Categories
Nevin Manimala Statistics

Radium-223 plus Enzalutamide versus Enzalutamide in Metastatic Castration-Refractory Prostate Cancer: Final Safety and Efficacy Results

Oncologist. 2021 Aug 22. doi: 10.1002/onco.13949. Online ahead of print.

ABSTRACT

LESSONS LEARNED: Long-term safety of radium-223 with enzalutamide was confirmed in this clinical trial. PSA-PFS2 was prolonged with the combination compared with enzalutamide alone.

BACKGROUND: Previously, we showed the combination of radium-223 and enzalutamide to be safe and associated with improved efficacy based on a concomitant decline in serum bone metabolism markers compared with enzalutamide alone in a phase II trial of men with metastatic castration resistant prostate cancer (mCRPC) [1].

METHODS: Secondary endpoints were not included in our initial report, and we include them herein, after a median follow-up of 22 months. These objectives included long term safety, PSA progression-free survival (PFS), and radiographic progression-free survival ; PSA-PFS2 (time from start of protocol therapy to PSA progression on subsequent therapy); time to next subsequent therapy (TTNT); and overall survival (OS). Survival analysis and log-rank tests were performed using the R statistical package v.4.0.2 (https://www.r-project.org). Statistical significance was defined as p < .05.

RESULTS: Of 47 patients (median age, 68 years), 35 received the combination and 12 enzalutamide alone. After a median follow-up of 22 months, final safety results did not show any increase in fractures or other adverse events in the combination arm. PSA-PFS2 was significantly improved, and other efficacy parameters were numerically improved in the combination over the enzalutamide arm.

CONCLUSION: The combination of enzalutamide and radium-223 was found to be safe and associated with promising efficacy in men with mCRPC. These hypothesis-generating results portend well for the ongoing phase III PEACE-3 trial in this setting.

PMID:34423501 | DOI:10.1002/onco.13949

Categories
Nevin Manimala Statistics

A comparative study of the opinions, experiences and individual innovativeness characteristics of operating room nurses on robotic surgery

J Adv Nurs. 2021 Aug 23. doi: 10.1111/jan.15020. Online ahead of print.

ABSTRACT

AIM: To compare and evaluate operating room nurses’ opinions about robotic surgery with their individual innovativeness metric scores. The aim was also to identify the experiences, adaptation processes and influencing factors of operating room nurses working in robotic surgery rooms in Turkey.

DESIGN: This was a comparative descriptive study.

METHODS: The sample included 114 operating room nurses working in 12 institutions that performed robotic surgery in Turkey. Data were collected between January 2018 and September 2019 using the Demographic Characteristics of Nurses and Robotic Surgery Evaluation Form and the Individual Innovativeness Scale, and were analysed using a quantitative statistical approach (independent samples t-test, one-way analysis of variance and Kruskal-Wallis H test). The data obtained from the Robotic Surgery Evaluation section, which consisted of open-ended and closed-ended questions, were analysed with appropriate steps. In particular, answers to open-ended questions were grouped and coded according to their content.

RESULTS: Operating room nurses held positive opinions about robotic surgery. Only 35.8% of the nurses had received training before joining the robotic team, while 55.2% had individually searched for information. Operating room nurses with robotic surgery experience had significantly higher (p < .001) individual innovativeness scores. Over 85% of nurses who received training adapted to robotic surgery in 3 months or less, while nurses with higher individual innovativeness scores adapted in a statistically significantly (p < .05) shorter period. Training, teamwork, and practical experience were mentioned as facilitating factors; inadequate training and technical problems were reported as obstructing factors.

CONCLUSION: Operating room nurses hold positive opinions about robotic surgery; nurses with robotic surgery experience have higher levels of individual innovativeness; and nurses who have received training are significantly better adapted.

IMPACT: What problem did the study address? This study addresses the need for a better understanding of operating room nurses’ opinions and experiences about robotic surgery and the influencing factors of adapting to it. This study also offers an evaluation and comparison of the nurses’ individual innovativeness characteristics and the correlation with their adaptation processes to the new role. What were the main findings? The main findings show a correlation between specific education/training and nurses’ adaptation to the new role of robotic surgery, the individual innovativeness characteristics metric of nurses with or without robotic surgery experience and the time frame of their adaptation. Where and on whom will the research have an impact? This research traces the profile of current operating room nurses working in the robotic surgery field and the factors influencing their experience. These findings and conclusions have a much broader impact than in Turkey alone. The findings raise awareness of the importance of educating and preparing operating room nurses before introducing them to the new roles and responsibilities inherent to robotic surgery.

PMID:34423468 | DOI:10.1111/jan.15020

Categories
Nevin Manimala Statistics

Effects of different feeding intervals on the feeding outcomes of infants who underwent surgical repair of ventricular septal defects

J Card Surg. 2021 Aug 21. doi: 10.1111/jocs.15933. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of the present study is to explore the effect of different feeding intervals on the feeding outcomes of infants who underwent ventricular septal defect (VSD) closure.

METHODS: This study is a prospective, randomized controlled trial conducted by a provincial hospital in China. According to different feeding intervals, 78 eligible participants were randomly divided into Group A (2-h interval, n = 39) and Group B (3-h interval, n = 39). The basic clinical data, total feeding time, incidence of feeding intolerance, and nurse job satisfaction scores of the two groups were collected.

RESULTS: The total feeding time in Group A was significantly longer than that in Group B (142.5 ± 15.4 vs. 132.0 ± 16.1 min/d, p = .020). The nurse job satisfaction scores in Group A were significantly lower than those in Group B (101.7 ± 9.8 vs. 108.8 ± 10.1, p = .005). There were no significant differences in the duration of mechanical ventilation (3.7 ± 1.1 vs. 3.9 ± 1.0 d, p = .272), length of ICU stay (4.5 ± 1.1 d vs. 4.7 ± 0.9 d, p = .451), or length of hospital stay (13.2 ± 1.4 vs. 13.3 ± 1.0 d, p = .642) between the two groups. Although the incidence of feeding intolerance in Group A was slightly lower than that in Group B, the difference was not statistically significant.

CONCLUSION: Feeding at an interval of 2 or 3 h has no significant effect on the feeding outcomes of infants, and feeding at intervals of 3 h can reduce nurses’ workload and improve nursing job satisfaction.

PMID:34423474 | DOI:10.1111/jocs.15933

Categories
Nevin Manimala Statistics

Pediatric aortic valve repair: Any development in the material for cusp extension valvuloplasty?

J Card Surg. 2021 Aug 22. doi: 10.1111/jocs.15931. Online ahead of print.

ABSTRACT

BACKGROUND: Aortic cusp extension is a technique for aortic valve (AV) repairs in pediatric patients. The choice of the material used in this procedure may influence the time before reoperation is required. We aimed to assess postoperative and long-term outcomes of patients receiving either pericardial or synthetic repairs.

METHODS: We conducted a single-center, retrospective study of pediatric patients undergoing aortic cusp extension valvuloplasty (N = 38) with either autologous pericardium (n = 30) or CorMatrix (n = 8) between April 2009 and July 2016. Short- and long-term postoperative outcomes were compared between the two groups. Freedom from reoperation was compared using Kaplan-Meier analysis. Degree of aortic stenosis (AS) and aortic regurgitation (AR) were recorded at baseline, postoperatively, and at outpatient follow-up.

RESULTS: At 5 years after repair, freedom from reoperation was significantly lower in the CorMatrix group (12.5%) compared to the pericardium group (62.5%) (p = .01). For the entire cohort, there was a statistically significant decrease in the peak trans-valvar gradient between preoperative and postoperative assessments with no significant change at outpatient follow-up. In the pericardium group, 28 (93%) had moderate to severe AR at baseline which improved to 11 (37%) postoperatively and increased to 21 (70%) at time of follow-up. In the biomaterial group, eight (100%) had moderate to severe AR which improved to three (38%) postoperatively and increased to seven (88%) at time of follow-up.

CONCLUSION: In terms of durability, the traditional autologous pericardium may outperform the new CorMatrix for AV repairs using the cusp extension method.

PMID:34423475 | DOI:10.1111/jocs.15931

Categories
Nevin Manimala Statistics

Antenatal counselling for prospective parents whose fetus has a neurological anomaly: part 1, experiences and recommendations for service design

Dev Med Child Neurol. 2021 Aug 22. doi: 10.1111/dmcn.15022. Online ahead of print.

ABSTRACT

Prospective parents whose fetus is diagnosed with a neurological anomaly go through a complex range of emotions. They describe their discussions of antenatal counselling from health care professionals as focusing too much on the nature of the anomaly involving unintelligible medical terminology, when what they really want is a picture of the best- and worst-case scenarios. Whilst information on the level of risk for their fetus is important, it is not the parents’ primary concern. When statistics for risk are given, they may not be as well understood as the health care professionals think. This review discusses the published evidence on antenatal counselling and recommendations for explaining risk to parents of fetuses with neurological anomalies. From this data we make recommendations for the organization of antenatal counselling services.

PMID:34423423 | DOI:10.1111/dmcn.15022

Categories
Nevin Manimala Statistics

Social integration after moving to a new city predicts lower systolic blood pressure

Psychophysiology. 2021 Aug 22:e13924. doi: 10.1111/psyp.13924. Online ahead of print.

ABSTRACT

Residential mobility is linked to higher incidence of cardiovascular disease (CVD) and mortality. A mechanism by which residential relocation may impact health is through the disruption of social networks. To examine whether moving to a new city is associated with increased CVD risk and whether the extent to which movers rebuild their social network after relocating predicts improved CVD risk and psychosocial well-being, recent movers (n = 26), and age- and sex-matched nonmovers (n = 20) were followed over 3 months. Blood pressure, C-reactive protein/albumin ratio (CRP/ALB), social network size, and psychosocial well-being were measured at intake (within 6 weeks of residential relocation for movers) and 3 months later. Multiple regression indicated higher systolic blood pressure (SBP) for movers (M = 107.42, SD = 11.39), compared with nonmovers (M = 102.37, SD = 10.03) at intake, though this trend was not statistically significant. As predicted, increases in movers’ social network size over 3 months predicted decreases in SBP, even after controlling for age, sex, and waist-to-hip ratio, b = -2.04 mmHg, 95% CI [-3.35, -.73]. Associations between increases in movers’ social ties and decreases in depressive symptoms and stress were in the predicted direction but did not meet the traditional cutoff for statistical significance. Residential relocation and movers’ social network size were not associated with CRP/ALB in this healthy sample. This study provides preliminary evidence for increased SBP among recent movers; furthermore, it suggests that this elevation in CVD risk may decrease as individuals successfully rebuild their social network.

PMID:34423451 | DOI:10.1111/psyp.13924

Categories
Nevin Manimala Statistics

Outcomes of dental implants in young patients with congenital versus non-congenital missing teeth

Int J Implant Dent. 2021 Aug 23;7(1):92. doi: 10.1186/s40729-021-00362-7.

ABSTRACT

OBJECTIVE: This cross-sectional study aims to investigate the effect of the cause of missing teeth on the survival and subjective success of dental implant treatment (DIT) in young patients with missing teeth due to non-congenital causes (tooth loss) in comparison to patients with missing teeth because of congenital causes (hypodontia and oligodontia).

MATERIAL AND METHODS: All patients were asked 7 questions to extract information about the survival and subjective success of DIT. Implant survival function was designed using the Kaplan-Meier analysis. Differences in implant success outcomes were studied using binary logistic regression analysis.

RESULTS: One hundred ten patients aged 18 to 40 years old were included, whereof 32 patients with tooth loss, 25 patients with hypodontia and 53 patients with oligodontia. In the tooth loss group, implant survival reached 96.9%; in the hypodontia group 96.0%; and in the oligodontia group 88.7%. Regarding subjective implant success, patient satisfaction was significantly higher (p < 0.040) among patients with congenital missing teeth in comparison to patients with tooth loss. Other implant success components showed no statistically significant difference (p > 0.050) between the groups.

CONCLUSION: The cause of missing teeth does not influence implant survival. However, the cause of missing teeth does have a significant impact on patient satisfaction (implant success), ascertaining young patients with congenital missing teeth as more satisfied of DIT than young patients with tooth loss.

CLINICAL RELEVANCE: Young patients with tooth agenesis and with an increased number of missing teeth are more content about the treatment with dental implants than patients with tooth loss. Furthermore, a consensus regarding the assessment of implant success is an essential concern for clarification.

PMID:34423396 | DOI:10.1186/s40729-021-00362-7

Categories
Nevin Manimala Statistics

Interobserver reliability is higher for assessments with 3D software-generated models than with conventional MRI images in the classification of trochlear dysplasia

Knee Surg Sports Traumatol Arthrosc. 2021 Aug 22. doi: 10.1007/s00167-021-06697-3. Online ahead of print.

ABSTRACT

PURPOSE: Trochlear dysplasia is a significant risk factor for patellofemoral instability. The severity of trochlear dysplasia is commonly evaluated based on the Dejour classification in axial MRI slices. However, this often leads to heterogeneous assessments. A software to generate MRI-based 3D models of the knee was developed to ensure more standardized visualization of knee structures. The purpose of this study was to assess the intra- and interobserver agreements of 2D axial MRI slices and an MRI-based 3D software generated model in classification of trochlear dysplasia as described by Dejour.

METHODS: Four investigators independently assessed 38 axial MRI scans for trochlear dysplasia. Analysis was made according to Dejour’s 4 grade classification as well as differentiating between 2 grades: low-grade (types A + B) and high-grade trochlear dysplasia (types C + D). Assessments were repeated following a one-week interval. The inter- and intraobserver agreement was determined using Cohen’s kappa (κ) and Fleiss kappa statistic (κ). In addition, the proportion of observed agreement (po) was calculated for assessment of intraobserver agreement.

RESULTS: The assessment of the intraobserver reliability with regard to the Dejour-classification showed moderate agreement values both in the 2D (κ = 0.59 ± 0.08 SD) and in the 3D analysis (κ = 0.57 ± 0.08 SD). Considering the 2-grade classification, the 2D (κ = 0.62 ± 0.12 SD) and 3D analysis (κ = 0.61 ± 0.19 SD) each showed good intraobserver matches. The analysis of the interobserver reliability also showed moderate agreement values with differences in the subgroups (2D vs. 3D). The 2D evaluation showed correspondences of κ = 0.48 (Dejour) and κ = 0.46 (high / low). In the assessment based on the 3D models, correspondence values of κ = 0.53 (Dejour) and κ = 0.59 (high / low) were documented.

CONCLUSION: Overall, moderate-to-good agreement values were found in all groups. The analysis of the intraobserver reliability showed no relevant differences between 2 and 3D representation, but better agreement values were found in the 2-degree classification. In the analysis of interobserver reliability, better agreement values were found in the 3D compared to the 2D representation. The clinical relevance of this study lies in the superiority of the 3D representation in the assessment of trochlear dysplasia, which is relevant for future analytical procedures as well as surgical planning.

LEVEL OF EVIDENCE: Level II.

PMID:34423397 | DOI:10.1007/s00167-021-06697-3

Categories
Nevin Manimala Statistics

The effect of 12 weeks of mechanical vibration on root resorption: a micro-CT study

Prog Orthod. 2021 Aug 23;22(1):28. doi: 10.1186/s40510-021-00369-1.

ABSTRACT

OBJECTIVE: The aim was to investigate the effect of mechanical vibration on root resorption with or without orthodontic force application.

MATERIAL AND METHODS: Twenty patients who required maxillary premolar extractions as part of orthodontic treatment were randomly divided into two groups of 10: no-force group and force group. Using a split-mouth procedure, each patient’s maxillary first premolar teeth were randomly assigned as either vibration or control side for both groups. A buccally directed vibration of 50 Hz, with an Oral-B HummingBird device, was applied to the maxillary first premolar for 10 min/day for 12 weeks. After the force application period, the maxillary first premolars were extracted and scanned with micro-computed tomography. Fiji (ImageJ), performing slice-by-slice quantitative volumetric measurements, was used for resorption crater calculation. Total crater volumes were compared with the Wilcoxon and Mann-Whitney U tests.

RESULTS: The total crater volumes in the force and no-force groups were 0.476 mm3 and 0.017 mm3 on the vibration side and 0.462 mm3 and 0.031 mm3 on the control side, respectively. There was no statistical difference between the vibration and control sides (P > 0.05). There was more resorption by volume in the force group when compared to the no-force group (P < 0.05).

CONCLUSION: Mechanical vibration did not have a beneficial effect on reducing root resorption; however, force application caused significant root resorption.

PMID:34423388 | DOI:10.1186/s40510-021-00369-1

Categories
Nevin Manimala Statistics

Sex matters: association between callous-unemotional traits and uncinate fasciculus microstructure in youths with conduct disorder

Brain Imaging Behav. 2021 Aug 23. doi: 10.1007/s11682-021-00499-4. Online ahead of print.

ABSTRACT

Among youths with conduct disorder, those with callous-unemotional traits are at increased risk for persistent antisocial behaviour. Although callous-unemotional traits have been found to be associated with white-matter brain abnormalities, previous diffusion imaging studies were conducted in small samples, preventing examination of potential sex by callous-unemotional traits interaction effects on white matter. Here, we used tract-based spatial statistics at a whole-brain level and within regions of interest to compare the white matter correlates of callous-unemotional traits in female vs. male youths with conduct disorder, in a sample (n = 124) recruited through a multi-site protocol. A sex-specific association between callous-unemotional traits and white matter was found in the left uncinate fasciculus, where callous-unemotional traits were positively associated with axial diffusivity in males, while an opposite pattern was found in females. These findings are in line with previous studies suggesting that the uncinate fasciculus is a key tract implicated in the development of psychopathy, but also add to recent evidence showing that sexual dimorphism needs to be taken into account when examining the structural correlates of mental disorders in general, and callous-unemotional traits in conduct disorder in particular.

PMID:34423395 | DOI:10.1007/s11682-021-00499-4