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

BackgroundThe 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.MethodsMulticenter, 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.DiscussionThe 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 registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021

Redistribution of Ca2+ among cytosol and organella during stimulation of bovine chromaffin cells

Recent results indicate that Ca2+ transport by organella contributes to shaping Ca2+ signals and exocytosis in adrenal chromaffin cells. Therefore, accurate measurements of [Ca2+] inside cytoplasmic organella are essential for a comprehensive analysis of the Ca2+ redistribution that follows cell stimulation. Here we have studied changes in Ca2+ inside the endoplasmic reticulum, mitochondria, and nucleus by imaging aequorins targeted to these compartments in cells stimulated by brief depolarizing pulses with high K+ solutions. We find that Ca2+ entry through voltage-gated Ca2+ channels generates subplasmalemmal high [Ca2+]c domains adequate for triggering exocytosis. A smaller increase of [Ca2+]c is produced in the cell core, which is adequate for recruitment of the reserve pool of secretory vesicles to the plasma membrane. Most of the Ca2+ load is taken up by a mitochondrial pool, M1, closer to the plasma membrane; the increase of [Ca2+]M stimulates respiration in these mitochondria, providing local support for the exocytotic process. Relaxation of the [Ca2+]c transient is due to Ca2+ extrusion through the plasma membrane. At this stage, mitochondria release Ca2+ to the cytosol through the Na+/Ca2+ exchanger, thus maintaining [Ca2+]c discretely increased, especially at core regions of the cell, for periods that outlast the duration of the stimulus.This work was supported by the Spanish Dirección General de Enseñanza Superior (DGES, grants PB97–0474, APC1999–011, and 1FD97–1725-C02–02 to J.G.S., PM98–0142 to J.A., and PM99–0005 to A.G.G.) and the Instituto de Salud Carlos III (to A.G.G.). C.V. and L.N. hold postdoctoral fellowships from the Spanish DGES.Peer Reviewe

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

Abstract 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