Search

Summary Objectives The vocal tract discomfort scale is a self-rating seven-point Likert scale that quantifies frequency and severity of eight qualitative descriptors including burning, tight, dry, aching, tickling, sore, irritable, and lump in the throat, and ranges from 0 (never/none) to 6 (always/extreme; Mathieson et al. 2009). The objectives of the current study were to compare the vocal tract discomfort scale results between elementary school teachers and high school teachers and between male and female teachers using the Persian vocal tract discomfort scale. Also, teachers in different age ranges and with different experiences were compared regarding vocal tract discomfort symptoms. Methods The researchers chose 20 elementary and high schools by simple random sampling in Khorramabad, Iran. The survey was given to available teachers of the selected schools. Considering the inclusion criteria, required sample size, and after excluding questionnaires that were not correctly answered, 120 were selected such that 30 were chosen for each subgroup. Subjects consisted of 60 elementary school teachers (30 females and 30 males) with the mean age of 40.92 years (standard deviation = 6.07) and 60 high school teachers (30 females and 30 males) with the mean age of 40.67 years (standard deviation = 6.00). SPSS 25 was used for analyzing the data. Results Results indicated that the frequency and severity of the vocal tract discomfort in elementary school teachers were significantly higher than for the high school teachers with a medium to large effect size. Although the frequency and severity of the symptoms were higher in female compared with male teachers, those differences were not significantly different. Younger teachers had lower frequency and severity ratings of vocal tract discomfort symptoms than older teachers. Teaching experience was not an important factor in predicting vocal tract discomfort symptoms in teachers. Conclusions The results of this study suggest that there is higher frequency, greater severity, and higher percentages of vocal tract discomfort symptoms in elementary compared with high school teachers. In addition, although the mean frequency and severity of vocal tract discomfort symptoms were not significantly different between females and males, females reported higher percentages of the symptoms. Because each of the eight vocal tract symptoms was experienced at the time of testing by between 42% (tightness) and 68% (dryness) of the participants, it is suggested that an educational program regarding vocal tract discomfort may be helpful for this profession.

Background Course of Alcohol Dependence Syndrome (ADS) is studded with multiple relapses. Personality factors are implicated as one of the influencing factors in the course of this disorder. Keeping in view of scarcity of Indian data available, the study was planned with the aim to find Personality traits more commonly associated with ADS patients, and identify specific traits, associated with relapses of ADS. Method With sample size of 100 consecutive cases and 100 controls, socio-demographic data was collected. Alcohol Use Disorder Identification Test (AUDIT) and Severity of Alcohol Use Disorder Test (SAD-Q) were administered to each of these patient. Personality dimensions were assessed with NEO-five factor inventory (NEO-FFI) (Costa and McCrae), for both groups and further compared for differences in the dimensions in each of its subscale. Results The NEO scores, showed statistically significant difference with Cases having higher scores in Neuroticism and control group in Openness and Conscientiousness. Neuroticism linked to higher scores of AUDIT and SADQ and also associated with relapses. Other traits also showed statistically significant association which are discussed. Conclusion As new factors are being explored for effective management, routine personality profiling is easily accomplished and can give delightful insight into focused and designed management plan.

Summary Introduction Vocal cord vibration after transoral CO2 LASER-guided thyroarytenoid (TA) myoneurectomy in adductor spasmodic dysphonia (AdSD) patients is unclear to date. The precise vibratory patterns in AdSD patients are difficult to evaluate with routine videolaryngostroboscopy. High-speed videolaryngoscopy (HSV) is an ideal choice to evaluate such patients. This study was performed to compare pre- and postoperative, after 6 months, vocal fold vibratory onset delay (VFVOD) and closed phase glottal cycle (CPGC) in AdSD patients following transoral CO2 LASER-guided TA myoneurectomy using the HSV. Materials and methods Retrospective study, conducted from January, 2016 to January, 2019, of the AdSD patients who underwent transoral CO2 LASER-guided TA myoneurectomy using the HSV. Patient data were acquired from the hospital database to evaluate VFVOD and CPGC from HSV recordings of the patients. VFVOD was calculated as sum of prephonatory delay (PPD) and steady-state delay (SSD). The PPD and SSD were evaluated and compared separately for each patient. The MedCal Version 19.2.6 was used for data analysis. Paired sample t test was performed to compute the significance of the difference between the mean of the dataset. A P value less than 0.05 was considered significant. Results A total of nine patients were included in the study, out of which three were females and six were males. The average age was 45.5 ± 6.9 years. The mean of postoperative PPD (166.8 ± 22.1), SSD (76.5 ± 8.6), and CPGC (62.6 ± 4.8) were significantly less than mean of preoperative PPD (222.6 ± 22.1), SSD (97.7 ± 9.5), and CPGC (71.6 ± 5 %), with P values of 0.0007, 0.0001, and 0.0001, respectively. Conclusions There was a significant decrease in VFVOD and CPGC posttransoral CO2 LASER-guided TA myoneurectomy in AdSD patients after 6 months follow-up. This study also establishes efficiency of the HSV to measure the vocal cord vibration in the patients with AdSD. The primary limitations of the study were the small sample size and its retrospective nature. Future prospective studies with increased sample size can further substantiate the findings of the work performed here.

OBJECTIVES: Observational studies report mixed findings regarding the association between vitamin D and JIA incidence or activity, however such studies are susceptible to considerable bias. Since low vitamin D levels are common within the general population and easily corrected, there is potential public health benefit in identifying a causal association between vitamin D insufficiency and JIA incidence. To limit bias due to confounding and reverse causation we examined the causal effect of the major circulating form of vitamin D, 25-(OH)D, on JIA incidence using Mendelian randomization (MR).METHODS: In this two sample MR analysis we used summary level data from the largest and most recent genome wide association study (GWAS) of 25-(OH)D levels (sample size 443,734), alongside summary data from two JIA GWASs (sample sizes 15,872 and 12,501), all from European populations. To test and account for potential bias due to pleiotropy we employed multiple MR methods and sensitivity analyses.RESULTS: We found no evidence of a causal relationship between genetically predicted 25-(OH)D levels and JIA incidence (OR 1.00, 95% CI 0.76-1.33 per standard deviation increase in standardised natural-log transformed 25-(OH)D levels). This estimate was consistent across all methods tested. Additonally there was no evidence that genetically predicted JIA causally influences 25-(OH)D levels (-0.002 standard deviation change in standardised natural-log transformed 25-(OH)D levels per doubling odds in genetically predicted JIA, 95% CI -0.006-0.002).CONCLUSION: Given the lack of a causal relationship between 25-(OH)D levels and JIA, population level vitamin D supplementation is unlikely to reduce JIA incidence.

Introduction: Hydroxychloroquine (HCQ) has recently become the focus of attention in the current COVID-19 pandemic. With an increase in the off-label use of HCQ, concern for the safety of HCQ has been raised. We, therefore, performed this systematic review to analyze the safety data of HCQ against placebo and active treatment in various disease conditions. Methods: We searched PubMed, Embase, and Cochrane for Randomized Controlled Trials (RCTs) and Observational Studies (OSs) that evaluated HCQ for the treatment of any disease other than COVID19 in adult patients up to May 2020. We assessed the quality of the included studies using Risk of Bias 2 (for RCTs) and Newcastle–Ottawa Scale (for OSs). Data were analyzed with randomeffect meta-analysis. Sensitivity and subgroup analyses were performed to identify heterogeneity. Results: A total of 6641 studies were screened, and 49 studies (40 RCTs and 9 OSs) with a total sample size of 35044 patients were included. The use of HCQ was associated with higher risks of TDAEs as compared to placebo/no active treatment [RR 1.47, 95%CI 1.03-2.08]. When HCQ was compared with active treatments, the risks of AEs [RR 0.74, 95% CI 0.63-0.86] and TDAEs were less in the HCQ arm [RR 0.57, 95% CI 0.39-0.81]. The outcomes did not differ in the sensitivity analysis. Conclusion: The results suggest that the use of HCQ was associated with a lower risk of AEs and TDAEs as compared to active treatment, whereas posing higher risk of TDAEs as compared to placebo.

Summary Introduction Prehabilitation is defined as preoperative conditioning of patients in order to improve post-operative outcomes. Some studies showed an increase in functional recovery following colorectal surgery, but its effect in hepato-pancreato-biliary (HPB) surgery is unclear. The aim of this study was to realize a systematic literature review and meta-analysis on the current available evidence on prehabilitation in HPB surgery. Materials and methods A systematic review and a metanalysis were carried out on prehabilitation (physical, nutritional and psychological interventions) in HPB surgery (2009-2019). Assessed outcomes were postoperative complications, length of stay (LOS), 30-day readmission, and mortality. Main results Four studies among the 191 screened were included in this systematic review (3 randomized controlled trials, 1 case-control propensity score study), involving 419 patients (prehabilitation group, n = 139; control group, n = 280). After pooling, no difference was observed on LOS ((−4.37 days [95% CI: −8.86; 0.13]) or postoperative complications (RR 0.83 [95%CI: 0.62; 1.10]), reported by all the included studies. Two trials reported on readmission rate, but given the high heterogeneity, a meta-analysis was not realized. No deaths were reported among the included studies. Conclusion No effect of prehabilitation programs in HPB surgery was observed on LOS or postoperative complications rate. Future trials with standardized outcomes of measure, and adequately powered samples calculations are thus required. PROSPERO registration CRD42020165218.

How variable is the functionally-defined structure of early visual areas in human cortex and how much variability is shared between twins? Here we quantify individual differences in the best understood functionally-defined regions of cortex: V1, V2, V3. The Human Connectome Project 7T Retinotopy Dataset includes retinotopic measurements from 181 subjects, including many twins. We trained four “anatomists” to manually define V1-V3 using retinotopic features. These definitions were more accurate than automated anatomical templates and showed that surface areas for these maps varied more than three-fold across individuals. This three-fold variation was little changed when normalizing visual area size by the surface area of the entire cerebral cortex. In addition to varying in size, we find that visual areas vary in how they sample the visual field. Specifically, the cortical magnification function differed substantially among individuals, with the relative amount of cortex devoted to central vision varying by more than a factor of 2. To complement the variability analysis, we examined the similarity of visual area size and structure across twins. Whereas the twin sample sizes are too small to make precise heritability estimates (50 monozygotic pairs, 34 dizygotic pairs), they nonetheless reveal high correlations, consistent with strong effects of the combination of shared genes and environment on visual area size. Collectively, these results provide the most comprehensive account of individual variability in visual area structure to date, and provide a robust population benchmark against which new individuals and developmental and clinical populations can be compared.Significance StatementAreas V1, V2, and V3 are among the best studied functionally-defined regions in human cortex. Using the largest retinotopy dataset to date, we characterized the variability of these regions across individuals and the similarity between twin pairs. We find that the size of visual areas varies dramatically (up to 3.5x) across healthy young adults, far more than the variability of the cerebral cortex size as a whole. Much of this variability appears to arise from inherited factors, as we find very high correlations in visual area size between monozygotic twin-pairs, and lower but still substantial correlations between dizygotic twin pairs. These results provide the most comprehensive assessment of how functionally defined visual cortex varies across the population to date.

Background Three-dimensional (3D) models improve the comprehension of renal anatomy. Objective To evaluate the impact of novel 3D-derived parameters, to predict surgical outcomes after robot-assisted partial nephrectomy (RAPN). Design, setting, and participants Sixty-nine patients with cT1-T2 renal mass scheduled for RAPN were included. Three-dimensional virtual modeling was achieved from computed tomography. The following volumetric and morphological 3D parameters were calculated: VT (volume of the tumor); VT/VK (ratio between tumor volume and kidney volume); CSA3D (ie, contact surface area); UCS3D (contact to the urinary collecting system); Tumor-Artery3D: tumor’s blood supply by tertiary segmental arteries (score = 1), secondary segmental artery (score = 2), or primary segmental/main renal artery (scoren = 3); ST (tumor’s sphericity); ConvT (tumor’s convexity); and Endophyticity3D (ratio between the CSA3D and the global tumor surface). Intervention RAPN with a 3D model. Outcome measurements and statistical analysis Three-dimensional parameters were compared between patients with and without complications. Univariate logistic regression was used to predict overall complications and type of clamping; linear regression was used to predict operative time, warm ischemia time, and estimated blood loss. Results and limitations Overall, 11 (15%) individuals experienced overall complications (7.2% had Clavien ≥3 complications). Patients with urinary collecting system (UCS) involvement at 3D model (UCS3D = 2), tumor with blood supply by primary or secondary segmentary arteries (Tumor-Artery3D = 1 and 2), and high Endophyticity3D values had significantly higher rates of overall complications (all p ≤ 0.03). At univariate analysis, UCS3D, Tumor-Artery3D, and Endophyticity3D are significantly associated with overall complications; CSA3D and Endophyticity3D were associated with warm ischemia time; and CSA3D was associated with selective clamping (all p ≤ 0.03). Sample size and the lack of interobserver variability are the main limits. Conclusions Three-dimensional modeling provides novel volumetric and morphological parameters to predict surgical outcomes after RAPN. Patient summary Novel morphological and volumetric parameters can be derived from a three-dimensional model to describe surgical complexity of renal mass and to predict surgical outcomes after robot-assisted partial nephrectomy.

During the COVID-19 pandemic, there has been an increasing rollout of non-contact fever screening solutions to assist in curbing the spread of disease. This study begins by describing how screening for disease has historically been performed. It proposes four measurement characteristics of an ideal screening solution: non-contact, effective, rapid and low-cost measurements. Next, it reviews the existing literature on fever-screening using non-contact infrared thermometer (NCIT) devices as well as infrared thermography (IRT) devices, as these are two technologies which have experienced increasing use. For this review, 185 research papers were identified, 21 research studies were included after inclusion and exclusion criteria were applied. A total of 35 experiments were identified for analysis and their results tabulated. Of these studies, 66% are IRT and 34% are NCIT, with a median sample size of 430 subjects. 26 experiments involve febrile participants, with a median febrile percentage of 11.22 % of population. The reported sensitivity of febrile detection using NCIT varies from 3.7% to 97% and when using IRT it varies from 15% to 100%. Both indoor and outdoor studies are investigated, as well as those conducted in acute and non-acute settings. The results of this review show a clear lack of consensus on the effectiveness of these systems. Overall, these results indicate that sensitivity and specificity are reduced when using IRT and NCIT technologies compared to other thermometers used in medical practice. Their use should be carefully assessed based on the risks present in each particular measurement scenario. CCBY

BACKGROUND Donepezil had been recognized to have impact on sleep quality in demented patients. However, there was insufficient evidences about the actual effect of donepezil in the sleep architectures. Our meta-analysis aimed to evaluate the changes of sleep architectures related to donepezil use. METHODS Followed the PRISMA2020 and AMSTAR2 guidelines, electronic search had been performed on the databases of PubMed, Embase, ScienceDirect, ClinicalKey, Cochrane CENTRAL, ProQuest, Web of Science, and ClinicalTrials.gov. The outcome measurement was changes of sleep parameters detected by polysomnography. A random-effects meta-analysis was conducted. RESULTS Total twelve studies had been involved. The percentage of REM sleep would significantly increase after donepezil treatment (Hedges' g = 0.694, p

Background: The use of levetiracetam (LEV) has been increasing given its favorable pharmacokinetic profile. Numerous population pharmacokinetic studies for LEV have been conducted. However, there are some discrepancies regarding factors affecting its pharmacokinetic variability. Therefore, this systematic review aimed to summarize significant predictors for LEV pharmacokinetics as well as the need for dosage adjustments. Methods: We performed a systematic search for population pharmacokinetic studies of LEV conducted using a nonlinear-mixed effect approach from PubMed, Scopus, CINAHL Complete, and Science Direct databases from their inception to March 2020. Information on study design, model methodologies, significant covariate-parameter relationships, and model evaluation was extracted. The quality of the reported studies was also assessed. Results: A total of 16 studies were included in this review. Only two studies were conducted with a two-compartment model, while the rest were performed with a one-compartment structure. Bodyweight and creatinine clearance were the two most frequently identified covariates on LEV clearance (CLLEV). Additionally, postmenstrual age (PMA) or postnatal age (PNA) were significant predictors for CLLEV in neonates. Only three studies externally validated the models. Two studies conducted pharmacodynamic models for LEV with relatively small sample size. Conclusion: Significant predictors for LEV pharmacokinetics are highlighted in this review. For future research, a population pharmacokinetic-pharmacodynamic model using a larger sample size should be conducted. From a clinical perspective, the published models should be externally evaluated before clinical implementation.

Context Athletes with anterior cruciate ligament (ACL) reconstruction (ACLR) exhibit increased cortical motor planning during simple sensorimotor tasks compared with healthy athletes serving as control groups. This may interfere with proper decision making during time-constrained movements, elevating the reinjury risk. Objective To compare cortical motor planning and biomechanical stability during jump landings between participants with ACLR and healthy individuals. Design Cross-sectional study. Setting Laboratory. Patients or Other Participants Ten men with ACLR (age = 28 ± 4 years, time after surgery = 63 ± 35 months) and 17 healthy men (age = 28 ± 4 years) completed 43 ± 4 preplanned (landing leg shown before takeoff) and 51 ± 5 unplanned (visual cue during flight) countermovement jumps with single-legged landings. Main Outcome Measure(s) Movement-related cortical potentials (MRCPs) and frontal θ frequency power before the jump were analyzed using electroencephalography. Movement-related cortical potentials were subdivided into 3 successive 0.5-second time periods (readiness potential [RP]-1, RP-2, and negative slope [NS]) relative to movement onset, with higher values indicating more motor planning. Theta power was calculated for the last 0.5 second before movement onset, with higher values demonstrating more focused attention. Biomechanical landing stability was measured via peak vertical ground reaction force, time to stabilization, and center of pressure. Results Both the ACLR and healthy groups evoked MRCPs at all 3 time periods. During the unplanned task analyzed using P values and Cohen d, the ACLR group exhibited slightly higher but not different MRCPs, achieving medium effect sizes (RP-1: P = .25, d = 0.44; RP-2: P = .20, d = 0.53; NS: P = .28, d = 0.47). The ACLR group also showed slightly higher θ power values that were not different during the preplanned (P = .18, d = 0.29) or unplanned (P = .42, d = 0.07) condition, achieving small effect sizes. The groups did not differ in their biomechanical outcomes (P values > .05). No condition × group interactions occurred (P values > .05). Conclusions Our jump-landing task evoked MRCPs. Although not different between groups, the observed effect sizes provided the first indication that men with ACLR might have consistently relied on more cortical motor planning associated with unplanned jump landings. Confirmatory studies with larger sample sizes are warranted.

Central obesity is influenced by many factors such as changes in age, gender, economic status, life habits including lack of physical activity, low fiber consumption, consumption of simple carbohydrates, consumption of fatty foods, and smoking behavior. Smoking behavior is thought to be a significant factor in forming central obesity in adult males. The purpose of this study was to determine the relationship between smoking behavior and central obesity in healthy adults. This study used an analytic observational design with a cross-sectional research design. The research was conducted in Suradadi Village, Suradadi District, Tegal Regency. Sampling was carried out by stratified sampling in November 2020 – January 2021. The sample size was 90 men aged 25-60 years. Data were collected by measuring the waist circumference of the respondents and recording other personal data such as age, occupation, and smoking status. Data processing is done descriptively and cross-tabulation. Testing the relationship between smoking behavior and obesity was carried out using the chi-square statistical test with the help of the SPSS version 22 application. The majority of respondents in this study had a smoking status of 68.9% and did not have central obesity 64.4%. The results of the test of the relationship between smoking status and central obesity got a p-value of 0.813. There is no significant relationship between smoking status and central obesity.

Introduction and objectives Most of the studies evaluating the effect of cross links on spinal stability are performed in vitro on porcine or human spine segments and there is limited data regarding clinical benefits of cross link augmentation in traumatic injuries. In this study we aimed to evaluate the effects of cross-links insertion between rods on the fusion rates and post-surgical patients’ satisfaction among patients with traumatic thoracolumbar fractures who underwent posterior spinal fixation with pedicle screws. Materials and methods This study was conducted as a randomized clinical trial on 60 patients suffering from traumatic thoracolumbar vertebrae fractures. Patients were randomized into three groups: A (without any cross-link), B (One cross-link insertion) and C (two cross-links insertion). Six months after surgery outcomes were evaluated: fusion rates (plain X-ray and CT scan), Back pain (Visual Analog Scale) and patient satisfaction (fair, good, excellent). Results In group A 13 (65%) patients had structured bone fusion, but in 7 (35%) patients bone fusion was not observed. In both groups B and C, 19 patients (95%) had bone fusion, but only in 1 patient (5%) fusion failed (p = 0.009). In group A, fair satisfaction has the highest rate (8 patients (40%)) compared to the other groups. The highest reported severity of back pain was observed in group A while the lowest reported intensity of back pain was related to group B (p = 0.001). Conclusions Adding cross link to posterior spinal fixations of patients with traumatic thoracolumbar fractures can be associated with better final fusion results and patients’ satisfaction. However it is necessary to design studies with greater sample sizes to confirm this theory. Trial registration number: IRCT20120527009878N3.

The status of malnutrition and malnutrition is caused by various interrelated factors, including family behavior factors in providing food, breastfeeding and complementary feeding, and nutrition service efforts. This study aims to analyze the relationship between nutritionally conscious families (Kadarzi) and the nutritional status of children under five in the Work Area of the Puskesmas Pelambuan, Banjarmasin. This study used an analytic method with a cross sectional approach. The sampling technique used was proportional random sampling with a sample size of 82 parents of children under five. The measuring instrument used was a questionnaire and observation with weighing tools, the data analysis used the Spearman rank test. The location of this research was conducted in the Working Area of the Pelambuan Health Center, Banjarmasin City. Based on the results of the study, families who were aware of nutrition tended to have normal nutritional status totaling 27 (79.4%) and more than 7 (20.6%). Meanwhile, families who were not aware of nutrition tended to have malnutrition status, amounting to 31 people (64.6%) and malnutrition status 17 (35.4%). The spearman rank statistical test obtained p value 0.000 smaller than α = 0.05. There is a relationship between nutritionally conscious families (adarzi) with the nutritional status of children under five in the working area of Puskesmas Pelambuan, Banjarmasin City. Keywords : Nutritional awareness family, nutritional status, children

Objective There is an unmet need for therapies that target the underlying pathophysiology of osteoarthritis (OA). However, defining appropriate measures for clinical trials of such therapies is challenging. Our objective is to propose concept clinical endpoints that directly capture clinical benefit in this setting and evaluate the feasibility of their use. Methods This analysis used the multi-center, longitudinal, observational Osteoarthritis Initiative (OAI) database. OAI participants primarily had knee OA, with follow-up of up to nine years and assessments of joints, surgical interventions, performance outcomes, and patient-reported outcomes (PROs). We examined this dataset to identify existing outcome measures of direct clinical benefit. We evaluated the feasibility of conducting trials using these candidate endpoints by estimating incidence rates and resulting required sample sizes and study durations in time-to-event analyses. Results We identified candidate endpoints based on total knee replacement (TKR) and composite endpoints defined by TKR and conservative thresholds of PROs of pain and function. Using time to TKR as an endpoint, a study with an average follow-up time of three years requires approximately 3,000 to 18,000 subjects depending on effect size. Alternatively, a composite endpoint such as 'time to TKR or severe pain or severely impaired functioning', the required sample sizes ranged from approximately 2,000 to 11,000 for a three-year study. Conclusion The proposed concept endpoints can reliably and feasibly evaluate effectiveness of therapies for this unmet need. In particular, the composite endpoint approach can substantially reduce sample sizes (up to approximately 40%) compared to the use of TKR alone.

Background: This study aimed at understanding the trend in extracellular fluid (ECF) change and estimating the efficacy of the early complex decongestive therapy (CDT) program in terms of prevalence of lower limb lymphedema, as well as at identifying the quality of life (QoL) associated with response to CDT after gynecological cancer therapy. Methods and Results: Thirty-one patients undergoing gynecological cancer treatment were enrolled and randomly assigned to the CDT and control groups. In the CDT group, CDT was started within 2 weeks after surgery for 30 minutes a day, for 2 weeks (5 days per week). The patients' QoL was assessed through the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire; version 3. Inbody S10® (Biospace, Seoul, South Korea) was used to calculate the ECF. The assessment was performed at pre- and post-surgery and at 3, 6, and 12 months after surgery. Statistically significant differences, in favor of the CDT group, were encountered at the 3-month follow-up visit, especially with respect to the QoL score. Regarding the prevalence of lymphedema, no significant difference was observed between groups. The mean value of the impedance ratio was low in the CDT group during the entire 12 month follow-up. Conclusions: The results of the present study show that early CDT had a positive effect on the prevalence of lymphedema and body composition. Long-term follow-up studies with a larger sample size are needed to warrant the time-group effect of early rehabilitation.

BACKGROUND/SIGNIFICANCE The pain-reducing effect of applying vibration, which is used as a nonpharmacological method in pain management, is explained by the gate control theory developed by Melzack and Wall. Studies that are based on this theory have shown similar results to those of Melzack and Wall, indicating that pain-transmitting nerves are suppressed by vibrations, leading to higher pain thresholds. PURPOSE The study aimed to evaluate the effect of applying vibration to manage pain during heel lance procedures in newborns. METHODS This is a randomized, controlled experimental study. The study sample included 56 newborns determined using power analysis (vibration group = 28; control group = 28). For those in the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and then continued throughout the procedure. No interventions were provided to the newborns in the control group. Pain in the newborns was evaluated by the nurse who performed the heel lance procedures, before the procedures and 15 to 20 seconds and 5 minutes after procedures, and by 2 specialists who viewed the video footage and conducted the Neonatal Infant Pain Scale examination. RESULTS The pain scores were significantly lower at 15 to 20 seconds and 5 minutes after the heel lance procedures in the group that received vibrations than in the control group (P < .05). IMPLICATIONS FOR PRACTICE The application of vibration, which is effective, nonpharmacological, and noninvasive, could help nurses manage pain in newborns as a nonpharmacological method. IMPLICATIONS FOR RESEARCH The number of studies that examine the effect that vibration has on pain associated with heel lance procedures in newborns is very limited, and it is recommended that further studies be conducted with larger sample sizes.

This list includes some of the reference ranges laboratory values used most frequently in pediatric endocrinology with standards, sample preparation and sample sizes from Quest Diagnostics/Nichols Institute and Esoterix/Labcorp. Other laboratories perform these tests and a few also have pediatric standards (e.g., ARUP). However, we do not recommend using a laboratory that has not established pediatric standards because the lower detectable limits, or the accurate area of the standard curves of the laboratory, might be well above pediatric values. Laboratories that are set up for pediatric endocrine samples will accept smaller volumes than requested of adult patients. The minimum volumes listed here can be used for smaller children but there may not be a duplicate test available to check results when such small quantities are utilized; consult with the laboratory for details of the most recent collection size, storage, and transport. You must check your results against the standards of the laboratory you choose, as the laboratories recommend, as the reference ranges can change since the time of publication of this book; the following is only a guide.

Contains fulltext : 235093.pdf (Publisher’s version ) (Open Access) Proper use of neuropsychological tests in Indonesia is hindered by a lack of properly adapted neurocognitive tests as well as an absence of normative data. In 2016, we started adapting ten of these tests for use in Indonesia and collected data from healthy participants in Java. Here we introduce and propose a system that will facilitate the proper usage and interpretation of test scores: an online platform and a dynamic database. Newly collected data (492 healthy adults) of the Indonesian version of the Boston Naming Test (I-BNT) were used to illustrate the usefulness of the two functions. Analysis of variances, post-hoc tests, and a simulation study revealed the effects of age and education on the I-BNT, indicating that it is imperative to fine-tune the reference group based on these demographic factors. Putative inadequate sample size issues for obtaining reliable normative scores were overcome by employing regression analyses and the prediction of normative scores. It can be concluded that a flexible online platform is available for the calculation of normative scores either based on the whole population, on fine-tuned reference groups, or on predicted scores. The dynamic database's growth will allow to obtain even more fine-tuned and more reliable reference data as well as more accurate predictions. Fine-tuned reference data are badly needed for the heterogenous Indonesian population. 10 p.

The number needed to treat (NNT) is a method of reporting outcomes from clinical trials.1 Treatment efficacy is determined by evaluating the outcome of one treatment relative to another treatment or to a control group when the only difference between the groups is the intervention of interest. The NNT can also be used to express the size of the outcome of one treatment relative to another. The NNT is expressed in terms designed to help decide whether the intervention might be valuable in clinical practice: the number of patients who need to be treated before a therapist can be sure that one patient improved who would not have improved without the intervention. For example, when comparing treatment X and treatment Y, an NNT score of 5 for treatment X indicates that, on average, after treating 5 patients, treatment X will have achieved one more positive outcome than if treatment Y had been used. The NNT does not tell the clinician which of those 5 patients will respond, only that 1 patient is likely to do so. The NNT was described in 1988 by Laupacis et al,2 and, although its use is becoming more popular, it is still not widely used. A search of MEDLINE back to 1991 using the search terms “number needed to treat” or “NNT” identified 121 citations reporting NNT information. Of these citations, only 3 concerned outcomes of physical therapy3–5 and, of these, only one5 described the use of NNT in a journal with content relevant to physical therapists. The NNT can be used to gauge the relative effectiveness of different treatments in restoring normal function or preventing future disability. If the treatment has a potentially harmful outcome (eg, stroke, headache, death from cervical manipulation), a similar calculation can be used …

Physical activity (PA) and exercise have numerous benefits in Cystic Fibrosis (CF) including improved lung function, exercise capacity and quality of life. Despite these benefits, the effectiveness of interventions to promote PA in this population are still largely unknown. The objective of this review was to synthesise existing research and determine whether exercise interventions are effective in promoting PA in people with CF. Using the PRISMA guidelines, a comprehensive search was conducted. Fifteen studies (463 participants) met the inclusion criteria. Eleven studies demonstrated improvements in PA in both short- and long-term interventions. However, the interventions were variable across the included studies, with a large inconsistency in PA assessment tools used. Aerobic training and activity counselling were the two elements identified in this review which most consistently improved PA. Future research should consider larger sample sizes and the use of accurate instruments to assess and track PA levels longitudinally.

Objectives To investigate the general population’s view on artificial intelligence (AI) in medicine with specific emphasis on 3 areas that have experienced major progress in AI research in the past few years, namely radiology, robotic surgery, and dermatology. Methods For this prospective study, the April 2020 Online Longitudinal Internet Studies for the Social Sciences Panel Wave was used. Of the 3117 Longitudinal Internet Studies For The Social Sciences panel members contacted, 2411 completed the full questionnaire (77.4% response rate), after combining data from earlier waves, the final sample size was 1909. A total of 3 scales focusing on trust in the implementation of AI in radiology, robotic surgery, and dermatology were used. Repeated-measures analysis of variance and multivariate analysis of variance was used for comparison. Results The overall means show that respondents have slightly more trust in AI in dermatology than in radiology and surgery. The means show that higher educated males, employed or student, of Western background, and those not admitted to a hospital in the past 12 months have more trust in AI. The trust in AI in radiology, robotic surgery, and dermatology is positively associated with belief in the efficiency of AI and these specific domains were negatively associated with distrust and accountability in AI in general. Conclusions The general population is more distrustful of AI in medicine unlike the overall optimistic views posed in the media. The level of trust is dependent on what medical area is subject to scrutiny. Certain demographic characteristics and individuals with a generally positive view on AI and its efficiency are significantly associated with higher levels of trust in AI.

Background Misclassification bias is introduced into medical claims-based research because of reliance on diagnostic coding rather than full medical record review. We sought to characterize this bias for idiopathic intracranial hypertension (IIH) and evaluate strategies to reduce it. Methods A retrospective review of medical records was conducted using a clinical data warehouse containing medical records and administrative data from an academic medical center. Patients with 1 or more instances of International Classification of Diseases (ICD)-9 or -10 codes for IIH (348.2 or G93.2) between 1989 and 2017 and original results of neuroimaging (head CT or MRI), lumbar puncture, and optic nerve examination were included in the study. Diagnosis of IIH was classified as definite, probable, possible, or inaccurate based on review of medical records. The positive predictive value (PPV) for IIH ICD codes was calculated for all subjects, subjects with an IIH code after all testing was completed, subjects with high numbers of IIH ICD codes and codes spanning longer periods, subjects with IIH ICD codes associated with expert encounters (ophthalmology, neurology, or neurosurgery), and subjects with acetazolamide treatment. Results Of 1,005 patients with ICD codes for IIH, 103 patients had complete testing results and were included in the study. PPV of ICD-9/-10 codes for IIH was 0.63. PPV in restricted samples was 0.82 (code by an ophthalmologist n = 57), 0.70 (acetazolamide treatment n = 87), and 0.72 (code after all testing, n = 78). High numbers of code instances and longer duration between the first and last code instance also increased the PPV. Conclusions An ICD-9 or -10 code for IIH had a PPV of 63% for probable or definite IIH in patients with necessary diagnostic testing performed at a single institution. Coding accuracy was improved in patients with an IIH ICD code assigned by an ophthalmologist. Use of coding algorithms considering treatment providers, number of codes, and treatment is a potential strategy to reduce misclassification bias in medical claims-based research on IIH. However, these are associated with a reduced sample size.

Atrial fibrillation after cardiac surgery (AFACS) is a serious postoperative complication. There is significant research interest in this field but also relevant heterogeneity in reported AFACS definitions and approaches used for its identification. Few data exist on the extent of this variation in clinical studies. The authors reviewed the literature since 2001 and included manuscripts reporting outcomes of AFACS in adults. They excluded smaller studies and studies in which patients did not undergo a sternotomy. The documented protocol in each manuscript was analyzed according to six different categories to determine how AFACS was defined, which techniques were used to identify it, and the inclusion and/or exclusion criteria. They also noted when a category was not described in the documented protocol. The authors identified 302 studies, of which 92 were included. Sixty-two percent of studies were randomized controlled trials. There was significant heterogeneity in the manuscripts, including the exclusion of patients with preoperative AF, the definition and duration of AF needed to meet the primary endpoint, the type of screening approach (continuous, episodic, or opportunistic), the duration of monitoring during the study period in days, the diagnosis with predefined electrocardiogram criteria, and the requirement for independent confirmation by study investigators. Furthermore, the definitions of these criteria frequently were not described. Consistent reporting standards for AFACS research are needed to advance scientific progress in the field. The authors here propose pragmatic standards for trial design and reporting standards. These include adequate sample size estimation, a clear definition of the AFACS endpoints, and a protocol for AFACS detection.

PURPOSE To compare Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) with traditional ("legacy") patient-reported outcome measures (PROMs) in regard to correlations, ease of use, and quality criteria for upper (UE) and lower extremity (LE) orthopaedic conditions. METHODS A systematic search of the PubMed/MEDLINE database was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify published articles that referenced the various PROMIS PF measures. Two authors independently reviewed selected studies. The search returned 857 studies, 85 of which were selected for independent review by 2 authors. Of these, 54 were selected for inclusion. Mixed linear models were performed to assess for differences between legacy PROMs and PROMIS measures. RESULTS The combined sample size of all included studies yielded 6,074 UE and 9,366 LE patients. Overall, PROMIS PF measures demonstrated strong correlations with legacy PROMs among UE (weighted Pearson correlation, 0.624, standard error [SE] = 0.042; weighted Spearman correlation, 0.566, SE = 0.042) and LE patients (weighted Pearson correlation, 0.645, SE = 0.062; weighted Spearman correlation, 0.631, SE = 0.041). PROMIS PF questionnaires completed by UE patients had fewer questions than legacy PROMs (5.9 vs 17.7, P = .0093) and were completed in less time (90.5 vs 223.8 seconds, P = .084). PROMIS PF questionnaires completed by LE patients had fewer questions than legacy PROMs (4.81 vs 15.33, P < .001) and were completed in less time (63.6 vs 203.2 seconds, P = .0063). The differences for the reliability measures were not significant. CONCLUSIONS PROMIS PF scores correlate strongly with commonly used legacy PROMs in orthopaedics, particularly in UE and LE patients. PROMIS PF forms can be administered efficiently and to a broad patient population while remaining highly reliable. Therefore, they can be justified for standardized use among orthopaedic patients with UE and LE conditions, improving the ability to aggregate and compare outcomes in orthopaedic research. LEVEL OF EVIDENCE Level IV, systematic review of Level I-IV evidence.

Summary: To compare the clinical efficacy and safety of Thulium laser enucleation of prostate (ThuLEP) and Holmium laser enucleation of prostate (HoLEP). We systematically searched PubMed, Embase, and Cochrane Library databases within a period from the date of database establishment to October 2020. RevMan 5.4. was used for calculation and statistical analyses. 8 studies of 2125 patients were included. ThuLEP provided less hemoglobin decrease (MD: −0.37, 95%CI -0.61 to −0.14, P = 0.002) and shorter length of hospital stay (MD: −0.41, 95%CI -0.72 to −0.10, P = 0.01). During the postoperative follow-ups, statistically significant differences only were found in IPSS (MD: −0.96; 95%CI -1.27 to −0.65; P

Introduction Hyperinflammatory state has a role in the pathogenesis of COVID‐19. Anakinra could reduce inflammation and help to combat the condition. In this study, we aimed to assess the safety and efficacy of anakinra (PerkinRA®) in severe COVID‐19. Method The study was an open‐label, randomized, controlled trial conducted in Imam Hossein Medical Center from May to July 2020. Patients with a confirmed diagnosis of COVID‐19 were included in this study. We administered anakinra 100 mg daily intravenously. All patients received COVID‐19 pharmacotherapy based on the represented national guideline. The need for invasive mechanical ventilation is considered the primary outcome. Results Thirty patients were included in this study, and 15 of them received Anakinra. Nineteen patients were male (63.3%), and 11 were female (36.7%). The mean age of patients was 55.77 ± 15.89 years. In the intervention group, the need for invasive mechanical ventilation was significantly reduced compared to the control group (20.0% vs. 66.7%, p = .010). Also, these patients had a significantly lower length of hospital stay (p = .043). No significant higher rate of infection was recorded. Conclusion Anakinra as an immunomodulatory agent has been associated with the reduced need for mechanical ventilation in patients admitted to intensive care units because of severe COVID‐19. The medication reduced the hospital length of stay. Furthermore, no increased risk of infection was observed. Further randomized placebo‐controlled trials with a larger sample size are needed to confirm these findings., Anakinra administration significantly reduces the need for mechanical ventilation. No increased risk of infection was observed because of anakinra use. Reduced hospitalization duration observed in patients who received anakinra.

BackgroundThe number of new noncommercial clinical studies conducted in Japan declined within the first year of the implementation of the Clinical Trials Act (CTA) on April 1, 2018. This study aimed to examine the impact of the CTA’s enforcement on the number of new noncommercial clinical studies registered in the Japanese Clinical Trial Registry.MethodsAn interrupted time-series design was used in the analysis, which was conducted for the period of April 2015 to March 2019. We collected data for trials registered in the Clinical Trial Registry, managed by the University Hospital Medical Information Network.ResultsIn total, 35,811 studies were registered in the registry; of these, 16,455 fulfilled the eligibility criteria. The difference in the trend of monthly number of new trials after CTA enforcement decreased significantly by 15.0 trials (95% CI, −18.7 to −11.3), and the level decreased by 40.8 (95% CI, −68.2 to −13.3) from the pre-enforcement to the post-enforcement period. Multigroup analyses indicated that the act exerted a significant effect on the trend of new clinical trials, particularly those with smaller sample sizes, interventional study designs, and nonprofit funding sponsors.ConclusionsThe number of Japanese noncommercial clinical studies declined significantly following implementation of the CTA. It is necessary to establish a system to promote clinical studies in Japan while ensuring transparency and safety.

Metabolic and bariatric surgery helps women achieve a healthier weight, reduce co-morbid conditions, increase fertility rates, and improve pregnancy outcomes compared with counterparts who are obese. Breastfeeding is known to provide both infant and maternal health benefits as well. Less is known about the impact of bariatric surgery on breastfeeding. The objective of this study was to review the impact of bariatric surgery on breastfeeding following the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. PubMed and Medline databases were searched using terms such as “bariatric surgery,” “postnatal care,” “lactation,” and “breastfeeding.” Reference lists were also used to find relevant articles. A total of 49 records were identified. Abstracts were screened, and 11 observational studies were identified after meeting inclusion criteria, which included the use of original research on breastfeeding and women who have had bariatric surgery. The available research shows that breast milk after bariatric surgery is adequate in nutrients and that no long-term effects were reported in cases studies when nutrient deficiencies were corrected. Limitations include observational study design and small sample sizes. This systematic review suggests that breastfeeding after bariatric surgery should be recommended along with monitoring and micronutrient supplementation. However, additional research and increased sample sizes are needed to further examine the relationship, and such studies should be conducted to strengthen the evidence and explore ways to improve breastfeeding rates in this population.

Background Sarcopenia is defined as either low pre-operative muscle mass or low muscle density on abdominal CT imaging. It has been associated with worse short-term outcomes after surgery for colorectal liver metastases. This study aimed to evaluate whether sarcopenia also impacts long-term survival outcomes in these patients. Methods A random-effects meta-analysis was conducted following the PRISMA guidelines. Overall survival (OS) and disease-free survival (DFS) outcomes were evaluated. Results Eleven studies were included, ten reporting on the impact of low muscle mass and four on low muscle density. Sample sizes ranged between 47 and 539 (2124 patients in total). Altogether, 897 (42%) patients were considered sarcopenic, although definitions varied between studies. Median follow-up was 21–74 months. Low muscle mass (hazard ration (HR) 1.35, 95%CI 1.08–1.68) and low muscle density (HR 1.97, 95%CI 1.07–3.62) were associated with impaired OS. Low muscle mass (pooled HR 1.17, 95%CI 0.94–1.46) and low muscle density (pooled HR 1.13, 95%CI 0.85–1.50) were not associated with impaired RFS. Discussion Sarcopenia is associated with poorer OS, but not RFS, in patients with CRLM. Additional studies with standardized sarcopenia definitions are needed to better assess the impact of sarcopenia in patients with CRLM.

Background The diagnosis of subclinical depression (SD) currently relies exclusively on subjective clinical scores and structured interviews, which shares great similarities with major depression (MD) and increases the risk of misdiagnosis of SD and MD. This study aimed to develop a method of disease classification for SD and MD by resting-state functional features using radiomics strategy. Methods Twenty-six SD, 36 MD subjects and 33 well-matched healthy controls (HC) were recruited and underwent resting-state functional magnetic resonance imaging (rs-fMRI). A novel radiomics analysis was proposed to discriminate SD from MD. Multi-scale brain functional features were extracted to explore a comprehensive representation of functional characteristics. A two-level feature selection strategy and support vector machine (SVM) were employed for classification. Results The overall classification accuracy among SD, MD and HC groups was 84.21%. Particularly, the model excellently distinguished SD from MD with 96.77% accuracy, 100% sensitivity, and 92.31% specificity. Moreover, features with high discriminative power to distinguish SD from MD showed a strong association with default mode network, frontoparietal network, affective network, and visual network regions. Limitation The sample size was relatively small, which may limit the application in clinical translation to some extent. Conclusion These findings demonstrated that a valid radiomics approach based on functional measures can discriminate SD from MD with a high classification performance, facilitating an objective and reliable diagnosis individually in clinical practice. Features with high discriminative power may provide insight into a profound understanding of the brain functional impairments and pathophysiology of SD and MD.

Background Childhood anxiety and depression lead to great distress and impairment. Preventing them simultaneously in early life is critically important. We evaluated the long-term efficacy of an emotion regulation-based (ER) and a behavioural activation-based (BA) program. Both aimed to build resilience to prevent worry, a transdiagnostic feature across anxiety and depression. Methods Participants were 316 students (52.2% female; 8–13 years) from six South Australian primary schools. Schools were randomised to the ER, BA or a control condition. Measures of resilience, worry, anxiety, and depression were taken at pre- and post- program, and at 6- and 12-month follow-up. In addition, levels of emotion regulation, behavioural activation and resilience were measured as potential mediators of changes in anxiety and depression. Results No significant condition × time interactions were observed. However, the percentage of children who met the clinical cut-offs for generalised anxiety disorder and major depressive disorder decreased significantly in the BA condition at 12-month follow-up, as well as the percentage of children who met the clinical cut-off for obsessive compulsive disorder in the ER condition. Furthermore, emotion regulation mediated the relationship between condition and worry at post-program in the ER condition. Limitations The sample size is relatively small. Reliance on child self-report may have resulted in inaccurate responses. Conclusion The ER and BA transdiagnostic prevention programs for childhood anxiety and depression showed promising results for certain anxiety disorders not otherwise observed in universal school-based studies. Future research should consider evaluating the programs with a larger sample using alternative outcome measures.

Aim: Missing data cause problems through decreasing sample size and the potential for introducing bias. We tested four missing data methods on the Sequential Organ Failure Assessment (SOFA) score, an intensive care research severity adjuster. Methods: Simulation study using 2015–2017 electronic health record data, where the complete dataset was sampled, missing SOFA score elements imposed and performance examined of four missing data methods – complete case analysis, median imputation, zero imputation (recommended by SOFA score creators) and multiple imputation (MI) – on the outcome of in-hospital mortality. Results: MI performed well, whereas other methods introduced varying amounts of bias or decreased sample size. Conclusion: We recommend using MI in analyses where SOFA score component values are missing in administrative data research.

ObjectivesPrevious studies on the association between psychosocial work factors and blood pressure mainly focused on specific occupations or populations and had limited sample sizes. We, therefore, investigated the associations between psychosocial work factors and blood pressure in a large general working population in the Netherlands.MethodsWe included 63 800 employees from the Netherlands, aged 18–65 years, with blood pressure measurements and a reliable job code at baseline. Psychosocial work factors (job strain, effort–reward imbalance (ERI) and emotional demands) in the current job were estimated with three recently developed psychosocial job exposure matrices. To examine the associations, regression analyses adjusted for covariates (age, sex, body mass index, education, monthly income, pack-years, smoking, alcohol consumption and antihypertensive medication (not included for hypertension)) were performed.ResultsHigher job strain was associated with higher systolic blood pressure (SBP) (B (regression coefficients) (95% CI) 2.14 (1.23 to 3.06)) and diastolic blood pressure (DBP) (B (95% CI) 1.26 (0.65 to 1.86)) and with higher odds of hypertension (OR (95% CI) 1.43 (1.17 to 1.74)). Higher ERI was associated with higher DBP (B (95% CI) 4.37 (3.05 to 5.68)), but not with SBP or hypertension. Higher emotional demands were associated with lower SBP (B (95% CI) −0.90 (−1.14 to −0.66)) and lower odds of hypertension ((OR) (95% CI) 0.91 (0.87 to 0.96)).ConclusionsIn the general working population, employees in jobs with high job strain and ERI have higher blood pressure compared with employees with low job strain and ERI. Emotional demands at work are inversely associated with blood pressure.

This meta-analysis was conducted to determine the effect of animal-assistant therapy on the quality of life of older adults. This research systematically searched electronic databases (CINAHL, Cochrane Central, Medline/ PubMed, Web of Science, Science Direct, and the National Thesis Centre and ULAKBI_M of the Council of Higher Education) for studies published between April June 2021. Seven studies with experimental design were used, three were quasi-experimental and four were randomly controlled studies. The total sample size in the meta-analysis was 375 (experimental group: 177 and control group: 198). The mean duration of animal-assistant therapy was 38.5 12.4 min. Animal-assistant therapy had a significant effect on the quality of life of older adults (mean difference:-4.59 p: 0.03, Z:2.23). Therefore, animal assistant therapy is an effective method to improve older adults' quality of life. (c) 2021 Elsevier Inc. All rights reserved.

Background Instability constitutes over 20% of revisions after total hip arthroplasty (THA). Dual mobility (DM) designs were introduced as a solution to this problem. However, the few publications that have reported promising results for monobloc DM constructs have been limited by sample size or length of follow-up. The purpose of this study is to evaluate mid-term outcomes (minimum 5-year follow-up) of a single-surgeon series utilizing a monobloc DM acetabular component in patients with high risk for dislocation. Methods This is a single-surgeon consecutive series of 207 primary THAs implanted with a monobloc DM component in patients who were considered at high risk for dislocation. Patient demographics and case-specific data were collected retrospectively. All patients had a minimum of 5-year follow-up. The Mann-Whitney U test was used to assess continuous variables, whereas categorical variables were analyzed using the chi-square test. Survival probability was calculated using the Kaplan-Meier method. Results Radiographic analysis did not reveal acetabular radiolucency in any patients, and there were no revisions for aseptic loosening. In addition, there were no dislocations. Seven of 205 patients (3.4%) were revised, 5 on the femoral side due to periprosthetic fracture and the remaining two for infection. Survivorship of the acetabular component from revision was 99%. The mean Veteran RAND (VR-12) physical score improved from 7 (standard deviation [SD]: 13.7) preoperatively to 9.5 (SD: 17.6) at the final follow-up. Similarly, the hip disability osteoarthritis score improved from 8 (SD: 17.9) preoperatively to 21.2 (SD: 37). Conclusion Monobloc DM components reliably prevent dislocation after primary THA in high-risk patients. At mid-term follow-up, this DM monobloc component demonstrates excellent implant survivorship, radiographic fixation, and improved functional outcomes.

PURPOSE This study evaluated clinician adherence to the American College of Physicians Best Practice Advice for diagnosis of pulmonary embolism. DESIGN A prospective, single-center, descriptive design was utilized. METHODS A heterogeneous sample of 111 hemodynamically stable adult inpatients with a computed tomography pulmonary angiogram ordered was consented. Electronic medical records were reviewed for demographic and clinical variables to determine adherence. The 6 individual best practice statements and the overall adherence were evaluated by taking the sum of "yes" answers divided by the sample size. RESULTS Overall adherence was 0%. Partial adherence was observed with clinician-recorded clinical decisions rules and obtaining d-dimer (3.6% [4/111] and 10.2% [9/88], respectively) of low/intermediate probability scorers. Age adjustment of d-dimer was not recorded. Computed tomography pulmonary angiogram was the first diagnostic test in 89.7% (79/88) in low/intermediate probability patients. CONCLUSION In hemodynamically stable, hospitalized adults, adherence to best practice guidelines for diagnosis of pulmonary embolism was minimal. Clinical utility of the guidelines in hospitalized adults needs further evaluation. Systems problems (eg, lack of standardized orders, age-adjusted d-dimer values, information technology support) likely contributed to poor guideline adherence.

A key goal of orthodontic treatment with fixed appliances is alignment of the dentition, and this remains a commonly selected outcome in clinical studies investigating orthodontic tooth movement. This systematic review has evaluated treatment duration to achieve alignment of the mandibular dentition using fixed appliances.Systematic literature searches without restrictions were undertaken in 9 databases for randomized clinical trials (RCTs) assessing duration and rate of tooth alignment using fixed appliances with or without treatment adjuncts published up to January 2021. After duplicate study selection, data extraction, and risk of bias assessment according to Cochrane, random-effects meta-analyses of aggregate data, and individual patient data were conducted.Thirty-five trials were included with 2258 participants (39% male; mean age 17.8 years), giving a pooled duration to achieve whole-arch alignment of the mandibular dentition of 263.0 days (4 trials; 95% confidence interval [CI], 186.7-339.4 days) and incisor alignment in the mandibular arch of 100.7 days (9 trials; 95% CI, 84.1-117.4 days). Surgical-assisted orthodontics was associated with reduced duration of incisor alignment: mean difference of 44.3 days less (4 trials; 95% CI, 20.0-68.9 days; P 0.001; high quality of evidence), whereas subgroup and meta-regression analyses indicated significant effects of baseline crowding and premolar extractions. Individual patient data analysis from 3 RCTs indicated that for each additional participant age year, whole-arch alignment of the mandibular dentition took 13.7 days longer (3 trials; 95% CI, 7.7-17.7 days; P 0.001) and for each additional mm of irregularity, 17.5 days more were needed (2 trials; 95% CI, 9.8-25.2 days; P 0.001).Patient and treatment-related characteristics can significantly affect the duration of tooth alignment and should be taken into account both clinically and when designing trial outcomes. Future research studies investigating rates of orthodontic tooth alignment would benefit from adequate sample sizes and a more consistent methodology in outcome assessment. Data in this systematic review provides a basis for appropriate trial design for future RCTs investigating the rate of orthodontic tooth alignment with fixed appliances.

In node positive breast cancer patients who are treated with neoadjuvant systemic therapy, axillary staging and treatment is still a topic of debate. This multicenter study will contribute to evidence-based guidelines with regard to the oncologic safety and impact on quality of life of less vs. more invasive axillary staging and treatment strategies.Background: Node positive breast cancer (cN+) patients with an axillary pathologic complete response after neoadjuvant systemic therapy (NST) are not expected to benefit from axillary lymph node dissection (ALND). Therefore, less invasive axillary staging procedures have been introduced to establish response-guided treatment. However, evidence is lacking with regard to their oncologic safety and impact on quality of life (QoL). We hypothesize that if response-guided treatment is given, less invasive staging procedures are non-inferior to standard ALND in terms of oncologic safety, and superior to standard ALND in terms of QoL. Patients and Methods: MINIMAX is a Dutch multicenter registry study that includes patients with cN1-3M0 unilateral invasive breast cancer, who receive NST, followed by axillary staging and treatment according to local protocols. In a retrospective registry of +/- 4000 patients, the primar y endpoint is oncologic safety at 5 and 10 years (disease-free, breast-cancer-specific and overall survival, and axillary recurrence rate). In a prospective multicenter registry, the primar y endpoints are QoL at 1 and 5 years, and we aim to verify the 5-year oncologic safety. With an estimated 5-year disease-free survival of 72.5% and anticipated loss to follow-up of 10%, a sample size of 549 is needed to have 80% power to detect non-infer iority (with a 10% margin) of less invasive staging procedures. Conclusion: In cN+ patients treated with NST, less invasive axillary staging procedures are already implemented globally. Evidence is needed to support the assumed oncologic safety and superior QoL of such procedures. This study will contribute to evidence-based guidelines. (C) 2021 The Authors. Published by Elsevier Inc.

Objectives Recent advancements in high-resolution imaging have improved the diagnostic assessment of magnetic resonance imaging (MRI) for intralabyrinthine schwannoma (ILS). This systematic review aimed to evaluate the diagnostic performance of MRI for patients with ILS. Methods Ovid-MEDLINE and EMBASE databases were searched for related studies on the diagnostic performance of MRI for patients with ILS published up to February 10, 2020. The primary endpoint was the diagnostic performance of MRI for ILS. The quality of the enrolled studies was assessed using tailored questionnaires and the Quality Assessment of Diagnostic Accuracy Studies-2 criteria. Results Overall, 6 retrospective studies that included 122 patients with ILS from a parent population of 364 were included. The sample size, parent population and its composition, reference standard, detailed parameters of MRI, and even the diagnostic methods varied between the studies. The studies had moderate quality. The sensitivity of combination of T2WI and CE-T1WI was over 90%. Relative sensitivity of T2WI comparative to CE-T1WI ranged from 62% to 100%, and the specificity were 100%. Conclusions MRI has acceptable diagnostic performance for ILS. There is a need for well-organized research to reduce the factors causing heterogeneity.

The FOURIER (Further Cardiovascular Outcomes Research with PCSK9 inhibition in Subjects with Elevated Risk) trial was conducted to study cardiovascular outcomes of treatment with evolocumab. The trial was terminated after a median follow-up of 2.2 years instead of the planned 3.6 years. We question this decision. According to the investigators, the event rate was 50% higher than expected. However, the accrued number of key secondary events (1829) was only 12% higher than the targeted number (1630). Also, around one-third of the events consisted of non-atherosclerotic myocardial infarctions, hemorrhagic strokes, and cardiovascular deaths unrelated to myocardial infarction or stroke. Moreover, halfway through the trial, the sample size changed from 22,500 to 27,500, even though the accrual of the targeted number of events was on track. Finally, the rate of all-cause mortality had started to diverge in favor of placebo after 2 years of follow-up. It was 4.8% for evolocumab and 4.3% for placebo in participants with > 2.5 years of follow-up. A long-term follow-up would have yielded more events and thus more power to evaluate the effect of evolocumab on all-cause mortality. We conclude that adaptive designs carry a recognized risk of false-positive efficacy results, but the risk of false-negative safety results is underappreciated.

European journal of cancer 160, 80-91 (2022). doi:10.1016/j.ejca.2021.10.007, Published by Elsevier, Amsterdam [u.a.]

Background The objective of this study was to identify the predictors of the conservative management outcomes in patients with lumbar herniated nucleus pulposus (HNP). Methods A prospective study was conducted between June 2010 and April 2012 in Banda Aceh, Indonesia. Clinical and baseline neurologic examinations such as passive straight leg raising test (SLRT), cross SLRT, and patellar and Achilles reflexes were assessed prior to the conservative management. The patients were evaluated at 2nd, 4th, 8th, 12th and 24th week following commencement of the conservative management. Results We recruited and followed 171 HNP patients of which 35.7% of them had good outcome. At univariate analysis, patients with more than 12 months duration of complaint, those with dominant radicular pain, severe pain intensity (visual analogue scale 7–10), positive SLRT, positive cross SLRT, and reduced motor power of knee extensors (muscle strength grade 1–4), were associated with poor outcome. Multivariate analysis suggested that patients with dominant radicular type of pain were likely to had poor outcome compared to those with dominant back pain (odd ratio (OR) 10.57 with 95% confidence interval (CI) 1.15–96.93). Patients with reduced motor power of knee extensors also had a higher chance to have poor outcome compared to those who were normal (OR: 10.57; 95% CI: 1.15–96.93). Conclusion Type of pain and the strength of lower extremities could be able to predict the failure of conservative management in patients with lumbar disc herniation. However, further studies with the bigger sample size are warrant to validate our results.

Abnormalities of the brain network organization in focal epilepsy have been extensively quantified. However, the extent and directionality of abnormalities are highly variable and subtype insensitive. We conducted meta-analyses to obtain a more accurate and epilepsy type-specific quantification of the interictal global brain network organization in focal epilepsy. By using random-effects models, we estimated differences in average clustering coefficient, average path length, and modularity between patients with focal epilepsy and controls, based on 45 studies with a total sample size of 1,468 patients and 1,021 controls. Structural networks had a significant lower level of integration in patients with epilepsy as compared to controls, with a standardized mean difference of -0.334 (95 % confidence interval -0.631 to -0.038; p-value 0.027). Functional networks did not differ between patients and controls, except for the beta band clustering coefficient. Our meta-analyses show that differences in the brain network organization are not as well defined as individual studies often propose. We discuss potential pitfalls and suggestions to enhance the yield and clinical value of network studies.

Left–right asymmetry of the human brain is one of its cardinal features, and also a complex, multivariate trait. Decades of research have suggested that brain asymmetry may be altered in psychiatric disorders. However, findings have been inconsistent and often based on small sample sizes. There are also open questions surrounding which structures are asymmetrical on average in the healthy population, and how variability in brain asymmetry relates to basic biological variables such as age and sex. Over the last 4 years, the ENIGMA‐Laterality Working Group has published six studies of gray matter morphological asymmetry based on total sample sizes from roughly 3,500 to 17,000 individuals, which were between one and two orders of magnitude larger than those published in previous decades. A population‐level mapping of average asymmetry was achieved, including an intriguing fronto‐occipital gradient of cortical thickness asymmetry in healthy brains. ENIGMA's multi‐dataset approach also supported an empirical illustration of reproducibility of hemispheric differences across datasets. Effect sizes were estimated for gray matter asymmetry based on large, international, samples in relation to age, sex, handedness, and brain volume, as well as for three psychiatric disorders: autism spectrum disorder was associated with subtly reduced asymmetry of cortical thickness at regions spread widely over the cortex; pediatric obsessive–compulsive disorder was associated with altered subcortical asymmetry; major depressive disorder was not significantly associated with changes of asymmetry. Ongoing studies are examining brain asymmetry in other disorders. Moreover, a groundwork has been laid for possibly identifying shared genetic contributions to brain asymmetry and disorders., Left–right asymmetry of the human brain is one of its cardinal features, and also a complex, multivariate trait. Over the last four years, the ENIGMA‐Laterality Working Group has published six studies of grey matter morphological asymmetry in health and disease, based on total sample sizes from roughly 3,500 to 17,000 individuals, which were between one and two orders of magnitude larger than those published in previous decades. Here we review the findings from these six studies.

Background & Objective: The prevalence of COVID-19 and its severity have been observed to be on a lower level in underdeveloped countries with poorer standards of hygiene. This disparity may be attributed to the higher seroprevalence of other viral diseases which can result in the presence of antibodies protective against COVID-19. Two of the widespread diseases in such countries are infection to hepatitis A and E viruses (HAV and HEV). In the present study, we explored the relationship between the level of antibodies against these viruses and the susceptibility to COVID-19. Methods: Ninety patients were studied in two groups of controls and cases each consisting 45 individuals. The cases were patients with the clinical symptoms of COVID-19 and positive RT-PCR test results. The controls were individuals referred to the respiratory triage of Imam Khomeini Hospital Complex and were not demonstrating relevant clinical symptoms of COVID-19 and their RT-PCR test results were negative. Levels of HAV and HEV antibodies were measured and compared in these two groups. Results: The median of HAV antibody level was 13.6 (IQR=11.5-16.9) and 13.2 (IQR =10.7-14.7) in cases and controls, respectively, showing no statistically significant difference (P = 0.1). Likewise, the median of HEV antibody level was 6.7 (IQR=5.3-7.1) and 7.1 (IQR=6.3-7.5) in cases and controls, respectively, which again showed no statistically significant difference (P=0.41). Conclusion: The present study was carried out in a region with a relatively high prevalence of HAV and HEV infections. Contrary to our expectations, no statistically significant relationship was observed between the levels of antibodies against these viruses and the susceptibility to COVID-19. Further studies with larger sample sizes and in other countries are needed to come to a definite conclusion.

Purpose: Physically active adults have experienced training benefits from fish oil–derived omega-3 fatty acid (FO n3), which may also be of benefit to singers. The purpose of this research study was to determine if self-reported vocal adaptations and body composition changes occur in singers following FO n3 supplementation in conjunction with a singer's normal training regimen. Method: Twenty college students, currently enrolled in vocal lessons at a university, were randomized to receive either 3.0 g of FO n3 or placebo, which they took during a 10-week study period. Participants were blinded to group assignment. Participants completed the Reflux Symptom Index (RSI), Singing Voice Handicap Index-10 (SVHI-10), and the Evaluation of Ability to Sing Easily (EASE) and submitted to body composition measures (weight, skeletal mass, and body fat mass) before and after the study period. Results: Sixteen participants completed all parts of the study protocol. Mean compliance for the placebo group (83.9%) and the supplement group (75.2%) was similar. There were no significant differences in body composition measures, RSI scores, and EASE scores between groups. Scores on the SVHI-10 decreased significantly over time for all participants. Conclusions: Improvements seen in the SVHI-10 were not meaningfully different between the supplement and placebo group, pointing to the benefit of weekly lessons. The lack of changes in the questionnaire scores in the supplement group are partially attributed to the low compliance rate and low sample size, which is supported by the lack of change in the body composition measures.

Electroencephalographic (EEG) neurofeedback has been utilised to regulate abnormal brain activity associated with chronic pain. In this systematic review, we synthesised the evidence from randomised controlled trials (RCTs) to evaluate the effect of EEG neurofeedback on chronic pain using random effects meta-analyses. Additionally, we performed a narrative review to explore the results of non-randomised studies. The quality of included studies was assessed using Cochrane risk of bias tools, and the GRADE system was used to rate the certainty of evidence. Ten RCTs and 13 non-randomised studies were included. The primary meta-analysis on nine eligible RCTs indicated that although there is low confidence, EEG neurofeedback may have a clinically meaningful effect on pain intensity in short-term. Removing the studies with high risk of bias from the primary meta-analysis resulted in moderate confidence that there remained a clinically meaningful effect on pain intensity. We could not draw any conclusion from the findings of non-randomised studies, as they were mostly non-comparative trials or explorative case series. However, the extracted data indicated that the neurofeedback protocols in both RCTs and non-randomised studies mainly involved the conventional EEG neurofeedback approach, which targeted reinforcing either alpha or sensorimotor rhythms and suppressing theta and/or beta bands on one brain region at a time. A post-hoc analysis of RCTs utilising the conventional approach resulted in a clinically meaningful effect estimate for pain intensity. Although there is promising evidence on the analgesic effect of EEG neurofeedback, further studies with larger sample sizes and higher quality of evidence are required.

BACKGROUND & AIMS Fungal infections (FIs) have serious implications, yet understated in cirrhosis. Therefore, we reviewed the epidemiology and trends of FIs among cirrhotics. METHODS Four electronic-databases were searched for full-text articles describing prevalence of FIs in cirrhosis. Studies from post-transplant, malignancy and classical-immuno-deficiency patients were excluded. A random-effects meta-analysis was done to pool estimates of FIs (overall, and by type and infection-site), and their variation(I2 ) was explored on moderator-analysis and meta-regression. Risk of bias and asymmetry in estimates was assessed by a checklist and Eggers-regression, respectively.(CRD42019142782) RESULTS: Thirty-four low-risk and four moderate-risk studies (31984 cirrhotics) were included. Pooled-estimates of overall-FIs (17 studies), invasive fungal infections (IFIs; 17 studies), invasive-candidiasis (23 studies), and invasive-aspergillosis (16 studies) in cirrhosis were 10.2%(6.0-16.9), 9.5%(5.4-16.2), 4.0%(2.0-8.0) and 2.8%(1.5-5.3); respectively (I2 >90%;each). Site of FIs in decreasing order of pooled-prevalence was pulmonary, urinary-tract, bloodstream, peritoneal, esophageal, and cerebral. Geographic differences in these estimates were remarkable, with highest burden of overall-FIs from Belgium, USA, and India. Non-albicans-Candida and Aspergillus infections have increased over the last-decade in cirrhosis. Intensive-care-unit (ICU)-admitted and acute-on-chronic liver failure (ACLF) patients had the highest prevalence of IFIs. MELD-score(cases), bias-score, and sample size across studies were the predictors of variance in overall-FI-estimates. Diabetes, steroid and broad-spectrum antibiotic-exposure, and multiple organ failures were the common predispositions reported in patients with FIs. CONCLUSIONS FIs impose a substantial burden in cirrhosis. ACLF and ICU-admission should be considered as a host factor for defining IFIs. Epidemiology of FIs can guide interpretation of biomarkers and antifungal treatment in cirrhosis.