FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4386220229> ?p ?o ?g. }

• W4386220229 abstract "Objective The aim of the study was to assess the viability of auto-injector systems (A-INJ) for preserving investigator blinding in randomized controlled trials (RCT). Background Blinding refers to the concealment of group allocation from one or more individuals involved in a clinical research study. In the dosing of subcutaneous (SC) and intramuscular (IM) investigational medicinal products (IMP), specific challenges arise in maintaining investigator blinding. These challenges primarily involve the active injectate's viscosity and visual appearance (colour/translucency) in comparison to the placebo. Existing methods to control these issues are not perfect. Common approaches include using unblinded investigators or applying films or additives to make the active and placebo injectates appear similar. Method A single-centre experimental and descriptive study was carried out to compare the use of an A-INJ (Owen Mumford, Autoject 2) with the use of a conventional syringe (CS) in delivering a 1 ml dose of both placebo and reference IMP. The percentage delivery of the injectate was compared between the A-INJ IMP and placebo groups. Additionally, eight trained research physicians serving as investigators recorded their assessments of safety and effectiveness after performing serial injections with the A-INJ into a human-tissue analogue. Results Overall, a mean of 95.38% of 1ml placebo injectate was released from the A-INJ, compared to 96.00% from the CS. A total of 94.715% of 1 ml IMP injectate was released from the A-INJ, as opposed to 94.74% from the CS. Independent t-test analyses showed no statistical significance between the experimental arms. The mean administration time was 8.5 seconds. Investigators were unable to differentiate between the two solutions when using the A-INJ. There were no recorded concerns about investigators becoming unblinded, which stands in contrast to concerns associated with using the CS. Conclusion In assessing the viability of A-INJ use in RCTs, we noted a marked improvement when blinding was used. A-INJ systems effectively administer both placebo and active injectates, thereby maintaining the benefit of blinding without the need to alter the placebo through the addition of colourants or viscosity additives. While audio cues from the A-INJ and the time required to administer the injectate pose challenges, solutions are suggested. Although our findings are preliminary, they add to the existing literature on the advantages of A-INJs for administering injectable compounds and offer new perspectives on their utility in RCTs." @default.
• W4386220229 created "2023-08-29" @default.
• W4386220229 creator A5036549315 @default.
• W4386220229 creator A5040934216 @default.
• W4386220229 creator A5082211920 @default.
• W4386220229 creator A5083601745 @default.
• W4386220229 date "2023-08-28" @default.
• W4386220229 modified "2023-10-18" @default.
• W4386220229 title "Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials" @default.
• W4386220229 cites W135508456 @default.
• W4386220229 cites W1718641735 @default.
• W4386220229 cites W2002251042 @default.
• W4386220229 cites W2011855620 @default.
• W4386220229 cites W2020597121 @default.
• W4386220229 cites W2081859324 @default.
• W4386220229 cites W2106238360 @default.
• W4386220229 cites W2125478133 @default.
• W4386220229 cites W2168254750 @default.
• W4386220229 cites W2493163412 @default.
• W4386220229 cites W2955570986 @default.
• W4386220229 cites W2995927882 @default.
• W4386220229 cites W3012372953 @default.
• W4386220229 cites W3098253685 @default.
• W4386220229 cites W3175462489 @default.
• W4386220229 cites W3193959153 @default.
• W4386220229 cites W3201212163 @default.
• W4386220229 cites W4292987041 @default.
• W4386220229 cites W4294281312 @default.
• W4386220229 doi "https://doi.org/10.7759/cureus.44244" @default.
• W4386220229 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37772251" @default.
• W4386220229 hasPublicationYear "2023" @default.
• W4386220229 type Work @default.
• W4386220229 citedByCount "0" @default.
• W4386220229 crossrefType "journal-article" @default.
• W4386220229 hasAuthorship W4386220229A5036549315 @default.
• W4386220229 hasAuthorship W4386220229A5040934216 @default.
• W4386220229 hasAuthorship W4386220229A5082211920 @default.
• W4386220229 hasAuthorship W4386220229A5083601745 @default.
• W4386220229 hasBestOaLocation W43862202291 @default.
• W4386220229 hasConcept C118552586 @default.
• W4386220229 hasConcept C126322002 @default.
• W4386220229 hasConcept C141071460 @default.
• W4386220229 hasConcept C142724271 @default.
• W4386220229 hasConcept C168563851 @default.
• W4386220229 hasConcept C204243189 @default.
• W4386220229 hasConcept C204787440 @default.
• W4386220229 hasConcept C27081682 @default.
• W4386220229 hasConcept C2771230 @default.
• W4386220229 hasConcept C2777288759 @default.
• W4386220229 hasConcept C2778571141 @default.
• W4386220229 hasConcept C535046627 @default.
• W4386220229 hasConcept C71924100 @default.
• W4386220229 hasConceptScore W4386220229C118552586 @default.
• W4386220229 hasConceptScore W4386220229C126322002 @default.
• W4386220229 hasConceptScore W4386220229C141071460 @default.
• W4386220229 hasConceptScore W4386220229C142724271 @default.
• W4386220229 hasConceptScore W4386220229C168563851 @default.
• W4386220229 hasConceptScore W4386220229C204243189 @default.
• W4386220229 hasConceptScore W4386220229C204787440 @default.
• W4386220229 hasConceptScore W4386220229C27081682 @default.
• W4386220229 hasConceptScore W4386220229C2771230 @default.
• W4386220229 hasConceptScore W4386220229C2777288759 @default.
• W4386220229 hasConceptScore W4386220229C2778571141 @default.
• W4386220229 hasConceptScore W4386220229C535046627 @default.
• W4386220229 hasConceptScore W4386220229C71924100 @default.
• W4386220229 hasLocation W43862202291 @default.
• W4386220229 hasLocation W43862202292 @default.
• W4386220229 hasOpenAccess W4386220229 @default.
• W4386220229 hasPrimaryLocation W43862202291 @default.
• W4386220229 hasRelatedWork W1999967090 @default.
• W4386220229 hasRelatedWork W2019275370 @default.
• W4386220229 hasRelatedWork W2043486613 @default.
• W4386220229 hasRelatedWork W2057212716 @default.
• W4386220229 hasRelatedWork W2068364322 @default.
• W4386220229 hasRelatedWork W2076362722 @default.
• W4386220229 hasRelatedWork W2089908284 @default.
• W4386220229 hasRelatedWork W2206548554 @default.
• W4386220229 hasRelatedWork W3207429845 @default.
• W4386220229 hasRelatedWork W4377151426 @default.
• W4386220229 isParatext "false" @default.
• W4386220229 isRetracted "false" @default.
• W4386220229 workType "article" @default.