Creatine supplementation and VO2max: a systematic review and meta-analysis.

Although creatine supplementation is well-known to increase exercise performance in acute high-intensity exercises, its role in aerobic performance based on VO2max is more controversial. Thus, we performed a systematic review and meta-analysis on the effects of creatine supplementation on VO2max. PubMed, Cochrane, Embase, and ScienceDirect were searched for randomized controlled trials (RCTs) reporting VO2max in creatine supplementation and placebo groups before and after supplementation. We computed a random-effects meta-analysis on VO2max at baseline, within groups following supplementation, on changes on VO2max between groups, and after supplementation between groups. Sensitivity analyses and meta-regression were conducted. We included 19 RCTs for a total of 424 individuals (mean age 30 years old, 82% men). VO2max did not differ at baseline between groups (creatine and placebo). Participants in both groups were engaged in exercise interventions in most studies (80%). Using changes in VO2max, VO2max increased in both groups but increased less after creatine supplementation than placebo (effect size [ES] = -0.32, 95%CI = -0.51 to -0.12, p = 0.002). Comparisons after creatine supplementation confirmed a lower VO2max in the creatine group compared to the placebo group (ES= -0.20, 95%CI = -0.39 to -0.001, p = 0.049). Meta-analysis after exclusion from meta-funnel resulted in similar outcomes in a subgroup of young and healthy participants. Meta-regressions on characteristics of supplementation, physical training, or sociodemographic were not statistically significant. Creatine supplementation has a negative effect on VO2max, regardless of the characteristics of training, supplementation, or population characteristics.Supplemental data for this article is available online at https://doi.org/10.1080/10408398.2021.2008864 .

Cardiorespiratory Fitness and Bone Turnover Markers in Adults With Metabolic Syndrome: The Mediator Role of Inflammation.

The relationship between inflammatory markers and bone turnover in adults is well known, and a negative association between cardiorespiratory fitness (CRF) and inflammatory markers has also been described. Hence, we tested whether the association between CRF and bone turnover markers is mediated by inflammatory markers in adults with metabolic syndrome. A total of 81 adults (58.5 ± 5.0 years, 62.7% women) were included in the analysis. CRF was measured by the 6-min walking test. Serum interleukin (IL)-1ß, IL-6, IL-10, tumor necrosis factor alpha, high-sensitivity c-reactive protein (hsCRP) and vascular endothelial growth factor, collagen type I cross-linked C-telopeptide, procollagen type I N-terminal propeptide (P1NP), and total osteocalcin were assessed using a sensitive ELISA kit. Body composition was assessed by dual-energy X-ray absorptiometry. Partial correlation was used to test the relationship between CRF, inflammatory markers, and bone turnover markers, controlling for sex, lean mass, and fat mass. Boot-strapped mediation procedures were performed, and indirect effects with confidence intervals not including zero were interpreted as statistically significant. CRF was positively correlated with P1NP levels (r = .228, p = .044) and osteocalcin levels (r = .296, p = .009). Furthermore, CRF was positively correlated with IL-1ß levels (r = .340, p = .002) and negatively correlated with hsCRP levels (r = -.335, p = .003), whereas IL-1ß levels were positively correlated with P1NP levels (r = .245, p = .030), and hsCRP levels were negatively correlated with P1NP levels (r = -.319, p = .004). Finally, the association between CRF and P1NP levels was totally mediated by hsCRP (percentage of mediation = 39.9). Therefore, CRF benefits on bone formation could be dependent on hsCRP concentrations in this population.

Sense of happiness in Polish patients with multiple sclerosis.

INTRODUCTION: Happiness is crucial to patient well-being and their acceptance of their disease. The aim of this study was to assess the sense of happiness in persons with multiple sclerosis (PwMS), compare it to the level of happiness in patients with other neurological conditions, and determine which factors affect the sense of happiness in PwMS. MATERIAL AND METHODS: Five hundred and eighty-nine PwMS and 145 control subjects (post-stroke patients with chronic pain syndromes and neuropathies) were included in the study. Due to the differences between the groups in terms of demographic variables, an adjusted group of PwMS (n = 145) was selected from the entire group of PwMS. All patients were assessed using the Oxford Happiness Questionnaire (OHQ), the Satisfaction with Life Scale (SLS), and the Family APGAR Questionnaire. Based on regression analysis, the study examined which variables affected the level of happiness in the groups. RESULTS: Analysis of the OHQ scores showed that PwMS had a lower sense of happiness compared to the control group in the overall score [113.21 (25-42) vs. 119.88 (25-49), respectively; p = 0.031] and the subscales (OHQ subscale 1 - 54.52 vs. 57.84, respectively; p = 0.027; subscale 2 - 35.61 vs. 37.67; respectively; p = 0.044). Based on linear regression analysis, life satisfaction (ß = 0.40; p < 0.001), positive orientation (ß = 0.32; p < 0.001), and primary education (ß = 0.08; p = 0.009) were the most significant predictors of a higher level of happiness in PwMS. Similar results were found in the control group. CONCLUSIONS: The sense of happiness in PwMS was lower than in patients with other conditions. The most important factors influencing happiness included life satisfaction and positive orientation. Influencing these predictors should be the aim of psychological interventions, especially in patients with a reduced sense of happiness.

Physical Activity of Women After Radical Unilateral Mastectomy and Its Impact on Overall Quality of Life.

Radical unilateral mastectomy is an acknowledged source of traumatic experience for women, adversely affecting their behavioral and emotional paradigm. The present study aimed to assess the quality of life in physically active and inactive postmastectomy women. Population sample involved 100 women, aged 50 to 60 years, having undergone radical unilateral mastectomy, allocated into 2 groups, upon assumption of undertaking physical activity. The abbreviated version of WHOQOL-BREF questionnaire was a research tool of choice. The data were analyzed with the aid of χ2 test, Kruskal-Wallis test, and Mann-Whitney U test. Statistically significant dependence was established between physical activity actually pursued and self-assessment of overall quality of life (P = .014) and overall the self-rated perception of health (P < .001). In the group of physically inactive women, physical health was a variable dependent upon individual level of education (P = .031). The highest scores in this domain were noted in the women boasting secondary education, whereas the lowest in the ones with vocational education. Social domain was the highest rated aspect of quality of life in both the physically active and inactive postmastectomy women, while the physical health domain was rated the lowest. Both in the case of physically active and inactive postmastectomy women, the quality of life in the respective domains, as listed in the WHOQOL-BREF questionnaire, was found independent of the living environment.

Utility valuation of health states for haemophilia and related complications in Europe and in the United States.

INTRODUCTION: There is currently a paucity of health utility data describing the consequences of haemophilia and related complications. AIM: To quantify the impact of distinct stages of severity of haemophilia and disease-related complications on health-related quality of life, expressed as health utilities in Europe and the United States. METHODS: Nine health state descriptions were developed based on literature review and interviews with haematologists and haemophilia patients. Three descriptions characterized the impact of mild, moderate and severe haemophilia without inhibitors. Six descriptions characterized disease-related complications added to the moderate haemophilia description (arthroscopic synovectomy, prosthetic joint replacement, chronic pain, spontaneous bleed, traumatic bleed and end-stage joint disease). Time trade-off (TTO) interviews were conducted with 100 adults from the general public in the UK, France, Germany, Italy, Sweden and the United States. Mean TTO-derived utility values were expressed on a scale from 0 (death) to 1 (full health). RESULTS: Utility values obtained for the health states corresponding to mild (0.73-0.86), moderate (0.68-0.76) and severe (0.64-0.71) haemophilia followed the increase in severity. The addition of a complication to the "moderate" state leads to a decrease in the associated utility value. The most severe disutility (0.23-0.36) across all countries was associated with the burden of end-stage joint disease. CONCLUSIONS: This study underlines the value that the French, Italian, German, Swedish, United States and UK populations ascribe to the avoidance of disease progression in haemophilia without inhibitors. Improved treatment options hold a potential for important benefits to haemophilia patients.

Foot Deformities in Women Are Associated with Wearing High-Heeled Shoes.

BACKGROUND The aim of this study was to assess the association between foot deformities and type of shoe regularly worn at work. MATERIAL AND METHODS We studied 150 employed women ages 30-40 years and divided them into 3 groups according to type of footwear worn: women in Group I wore flat-soled shoes, women in Group II wore mid-heeled shoes (heels 4.0±0.5 cm), and women in Group III wore high-heeled shoes (heels 10.0±0.5 cm). We used the CQ-ST podoscope for measurements. RESULTS We found significant differences in right foot γ angle between Groups I and III (p=0.033) and between Groups II and III (p=0.040). For the left foot, differences were noted between Groups I and III (p=0.012). Group III subjects had higher values of alpha angle compared to Group I (p=0.000) and Group II (p=0.000). Significant correlations were also found between specific type of footwear worn and the incidence of hallux valgus of the right foot (p=0.010) and left foot (p=0.000), and the varus deformity of the fifth toe (ß) of the left foot (p=0.015). CONCLUSIONS The feet of women wearing high-heeled shoes were significantly flatter transversely, with a more laterally flexed hallux, as compared to those wearing low-heeled or flat-soled shoes. Wearing high-heeled shoes was associated with higher incidence of hallux valgus. The incidence of varus deformity of the fifth toe was associated with wearing high-heeled shoes.

Feet deformities and their close association with postural stability deficits in children aged 10-15 years.

BACKGROUND: Children and young people make up an age group most vulnerable to falls. Various stability disorders may become instrumental in sustaining more frequent falls and resultant fractures. Correct morphological structure impacts overall efficiency of the foot, as well as offers significant diagnostic potential. Even minor foot disorders may affect the entire bio kinematic chain, also impacting the foot's motility. Structural alterations within a foot may also impair balance in the standing position, and contribute to more frequent injuries. The study aimed to assess the relationship between feet deformities and postural stability deficits in schoolchildren prone to sustain accidental falls. METHODS: The study involved 200 children (101 girls and 99 boys) aged 10-15 years, randomly selected from primary schools. A 2D podoscan was used to assess the plantar part of the foot, while stabilometric examination was aided by the FreeMed dynamometric platform. RESULTS: Correlation between respective variables was reflected by Spearman's rank coefficient. The subjects' age negatively correlated with the COP range of movement along the Y axis, and the COP surface area, while their BMI negatively correlated with the COP trajectory's length. Step regression analysis indicated that the width of the left foot, the left foot Wejsflog index, the left foot Clark's angle, the hallux valgus angle were the essential predictors of stabilometric variables in girls. In boys, though, predictive value was associated with Clarke's angle of the left and right foot, Wejsflog index of the right foot, and the width of both the left and right foot. CONCLUSIONS: There is a statistically significant correlation between morphological variables of the foot and postural stability. When assessing the key variables of the foot and their interrelationship with postural stability, the Clarke's angle, Wejsflog index, hallux valgus angle, and foot width, should be granted due prominence in the girls. As regards the boys, the following variables were established as predictive in assessing postural stability: Clarke's angle, Wejsflog index, and foot width.

[Physiotherapy in geriatrics - its significance in overall treatment management].

As UN research indicates, populations in approx. 40% of the world's countries presently meet the criteria of demographic old age. It is estimated that by 2050, those criteria will have applied to 84% of them, out of which 65% will have entered an advanced stage. Data current for 2017 put the estimated number of seniors around the world at approx. 962 million, i.e. 13% of the world's population. Population ageing process has already reached its top dynamics in Poland. Both international studies, and our own research experience imply that only an interdisciplinary and holistic approach to the seniors may help fully appreciate overall complexity of this challenge, and consequently offer an adequate platform for mapping out effective therapeutic management. Provision of a scope of wide-ranging, physiotherapeutic regimens for the seniors requires of any attending therapeutic team a specialist body of knowledge, pertinent expertise in geriatrics and physiotherapy, and plenty of hands-on skills. Physiotherapy in geriatrics is a complex, teamwork-based approach targeted at the seniors of appreciably reduced functional capabilities, and/or burdened with concomitant risk factors for a number of diseases, and/or prone to sustaining other adverse incidents (e.g. falls) typical for older age. In physiotherapeutic management offered to the seniors, as opposed to other age groups, by far the most essential issue consists in multiple concomitant diseases and polypragmacy. After a patient has been diagnosed by an attending physician, and his functional capabilities have been assessed by a physiotherapist, the therapeutic team should primarily focus upon securing for him the most essential goals, as identified at the time. Increased life expectancy raises a number of questions and challenges, to be urgently addressed by the medical sciences; the most basic and pragmatic question being - how are physicians, physiotherapists, and other health care professionals presently prepared to deal effectively with the seniors in terms of the actual treatment management, and a scope of physiotherapeutic interventions urgently required?

The Danish version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

The Juvenile Arthritis Multidimensional Assessment Report (JAMAR) is a new parent/patient-reported outcome measure that enables a thorough assessment of the disease status in children with juvenile idiopathic arthritis (JIA). We report the results of the cross-cultural adaptation and validation of the parent and patient versions of the JAMAR in the Danish language. The reading comprehension of the questionnaire was tested in ten JIA parents and patients. Each participating centre was asked to collect demographic, clinical data and the JAMAR in 100 consecutive JIA patients or all consecutive patients seen in a 6-month period and to administer the JAMAR to 100 healthy children and their parents. The statistical validation phase explored descriptive statistics and the psychometric issues of the JAMAR: the three Likert assumptions, floor/ceiling effects, internal consistency, Cronbach's alpha, interscale correlations, test-retest reliability and construct validity (convergent and discriminant validity). A total of 303 JIA patients (7.9% systemic, 35% oligoarticular, 22.1% RF negative polyarthritis, 35% other categories) and 99 healthy children, were enrolled in three centres. The JAMAR components discriminated well healthy subjects from JIA patients. All JAMAR components revealed good psychometric performances. In conclusion, the Danish version of the JAMAR is a valid tool for the assessment of children with JIA and is suitable for use both in routine clinical practice and clinical research.

High-sensitive CRP as a predictive marker of long-term outcome in juvenile idiopathic arthritis.

To evaluate whether C-reactive protein (CRP), including variation within the normal range, is predictive of long-term disease outcome in Juvenile Idiopathic Arthritis (JIA). Consecutive patients with newly diagnosed JIA were included prospectively from defined geographic areas of the Nordic countries from 1997 to 2000. Inclusion criteria were availability of a baseline serum sample within 12 months after disease onset and 8-year clinical assessment data. Systemic onset JIA was not included. CRP was measured by high-sensitive ELISA (detection limit of 0.2 mg/l). One hundred and thirty participants with a median follow-up time of 97 months (range 95-100) were included. At follow-up, 38% of the patients were in remission off medication. Absence of remission was associated with elevated level of CRP at baseline (odds ratio (OR) 1.33, confidence interval (CI) 1.08-1.63, p = 0.007). By applying a cutoff at the normal upper limit (>10 mg/l), the risk of not achieving remission was increased to an OR of 8.60 (CI 2.98-24.81, p < 0.001). Variations of CRP within the normal range had no predictive impact on disease activity at follow-up. Baseline levels of ESR were available in 80 patients (61%) and elevated ESR was associated with absence of remission in a multivariable logistic regression analysis (OR 2.32, CI 1.35-4.00, p = 0.002). This results of this study indicate that baseline CRP concentrations above 10 mg/l are predictive of a poor outcome at 8-year follow-up. We could not demonstrate any predictive value of CRP variations within the normal range.

Ankle arthritis predicts polyarticular disease course and unfavourable outcome in children with juvenile idiopathic arthritis.

OBJECTIVES: To evaluate the occurrence, clinical characteristics and prognostic factors associated with ankle arthritis in children with juvenile idiopathic arthritis (JIA). METHODS: 440 children with JIA were followed for eight years in a prospective Nordic population-based cohort study. Data on remission was available for 427 of these children. Occurrence of clinically assessed ankle arthritis was analysed in relation to JIA category, clinical characteristics and remission data eight years after disease onset. RESULTS: In 440 children with JIA, 251 (57%) experienced ankle arthritis during the first eight years of disease. Ankle arthritis was least common in the persistent oligoarticular category (25%) and most common in children with extended oligoarticular (83%) and polyarticular RF-negative (85%) JIA. Children who developed ankle arthritis during the first year of disease were younger at disease onset (median age 4.9 (IQR 2.1-8.8) vs. 6.6 (IQR 2.8-10.1) years, p<0.003) and had more cumulative affected joints at 8-year follow-up (median involved joints 10 (IQR 6-16) vs. 3 (IQR 2-9), p<0.001). The odds ratio for not achieving remission eight years after disease onset, if the ankle joint was involved during the first year of disease was 2.0 (95 % CI:1.3-3.0, p<0.001). Hind-, mid- and forefoot involvements were more common compared to patients without ankle arthritis. CONCLUSIONS: In this Nordic population-based 8-year follow-up study, occurrence of ankle arthritis during the first year was associated with an unfavourable disease outcome. We suggest that ankle arthritis should be recognised in the assessment of prognosis and choice of treatment strategy in JIA.

The Managerial Role and Psychosocial Factors of Job Satisfaction: A Cross-sectional Study Among Wittyfit's Users.

OBJECTIVE: Job satisfaction is an emerging indicator for measuring workers' occupational well-being; however, this has been poorly studied in managers. We aimed to explore job satisfaction between managers and employees and assess its factors. METHODS: Data from Wittyfit's users were collected between January 2018 and February 2020. Volunteers anonymously provided their sociodemographic profile, their sense of job satisfaction, and their psychosocial feelings (ambiance, meaning, organization, recognition, values, work-life balance). RESULTS: Data of 10,484 employees and 836 managers were collected. Job satisfaction was higher in managers than employees. All psychosocial factors had an impact on job satisfaction in workers. There was a higher prevalence of satisfied managers than employees. Managerial position and other sociodemographic variables influenced this prevalence. CONCLUSIONS: Managers seem to be more satisfied than employees. Psychosocial and sociodemographic factors can influence workers' job satisfaction.

The influence of burnout on cardiovascular disease: a systematic review and meta-analysis.

Background: Burnout is a public health problem with various health consequences, among which cardiovascular disease is the most investigated but still under debate. Our objective was to conduct a systematic review and meta-analysis on the influence of burnout on cardiovascular disease. Methods: Studies reporting risk (odds ratio, relative risk, and hazard ratio) of cardiovascular disease following burnout were searched in PubMed, PsycINFO, Cochrane, Embase, and ScienceDirect. We performed a random-effect meta-analysis stratified by type of cardiovascular disease and searched for putative influencing variables. We performed sensitivity analyses using the most adjusted models and crude risks. Results: We included 25 studies in the systematic review and 9 studies in the meta-analysis (4 cross-sectional, 4 cohort, and 1 case-control study) for a total of 26,916 participants. Burnout increased the risk of cardiovascular disease by 21% (OR = 1.21, 95% CI 1.03 to 1.39) using the most adjusted risks and by 27% (OR = 1.27, 95% CI 1.10 to 1.43) using crude risks. Using stratification by type of cardiovascular disease and the most adjusted risks, having experienced burnout significantly increased the risk of prehypertension by 85% (OR = 1.85, 95% CI 1.00 to 2.70) and cardiovascular disease-related hospitalization by 10% (OR = 1.10, 95% CI 1.02 to 1.18), whereas the risk increase for coronary heart disease (OR = 1.79, 95% CI 0.79 to 2.79) and myocardial infarction (OR = 1.78, 95% CI 0.85 to 2.71) was not significant. Results were also similar using crude odds ratio. The risk of cardiovascular disease after a burnout was not influenced by gender. Insufficient data precluded other meta-regressions. Conclusions: Burnout seems to increase the risk of cardiovascular disease, despite the few retrieved studies and a causality weakened by cross-sectional studies. However, numerous studies focused on the pathophysiology of cardiovascular risk linked to burnout, which may help to build a preventive strategy in the workplace.

Body mass index is associated with health-related quality of life and disease characteristics in young adults with juvenile idiopathic arthritis.

BACKGROUND: There is a growing interest concerning the relationship between obesity and several medical conditions and inflammation. Nevertheless, there is a lack of studies regarding body mass index (BMI) among patients with juvenile idiopathic arthritis (JIA). Our aim was to investigate the impact of BMI on health-related quality of life (HRQoL) measured with a 36-Item Short Form Survey (SF-36), disease activity, and disability in young adults with JIA. METHODS: This study is a part of the population-based Nordic JIA cohort study. All newly diagnosed patients with JIA were recruited consecutively between 1997-2000 in specific regions in the Nordic countries. Patients in this sub-study were enrolled from 434 patients who attended their 18-year follow-up visit. Patients were classified according to the World Health Organization (WHO) into four groups based on their BMI. HRQoL, disease characteristics, disability, fatigue, sleep quality, physical activity, pain, comorbidities, and social status were assessed. RESULTS: Three hundred fifty-five patients from the original study cohort were enrolled in this study and 72% of them were female. Mean age was 23.9 (± SD 4.4) years. A significant relationship was found between the JIA categories and BMI groups (p = 0.014). A significant relationship was also found between BMI and disease activity scores (DAS28) (p = 0.028), disability (p < 0.001), pain (p = 0.013), fatigue (p = 0.035), and sleep quality (p = 0.044). Moreover, a significant relationship between BMI and HRQoL regarding bodily pain (p = 0.010) and general health (p = 0.048) was revealed when adjusted for sex, age, and JIA subtype. CONCLUSION: We discovered that BMI was significantly related to HRQoL, disease activity, and disability. BMI deserves more attention considering the treatment options and outcome of JIA in young adults.

Multicentric osteolysis with nodulosis and arthropathy (MONA) with cardiac malformation, mimicking polyarticular juvenile idiopathic arthritis: case report and literature review.

UNLABELLED: The 'vanishing bone' syndrome multicentric osteolysis with nodulosis and arthropathy (MONA) is a rare chronic skeleton disorder caused by matrix metalloproteinase 2 (MMP2) deficiency, mimicking erosive polyarticular juvenile idiopathic arthritis. MONA is characterised by facial dysmorphism, subcutaneous fibrocollagenous nodules, carpal and tarsal osteolysis and interphalangeal joint erosions. We present the case of a 5-year-old boy with double outlet right ventricle, ventricular septal defect, coarctation of the aorta and MONA. Previously, a total of 24 cases of MONA have been reported of which six also had congenital cardiac malformations. Despite treatment attempts of our patient with methotrexate, eternacept and prednisolone, serial X-ray studies documented continuous severe bone degeneration. CONCLUSION: The case documents the natural history of MONA and establishes a link between MMP2 deficiency and heart development, and given the recurring cardiac association, we suggest that all MONA patients be examined for possible cardiac defects.

Agreement between Accelerometer-Assessed and Self-Reported Physical Activity and Sedentary Behavior in Female Breast Cancer Survivors.

An accurate quantitative assessment of physical activity and sedentary lifestyles enables a better understanding of their relationship with the health records of cancer survivors. The objective of this study was to compare the subjective and objective methods of physical activity measurement in female breast cancer survivors. Materials and methods: In total, 135 female breast cancer survivors at the Holycross Cancer Center, Kielce, Poland, were included in this study. A shortened version of the International Physical Activity Questionnaire (IPAQ) was used to subjectively assess the participants' physical activity (PA), and an ActiGraph GT3X-BT accelerometer was used for an objective assessment. In total, 75% of the studied women did not report any vigorous PA, irrespective of the measurement method. The average values of moderate PA and moderate-to-vigorous PA (MVPA) measured with IPAQ compared with the accelerometer were sevenfold and tenfold higher, respectively. Conversely, the sedentary behavior values measured with the accelerometer were almost three times higher than those measured with IPAQ. The PA and sedentary behavior measurements were significantly different. Irrespective of PA intensity, the accelerometer-based measurements produced significantly lower results than IPAQ, while higher results were observed for sedentary behavior. The measurement differences between these two methods increased as the average differences grew. Regardless of the measurement method, a negative association was observed between moderate PA with general adiposity and adipose tissue distribution, whereas sedentary behavior demonstrated an opposite trend. This indicates the detrimental role of obesity in limiting PA.

The immunogenicity, safety, and efficacy of N8-GP in previously untreated patients with severe hemophilia A: pathfinder6 end-of-trial results.

BACKGROUND: The pathfinder6 (NCT02137850) international phase 3 trial examined immunogenicity, safety, and efficacy of the extended half-life factor VIII (FVIII) replacement product N8-GP (turoctocog alfa pegol; Esperoct) in previously untreated patients (PUPs) with hemophilia A. OBJECTIVES: We present end-of trial results for extended PUP N8-GP treatment for up to a median (range) 2.5 (0.0; 7.4) years. PATIENTS/METHODS: Longer-term N8-GP treatment in PUPs with hemophilia A was examined. The prophylaxis regimen was ∼60 IU/kg N8-GP i.v. twice weekly, or every 3 or 7 days. The primary endpoint was the incidence of FVIII inhibitors. RESULTS: Overall, 81 patients received N8-GP and were included in this analysis. The inhibitor incidence was 30.0% (15.7% high-titer [>5 BU]) for the extension phase. Patients had a median (range) 2.9 (0.1; 7.2) years of prophylaxis following the pre-prophylaxis period. During prophylaxis, the median annualized bleeding rate (ABR) (interquartile range) was 1.4 (0.6; 3.5), 13% of patients experienced no bleeding episodes, and 55.1% of patients experienced no spontaneous bleeds. The proportion of patients without any spontaneous bleeding episodes increased after the first year of prophylaxis. The hemostatic success rate in the treatment of bleeding episodes was 87.6%. No additional safety concerns were observed in patients with previously reported observation of temporarily decreased incremental recovery (IR). CONCLUSION: Long-term end-of-trial PUP N8-GP prophylaxis data indicate that PUPs respond well to long-term N8-GP treatment. The inhibitor incidence was consistent with previous results. Median ABR during prophylaxis was 1.4. There were no lasting clinical impacts or safety concerns for patients with an observation of temporarily decreased IR.

Occupational Risk Factors by Sectors: An Observational Study of 20,000 Workers.

OBJECTIVE: We aimed to assess the prevalence of exposure by sector and the sectors of activity most exposed to each exposure, using routine occupational health data, and to quantify the risk of being exposed. METHOD: Occupational risk factors were assessed by workers followed by the Occupational Health Service of Cher, using self-reported questionnaires. The sectors of activity were grouped into seven sectors, and the risks were grouped into six occupational exposure groups. Comparisons were made using the Chi-squared test and Cramer's V, and the odds ratios were calculated by using logistic regression. RESULTS: We included 19,891 workers. The construction sector had the highest prevalence (p < 0.05 vs. all other sectors) of exposure to physical (76%) and biomechanical factors (82%), as well as chemical risks (75%). Human health and social work was the sector with the highest prevalence of exposure to biological factors (69%), psychosocial factors (90%), and atypical working hours (61%). With workers from administrative and support sectors as the reference, construction workers had more chance of declaring exposure to physical factors (OR = 3.28, 95%CI = 2.89 to 3.72), biomechanical factors (1.82, 1.58 to 2.09), and chemical agents (3.83, 3.38 to 4.33). Workers from the human health and social sectors had more chance of being exposed to biological agents (13.4, 11.9 to 15.2), atypical working hours (1.93, 1.75 to 2.14), and psychosocial factors (2.74, 2.38 to 3.16). CONCLUSION: Psychosocial risk factors were commonly reported in all sectors. Workers in the construction, human health, and social sectors seem to report more exposures than those in other sectors. The analysis of occupational exposures is a necessary basis to build an efficient preventive strategy for occupational health.

The safety and efficacy of N8-GP (turoctocog alfa pegol) in previously untreated pediatric patients with hemophilia A.

N8-GP (turoctocog alfa pegol) is a recombinant, glycoPEGylated, extended half-life, factor VIII replacement product. Here, we examined the immunogenicity, safety, and efficacy of N8-GP in previously untreated patients (PUPs). pathfinder6 is an ongoing, open-label, phase 3 trial that enrolled PUPs with severe hemophilia A and were aged <6 years. The primary end point was the incidence of factor VIII inhibitors (≥0.6 Bethesda units [BU]). Eighty patients received ≥1 N8-GP dose and were included in this analysis; ≥50 patients had ≥50 exposure days to N8-GP. The inhibitor incidence was 29.9% (14.9% high-titer [>5 BU]). Sixty-five patients received N8-GP prophylaxis for an average of 2.17 years with a median annualized bleeding rate (interquartile range) of 1.42 (0.76; 3.13) and a 90.5% hemostatic success rate. Temporarily decreased incremental recovery (IR), defined as ≥2 consecutive measurements of IR <0.6 (IU/dL)/(IU/kg) but no inhibitors, was observed in 17 patients within 5 exposure days to N8-GP and had a strong temporal correlation with anti-polyethylene glycol immunoglobulin G antibody titers. IR returned within the expected range with continued N8-GP dosing. During the period of decreased IR, hemostatic response was similar to that of the overall trial population, and no hypersensitivity related to N8-GP or unexpected new adverse events were reported. N8-GP prophylaxis was efficacious for the prevention and treatment of bleeding episodes in PUPs with severe hemophilia A. The inhibitor incidence was 29.9%. All patients with temporarily decreased IR continuing on N8-GP dosing returned within the expected range and had no evident lack of efficacy. This trial was registered at www.clinicaltrials.gov as #NCT02137850.

Rehabilitation in Older Adults Affected by Immobility Syndrome, Aided by Virtual Reality Technology: A Narrative Review.

Individual mobility deficit in older adults induces a variety of medical conditions, diminishing their functional capacity in pursuing activities of daily living. In immobility syndrome patients, such conditions are prone further deterioration through a drastically reduced scope of physical activity, owing mostly to poor self-motivation and the monotonous character of conventional rehabilitation regimens. As evidenced by published research, virtual reality technology solutions in rehabilitation management actually add significantly to patients' self-motivation, while promoting their active involvement in therapy through visual, auditory, and kinaesthetic stimuli. Effective rehabilitation training aided by virtual reality solutions helps patients acquire specific physical and cognitive skills to be subsequently emulated in the real-world environment. The extra added advantage lies in facilitating such training within patients' own home environments, combined with online monitoring of their progress, when not personally supervised by a physiotherapist, which also boosts the overall cost effectiveness of the therapeutic management itself. This narrative review appears to be the very first one principally focused on critically comparing individual immobilisation with immobility syndrome, especially through the application of the Authors' own substantial hands-on therapeutic experience in managing various rehabilitation schemes, specifically aided by diverse virtual reality technology solutions.