Association of Multimodal Pain Control with Patient-Reported Outcomes in Children Undergoing Surgery

IntroductionOur aim was to describe practices in multimodal pain management at US children's hospitals and evaluate the association between non-opioid pain management strategies and pediatric patient-reported outcomes (PROs).MethodsData were collected as part of the 18-hospital ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) clinical trial. Non-opioid pain management strategies included use of preoperative and postoperative non-opioid analgesics, regional anesthetic blocks, and a biobehavioral intervention. PROs included perioperative nervousness, pain-related functional disability, health-related quality of life (HRQoL). Associations were analyzed using multinomial logistic regression models.ResultsAmong 186 patients, 62 (33%) received preoperative analgesics, 186 (100%) postoperative analgesics, 81 (44%) regional anesthetic block, and 135 (73%) used a biobehavioral intervention. Patients were less likely to report worsened as compared to stable nervousness following regional anesthetic block (relative risk ratio [RRR]:0.31, 95% confidence interval [CI]:0.11–0.85), use of a biobehavioral technique (RRR:0.26, 95% CI:0.10–0.70), and both in combination (RRR:0.08, 95% CI:0.02–0.34). There were no associations of non-opioid pain control modalities with pain-related functional disability or HRQoL.ConclusionUse of postoperative non-opioid analgesics have been largely adopted, while preoperative non-opioid analgesics and regional anesthetic blocks are used less frequently. Regional anesthetic blocks and biobehavioral interventions may mitigate postoperative nervousness in children.Level of evidenceIII.     

Minimum information to report about a flow cytometry experiment on extracellular vesicles: Communication from the ISTH SSC subcommittee on vascular biology

The Extracellular Vesicle Flow Cytometry Working Group ( http://www.evflowcytometry.org ) is formed by members of the International Society for Extracellular Vesicles (ISEV), the International Society for Advancement of Cytometry (ISAC), and the International Society on Thrombosis and Haemostasis (ISTH). This working group of flow cytometry experts develops guidelines for best practices regarding flow cytometry detection of extracellular vesicles. To improve rigor and standardization, this working group published a framework outlining the minimal information to report about a flow cytometry experiment on extracellular vesicles (MIFlowCyt-EV) in the Journal of Extracellular Vesicles, the ISEV journal, in 2020. In parallel, an article explaining MIFlowCyt-EV was published in Cytometry Part A, one of the ISAC journals, and now will be introduced to the ISTH as an SSC Communication in the Journal of Thrombosis and Haemostasis. The goal of this SSC Communication is to explain why flow cytometry is becoming the instrument of choice to characterize single extracellular vesicles, the obstacles that have been identified and (mostly) overcome by developing procedures to calibrate flow cytometers, and the relevance of reporting minimal information to improve reliability and reproducibility of experiments in which flow cytometers are used for characterization of extracellular vesicles.     

Alzheimer's Disease THErapy With NEuroaid (ATHENE): A Randomized Double-Blind Delayed-Start Trial

ObjectivesPreclinical and clinical studies indicate a role for MLC901 (NeuroAiD II) in Alzheimer's disease (AD). The primary aim was to investigate its safety as add-on therapy to standard treatment and the secondary aims its effect on cognition and slowing disease progression.DesignRandomized double-blind placebo-controlled delayed-start study.Setting and ParticipantPatients with mild to moderate probable AD by NINCDS-ADRDA criteria, stable on acetylcholinesterase inhibitors or memantine (n = 125), were randomized to receive MLC901 (early starters) or placebo (delayed starters) for 6 months, followed by a further 6 months when all patients received MLC901, in a delayed-start design (clinical trial registration: ClinicalTrials.gov, NCT03038035).MethodsThe primary outcome measure was occurrence of serious adverse events (SAEs) at 6 months. Secondary outcomes included the Alzheimer's Disease Assessment Scale–Cognitive subscale (ADAS-Cog) and other assessment scales.ResultsThere was no significant difference in the risk of SAEs between early and delayed starters at month (M) 6 (22.6% vs 27.0%, risk difference ?4.4%, 90% CI –16.9% to 8.3%). Similarly, there was no significant difference in the risk of adverse events and the occurrence of stroke or vascular events between early and delayed starters throughout the 12-month study period. Early starters did not differ significantly on ADAS-Cog from delayed starters at M6 [mean difference (MD) ?1.0, 95% CI –3.3 to 1.3] and M12 (MD –2.35, 95% CI –5.45 to 0.74) on intention-to-treat analysis. Other cognitive assessment scales did not show significant differences.Conclusions and ImplicationsThis study of 125 persons with dementia found no evidence of a significant increase in adverse events between MLC901 and placebo, thus providing support for further studies on both efficacy and safety. Analyses suggest the potential of MLC901 in slowing down AD progression, but this requires further confirmation in larger and longer studies using biomarkers for AD.     

Medición automática de la zona avascular foveal de ojos sanos en angiografía por tomografía de coherencia óptica de dominio espectral Heidelberg

PurposeTo develop and evaluate an automated method to measure the foveal avascular zone (FAZ) area in healthy eyes on Heidelberg Spectralis Optical Coherence Tomography Angiography (HS-OCTA). This method is referred to as the modified Kanno-Saitama macro (mKSM) which is an evolution of the Kanno-Saitama macro (KSM) approach.MethodsThis cross-sectional study included 29 eyes of 25 healthy volunteers who underwent HS-OCTA at the macular area twice at the same time. Regardless of the quality of the images, all of them were included. Macular data on the superficial vascular plexus, intermediate capillary plexus (ICP) and deep capillary plexus were processed by mKSM. The FAZ area was measured twice automatically using the mKSM and KSM and twice manually by two independent examiners.ResultsFrom 174 images, KSM could not measure correctly 31% while mKSM could successfully measure all of them. Intrascan intraclass coefficient ranged from 0.948 to 0.993 for manual measurements and was 1 for mKSM method. Despite that the difference between human examiners is smaller than between human examiners and mKSM according to Bland-Altman plots, the scatterplots show a strong correlation between human and automatic measurements. The best results are obtained in ICP.ConclusionsWith mKSM, the automated determination of the FAZ area in HS-OCTA is feasible and less human-dependent. It solves the inability of KSM to measure the FAZ area in suboptimal quality images which are frequent in daily clinical practice. Therefore, the mKSM processing could contribute to our understanding of the three vascular plexuses.     

Changes in Health Literacy during the first year following a kidney transplantation: Using the Health Literacy Questionnaire

ObjectivesThe study aimed to identify changes in health literacy (HL) and associated variables during the first year following a kidney transplantation.MethodsA total of 196 transplant recipients were included in a prospective follow-up study. The patients answered the Health Literacy Questionnaire (HLQ) at 5 days, 8 weeks, 6 and 12 months following the kidney transplantation. Mixed linear models were used to analyze changes in HL and backward elimination was used to identify variables associated with HL.ResultsTwo main patterns of change were identified: a) HL increased during the first 8 weeks of close follow-up and b) in several domains, the positive increase from 5 days to 8 weeks flattened out from 5 days to 6 and 12 months. Self-efficacy, transplant-related knowledge, and general health were core variables associated with HL.ConclusionsOverall, HL increased during the 8 weeks of close follow-up following the kidney transplantation, while 6 months seem to be a more vulnerable phase. Furthermore, low self-efficacy, less knowledge, and low self-perceived health may represent vulnerable characteristics in patients.Practical implicationsFuture kidney transplant care should take into account patients’ access to and appraisal of health information and social support, and draw attention to potentially vulnerable groups.     

A Perioperative Care Display for Understanding High Acuity Patients

Background  The data visualization literature asserts that the details of the optimal data display must be tailored to the specific task, the background of the user, and the characteristics of the data. The general organizing principle of a concept-oriented display is known to be useful for many tasks and data types. Objectives  In this project, we used general principles of data visualization and a co-design process to produce a clinical display tailored to a specific cognitive task, chosen from the anesthesia domain, but with clear generalizability to other clinical tasks. To support the work of the anesthesia-in-charge (AIC) our task was, for a given day, to depict the acuity level and complexity of each patient in the collection of those that will be operated on the following day. The AIC uses this information to optimally allocate anesthesia staff and providers across operating rooms. Methods  We used a co-design process to collaborate with participants who work in the AIC role. We conducted two in-depth interviews with AICs and engaged them in subsequent input on iterative design solutions. Results  Through a co-design process, we found (1) the need to carefully match the level of detail in the display to the level required by the clinical task, (2) the impedance caused by irrelevant information on the screen such as icons relevant only to other tasks, and (3) the desire for a specific but optional trajectory of increasingly detailed textual summaries. Conclusion  This study reports a real-world clinical informatics development project that engaged users as co-designers. Our process led to the user-preferred design of a single binary flag to identify the subset of patients needing further investigation, and then a trajectory of increasingly detailed, text-based abstractions for each patient that can be displayed when more information is needed.     

Comparison of three different types of splints and templates for maxilla repositioning in bimaxillary orthognathic surgery: a randomized controlled trial

The selection and implementation of a plan for maxillary surgery is of the utmost importance in achieving the desired outcome for the patient undergoing two-jaw orthognathic surgery. Some splint-based and splintless methods, accompanied by computer-assisted techniques, are helpful in improving surgical plan implementation. However, randomized controlled trials focused on this procedure are lacking. This study included 61 patients who underwent bimaxillary surgeries. The patients were randomly assigned to a conventional resin occlusal splint (CROS) group, a digital occlusal splint (DOS) group, or a digital templates (DT) group, in a 1:1:1 ratio. The mean linear distance between the planned and actual postoperative positions of eight selected points on the surfaces of the maxillary teeth was selected as the outcome measure. The distance was significantly smaller in the DT group (1.17 ± 0.66 mm) when compared to both the CROS group (2.55 ± 0.95 mm, P < 0.05) and DOS group (2.15 ± 1.12 mm, P < 0.05). However, the difference between the CROS group and DOS group was not statistically significant. These findings indicate that using digital templates results in the best performance in transferring the surgical plan to the operation environment as compared to the other two types of splints. This suggests that the application of digital templates could provide a reliable treatment option.     

应用 σ度量对深圳市龙华区三家综合医院临床生化检验结果互认的评价研究

目的　探讨 σ度量在深圳市龙华区三家综合医院临床生化检验结果互认中的应用价值。方法　收集三家医院 2019年广东省临检中心常规化学，特殊蛋白前两次的室间质评（ EQA）样本，经混匀并分割成比对样本送至各评价实验室进行检测；以卫生部临检中心（ NCCL)标准和生物学变异导出的允许总误差（ TEa%）为质量规范，通过加权法计算出各项目 2019年 1～ 6月期间室内质控在控数据的不精密度，以 2018年参加卫生部室间质评（ EQA）数据作为偏倚（ bias%）来源，计算三家医院 29个检验项目的 σ度量值并进行性能评价，利用质量目标指数（ QGI)提出改善方法；将评价项目的 σ度量值与直接比对试验进行比较，通过统计分析确定 σ截断值（ cut-off）。结果　①三家医院 29个生化项目的性能并不一致，将项目中、高值的 σ值进行配对 t检验，其 t值分别为 2.28，3.01和 0.74，按 α =0.05水准判断得出医院 A与 B，医院 A与 C间的性能差异有统计学意义，医院 B与 C间的性能差异无统计学意义，医院 A项目性能要优于 B，C医院。评估的 87个项目中有 53项 σ平均值 <6，根据 QGI判断，3个项目需优先改善准确度，10个项目需同步改善准确度和精密度，另 40个项目需优先改善精密度。②对医院间项目比对通过率进行配对 χ2检验，其 χ2分别为 5.33，6.25和 2.5，按α=0.05水准判断， B与 A医院比对通过率低于 C与 A医院、 C与 B医院，差异有统计学意义； C与 A医院比对通过率跟 C与 B医院差异无统计学意义。③将 σ度量值与直接比对试验进行比较，经配对 χ2检验，当 σ cut-off值取≥ 2σ， ≥ 3σ，≥ 4σ，≥ 5σ和≥ 6σ时，其 χ2分别为 7.20，0.00，9.09，15.06和 16.06，按 χ20.05，1=3.84，α=0.05水准判断，当σcut-off值取≥ 3σ时，两种比对方法的差异无统计学意义。结论　σ度量值可以单独用于评价医院间生化检验结果的互认，在判断项目是否具有可比性时，可考虑将 σ cut-off值设为≥ 3σ。