Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study.

BACKGROUND: The use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting. METHODS: Multicenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024. DISCUSSION: The scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript. TRIAL REGISTRATION: NCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.

COVID-19: Clinical Presentation and Prognostic Factors of Severe Disease and Mortality in the Oldest-Old Population: A Cohort Study.

INTRODUCTION: The oldest-old population (80 years or older) has the highest lethality from COVID-19. There is little information on the clinical presentation and specific prognostic factors for this group. This trial evaluated the clinical presentation and prognostic factors of severe disease and mortality in the oldest-old population. METHODS: This is an ambispective cohort study of oldest-old patients hospitalized for respiratory infection associated with COVID-19 and with a positive test by RT-PCR. The clinical presentation and the factors associated with severe disease and mortality were evaluated (logistic regression). All patients were followed up until discharge or death. RESULTS: A total of 103 patients (59.2% female) were included. The most frequent symptoms were fever (68.9%), dyspnoea (60.2%), and cough (39.8%), and 11.7% presented confusion. Fifty-nine patients (57.3%) presented severe disease, and 59 died, with 43 patients (41.7%) presenting both of these. In the multivariate analysis, female sex (odds ratio [OR] 0.31, 95% confidence interval [95% CI] 0.13-0.73, p 0.0074) and serum lactate dehydrogenase (LDH) (OR 2.55, 95% CI 1.21-5.37, p 0.0139) were associated with severe disease, and serum sodium was associated with mortality (OR 3.12, 95% CI 1.18-8.26, p 0.0222). No chronic disease or pharmacological treatment was associated with worse outcomes. CONCLUSIONS: The typical presenting symptoms of respiratory infection in COVID-19 are less frequent in the oldest-old population. Male sex and LDH level are associated with severe disease, and the serum sodium level is associated with mortality in this population.

Efectividad de un protocolo de ahorro de transfusión en la disminución de consumo de hematíes en cirugía protésica / Effectiveness of a patient blood management protocol on reduction of allogeneic red blood cell transfusions in orthopedic surgery

Antecedentes y objetivos: Los programas de ahorro de transfusión disminuyen el consumo de concentrados de hematíes en cirugía protésica. Se evalúa la efectividad de un protocolo basado en el Consenso de Sevilla en la disminución de la tasa transfusional y se propone una ecuación predictiva en cirugía de rodilla. Pacientes y métodos: Estudio de cohortes en pacientes sometidos a prótesis de rodilla y cadera en 2014 y 2015 en el Hospital Comarcal de l'Alt Penedès (HCAP). Pacientes con hemoglobina (Hb) entre 10 y 13g/dl se clasificaron en anemia con o sin déficit de hierro y recibieron hierro o combinación de hierro y eritropoyetina. El día de la cirugía se administró ácido tranexámico, al día siguiente se midió la caída de Hb y durante su estancia los requerimientos y el dintel transfusional. Resultados: El estudio incluyó 334 pacientes. El protocolo disminuyó la tasa de transfusión del 41,5 al 14,8%. En cirugía de cadera los pacientes transfundidos fueron mayores, con mayor porcentaje de comorbilidad y uso de anticoagulantes y menor Hb preoperatoria. El ácido tranexámico no se asoció a disminución del sangrado. En cirugía de rodilla, el análisis multivariante mostró que la administración de ácido tranexámico fue la variable que más disminuyó el riesgo de transfusión, seguido de valores de Hb preoperatoria más altos. La ecuación resultante predice la tasa transfusional, con una sensibilidad del 55% y una especificidad del 95,7%. Conclusión: La implantación del programa disminuyó la tasa transfusional. La efectividad de ácido tranexámico varía según la artroplastia. El uso conjunto de hierro y eritropoyetina recombinante humana es necesario para mejorar la Hb

Background and objectives: Patient blood management in orthopaedic surgery reduces transfusion risk. The best protocol is unknown. The effectiveness of a protocol based on the Seville Consensus on the reduction of transfusion risk is evaluated and a predictive transfusion equation is proposed in knee surgery. Patients and methods: Cohort study in patients undergoing knee and hip arthroplasty from January 2014 to December 2015 at a second level complexity hospital in Vilafranca del Penedès (Barcelona). Patients with Hb between 10 and 13g/dL were classified as anaemic with or without iron deficiency and received iron or combination of iron and erythropoietin. On the day of surgery, tranexamic acid was administered, the Hb drop was measured the next day and the requirements and the transfusion lintel were measured during the stay. Results: A total of 334 patients were included in the study. The implementation of the programme decreased the transfusion risk from 41.5% to 14.8% at the end of the study. In hip surgery, transfused patients were significantly older, sicker and with lower preoperative Hb. Tranexamic acid did not decrease bleeding. In knee surgery, the administration of tranexamic acid was the variable that most decreased the transfusion risk followed by a high preoperative Hb. The equation predicts transfusion risk with a sensitivity of 55% and specificity of 95.7%. Conclusion: The implementation of the programme reduces transfusion risk. The effectiveness of tranexamic acid varies according to surgery site. The use of iron and recombinant human erythropoietin is necessary to improve Hb

Effectiveness of a patient blood management protocol on reduction of allogeneic red blood cell transfusions in orthopedic surgery. / Efectividad de un protocolo de ahorro de transfusión en la disminución de consumo de hematíes en cirugía protésica.

BACKGROUND AND OBJECTIVES: Patient blood management in orthopaedic surgery reduces transfusion risk. The best protocol is unknown. The effectiveness of a protocol based on the Seville Consensus on the reduction of transfusion risk is evaluated and a predictive transfusion equation is proposed in knee surgery. PATIENTS AND METHODS: Cohort study in patients undergoing knee and hip arthroplasty from January 2014 to December 2015 at a second level complexity hospital in Vilafranca del Penedès (Barcelona). Patients with Hb between 10 and 13g/dL were classified as anaemic with or without iron deficiency and received iron or combination of iron and erythropoietin. On the day of surgery, tranexamic acid was administered, the Hb drop was measured the next day and the requirements and the transfusion lintel were measured during the stay. RESULTS: A total of 334 patients were included in the study. The implementation of the programme decreased the transfusion risk from 41.5% to 14.8% at the end of the study. In hip surgery, transfused patients were significantly older, sicker and with lower preoperative Hb. Tranexamic acid did not decrease bleeding. In knee surgery, the administration of tranexamic acid was the variable that most decreased the transfusion risk followed by a high preoperative Hb. The equation predicts transfusion risk with a sensitivity of 55% and specificity of 95.7%. CONCLUSION: The implementation of the programme reduces transfusion risk. The effectiveness of tranexamic acid varies according to surgery site. The use of iron and recombinant human erythropoietin is necessary to improve Hb.