FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4220667051> ?p ?o ?g. }

• W4220667051 abstract "Optimise:MS is an observational pharmacovigilance study aimed at characterizing the safety profile of disease-modifying therapies (DMTs) for multiple sclerosis (MS) in a real world population. The study will categorize and quantify the occurrence of serious adverse events (SAEs) in a cohort of MS patients recruited from clinical sites around the UK. The study was motivated particularly by a need to establish the safety profile of newer DMTs, but will also gather data on outcomes among treatment-eligible but untreated patients and those receiving established DMTs (interferons and glatiramer acetate). It will also explore the impact of treatment switching.Causal pathway confounding between treatment selection and outcomes, together with the variety and complexity of treatment and disease patterns observed among MS patients in the real world, present statistical challenges to be addressed in the analysis plan. We developed an approach for analysis of the Optimise:MS data that will include disproportionality-based signal detection methods adapted to the longitudinal structure of the data and a longitudinal time-series analysis of a cohort of participants receiving second-generation DMT for the first time. The time-series analyses will use a number of exposure definitions in order to identify temporal patterns, carryover effects and interactions with prior treatments. Time-dependent confounding will be allowed for via inverse-probability-of-treatment weighting (IPTW). Additional analyses will examine rates and outcomes of pregnancies and explore interactions of these with treatment type and duration.To date 14 hospitals have joined the study and over 2,000 participants have been recruited. A statistical analysis plan has been developed and is described here.Optimise:MS is expected to be a rich source of data on the outcomes of DMTs in real-world conditions over several years of follow-up in an inclusive sample of UK MS patients. Analysis is complicated by the influence of confounding factors including complex treatment histories and a highly variable disease course, but the statistical analysis plan includes measures to mitigate the biases such factors can introduce. It will enable us to address key questions that are beyond the reach of randomized controlled trials." @default.
• W4220667051 created "2022-04-03" @default.
• W4220667051 creator A5016778416 @default.
• W4220667051 creator A5049611050 @default.
• W4220667051 creator A5070529061 @default.
• W4220667051 creator A5087589112 @default.
• W4220667051 date "2022-03-28" @default.
• W4220667051 modified "2023-09-26" @default.
• W4220667051 title "Challenges and Opportunities of Real-World Data: Statistical Analysis Plan for the Optimise:MS Multicenter Prospective Cohort Pharmacovigilance Study" @default.
• W4220667051 cites W1503984541 @default.
• W4220667051 cites W1963805911 @default.
• W4220667051 cites W2009187570 @default.
• W4220667051 cites W2009202077 @default.
• W4220667051 cites W2010698721 @default.
• W4220667051 cites W2015487160 @default.
• W4220667051 cites W2021583648 @default.
• W4220667051 cites W2035138894 @default.
• W4220667051 cites W2039594635 @default.
• W4220667051 cites W2070255966 @default.
• W4220667051 cites W2103672365 @default.
• W4220667051 cites W2110818436 @default.
• W4220667051 cites W2112165124 @default.
• W4220667051 cites W2124876714 @default.
• W4220667051 cites W2142495742 @default.
• W4220667051 cites W2146229086 @default.
• W4220667051 cites W2158299492 @default.
• W4220667051 cites W2296396293 @default.
• W4220667051 cites W2777074421 @default.
• W4220667051 cites W2991623378 @default.
• W4220667051 cites W3147894994 @default.
• W4220667051 cites W3214882418 @default.
• W4220667051 doi "https://doi.org/10.3389/fneur.2022.799531" @default.
• W4220667051 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35418938" @default.
• W4220667051 hasPublicationYear "2022" @default.
• W4220667051 type Work @default.
• W4220667051 citedByCount "0" @default.
• W4220667051 crossrefType "journal-article" @default.
• W4220667051 hasAuthorship W4220667051A5016778416 @default.
• W4220667051 hasAuthorship W4220667051A5049611050 @default.
• W4220667051 hasAuthorship W4220667051A5070529061 @default.
• W4220667051 hasAuthorship W4220667051A5087589112 @default.
• W4220667051 hasBestOaLocation W42206670511 @default.
• W4220667051 hasConcept C126322002 @default.
• W4220667051 hasConcept C177713679 @default.
• W4220667051 hasConcept C17923572 @default.
• W4220667051 hasConcept C197934379 @default.
• W4220667051 hasConcept C201903717 @default.
• W4220667051 hasConcept C23131810 @default.
• W4220667051 hasConcept C23276603 @default.
• W4220667051 hasConcept C2426938 @default.
• W4220667051 hasConcept C26831200 @default.
• W4220667051 hasConcept C2779915747 @default.
• W4220667051 hasConcept C2908647359 @default.
• W4220667051 hasConcept C535046627 @default.
• W4220667051 hasConcept C57658597 @default.
• W4220667051 hasConcept C71924100 @default.
• W4220667051 hasConcept C72563966 @default.
• W4220667051 hasConcept C77350462 @default.
• W4220667051 hasConcept C98274493 @default.
• W4220667051 hasConcept C99454951 @default.
• W4220667051 hasConceptScore W4220667051C126322002 @default.
• W4220667051 hasConceptScore W4220667051C177713679 @default.
• W4220667051 hasConceptScore W4220667051C17923572 @default.
• W4220667051 hasConceptScore W4220667051C197934379 @default.
• W4220667051 hasConceptScore W4220667051C201903717 @default.
• W4220667051 hasConceptScore W4220667051C23131810 @default.
• W4220667051 hasConceptScore W4220667051C23276603 @default.
• W4220667051 hasConceptScore W4220667051C2426938 @default.
• W4220667051 hasConceptScore W4220667051C26831200 @default.
• W4220667051 hasConceptScore W4220667051C2779915747 @default.
• W4220667051 hasConceptScore W4220667051C2908647359 @default.
• W4220667051 hasConceptScore W4220667051C535046627 @default.
• W4220667051 hasConceptScore W4220667051C57658597 @default.
• W4220667051 hasConceptScore W4220667051C71924100 @default.
• W4220667051 hasConceptScore W4220667051C72563966 @default.
• W4220667051 hasConceptScore W4220667051C77350462 @default.
• W4220667051 hasConceptScore W4220667051C98274493 @default.
• W4220667051 hasConceptScore W4220667051C99454951 @default.
• W4220667051 hasFunder F4320308992 @default.
• W4220667051 hasFunder F4320309086 @default.
• W4220667051 hasFunder F4320311647 @default.
• W4220667051 hasLocation W42206670511 @default.
• W4220667051 hasLocation W42206670512 @default.
• W4220667051 hasLocation W42206670513 @default.
• W4220667051 hasLocation W42206670514 @default.
• W4220667051 hasLocation W42206670515 @default.
• W4220667051 hasOpenAccess W4220667051 @default.
• W4220667051 hasPrimaryLocation W42206670511 @default.
• W4220667051 hasRelatedWork W1566271801 @default.
• W4220667051 hasRelatedWork W2041141466 @default.
• W4220667051 hasRelatedWork W2337449242 @default.
• W4220667051 hasRelatedWork W2765233788 @default.
• W4220667051 hasRelatedWork W2766075456 @default.
• W4220667051 hasRelatedWork W3023403406 @default.
• W4220667051 hasRelatedWork W3205211596 @default.
• W4220667051 hasRelatedWork W4221047947 @default.
• W4220667051 hasRelatedWork W4224299476 @default.
• W4220667051 hasRelatedWork W2139156727 @default.
• W4220667051 hasVolume "13" @default.
• W4220667051 isParatext "false" @default.

• next