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In clinical trials, biochemical markers provide useful information on the drug’s mode of action, therapeutic response and side effect monitoring and can act as surrogate endpoints. In pharmacological intervention development for sarcopenia management, there is an urgent need to identify biomarkers to measure in clinical trials and that could be used in the future in clinical practice. The objective of the current consensus paper is to provide a clear list of biochemical markers of musculoskeletal health and aging that can be recommended to be measured in Phase II and Phase III clinical trials evaluating new chemical entities for sarcopenia treatment. A working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposed classifying biochemical markers into 2 series: biochemical markers evaluating musculoskeletal status and biochemical markers evaluating causal factors. For series 1, the group agreed on 4 biochemical markers that should be assessed in Phase II or Phase III trials (i.e., Myostatin-Follistatin, Brain Derived Neurotrophic Factor, N-terminal Type III Procollagen and Serum Creatinine to Serum Cystatin C Ratio – or the Sarcopenia Index). For series 2, the group agreed on 6 biochemical markers that should be assessed in Phase II trials (i.e., the hormones insulin-like growth factor-1 (IGF-I), dehydroepiandrosterone sulphate, and cortisol, and the inflammatory markers C-reactive protein (CRP), interleukin-6 and tumor necrosis factor-α), and 2 in Phase III trials (i.e., IGF-I and CRP). The group also proposed optional biochemical markers that may provide insights into the mode of action of pharmacological therapies. Further research and development of new methods for biochemical marker assays may lead to the evolution of these recommendations.

Patient perspectives are now widely recognized as a key element in the evaluation of health interventions. Therefore, the provision of specific and validated Patient Reported Outcome Measures that emphasize the lived experience of patients suffering from specific diseases is very important. In the field of sarcopenia, the only validated specific health-related quality of life (HRQoL) instrument available is the Sarcopenia Quality of Life questionnaire (SarQoL). This self-administrated HRQoL questionnaire, developed in 2015, consists of 55 items arranged into 22 questions and has currently been translated into 35 languages. Nineteen validation studies performed on SarQoL have consensually confirmed the capacity of SarQoL to detect difference in HRQoL between older people with and without sarcopenia, its reliability and its validity. Two further observational studies have also indicated its responsiveness to change. A short form SarQoL, including only 14 items has further been developed and validated to reduce the potential burden of administration. Research on the psychometric properties of SarQoL questionnaire is still encouraged as the responsiveness to change of SarQoL has not yet been measured in the context of interventional studies, as limited prospective data currently exist and as there is still not cut-off score to define a low HRQoL. In addition, SarQoL has mainly been used in community-dwelling older individuals with sarcopenia and would benefit to be studied in other types of populations. This review aims to provide to researchers, clinicians, regulators, pharmaceutical industries and other stakeholders a clear summary of comprehensive evidence on the SarQoL questionnaire published up to January 2023Query.

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients' needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken.

Despite immunisation being one of the greatest medical success stories of the twentieth century, there is a growing lack of confidence in some vaccines. Improving communication about the direct benefits of vaccination as well as its benefits beyond preventing infectious diseases may help regain this lost confidence. A conference was organised at the Fondation Merieux in France to discuss what benefits could be communicated and how innovative digital initiatives can used for communication. During this meeting, a wide range of indirect benefits of vaccination were discussed. For example, influenza vaccination can reduce hospitalisations and deaths in older persons with diabetes by 45% and 38%, respectively, but the link between influenza and complications from underlying chronic non-communicable diseases such as diabetes is frequently underestimated. Vaccination can reduce antimicrobial resistance (AMR), which is growing, by reducing the incidence of infectious disease (though direct and indirect or herd protection), by reducing the number of circulating AMR strains, and by reducing the need for antimicrobial use. Disease morbidity and treatment costs in the elderly population are likely to rise substantially, with the ageing global population. Healthy ageing and life-course vaccination approaches can reduce the burden of vaccine-preventable diseases, such as seasonal influenza and pneumococcal diseases, which place a significant burden on individuals and society, while improving quality of life. Novel disease surveillance systems based on information from Internet search engines, mobile phone apps, social media, cloud-based electronic health records, and crowd-sourced systems, contribute to improved awareness of disease burden. Examples of the role of new techniques and tools to process data generated by multiple sources, such as artificial intelligence, to support vaccination programmes, such as influenza and dengue, were discussed. The conference participants agreed that continual efforts are needed from all stakeholders to ensure effective, transparent communication of the full benefits and risks of vaccination.

Gasparik, Andrea Ildiko/0000-0002-1848-2410; Gasparik, Andrea Ildiko/0000-0002-1848-2410; Cooper, Cyrus/0000-0003-3510-0709; Vrijens, Bernard/0000-0002-9090-1253; Abrahamsen, Bo/0000-0002-2730-6080; Dennison, Elaine/0000-0002-3048-4961 WOS:000501843100001 PubMed ID: 31388696 A Summary Many patients at increased risk of fractures do not take their medication appropriately, resulting in a substantial decrease in the benefits of drug therapy. Improving medication adherence is urgently needed but remains laborious, given the numerous and multidimensional reasons for non-adherence, suggesting the need for measurement-guided, multifactorial and individualized solutions. Introduction Poor adherence to medications is a major challenge in the treatment of osteoporosis. This paper aimed to provide an overview of the consequences, determinants and potential solutions to poor adherence and persistence to osteoporosis medication. Methods A working group was organized by the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) to review consequences, determinants and potential solutions to adherence and to make recommendations for practice and further research. A systematic literature review and a face-to-face experts meeting were undertaken. Results Medication non-adherence is associated with increased risk of fractures, leading to a substantial decrease in the clinical and economic benefits of drug therapy. Reasons for non-adherence are numerous and multidimensional for each patient, depending on the interplay of multiple factors, suggesting the need for multifactorial and individualized solutions. Few interventions have been shown to improve adherence or persistence to osteoporosis treatment. Promising actions include patient education with counselling, adherence monitoring with feedback and dose simplification including flexible dosing regimen. Recommendations for practice and further research were also provided. To adequately manage adherence, it is important to (1) understand the problem (initiation, implementation and/or persistence), (2) to measure adherence and (3) to identify the reason of non-adherence and fix it. Conclusion These recommendations are intended for clinicians to manage adherence of their patients and to researchers and policy makers to design, facilitate and appropriately use adherence interventions. European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) The meeting was funded by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

The recommended intake of vitamin D-fortified dairy products can substantially decrease the burden of osteoporotic fractures and seems an economically beneficial strategy in the general French population aged over 60 years.This study aims to assess the public health and economic impact of vitamin D-fortified dairy products in the general French population aged over 60 years.We estimated the lifetime health impacts expressed in number of fractures prevented, life years gained, and quality-adjusted life years (QALY) gained of the recommended intake of dairy products in the general French population over 60 years for 1 year (2015). A validated microsimulation model was used to simulate three age cohorts for both women and men (60-69, 70-79, and > 80 years). The incremental cost per QALY gained of vitamin D-fortified dairy products compared to the absence of appropriate intake was estimated in different populations, assuming the cost of two dairy products per day in base case.The total lifetime number of fractures decreased by 64,932 for the recommended intake of dairy products in the general population over 60 years, of which 46,472 and 18,460 occurred in women and men, respectively. In particular, 15,087 and 4413 hip fractures could be prevented in women and men. Vitamin D-fortified dairy products also resulted in 32,569 QALYs and 29,169 life years gained. The cost per QALY gained of appropriate dairy intake was estimated at a,notsign58,244 and fall below a threshold of a,notsign30,000 per QALY gained in women over 70 years and in men over 80 years.Vitamin D-fortified dairy products have the potential to substantially reduce the burden of osteoporotic fractures in France and seem an economically beneficial strategy, especially in the general population aged above 70 years.

Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types.

BACKGROUND: Sarcopenia is increasingly recognized as a correlate of ageing and is associated with increased likelihood of adverse outcomes including falls, fractures, frailty and mortality. Several tools have been recommended to assess muscle mass, muscle strength and physical performance in clinical trials. Whilst these tools have proven to be accurate and reliable in investigational settings, many are not easily applied to daily practice. METHODS: This paper is based on literature reviews performed by members of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) working group on frailty and sarcopenia. Face-to-face meetings were afterwards organized for the whole group to make amendments and discuss further recommendations. RESULTS: This paper proposes some user-friendly and inexpensive methods that can be used to assess sarcopenia in real-life settings. Healthcare providers, particularly in primary care, should consider an assessment of sarcopenia in individuals at increased risk; suggested tools for assessing risk include the Red Flag Method, the SARC-F questionnaire, the SMI method or different prediction equations. Management of sarcopenia should primarily be patient centered and involve the combination of both resistance and endurance based activity programmes with or without dietary interventions. Development of a number of pharmacological interventions is also in progress. CONCLUSIONS: Assessment of sarcopenia in individuals with risk factors, symptoms and/or conditions exposing them to the risk of disability will become particularly important in the near future. ispartof: BMC Geriatrics vol:16 issue:1 pages:170-179 ispartof: location:England status: published

Background: Symptomatic slow-acting drugs (SYSADOA) have been largely studied over the last decade. The objective of this study is to prepare a document providing recommendations for the use of SYSADOA in osteoarthritis (OA). Methods: The following interventions were taken into consideration: avocado/soybean unsaponifiables, chondroitin sulfate, diacereine, glucosamine sulfate, hyaluronic acid, oral calcitonin, risedronate, strontium ranelate. Recommendations were based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. The GRADE system is based on a sequential assessment of the quality of evidence, followed by assessment of the balance between benefits versus downsides and subsequent judgment about the strength of recommendations. Results: Chondroitin sulfate, diacereine, glucosamine sulfate, avocado/soybean unsaponifiables and hyaluronic acid have demonstrated pain reduction and physical function improvement with very low toxicity, with moderate to high quality evidence. Even if pre-clinical data and some preliminary in vivo studies have suggested that oral calcitonin and strontium ranelate could be of potential interest in OA, additional well-designed studies are needed. Conclusion: In the benefit/risk ratio, the use of chondroitin sulfate, diacereine, glucosamine sulfate, avocado/soybean unsaponifiables and hyaluronic acid could be of potential interest for the symptomatic management of OA.

A Summary Titrated supplementations with vitamin D-fortified yogurt, based on spontaneous calcium and vitamin D intakes, can be cost-effective in postmenopausal women with or without increased risk of osteoporotic fractures.Introduction The objective of this study is to assess the cost-effectiveness of the vitamin D-fortified yogurt given to women with and without an increased risk of osteoporotic fracture.Methods A validated cost-effectiveness microsimulation Markov model of osteoporosis management was used. Three personalized supplementation scenarios to reflect the Ca/Vit D needs taking into account the well-known variations in dietary habits and a possible pharmacological supplementation in Ca/Vit D, given above or in combination with anti-osteoporosis medications: one yogurt per day, i.e., 400 mg of Ca + 200 IU of Vit D (scenario 1 U), two yogurts per day, i.e., 800 mg of Ca + 400 IU of Vit D (scenario 2 U), or three yogurts per day, i.e., 1,200 mg of Ca + 600 IU of Vit D (scenario 3 U). Results One yogurt is cost-effective in the general population above the age of 70 years and in all age groups in women with low bone mineral density (BMD) or prevalent vertebral fracture (PVF). The daily intake of two yogurts is cost-effective above 80 years in the general population and above 70 years in the two groups of women at increased risk of fractures. However, an intake of three yogurts per day is only cost-effective above 80 years old in the general population, as well as in women with low BMD or PVF.Conclusions Our study is the first economic analysis supporting the cost-effectiveness of dairy products, fortified with vitamin D, in the armamentarium against osteoporotic fractures.

Background Dietary sources of calcium and vitamin D are recommended as a first-line strategy in prevention of osteoporosis-related fractures but their public health and economic impact has never been studied. Methods We designed a population-based model to forecast the potential health outcomes and medical effectiveness of the daily administration of dairy supplements containing 800 IU of vitamin D and 1 g of calcium in cohorts of subjects, from both genders, aged 50, 60, 70 and 80 years. Annual costs of dairy products were tested at €150, €250 and €350. Results In total, the daily intake of vitamin-D rich dairy products reduces by 30,376 and 16,105 events the number of osteoporotic fractures in women and men respectively and permits to gain 6605 and 6144 life-years, in women and men respectively. This intervention is cost-effective from 70 years on in the general population and from 60 years on in patients at increased risk of osteoporotic fractures. Conclusion The recommendation to use dairy products as the preferred source of calcium and vitamin D in aging males and females is supported by public health and health economic analyses. Electronic supplementary material The online version of this article (doi:10.1186/s13690-015-0099-3) contains supplementary material, which is available to authorized users.

Introduction The primary complaint of patients with hand osteoarthritis (OA) is frequently the inelegant appearance of their hands. Only one study has been conducted to assess the magnitude of and identify the determinants of aesthetic discomfort in hand OA. Methods The LIège Hand Osteoarthritis Cohort is a prospective cohort of 203 patients diagnosed with hand OA. At baseline, these patients rated their aesthetic discomfort on a 100-mm visual analogue scale (VAS) and used a Likert scale (range 0–7) to quantify the magnitude of their aesthetic damage. Results The median value of the aesthetic discomfort VAS was 35.0 [interquartile range (Q1–Q3) 6.0–59.0]. The median damage was rated 3.0 (Q1–Q3 1.0–4.0), corresponding to a moderate level. Both were significantly (p 10 years (p = 0.001), and presence of erosive joints (p

Radiological severity and impact of hand osteoarthritis on functional disability, health-related quality of life, and psychological status. (DOC 38 kb)

Characteristics of patients reporting high (HAD) or low (LAD) (aesthetic discomfort). (DOC 55 kb)

Results in women and men. (PDF 212 kb)

Background Dissatisfaction with hand appearance is frequently the presenting complaint of patients with hand osteoarthritis (HOA), yet no tool exists for its measurement and few studies have examined aesthetic discomfort. Objectives The aims of this study were to measure the extent and to explore the associations of aesthetic concerns in HOA. Methods 172 patients with HOA were assessed with tender joint and node count, global and pain scores, Functional Index for Hand Osteoarthritis, Short Form-12, Hospital Anxiety and Depression Scale and posterior–anterior hand radiographs. Patients scored the aesthetic impact of the disease on a Visual Analogue Scale of 0–100 mm and were classifi ed into low, intermediate and high aesthetic concern (HAC) based on this score. Results Of 172 patients (155 women), the majority (92%) had nodes and 46% had erosive disease. The mean aesthetic score was 44.8 mm (SD 35.9), and 59 (34.3%) patients scored their aesthetic discomfort ≥66 mm. Factors associated with HAC were female gender, a high number of tender joints and nodes, high global and pain scores, high radiological damage scores, the presence of erosions and high depression and anxiety levels. The multivariate analysis identifi ed two independent factors associated with HAC: patient’s global assessment (p=0.0005) and radiographic erosions (p=0.03). Conclusions Aesthetic discomfort is a major concern for a signifi cant number of patients with HOA, particularly women, those with a high burden of HOA disease and those with erosive osteoarthritis, and is also associated with depression, anxiety and poor health-related quality of life.

Background Whereas hand osteoarthritis (OA) is a frequent disease, which may lead to considerable pain and physical limitations, limited research has been performed, compared to lower limbs OA. Objectives To better understand the impact of hand osteoarthritis on quality of life and health resources utilization of interdigital osteoarthritis. Methods We decided to prospectively follow a cohort of 203 individuals, diagnosed with hand OA during consultations held at a tertiary care facility specialized in bone and cartilage metabolism and called the Liege Hand Osteoarthritis Cohort (LIHOC). Results As expected, the vast majority of patients (90.1%) were of female gender with 46.8% having a family history of hand OA. The median age of the population was 69.1 years (Q1 61.9-Q3 75.6). Body Mass Index (kg/m2) median was 25.6 (22.9-28.9). Hand OA was associated with other joint involvement in 87.1% of the cases {mainly spine (70.8%) and knee (69.0%)}. On a Visual Analog Scale reflecting pain in hand joints, graded from 0 to 100, the median score was 50.0 (29.0-59.0), with a median number of painful joints at pressure of 5.0 (2.0-10.0). The median number of swollen joints and of joint with bony deformations was respectively 2.0 (1.0-4.0) and 10.0 (6.0-15.0). The total normalized Auscan score (0-300) median value was 129.0 (71.1-182.5) while the median Functional Index for Hand Osteoarthritis (FIHOA) score (0-30) was 5.0 (2.0-11.0). Radiologic assessment of hand OA showed a Verbruggen total score (0-218) median value of 31.6 (20.9-48.2) whereas the Kellgren-Lawrence total score (0-128) median value was 54.0 (40.0-66.0). Conclusions The LIHOC will be followed for a total duration of 5 years, with the objective to better understand the determinants of clinical and radiologic progression as well as the impact of hand OA on quality of life and health resources utilization. Disclosure of Interest None declared

Background Whereas hand osteoarthritis (OA) is a frequent disease, which may lead to considerable pain and physical limitations, limited research has been performed, compared to lower limbs OA. The primary complaint of patients is frequently related to the disgracious appearance of their hand joints. However, few studies have been conducted to identify the magnitude and the determinants of aesthetic discomfort in hand OA. Objectives The LIege Hand Osteoarthritis Cohort (LIHOC) is a prospective cohort of 203 patients diagnosed with hand OA which are prospectively followed to better understand the impact of hand OA on quality of life and health resources utilization. Methods At baseline, these patients were asked to rate their aesthetic discomfort related to hand OA on a 100 mm Visual Analog Scale and also use a seven-point Likert scale (0-7), commonly used in forensic medicine, to quantify the magnitude of their aesthetic damage. Results The median value of the aesthetic discomfort VAS was 35.0 (Q1: 6.0-Q3: 59.0). Correlation analyses were performed between these scorings and clinical hand parameters. The median damage was rated at 3.0 (1.0-4.0), corresponding to a “moderate” level. Aesthetic discomfort (VAS) and the magnitude of the aesthetic damage (Likert) were significantly (p Conclusions Aesthetic discomfort and aesthetic damage are significant complaints in patients presenting with hand OA. The major determinants of their impact are gender, duration of hand OA, number of erosive joints and the Australian Canadian Osteoarthritis Hand Index. Disclosure of Interest None declared