Practical and analytical considerations when performing interim analyses in diagnostic test accuracy studiesMethodology Published on 2024-08-202024-09-05 Journal: Diagnostic and Prognostic Research [Category] update2024, [키워드] adaptive design Diagnostic accuracy Group sequential methods interim analysis sensitivity specificity stopping rule [DOI] 10.1186/s41512-024-00174-4 PMC 바로가기 [Article Type] Methodology
Adaptive designs in critical care trials: a simulation studyarticle Published on 2023-10-182024-09-05 Journal: BMC Med Res Methodol [Category] update2024, [키워드] adaptive design Bayesian Critical care Group sequential design interim analysis Interim monitoring randomised controlled trial Statistical simulation [DOI] 10.1186/s12874-023-02049-6 PMC 바로가기 [Article Type] article
A home-based, multidisciplinary liver optimisation programme for the first 28 days after an admission for acute-on-chronic liver failure (LivR well): a study protocol for a randomised controlled trialArticle Published on 2022-09-052022-10-05 Journal: Trials [Category] 임상, [키워드] 1:1 28-day mortality addition Admission Admissions Analysis Appendix 1 benefit Care changes in chronic chronic condition chronic disease chronic liver disease cirrhosis clinical Clinical improvement Clinicians Cohort conducted COVID-19 COVID-19 pandemic criteria disease evaluated exploratory subgroup analysis feasibility generalisability generate global healthcare Health Health Service health team healthcare Healthcare systems heart failure hospitalisation implementation implication include Interdisciplinary health team. interim analysis Intervention intervention arm liver Liver disease Melbourne, Australia Mortality mortality risk New outcome participant Patient performed Prevalence Primary outcome Quality of life randomisation randomised randomised controlled trial RCT readmission recruit recruited recruitment reduced reducing Registered Registration registry required resource rising robust Safe secondary severity small sample size social work Study protocol suggested Treatment Trial well WHO [DOI] 10.1186/s13063-022-06679-x PMC 바로가기 [Article Type] Article
A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load코로나19 고위험 보행 환자를 대상으로 한 밤라니비맙과 에테세비맙의 무작위 위약 대조 임상 시험 및 지속적으로 높은 바이러스 부하의 예후 가치 검증Randomized Controlled Trial Published on 2022-08-242022-09-11 Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 변종, 임상, 진단, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 age ambulatory ambulatory patient ambulatory patients antibody treatment applicability bamlanivimab baseline characterized clinical clinical status Cohort confidence interval coronavirus coronavirus disease Coronavirus disease 2019 correlated COVID-19 COVID-19 test Day death determine etesevimab expand first positive greater high risk Hospitalization infused Interim analyses interim analysis intravenously investigated load lower dose median median age Mild-to-moderate NCT04427501 occurred optimal dose outcome Patient persistently high viral load. phase Placebo placebo group receiving reduction in respiratory risk factor SARS-CoV-2 severe acute respiratory syndrome Coronavirus severe COVID-19 Support the placebo group These data those receiving placebo Treatment Trial validation value variant Viral Viral load [DOI] 10.1093/cid/ciab912 PMC 바로가기 [Article Type] Randomized Controlled Trial
Facing the Omicron variant-how well do vaccines protect against mild and severe COVID-19? Third interim analysis of a living systematic reviewArticle Published on 2022-08-242022-11-16 Journal: Frontiers in Immunology [Category] SARS, 변종, [키워드] 95% CI acute respiratory syndrome Against approved booster booster dose booster vaccination characterized coronavirus coronavirus disease COVID-19 COVID-19 vaccine Critical death dominant variant Effectiveness estimate European evaluated Evidence Hospitalization ICU admission Immunity immunization indicated Infection interim analysis long-lasting Mild moderate omicron Omicron variant outcomes Participants performed PROTECT ranged receiving remained risk of bia robust SARS-CoV-2 SARS-COV-2 infection searched severe COVID-19 study heterogeneity symptomatic systematic review the SARS-CoV-2 union vaccination Vaccine vaccine effectiveness variant variant of concern website [DOI] 10.3389/fimmu.2022.940562 PMC 바로가기
Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia케냐, 말리, 잠비아에서 매력적인 표적 설탕 미끼 3상 시험Clinical Trial Published on 2022-08-092022-09-11 Journal: Trials [Category] 말라리아, 임상, 치료제, [키워드] adaptive ARMS Attractive targeted sugar bait children Cluster cluster separation Cluster-randomized controlled trial Clusters Cohort Contamination Controlled trial core covariate covariates COVID-19 pandemic detect determine dinotefuran Effects External validity Follow-up Imbalance IMPROVE incidence include insecticidal insecticide interim analysis internal validity Intervention Kenya kill Longevity malaria morbidity mosquito density Open-label open-label design phase III trial Prevalence Primary outcome Primary outcomes randomization receive reduce reduction in reductions in Restricted resulting risk Sample size secondary outcome strength Structure sugar threat Transmission transmission pattern Trial Two-arm Validity Variation vector vector control vectors [DOI] 10.1186/s13063-022-06555-8 PMC 바로가기 [Article Type] Clinical Trial
Enoxaparin for primary thromboprophylaxis in symptomatic outpatients with COVID-19 (OVID): a randomised, open-label, parallel-group, multicentre, phase 3 trialClinical Trial Published on 2022-08-012022-10-05 Journal: The Lancet. Haematology [Category] COVID19(2023년), SARS, 임상, 치료제, [키워드] 1:1 95% CI acute COVID-19 adjusted relative risk age Anti-inflammatory effects Antithrombotic antiviral properties assigned assumption Berlin body temperature clinically Control control group COVID-19 criteria death Efficacy eight eligible enoxaparin event rates foundation futility Germany heparin hospitalisation independent initial intention-to-treat population interim analysis investigator-initiated IQR Johanna major bleeding major bleeding event median age multicentre nine not reduce Older older patient Open-label outcome Outpatient parallel-group participant phase 3 trial Prevent Primary outcome Probability prothrombotic randomisation randomised Randomly receive Registered reported respiratory infection respiratory symptom risk Safety Monitoring Board Serious Adverse Event Standard of care statistical Study design study population Switzerland symptomatic Thromboprophylaxis Treatment Trial university University of Zurich was done were recorded with COVID-19 women [DOI] 10.1016/S2352-3026(22)00175-2 PMC 바로가기 [Article Type] Clinical Trial
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273)Research article Published on 2022-08-012022-10-05 Journal: Vaccine [Category] COVID19(2023년), SARS, 변종, 비임상, 임상, [키워드] acute respiratory syndrome assessment authorization Benefit/Risk caused collaboration coronavirus coronavirus disease COVID-19 develop DNA effective Efficacy Efficacy and safety Emergency FDA approval feature group interim analysis key consideration Moderna mRNA mRNA vaccine mRNA-1273 nucleic acid pandemic Phase 3 placebo-controlled platform Prevent RNA Safety SARS-CoV-2 Trial unblinding Vaccine vaccine platform Vaccines working [DOI] 10.1016/j.vaccine.2022.06.005 [Article Type] Research article
Predictive performance and clinical application of COV50, a urinary proteomic biomarker in early COVID-19 infection: a prospective multicentre cohort studyResearch article Published on 2022-08-012022-10-05 Journal: International Journal of Environmental Research an [Category] COVID19(2023년), SARS, 바이오마커, 유전자 메커니즘, 진단, [키워드] 95% CI Accuracy adjusted age Analysis AUC baseline Biomarker BMI capillary electrophoresis Care characteristic cohort study Comorbidities country COVID-19 dataset death died Disease progression eight Euro European country finding France funding Germany Greece high risk hospital hospitalisation Infection interim analysis less Logistic regression marker Markov chain Mild-to-moderate Ministry of Health Mortality multicentre North Odds ratio outcomes participant Participants PCR-confirmed PCR-confirmed COVID-19 peptide pilot study Poland predicted Predictive Probability progression proteomic recruited reducing reduction resulting risk SARS-CoV-2 SARS-CoV-2 pandemic Sex Spain threshold Treatment was used WHO [DOI] 10.1016/S2589-7500(22)00150-9 [Article Type] Research article
Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at risk of adverse outcomes: a randomised controlled trial (COVERAGE)Randomized Controlled Trial Published on 2022-07-012022-10-04 Journal: Clinical microbiology and infection : the official [Category] COVID19(2023년), SARS, 신약개발, 임상, 치료법, [키워드] absence Adults adverse events adverse outcome alleviation of symptoms Analysis ARMS Blood Ciclesonide clinical Comorbidity control arm COVID-19 COVID-19 outpatient criteria Day death died Efficacy Endpoint European Medicines Agency Evidence Evolution Follow-up Hospitalization Hospitalized improvement Inhaled inhaled corticosteroid inhaled corticosteroids intent-to-treat interim analysis interquartile range involved median age median time men Open-label Other outcome Outpatient outpatients Oxygen therapy parameter participant patients with COVID-19 primary efficacy endpoint primary endpoint randomised controlled trial Randomized controlled trial Randomly reached reducing reported risk risk factor RT-PCR Safety Monitoring Board scale secondary sustained Symptom the WHO Treatment Trial women worsening [DOI] 10.1016/j.cmi.2022.02.031 PMC 바로가기 [Article Type] Randomized Controlled Trial