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Validation and Final Results from the First Cardiac Lead Post-Approval Study Using Real-World Data.
Pragmat Obs Res
December 2024
BIOTRONIK Inc., Lake Oswego, OR, 97035, USA.
Background: As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications.
Methods: Lead complications were identified using a combination of diagnosis and procedure codes from 2013 to 2020 fee-for-service Medicare claims data along with BIOTRONIK device registration and Medical Device Reporting data from patients implanted between 2013 and 2015 with a Solia S lead. A proof-of-concept analysis was performed using McNemar's test to compare lead complications reported in the traditional PAS with lead complications identified in the RWD.
Smartphone application-based pulmonary rehabilitation in COPD: a multicentre randomised controlled trial.
Thorax
December 2024
Institute for Pulmonary Rehabilitation Research, Schön Klinik Berchtesgadener Land, Schönau am Königssee, Germany.
Background: Pulmonary rehabilitation (PR) is an essential element of chronic obstructive pulmonary disease (COPD) management. However, access to conventional face-to-face PR programmes is limited.
Methods: This multicentre, randomised controlled trial recruited patients with COPD from 18 sites in Germany and Switzerland, aiming to evaluate the impact of 12 weeks of a mobile app (intervention group; IVG) on quality of life, measured by COPD Assessment Test (CAT), and exercise capacity, assessed by 1-minute-sit-to-stand-test (1MSTST), compared with a control group (CTG) receiving 'enhanced standard-of-care'.
An open-label, randomized phase III study of early switch maintenance vs delayed second-line nivolumab in advanced stage squamous non-small cell lung cancer (NSCLC) patients after standard first-line platinum-based chemotherapy-EDEN trial GOIRC 04-2016.
Lung Cancer
December 2024
Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Background: As for squamous (Sq)-NSCLC, Checkmate-017 trial showed a significant overall survival (OS) improvement in favor of Nivolumab (Nivo) over Docetaxel in 2nd-line. We hypothesized that anticipating Nivo use, as early switch maintenance after 1st-line chemotherapy (CHT), might have improved survival as compared to delayed 2nd-line treatment.
Methods: EDEN was an open-label, 2-arm, phase III study which randomized (1:1) stage IIIB/IV Sq-NSCLC pts non-progressive after 1st-line platinum-based CHT, to receive early Nivo as switch maintenance (Arm A) or standard best supportive care followed by 2nd-line Nivo at disease progression (Arm B).
Prevalence and solving strategies of drug-related problems in adult psychiatric inpatients - a systematic review.
Front Psychiatry
December 2024
Department of Psychiatry and Psychotherapy, Center for Integrative Psychiatry, University Medical Center Schleswig-Holstein, Lübeck, Germany.
Introduction: Most psychiatric inpatients receive psychopharmacological treatment indicated for their mental diseases. The aim of this systematic review is to give clinical pharmacists and physicians a comprehensive summary of common drug-related problems (DRPs) in adult psychiatric inpatients and of potential interventions to solve them in clinical practice.
Methods: Six databases and registers were searched for English, German and French articles published between 1999 and 2023 with content regarding the prevalence and/or type or interventions to solve DRPs in adult psychiatric inpatients.
An integrated, multidisciplinary management team intervention to improve patient-centeredness, HIV, and maternal-child outcomes in Lesotho: formative research on participatory implementation strategies.
BMC Health Serv Res
December 2024
Johns Hopkins University, Bloomberg School of Public Health, Department of Health, Behavior and Society, Baltimore, MD, USA.
Background: Reducing perinatal HIV transmission and optimizing maternal and child health (MCH) outcomes in high HIV prevalence settings is an urgent, but complex, priority. Extant interventions over-emphasize individual-level provider and patient behaviors, and neglect critical health systems-level changes. The 'Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)' study implemented a three-part, patient-centered, health-systems-level intervention to improve MCH and HIV outcomes in Lesotho.
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