Evaluación de la causalidad en estudios observacionales: Aplicación en una cohorte de enfermos críticos y en una cohorte de pacientes con trombosis venosa profunda

Tesis doctoral inédita leída en la Universidad Autónoma de Madrid, Facultad de Medicina, Departamento de Medicina Preventiva y Salud Pública y Microbiología. Fecha de lectura: 26-02-201

Responsiveness of the Spanish Version of Newcastle Stroke-Specific Quality of Life (NEWSQOL)

A prospective observational study was conducted to assess the responsiveness of the Spanish version of NEWSQOL. The sample contained 128 patients who filled in the question-naires before and after a physical therapy intervention. The responsiveness was assessed with p-values using the effect size (ES) and the standardized response means (SRMs) of the change. Besides, two other external criteria were used to distinguish patients who improved with the treatment from those who remained stable. This classification was based on one functional independence measure (the Barthel Index) and one disability measure (the modified Rankin Scale). Results: There was a statistically significant correlation (Spearman?s coefficient = p < 0.01) between the domains of the Spanish version of NEWSQOL in relation to the Barthel Index and the modified Rankin Scale. All domains showed between marked-to-mild change responsiveness except sleep and relationships; mobility (ES 0.66 and SRM 0.92) and activities of daily living (ES 0.75 and SRM 0.87) were markedly responsive; communication (ES 0.38 and SRM 0.61) was moderately responsive; and pain, vision, cognition, feelings, emotions and fatigue were mildly responsive (ES 0.21-0.41 and SRM 0.23-0.44). Conclusion: The Spanish version of NEWSQOL shows between marked and mild responsiveness to measure the perception of QoL in post-stroke patients. Therefore, its use can be suitable for eval-uation studies, clinical trials and clinical practice

Predicting the evolution of neck pain episodes in routine clinical practice

[EN] Background: The objective of this study was to develop models for predicting the evolution of a neck pain (NP) episode. Methods: Three thousand two hundred twenty-five acute and chronic patients seeking care for NP, were recruited consecutively in 47 health care centers. Data on 37 variables were gathered, including gender, age, employment status, duration of pain, intensity of NP and pain referred down to the arm (AP), disability, history of neck surgery, diagnostic procedures undertaken, imaging findings, clinical diagnosis, and treatments used. Three separate multivariable logistic regression models were developed for predicting a clinically relevant improvement in NP, AP and disability at 3 months. Results: Three thousand one (93.5%%) patients attended follow-up. For all the models calibration was good. The area under the ROC curve was ≥0.717 for pain and 0.664 for disability. Factors associated with a better prognosis were: a) For all the outcomes: pain being acute (vs. chronic) and having received neuro-reflexotherapy. b) For NP: nonspecific pain (vs. pain caused by disc herniation or spinal stenosis), no signs of disc degeneration on imaging, staying at work, and being female. c) For AP: nonspecific NP and no signs of disc degeneration on imaging. d) For disability: staying at work and no signs of facet joint degeneration on imaging. Conclusions: A prospective registry can be used for developing valid predictive models to quantify the odds that a given patient with NP will experience a clinically relevant improvementSIThis study was funded by the Spanish Back Pain Research Network (REIDE), a Spanish not-for-profit organization which specializes in neck and back pain research. REIDE is funded by: a) The Kovacs Back pain Unit in the Hospital Universitario HLA-Moncloa, a private organization specializing in neck and back pain, dedicated to medical research, health care and promotion of public health, with no links to the health industry b) Fundación ASISA, a Spanish non-profit institution linked to a health insurance company (ASISA) owned by a physician’s cooperativ

Basal procalcitonin, C-reactive protein, interleukin-6, and presepsin for prediction of mortality in critically ill septic patients: a systematic review and meta-analysis

Biomarkers; Mortality; SepsisBiomarcadores; Mortalidad; SepsisBiomarcadors; Mortalitat; SèpsiaBackground Numerous biomarkers have been proposed for diagnosis, therapeutic, and prognosis in sepsis. Previous evaluations of the value of biomarkers for predicting mortality due to this life-threatening condition fail to address the complexity of this condition and the risk of bias associated with prognostic studies. We evaluate the predictive performance of four of these biomarkers in the prognosis of mortality through a methodologically sound evaluation. Methods We conducted a systematic review a systematic review and meta-analysis to determine, in critically ill adults with sepsis, whether procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6), and presepsin (sCD14) are independent prognostic factors for mortality. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to March 2023. Only Phase-2 confirmatory prognostic factor studies among critically ill septic adults were included. Random effects meta-analyses pooled the prognostic association estimates. Results We included 60 studies (15,681 patients) with 99 biomarker assessments. Quality of the statistical analysis and reporting domains using the QUIPS tool showed high risk of bias in > 60% assessments. The biomarker measurement as a continuous variable in models adjusted by key covariates (age and severity score) for predicting mortality at 28–30 days showed a null or near to null association for basal PCT (pooled OR = 0.99, 95% CI = 0.99–1.003), CRP (OR = 1.01, 95% CI = 0.87 to 1.17), and IL-6 (OR = 1.02, 95% CI = 1.01–1.03) and sCD14 (pooled HR = 1.003, 95% CI = 1.000 to 1.006). Additional meta-analyses accounting for other prognostic covariates had similarly null findings. Conclusion Baseline, isolated measurement of PCT, CRP, IL-6, and sCD14 has not been shown to help predict mortality in critically ill patients with sepsis. The role of these biomarkers should be evaluated in new studies where the patient selection would be standardized and the measurement of biomarker results.Instituto de Salud Carlos III, Spain and European Union (“Fondo Europeo de Desarrollo Regional, Una manera de hacer Europa”), grant number [PI 19/0048]

Mechanically reconfigurable linear phased array antenna based on single-block waveguide reflective phase shifters with tuning screws

This work presents the design and prototyping of a reconfigurable phased array in Ku band (16 to 18 GHz) implemented in waveguide technology. The design is based on the use of a novel seamless waveguide module integrating four reconfigurable phase shifters to adjust the relative phase shift between the unitary elements of a linear array, which are illuminated uniformly by a corporate waveguide feeding network. The phase shifters are implemented by a 90º hybrid coupler in waveguide technology where two of its ports are loaded with a tunable reactive load, implemented in this proof of concept with a tuning screw. The four phase shifters have been manufactured in a single part using direct metal laser sintering, avoiding the losses related to bad electric contacts and misalignments associated to multipart devices. This also simplifies the assembly of the full phased array, leading to a modular approach with three parts whose design can be addressed separately. The experimental results for the complete array antenna show great performance and demonstrate that the main-lobe of the radiation pattern can be effectively scanned continuously between the angles - 25º and 25º, with a high efficiency in the whole design band thanks to the proposed waveguide implementationThis work was supported by the Spanish Government, Agencia Estatal de Investigación, Fondo Europeo de Desarrollo Regional: AEI/FEDER, UE, under Grant TEC2016-76070-C3-1-

Four chamber right ventricular longitudinal strain versus right free wall longitudinal strain. Prognostic value in patients with left heart disease

Background: There is no consensus on which right ventricle (RV) strain parameter should be used in the clinical practice: four chamber RV longitudinal strain (4CH RV-LS) or free wall longitudinal strain (FWLS). The aim of this study was to analyze which RV strain parameter better predicts prognosis in patients with left heart disease. Methods: One hundred and three outpatients with several degrees of functional tricuspid regurgitation severity secondary to left heart disease were prospectively included. 4CH RV-LS and FWLS were assessed using speckle tracking. Left ventricular (LV) systolic function was determined using LV ejection fraction and RV systolic function using tricuspid annular plane systolic excursion (TAPSE). Patients were followed up for 23.1 ± 12.4 months for an endpoint of cardiac hospitalization due to heart failure. Results: The cutoff value related to RV dysfunction (TAPSE &lt; 17 mm) was lower, in absolute value, for 4CH RV-LS (4CH RV-LS = –17.3%; FWLS = –19.5%). There were 33 adverse events during the follow-up. Patients with 4CH RV-LS &gt; –17.3% (log rank [LR] = 22.033; p &lt; 0.001); FWLS &gt; –19.5% (LR = 12.2; p &lt; 0.001), TAPSE &lt; 17 mm (LR = 17.4; p &lt; 0.001) and LV systolic dysfunction (LR = 13.3; p &lt; 0.001) had lower event-free survival (Kaplan Meier). In Cox multivariate analysis, 4CH RV-LS &gt; –17.3% (hazard ratio [HR] = 3.593; p &lt; 0.002), TAPSE &lt; 17 (HR = 2.093; p &lt; 0.055) and LV systolic dysfunction (HR = 2.087; p &lt; 0,054) had prognostic value, whereas FWLS did not reach significance. Conclusions: Although both 4CH RV-LS and FWLS have prognostic value, 4CH RV-LS is a better predictor of episodes of heart failure in patients with left heart disease, providing additional information to that obtained by TAPSE.

Recommendations for SARS-CoV- 2/ COVID-19 testing: a scoping review of current guidance

Background Testing used in screening, diagnosis and follow-up of COVID-19 has been a subject of debate. Several organisations have developed formal advice about testing for COVID-19 to assist in the control of the disease. We collated, delineated and appraised current worldwide recommendations about the role and applications of tests to control SARS-CoV- 2/COVID-19. Methods We searched for documents providing recommendations for COVID-19 testing in PubMed, EMBASE, LILACS, the Coronavirus Open Access Project living evidence database and relevant websites such as TRIP database, ECRI Guidelines Trust, the GIN database, from inception to 21 September 2020. Two reviewers applied the eligibility criteria to potentially relevant citations without language or geographical restrictions. We extracted data in duplicate, including assessment of methodological quality using the Appraisal of Guidelines for Research and Evaluation-II tool. Results We included 47 relevant documents and 327 recommendations about testing. Regarding the quality of the documents, we found that the domains with the lowest scores were ‘Editorial independence’ (Median=4%) and ‘Applicability’ (Median=6%). Only six documents obtained at least 50% score for the ‘Rigour of development’ domain. An important number of recommendations focused on the diagnosis of suspected cases (48%) and deisolation measures (11%). The most frequently recommended test was the reverse transcription-PCR (RT-PCR) assay (87 recommendations) and the chest CT (38 recommendations). There were 22 areas of agreement among guidance developers, including the use of RT-PCR for SARS-Cov- 2 confirmation, the limited role of bronchoscopy, the use chest CT and chest X-rays for grading severity and the co-assessment for other respiratory pathogens. Conclusion This first scoping review of recommendations for COVID-19 testing showed many limitations in the methodological quality of included guidance documents that could affect the confidence of clinicians in their implementation. Future guidance documents should incorporate a minimum set of key methodological characteristics to enhance their applicability for decision making.Instituto de Salud Carlos III 2017/CD17/00219European Social Fund 2014-2020, 'Investing in your future'Spanish Governmen

Effectiveness of Text Message Reminders on Adherence to Inhaled Therapy in Patients With Asthma : Prospective Multicenter Randomized Clinical Trial

Poor adherence to inhaled medication in asthma patients is of great concern. It is one of the main reasons for inadequate asthma control. The goal of the research was to determine if motivational messages using short message service (SMS, or text) improved adherence to inhaled medication in patients with asthma. A prospective multicenter randomized parallel-group clinical trial was conducted in 10 asthma clinics in Spain. Adherence was assessed with electronic monitors (Smartinhaler, Adherium Ltd) connected to inhalers. Patients in the SMS group received psychologist-developed motivational messages every 3 days for 6 months. There were 53 patients in the SMS group and 88 patients in the control group. After 6 months, mean electronic adherence was 70% (SD 17%) in the intervention group and 69% (SD 17%) in the control group (P =.82). Significant differences between the study groups in morning and evening adherence to inhaled therapy, asthma control, exhaled nitric oxide levels, or improvement of lung functions were not observed. Motivational messages were not useful to improve adherence to inhaled asthma medication compared with usual care

Suppressive Antibiotic Therapy in Prosthetic Joint Infections: A Multicentre Cohort Study

Objectives: The aim was to describe the effectiveness of suppressive antibiotic treatment (SAT) in routine clinical practice when used in situations in which removal of a prosthetic implant is considered essential for the eradication of an infection, and it cannot be performed. Methods: This was a descriptive retrospective and multicentre cohort study of prosthetic joint infection (PJI) cases managed with SAT. SAT was considered to have failed if a fistula appeared or persisted, if debridement was necessary, if the prosthesis was removed due to persistence of the infection or if uncontrolled symptoms were present. Results: In total, 302 patients were analysed. Two hundred and three of these patients (67.2%) received monotherapy. The most commonly used drugs were tetracyclines (39.7% of patients) (120/302) and cotrimoxazole (35.4% of patients) (107/302). SAT was considered successful in 58.6% (177/302) of the patients (median time administered, 36.5 months; IQR 20.75-59.25). Infection was controlled in 50% of patients at 5 years according to Kaplan-Meier analysis. Resistance development was documented in 15 of 65 (23.1%) of the microbiologically documented cases. SAT failure was associated with age <70 years (sub-hazard ratio (SHR) 1.61, 95% CI 1.1-2.33), aetiology other than Gram-positive cocci (SHR 1.56, 95% CI 1.09-2.27) and location of the prosthesis in the upper limb (SHR 2.4, 95% CI 1.5-3.84). SAT suspension was necessary due to adverse effects in 17 of 302 patients (5.6%). Conclusions: SAT offers acceptable results for patients with PJI when surgical treatment is not performed or when it fails to eradicate the infection

Prognostic models for mortality after cardiac surgery in patients with infective endocarditis: a systematic review and aggregation of prediction models.

Background There are several prognostic models to estimate the risk of mortality after surgery for active infective endocarditis (IE). However, these models incorporate different predictors and their performance is uncertain. Objective We systematically reviewed and critically appraised all available prediction models of postoperative mortality in patients undergoing surgery for IE, and aggregated them into a meta-model. Data sources We searched Medline and EMBASE databases from inception to June 2020. Study eligibility criteria We included studies that developed or updated a prognostic model of postoperative mortality in patient with IE. Methods We assessed the risk of bias of the models using PROBAST (Prediction model Risk Of Bias ASsessment Tool) and we aggregated them into an aggregate meta-model based on stacked regressions and optimized it for a nationwide registry of IE patients. The meta-model performance was assessed using bootstrap validation methods and adjusted for optimism. Results We identified 11 prognostic models for postoperative mortality. Eight models had a high risk of bias. The meta-model included weighted predictors from the remaining three models (EndoSCORE, specific ES-I and specific ES-II), which were not rated as high risk of bias and provided full model equations. Additionally, two variables (age and infectious agent) that had been modelled differently across studies, were estimated based on the nationwide registry. The performance of the meta-model was better than the original three models, with the corresponding performance measures: C-statistics 0.79 (95% CI 0.76–0.82), calibration slope 0.98 (95% CI 0.86–1.13) and calibration-in-the-large –0.05 (95% CI –0.20 to 0.11). Conclusions The meta-model outperformed published models and showed a robust predictive capacity for predicting the individualized risk of postoperative mortality in patients with IE. Protocol registration PROSPERO (registration number CRD42020192602).pre-print270 K