Dolutegravir-Based Dual Therapies in HIV Pretreated Patients: A Real-Life Study in Madrid.

BACKGROUND: Few studies describe the use of dolutegravir (DTG)-based dual therapies under routine clinical practice. OBJECTIVES: To report real-life data on the use of DTG-based dual therapies in treatment-experienced patients. METHODS: This was an observational, retrospective study. It included all treatment-experienced HIV patients starting a DTG-based dual therapy from 2014 to 2018. The primary end point was to identify the incidence and reasons for the switch. The secondary end points were to assess the effectiveness, safety, adherence, and costs after 48 weeks of treatment (W48). RESULTS: The incidence of the switch to a DTG-based dual therapy increased from 1.6 patients per 1000 patient-years in 2014 to 38.6 in 2018. A total of 241 patients initiated this therapy: 113 (46.9%) patients started DTG plus rilpivirine (RPV), 72 (29.9%), DTG plus lamivudine (3TC), and 68 (28.2%), DTG plus boosted-darunavir (b-DRV). A total of 170 patients completed W48 of follow-up. By intention-to-treat analysis, 89.3% of virologically suppressed (VS) patients (94.3% with DTG plus b-DRV, 91.3% with DTG plus 3TC, and 87.2% with DTG plus RPV) and 56.7% of non-VS patients (71.4% with DTG plus RPV and 52.2% with DTG plus b-DRV) achieved a viral load <50 copies/mL at W48. The protocol-defined virological failure was 6.5%. Overall, 8.8% of patients had early discontinuation. The annual cost increased by €800 per patient ($916). CONCLUSIONS AND RELEVANCE: The use of DTG-based dual therapies has increased in real life, showing a favorable effectiveness and safety profile. Treatment costs increased, except for the switch to DTG plus 3TC.

Clinical evaluation of pulmonary hypertension using patient-reported outcomes: a cross-sectional study.

BACKGROUND: Patients with pulmonary hypertension (PH) have progressive and disabling symptoms, as well as a burden of treatments and a difficult clinical evaluation that make health-related quality of life a particularly relevant endpoint in this disease. The objective of the study was to evaluate patient-reported outcomes of patients receiving specific treatment for PH in a tertiary hospital using a specific questionnaire (Cambridge Pulmonary Hypertension Outcome Review-CAMPHOR) in the pharmacy consultation. METHODS: A cross-sectional, observational, descriptive study was conducted. It included all patients receiving specific treatment for PH in a tertiary hospital in Madrid, Spain. The inclusion period comprised between August to December 2019. CAMPHOR questionnaires containing three domains: symptoms, activities and quality of life were completed by the patients at the pharmacy consultation. Demographic and clinical variables, including WHO Functional Class (WHO FC), PH-specific tests and hemodynamic parameters, were recorded. Non-parametric analyses to assess relations between variables and CAMPHOR domains were performed. RESULTS: Thirty-six patients consented to participate in the study and completed the questionnaire. Median scores for symptoms, activities, and quality of life domains were 5.5 (2.5-10), 8.0 (4.5-10.5) and 3.5 (1-7.5), respectively. Statistically significant differences were found in the three domains when comparing by WHO FC, in the activities domain for 6-m walking test and in the quality of life domain for patients who had emergency visits or hospitalizations in the last year. CONCLUSIONS: The CAMPHOR questionnaire could be useful as a complementary test to achieve an integrated evaluation of PH patients, who could complete it easily during their routine pharmacy visits.

Effects of a Pharmacist-Designed Clinical Decision Support System on Antimicrobial Stewardship.

BACKGROUND: Clinical decision support systems (CDSSs) are computer applications, which can be applied to give guidance to practitioners in antimicrobial stewardship (AS) activities; however, further information is needed for their optimal use. OBJECTIVES: Our objective was to analyze the implementation of a CDSS program in a second-level hospital, describing alerts, recommendations, and the effects on consumption and clinical outcomes. METHODS: In October 2020, a pharmacist-driven CDSS designed for AS was implemented in a second-level hospital. The program provides a list of alerts related to antimicrobial treatment and microbiology, which were automatized for revision by the AS professionals. To analyze the implementation of the CDSS, a pre-post-intervention, retrospective study was designed. AS-triggered alerts and recommendations (total number and rate of acceptance) were compiled. The effect of the CDSS was measured using antimicrobial consumption, duration of antimicrobial treatments, in-hospital mortality, and length of stay (LOS) for patients admitted for infectious causes. RESULTS: The AS team revised a total of 7,543 alerts and 772 patients had at least one recommendation, with an acceptance rate of 79.3%. Antimicrobial consumption decreased from 691.1 to 656.8 defined daily doses (DDD)/1,000 beds-month (p = 0.04) and the duration of antimicrobial treatment from 3.6 to 3.3 days (p < 0.01). In-hospital mortality decreased from 6.6 to 6.2% (p = 0.46) and mean LOS from 7.2 to 6.2 days (p < 0.01). CONCLUSION: The implementation of a CDSS resulted in a significant reduction of antimicrobial DDD, duration of antimicrobial treatments, and hospital LOS. There was no significant difference in mortality.

National record and analysis of pharmaceutical interventions in critical care units: PHARMACRITIC study. / Registro nacional y análisis de intervenciones farmacéuticas en unidades de cuidados críticos: estudio FARMACRITIC.

OBJECTIVE: To design a homogeneous methodology for the registration and analysis of pharmaceutical interventions performed in Spanish critical adults' care units. METHOD: Observational, prospective and multicenter study. In the first stage, a national registry of pharmaceutical interventions will be agreed upon and subsequently all the pharmaceutical interventions performed on adult patients admitted to Spanish CCUs during eight weeks will be recorded. Variables related to the type of CCU, the drug involved in the intervention, type of intervention (indication, effectiveness, safety), recommendation made by the pharmacist and the degree of acceptance will be evaluated. Risk and incidence will be calculated for each of the medication errors detected. The χ2-squared test or Fisher exact test will be used for categorical variables and Mann-Whitney U or Kruskal-Wallis test for continuous variables. All tests will be performed with a significance level α = 0.05 and confidence intervals with confidence 1- α. DISCUSSION: The results obtained from this project will make it possible to obtain a homogeneous classification of the pharmaceutical interventions performed in CCU, a national record and an evaluation of the weak points with the aim of developing strategies for improvement in the pharmaceutical care of the critically ill patient.

Mobile Apps for Hematological Conditions: Review and Content Analysis Using the Mobile App Rating Scale.

BACKGROUND: Hematological conditions are prevalent disorders that are associated with significant comorbidities and have a major impact on patient care. Concerning new tools for the care of these patients, the number of health apps aimed at hematological patients is growing. Currently, there are no quality analyses or classifications of apps for patients diagnosed with hematological conditions. OBJECTIVE: The aim of this study is to analyze the characteristics and quality of apps designed for patients diagnosed with hematological conditions by using the Mobile App Rating Scale (MARS). METHODS: We performed an observational, cross-sectional descriptive study of all smartphone apps for patients diagnosed with hematological conditions. A search was conducted in March 2021 using the following terms: anemia, blood cancer, blood disorder, hematological cancer, hematological malignancy, hematological tumor, hematology, hemophilia, hemorrhage, lymphoma, leukemia, multiple myeloma, thalassemia, thrombocytopenia, and thrombosis. The apps identified were downloaded and evaluated by 2 independent researchers. General characteristics were registered, and quality was analyzed using MARS scores. Interrater reliability was measured by using the Cohen κ coefficient. RESULTS: We identified 2100 apps in the initial search, and 4.19% (88/2100) of apps met the inclusion criteria and were analyzed. Of the 88 apps, 61% (54/88) were available on Android, 30% (26/88) were available on iOS, and 9% (8/88) were available on both platforms. Moreover, 7% (6/88) required payment, and 49% (43/88) were updated in the last year. Only 26% (23/88) of the apps were developed with the participation of health professionals. Most apps were informative (60/88, 68%), followed by preventive (23/88, 26%) and diagnostic (5/88, 6%). Most of the apps were intended for patients with anemia (23/88, 26%). The mean MARS score for the overall quality of the 88 apps was 3.03 (SD 1.14), ranging from 1.19 (lowest-rated app) to 4.86 (highest-rated app). Only 47% (41/88) of the apps obtained a MARS score of over 3 points (acceptable quality). Functionality was the best-rated section, followed by aesthetics, engagement, information, and app subjective quality. The five apps with the highest MARS score were the following: Multiple Myeloma Manager, Hodgkin Lymphoma Manager, Focus On Lymphoma, ALL Manager, and CLL Manager. The analysis by operating system, developer, and cost revealed statistically significant differences in MARS scores (P<.001, P<.001, and P=.049, respectively). The interrater agreement between the 2 reviewers was substantial (k=0.78). CONCLUSIONS: There is great heterogeneity in the quality of apps for patients with hematological conditions. More than half of the apps do not meet acceptable criteria for quality and content. Most of them only provide information about the pathology, lacking interactivity and personalization options. The participation of health professionals in the development of these apps is low, although it is narrowly related to better quality.

Does timing matter on tocilizumab administration? Clinical, analytical and radiological outcomes in COVID-19.

INTRODUCTION: While there are no pharmacological treatments with proven efficacy for coronavirus disease 2019 (COVID-19), tocilizumab has emerged as a candidate therapy. Some aspects of this therapy are still unknown, including the optimal timing of administration. OBJECTIVE: This observational study aimed to compare the 90-day mortality in two cohorts of patients when the drug was administered within the first 10 days from onset of symptoms or after day 11. METHODS: Patients hospitalised with severe COVID-19 pneumonia who had received tocilizumab were divided into two groups according to when the medication was administered. The primary outcome was 90-day mortality. Secondary outcomes were 30-day mortality, clinical improvement on a 6-item scale by day 6, biomarker improvement by day 6, radiological image improvement by day 10 and SaO2 quotient by day 6. The results in the two groups were compared. Additionally, adverse events relating to tocilizumab were recorded. RESULTS: A total of 112 patients were analysed. Both groups were epidemiologically comparable. The results obtained in the primary efficacy variable of the study (90-day mortality) showed a statistically significant difference in the subgroups according to the time of administration of tocilizumab (18.6% vs 5.0%, p=0.048). There was clinical improvement in 24.1% of patients at 6 days, with similar behaviour in both subgroups. No statistically significant differences were found in the percentage of patients who achieved radiological improvement at 10 days or in the other inflammatory parameters, with the exception of significant reductions in lactate dehydrogenase and C-reactive protein. Administration of tocilizumab was not associated with relevant adverse events. CONCLUSION: To our knowledge, this is the first report of data regarding the timing of administration of tocilizumab in patients with COVID-19 pneumonia. A strategy involving tocilizumab administration after 10 days from onset of symptoms may decrease mortality. Further randomised controlled trials are needed to confirm this emerging hypothesis.

COVID-19 in hospitalised patients in Spain: a cohort study in Madrid.

Few large series describe the clinical characteristics, outcomes and costs of COVID-19 in Western countries. This cohort reports the first 1255 adult cases receiving anti-COVID-19 treatment at a Spanish hospital (1-24 March 2020). Treatment costs were calculated. A logistic regression model was used to explore risk factors on admission associated with ARDS. A bivariate Cox proportional hazard ratio (HR) model was employed to determine the HR between individual factors and death. We included 1255 patients (median age 65 years; 57.8% male), of which 92.3% required hospitalisation. The prevalence of hypertension, cardiovascular disease and diabetes mellitus (DM) was 45.1%, 31.4% and 19.9%, respectively. Lymphocytopenia (54.8%), elevated alanine aminotransferase (33.0%) and elevated lactate dehydrogenase (58.5%) were frequent. Overall, 36.7% of patients developed ARDS, 10.0% were admitted to an ICU and 21.3% died. The most frequent antiviral combinations were lopinavir/ritonavir plus hydroxychloroquine (44.2%), followed by triple therapy with interferon beta-1b (32.7%). Corticosteroids and tocilizumab were used in 25.3% and 12.9% of patients, respectively. Total cost of anti-COVID-19 agents was €511 825 (€408/patient). By multivariate analysis, risk factors associated with ARDS included older age, obesity, DM, severe hypoxaemia, lymphocytopenia, increased creatine kinase and increased C-reactive protein. In multivariate Cox model, older age (HR 1.07, 95% CI 1.06-1.09), cardiovascular disease (HR 1.34, 95% CI 1.01-1.79), DM (HR 1.45, 95% CI 1.09-1.92), severe hypoxaemia (HR 2.01, 95% CI 1.49-2.72), lymphocytopenia (HR 1.62, 95% CI 1.20-2.20) and increased C-reactive protein (HR 1.04, 95% CI 1.02-1.06) were risk factors for mortality.

Assessing Apps for Patients with Genitourinary Tumors Using the Mobile Application Rating Scale (MARS): Systematic Search in App Stores and Content Analysis.

BACKGROUND: The large number of available cancer apps and their impact on the population necessitates a transparent, objective, and comprehensive evaluation by app experts, health care professionals, and users. To date, there have been no analyses or classifications of apps for patients with genitourinary cancers, which are among the most prevalent types of cancer. OBJECTIVE: The objective of our study was to analyze the quality of apps for patients diagnosed with genitourinary cancers using the Mobile Application Rating Scale (MARS) and identify high-quality apps. METHODS: We performed an observational cross-sectional descriptive study of all smartphone apps for patients diagnosed with genitourinary cancers available on iOS and Android platforms. In July 2019, we searched for all available apps for patients with genitourinary cancers (bladder, prostate, cervical, uterine, endometrial, kidney, testicular, and vulvar) or their caregivers. Apps were downloaded and evaluated, and the general characteristics were entered into a database. The evaluation was performed by 2 independent researchers using the MARS questionnaire, which rates 23 evaluation criteria clustered in 5 domains (Engagement, Functionality, Esthetics, Information, and Subjective Quality) on a scale from 1 to 5. RESULTS: In total, 46 apps were analyzed. Of these, 31 (67%) were available on Android, 6 (13%) on iOS, and 9 (20%) on both platforms. The apps were free in 89% of cases (41/46), and 61% (28/46) had been updated in the previous year. The apps were intended for prostate cancer in 30% of cases (14/46) and cervical cancer in 17% (8/46). The apps were mainly informative (63%, 29/46), preventive (24%, 11/46), and diagnostic (13%, 6/46). Only 7/46 apps (15%) were developed by health care organizations. The mean MARS score for the overall quality of the 46 apps was 2.98 (SD 0.77), with a maximum of 4.63 and a minimum of 1.95. Functionality scores were quite similar for most of the apps, with the greatest differences in Engagement and Esthetics, which showed acceptable scores in one-third of the apps. The 5 apps with the highest MARS score were the following: "Bladder cancer manager," "Kidney cancer manager," "My prostate cancer manager," "Target Ovarian Cancer Symptoms Diary," and "My Cancer Coach." We observed statistically significant differences in the MARS score between the operating systems and the developer types (P<.001 and P=.01, respectively), but not for cost (P=.62). CONCLUSIONS: MARS is a helpful methodology to decide which apps can be prescribed to patients and to identify which features should be addressed to improve these tools. Most of the apps designed for patients with genitourinary cancers only try to provide data about the disease, without coherent interactivity. The participation of health professionals in the development of these apps is low; nevertheless, we observed that both the participation of health professionals and regular updates were correlated with quality.

Multidisciplinary strategy to reduce errors with the use of medical gases.

OBJECTIVE: Lack of awareness of the risks associated with the use of medical  gases amongst health professionals and health organizations is concerning. The  objective of this study is to redefine the use process of medical gases in a  hospital setting. METHOD: A sentinel event took place in a clinical unit, the incorrect administration of a medical gas to an inpatient. A multidisciplinary  causeroot analysis of the sentinel event was carried out. Different improvement points were identified for each error detected and so we defined a  good strategy to ensure the safe use of these drugs. RESULTS: 9 errors were identified and the following improvement actions were  defined: storage (gases of clinical use were separated from those of industrial  use and proper identification signs were placed), prescription (6 protocols were  included in the hospital´s Computerized Physician Order Entry software),  validation (pharmacist validation of the prescription to ensure appropriate use of  these), dispensation (a new protocol for medical gases dispensation and  transportation was designed and implemented) and administration (information  on the pressure gauges used for each type of gas was collected and reviewed).  72 Signs with recommendations for medical gases identification and  administration were placed in all the clinical units. Specific training on the safe  use of medical gases and general safety training was imparted. CONCLUSIONS: The implementation of a process that integrates all phases of use  of medical gases and applies to all professionals involved is presented here as a  strategy to increase safety in the use of these medicines.

Objetivo: Existe una falta de concienciación sobre los riesgos asociados al uso  de los gases medicinales tanto por parte de los profesionales como por parte de  las organizaciones sanitarias, que no han definido estrategias que garanticen la  seguridad en su utilización. Nuestro objetivo fue redefinir el circuito de  utilización de los gases medicinales en el ámbito hospitalario.Método: En una unidad de hospitalización tuvo lugar un evento centinela, la  administración incorrecta de un gas medicinal a un paciente ingresado. Un  equipo multidisciplinar realizó el análisis causa-raíz del evento. Se propusieron áreas de mejora encaminadas a actuar sobre los errores detectados y así definir un programa que garantizara la seguridad en el uso de los gases medicinales.Resultados: Se identificaron nueve errores y se definieron acciones de mejora  en: almacenamiento (separación e identificación de los gases de uso clínico y de  los de uso industrial); prescripción (inclusión de seis protocolos en el programa  de prescripción electrónica); validación (revisión de la prescripción de los gases  medicinales por un farmacéutico); dispensación (implantación de un protocolo  de traslados), y administración (información sobre los manómetros utilizados  para cada tipo de gas). Además, se impartió formación relativa al uso de los  gases medicinales. Se colocaron 72 pósteres en las unidades clínicas con  recomendaciones para su uso seguro. Conclusiones: La implantación de un circuito que integra todas las fases de  utilización de los gases medicinales e implica a todos los profesionales involucrados se presenta como la estrategia dirigida a aumentar la seguridad en  la utilización de estos medicamentos.