Category: Statistics

Clin Hemorheol Microcirc. 2022 Dec 23. doi: 10.3233/CH-221658. Online ahead of print.

ABSTRACT

OBJECTIVE: assessment of the effect of a series of 20 whole-body cryotherapy sessions on the morphological and rheological indicators of blood in healthy people.

METHODS: The experimental group consisted of 15 women and 15 men who underwent a series of whole-body cryotherapy treatments. The control group consisted of 15 women and 15 men – without intervention. For the analysis of blood biochemical parameters, venous blood was collected twice: Study 1: on the day of the commencement of whole body cryotherapy / from the control group; and Study 2: after a series of 20 cryotherapy sessions / from the control group (4 weeks).

RESULTS: After whole-body cryotherapy a statistically significant decrease in RBC, HGB, HCT, MCV, EI 0.30 and an increase in MCHC and EI 2.19-60.30 were observed in women, as well as a decrease in MCV, MCH, AI and an increase in PLT, EI 0.30-60.30, AMP, T1/2 in men.

CONCLUSIONS: The use of whole-body cryotherapy causes changes in blood counts in various directions and has a positive effect on the rheological properties of blood in women and men – it increases the elongation index and reduces the aggregation index.

PMID:36565109 | DOI:10.3233/CH-221658

Clin Hemorheol Microcirc. 2022 Dec 23. doi: 10.3233/CH-221610. Online ahead of print.

ABSTRACT

BACKGROUND: Venous malformations tend to retain their slow-flow behavior, even in progressive disease or regression following therapy.

OBJECTIVE: The aim of this study is to analyze the development of acquired hemodynamic relevant arterio-venous fistulae in patients with slow-flow malformations.

METHODS: This study is a retrospective analysis based on a consecutive local registry at a tertiary care Interdisciplinary Center for Vascular Anomalies. Patients with venous malformations and development of secondary arterio-venous fistulae were included. Indications for therapy of the vascular malformation were based on patients’ symptoms and complications. The following endpoints were of clinical interest and were assessed: origin of development of arteriovenous fistula, development of secondary comorbidities as a result of the vascular malformation. For analysis we focused on descriptive statistics.

RESULTS: Out of 1213 consecutive patients with vascular malformations, in 6 patients perfusion changed from slow flow to arterio-venous fast-flow patterns. Four patients developed the fistula after local trauma in the area of the malformation, the other 2 patients developed the fistula due to progression of the disease and recurrent thrombophlebitis. These 2 patients had no trauma or interventions at the time of arterio-venous fistula development.

CONCLUSIONS: Acquired arterio-venous fast-flow fistula in patients with slow flow vascular malformation is very rare and might be a result of local trauma or the progression of the disease with recurrent thrombophlebitis. Specific evidence-based treatment options for these patients do not exist.

PMID:36565106 | DOI:10.3233/CH-221610

J Back Musculoskelet Rehabil. 2022 Dec 15. doi: 10.3233/BMR-220156. Online ahead of print.

ABSTRACT

BACKGROUND: For the treatment of single-level lumbar degenerative disc disease (DDD), oblique lateral interbody fusion (OLIF) has clinical advantages. Whether internal fixation needs to be combined for treatment has been the subject of debate.

OBJECTIVE: To compare the early clinical effects of standalone oblique lateral interbody fusion (S-OLIF) versus OLIF combined with lateral screw fixation of the vertebral body (F-OLIF) on single-level lumbar DDD.

METHODS: A retrospective analysis was performed on the data of 34 patients for whom the OLIF technique was applied to treat single-level lumbar DDD from August 2018 to May 2021. Patients were divided into the S-OLIF (n= 18) and F-OLIF groups (n= 16). Intraoperative blood loss, operative time, and length of hospital stay were recorded. The pain visual analogue scale (VAS) and Oswestry disability index (ODI) before and after the operation were evaluated. The disc height (DH), foraminal height (FH), fused segment lordosis (FSL), lumbar lordosis (LL), cage subsidence, and fusion by CT examination were measured before and after the operation.

RESULTS: The S-OLIF group experienced a shorter operative time and less intraoperative blood loss than the F-OLIF group, and the differences were statistically significant (p< 0.05), but the difference in the length of hospital stay was not statistically significant. The postoperative VAS score and ODI of the two groups were significantly lower than those before the operation, but the postoperative differences between the two groups were not statistically significant. Differences were not statistically significant in postoperative FH, DH, FSL and LL of the two groups. Both groups were followed up for no less than 12 months. In the two groups, fusion was achieved at the last follow-up visit.

CONCLUSION: According to short-term follow-up results, both S-OLIF and F-OLIF can achieve reliable and stable fusion and good clinical effect in the treatment of single-level lumbar DDD.

PMID:36565101 | DOI:10.3233/BMR-220156

Work. 2022 Dec 19. doi: 10.3233/WOR-211318. Online ahead of print.

ABSTRACT

BACKGROUND: Nurses worldwide were exposed to increased levels of occupational stress during the COVID-19 pandemic which could have hindered their level of health-related quality of life (HRQoL).

OBJECTIVES: This project investigated HRQoL level in nurses during the COVID-19 pandemic and its health and occupational predictors.

METHODS: A cross-sectional design was adopted and targeted full-time nurses in Jordan. Study collected data included demographics, 12-item Short Form health survey (SF-12) to measure HRQoL, Nordic musculoskeletal questionnaire (NMQ), nurses’ evaluation of work conditions during COVID-19, and Depression Anxiety Stress Scale (DASS21). Data was analyzed descriptively to summarize main outcome measures and using multiple linear regression model to identify factors significantly associated with HRQoL.

RESULTS: In total 245 nurses successfully completed the survey, 39.6% were males with a mean age of 35±6 years. Participant SF12 scores were 65.94±17.85 for physical component and 50.09±19.36 mental component. The statistical model significantly explained 53.2% of variance in HRQoL (r2 = 0.534, F = 57.849, p < 0.001). Better sleep quality self-evaluation was significantly associated with higher HRQoL levels, while increased levels of depression, musculoskeletal pain, and financial burden on family were significantly associated with worse HRQoL level.

CONCLUSION: Jordanian nurses’ HRQoL level was relatively low during COVID-19. Sleep quality, mental health status, musculoskeletal health status, and financial status were identified as factors possibly influenced HRQoL among nurses during the COVID-19 pandemic. Nurses’ quality of life along with their mental and physical health should be considered by healthcare administrators in the remaining period of COVID-19 and in future similar emergencies.

PMID:36565084 | DOI:10.3233/WOR-211318

Nurs Open. 2022 Dec 24. doi: 10.1002/nop2.1529. Online ahead of print.

ABSTRACT

AIM: Post-embolization syndrome is a common adverse event following trans-arterial chemoembolization, which negatively impacts the daily life of the patients involved. This study examined whether perceptions around post-embolization syndrome and symptom interference among nurses affect their comfort care performance toward patients who have undergone this procedure.

DESIGN: A descriptive cross-sectional study.

METHODS: One hundred and fifty registered nurses were surveyed from September to November 2020. Perceived post-embolization syndrome, symptom interference, and comfort care (including physical, psychospiritual, sociocultural, and environmental dimensions) were measured. Data were analyzed using t-tests, analysis of variance, Pearson’s correlation, and a multivariate analysis of variance.

RESULTS: There were no individual effects found of perceived post-embolization syndrome or symptom interference on nurses’ comfort care performance. However, statistically significant interaction effects were found in terms of their sociocultural and environmental care.

CONCLUSION: Nurses who recognized both high post-embolization syndrome and symptom interference among their patients were found to provide greater sociocultural and environmental care. As such, nurses should improve their early symptom and symptom interference detection protocols based on current care guidelines and provide physical, psychospiritual, sociocultural, and environmental comfort care.

PMID:36565057 | DOI:10.1002/nop2.1529

Stat Med. 2022 Dec 24. doi: 10.1002/sim.9632. Online ahead of print.

ABSTRACT

Multivariate outcomes are common in pragmatic cluster randomized trials. While sample size calculation procedures for multivariate outcomes exist under parallel assignment, none have been developed for a stepped wedge design. In this article, we present computationally efficient power and sample size procedures for stepped wedge cluster randomized trials (SW-CRTs) with multivariate outcomes that differentiate the within-period and between-period intracluster correlation coefficients (ICCs). Under a multivariate linear mixed model, we derive the joint distribution of the intervention test statistics which can be used for determining power under different hypotheses and provide an example using the commonly utilized intersection-union test for co-primary outcomes. Simplifications under a common treatment effect and common ICCs across endpoints and an extension to closed-cohort designs are also provided. Finally, under the common ICC across endpoints assumption, we formally prove that the multivariate linear mixed model leads to a more efficient treatment effect estimator compared to the univariate linear mixed model, providing a rigorous justification on the use of the former with multivariate outcomes. We illustrate application of the proposed methods using data from an existing SW-CRT and present extensive simulations to validate the methods.

PMID:36565050 | DOI:10.1002/sim.9632

Int Endod J. 2022 Dec 24. doi: 10.1111/iej.13884. Online ahead of print.

ABSTRACT

AIM: To explore the effects of phase-transited lysozyme (PTL) coated dentine slices on cell adhesion, migration and odontogenic differentiation of human dental pulp cells (HDPCs).

METHODOLOGY: Cell growth and cell cycle analysis were conducted to verify the biocompatibility of PTL for HDPCs. Cell adhesion, cell morphology and proliferation were explored by DiI staining, Scanning electron microscopy (SEM), and MTT assay. Cell migration was investigated by Transwell assay. The effects of PTL on the odontogenesis and mineralization of HDPCs were assessed by Real-time quantitative polymerase chain reaction (RT-qPCR) and Western blot (WB). The mineralization of HDPCs was evaluated by Alizarin red staining. HDPCs were isolated from extracted third molars. The level of statistically significant difference was accepted at P<0.05.

RESULTS: PTL showed no negative effect on cell cycle of HDPCs and compared with the blank group, HDPCs labelled with DiI staining showed significantly more adhered cells at 48h (P<0.05), extending cell processes and more finger-like or reticular pseudopodia on PTL-coated dentine slices. The results of MTT and Transwell assay showed that PTL promoted the proliferation (P<0.05) and migration (P<0.01) of HDPCs respectively. Compared with the blank group, the gene expression of dentine sialophosphoprotein (DSPP), osteopontin (OPN) and bone sialoprotein (BSP) in HDPCs cultured on PTL was significantly upregulated on day 3 and 7 (P<0.05), while the protein expression of DSPP showed no significant change on both day 7 and day 14. Alizarin red staining showed that PTL promoted more mineralization nodules formation of HDPCs (P<0.05).

CONCLUSIONS: PTL promoted the adhesion, proliferation and migration of HDPCs on dentine slices, and positively affected odontogenic differentiation and mineralization of HDPCs.

PMID:36565046 | DOI:10.1111/iej.13884

Mol Nutr Food Res. 2022 Dec 24:e2200615. doi: 10.1002/mnfr.202200615. Online ahead of print.

ABSTRACT

SCOPE: The primary aim of the present study was to study the effect of acute ketosis on parameters of appetite regulation in prediabetes. The secondary aim was to investigate whether the effect is influenced by eating behaviours.

METHODS AND RESULTS: This was a randomised controlled trial. After an overnight fast, 18 adults with prediabetes (defined in line with the American Diabetes Association criteria) were assigned to consume either a ketone monoester (D-β-hydroxybutyrate-(R)-1,3 butanediol) drink (energy content 123 kcal) or a placebo drink (containing virtually no calories) in cross-over fashion. Blood samples were collected every 30 mins, from baseline to 150 minutes. Paired t-test was used to compare the total area under the curve (AUC) for the changes in parameters of appetite regulation (acylated ghrelin, peptide YY (PYY), and hunger) following both drinks. Eating behaviours were determined with the use of the three-factor eating questionnaire. Significant elevation in blood β-hydroxybutyrate from 0.2 mmol/L to 3.5 mmol/L (p < 0.001) was achieved within 30 minutes. Acute ketosis did not result in statistically significant differences in the AUCs for ghrelin, PYY, and hunger. No statistically significant difference in the AUCs was also observed when participants were stratified by their eating behaviours.

CONCLUSION: Acute ketosis consistently did not affect both objective and subjective parameters of appetite regulation in prediabetes. No subset of people with prediabetes according to eating behaviours had a significant effect of acute ketosis on appetite regulation. This article is protected by copyright. All rights reserved.

PMID:36565045 | DOI:10.1002/mnfr.202200615

Int Endod J. 2022 Dec 24. doi: 10.1111/iej.13886. Online ahead of print.

ABSTRACT

INTRODUCTION: Regenerative endodontic procedures have been recently suggested as a treatment of mature permanent teeth with peri-apical periodontitis due to favorable outcomes in the resolution of signs and symptoms and the healing of apical periodontitis. Most of the randomized clinical trials were conducted for anterior teeth rather than mature molar teeth.

AIM: To evaluate the postoperative pain and the healing of necrotic mature permanent mandibular molar teeth with peri-apical periodontitis after conventional endodontic treatment versus after PRP revascularization.

METHODS: The protocol of this randomized clinical trial was registered at www.

CLINICALTRIALS: gov with identification number NCT03350841. Twenty-eight patients were included in the study after confirming the diagnosis clinically and radiographically. In the first visit, the mandibular molar teeth of both groups were mechanically prepared. The double antibiotic paste was injected into the canals and the cavity was sealed using glass ionomer. At the second visit, the patients were randomized either to the control group where the endodontic treatment was completed by lateral condensation technique or assigned to the intervention group where PRP revascularization was used. The degree of spontaneous pain was assessed using a numerical rating scale (NRS) pre-operatively, then post-operatively after 6, 12 hours and daily for 5 days. Patients were given a placebo to be administrated in case of pain. An analgesic (ibuprofen 400mg) was prescribed in case of persistent pain. Clinical and radiographic healing was assessed after 6 and 12 months. All demographic, baseline and outcome data were statistically analyzed.

RESULTS: Regarding the post-revascularization/ obturation pain, there was no statistically significant difference between the severity of pain in the two groups at all time intervals except after 12 hours, revascularization group showed a statistically significantly higher prevalence of no pain than the endodontic treatment group. Regarding the healing; the peri-apical lesions decrease in size significantly from the pre-operative lesion size in both groups without significant difference.

CONCLUSION: Both PRP revascularization and endodontic treatment resulted in a significant reduction in peri-apical lesion size related to mature necrotic mandibular molar teeth but further randomized clinical trials with standardized techniques, larger sample sizes and longer follow-up periods are recommended.

PMID:36565044 | DOI:10.1111/iej.13886

Int Endod J. 2022 Dec 23. doi: 10.1111/iej.13885. Online ahead of print.

ABSTRACT

AIM: To compare the odontogenic differentiation potential of a composite scaffold (CSHA) comprising of nanohydroxyapatite (nHAp) and carboxymethyl-chitosan (CMC) with Biodentine on human dental pulp stem cells (hDPSCs).

METHODOLOGY: A CSHA scaffold was prepared through an ultrasonication route by adding nHAp and CMC (1:5 w/w) in water medium followed by freeze-drying. Physico-chemical characterization was achieved using scanning electron microscopy with energy dispersive X-ray spectroscopy, X-ray diffraction and Fourier transform infrared spectroscopy. In-vitro bioactivity and pH assessments were done by soaking in simulated body fluid (SBF) for 28 days. The angiogenic and odontogenic differentiation abilities were assessed by expression of vascular endothelial growth factor (VEGF) and Dentine sialophosphoprotein (DSPP) markers on cultured hDPSCs by flow-cytometry and RT-qPCR at 7,14 and 21 days. Cell viability/proliferation and biomineralization abilities of CSHA were compared with Biodentine by MTT assay, alkaline phosphatase (ALP) activity, Alizarin Red Staining (ARS) and osteopontin (OPN) expression on hDPSCs following 7 and 14 days. Data were statistically analyzed with Kruskal Wallis and Friedman tests as well as one way ANOVA followed by appropriate post hoc tests (p < 0.05).

RESULTS: Characterization experiments revealed a porous microstructure of CSHA with pore diameter ranging between 60-200 μm and 1.67 Ca/P molar ratio along with the characteristic functional groups of both HAp and CMC. CSHA displayed bioactivity in SBF by forming apatite-like crystals and maintained a consistent pH value of 7.70 during 28 days’ in-vitro studies. CSHA significantly upregulated VEGF and DSPP levels on hDPSCs on day 21 compared with day 7 (p < 0.05). Further, CSHA supported cell viability/proliferation over 14 days like Biodentine with no statistical differences (p > 0.05). However, CSHA exhibited increased ALP and ARS activity with an intense OPN staining compared with Biodentine after 14 days (p < 0.05).

CONCLUSION: The results highlighted the odontogenic differentiation and biomineralization abilities of CSHA on hDPSCs with significant VEGF and DSPP gene upregulations. Further, CSHA exhibited enhanced mineralization activity than Biodentine, as evidenced by increased ALP, ARS and OPN activity on day 14. The nHAp-CMC scaffold has the potential to act as an effective pulp capping agent, however, this needs to be further validated through in-vivo animal studies.

PMID:36565040 | DOI:10.1111/iej.13885