Effectiveness of a new one-hour blood pressure monitoring method to diagnose hypertension: a diagnostic accuracy clinical trial protocol

INTRODUCTION: 24-hour ambulatory blood pressure monitoring (ABPM) is the gold standard diagnostic method for hypertension, but has some shortcomings in clinical practice while clinical settings often lack sufficient devices to accommodate all patients with suspected hypertension. Home blood pressure monitoring (HBPM) and office blood pressure monitoring (OBPM) also have shortcomings, such as the white coat effect or a lack of accuracy. This study aims to study the validity of a new method of diagnosing hypertension consisting of monitoring blood pressure (BP) for 1 hour and comparing it with OBPM and HBPM and examining the sensitivity and specificity of this method compared with 24-hour ABPM. The patient experience will be examined in each method. METHODS AND ANALYSIS: A minimum sample of 214 patients requiring a diagnostic test for hypertension from three urban primary healthcare centres will be included. Participants will undergo 24-hour ABPM, 1-hour BP measurement (1-BPM), OBPM for three consecutive weeks and HBPM. Patients will follow a random sequence to first receive 24-hour ABPM or 1-hour ABPM. Daytime 24-hour ABPM records will be compared with the other monitoring methods using the correlation coefficient and Bland Altman plots. The kappa concordance index and the sensitivity and specificity of the methods will be calculated. The patient's experience will be studied, with selected indicators of efficiency and satisfaction calculated using parametric tests. ETHICS AND DISSEMINATION: The protocol has been authorised by the research ethics committee of the Hospital Clinic of Barcelona (Ref. HCB/2014/0615): protocol details and amendments will be recorded and reported to ClinicalTrials.com. The results will be disseminated in peer-reviewed literature, and to policy makers and healthcare partners. TRIAL REGISTRATION: NCT03147573; Pre-results

Problemas relacionados con la medicación de los pacientes procedentes de un centro de salud que son causa de ingreso en su hospital de referencia

[spa] Los problemas relacionados con los medicamentos (PRM) son problemas de salud vinculados al tratamiento farmacológico del paciente y que interfieren o pueden interferir con los resultados esperados en su salud. La prevalencia de PRM es alta y en un alto porcentaje evitable. El presente estudio tiene como objetivo determinar la prevalencia de los PRM que son causa de ingreso en el Hospital Clínico de Barcelona de los pacientes procedentes del Centro de Salud (CS) Les Corts, su evitabilidad y los medicamentos relacionados. La metodología es una revisión de la historia clínica del paciente ingresado y la del centro de salud que permitirá la detección y evaluación de PRM a cargo de una pareja de médico y farmacéutico. Las conclusiones son las siguientes: 1. El 13,4 % de todas las altas (médicas y quirúrgicas) producidas en el hospital de referencia de los pacientes adscritos al CS Les Corts presentan PRM, estando éstos mayoritariamente implicados en el ingreso hospitalario. 2. Las altas con PRM corresponden mayoritariamente a varones mayores de 75 años, a diferencia de las altas sin PRM, donde predominan las mujeres menores de 65 años. 3. La inefectividad es la categoría de PRM mayoritaria, seguida de la seguridad y por último la necesidad. 4. Los servicios de medicina interna, cardiología y neumología son los que presentan una mayor probabilidad de recibir ingresos debidos a PRM. 5. Los problemas de salud motivo de ingreso hospitalario son mayoritariamente circulatorios (38,5%) y respiratorios (11,5%). Entre los primeros destacan la insuficiencia cardiaca congrestiva, el accidente cerebrovascular y el infarto agudo de miocardio, y entre los segundos las infecciones respiratorias. 6. En una 57,3% del total de altas con un PRM como responsable del ingreso hospitalario se ha considerado que dicho PRM es evitable. 7. El 80% de los PRM son de gravedad moderada. 8. Los grupos terapéuticos más frecuentemente implicados en los PRM son el cardiovascular (C), hematológico (B), antiinfeccioso vía sistémica (J) y sistema nervioso (N)

A meta-learning framework for pattern classification by means of data complexity measures

It is widely accepted that the empirical behavior of classifiers strongly depends on available data. For a given problem, it is rather difficult to guess which classifier will provide the best performance or to set a proper expectation on classification performance. Traditional experimental studies consist of presenting accuracy of a set of classifiers on a small number of problems, without analyzing why a classifier outperforms other classification algorithms. Recently, some researchers have tried to characterize data complexity and relate it to classifier performance. In this paper, we present a general meta-learning framework based on a number of data complexity measures. We also discuss the applicability of this method to several problems in pattern analysis

Factores relacionados con la inhibición de la lactancia por medios farmacológicos al nacer en un hospital de referencia español (2011-2017)

Objective To describe the maternal, neonatal and pregnancy characteristics related to inhibition of lactation (IL) with cabergoline. Method We assessed 20,965 occasions of breastfeeding initiation, according to data collected from obstetric records at the Hospital Clinic of Barcelona (Spain) between January 2011 and December 2017. Results IL decreased over the study period from 8.78% to 6.18% (odds ratio [OR]: 0.93 per year; 95% confidence interval [95%CI]: 0.90-0.95). Women with a lower educational level (OR: 2.5; 95%CI: 2.0-3.0), mothers living in more depressed areas (OR: 1.08 per 10 extra points over 100; 95%CI: 1.04-1.12), smokers (OR: 2.2; 95%CI: 1.9-2.6), and those with more children (OR: 1.2 for each sibling; 95%CI: 1.1-1.3), preterm birth (OR: 1.8; 95%CI: 1.4-2.3), multiple births (OR: 1.6; 95%CI: 1.2-2.1) and a higher risk pregnancy (OR: 1.3 per risk point; 95%CI: 1.2-1.4) showed a higher prevalence of IL. Compared to women born in Spain, IL was less likely in all other women with the exception of Chinese women (OR: 7.0; 95%CI: 5.7-8.6). These disparities remained during the study period. Conclusions Factors related to lower socioeconomic status and poor health were more likely to be associated with IL. The overall use of cabergoline decreased during the study period while inequalities persisted. Taking these inequalities into account is the first step to addressing them.Peer ReviewedPostprint (published version

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trialResearch in context

Summary: Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols