- MeSH
- Child MeSH
- Clinical Competence MeSH
- Humans MeSH
- Minimally Invasive Surgical Procedures education MeSH
- Specialties, Surgical * education MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
OBJECTIVE: The role of inspiratory muscle performance in functional performance in patients with coronavirus disease 2019 (COVID-19) is poorly understood. The purpose of this study was to perform a longitudinal examination of inspiratory and functional performance from intensive care unit (ICU) discharge (ICUD) to hospital discharge (HD) and symptoms at HD and 1 month after HD in patients with COVID-19. METHODS: Thirty patients (19 men, 11 women) with COVID-19 were included. Examination of inspiratory muscle performance at ICUD and HD was performed with an electronic manometer, which provided the maximal inspiratory pressure (MIP) and several other inspiratory measures. Examination of dyspnea and functional performance was performed at ICUD and HD with the Modified Borg Dyspnea Scale and the 1-minute sit-to-stand test (1MSST), respectively. RESULTS: The mean age was 71 (SD = 11) years, the mean length of ICU stay was 9 (SD = 6) days, and the mean length of hospital stay was 26 (SD = 16) days. Most of the patients were diagnosed with severe COVID-19 (76.7%) and had a mean Charlson Comorbidity Index of 4.4 (SD = 1.9), reflecting high comorbidity. The mean MIP of the entire cohort increased minimally from ICUD to HD (from 36 [SD = 21] to 40 [SD = 20] cm H2O), reflecting predicted values for men and women at ICUD and HD of 46 (25%) to 51 (23%) and 37 (24%) to 37 (20%), respectively. The 1MSTS score increased significantly from ICUD to HD (9.9 [SD = 7.1] vs 17.7 [SD = 11.1]) for the entire cohort but remained far below population-based reference values (2.5th percentile) for the majority of patients at ICUD and HD. At ICUD, MIP was found to be a significant predictor of a favorable change in 1MSTS performance (β = 0.308; odds ratio = 1.36) at HD. CONCLUSION: A significant reduction in inspiratory and functional performance exists in patients with COVID-19 at both ICUD and HD, with a greater MIP at ICUD being a significant predictor of a greater 1MSTS score at HD. IMPACT: This study shows that inspiratory muscle training may be an important adjunct after COVID-19.
- MeSH
- COVID-19 * MeSH
- Respiratory Muscles * MeSH
- Dyspnea MeSH
- Humans MeSH
- Hospitals MeSH
- Critical Care MeSH
- Patient Discharge MeSH
- Aged MeSH
- Physical Functional Performance MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
STATEMENT OF PROBLEM: Evaluating the effectiveness of the management of Olfactory Dysfunction (OD) has been limited by a paucity of high-quality randomised and/or controlled trials. A major barrier is heterogeneity of outcomes in such studies. Core outcome sets (COS) - standardized sets of outcomes that should be measured/reported as determined by consensus-would help overcome this problem and facilitate future meta-analyses and/or systematic reviews (SRs). We set out to develop a COS for interventions for patients with OD. METHODS: A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic analysis of a wide range of stakeholders' views and systematic analysis of currently available Patient Reported Outcome Measures (PROMs). A subsequent e-Delphi process allowed patients and healthcare practitioners to individually rate the outcomes in terms of importance on a 9-point Likert scale. RESULTS: After 2 rounds of the iterative eDelphi process, the initial outcomes were distilled down to a final COS including subjective questions (visual analogue scores, quantitative and qualitative), quality of life measures, psychophysical testing of smell, baseline psychophysical testing of taste, and presence of side effects along with the investigational medicine/device and patient's symptom log. CONCLUSIONS: Inclusion of these core outcomes in future trials will increase the value of research on clinical interventions for OD. We include recommendations regarding the outcomes that should be measured, although future work will be required to further develop and revalidate existing outcome measures.
IMPORTANCE: Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy. OBJECTIVE: To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD). DESIGN, SETTING, AND PARTICIPANTS: This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up. INTERVENTION: Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56. MAIN OUTCOMES AND MEASURES: The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of -3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity. RESULTS: The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, -110.4 μm vs AFL, -115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable. CONCLUSIONS AND RELEVANCE: In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04450329.
- MeSH
- Biosimilar Pharmaceuticals * adverse effects MeSH
- Angiogenesis Inhibitors adverse effects MeSH
- Intravitreal Injections MeSH
- Humans MeSH
- Macular Degeneration * drug therapy MeSH
- Ranibizumab therapeutic use MeSH
- Receptors, Vascular Endothelial Growth Factor therapeutic use MeSH
- Recombinant Fusion Proteins adverse effects MeSH
- Aged MeSH
- Wet Macular Degeneration * diagnosis drug therapy chemically induced MeSH
- Treatment Outcome MeSH
- Visual Acuity MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Keywords
- hospitalizovaní pacienti s omezenou svéprávností,
- MeSH
- Inpatients legislation & jurisprudence MeSH
- Humans MeSH
- Visitors to Patients legislation & jurisprudence MeSH
- Minors MeSH
- Delivery of Health Care * organization & administration legislation & jurisprudence MeSH
- Patient Rights legislation & jurisprudence MeSH
- Parents MeSH
- Practice Guidelines as Topic MeSH
- Legal Guardians MeSH
- Legislation as Topic MeSH
- Check Tag
- Humans MeSH
- MeSH
- Adult MeSH
- Carcinoid Tumor diagnosis drug therapy pathology MeSH
- Humans MeSH
- Interdisciplinary Communication MeSH
- Head and Neck Neoplasms classification therapy MeSH
- Stomach Neoplasms diagnosis classification pathology MeSH
- Neuroendocrine Tumors * diagnosis drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Publication type
- Case Reports MeSH
