FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2908258778> ?p ?o ?g. }

• W2908258778 endingPage "583" @default.
• W2908258778 startingPage "582" @default.
• W2908258778 abstract "The article by Tettelbach et al1, A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicenter, randomized, controlled study of 110 patients from 14 wound clinics reports on outcomes from a study designed to address an important question. The article purports to provide Level 1 evidence to support findings from studies limited by few participating centres and geographic region. Both the abstract and the title of the article are misleading. Both suggest 110 participants were randomised when, in fact, 126 were randomised, and 16 (nearly 13% of the population) were excluded because of poor execution of eligibility assessment. Another 12 participants did not complete the protocol. This leaves 98 of 126 randomised participants (78%) who were eligible and completed the protocol, dropping this study to Level 2 evidence, not Level 1. These exclusions increase the risk of bias, and the last observation carried forward (LOCF) as a means to include those not followed cannot overcome this bias. The imbalance in plantar ulcer location may be a result of the exclusions. Details should have been included in the Consort diagram as to the disposition at 12 weeks of all randomised participants. The authors included a time-varying covariate in their Cox model, lack of adequate debridement of ulcer during the study period, and did not describe in the Methods section how this variable was included in the model. As a result, it is not possible to evaluate whether this analysis was conducted appropriately. Furthermore, the authors did not mention this study's regulatory status with the United States food and drug administration (FDA) in terms of being conducted under an investigational new drug application (IND) or whether it received a waiver given that the tested intervention would be considered a biologic. A possible limitation to this study is imbalance in perfusion between intervention groups. The inclusions describe “adequate circulation” based on transcutaneous oxygen (TcPO2) values and arterial-brachial index (ABI) values. However, no details of transcutaneous oximetry are provided. A dorsal foot TcPO2 value often does not reflect oxygen levels on the plantar aspect of the foot, or even in regions distant to the TcPO2 measure. In addition, the ABI range specified as an inclusion (0.7–1.2) is a large range and would not rule out more distal arterial insufficiency that could have severely affected outcomes. The opportunity for heterogeneity affecting outcome in this trial is large. The blinded review for efficacy and debridement is a strength; however, because the principle investigators conducted the wound outcome assessment, their awareness of participant allocation may have subconsciously biased the results, favouring the group treated with the product. The study would have been considerably strengthened had it been a double-blind study, with investigators not enrolling participants used as the assessors. It is not difficult to create a sham product, and the authors do not discuss this aspect as a limitation. Adverse events were not assessed in a blinded fashion, and this is a weakness. There was no mention in the results or discussion of the use of hyperbaric oxygen and its potential role, nor was there a table of by-site enrolment and outcome disposition for the reader to evaluate whether these results truly represent a multicentre effort, or if any one site dominated study results. A Kaplan–Meier plot of time to heal for all 126 randomised subjects with censoring as of the time of last follow up would provide a more real-world estimate of use of this product, as would Kaplan–Meier estimates of complete healing at 16 weeks, with inclusion of all randomised participants and appropriate censoring. Finally, Clinicaltrials.gov shows LDS Hospital and Intermountain Medical Center as having “completed data,” but these sites did not participate. In addition, the Clinicaltrials.gov information about this study should be updated to show that the study is over and its results. In conclusion, this study as presented in this report had the potential to contribute Level 1 evidence on this topic but failed in aspects of design, execution, and analysis to meet this bar." @default.
• W2908258778 created "2019-01-11" @default.
• W2908258778 creator A5078244332 @default.
• W2908258778 creator A5087667863 @default.
• W2908258778 date "2018-12-26" @default.
• W2908258778 modified "2023-10-16" @default.
• W2908258778 title "Tettelbach et al fail to meet the bar for Level 1 evidence in their report of dHACM allograft in the management of diabetic foot ulcers" @default.
• W2908258778 cites W2888059637 @default.
• W2908258778 doi "https://doi.org/10.1111/iwj.13059" @default.
• W2908258778 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/7949268" @default.
• W2908258778 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30588747" @default.
• W2908258778 hasPublicationYear "2018" @default.
• W2908258778 type Work @default.
• W2908258778 sameAs 2908258778 @default.
• W2908258778 citedByCount "1" @default.
• W2908258778 countsByYear W29082587782020 @default.
• W2908258778 crossrefType "journal-article" @default.
• W2908258778 hasAuthorship W2908258778A5078244332 @default.
• W2908258778 hasAuthorship W2908258778A5087667863 @default.
• W2908258778 hasBestOaLocation W29082587781 @default.
• W2908258778 hasConcept C134018914 @default.
• W2908258778 hasConcept C141071460 @default.
• W2908258778 hasConcept C142724271 @default.
• W2908258778 hasConcept C168563851 @default.
• W2908258778 hasConcept C1862650 @default.
• W2908258778 hasConcept C188816634 @default.
• W2908258778 hasConcept C204787440 @default.
• W2908258778 hasConcept C2777858829 @default.
• W2908258778 hasConcept C2780385302 @default.
• W2908258778 hasConcept C2908647359 @default.
• W2908258778 hasConcept C555293320 @default.
• W2908258778 hasConcept C71924100 @default.
• W2908258778 hasConcept C99454951 @default.
• W2908258778 hasConceptScore W2908258778C134018914 @default.
• W2908258778 hasConceptScore W2908258778C141071460 @default.
• W2908258778 hasConceptScore W2908258778C142724271 @default.
• W2908258778 hasConceptScore W2908258778C168563851 @default.
• W2908258778 hasConceptScore W2908258778C1862650 @default.
• W2908258778 hasConceptScore W2908258778C188816634 @default.
• W2908258778 hasConceptScore W2908258778C204787440 @default.
• W2908258778 hasConceptScore W2908258778C2777858829 @default.
• W2908258778 hasConceptScore W2908258778C2780385302 @default.
• W2908258778 hasConceptScore W2908258778C2908647359 @default.
• W2908258778 hasConceptScore W2908258778C555293320 @default.
• W2908258778 hasConceptScore W2908258778C71924100 @default.
• W2908258778 hasConceptScore W2908258778C99454951 @default.
• W2908258778 hasIssue "2" @default.
• W2908258778 hasLocation W29082587781 @default.
• W2908258778 hasLocation W29082587782 @default.
• W2908258778 hasOpenAccess W2908258778 @default.
• W2908258778 hasPrimaryLocation W29082587781 @default.
• W2908258778 hasRelatedWork W2115862042 @default.
• W2908258778 hasRelatedWork W2157775732 @default.
• W2908258778 hasRelatedWork W2333098524 @default.
• W2908258778 hasRelatedWork W2340920661 @default.
• W2908258778 hasRelatedWork W2384279291 @default.
• W2908258778 hasRelatedWork W2389704575 @default.
• W2908258778 hasRelatedWork W2516824191 @default.
• W2908258778 hasRelatedWork W2606651167 @default.
• W2908258778 hasRelatedWork W4220834409 @default.
• W2908258778 hasRelatedWork W4256514411 @default.
• W2908258778 hasVolume "16" @default.
• W2908258778 isParatext "false" @default.
• W2908258778 isRetracted "false" @default.
• W2908258778 magId "2908258778" @default.
• W2908258778 workType "article" @default.