Purpose: Mesenchymal stem/stromal cell therapy may reduce radiation-induced xerostomia. We investigated the long-term safety of autologous adipose tissue-derived mesenchymal stem/stromal cells (ASC) injections into the submandibular glands. Patients and Methods: A investigator-initiated, randomized, single-center, placebo-controlled trial. Previous oropharyngeal squamous cell carcinoma patients with radiation-induced xerostomia were randomly (1:1) allocated to receive a 2.8 million ASCs/cm3 injection or placebo in both submandibular glands and followed for minimally 2 years. The primary endpoint was number of serious adverse events (SAEs). Secondary endpoints included whole saliva flow rates and xerostomia-related symptoms. Data analysis was based on the intention-to-treat (ITT) population using repeated measures mixed-effects linear models. Results: Thirty-three patients were randomized; 30 patients were treated (ASC group, n=15; placebo group, n=15). Long-term safety data were collected from all 30 patients. During follow-up, 6/15 (40%) of the ASC-treated patients versus 5/15 (33%) of the placebo patients experienced an SAE; no SAEs appeared to be treatment-related. Unstimulated whole saliva flow rate increased to 0.20 and 0.16 mL/min in the ASC and placebo group, respectively, yielding a 0.05 mL/min (95% CI: 0.00 to 0.10, P=.051) difference between groups. Patient-reported xerostomia symptoms diminished according to a decreased Xerostomia Questionnaire summary score of 35.0 and 45.1, respectively (-10.1 [-18.1 to -2.2], P=.013). Three of the Visual Analog Scale xerostomia measures indicated clinical benefit following use of ASC. Conclusions:Our data show that ASC therapy is safe with a clinically relevant effect on xerostomia-related symptoms. Confirmation in larger randomized controlled trials is warranted.
Purpose To perform a systematic review of the effect of simulation-based training (SBT) of percutaneous abdominal and thoracic ultrasound-guided procedures and to assess the transfer of procedural competence to a clinical context. Materials and Methods This systematic review was conducted in accordance with the PRISMA statement. Pubmed, Embase, Web of Science, and the Cochrane Library were searched for studies assessing procedural competence after SBT. Two authors independently reviewed all studies and extracted data. Risk of bias was assessed using the Cochrane tool for randomized studies (RoB) and non-randomized studies (ROBINS-I). Quality of evidence was assessed using the GRADE approach. Results 42 studies were included. 6 were randomized controlled, 3 non-randomized controlled, and 33 non-randomized non-controlled. 26 studies examined US-guided abdominal procedures, 13 examined thoracic procedures, and 3 examined both. The results favored SBT compared to other educational interventions and found that training was superior to no training. Only two studies examined the transfer of procedural skills to a clinical context. All studies had a high or critical risk of bias. Thus, the quality of evidence for the effect of SBT on procedural competence was low, and evidence for its transfer to a clinical context was very low. Conclusion The evidence supporting SBT of percutaneous abdominal and thoracic US-guided procedures remains insufficient due to methodological problems and a high risk of bias. Future studies should be randomized and single-blinded, use assessment tools supported by validity evidence, compare different educational strategies, and examine the transfer of skills to a clinical setting.
Consistent annotation of data is a prerequisite for the successful training and testing of artificial intelligence-based decision support systems in radiology. This can be obtained by standardizing terminology when annotating diagnostic images. The purpose of this study was to evaluate the annotation consistency among radiologists when using a novel diagnostic labeling scheme for chest X-rays. Six radiologists with experience ranging from one to sixteen years, annotated a set of 100 fully anonymized chest X-rays. The blinded radiologists annotated on two separate occasions. Statistical analyses were done using Randolph’s kappa and PABAK, and the proportions of specific agreements were calculated. Fair-to-excellent agreement was found for all labels among the annotators (Randolph’s Kappa, 0.40–0.99). The PABAK ranged from 0.12 to 1 for the two-reader inter-rater agreement and 0.26 to 1 for the intra-rater agreement. Descriptive and broad labels achieved the highest proportion of positive agreement in both the inter- and intra-reader analyses. Annotating findings with specific, interpretive labels were found to be difficult for less experienced radiologists. Annotating images with descriptive labels may increase agreement between radiologists with different experience levels compared to annotation with interpretive labels.
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