Articles de revista
http://hdl.handle.net/2117/79819
2024-03-29T02:29:40Z
2024-03-29T02:29:40Z
Determining the degree of deformation in rain drainage installations through point cloud modelling
Pawlowicz, Joanna A.
Skotnicka-Siepsiak, Aldona
Serrat Piè, Carles
http://hdl.handle.net/2117/405016
2024-03-20T13:10:12Z
2024-03-20T13:07:41Z
Determining the degree of deformation in rain drainage installations through point cloud modelling
Pawlowicz, Joanna A.; Skotnicka-Siepsiak, Aldona; Serrat Piè, Carles
Buildings are often complex and hindered by identifying and measuring deformation in both the building itself and its elements. However, we have the assistance of 3D laser scanning technology which allows us to collect geometric data. Scanners are particularly effective for measuring high and hard-to-reach locations. This paper focuses on the measuring and modeling of roof drainage installations, which are usually placed at elevated heights, making it impossible to measure using traditional methods. Rain gutters need constant monitoring in order to fulfill their function and ensure proper drainage of rainwater. Laser scanning produces a point cloud which can be converted in a 3D model using software such as Leica Cyclone, AutoCad and ReCap. This study demonstrates the successful utilization of laser scanning in identifying geometric features and deformations in building installations.
2024-03-20T13:07:41Z
Pawlowicz, Joanna A.
Skotnicka-Siepsiak, Aldona
Serrat Piè, Carles
Buildings are often complex and hindered by identifying and measuring deformation in both the building itself and its elements. However, we have the assistance of 3D laser scanning technology which allows us to collect geometric data. Scanners are particularly effective for measuring high and hard-to-reach locations. This paper focuses on the measuring and modeling of roof drainage installations, which are usually placed at elevated heights, making it impossible to measure using traditional methods. Rain gutters need constant monitoring in order to fulfill their function and ensure proper drainage of rainwater. Laser scanning produces a point cloud which can be converted in a 3D model using software such as Leica Cyclone, AutoCad and ReCap. This study demonstrates the successful utilization of laser scanning in identifying geometric features and deformations in building installations.
Survival analysis with censored data: a further twist on ignorability conditions
Oller Piqué, Ramón
Gómez Melis, Guadalupe
http://hdl.handle.net/2117/402108
2024-02-18T21:52:56Z
2024-02-16T14:34:50Z
Survival analysis with censored data: a further twist on ignorability conditions
Oller Piqué, Ramón; Gómez Melis, Guadalupe
A key assumption for the application of methods concerning censored data is that the random nature of the censoring mechanism should be ignorable when making likelihood-based inferences. The constant-sum property is an ignorability assumption that is critical for the correct use of a simplified version of the likelihood function and for the identifiability of the survival function [Oller R, Gómez G, Calle ML. Interval censoring: identifiability and the constant-sum property. Biometrika. 2007;94(1):61–70]. It has been proven to be weaker than the assumption of independence between the lifetime variable and the assessment process that leads to censored data. An important caveat is that the theoretical framework established in the class of constant-sum censoring models requires full knowledge of the support of the lifetime variable. In the present work we investigate the consequences of a wrong specification of the support. One might naively expect that this information is not necessary and that, for instance, the estimation of the survival function would assign null or almost null probabilities to regions outside the support. We reveal via examples that this premise is generally true but there are also several exceptions. To shed light on this issue, we introduce a new ignorability condition that extends the constant-sum property and removes the knowledge of the support from the equation. We also show that the independence assumption is stronger than the new extended constant-sum condition.
© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/),
2024-02-16T14:34:50Z
Oller Piqué, Ramón
Gómez Melis, Guadalupe
A key assumption for the application of methods concerning censored data is that the random nature of the censoring mechanism should be ignorable when making likelihood-based inferences. The constant-sum property is an ignorability assumption that is critical for the correct use of a simplified version of the likelihood function and for the identifiability of the survival function [Oller R, Gómez G, Calle ML. Interval censoring: identifiability and the constant-sum property. Biometrika. 2007;94(1):61–70]. It has been proven to be weaker than the assumption of independence between the lifetime variable and the assessment process that leads to censored data. An important caveat is that the theoretical framework established in the class of constant-sum censoring models requires full knowledge of the support of the lifetime variable. In the present work we investigate the consequences of a wrong specification of the support. One might naively expect that this information is not necessary and that, for instance, the estimation of the survival function would assign null or almost null probabilities to regions outside the support. We reveal via examples that this premise is generally true but there are also several exceptions. To shed light on this issue, we introduce a new ignorability condition that extends the constant-sum property and removes the knowledge of the support from the equation. We also show that the independence assumption is stronger than the new extended constant-sum condition.
Burnout in residents during the first wave of the COVID-19 pandemic: a systematic review and meta-analysis
Navinés, Ricard
Olivé, Victòria
Hidalgo Mazzei, Diego
Langohr, Klaus
Vieta, E.
Martín-Santos, Rocío
http://hdl.handle.net/2117/401593
2024-02-09T12:20:21Z
2024-02-09T12:19:55Z
Burnout in residents during the first wave of the COVID-19 pandemic: a systematic review and meta-analysis
Navinés, Ricard; Olivé, Victòria; Hidalgo Mazzei, Diego; Langohr, Klaus; Vieta, E.; Martín-Santos, Rocío
The high prevalence of burnout in resident physicians is expected to have increased as a result of the expansion of the pandemic. We conducted a systematic review with a meta-analysis of studies conducted during the first wave of the COVID-19 pandemic on burnout in residents and potential associated risk factors.
Methods: The search was done in the Web of Science, MEDLINE, Scopus, and Lillac databases (April 2020–October 2021) using a priori protocol based on the PRISMA guidelines. The Newcastle Ottawa Scale was used to assess the risk of bias in the included studies. We estimated the pooled prevalence (95% CI) of burnout and the prevalence ratio (95% CI) of each risk factor associated.
Results: We included 23 studies from 451 potential initial articles and those written in the English language; all of the collected studies were cross-sectional with anonymous online surveys, involving 4,998 responders (34%), of which 53.2% were female responders, 51% were R1-2, and 71% were in direct contact with COVID-19 patients. Eighty-seven percent presented a low-to-moderate risk of bias. Publication bias was not shown. The estimated pooled prevalence of burnout was 40% (95% CI = 0.26 – 0.57). Burnout was associated with psychiatry history (PR = 4.60, 95% CI = 1.06 – 20.06). There were no differences by gender, civil status, children in-charge, year of residency, or time exposure to COVID-19.
Discussion: The overall prevalence of burnout in residents during the first wave of the pandemic was in line with the results described in this collective before the pandemic. The presence of a psychiatry history was a potential burnout risk factor, suggesting a high vulnerability during the peak of the stress period and the need to implement mental health surveillance for this subgroup.
© 2024 The authors. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY).
2024-02-09T12:19:55Z
Navinés, Ricard
Olivé, Victòria
Hidalgo Mazzei, Diego
Langohr, Klaus
Vieta, E.
Martín-Santos, Rocío
The high prevalence of burnout in resident physicians is expected to have increased as a result of the expansion of the pandemic. We conducted a systematic review with a meta-analysis of studies conducted during the first wave of the COVID-19 pandemic on burnout in residents and potential associated risk factors.
Methods: The search was done in the Web of Science, MEDLINE, Scopus, and Lillac databases (April 2020–October 2021) using a priori protocol based on the PRISMA guidelines. The Newcastle Ottawa Scale was used to assess the risk of bias in the included studies. We estimated the pooled prevalence (95% CI) of burnout and the prevalence ratio (95% CI) of each risk factor associated.
Results: We included 23 studies from 451 potential initial articles and those written in the English language; all of the collected studies were cross-sectional with anonymous online surveys, involving 4,998 responders (34%), of which 53.2% were female responders, 51% were R1-2, and 71% were in direct contact with COVID-19 patients. Eighty-seven percent presented a low-to-moderate risk of bias. Publication bias was not shown. The estimated pooled prevalence of burnout was 40% (95% CI = 0.26 – 0.57). Burnout was associated with psychiatry history (PR = 4.60, 95% CI = 1.06 – 20.06). There were no differences by gender, civil status, children in-charge, year of residency, or time exposure to COVID-19.
Discussion: The overall prevalence of burnout in residents during the first wave of the pandemic was in line with the results described in this collective before the pandemic. The presence of a psychiatry history was a potential burnout risk factor, suggesting a high vulnerability during the peak of the stress period and the need to implement mental health surveillance for this subgroup.
Gut microbiome signatures linked to HIV-1 reservoir size and viremia control
Borgognone, Alessandra
Noguera Julian, Marc
Oriol, Bruna
Noël Romas, Laura
Ruiz Riol, Marta
Guillen, Yolanda
Parera, Mariona
Casadellà, Maria
Duran, Clara
Puertas Castro, Maria C.
Català Moll, Francesc
De Leon, Marlon
Knodel, Samantha
Pérez Álvarez, Nuria
http://hdl.handle.net/2117/400986
2024-02-12T01:38:59Z
2024-02-05T12:27:44Z
Gut microbiome signatures linked to HIV-1 reservoir size and viremia control
Borgognone, Alessandra; Noguera Julian, Marc; Oriol, Bruna; Noël Romas, Laura; Ruiz Riol, Marta; Guillen, Yolanda; Parera, Mariona; Casadellà, Maria; Duran, Clara; Puertas Castro, Maria C.; Català Moll, Francesc; De Leon, Marlon; Knodel, Samantha; Pérez Álvarez, Nuria
Background The potential role of the gut microbiome as a predictor of immune-mediated HIV-1 control in the absence of antiretroviral therapy (ART) is still unknown. In the BCN02 clinical trial, which combined the MVA.HIVconsv immunogen with the latency-reversing agent romidepsin in early-ART treated HIV-1 infected individuals, 23% (3/13) of participants showed sustained low-levels of plasma viremia during 32 weeks of a monitored ART pause (MAP). Here, we present a multi-omics analysis to identify compositional and functional gut microbiome patterns associated with HIV-1 control in the BCN02 trial. Results Viremic controllers during the MAP (controllers) exhibited higher Bacteroidales/Clostridiales ratio and lower microbial gene richness before vaccination and throughout the study intervention when compared to non-controllers. Longitudinal assessment indicated that the gut microbiome of controllers was enriched in pro-inflammatory bacteria and depleted in butyrate-producing bacteria and methanogenic archaea. Functional profiling also showed that metabolic pathways related to fatty acid and lipid biosynthesis were significantly increased in controllers. Fecal metaproteome analyses confirmed that baseline functional differences were mainly driven by Clostridiales. Participants with high baseline Bacteroidales/Clostridiales ratio had increased pre-existing immune activation-related transcripts. The Bacteroidales/Clostridiales ratio as well as host immune-activation signatures inversely correlated with HIV-1 reservoir size. Conclusions The present proof-of-concept study suggests the Bacteroidales/Clostridiales ratio as a novel gut microbiome signature associated with HIV-1 reservoir size and immune-mediated viral control after ART interruption.
2024-02-05T12:27:44Z
Borgognone, Alessandra
Noguera Julian, Marc
Oriol, Bruna
Noël Romas, Laura
Ruiz Riol, Marta
Guillen, Yolanda
Parera, Mariona
Casadellà, Maria
Duran, Clara
Puertas Castro, Maria C.
Català Moll, Francesc
De Leon, Marlon
Knodel, Samantha
Pérez Álvarez, Nuria
Background The potential role of the gut microbiome as a predictor of immune-mediated HIV-1 control in the absence of antiretroviral therapy (ART) is still unknown. In the BCN02 clinical trial, which combined the MVA.HIVconsv immunogen with the latency-reversing agent romidepsin in early-ART treated HIV-1 infected individuals, 23% (3/13) of participants showed sustained low-levels of plasma viremia during 32 weeks of a monitored ART pause (MAP). Here, we present a multi-omics analysis to identify compositional and functional gut microbiome patterns associated with HIV-1 control in the BCN02 trial. Results Viremic controllers during the MAP (controllers) exhibited higher Bacteroidales/Clostridiales ratio and lower microbial gene richness before vaccination and throughout the study intervention when compared to non-controllers. Longitudinal assessment indicated that the gut microbiome of controllers was enriched in pro-inflammatory bacteria and depleted in butyrate-producing bacteria and methanogenic archaea. Functional profiling also showed that metabolic pathways related to fatty acid and lipid biosynthesis were significantly increased in controllers. Fecal metaproteome analyses confirmed that baseline functional differences were mainly driven by Clostridiales. Participants with high baseline Bacteroidales/Clostridiales ratio had increased pre-existing immune activation-related transcripts. The Bacteroidales/Clostridiales ratio as well as host immune-activation signatures inversely correlated with HIV-1 reservoir size. Conclusions The present proof-of-concept study suggests the Bacteroidales/Clostridiales ratio as a novel gut microbiome signature associated with HIV-1 reservoir size and immune-mediated viral control after ART interruption.
Heterogeneity of treatment response to beta-blockers in the treatment of portal hypertension: a systematic review
Alsaeid, Mohammad
Sung, Shuen
Bai, Wayne
Tam, Matthew
Wong, Yu Jun
Cortés Martínez, Jordi
Cobo Valeri, Erik
González Alastrué, José Antonio
González Abraldes, Juan
http://hdl.handle.net/2117/400928
2024-02-05T09:20:21Z
2024-02-05T09:13:37Z
Heterogeneity of treatment response to beta-blockers in the treatment of portal hypertension: a systematic review
Alsaeid, Mohammad; Sung, Shuen; Bai, Wayne; Tam, Matthew; Wong, Yu Jun; Cortés Martínez, Jordi; Cobo Valeri, Erik; González Alastrué, José Antonio; González Abraldes, Juan
Background: It has been suggested that a relevant proportion of patients do not respond to nonselective beta-blockers (NSBB)s, which raises questions regarding the need for individualized therapy. The existence of potential heterogeneity in the treatment response can be assessed using the variability ratio (VR) of the outcome measurement (in this case, HVPG) between the treated and placebo groups. We conducted a systematic review and meta-analysis of randomized controlled trials to assess the potential heterogeneity in the portal pressure response to NSBBs. Methods: After a systematic search, we quantified the heterogeneity of treatment response with the VR between the treatment and control groups, with VR > 1 indicating potential heterogeneity. We used a similar approach to compare carvedilol with propranolol and statins with placebo. Results: We identified 18 studies that included 965 patients. A comparison between beta-blockers and placebo showed a pooled VR of 0.99 (95% CI:0.87–1.14), which suggests a homogeneous HVPG response to NSBB at the individual patient level (ie, no evidence to support that some patients responded to beta-blockers and others did not). For the comparison between carvedilol and propranolol, pooled VR was 0.97 (95% CI 0.82–1.14), suggesting that carvedilol achieves a greater average response (rather than an increase in the proportion of responders). There was no evidence of a heterogeneous response to statins. Conclusion: Our analysis did not support the existence of a heterogeneous patient-by-patient response to NSBBs in cirrhosis. These findings challenge the concept of personalized therapy based on portal pressure response and indicate that routine portal pressure measurement may not be necessary to guide NSBB therapy.
2024-02-05T09:13:37Z
Alsaeid, Mohammad
Sung, Shuen
Bai, Wayne
Tam, Matthew
Wong, Yu Jun
Cortés Martínez, Jordi
Cobo Valeri, Erik
González Alastrué, José Antonio
González Abraldes, Juan
Background: It has been suggested that a relevant proportion of patients do not respond to nonselective beta-blockers (NSBB)s, which raises questions regarding the need for individualized therapy. The existence of potential heterogeneity in the treatment response can be assessed using the variability ratio (VR) of the outcome measurement (in this case, HVPG) between the treated and placebo groups. We conducted a systematic review and meta-analysis of randomized controlled trials to assess the potential heterogeneity in the portal pressure response to NSBBs. Methods: After a systematic search, we quantified the heterogeneity of treatment response with the VR between the treatment and control groups, with VR > 1 indicating potential heterogeneity. We used a similar approach to compare carvedilol with propranolol and statins with placebo. Results: We identified 18 studies that included 965 patients. A comparison between beta-blockers and placebo showed a pooled VR of 0.99 (95% CI:0.87–1.14), which suggests a homogeneous HVPG response to NSBB at the individual patient level (ie, no evidence to support that some patients responded to beta-blockers and others did not). For the comparison between carvedilol and propranolol, pooled VR was 0.97 (95% CI 0.82–1.14), suggesting that carvedilol achieves a greater average response (rather than an increase in the proportion of responders). There was no evidence of a heterogeneous response to statins. Conclusion: Our analysis did not support the existence of a heterogeneous patient-by-patient response to NSBBs in cirrhosis. These findings challenge the concept of personalized therapy based on portal pressure response and indicate that routine portal pressure measurement may not be necessary to guide NSBB therapy.
Prevalence, progression, and management of advanced chronic kidney disease in a cohort of people living with HIV
Bonjoch Badia, Anna
Juega Mariño, Javier
Echeverria Liras, Patricia
Puig, Jordi
Pérez Álvarez, Nuria
Bonal, Jordi
Loste, Cora
Clotet, Bonaventura
Negredo Puigmal, Eugènia
http://hdl.handle.net/2117/400730
2024-02-04T23:02:52Z
2024-02-01T08:31:01Z
Prevalence, progression, and management of advanced chronic kidney disease in a cohort of people living with HIV
Bonjoch Badia, Anna; Juega Mariño, Javier; Echeverria Liras, Patricia; Puig, Jordi; Pérez Álvarez, Nuria; Bonal, Jordi; Loste, Cora; Clotet, Bonaventura; Negredo Puigmal, Eugènia
This is the peer reviewed version of the following article: Bonjoch, A. [et al.]. Prevalence, progression, and management of advanced chronic kidney disease in a cohort of people living with HIV. "HIV Medicine", 26 Abril 2022, vol. 23, núm. 10, p. 1078-1084, which has been published in final form at https://onlinelibrary.wiley.com/doi/10.1111/hiv.13317. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited
2024-02-01T08:31:01Z
Bonjoch Badia, Anna
Juega Mariño, Javier
Echeverria Liras, Patricia
Puig, Jordi
Pérez Álvarez, Nuria
Bonal, Jordi
Loste, Cora
Clotet, Bonaventura
Negredo Puigmal, Eugènia
Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study
Ramon Santos, Jose
Casadellà, Maria
Noguera Julian, Marc
Micán Rivera, Rafael
Domingo Pedrol, Pere
Antela, Antonio
Portilla, Joaquin
Sanz Sanz, Jesús
Montero Alonso, Marta
Navarro Mercade, Jordi
Masiá, Mar
Valcarce Pardeiro, Nieves
Pérez Álvarez, Nuria
http://hdl.handle.net/2117/400635
2024-02-04T23:00:15Z
2024-01-31T12:32:35Z
Effectiveness and safety of integrase strand transfer inhibitors in Spain: a prospective real-world study
Ramon Santos, Jose; Casadellà, Maria; Noguera Julian, Marc; Micán Rivera, Rafael; Domingo Pedrol, Pere; Antela, Antonio; Portilla, Joaquin; Sanz Sanz, Jesús; Montero Alonso, Marta; Navarro Mercade, Jordi; Masiá, Mar; Valcarce Pardeiro, Nieves; Pérez Álvarez, Nuria
Introduction: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. Methods: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. Results: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. Discussion: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.
2024-01-31T12:32:35Z
Ramon Santos, Jose
Casadellà, Maria
Noguera Julian, Marc
Micán Rivera, Rafael
Domingo Pedrol, Pere
Antela, Antonio
Portilla, Joaquin
Sanz Sanz, Jesús
Montero Alonso, Marta
Navarro Mercade, Jordi
Masiá, Mar
Valcarce Pardeiro, Nieves
Pérez Álvarez, Nuria
Introduction: Second-generation integrase strand transfer inhibitors (INSTIs) are preferred treatment options worldwide, and dolutegravir (DTG) is the treatment of choice in resource-limited settings. Nevertheless, in some resource-limited settings, these drugs are not always available. An analysis of the experience with the use of INSTIs in unselected adults living with HIV may be of help to make therapeutic decisions when second-generation INSTIs are not available. This study aimed to evaluate the real-life effectiveness and safety of dolutegravir (DTG), elvitegravir/cobicistat (EVG/c), and raltegravir (RAL) in a large Spanish cohort of HIV-1-infected patients. Methods: Real-world study of adults living with HIV who initiated integrase INSTIs DTG, EVG/c, and RAL-based regimens in three settings (ART-naïve patients, ART-switching, and ART-salvage patients). The primary endpoint was the median time to treatment discontinuation after INSTI-based regimen initiation. Proportion of patients experiencing virological failure (VF) (defined as two consecutive viral loads (VL) =200 copies/mL at 24 weeks or as a single determination of VL =1,000 copies/mL while receiving DTG, EVG/c or RAL, and at least 3 months after INSTI initiation) and time to VF were also evaluated. Results: Virological effectiveness of EVG/c- and RAL-based regimens was similar to that of DTG when given as first-line and salvage therapy. Treatment switching for reasons other than virological failure was more frequent in subjects receiving EVG/c and, in particular, RAL. Naïve patients with CD4+ nadir <100 cells/µL were more likely to develop VF, particularly if they initiated RAL or EVG/c. In the ART switching population, initiation of RAL and EVG/c was associated with both VF and INSTI discontinuation. There were no differences in the time to VF and INSTI discontinuation between DTG, EVG/c and RAL. Immunological parameters improved in the three groups and for the three drugs assessed. Safety and tolerability were consistent with expected safety profiles. Discussion: Whereas second-generation INSTIs are preferred treatment options worldwide, and DTG is one of the treatment of choices in resource-limited settings, first-generation INSTIs may still provide high virological and immunological effectiveness when DTG is not available.
Safety and efficacy of ApTOLL in patients with ischemic stroke undergoing endovascular treatment: a phase 1/2 randomized clinical trial
Hernández Jiménez, Macarena
Abad Santos, Francisco
Cotgreave, Ian
Gallego Pérez de Larraya, Jaime
Jilma, Bernd
Flores, Alan
Jovin, Tudor G.
Vivancos, José
Hernández Pérez, María
Molina Cateriano, Carlos
Montaner Villalonga, Joan
Casariego García, Joaquín
Dalsgaard, Mad
Liebeskind, David S.
Cobo Valeri, Erik
Castellanos Arboleda, Maria Isabel
http://hdl.handle.net/2117/394817
2023-10-22T02:12:37Z
2023-10-11T08:06:40Z
Safety and efficacy of ApTOLL in patients with ischemic stroke undergoing endovascular treatment: a phase 1/2 randomized clinical trial
Hernández Jiménez, Macarena; Abad Santos, Francisco; Cotgreave, Ian; Gallego Pérez de Larraya, Jaime; Jilma, Bernd; Flores, Alan; Jovin, Tudor G.; Vivancos, José; Hernández Pérez, María; Molina Cateriano, Carlos; Montaner Villalonga, Joan; Casariego García, Joaquín; Dalsgaard, Mad; Liebeskind, David S.; Cobo Valeri, Erik; Castellanos Arboleda, Maria Isabel
Importance ApTOLL is a TLR4 antagonist with proven preclinical neuroprotective effect and a safe profile in healthy volunteers. Objective To assess the safety and efficacy of ApTOLL in combination with endovascular treatment (EVT) for patients with ischemic stroke. Design, Setting, and Participants This phase 1b/2a, double-blind, randomized, placebo-controlled study was conducted at 15 sites in Spain and France from 2020 to 2022. Participants included patients aged 18 to 90 years who had ischemic stroke due to large vessel occlusion and were seen within 6 hours after stroke onset; other criteria were an Alberta Stroke Program Early CT Score of 6 to 10, estimated infarct core volume on baseline computed tomography perfusion of 5 to 70 mL, and the intention to undergo EVT. During the study period, 4174 patients underwent EVT. Interventions In phase 1b, 0.025, 0.05, 0.1, or 0.2 mg/kg of ApTOLL or placebo; in phase 2a, 0.05 or 0.2 mg/kg of ApTOLL or placebo; and in both phases, treatment with EVT and intravenous thrombolysis if indicated. Main Outcomes and Measures The primary end point was the safety of ApTOLL based on death, symptomatic intracranial hemorrhage (sICH), malignant stroke, and recurrent stroke. Secondary efficacy end points included final infarct volume (via MRI at 72 hours), NIHSS score at 72 hours, and disability at 90 days (modified Rankin Scale [mRS] score). Results In phase Ib, 32 patients were allocated evenly to the 4 dose groups. After phase 1b was completed with no safety concerns, 2 doses were selected for phase 2a; these 119 patients were randomized to receive ApTOLL, 0.05 mg/kg (n¿=¿36); ApTOLL, 0.2 mg/kg (n¿=¿36), or placebo (n¿=¿47) in a 1:1:v2 ratio. The pooled population of 139 patients had a mean (SD) age of 70 (12) years, 81 patients (58%) were male, and 58 (42%) were female. The primary end point occurred in 16 of 55 patients (29%) receiving placebo (10 deaths [18.2%], 4 sICH [7.3%], 4 malignant strokes [7.3%], and 2 recurrent strokes [3.6%]); in 15 of 42 patients (36%) receiving ApTOLL, 0.05 mg/kg (11 deaths [26.2%], 3 sICH [7.2%], 2 malignant strokes [4.8%], and 2 recurrent strokes [4.8%]); and in 6 of 42 patients (14%) receiving ApTOLL, 0.2 mg/kg (2 deaths [4.8%], 2 sICH [4.8%], and 3 recurrent strokes [7.1%]). ApTOLL, 0.2 mg/kg, was associated with lower NIHSS score at 72 hours (mean difference log-transformed vs placebo, -45%; 95% CI, -67% to -10%), smaller final infarct volume (mean difference log-transformed vs placebo, -42%; 95% CI, -66% to 1%), and lower degrees of disability at 90 days (common odds ratio for a better outcome vs placebo, 2.44; 95% CI, 1.76 to 5.00). Conclusions and Relevance In acute ischemic stroke, 0.2 mg/kg of ApTOLL administered within 6 hours of onset in combination with EVT was safe and associated with a potential meaningful clinical effect, reducing mortality and disability at 90 days compared with placebo. These preliminary findings await confirmation from larger pivotal trials.
2023-10-11T08:06:40Z
Hernández Jiménez, Macarena
Abad Santos, Francisco
Cotgreave, Ian
Gallego Pérez de Larraya, Jaime
Jilma, Bernd
Flores, Alan
Jovin, Tudor G.
Vivancos, José
Hernández Pérez, María
Molina Cateriano, Carlos
Montaner Villalonga, Joan
Casariego García, Joaquín
Dalsgaard, Mad
Liebeskind, David S.
Cobo Valeri, Erik
Castellanos Arboleda, Maria Isabel
Importance ApTOLL is a TLR4 antagonist with proven preclinical neuroprotective effect and a safe profile in healthy volunteers. Objective To assess the safety and efficacy of ApTOLL in combination with endovascular treatment (EVT) for patients with ischemic stroke. Design, Setting, and Participants This phase 1b/2a, double-blind, randomized, placebo-controlled study was conducted at 15 sites in Spain and France from 2020 to 2022. Participants included patients aged 18 to 90 years who had ischemic stroke due to large vessel occlusion and were seen within 6 hours after stroke onset; other criteria were an Alberta Stroke Program Early CT Score of 6 to 10, estimated infarct core volume on baseline computed tomography perfusion of 5 to 70 mL, and the intention to undergo EVT. During the study period, 4174 patients underwent EVT. Interventions In phase 1b, 0.025, 0.05, 0.1, or 0.2 mg/kg of ApTOLL or placebo; in phase 2a, 0.05 or 0.2 mg/kg of ApTOLL or placebo; and in both phases, treatment with EVT and intravenous thrombolysis if indicated. Main Outcomes and Measures The primary end point was the safety of ApTOLL based on death, symptomatic intracranial hemorrhage (sICH), malignant stroke, and recurrent stroke. Secondary efficacy end points included final infarct volume (via MRI at 72 hours), NIHSS score at 72 hours, and disability at 90 days (modified Rankin Scale [mRS] score). Results In phase Ib, 32 patients were allocated evenly to the 4 dose groups. After phase 1b was completed with no safety concerns, 2 doses were selected for phase 2a; these 119 patients were randomized to receive ApTOLL, 0.05 mg/kg (n¿=¿36); ApTOLL, 0.2 mg/kg (n¿=¿36), or placebo (n¿=¿47) in a 1:1:v2 ratio. The pooled population of 139 patients had a mean (SD) age of 70 (12) years, 81 patients (58%) were male, and 58 (42%) were female. The primary end point occurred in 16 of 55 patients (29%) receiving placebo (10 deaths [18.2%], 4 sICH [7.3%], 4 malignant strokes [7.3%], and 2 recurrent strokes [3.6%]); in 15 of 42 patients (36%) receiving ApTOLL, 0.05 mg/kg (11 deaths [26.2%], 3 sICH [7.2%], 2 malignant strokes [4.8%], and 2 recurrent strokes [4.8%]); and in 6 of 42 patients (14%) receiving ApTOLL, 0.2 mg/kg (2 deaths [4.8%], 2 sICH [4.8%], and 3 recurrent strokes [7.1%]). ApTOLL, 0.2 mg/kg, was associated with lower NIHSS score at 72 hours (mean difference log-transformed vs placebo, -45%; 95% CI, -67% to -10%), smaller final infarct volume (mean difference log-transformed vs placebo, -42%; 95% CI, -66% to 1%), and lower degrees of disability at 90 days (common odds ratio for a better outcome vs placebo, 2.44; 95% CI, 1.76 to 5.00). Conclusions and Relevance In acute ischemic stroke, 0.2 mg/kg of ApTOLL administered within 6 hours of onset in combination with EVT was safe and associated with a potential meaningful clinical effect, reducing mortality and disability at 90 days compared with placebo. These preliminary findings await confirmation from larger pivotal trials.
Análisis estadístico de los factores de riesgo asociados a las patologías de la columna lumbar para la población empleada
Mena, Vanessa
Fernández Martínez, Daniel
Guevara, Patricia
http://hdl.handle.net/2117/394709
2023-10-06T12:10:13Z
2023-10-06T12:02:50Z
Análisis estadístico de los factores de riesgo asociados a las patologías de la columna lumbar para la población empleada
Mena, Vanessa; Fernández Martínez, Daniel; Guevara, Patricia
Objetivo: Determinar los factores de riesgo de patologías lumbares en pacientes empleados y afiliados al sistema de salud, a partir de la exploración física, hábitos, antecedentes personales y factores de riesgo laborales.
Métodos: El diseño del estudio es retrospectivo, transversal. En una muestra de 668 adultos trabajadores del Ecuador, se aplicó y evaluó el modelo predictivo de respuesta binaria logit para identificar factores de riesgo y se usaron métodos de aprendizaje supervisado (árboles de clasificación) para clasificar a los pacientes según el grado de patología lumbar.
Resultados: El modelo predictivo logístico presentó una sensibilidad del 62,5%, una especificidad del 63,7%, el área bajo la curva ROC fue 0,63 y se determinó una precisión del 63,4%.
Conclusión: Los factores que aumentan el riesgo de la patología de columna lumbar más frecuente (lumbalgia) y en orden de importancia en los pacientes son: menor edad, sexo femenino, tienden a exponerse a factores de riesgo psicosocial en su trabajo
2023-10-06T12:02:50Z
Mena, Vanessa
Fernández Martínez, Daniel
Guevara, Patricia
Objetivo: Determinar los factores de riesgo de patologías lumbares en pacientes empleados y afiliados al sistema de salud, a partir de la exploración física, hábitos, antecedentes personales y factores de riesgo laborales.
Métodos: El diseño del estudio es retrospectivo, transversal. En una muestra de 668 adultos trabajadores del Ecuador, se aplicó y evaluó el modelo predictivo de respuesta binaria logit para identificar factores de riesgo y se usaron métodos de aprendizaje supervisado (árboles de clasificación) para clasificar a los pacientes según el grado de patología lumbar.
Resultados: El modelo predictivo logístico presentó una sensibilidad del 62,5%, una especificidad del 63,7%, el área bajo la curva ROC fue 0,63 y se determinó una precisión del 63,4%.
Conclusión: Los factores que aumentan el riesgo de la patología de columna lumbar más frecuente (lumbalgia) y en orden de importancia en los pacientes son: menor edad, sexo femenino, tienden a exponerse a factores de riesgo psicosocial en su trabajo
Prognostic accuracy of N20 somatosensory potential in patients with acute ischemic stroke and endovascular thrombectomy
Martínez Piñeiro, Alicia
Lucente, Giuseppe
Hernández Pérez, María
Cortés Martínez, Jordi
Arbex Bassols, Andrea
Pérez de la Ossa, Natalia
Ramos Fransi, Alba
Almendrote Muñoz, Miriam
Millán Torné, Mònica
Gomis Cortina, Meritxell
Dorado, Laura
Castaño Duque, Carlos
Remollo Friedemann, Sebastián
Cuadras Collsamata, Patricia
Garrido Pla, Alicia
Guanyabens Buscà, Nicolau
López Cancio, Elena
Coll Canti, Jaume
Dávalos Errando, Antoni
http://hdl.handle.net/2117/393124
2023-09-05T12:10:12Z
2023-09-05T12:05:18Z
Prognostic accuracy of N20 somatosensory potential in patients with acute ischemic stroke and endovascular thrombectomy
Martínez Piñeiro, Alicia; Lucente, Giuseppe; Hernández Pérez, María; Cortés Martínez, Jordi; Arbex Bassols, Andrea; Pérez de la Ossa, Natalia; Ramos Fransi, Alba; Almendrote Muñoz, Miriam; Millán Torné, Mònica; Gomis Cortina, Meritxell; Dorado, Laura; Castaño Duque, Carlos; Remollo Friedemann, Sebastián; Cuadras Collsamata, Patricia; Garrido Pla, Alicia; Guanyabens Buscà, Nicolau; López Cancio, Elena; Coll Canti, Jaume; Dávalos Errando, Antoni
Background Somatosensory evoked potentials (SEP) may add substantial prognostic value in patients with acute ischemic stroke (AIS) and contribute to the selection of patients that may benefit from revascularization therapies beyond the accepted therapeutic time windows. We aimed to study the prognostic accuracy of N20 SEP component of the ischemic hemisphere in patients with anterior large vessel occlusion undergoing endovascular thrombectomy (EVT). Methods: Presence and amplitude of the N20 response were recorded before and after EVT. Its adjusted predictive value for functional independence (modified Rankin scale score, =2) at day 7 was analysed by binary logistic regression adjusting by age, mean arterial blood pressure, NIHSS, ASPECTS score and serum glucose. N20 predictive power was compared with that of clinical and imaging models by using Receiving Operating Characteristics Curve (ROC) analysis. Results: 223 consecutive patients were studied (mean age, 70y; median NIHSS, 18). SEP recordings identified presence of N20 in 110 (49.3%), absence in 58 (26%) and not assessable in 55 patients due to radiofrequency interferences in the angiography room. Prior to EVT, N20 predicted functional independence with a sensitivity of 93% (95%CI, 78-98%) and negative predictive value of 93% (80-98%). The adjusted odds ratio for functional independence was 9.9 (95%CI, 3.1-44.6). In ROC analysis, N20 amplitude showed a higher area under the curve than models using pre-hospital or in-hospital variables, including advanced imaging. Sensitivity increased to 100% (95% CI, 0.85-1) at the end of EVT. Conclusions: SEP monitoring is a non-invasive and bedside technique that could help eligibility of AIS patients for EVT and predict functional recovery.
2023-09-05T12:05:18Z
Martínez Piñeiro, Alicia
Lucente, Giuseppe
Hernández Pérez, María
Cortés Martínez, Jordi
Arbex Bassols, Andrea
Pérez de la Ossa, Natalia
Ramos Fransi, Alba
Almendrote Muñoz, Miriam
Millán Torné, Mònica
Gomis Cortina, Meritxell
Dorado, Laura
Castaño Duque, Carlos
Remollo Friedemann, Sebastián
Cuadras Collsamata, Patricia
Garrido Pla, Alicia
Guanyabens Buscà, Nicolau
López Cancio, Elena
Coll Canti, Jaume
Dávalos Errando, Antoni
Background Somatosensory evoked potentials (SEP) may add substantial prognostic value in patients with acute ischemic stroke (AIS) and contribute to the selection of patients that may benefit from revascularization therapies beyond the accepted therapeutic time windows. We aimed to study the prognostic accuracy of N20 SEP component of the ischemic hemisphere in patients with anterior large vessel occlusion undergoing endovascular thrombectomy (EVT). Methods: Presence and amplitude of the N20 response were recorded before and after EVT. Its adjusted predictive value for functional independence (modified Rankin scale score, =2) at day 7 was analysed by binary logistic regression adjusting by age, mean arterial blood pressure, NIHSS, ASPECTS score and serum glucose. N20 predictive power was compared with that of clinical and imaging models by using Receiving Operating Characteristics Curve (ROC) analysis. Results: 223 consecutive patients were studied (mean age, 70y; median NIHSS, 18). SEP recordings identified presence of N20 in 110 (49.3%), absence in 58 (26%) and not assessable in 55 patients due to radiofrequency interferences in the angiography room. Prior to EVT, N20 predicted functional independence with a sensitivity of 93% (95%CI, 78-98%) and negative predictive value of 93% (80-98%). The adjusted odds ratio for functional independence was 9.9 (95%CI, 3.1-44.6). In ROC analysis, N20 amplitude showed a higher area under the curve than models using pre-hospital or in-hospital variables, including advanced imaging. Sensitivity increased to 100% (95% CI, 0.85-1) at the end of EVT. Conclusions: SEP monitoring is a non-invasive and bedside technique that could help eligibility of AIS patients for EVT and predict functional recovery.