The influence of Visfatin, RBP-4 and insulin resistance on bone mineral density in women with treated primary osteoporosis.

INTRODUCTION: The impact of the two adipokines, visfatin and retinol-binding protein 4 (RBP-4) on bone mineral density (BMD) has been analysed in various studies with conflicting results. Visfatin is highly expressed in visceral fat with stimulatory effect on osteoblast proliferation and inhibition on osteoclast formation, while RBP-4 acts as a transporter protein for retinol, associated with changes in insulin sensitivity, independent of obesity, with no consensus on its effect on bone metabolism. We evaluated the relationship between serum concentrations of visfatin, RBP-4, markers of insulin resistance and current BMD in treated postmenopausal osteoporosis (PO). METHODS: Demographics, previous treatment, metabolic status, anthropometry, serum Alkaline phosphatise (ALP), visfatin, RBP-4, the HOMA IR (homeostatic model assessment of insulin resistance) index and BMD were evaluated in 61 subjects with PO. Statistical analysis used SPSS v. 25.0, with a level of significance α = 0.05. Regression models were constructed to evaluate the relationship between adipokines and BMD, adjusting for covariates. RESULTS: In multilinear regression analysis, the strongest predictor for current BMD was a previous BMD, followed by ALP and age. RBP4 and HOMA IR were significant predictors, while visfatin had no significant effect. A significant correlation between body mass index (BMI) and BMD at the femoral neck was observed. ALP was negatively correlated with BMD and visfatin positively with RBP4. CONCLUSIONS: Data indicate a positive relationship between BMD and RBP-4, an inverse relationship between markers of insulin resistance, bone turn-over and current BMD. No significant effect of visfatin on BMD was observed.

[Sarcopenia and quality of life: the validated Hungarian translation of the Sarcopenia Quality of Life (SarQoL) questionnaire]. / Sarcopenia és életminoség: a Sarcopenia Quality of Life (SarQoL) kérdoív hiteles magyar fordítása.

INTRODUCTION: Sarcopenia, or age-related muscle loss, is emerging as a serious public health concern. Due to the impaired physical performance associated with sarcopenia, a reduced quality of life (QoL) has been evidenced in the affected individuals. Generic instruments, such as Rand Corporation Short Form 36 (SF-36) or the European Quality of Life (EuroQoL-5D) questionnaires do not accurately assess the impact of sarcopenia on QoL. SarQoL (Sarcopenia Quality of Life) questionnaire, was the first disease-specific questionnaire addressing the quality of life in patients with sarcopenia and has been recently designed for providing a global assessment of the quality of life in community-dwelling elderly subjects aged 65 years and older. AIM: Our aim was the development of a valid Hungarian version of the original SarQoL, through the translation, cultural adaptation and content validation of the original questionnaire. METHOD: We followed the recommended process, the international protocol of translation in five steps: two initial translations, synthesis of the two translations, backward translation, expert committee to compare translations with the original questionnaire and pretest. The pretest process involved 20 subjects (10 clinically sarcopenic and 10 non-sarcopenic with different educational and socioeconomic backgrounds) who were asked to complete the questionnaire. Feedbacks were requested from all subjects regarding the comprehensibility of questions or difficulties in completing the test. RESULTS: Using the recommended best practice protocol for translation, the pre-final version is comparable with the original instrument in terms of content and accuracy. CONCLUSION: After the content validation with clinically sarcopenic persons it should be a useful tool to assess the quality of life of people with sarcopenia among elderly Hungarian patients. Orv Hetil. 2018; 159(36): 1483-1486.

Recommendations for the conduct of clinical trials for drugs to treat or prevent sarcopenia.

PURPOSE: Sarcopenia is an age-related muscle condition which is frequently a precursor of frailty, mobility disability and premature death. It has a high prevalence in older populations and presents a considerable social and economic burden. Potential treatments are under development but, as yet, no guidelines support regulatory studies for new drugs to manage sarcopenia. The objective of this position paper is therefore to suggest a set of potential endpoints and target population definitions to stimulate debate and progress within the medico-scientific and regulatory communities. METHODS: A multidisciplinary expert working group was hosted by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, which reviewed and discussed the recent literature from a perspective of clinical experience and guideline development. Relevant parallels were drawn from the development of definition of osteoporosis as a disease and clinical assessment of pharmaceutical treatments for that indication. RESULTS: A case-finding decision tree is briefly reviewed with a discussion of recent prevalence estimations of different relevant threshold values. The selection criteria for patients in regulatory studies are discussed according to the aims of the investigation (sarcopenia prevention or treatment) and the stage of project development. The possible endpoints of such studies are reviewed and a plea is made for the establishment of a core outcome set to be used in all clinical trials of sarcopenia. CONCLUSIONS: The current lack of guidelines for the assessment of new therapeutic treatments for sarcopenia could potentially hinder the delivery of effective medicines to patients at risk.

Clinical setting influences patterns of interaction between osteoporosis patient and physician.

The importance of healthy behavior for bone health, as well as low adherence to anti-osteoporosis medication are well-described problems. Both, lifestyle habits and compliance with drug-therapy are influenced by the relationship between patients and physicians. We analyzed 152 consecutive doctor-patient interactions conducted in public and private practices specialized in the management of osteoporosis. We recorded the duration of the consultation and the relative length of: (a) Personal and medical history collection, (b) Physical examination, (c) Explanation of the diagnosis and treatment modalities, and (d) Administrative tasks. The overall length and the respective duration of the four phases of the consultation significantly differ in private versus public practices. In the private practice, doctors spend more time with the patient and dedicate a higher proportion of their time to history collection and explanation of diagnosis/treatment for osteoporosis. While we do not integrate data on medication adherence, we believe that since more time is dedicated to health education, patients consulting in the private sector have a greater probability to adopt a healthy lifestyle and better/ longer take anti-osteoporosis medications. Further investigations are needed to assess if the differences in patient and doctor behaviors in the public-private settings have a significant impact on therapeutic adherence and subsequently fracture reduction in patients receiving anti-osteoporosis treatment.

Quality of life in sarcopenia measured with the SarQoL questionnaire: A meta-analysis of individual patient data.

Age-related sarcopenia, resulting from a gradual loss in skeletal muscle mass and strength, is pivotal to the increased prevalence of functional limitation among the older adult community. The purpose of this meta-analysis of individual patient data is to investigate the difference in health-related quality of life between sarcopenic individuals and those without the condition using the Sarcopenia Quality of Life (SarQoL) questionnaire. A protocol was published on PROSPERO. Multiple databases and the grey literature were searched until March 2023 for studies reporting quality of life assessed with the SarQoL for patients with and without sarcopenia. Two researchers conducted the systematic review independently. A two-stage meta-analysis was performed. First, crude (mean difference) and adjusted (beta coefficient) effect sizes were calculated within each database; then, a random effect meta-analysis was applied to pool them. Heterogeneity was measured using the Q-test and I2 value. Subgroup analyses were performed to investigate the source of potential heterogeneity. The strength of evidence of this association was assessed using GRADE. From the 413 studies identified, 32 were eventually included, of which 10 were unpublished data studies. Sarcopenic participants displayed significantly reduced health-related quality of life compared with non-sarcopenic individuals (mean difference = -12.32; 95 % CI = [-15.27; -9.37]). The model revealed significant heterogeneity. Subgroup analyses revealed a substantial impact of regions, clinical settings, and diagnostic criteria on the difference in health-related quality of life between sarcopenic and non-sarcopenic individuals. The level of evidence was moderate. This meta-analysis of individual patient data suggested that sarcopenia is associated with lower health-related quality of life measured with SarQoL.

Predictors of mortality for patients with hip fracture: a study of the nationwide 1-year records of 24,950 fractures in Romania.

We conducted a study evaluating incidence rates and influencing factors in Romanian hip fracture patients. Our results showed that the type of fracture and its respective surgical procedure as well as hospital characteristics correlate with mortality. Updated incidences can result in updated treatment guidelines. PURPOSE: The aim of our study was to assess incidence rates for a revision-calibration of the Romanian FRAX tool and to evaluate particularities of hip fracture cases to determine patient- and hospital-related variables affecting mortality. METHODS: We conducted a retrospective study using hospital reports of hip fracture codes to the National School of Statistics (NSS) from January 1, 2019, until December 31, 2019. The study population included 24,950 patients presenting to Romanian public hospitals in all 41 counties: ≥ the age of 40 with diagnostic ICD 10 codes: S72.0 femoral neck fracture, S72.1 pertrochanteric femoral fracture, and S72.2 subtrochanteric femoral fracture and procedure codes: O11104 (trochanteric/sub capital internal fixation), O12101 (hemiarthroplasty), O11808 (closed femoral reduction with internal fixation), O12103 (partial arthroplasty), O12104 (total arthroplasty). Hospital length of stay (LoS) was classified as follows: < 6, 6-9, 10-14, and ≥ 15 days. RESULTS: Incidence of hip fractures was 248/100,000 among those aged 50 + and 184/100,000 within the 40 + age category. Average age of the patients was 77 years (80 for females, 71 for males); 83.7% of the patients were 65 + with equivalent urban-rural distributions. Males had a 1.7 times higher mortality risk. Each year increase in age added a mortality risk of 6.9%. In-hospital mortality was 1.34 times higher among patients living in urban areas. Hemiarthroplasty and partial/total unilateral/bilateral arthroplasty had a lower risk of mortality than trochanteric/sub capital internal fixation (p < 0.02, p < 0.033). CONCLUSION: Gender, age, residence, and procedure type had significant impact on mortality. Updated incidence rates will allow the revision of Romania's FRAX model.

Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia.

BACKGROUND: Economic evaluations are widely used to predict the economic impact of new treatment alternatives. Comprehensive economic reviews in the field of chronic lymphocytic leukemia (CLL) are warranted to supplement the existing analyses focused on specific therapeutic areas. METHODS: A systematic literature review was conducted based on literature searches in Medline and EMBASE to summarize the published health economics models related to all types of CLL therapies. Narrative synthesis of relevant studies was performed focusing on compared treatments, patient populations, modelling approaches and key findings. RESULTS: We included 29 studies, the majority of which were published between 2016 and 2018, when data from large clinical trials in CLL became available. Treatment regimens were compared in 25 cases, while the remaining four studies considered treatment strategies with more complex patient pathways. Based on the review results, Markov modelling with a simple structure of three health states (progression-free, progressed, death) can be considered as the traditional basis to simulate cost effectiveness. However, more recent studies added further complexity, including additional health states for different therapies (e.g. best supportive care or stem cell transplantation), for progression-free state (e.g. by differentiating between with or without treatment), or for response status (i.e. partial response and complete response). CONCLUSIONS: As personalized medicine is increasingly gaining recognition, we expect that future economic evaluations will also incorporate new solutions, which are necessary to capture a larger number of genetic and molecular markers and more complex patient pathways with individual patient-level allocation of treatment options and thus economic assessments.

Evaluation of the Hungarian-language SARC-F sarcopenia-screening questionnaire / A SARC-F sarcopeniaszuro kérdoív magyar változatának értékelése.

Összefoglaló. Bevezetés: A sarcopenia - idoskori izomero- és izomtömeg-csökkenés - a természetes öregedés része, ha viszont súlyos muködési zavarokat okoz, már betegségnek tekintendo. Ezért a szövodményes, rossz kimenetelek mérsékléséhez minél korábbi felismerése nélkülözhetetlen. Célkituzés: A sarcopenia kockázatának gyors értékelésére a SARC-F szerzoi egyszeru szuro kérdoívet alkottak, amelyet a sarcopeniát meghatározó diagnosztikus ajánlások kiemelten javallanak. E kérdoív magyar változatának jellemzoit vizsgáltuk, annak validálása céljából. Módszer: A kérdoívet 105, 65 éves vagy ennél idosebb személy bevonásával teszteltük. Az izomtömeg, az izomero és a teljesítmény értékelése elott a résztvevok kitöltöttek két generikus, valamint egy betegségspecifikus életminoség-kérdoívet. A megbízhatóság, konvergens, divergens, valamint konstruktumérvényesség vizsgálata mellett az eszköz diagnosztikus alkalmasságát is teszteltük. Statisztikai analízis: A Cronbach-alfa-érték, a Spearman/Pearson-féle korrelációs koefficiensek, a khi-négyzet-teszt, a szenzitivitás, a specificitás meghatározásához, a pozitív és negatív predikciós számításokhoz az SPSS 17.0 programot használtuk. Eredmények: A sarcopenia várható kockázata a SARC-F-teszt szerint (≥4 pont) 36%, míg az európai konszenzusdefiníció alapján sarcopeniásnak minosített esetek elofordulása 40% volt. A sarcopeniás egyéneknek jelentosen magasabb - domének szerinti és összesített - SARC-F-pontjaik voltak. A kérdoívet nagyon jó belso konzisztencia (Cronbach-alfa: 0,755), jó specificitás és magas negatív predikciós értékek jellemezték. Következtetés: A SARC-F magyar változata megbízható eszköznek tekintheto a sarcopenia kockázatának gyors és olcsó elorejelzésére. Orv Hetil. 2020; 161(47): 2000-2005. INTRODUCTION: Sarcopenia is an age-related involution process, causing a significant functional disability, therefore it can be classified as a disease. Early recognition of the disease is essential. Objetive: Authors of the original SARC-F questionnaire developed a simple and rapid screening tool, recommended by the European Working Group on Sarcopenia as the mandatory first step in the diagnostic process of sarcopenia. Our study aimed to test and validate the Hungarian version of this instrument. METHOD: 105 volunteers of 65+ years were recruited and evaluated for sarcopenia (muscle mass, strength and performance). Participants completed the SARC-F, other two generic and one disease-specific quality-of-life questionnaires. We checked the instrument for reliability, validity (discriminative power, construct, convergent and divergent validity) and screening performance. STATISTICAL ANALYSIS: Cronbach's alpha test, the Pearson/Spearman's correlation coefficient, chi-square test, sensitivity, specificity, positive and negative predictive value calculations have been performed. The SPSS 17.0 statistical program was used. RESULTS: The prevalence of sarcopenia according to the SARC-F test (score: ≥4) was 36%, while 40% was diagnosed with the European consensus definition. Sarcopenic individuals had significantly higher SARC-F total and domain scores. Very good internal consistency (Cronbach's alpha 0.755), specificity and negative predictive values were found. CONCLUSION: A reliable, rapid and inexpensive sarcopenia indicator is now available to timely detect the Hungarian-speaking patients at risk of sarcopenia. Orv Hetil. 2020; 161(47): 2000-2005.

Adolescent smoking and the social capital of local communities in three counties in Romania.

OBJECTIVE: To identify the effect of social capital on adolescent smoking. METHOD: A stratified random sample of 1313 7th and 8th grade students from three counties in Transylvania, Romania, completed a self-administered questionnaire on smoking-related knowledge, attitudes and behaviours. The impact of social capital was measured (personal and community activities, school achievements and smoking-related knowledge). Multivariate multinomial logistic regression models were used to measure the association between social participation and smoking. RESULTS: Experimenting with smoking was mostly related to knowledge about smoking, academic performance and second-hand tobacco smoke exposure at home. The strongest risk factor of adolescent smoking was the smoking behaviour of classmates: those who reported a significant proportion of smokers among their classmates were nine times more likely to smoke themselves than in other cases (adjusted odds ratio [aOR]: 9.05). Those who considered smoking to be harmless were 4 times more likely to be smokers than those who considered this behaviour to be dangerous (aOR: 4.28). Poor academic results increased adolescents' smoking (aOR: 3.22 and 2.66). The odds were significantly higher for smoking, if they had an active social life (aOR: 2.54). Regular church attendance proved to be a protective factor (aOR: 0.45). CONCLUSIONS: Several social capital factors can play a role in adolescent smoking. The organization and the development of community activities aimed at prevention must strengthen the factors related to the community's social capital to reduce the likelihood of teenage smoking.

Algorithm for the Use of Biochemical Markers of Bone Turnover in the Diagnosis, Assessment and Follow-Up of Treatment for Osteoporosis.

INTRODUCTION: Increased biochemical bone turnover markers (BTMs) measured in serum are associated with bone loss, increased fracture risk and poor treatment adherence, but their role in clinical practice is presently unclear. The aim of this consensus group report is to provide guidance to clinicians on how to use BTMs in patient evaluation in postmenopausal osteoporosis, in fracture risk prediction and in the monitoring of treatment efficacy and adherence to osteoporosis medication. METHODS: A working group with clinical scientists and osteoporosis specialists was invited by the Scientific Advisory Board of European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). RESULTS: Serum bone formation marker PINP and resorption marker ßCTX-I are the preferred markers for evaluating bone turnover in the clinical setting due to their specificity to bone, performance in clinical studies, wide use and relatively low analytical variability. BTMs cannot be used to diagnose osteoporosis because of low sensitivity and specificity, but can be of value in patient evaluation where high values may indicate the need to investigate some causes of secondary osteoporosis. Assessing serum levels of ßCTX-I and PINP can improve fracture prediction slightly, with a gradient of risk of about 1.2 per SD increase in the bone marker in addition to clinical risk factors and bone mineral density. For an individual patient, BTMs are not useful in projecting bone loss or treatment efficacy, but it is recommended that serum PINP and ßCTX-I be used to monitor adherence to oral bisphosphonate treatment. Suppression of the BTMs greater than the least significant change or to levels in the lower half of the reference interval in young and healthy premenopausal women is closely related to treatment adherence. CONCLUSION: In conclusion, the currently available evidence indicates that the principal clinical utility of BTMs is for monitoring oral bisphosphonate therapy.

Correction to: Psychometric performance of the Romanian version of the SarQoL®, a health-related quality of life questionnaire for sarcopenia.

The name and surname of the authors have been inverted. The correct order would be like this: Andrea Ildiko Gasparik, Gabriela Mihai, Charlotte Beaudart, Olivier Bruyere, Raluca-Monica Pop, Jean-Yves Reginster, Ionela Maria Pascanu.

Psychometric performance of the Romanian version of the SarQoL®, a health-related quality of life questionnaire for sarcopenia.

Our study assessed the psychometric properties of the Romanian SarQoL® questionnaire. Normal distribution and high internal consistency were found. Sarcopenic subjects reported a reduced global quality of life compared to non-sarcopenics. The Romanian version of the SarQoL® questionnaire, conceptually and literally equivalent with the source instrument, is qualified in terms of psychometric properties. PURPOSE/INTRODUCTION: We have recently provided a translated and culturally tailored version of the first quality of life (QoL) questionnaire specific for sarcopenia, the SarQoL®, in Romanian language. The aim of this study was to assess the psychometric performances of the translated questionnaire. METHODS: A total of 100 volunteers were enrolled in the study. Sarcopenia was diagnosed according to the algorithm proposed by the European Working Group on Sarcopenia in Older People (EWGSOP). To test the psychometric performance, discriminative power, internal consistency, floor and ceiling effects, and construct validity analyses were made. We assessed the correlation between SarQoL® and similar/different domains of other two QoL questionnaires. RESULTS: Sarcopenic subjects reported a reduced global QoL compared to non-sarcopenic individuals. Significantly (p = 0.018) higher total scores for non-sarcopenic subjects compared to those of sarcopenics indicate a good discriminative power of the Romanian questionnaire. Sarcopenic individuals had significantly lower scores in almost all domains. The Cronbach's alpha value of 0.946 indicates a high internal consistency. No floor or ceiling effects were found. A strong positive correlation was also found between similar domain scores from SF-36 and EQ-5D questionnaires with the Total SarQoL® score. Moreover, lower scores of quality of life have been shown to be significantly associated with lower muscle strength, in univariate analyses, and lower gait speed, both in univariate and multivariate analyses. CONCLUSIONS: Our results indicate that the Romanian version of the SarQoL® questionnaire, qualified in terms of psychometric properties, could be a useful tool to assess the sarcopenia-related QoL among frail Romanian individuals.

A reference case for economic evaluations in osteoarthritis: an expert consensus article from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

BACKGROUND: General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach. OBJECTIVES: To develop a reference case specific for economic studies in OA, including the standard optimal care, with which to judge new pharmacologic and non-pharmacologic interventions. METHODS: Four subgroups of an ESCEO expert working group on economic assessments (13 experts representing diverse aspects of clinical research and/or economic evaluations) were charged with producing lists of recommendations that would potentially improve the comparability of economic analyses in OA: outcome measures, comparators, costs and methodology. These proposals were discussed and refined during a face-to-face meeting in 2013. They are presented here in the format of the recommendations of the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, so that an initiative on economic analysis methodology might be consolidated with an initiative on reporting standards. RESULTS: Overall, three distinct reference cases are proposed, one for each hand, knee and hip OA; with diagnostic variations in the first two, giving rise to different treatment options: interphalangeal or thumb-based disease for hand OA and the presence or absence of joint malalignment for knee OA. A set of management strategies is proposed, which should be further evaluated to help establish a consensus on the "standard optimal care" in each proposed reference case. The recommendations on outcome measures, cost itemisation and methodological approaches are also provided. CONCLUSIONS: The ESCEO group proposes a set of disease-specific recommendations on the conduct and reporting of economic evaluations in OA that could help the standardisation and comparability of studies that evaluate therapeutic strategies of OA in terms of costs and effectiveness.