Category: Statistics

Cardiovasc Revasc Med. 2021 Apr 8:S1553-8389(21)00193-7. doi: 10.1016/j.carrev.2021.04.005. Online ahead of print.

ABSTRACT

BACKGROUND: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed.

METHODS: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up.

RESULTS: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES.

CONCLUSIONS: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

PMID:33903036 | DOI:10.1016/j.carrev.2021.04.005

Pain Manag Nurs. 2021 Apr 23:S1524-9042(21)00120-X. doi: 10.1016/j.pmn.2021.03.007. Online ahead of print.

ABSTRACT

BACKGROUND: Cold therapy is one of the most common nonpharmacologic pain treatments. Despite the existence of many studies about cold therapy, few have examined the effects of cold therapy after abdominal surgery.

AIMS: The purpose of the study was to investigate the effect of cold therapy applied to the incision area after abdominal surgery on postoperative pain and analgesic use.

DESIGN: This study was a randomized controlled trial METHODS: The sample included 60 patients (30 control, 30 experimental) undergoing abdominal surgery. Researchers recorded information from a patient information form, a visual analogue scale (VAS), a pain evaluation form, and the vital signs recording form.

RESULTS: There was no statistically significant difference in pain level between the experimental and control groups as measured by VAS at postoperative hour 1 (p > .05). Furthermore, no statistically significant difference in VAS pain levels between groups was observed at postoperative hours 1, 2, and 8 prior to application of cold therapy (p > .05). Then, when cold therapy was applied at hours 1, 2 and 8, the pain level decreased significantly in the experimental group (p =.001). Pain also decreased in the control group between hours 1 and 8, but this decrease was not as great as that in the experimental group (p = .024).

CONCLUSIONS: Both groups had decreased pain levels, and the decrease in the experimental group was greater than in the control group but cold therapy had no statistically significant effect on analgesics use.

PMID:33903052 | DOI:10.1016/j.pmn.2021.03.007

Eur J Vasc Endovasc Surg. 2021 Apr 23:S1078-5884(21)00190-8. doi: 10.1016/j.ejvs.2021.02.038. Online ahead of print.

ABSTRACT

OBJECTIVE: The decision to undertake a major lower limb amputation can be complex. This review evaluates the performance of risk prediction tools in estimating mortality, morbidity, and other outcomes following amputation.

METHODS: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting on risk prediction tools that predict outcomes following amputation. Outcome measures included the accuracy of the risk tool in predicting a range of post-operative complications, including mortality (both short and long term), peri-operative morbidity, need for re-amputation, and ambulation success. A narrative synthesis was performed in accordance with the Guidance on the Conduct of Narrative Synthesis In Systematic Reviews.

RESULTS: The search identified 518 database records. Twelve observational studies, evaluating 13 risk prediction tools in a total cohort of 61 099 amputations, were included. One study performed external validation of an existing risk prediction tool, while all other studies developed novel tools or modified pre-existing generic calculators. Two studies conducted external validation of the novel/modified tools. Nine tools provided risk estimations for mortality, two tools provided predictions for post-operative morbidity, two for likelihood of ambulation, and one for re-amputation to the same or higher level. Most mortality prediction tools demonstrated acceptable discrimination performance with C statistic values ranging from 0.65 to 0.81. Tools estimating the risk of post-operative complications (0.65 – 0.74) and necessity for re-amputation (0.72) also performed acceptably. The Blatchford Allman Russell tool demonstrated outstanding discrimination for predicting functional mobility outcomes post-amputation (0.94). Overall, most studies were at high risk of bias with poor external validity.

CONCLUSION: This review identified several risk prediction tools that demonstrate acceptable to outstanding discrimination for objectively predicting an array of important post-operative outcomes. However, the methodological quality of some studies was poor, external validation studies are generally lacking, and there are no tools predicting other important outcomes, especially quality of life.

PMID:33903018 | DOI:10.1016/j.ejvs.2021.02.038

Obes Res Clin Pract. 2021 Apr 23:S1871-403X(21)00061-2. doi: 10.1016/j.orcp.2021.04.004. Online ahead of print.

ABSTRACT

PURPOSE: This study evaluated the association between cardiorespiratory fitness, abdominal obesity, blood pressure, endothelial function, and autonomic modulation in school-age adolescents exhibiting different levels of habitual physical activity and nutritional status, through a multivariate statistical approach.

METHODS: 101 adolescents aged 15-18 years (54 females) underwent assessments of daily physical activity, body mass index, cardiorespiratory fitness, reactive hyperemia, and heart rate variability. Based on BMI adjusted for age and sex (z-BMI), 21 adolescents were classified as ‘overweight’ (9 girls), and 9 as ‘obese’ (4 girls). The common variation between those variables was assessed through Principal Component Analysis (PCA).

RESULTS: Main axis of common variation of outcomes analyzed defined four principal components (PCs) accounting for 69.7% of overall variance, related to ‘abdominal obesity and blood pressure’ (PC1; eigenvalue=2.76), ‘cardiorespiratory fitness, endothelial function, and autonomic modulation’ (PC2, eigenvalue=1.98), ‘cardiorespiratory fitness’ (PC3, eigenvalue=1.21), and ‘sedentary behavior’ (PC4, eigenvalue=1.02). Girls reported longer screen time and sedentary behavior than boys. Notwithstanding, in both sexes poorer cardiorespiratory fitness corresponded to lower reactive hyperemia and vagal modulation, irrespective of the nutritional status. Overall, adolescents classified as ‘obese’ and ‘sedentary’ exhibited poorer CRF concomitantly to autonomic and endothelial dysfunctions.

CONCLUSION: In school-age adolescents, endothelial and autonomic dysfunctions related to poor cardiorespiratory fitness, irrespective of the nutritional status and physical activity level. However, endothelial and autonomic dysfunctions were more prevalent among adolescents combining poor cardiorespiratory fitness, reduced levels of daily physical activity, and overweight/obesity.

PMID:33903023 | DOI:10.1016/j.orcp.2021.04.004

Arch Cardiovasc Dis. 2021 Apr 23:S1875-2136(21)00070-X. doi: 10.1016/j.acvd.2020.12.009. Online ahead of print.

ABSTRACT

BACKGROUND: Arterial stiffness has emerged as a strong predictor of cardiovascular disease, end-organ damage and all-cause mortality. Although increased arterial stiffness has been described as a predictor of atrial fibrillation, the relationship between arterial stiffness and atrial fibrillation is uncertain.

AIM: We assessed arterial stiffness in patients with atrial fibrillation compared with that in a control group.

METHODS: We enrolled 151 patients with atrial fibrillation who underwent pulmonary vein isolation (mean age 71.1±9.8 years) and 54 control patients with similar cardiovascular risk profiles and sinus rhythm, matched for age (mean age 68.6±15.7 years) and sex. Aortic distensibility as a measure of arterial stiffness was assessed by transoesophageal echocardiography. Patients with atrial fibrillation were followed over a median of 21 (15 to 31) months.

RESULTS: Compared with control patients, patients with atrial fibrillation had significantly lower aortic distensibility (1.8±1.1 vs. 2.1±1.1 10^-3mmHg^-1; P=0.02). Age (hazard ratio 0.67, 95% confidence interval 0.003 to 0.03; P=0.02) and pulse pressure (hazard ratio -1.35, 95% confidence interval -0.07 to -0.03; P<0.0001) were the strongest predictors of decreased aortic distensibility in the study cohort. This effect was independent of the type of atrial fibrillation (paroxysmal/persistent). During follow-up, decreased aortic distensibility was a predictor of cardiovascular and all-cause hospitalizations, as well as recurrences of atrial fibrillation, with a higher incidence rate of events in patients in the lowest aortic distensibility quartile (P=0.001).

CONCLUSIONS: Aortic distensibility was significantly reduced in patients with atrial fibrillation, with age and pulse pressure showing the strongest correlation, independent of the type of atrial fibrillation. Additionally, decreased aortic distensibility was associated with cardiovascular and all-cause hospitalizations, as well as recurrences of atrial fibrillation, which showed a quartile-dependent occurrence.

PMID:33903034 | DOI:10.1016/j.acvd.2020.12.009

Am J Orthod Dentofacial Orthop. 2021 Apr 23:S0889-5406(21)00187-6. doi: 10.1016/j.ajodo.2020.03.030. Online ahead of print.

ABSTRACT

INTRODUCTION: The relationship between malocclusion, orthodontic treatment, and oral health-related quality of life (OHRQOL) is complicated, with some traits, such as increased overjet, having a potentially greater adverse effect on an adolescent’s OHRQOL. The aim of this study was to evaluate the impact of malocclusion and orthodontic treatment on OHRQOL in adolescents presenting with Class II Division 1 malocclusion and explore the relationship between OHRQOL using a condition-specific and generic instrument and occlusal outcome.

METHODS: Two groups of adolescents were recruited from a United Kingdom university hospital: a pretreatment group of adolescents with Class II Division 1 malocclusion and a treated (posttreatment) group whose Class II Division 1 malocclusion had been corrected. Self-reported OHRQOL was assessed using the malocclusion impact questionnaire (MIQ) and the short form of Child Oral Health Impact Profile questionnaires. Occlusion severity and outcome were assessed using Peer Assessment Rating scores.

RESULTS: A total of 241 participants (106 male; 135 female) were recruited. MIQ scores differed significantly between the pretreatment and posttreatment groups, with scores being 11.35 times lower posttreatment than pretreatment, after adjusting for age and sex (95% confidence interval, -17.28 to -5.42; P <0.001). Females had higher total MIQ scores by 2.6 (95% confidence interval, 0.38 to 4.82), which was statistically significant (P = 0.022). There was a moderate correlation between MIQ and Peer Assessment Rating scores, but this relationship strengthened when omitting the global MIQ questions (Spearman’s correlation coefficient, 0.59).

CONCLUSIONS: Increased overjet was associated with impaired OHRQOL using a condition-specific measure. A deeper understanding of associations between malocclusion, orthodontic treatment, and OHRQOL would benefit from longitudinal evaluation.

PMID:33902978 | DOI:10.1016/j.ajodo.2020.03.030

Am J Orthod Dentofacial Orthop. 2021 Apr 23:S0889-5406(21)00185-2. doi: 10.1016/j.ajodo.2020.03.028. Online ahead of print.

ABSTRACT

INTRODUCTION: The objective of this 2-arm parallel trial was to investigate the recall and comprehension of the information of orthodontic patients undergoing fixed orthodontic treatment using either the verbal explanation supported with the British Orthodontic Society (BOS) leaflet or 3-dimensional (3D) animated content.

METHODS: Patients aged 12-18 years, with no relevant medical history or learning and reading difficulties, who were to undergo orthodontic treatment, were randomized to receive information about fixed orthodontic treatment, using either verbal explanation supported with the BOS leaflet or 3D animated content on the basis of the BOS leaflet. Randomization was performed by block randomization; block size of 4 was used, from which 6 blocks with 6 different sequences (AABB, ABBA, ABAB, BBAA, BAAB, BABA). The blinded author asked patients a series of open-ended questions. The primary outcome measure was the total score of the questions. An independent 2 sample t test was conducted to determine if there was a statistical difference in total questions score between the conventional method (verbal and leaflet) and the 3D animation at the time of consent taking (T0) and again 1 year later (T1). The secondary outcome measure was the time spent by the clinician delivering the information to the patient.

RESULTS: Thirty-two patients were randomized into each group. After 1 year, 1 patient was lost in each group. At the time of consent, the conventional group scored 79.1 ± 18.4 compared with 76.4 ± 12.8 for the 3D animation group with no statistically significant difference (95% confidence interval, -11.0 to 5.3), (P = 0.492). One year later, again, there was no statistically significant difference (P = 0.639) between the conventional group (75.6 ± 12.3) and the 3D animation group (74.4 ± 9.0) (95% confidence interval, -7.0 to 4.4). The average exposure time to the educational intervention in the conventional group was 8.5 minutes more than the 3D animation group.

CONCLUSIONS: The use of 3D animation or verbal and leaflet information is relatively equivalent in transferring knowledge to the orthodontic patient. The use of a 3D animated video reduces the clinician time needed in the clinic to deliver information to the patients and also allows multiple views and better suits the younger generation. Patients undergoing short- or long-term orthodontic treatment do not recall root damage as a risk of orthodontic treatment, which requires special attention from the orthodontist to reinforce this information.

REGISTRATION: This trial was not registered.

PROTOCOL: The protocol was not published before trial commencement.

PMID:33902979 | DOI:10.1016/j.ajodo.2020.03.028

Int J Obstet Anesth. 2021 Mar 11:102973. doi: 10.1016/j.ijoa.2021.102973. Online ahead of print.

ABSTRACT

The incidence of maternal hemorrhage and blood transfusion has increased over time. Causes of massive hemorrhage, defined as a transfusion greater than 10 units of erythrocytes, include abnormal placental insertion, preeclampsia, and placental abruption. Although ratio-based transfusion has been described for managing massive hemorrhage, a goal-directed approach using laboratory or point-of-care data may lead to better outcomes. Autotransfusion, which involves the collection, washing, and filtration of maternal shed blood, avoids many of the complications associated with allogeneic blood transfusion. In this review, we provide an overview of transfusion practices related to the management of obstetric hemorrhage.

PMID:33903001 | DOI:10.1016/j.ijoa.2021.102973

Clin Radiol. 2021 Apr 23:S0009-9260(21)00198-7. doi: 10.1016/j.crad.2021.02.031. Online ahead of print.

ABSTRACT

AIM: To explore the magnetic resonance imaging (MRI) differences between pancreatic neuroendocrine tumour grade 3 (pNET-G3) and pancreatic neuroendocrine carcinoma grade 3 (pNEC-G3).

MATERIALS AND METHODS: Between 2009 and 2019, 31 patients underwent pNEN-G3 resection with preoperative MRI in two local hospitals in China. The 31 patients were assigned to a pNET-G3 group (n=13) or a pNEC-G3 group (n=18). The MRI findings between the groups were compared.

RESULTS: There was no statistically significant difference between the two groups in lesion size, clinical characteristics, or laboratory indexes. The lesions showed high or slightly higher signal on diffusion-weighted imaging and decreased apparent diffusion coefficient (ADC) values, which differed between the two groups (p=0.013). The difference between the groups regarding positive enhancement integral, arterial phase and portal phase signal enhancement ratio were statistically significant; however, the delayed phase signal enhancement ratio was not significantly different.

CONCLUSIONS: pNET-G3 and pNEC-G3 showed different characteristics on MRI. In particular, the ADC value and dynamic enhanced imaging could have an important role in distinguishing between the two.

PMID:33902887 | DOI:10.1016/j.crad.2021.02.031

J Prosthet Dent. 2021 Apr 23:S0022-3913(21)00145-1. doi: 10.1016/j.prosdent.2021.03.007. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The accuracy of intraoral scanners is a prerequisite for the fabrication of dental restorations in computer-aided design and computer-aided manufacturing (CAD-CAM) dentistry. While the precision of intraoral scanners has been investigated in vitro, clinical data on the accuracy of intraoral scanning (IOS) are limited.

PURPOSE: The purpose of this clinical study was to determine the accuracy of intraoral scanning with different devices compared with extraoral scanning.

MATERIAL AND METHODS: An experimental appliance was fabricated for 11 participants and then scanned intraorally and extraorally with 3 different intraoral scanners and a reference scanner. Intraoral and extraoral scans were subdivided into complete-arch and short-span scans and compared with the reference scan to assess trueness. Repeated scans in each group were assessed for precision.

RESULTS: Precision and trueness were higher for extraoral scans compared with intraoral scans, except for complete-arch scans with 1 intraoral scanner. The median precision of short-span scans was higher (extraoral: 22 to 29 μm, intraoral: 23 to 43 μm) compared with complete-arch scans (extraoral: 81 to 165 μm, intraoral: 80 to 198 μm). The median trueness of short-span scans (extraoral: 28 to 40 μm, intraoral: 38 to 47 μm) was higher than that of complete-arch scans (extraoral: 118 to 581 μm, intraoral: 147 to 433 μm) for intraoral and extraoral scanning.

CONCLUSIONS: Intraoral conditions negatively influenced the accuracy of the scanning devices, which was also reduced for the complete-arch scans.

PMID:33902891 | DOI:10.1016/j.prosdent.2021.03.007