Emicizumab prophylaxis for people with hemophilia A: Waste estimation and the Brazilian perspective.

Costs of hemophilia A treatment are increasing. Waste of clotting products should be avoided. To estimate the first-year waste of emicizumab prophylaxis for people with hemophilia A and inhibitors (PwHAi) who failed immune tolerance induction (ITI), in Brazil. We evaluated the manufacturer and the Brazilian Ministry of Health (MoH) protocol-recommended regimens in a budget impact model. The loading dose consisted of 3.0 mg/kg/Q1W for 4 weeks, for both recommendations. The manufacturer maintenance regimens comprised 1.5 mg/kg/Q1W, 3.0 mg/kg/Q2W, and 6.0 mg/kg/Q4W. The MoH protocol maintenance regimen encompassed a hybrid Q1W/Q2W administration, depending on the body weight. The Q4W regimen was not recommended by the MoH protocol. Analyses were performed to estimate waste given its expense based on the World Health Organization body weight range (percentiles [P] 15, 50, and 85). The first-year emicizumab waste was estimated individually and for the disclosed PwHAi who failed ITI (n = 114). The highest emicizumab waste was estimated for the lowest body weights and the Q1W regimen. The Q4W regimen resulted in the lowest emicizumab waste, followed by the MoH protocol regimen. The total reconstituted costs estimated for the PwHAi who failed ITI according to the hybrid MoH protocol ranged from US$32,858,777 (P15) to US$47,186,858 (P85), with emicizumab waste ranging from 7.9 % (US$2,594,515) to 3.7 % (US$1,738,750), respectively. Lost resources due to current protocols for emicizumab prophylaxis for PwHAi who failed ITI in Brazil are considerable. Waste was more pronounced due to lower body weight and shorter administration intervals.

Chronic aerobic exercise prevents high-fructose diet-induced impairment in blood pressure in healthy young adults: a double-blind, randomised clinical trial.

The purpose of the study was to verify the effect of 4 weeks of a high-fructose diet (HFD) associated with aerobic training on the risk factors for cardiometabolic diseases. Twenty-one young adults were randomised into three groups: HFD (HFD: 1 g/kg body weight of fructose/day), high-glucose diet (HGD: 1 g/kg body weight of glucose/day) and high-fructose diet and exercise (HFDE: 1 g/kg body weight of fructose/day + 3 weekly 60-minute sessions of aerobic exercise). Before and after the 4 weeks of the intervention, blood samples were taken and flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, insulin sensitivity index and 24-h blood pressure were evaluated. HFD showed an increase in uric acid concentrations (P = 0·040), and HGD and HFDE groups showed no changes in this outcome between pre- and post-intervention; however, the HFDE group showed increased uric acid concentrations from the middle to the end of the intervention (P = 0·013). In addition, the HFD group showed increases in nocturnal systolic blood pressure (SBP) (P = 0·022) and nocturnal diastolic blood pressure (DBP) (P = 0·009). The HGD group exhibited decreases in nocturnal SBP (P = 0·028) and nocturnal DBP (P = 0·031), and the HFDE group showed a decrease in 24-h SBP (P = 0·018). The consumption of 1 g/kg of fructose per day may increase uric acid concentrations and blood pressure in adults. Additionally, aerobic exercises along with fructose consumption attenuate changes in uric acid concentrations and prevent impairment in nocturnal blood pressure.

Cardiometabolic health profile of young girls with aesthetic professions.

BACKGROUND: In the literature, professions that impose body standards for daily performance are designated as non-conventional professions (i.e. models, athletes, ballet dancers), with great emphasis on the female population. More than a job, it becomes a lifestyle to those inserted in this environment, thus, thousands of children and adolescents seek inclusion and success in these professions due to financial and media gains. Such professions are associated with several health-related risk factors. The purpose of this study was to identify and compare among physical fitness levels, cardiometabolic health markers, mental health and dietary habits in non-conventional professions. METHODS: The sample consisted of 41 female individuals aged between 14 and 24 years, allocated into four groups, control group composed by university students (UG = 11), models (MG = 11), ballet dancers (BG = 11), and athletes' group (AG = 8). Physical fitness outcomes (cardiorespiratory fitness, flexibility, maximal dynamic strength, muscular endurance and body composition); biochemical outcomes (high-density lipoprotein [HDL], low-density lipoprotein [LDL], total cholesterol [TC], fasting glucose [FG], fasting insulin [FI], C-reactive protein [CRP]), diet quality and mental health were evaluated. RESULTS: No impairments were observed in the health markers evaluated among groups, both for health-related physical fitness and biochemical outcomes. However, low levels of bone mineral density (BMD) were observed. Even with statistically significant differences between the groups for chronological age (p = 0.002), menarche (p = 0.004), career length (p = 0.001), height (p = 0.001), body mass index (p = 0.018), waist-to-height ratio (p < 0.001), %Fat (p = 0.020), VO2peak (p = 0.020), maximal dynamic strength of knee extensors (p = 0.031) and elbow flexors (p = 0,001) and flexibility (p < 0.001), all these values are within the normal range for health. CONCLUSION: The professions analyzed do not seem to interfere in the physical fitness and cardiometabolic health of the girls assessed. However, we identified that exposure to these profession can impair mental health (depressive symptoms in 100% of participants) and body composition (BMD 63% of participants).

A Cross-Sectional Study of Quality of Life Among Brazilian Adults With Type 1 Diabetes Treated With Insulin Glargine: Findings and Implications.

This article describes a cross-sectional study involving 401 adults with type 1 diabetes treated with insulin glargine in Minas Gerais, Brazil. Health-related quality of life was assessed, and worse scores were found to be associated with a low level of education, self-perceived health reported as poor/very poor, being bedridden and not physically exercised, having seen a doctor more than four times in the past year, and having reported comorbidities and episodes of hypoglycemia.

Validity of the Frequency of Suicidal Ideation Inventory in Brazilian adults.

We examined the validity of the Brazilian Frequency of Suicidal Ideation Inventory (FSII-Br), an adaptation of the Frequency of Suicidal Ideation Inventory (FSII), in 946 Brazilian undergraduates. Confirmatory factor analysis of the FSII-Br demonstrated a one-factor model accounting for 62.39% of the variance in FSII-Br scores with a good FIT index. Correlation analyses demonstrated that the FSII-Br was positively correlated with both measures of suicide ideation and suicide risk (viz., depressive symptoms, anxious symptoms, and hopelessness), providing construct validity. Thus, the FSII-Br was found to be a promising tool in assessing suicide risk among Brazilian adults.

Effects of Resistance Training Performed to Failure or Not to Failure on Muscle Strength, Hypertrophy, and Power Output: A Systematic Review With Meta-Analysis.

ABSTRACT: Vieira, AF, Umpierre, D, Teodoro, JL, Lisboa, SC, Baroni, BM, Izquierdo, M, and Cadore, EL. Effects of resistance training performed to failure or not to failure on muscle strength, hypertrophy, and power output: A systematic review with meta-analysis. J Strength Cond Res 35(4): 1165-1175, 2021-The aim of this review was to summarize the evidence from longitudinal studies assessing the effects induced by resistance training (RT) performed to failure (RTF) vs. not to failure (RTNF) on muscle strength, hypertrophy, and power output in adults. Three electronic databases were searched using terms related to RTF and RTNF. Studies were eligible if they met the following criteria: randomized and nonrandomized studies comparing the effects of RTF vs. RTNF on muscle hypertrophy, maximal strength, and muscle power in adults, and RT intervention ≥6 weeks. Results were presented as standardized mean differences (SMDs) between treatments with 95% confidence intervals, and calculations were performed using random effects models. Significance was accepted when p < 0.05. Thirteen studies were included in this review. No difference was found between RTF and RTNF on maximal strength in overall analysis (SMD: -0.08; p = 0.642), but greater strength increase was observed in RTNF considering nonequalized volumes (SMD: -0.34; p = 0.048). Resistance training performed to failure showed a greater increase in muscle hypertrophy than RTNF (SMD: 0.75; p = 0.005), whereas no difference was observed considering equalized RT volumes. No difference was found between RTF and RTNF on muscle power considering overall analysis (SMD: -0.20; p = 0.239), whereas greater improvement was observed in RTNF considering nonequalized RT volumes (SMD: -0.61; p = 0.025). Resistance training not to failure may induce comparable or even greater improvements in maximal dynamic strength and power output, whereas no difference between RTF vs. RTNF is observed on muscle hypertrophy, considering equalized RT volumes.

Real-world evaluation of the impact of statin intensity on adherence and persistence to therapy: A Scottish population-based study.

AIM: To assess associations between statin intensity and adherence, persistence and discontinuation of statin therapy in Scotland. METHOD: Retrospective cohort study, using linked electronic health records covering a period from January 2009 to December 2016. The study cohort included adult patients (≥18 years) newly initiating statins within Greater Glasgow and Clyde, Scotland. Study outcomes comprised adherence, discontinuation and persistence to treatment, stratified by three exposure groups (high, moderate and low intensity). Discontinuation and persistence were calculated using the refill-gap and anniversary methods, respectively. Proportion of days covered (PDC) was used as a proxy for adherence. Kaplan-Meier survival curves and Cox proportional hazard models were used to evaluate discontinuation, and associations between adherence/persistence and statin intensity were assessed using logistic regression. RESULTS: A total of 73 716 patients with a mean age of 61.4 ± 12.6 years were included; the majority (88.3%) received moderate intensity statins. Discontinuation rates differed between intensity levels, with high-intensity patients less likely to discontinue treatment compared to those on moderate intensity (prior cardiovascular disease [CVD]: HR 0.43 [95% CI 0.34-0.55]; no prior CVD: 0.80 [0.74-0.86]). Persistence declined over time, and high-intensity patients had the highest persistence rates. Overall, 52.6% of patients were adherent to treatment (PDC ≥ 80%), but adherence was considerably higher among high-intensity patients (63.7%). CONCLUSION: High-intensity statins were associated with better persistence and adherence to treatment, but overall long-term persistence and adherence remain a challenge, particularly among patients without prior CVD. This needs addressing.

Adaptations in mechanical muscle function, muscle morphology, and aerobic power to high-intensity endurance training combined with either traditional or power strength training in older adults: a randomized clinical trial.

PURPOSE: There is a lack of information on the effects of power training (PT) as an alternative to traditional strength training (TST) during concurrent training (CT) in older individuals. This study aimed to verify the neuromuscular adaptations that occurred following 16-week interventions with two CT models in older men: high-intensity interval training (HIIT) combined with either TST or PT. METHODS: Thirty-five older men (65.8 ± 3.9 years) were randomly assigned into one of two training groups CTS: TST + HIIT (n = 18) or CTP: PT + HIIT (n = 17). CTS performed resistance training at intensities ranging from 65 to 80% of 1 RM at slow controlled speed, whereas CTP trained at intensities ranging from 40 to 60% of 1 RM at maximal intentional speed. Lower body one-repetition maximum (1 RM), isometric rate of force development (RFD), countermovement jump (CMJ) muscle power output, quadriceps femoris muscles thickness (QF MT), and peak oxygen uptake (VO2peak) were assessed before training and after 8 and 16 weeks of CT. RESULTS: Groups improved similarly in all primary outcomes (P < 0.05), with mean increases ranging: 1 RM (from 39.4 to 75.8%); RFD (from 9.9 to 64.8%); and CMJ muscle power (from 1.8 to 5.2%). Significant increases (P < 0.05) were observed in all secondary outcomes (QF MT, specific tension and VO2peak) with no differences between groups. CONCLUSION: CT models were effective for improving maximal and explosive force (1 RM, RFD, and CMJ power), QF MT, and VO2peak. Moreover, despite that using lower loading intensities, PT induced similar adaptations to those of TST.

[Suicide and indigenous populations in Brazil: systematic reviewEl suicidio y los pueblos indígenas brasileños: revisión sistemática]. / Suicídio e povos indígenas brasileiros: revisão sistemática.

OBJECTIVE: To describe the frequency, characteristics, and factors contributing to suicide in indigenous populations in Brazil. METHOD: A systematic review of the literature was performed in PubMed, SciELO, PsycINFO, and LILACS. All population-based studies focusing on suicide among indigenous populations in Brazil were included. RESULTS: The search identified 111 articles, of which nine met the inclusion criteria. Three of these studies were performed in the Midwest and four in the North of Brazil, while two covered all Brazilian regions. The ethnic groups investigated were specified in three studies (Terena, Kadiweu, Guato, Ofaie-Xavante, Guarani, Guarani-Kaiowá, and Guarani-Nandeva). Suicide rates were highest among males, single individuals, those with 4 to 11 years of schooling, and those aged 15 to 24 years. Suicides occurred most often in the home and on weekends, mostly by hanging. The main risk factors for suicide identified in the articles were poverty, historical and cultural factors, poor wellbeing indicators, family disintegration, social vulnerability, and lack of life or future perspective. CONCLUSIONS: All the studies indicated the need to engage communities in developing strategies, considering their cosmovision and the social, historic, and cultural view of each ethnic group to minimize risk factors and reduce suicide rates.

OBJETIVO: Describir la frecuencia y las características del suicidio y sus factores contribuyentes en los pueblos indígenas brasileños. MÉTODO: Se realizó una revisión sistemática de la bibliografía a partir de las bases de datos PubMed, SciELO, PsycINFO y LILACS. Se incluyeron estudios de base poblacional enfocados en el suicidio en las poblaciones indígenas en el territorio brasileño. RESULTADOS: En la búsqueda se encontraron 111 artículos, de los cuales nueve se ciñeron a los criterios de inclusión. Se realizaron tres estudios en la región centro oeste y cuatro en la región norte, además de otros dos que abarcaron todas las regiones de Brasil. En tres estudios se citaron todas las siete etnias estudiadas (Terena, Kadiweu, Guato, Ofaie-Xavante, Guaraní, Guaraní-Kaiowá y E-Nandeva). En los estudios se demostró una mayor tasa de mortalidad por suicidio en personas solteras del sexo masculino, con 4 a 11 años de escolaridad, en el grupo de 15 a 24 años de edad, en el domicilio y en los fines de semana, principalmente por el método de ahorcamiento. Los principales factores de riesgo de suicidio fueron la pobreza, factores históricos y culturales, el índice de bienestar bajo, la desintegración de las familias, la vulnerabilidad social, y la falta de sentido de la vida y del futuro. CONCLUSIONES: Todos los estudios indicaron la necesidad de formular estrategias junto con las comunidades, dentro del marco de su cosmovisión y de los aspectos sociales, históricos y culturales de cada etnia, con el fin de reducir al mínimo los factores de riesgo y la tasa de mortalidad por suicidio.

Confidentiality agreements: a challenge in market regulation.

BACKGROUND: Sustainability and the ability to maintain the right to health, with the guarantee of access to quality medicines and health services, have been a great challenge for countries with universal health systems. The great technological advances bring with it an expressive increase in the expenditures of the health systems, especially those directed towards the acquisition of high-cost drugs, which are still under patent protection, have a high cost and, in some cases, present uncertainties about their effectiveness and safety. As a way of maintaining the proper functioning of the systems and guaranteeing access to these medicines, some countries started to negotiate discounts with manufacturing companies. Pricing agreements have been adopted by developed countries with the objective of reducing their spending on high-cost medicines and, although they represent an opportunity for better negotiation with the industries, they violate the principle of transparency that regulates the world market. However, the existence of confidentiality agreements has meant that the declared prices are not the actual prices, unfairly harming the countries that use these price lists as beacons in their systems. METHODS: Representatives of health, judicial, legislative, patient organizations and academics from eight countries in Latin America and South Korea participated in a meeting in September 2017 in Chile to discuss price confidentiality agreements and the impact on public health policies. During the meeting, participants were presented with a hypothetical case to subsidize the discussion on the topic. Divided into groups, participants should propose recommendations for the problem by pointing out the pros and cons if each proposed recommendation was adopted. The groups were then confronted by a simulated jury and finally issued a single and final recommendation for the problem. RESULTS: The topic was widely discussed and recommendations were raised by the participants. Among them, it is worth noting the elaboration of norms that regulate the negotiations of prices between the countries bringing transparency and harmony in the adopted conducts. In addition, the possible consequences and potential impacts of confidentiality on drug prices and inputs, such as information asymmetry and inequity of access between countries, were pointed out. CONCLUSION: Despite there are efforts to make price negotiations more transparent, there is still no well-established standardization that promotes a well-functioning market. Confidentiality agreements hamper the fairness of access to essential health products.

Who should pay for the continuity of post-trial health care treatments?

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.

Concurrent training performed with and without repetitions to failure in older men: A randomized clinical trial.

This study compared the effects of 20 weeks of concurrent training with and without repetitions to failure on neuromuscular and functional adaptations in older men. METHODS: Thirty-six older men (67.1 ± 5.1 years) were randomized into three groups: one performing repetitions to failure (RFG, n = 13), another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n = 12), and a third performing repetitions not to failure with equal training volume of the RFG (ENFG, n = 11). Training was performed twice a week for 20 weeks at intensities ranging from 65% to 80% of maximal strength. In each session, the individuals started with strengthening exercises and then performed aerobic exercise on a treadmill. Before and after the intervention, individuals were assessed for their one repetition maximum (1RM) for leg press (LP) and knee extension (KE) exercises, knee extensors' isometric peak torque (PTiso ), and rate of torque development (RTD) at 50 ms, 100 ms, and 250 ms, muscle thickness of the quadriceps, as well as functional performance on sit-to-stand, and timed up and go tests. RESULTS: After training, there were significant (P < 0.001) increases in the LP and KE 1RM, PTiso , and RTD outcomes in all groups. Also, there were significant increases in muscle thickness of the quadriceps and in the sit-to-stand test (P < 0.05) in all groups. No significant differences were observed between groups in any outcome. CONCLUSION: Concurrent training using repetitions to concentric failure did not promote additional benefits for neuromuscular function, muscle thickness, or functional capacity of older individuals.

Effects of photobiomodulation therapy associated with resistance training in elderly men: a randomized double-blinded placebo-controlled trial.

PURPOSE: The purpose of this study was to investigate the effects of photobiomodulation therapy (PBMT) combined with resistance training on knee extensors muscle mass, strength and functional capacity in elderly men. METHODS: In this randomized double-blinded placebo-controlled trial, healthy elderly men (age 60-80 years) completed 12 weeks of resistance training (2×/week) with application of placebo (n = 13) or active PBMT (n = 11) on quadriceps muscles (850 nm, 240 J per limb) before each training session. Leg press and knee extension one-repetition maximum (1RM) tests, isometric and concentric peak torques, rectus femoris (RF) and vastus lateralis (VL) muscle thickness, timed up-and-go (TUG) and chair rise-to-standing (CRS) tests were performed before and after the intervention period. RESULTS: There were significant improvements in all outcomes for both groups (p < 0.05), except for RF muscle thickness for the placebo group (p = 0.09). Large effect sizes (ES > 0.8) were observed for leg press and leg extension 1RM and CRS tests for both groups, as well as for TUG test for PBMT group. Isokinetic peak torque for both groups and TUG for placebo group had moderate increases (ES > 0.5). Muscle thicknesses and isometric peak torque had small increases (ES > 0.2) in both groups. Both null hypothesis analysis and magnitude-based inference support similar effects of PBMT and placebo treatments. CONCLUSION: Different than previously evidenced in young subjects, PBMT with the parameters used in this study did not provide any additional benefits in comparison to placebo application on muscle mass, strength and functional capacity of healthy elderly men engaged in a resistance training program.

Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines - a case study of oncology drugs.

BACKGROUND: We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. RESEARCH DESIGN AND METHODS: The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. RESULTS: The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions - Therapeutic Need and Added Therapeutic Value - and other two about methodological features - Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. CONCLUSION: This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors' weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.

Speed, agility, and musculoskeletal fitness are independently associated with areal bone mineral density in children.

Background: There is still little understanding of the associations between physical fitness variables and bone health in children taking into account key confounders. Aim: The aim of this study was to analyze the associations between performance in tests of speed, agility, and musculoskeletal fitness (power of the upper and lower limbs) with bone mass of different regions in children, considering the adjustment to maturity-offset, lean percentage, and sex. Methods: Cross-sectional study design: the sample consisted of 160 children aged 6-11 years. The physical fitness variables tested were 1) speed, assessed with the running test at a maximum speed of 20 m; 2) agility, assessed through the 4×4-m square test; 3) lower limb power, assessed using the standing long jump test, and 4) upper limb power, assessed using the 2-kg medicine ball throw test. Areal bone mineral density (aBMD) was obtained from the analysis of body composition by dual-energy X-ray absorptiometry (DXA). Simple and multiple linear regression models were performed using the SPSS software. Results: In the crude regression analyses, the results indicated a linear relationship between all the physical fitness variables and aBMD in all body segments, but maturity-offset, sex, and lean mass percentage seemed to have an effect on these relationships. Except for the upper limb power, the other physical capacities (speed, agility, and lower limb power) were associated with aBMD in at least three body regions in the adjusted analyses. These associations occurred in the spine, hip, and leg regions, and the aBMD of the legs presented the best association magnitude (R 2). Conclusion: There is a significant association between speed, agility, and musculoskeletal fitness, specifically the lower limb power and aBMD. That is, the aBMD is a good indicator of the relationship between fitness and bone mass in children, but it is essential to consider specific fitness variables and skeletal regions.

Best Laboratory Screening in Diagnosing Secondary Osteoporosis and Fracture Risk Assessment Tool and the National Osteoporosis Guideline Group Performance in Determining Clinical Risk: A Cross-Sectional Evaluation of the Bone Health in Postmenopausal Brazilian Women.

BACKGROUND: Identifying postmenopausal women with a high risk of having osteoporosis and fractures is a current challenge. This study aimed to assess the diagnostic performance of biochemical tests in identifying secondary osteoporosis and the fracture risk assessment tool (FRAX) in identifying fracture risk. METHODS: Data from biochemical tests and bone densitometry of postmenopausal women were analyzed. Additionally, the FRAX result was obtained and the patients were classified according to the National Osteoporosis Guideline Group (NOGG). RESULTS: A total of 646 women were evaluated, of whom 201 (31.1%) had osteoporosis or a previous frailty fracture. These women had statistically different parathyroid hormone (PTH) and alkaline phosphatase serum levels (p<0.01 and p=0.02, respectively) than those without osteoporosis or fracture. However, those at high risk had a higher prevalence of hypovitaminosis D (46% vs. 36%) and hypocalciuria (17% vs. 9%). The FRAX showed an area under the curve of 0.757 (p<0.01) and 0.788 (p<0.01) for identifying women at risk for "major fractures" and "hip," respectively. The NOGG categorization had a sensitivity of 19% to identify high-risk women, a specificity of 91.3% for low-risk women, with a positive predictive value of 57.4% and a negative predictive value of 64.6%. CONCLUSIONS: The evaluation of PTH, 25-hydroxy-vitamin D, serum calcium, and 24-hr urinary calcium proved adequate for initial osteoporosis screening. The FRAX tool has a regular ability to screen women at risk for fracture, and the NOGG method has high specificity to identify those at low risk.

Effects of short-term multicomponent exercise intervention on muscle power in hospitalized older patients: A secondary analysis of a randomized clinical trial.

BACKGROUND: Bed rest during hospitalization can negatively impact functional independence and clinical status of older individuals. Strategies focused on maintaining and improving muscle function may help reverse these losses. This study investigated the effects of a short-term multicomponent exercise intervention on maximal strength and muscle power in hospitalized older patients. METHODS: This secondary analysis of a randomized clinical trial was conducted in an acute care unit in a tertiary public hospital. Ninety (39 women) older patients (mean age 87.7 ± 4.8 years) undergoing acute-care hospitalization [median (IQR) duration 8 (1.75) and 8 (3) days for intervention and control groups, respectively]) were randomly assigned to an exercise intervention group (n = 44) or a control group (n = 46). The control group received standard care hospital including physical rehabilitation as needed. The multicomponent exercise intervention was performed for 3 consecutive days during the hospitalization, consisting of individualized power training, balance, and walking exercises. Outcomes assessed at baseline and discharge were maximal strength through 1 repetition maximum test (1RM) in the leg press and bench press exercises, and muscle power output at different loads (≤30% of 1RM and between 45% and 55% of 1RM) in the leg press exercise. Mean peak power during 10 repetitions was assessed at loads between 45% and 55% of 1RM. RESULTS: At discharge, intervention group increased 19.2 kg (Mean Δ% = 40.4%) in leg press 1RM [95% confidence interval (CI): 12.1, 26.2 kg; P < 0.001] and 2.9 kg (Mean Δ% = 19.7%) in bench press 1RM (95% CI: 0.6, 5.2 kg; P < 0.001). The intervention group also increased peak power by 18.8 W (Mean Δ% = 69.2%) (95% CI: 8.4, 29.1 W; P < 0.001) and mean propulsive power by 9.3 (Mean Δ% = 26.8%) W (95% CI: 2.5, 16.1 W; P = 0.002) at loads ≤30% of 1RM. The intervention group also increased peak power by 39.1 W (Mean Δ% = 60.0%) (95% CI: 19.2, 59.0 W; P < 0.001) and mean propulsive power by 22.9 W (Mean Δ% = 64.1%) (95% CI: 11.7, 34.1 W; P < 0.001) at loads between 45% and 55% of 1RM. Mean peak power during the 10 repetitions improved by 20.8 W (Mean Δ% = 36.4%) (95% CI: 3.0, 38.6 W; P = 0.011). No significant changes were observed in the control group for any endpoint. CONCLUSIONS: An individualized multicomponent exercise program including progressive power training performed over 3 days markedly improved muscle strength and power in acutely hospitalized older patients.

Similar body composition, muscle size, and strength adaptations to resistance training in lacto-ovo-vegetarians and non-vegetarians.

There is a popular belief that meat consumption is necessary to optimize adaptations to strength training (ST), but evidence to support this hypothesis is scarce. Therefore, this study aimed to compare ST adaptations in lacto-ovo-vegetarians (LOV) and non-vegetarians (NV) with adjusted protein intake per meal. Sixty-four LOV and NV performed 12 weeks of ST and were instructed to ingest at least 20 g of protein in each main meal during the experimental period. Quadriceps femoris muscle thickness (QFMT), knee extension one-repetition maximum (1RM), and isometric peak torque (PT), as well as participants' body composition were assessed before and after the intervention. Dietary intake was assessed throughout the study. After 12 weeks, similar increases in QFMT (LOV: 9.2 ± 5.4; NV: 5.5 ± 8.1 mm), knee extension 1RM (LOV: 24.7 ± 11.1; NV: 21.6 ± 9.8 kg), and PT (LOV: 29.8 ± 33.4; NV: 17.5 ± 19.4 N m) and lean body mass (LOV: 1.3 ± 0.9; NV: 1.4 ± 1.4 kg), alongside a decrease in body fat mass (LOV: -0.5 ± 1.6; NV -0.8 ± 1.6 kg) were observed in both groups at the end of the training period (p < 0.05). LOV had lower protein consumption than NV throughout the study (p < 0.05), but participants reached intake of at least 1.2 g of protein/kg/day during the experimental period. In conclusion, LOV and NV displayed similar improvements in muscle mass, strength, and in body composition after 12 weeks of ST, suggesting that meat consumption and higher protein intake in NV did not bring about further benefits to early adaptations to ST. This study was registered in Clinical Trials (NCT03785002) on 24 December 2018.

Efficacy/effectiveness and safety of emicizumab prophylaxis of people with hemophilia A: a systematic review and meta-analysis.

BACKGROUND: Emicizumab is a monoclonal antibody approved for prophylaxis against bleeds for people with hemophilia A (PwHA). A systematic review was conducted evaluating the efficacy/effectiveness and the safety of emicizumab as prophylaxis for PwHA compared to prophylaxis with factor VIII (FVIII) or bypassing agents (BPA), respectively in patients without and with inhibitors. RESEARCH DESIGN AND METHODS: Database-directed search strategies were performed in Aug/26/2022 and updated in Mar/16/2023. Studies evaluating the prophylaxis with emicizumab versus prophylaxis with FVIII or BPA in PwHA without or with inhibitors, respectively, were selected by two independent reviewers. Data were extracted by two independent reviewers. Annualized bleeding rates for total treated bleeding events (ABR-all) were evaluated by meta-analysis. The quality of studies and certainty of evidence were assessed. RESULTS: A total of 11 studies were included. The standard mean differences for ABR-all were -0.6 (95%CI -1.0 to -0.2, p-value = 0.0002), among PwHA without inhibitors, and -1.7 (95%CI -2.4 to -0.9, p-value <0.00001), among PwHA with inhibitors. However, there was moderate heterogeneity in both meta-analyses. The most frequent adverse event was injection site reaction. CONCLUSIONS: Emicizumab prophylaxis was superior in reducing the ABR-all when compared with prophylaxis with FVIII or BPA.

Effectiveness of nirmatrelvir-ritonavir for the treatment of patients with mild to moderate COVID-19 and at high risk of hospitalization: Systematic review and meta-analyses of observational studies.

OBJECTIVE: To assess the effectiveness of nirmatrelvir-ritonavir in the treatment of outpatients with mild to moderate COVID-19 who are at higher risk of developing severe illness, through a systematic review with meta-analyses of observational studies. METHODS: A systematic search was performed, in accordance with the Cochrane search methods, to identify observational studies that met the inclusion criteria. The outcomes of mortality and hospitalization were analyzed. Search was conducted on PubMed, EMBASE, and The Cochrane Library. Two reviewers independently screened references, selected the studies, extracted the data, assessed the risk of bias using ROBINS-I tool and evaluated the quality of evidence using the GRADE tool. This study followed the PRISMA reporting guideline. RESULTS: A total of 16 observational studies were finally included. The results of the meta-analysis showed that in comparison to standard treatment without antivirals, nirmatrelvir-ritonavir reduced the risk of death by 59% (OR = 0.41; 95% CI: 0.35-0.52; moderate certainty of evidence). In addition, a 53% reduction in the risk of hospital admission was observed (OR = 0.47; 95% CI: 0.36-0.60, with very low certainty of evidence). For the composite outcome of hospitalization and/or mortality, there was a 56% risk reduction (OR = 0.44; 95% CI: 0.31-0.64, moderate certainty of evidence). CONCLUSION: The results suggest that nirmatrelvir-ritonavir could be effective in reducing mortality and hospitalization. The results were valid in vaccinated or unvaccinated high-risk individuals with COVID-19. Data from ongoing and future trials may further advance our understanding of the effectiveness and safety of nirmatrelvir-ritonavir and help improve treatment guidelines for COVID-19.