity. Anticholinergic burden is defined in a very variable way and is described inconsistently using different scores and providing different interpretations of the risk of suffering from anticholinergic adverse effects. OBJECTIVE: The objective is to analyse the anticholinergic risk exposure in elderly complex chronic patients. METHODS: A observational multicentre study was performed for a cohort of complex chronic patients over 65 years who received treatment with at least one drug with anticholinergic activity. Anticholinergic exposure was assessed using ten scales included in the Anticholinergic Burden Calculator. RESULTS: 473 patients were recruited, being 67.7% with excessive polypharmacy. 80 was the total number of anticholinergic drugs with any scale, with a median of 2 drugs with anticholinergic activity per patient (IQR=2). Three scales evaluated more than 70% of the patients (Chew: 79.1%; Drug Burden Index (DBI): 77.8%; Anticholinergic Cognitive Burden (ACB): 75.9%). The percentage of different drugs with anticholinergic properties evaluated ranged from 13.8% (Anticholinergic Burden Classification (ABC)) to 57.5% (DBI) and anticholinergic drugs prescriptions oscillated from 14% (Anticholinergic Risk Scale (ARS)) to 53.3% (DBI). 71.1% of patients were at risk (moderate and high risk) according to DBI vs. 9.7% by ARS at the opposite side. Important differences of anticholinergic risk in patients with excessive polypharmacy were in ACB, ABC and DBI scales. CONCLUSION: This study has highlighted clear differences between the scales used. DBI seems to be the scale that identifies a higher number of elderly chronic complex patients at risk of developing anticholinergic adverse effects.

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.

Systematic review of gender bias in vortioxetine clinical trials.

This paper evaluates gender bias in the published clinical trials of Vortioxetine. We conducted a systematic review of controlled clinical trials of Vortioxetine for the treatment of depression. The literature search was performed using MEDLINE and following the corresponding international recommendations. We identified 42 articles, of which 23 were included. The proportion of women ranged from 47%-75% and the percentage of women included in the 10,404 total patients sample was 65%. The separate analysis of the main variable between the subpopulations of men and women was only carried out in 3/23 publications included. In contrast, 6/23 trials analyzed secondary variables separated by sex. No trials discussed the results separately by sex. The proportion of women included was slightly higher than that in clinical trials of other antidepressants. However, the analysis of the main result or secondary variables by sex, as well as discussing the results separately by sex, are scarce. This gives rise to gender bias in these works.

Development of a Trigger Tool to Identify Adverse Drug Events in Elderly Patients With Multimorbidity.

PURPOSE: Elderly patients with multimorbidity are especially vulnerable to adverse drug events (ADEs) and had high prevalence rates. Identifying ADEs is essential for enabling timely interventions that can mitigate the adverse events detected and for developing targeted strategies to prevent their occurrence as well as to monitor implementation. The aim of this study was to develop a set with appropriate triggers for detecting potential ADEs in elderly patients with multimorbidity. METHODS: A modified Delphi methodology was used to reach consensus. Existing triggers for detecting ADEs in adult patients were identified from a literature search in several databases (EMBASE, MEDLINE, Web of Science, Centre for Reviews and Dissemination, and Cochrane Library) and from Institute for Healthcare Improvement published lists. Twelve experts in patient/medication safety or in chronic diseases scored candidate triggers for appropriateness according to 3 criteria (evidence, usefulness for elderly patients, and feasibility of implementation in clinical practice). RESULTS: Seventy-two triggers were initially selected to be evaluated. The final set includes a total of 51 triggers for which the panelists who completed the 2 rounds of evaluation reached agreement. These triggers were organized into 5 modules: 11 as care module triggers, 10 as antidotes/treatment, 11 medication concentrations, 18 abnormal laboratory values, and 1 as emergency department trigger. CONCLUSIONS: A set of triggers for detecting ADEs in elderly patients with multimorbidity have been developed, following the consensus of a panel of experts. Subsequent validation in clinical practice is needed to confirm the accuracy and efficiency of these triggers for this population.