Category: Statistics

Scand J Caring Sci. 2021 Apr 24. doi: 10.1111/scs.12991. Online ahead of print.

ABSTRACT

AIM: To investigate if acupuncture reduces nausea and vomiting in terminally ill patients.

DESIGN: A comparative effectiveness research design was used to generate evidence-based knowledge close to practice for the use of clinicians. The sample size was calculated to 136 patients randomised into an intervention and a control group, respectively. Nausea and vomiting were measured using the EORTC QLQ-c15-PAL (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire, core 15, Palliation).

LOCATION: The trial was conducted among terminally ill patients admitted to three in-bed hospices in Demark.

PARTICIPANTS: Terminally ill patients suffering from nausea and/or vomiting; 95% of patients had cancer.

INTERVENTION: The intervention group received acupuncture in addition to usual care for three days. We used the acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang. The control group received usual care only.

RESULTS: In total, 136 patients were randomised, 24 patients withdrew resulting in a total sample of 112 patients: 52 patients in the intervention group and 60 patients in the control group. In the intervention group, 75% of the patients experienced a reduction of their nausea score after the intervention compared to 55% in the control group. The statistical difference was p = 0.028. In the intervention group, 52% of the patients did not experience nausea at all after the intervention compared to 30% in the control group. In the intervention group, 31% of the patients were still vomiting after the intervention compared to 34% in the control group; no statistically significant difference was found.

CONCLUSION: Acupuncture reduced the experience of nausea among terminally ill patients but did not reduce vomiting. Thus, acupuncture is recommended to reduce nausea among terminally ill patients.

PMID:33894009 | DOI:10.1111/scs.12991

Pharmacoecon Open. 2021 Apr 24. doi: 10.1007/s41669-021-00263-w. Online ahead of print.

ABSTRACT

INTRODUCTION: The type of methods used in economic evaluations of health technology can lead to results that may influence decisions. Despite the potential impact on decision making, there is very little documentation of methods used in economic evaluation in oncology pertaining to key assumptions and extrapolation methods of survival benefits, especially in terms of survival analysis techniques and methods for extrapolation.

OBJECTIVES: The primary objectives of this study were to identify, examine, and describe the methods used in economic evaluations in oncology over a 10-year period, while secondary objectives included examining the use of identified methods across different geographic regions.

METHODS: A systematic search of the published oncology literature was conducted to identify economic evaluations of advanced or metastatic cancers published between 2010 and 2019 using the PUBMED, Ovid MEDLINE, and EMBASE databases. A random sample was taken, and information on type of study, data source, modeling techniques, and survival analysis methods were abstracted and descriptively summarized.

RESULTS: A total of 8481 abstracts were identified and 76 economic evaluations were abstracted and assessed. Most identified studies were from North America (38%), East Asia (21%), continental Europe (18%), or the UK (16%), and most commonly focused on lung cancer (18%), colorectal cancer (16%), or breast cancer (13%). A large majority of studies were based on data from randomized controlled trials (82%), utilized a cost-utility approach (82%), and took a public healthcare system perspective (83%). Common model structures included Markov (49%) and partitioned survival (17%). Fitted parametric curves were the most commonly used extrapolation method (89%) for overall survival and most often utilized the Weibull distribution (64%). Secondary assessments showed modest regional variation in the use of identified methods, including the use of fitted parametric curves, testing of the proportional hazards assumption, and validation of results.

CONCLUSION: A majority of papers in the study sample reported basic characteristics of study type, data source used, modeling techniques, and utilization of survival analysis methods. However, greater detail in reporting extrapolation methods, statistical analyses, and validation of results could be potential improvements, especially across regions, in order to support greater consistency in decision making. Future research could document the diffusion of novel modeling techniques into economic evaluation.

PMID:33893974 | DOI:10.1007/s41669-021-00263-w

J Autism Dev Disord. 2021 Apr 23. doi: 10.1007/s10803-021-04988-9. Online ahead of print.

ABSTRACT

The addition of ‘clinically significant impairment’ (American Psychiatric Association, Diagnostic and statistical manual of mental disorders, Author, 2013) to the diagnostic criteria for autism in DSM-5 attempts to establish a threshold for the condition. However, the increased prominence of the neurodiversity paradigm and social model of disability runs counter to the idea that characteristics of autism are fundamentally impairing. Consequently, diagnostic criteria for autism are becoming misaligned with the contemporary views of ‘disorder’ and ‘disability’. In this commentary, we outline six clinical issues that arise from this misalignment during diagnostic assessment for autism, and the tension this creates in making diagnostic decisions. We conclude by considering ways the ‘clinically significant impairment’ criterion could be changed, and the implications this would have on clinical practice, and the concept of autism.

PMID:33893595 | DOI:10.1007/s10803-021-04988-9

Metabolomics. 2021 Apr 23;17(5):44. doi: 10.1007/s11306-021-01795-2.

ABSTRACT

INTRODUCTION: Manganese is important for the endocarditis pathogen Streptococcus sanguinis. Little is known about why manganese is required for virulence or how it impacts the metabolome of streptococci.

OBJECTIVES: We applied untargeted metabolomics to cells and media to understand temporal changes resulting from manganese depletion.

METHODS: EDTA was added to a S. sanguinis manganese-transporter mutant in aerobic fermentor conditions. Cell and media samples were collected pre- and post-EDTA treatment. Metabolomics data were generated using positive and negative modes of data acquisition on an LC-MS/MS system. Data were subjected to statistical processing using MetaboAnalyst and time-course analysis using Short Time series Expression Miner (STEM). Recombinant enzymes were assayed for metal dependence.

RESULTS: We observed quantitative changes in 534 and 422 metabolites in cells and media, respectively, after EDTA addition. The 173 cellular metabolites identified as significantly different indicated enrichment of purine and pyrimidine metabolism. Further multivariate analysis revealed that the top 15 cellular metabolites belonged primarily to lipids and redox metabolites. The STEM analysis revealed global changes in cells and media in comparable metabolic pathways. Glycolytic intermediates such as fructose-1,6-bisphosphate increased, suggesting that enzymes that utilize them require manganese for activity or expression. Recombinant enzymes were confirmed to utilize manganese in vitro. Nucleosides accumulated, possibly due to a blockage in conversion to nucleobases resulting from manganese-dependent regulation.

CONCLUSION: Differential analysis of metabolites revealed the activation of a number of metabolic pathways in response to manganese depletion, many of which are connected to carbon catabolite repression.

PMID:33893555 | DOI:10.1007/s11306-021-01795-2

Clin Oral Investig. 2021 Apr 24. doi: 10.1007/s00784-021-03949-x. Online ahead of print.

ABSTRACT

OBJECTIVE: Treatment of implants with peri-implantitis is often unsuccessful due to residual microbial biofilm hindering re-osseointegration. The aim of this study was to treat biofilm-grown titanium (Ti) implants with different modalities involving air abrasion (AA) and cold atmospheric plasma (CAP) to compare the effectiveness in surface decontamination and the alteration/preservation of surface topography.

MATERIALS AND METHODS: Saliva collected from a peri-implantitis patient was used to in vitro develop human biofilm over 35 implants with moderately rough surface. The implants were then mounted onto standardized acrylic blocks simulating peri-implantitis defects and treated with AA (erythritol powder), CAP in a liquid medium, or a combination (COM) of both modalities. The remaining biofilm was measured by crystal violet (CV). Surface features and roughness before and after treatment were assessed by scanning electron microscope (SEM). The data were statistically analyzed using Kruskal-Wallis followed by Tukey’s multiple comparison test.

RESULTS: In the present peri-implantitis model, the human complex biofilm growth was successful as indicated by the statistical significance between the negative and positive controls. All the treatment groups resulted in a remarkable implant surface decontamination, with values very close to the negative control for AA and COM. Indeed, statistically significant differences in the comparison between the positive control vs. all the treatment groups were found. SEM analysis showed no post-treatment alterations on the implant surface in all the groups.

CONCLUSIONS: Decontamination with AA delivering erythritol with or without CAP in liquid medium demonstrated compelling efficacy in the removal of biofilm from implants. All the tested treatments did not cause qualitative alterations to the Ti surface features. No specific effects of the CAP were observed, although further studies are necessary to assess its potential as monotherapy with different settings or in combination with other decontamination procedures.

CLINICAL RELEVANCE: CAP is a promising option in the treatment of peri-implantitis because it has potential to improve the elimination of bacterial plaque from implant surfaces, in inaccessible pockets or during open-flap debridement, and should stimulate the process of the re-osseointegration of affected dental implants by not altering surface features and roughness.

PMID:33893556 | DOI:10.1007/s00784-021-03949-x

Biomech Model Mechanobiol. 2021 Apr 23. doi: 10.1007/s10237-021-01456-2. Online ahead of print.

ABSTRACT

The phenomenological model for cell shape deformation and cell migration Chen (BMM 17:1429-1450, 2018), Vermolen and Gefen (BMM 12:301-323, 2012), is extended with the incorporation of cell traction forces and the evolution of cell equilibrium shapes as a result of cell differentiation. Plastic deformations of the extracellular matrix are modelled using morphoelasticity theory. The resulting partial differential differential equations are solved by the use of the finite element method. The paper treats various biological scenarios that entail cell migration and cell shape evolution. The experimental observations in Mak et al. (LC 13:340-348, 2013), where transmigration of cancer cells through narrow apertures is studied, are reproduced using a Monte Carlo framework.

PMID:33893558 | DOI:10.1007/s10237-021-01456-2

Microb Ecol. 2021 Apr 23. doi: 10.1007/s00248-021-01759-y. Online ahead of print.

ABSTRACT

The extraction of commercial minerals is often accompanied by the formation of large areas of quarry and dump technogenic ecosystems. This stimulates the search for measures to reduce their negative impact on the environment, as well as a detailed study of all the constituent elements of ecosystems that spontaneously or after reclamation form on them. Primary stages of syngenesis on the tailing dumps of iron ore mines in Kryvorizhzhia took place involving cyanobacteria and eukaryotic algae. The dynamics of the community structures of algae and cyanobacteria depends on the mineralogical composition of tailings, salinity conditions, pH, and content of particles of physical clay and humus. The assessment of the features of the dynamics of algae communities was carried out based on the ordination procedure because of the method of non-metric multidimensional scaling. The considered environmental variables were statistically significant predictors of community structure and could explain 47-90% of the variation in measurements. Diagnostic signs of the species composition of communities of algae and cyanobacteria tailing dumps were established by physical and chemical parameters. An increase in the content of physical clay particles in the substrate and a pH shift towards the alkaline side increased the species richness of cyanobacteria, while an increase in the humus content increased the total species diversity. Based on the specificity of the type of growth and the species composition of algae communities, when describing the primary successions, it is proposed to allocate the following stages of development of algae and cyanobacteria communities: dispersal aerophyton, stratose epilitophyton, algal crust, mixed moss and algal crust, and edaphone.

PMID:33893532 | DOI:10.1007/s00248-021-01759-y

Surg Endosc. 2021 Apr 23. doi: 10.1007/s00464-021-08466-2. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the outcome following the strategy of endoscopic R0 resection (ER) plus adjuvant treatment (AT) versus esophagectomy for esophageal squamous cell cancer in T1a invading muscularis mucosa (M3)-T1b stage.

METHODS: We evaluated the outcomes of 46 esophageal squamous cell cancer (ESCC) patients with T1aM3-T1b stage who underwent ER + AT from the Esophageal Cancer Endoscopic Therapy Consortium (ECETC) and compared these outcomes to 92 patients who underwent esophagectomy. Propensity score matching (1:2) was used, with overall survival (OS) and relapse-free survival (RFS) being compared between the two groups.

RESULTS: During a median follow-up of 32 months, there were no statistical differences (P = 0.226) in OS between the two groups. The 1-, 2-, and 3-year overall survival in the esophagectomy group was 95%, 91%, and 84%, respectively. There were no mortalities within three years in the ER + AT group. The RFS between the two groups was also not significantly different (P = 0.938). The 1-, 2-, and 3-year RFS of patients in the esophagectomy group was 90%, 90%, and 83%, respectively, while it was 97%, 94%, and 74% in the ER + AT group, respectively. The local recurrence rates between the two groups were not significantly different (P = 0.277).

CONCLUSIONS: This first multicenter analysis showed similar outcomes were found regarding OS and RFS between the two groups in T1aM3-T1b stage patients. ER + AT may be considered in high-risk patients or for those who refuse esophagectomy.

PMID:33893544 | DOI:10.1007/s00464-021-08466-2

Parasitol Res. 2021 Apr 24. doi: 10.1007/s00436-021-07147-2. Online ahead of print.

ABSTRACT

Culicoides biting midges are small dipterous insects (Diptera: Ceratopogonidae) which are known to be vectors of arboviruses, bacteria, protozoan and helminth parasites that can cause disease and mortality in livestock and poultry globally. Detailed knowledge of the Culicoides species composition and biology is essential to assess the risk of the introduction and transmission of pathogens. The aim of this study was to obtain data on Culicoides species composition and flying activity in southeastern Lithuania and to determine the meteorological variables related to the abundance of Culicoides biting midges. Biting midges were collected in Verkiai Regional Park, southeastern Lithuania, using an Onderstepoort trap once a week from April to October 2016 and 2018, and from April to July 2019; 7332 Culicoides females belonging to 22 species were identified. Both morphology and DNA barcoding were used for identification. The number of specimens trapped was highest for the Obsoletus Group, followed by Culicoides kibunensis and Culicoides impunctatus. The highest relative abundance and diversity of biting midges were found in May and June. The number of trapped biting midges correlated positively with the mean air temperature. The first biting midges in spring were caught when the mean daily temperature rose higher than 10 °C. No Culicoides were detected when the air temperature dropped below 5 °C in autumn. Wind speed and air humidity had no statistically significant effect on Culicoides abundance.

PMID:33893548 | DOI:10.1007/s00436-021-07147-2

J Orofac Orthop. 2021 Apr 23. doi: 10.1007/s00056-021-00295-1. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this randomized prospective clinical study was to determine whether there are differences between customized lingual brackets and conventional labial brackets regarding the alignment of the mandibular arch and a reduction of the irregularity index during an 18-week treatment interval.

METHODS: A total of 20 patients who presented with class I malocclusion for scheduled orthodontic treatment without tooth extraction were included. The patients were randomly assigned by numbered, opaque, sealed envelopes to treatment with customized lingual brackets or conventional labial brackets. During the initial alignment (T0), 0.012″ (T1), 0.014″ (T2), and 0.016″ (T3) nickel-titanium archwires were applied, respectively, and the control visits were scheduled at 6‑week intervals. In all sessions, digital models were obtained by an intraoral scanning device after removal of the archwire and were analyzed by software. Little’s irregularity index, intercanine width, intermolar width and arch length were evaluated at three time points and were statistically analyzed with a repeated measures analysis of variance (ANOVA). Changes in these measurements at the three intervals (T1-T0, T2-T1, T3-T2) and overall treatment effects were also compared using the Student t‑test.

RESULTS: Comparing the two treatments regimes, intergroup mean values at T0, T1, T2, and T3 were not significantly different regarding the irregularity index, intercanine width, intermolar width and arch length.

CONCLUSION: In this pilot study, no differences between the two treatment approaches could be detected for the phase of initial mandibular alignment.

PMID:33893516 | DOI:10.1007/s00056-021-00295-1