Real-world evidence: new opportunities for osteoporosis research. Recommendations from a Working Group from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. PURPOSE: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. METHODS: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. RESULTS: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. CONCLUSIONS: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.

Prevalence of diabetes, management and outcomes among Covid-19 adult patients admitted in a specialized tertiary hospital in Riyadh, Saudi Arabia.

This retrospective study aimed to characterize comorbidities and associated with mortality among hospitalized adults with Covid-19 managed as perthe Saudi Ministry of Health protocol in a specialized tertiary hospital in Riyadh, Saudi Arabia. Medical records of 300 adult patients with PCR-confirmed SARS-CoV2 infection and admitted in King Salman Hospital (KSH) from May 1 to July 31, 2020 were included. Medical history, management and outcomes were noted. Males significantly outnumber females (259 versus 41). South Asians comprise 41% of all admitted patients. Mortality rate was 10% and highest among Saudi males (28.9%). Type 2 diabetes mellitus (T2DM) was the most common comorbidity (45.7%). Almost all patients (99%) had pneumonia. Patients > 50 years were three times more likely to die (confidence interval, CI 1.3-6.9; p = 0.01) from Covid-19. Congestive heart failure (odds ratio OR 19.4, CI-1.5-260.0; p = 0.02) and acute kidney injury (OR 11.7, CI-4.7-28.6; p < 0.001) were significantly associated with higher mortality. Dexamethasone use significantly improved the final outcome based on net reclassification improvement (NRI) and integrated discrimination improvement (IDI) (p < 0.05). In this single-center study, T2DM was very common among hospitalized Covid-19 patients. Patients > 50 years, those with congestive heart failure and acute kidney injury are at higher risk for worse Covid-19 outcome.

Diagnosis and management of osteoporosis in postmenopausal women in Gulf Cooperation Council (GCC) countries: consensus statement of the GCC countries' osteoporosis societies under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).

A consensus platform is provided by the experts of the Gulf Cooperation Council (GCC) countries' respective osteoporosis societies, on which specific guidelines can be developed further for regional use on the assessment and treatment of postmenopausal women at risk from fractures due to osteoporosis. INTRODUCTION: Guidance is provided in a Gulf Cooperation Council (GCC) country setting on the assessment and treatment of postmenopausal women at risk from fractures due to osteoporosis, which is an adaptation of the European guidance by Kanis et al., jointly published by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). The respective osteoporosis societies of the Gulf Cooperation Council (GCC) countries assembled for a unifying consensus on the diagnosis and management of osteoporosis in postmenopausal women for the region. METHODS: The Chair for Biomarkers of Chronic Diseases (CBCD) in King Saud University (KSU), Riyadh, Kingdom of Saudi Arabia (KSA), in cooperation with the Saudi Osteoporosis Society (SOS), hosted regional experts and respective leaders from different GCC osteoporosis societies, together with an adviser from the ESCEO. An assembly of experts representing the different osteoporosis societies from Saudi Arabia, the UAE, Bahrain, Oman, and Kuwait gathered on February 15-16, 2019 in Riyadh, KSA for the formulation of a general osteoporosis consensus for the region. RESULTS: The following areas were covered: diagnosis of osteoporosis and assessment of fracture risk; general and pharmacological management of osteoporosis; and hip fractures, vitamin D, recommendation on which FRAX tool to follow, and the importance of country-specific FRAX® and fracture liaison services for secondary fracture prevention. CONCLUSIONS: A platform is provided on which specific guidelines can be developed for regional use in GCC.

Awareness and Knowledge Regarding the Consumption of Dietary Fiber and Its Relation to Self-Reported Health Status in an Adult Arab Population: A Cross-Sectional Study.

The objective of this study was to examine the awareness, knowledge, and habits regarding dietary fiber intake and to analyze its relationship with self-reported health status among Saudi adults. A survey-based study using face-to-face interview was designed, and 1363 apparently healthy adult Saudi males and females participated. Most participants were females (81.2%), aged 25 and above (87.2%), and were educated at least up to the secondary level of education (80.8%). The majority of the participants were aware of the role of fiber-rich foods in health conditions such as obesity (70.5%), cardiovascular diseases (68.9%), and regulation of blood sugar (68.9%), with females significantly having higher nutrition knowledge than males. A disconnect in translating this nutrition knowledge was observed particularly in food choices when eating out, where preferences for white bread (84.4%), fried potatoes (69.9%) and peeled fruits (60.6%) were significantly higher than preferences for cooked vegetables (29.6%) and brown bread (18.1%). The most common reason for this disconnect was due to perception that foods rich in dietary fibers were expensive (72.1%), have less health benefits (56.5%), were not readily available (51.6%), and participants' disliking of the taste (52.8%). Participants in the highest quartile (Q4) for dietary fiber consumption reported a lower prevalence of constipation (odds ratio, 95% confidence interval of 0.40, 0.28-0.57, p < 0.01), high cholesterol (0.43, 0.27-0.68, p < 0.01) and obesity (0.67, 0.44-0.98, p = 0.03) than participants in the lowest quartile (Q1). Dietary fiber intake appears to be protective against constipation, high cholesterol and obesity in Saudi adults. However, a disparity observed between knowledge and attitude towards intake of dietary fibers could limit its health benefits. Further studies including adolescents should be conducted to impart knowledge on the emotional, cognitive and sensory factors related to food choices in order to minimize the gap between nutrition knowledge and the consumption of healthy high-fiber diets.

The Prevalence and Awareness Concerning Dietary Supplement Use among Saudi Adolescents.

Current dietary supplement (DS) use among Saudi school students is not well described. In this study, we aim to investigate the prevalence and predictors of DS use among adolescents. This cross-sectional study collected data via self-administered questionnaire from 1221 students (12 to 18 years). The overall prevalence of DS use was 26.2%, significantly higher in females than males (33% vs. 17.9%, p < 0.001). High proportion of female DS users demonstrated normal BMI than males (84% vs. 56.5%, p < 0.001). High percentage of male DS users were engaged in vigorous and/or high physical activity (PA) levels than female DS users (58.2% vs. 43%, p = 0.022; and 57.1% vs. 20.7%, p < 0.001, respectively). The main reasons for DS use among females were vitamin deficiency (63.3%), hair condition (37.6%) and nail health (23.5%) while in males, the main reasons were vitamin deficiency (58.4%) and body building (34.4%). The predictors of DS use in Saudi adolescents included being female, having high family income and being physically active. In conclusion, the overall prevalence and preference of DS use, though low among Saudi adolescents, was driven mostly by gender, physical activity levels and socioeconomic factors like family income. DS use guidelines and counselling among Saudi adolescents are warranted to improve public health.

An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

OBJECTIVES: The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) sought to revisit the 2014 algorithm recommendations for knee osteoarthritis (OA), in light of recent efficacy and safety evidence, in order to develop an updated stepwise algorithm that provides practical guidance for the prescribing physician that is applicable in Europe and internationally. METHODS: Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process, a summary of evidence document for each intervention in OA was provided to all members of an ESCEO working group, who were required to evaluate and vote on the strength of recommendation for each intervention. Based on the evidence collected, and on the strength of recommendations afforded by consensus of the working group, the final algorithm was constructed. RESULTS: An algorithm for management of knee OA comprising a stepwise approach and incorporating consensus on 15 treatment recommendations was prepared by the ESCEO working group. Both "strong" and "weak" recommendations were afforded to different interventions. The algorithm highlights the continued importance of non-pharmacological interventions throughout the management of OA. Benefits and limitations of different pharmacological treatments are explored in this article, with particular emphasis on safety issues highlighted by recent literature analyses. CONCLUSIONS: The updated ESCEO stepwise algorithm, developed by consensus from clinical experts in OA and informed by available evidence for the benefits and harms of various treatments, provides practical, current guidance that will enable clinicians to deliver patient-centric care in OA practice.

Inappropriate claims from non-equivalent medications in osteoarthritis: a position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

Osteoarthritis (OA) is a progressive joint disease, that occurs frequently in the aging population and is a major cause of disability worldwide. Both glucosamine and chondroitin are biologically active molecules that are substrates for proteoglycan, an essential component of the cartilage matrix. Evidence supports the use of glucosamine and chondroitin as symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) with impact on OA symptoms and disease-modifying effects in the long term. Glucosamine and chondroitin are administered in exogenous form as a sulfate salt and multiple formulations of these agents are available, both as prescription-grade products and nutritional supplements. However, while all preparations may claim to deliver a therapeutic level of glucosamine or chondroitin not all are supported by clinical evidence. Only patented crystalline glucosamine sulfate (pCGS) is shown to deliver consistently high glucosamine bioavailability and plasma concentration in humans, which corresponds to demonstrated clinical efficacy. Similarly, clinical evidence supports only the pharmaceutical-grade chondroitin sulfate. The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) advocates, through careful consideration of the evidence base, that judicious choice of glucosamine and chondroitin formulation is essential to maximize clinical benefit, patient adherence and satisfaction with treatment. In future, the ESCEO recommends that complex molecules with biological activity such as pCGS may be treated as "biosimilars" akin to the European Medicines Agency guidance on biological medicinal products. It seems likely that for all other complex molecules classed as SYSADOAs, the recommendation to use only formulations clearly supported by the evidence-base should apply.

Awareness and Attitude Toward Use of Dietary Supplements and the Perceived Outcomes Among Saudi Adult Male Members of Fitness Centers in Saudi Arabia.

Dietary supplements are believed to enhance athletic performance and/or prevent/reverse pathological states. Despite the increasing use of dietary supplements in Saudi Arabia, systematic studies in this field are lacking. This study aims to assess the relation between demographic and social characteristics and dietary supplement use among adult males in Saudi Arabia. Demographic and dietary supplements data from fitness club participants were collected through a questionnaire, and the Pearson chi-square test was used to determine associations. A total of 448 apparently healthy adult males above 20 years of age, who were registered at fitness centers located in Saudi Arabia, participated in the study. The majority (275 [62%]) of the study participants were younger (20-30 years), of normal weight (189 [43%]), without health problems (332 [79%]), and obtained an undergraduate degree or higher (336 [77%]). The majority (58%) took supplements under the supervision of a professional and the rest depended on Internet (22%), friends (12%), or books (4%) for choosing supplement types. The main motives of the participants for visiting the fitness center were: weight loss (N = 149 [35%]), keeping fit (N = 101 [24%]), and muscle building (N = 151 [35%]). One hundred and fifty-five participants (44%) were taking supplements on a daily basis with 34 (10%) having taken it for a prolonged duration (>1 year). The most commonly used supplements were proteins (29%) and multivitamins (21%). Supplement use was not associated with the participants' family income or level of education but was positively associated with younger age (<31 years), χ2(2, N = 443) = 4.96, p = .03.

Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).

OBJECTIVES: To gather expert opinion on the conduct of clinical trials that will facilitate regulatory review and approval of appropriate efficacious pharmacological treatments for hand osteoarthritis (OA), an area of high unmet clinical need. METHODS: The European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal diseases (ESCEO) organized a working group under the auspices of the International Osteoporosis Foundation (IOF) and the World Health Organization (WHO). RESULTS: This consensus guideline is intended to provide a reference tool for practice, and should allow for better standardization of the conduct of clinical trials in hand OA. Hand OA is a heterogeneous disease affecting different, and often multiple, joints of the thumb and fingers. It was recognized that the various phenotypes and limitations of diagnostic criteria may make the results of hand OA trials difficult to interpret. Nonetheless, practical recommendations for the conduct of clinical trials of both symptom and structure modifying drugs are outlined in this consensus statement, including guidance on study design, execution, and analysis. CONCLUSIONS: While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA.

Prevalence of dietary supplement use and associated factors among female college students in Saudi Arabia.

BACKGROUND: The economic boom in Saudi Arabia indirectly prompted the use of dietary supplements in the last two decades. Our aim is to investigate the prevalence of dietary supplement use and its association with sociodemographic/lifestyle characteristics among Saudi female students. METHODS: In this cross-sectional study, 534 female participants (≥19 years of age) completed a self-administered questionnaire that include sociodemographic and lifestyle characteristics, perceived health status, dietary supplement use, general awareness, attitudes and behavior. RESULTS: In all participants, the prevalence of dietary supplement use was 76.6% (n = 409). High level of education (p = 0.002) and more physical activity (p = 0.008) exhibited a significant positive association with users than to non-users. The frequency showed that beta-carotene (54.2%), chamomile (54.2%), and glucosamine (53.8%) were the most preferred diet supplements under the category "when needed". Cod liver oil (71.3%), omega 3 (68.3%), multi-vitamins (61.5%), ginseng (60%), and vitamin A (60%), were mostly used "from time to time". Multi-minerals (34.4%) were the preferred choice when it comes to daily use. The main reasons for supplement use were to "maintain healthy hair" and "injury and illness" (both 26.2%). About 38.4% were not aware and 30.3% disagree on differences taking supplements with or without consulting a medical professional. About 36.7% lack information about side effects while, 35.0% were unaware about any health effect of dietary supplements. CONCLUSION: The prevalence of dietary supplement use was high in Saudi female students and was significantly associated with sociodemographic and lifestyle factors.

Vitamin D status correction in Saudi Arabia: an experts' consensus under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis, and Musculoskeletal Diseases (ESCEO).

BACKGROUND: Vitamin D deficiency is common in the Middle East and in Saudi Arabia, in particular. While several international recommendations on the management of vitamin D deficiency have been documented and practiced globally, these recommendations should be adapted to the conditions of the Middle Eastern region. To address this challenge, the Prince Mutaib Chair for Biomarkers of Osteoporosis (PMCO) in King Saud University (KSU), Riyadh, KSA, together with local experts and in cooperation with the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), organized a panel that formulated unified recommendations in the diagnosis and treatment of vitamin D deficiency in the region. METHODS: The selection of local and international experts commenced during the 2nd International Vitamin D Symposium conducted in Riyadh, Saudi Arabia, last January 20--21, 2016. Reviews of the most recent literature were done, and face-to-face meetings were conducted for revisions and final recommendations. RESULTS: Vitamin D sufficiency is defined as circulating serum 25(OH)D ≥50 nmol (≥20 ng/ml) for the general population and vitamin D adequacy as serum 25(OH)D >75 nmol/L l (>30 ng/ml) for the frail and osteoporotic elderly. Despite overwhelming prevalence of vitamin D deficiency, universal screening is not recommended. Recommendations for the general population, children, pregnant/lactating women, post-menopausal women, the elderly, and those with subsequent metabolic diseases were provided. RESULTS: Vitamin D sufficiency is defined as circulating serum 25(OH)D ≥50 nmol (≥20 ng/ml) for the general population and vitamin D adequacy as serum 25(OH)D >75 nmol/L l (>30 ng/ml) for the frail and osteoporotic elderly. Despite overwhelming prevalence of vitamin D deficiency, universal screening is not recommended. Recommendations for the general population, children, pregnant/lactating women, post-menopausal women, the elderly, and those with subsequent metabolic diseases were provided. CONCLUSION: Vitamin D supplementation/correction is advised in all persons whose serum 25(OH)D falls below 50 nmol/l (20 ng/ml), and achieving a target of 75 nmol/l (30 ng/ml) is particularly suited for frail, osteoporotic, and older patients. Conducting well-designed clinical trials in the region that will address economic implications and investigations on the treatment persistence and compliance to vitamin D treatment in the region are encouraged.

Sarcopenia in daily practice: assessment and management.

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.

Gender-dependent associations between socioeconomic status and metabolic syndrome: a cross-sectional study in the adult Saudi population.

BACKGROUND: To determine the gender-dependent association of socio-economic status variables with the prevalence of metabolic syndrome (MetS) in the adult Saudi population. METHODS: A total of 9164 adult Saudis (aged 18-70 years) were included in this cross-sectional study. Marital status, income, education, and occupation were used as socio-economic indicators while behavioral factor like physical exercise was also taken into account. MetS was defined using the criteria based from the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III). RESULTS: In males, the odds ratio (OR) of harboring MetS was higher in married [OR1.6 (Confidence Interval (CI) 1.1, 2.4); p < 0.03], and high income class [OR 2.3(CI 1.5, 3.5); p < 0.001] and lowest in retired and unemployed individuals [1.4(1.0, 1.9); p < 0.04, 0.61(0.45, 0.82); p < 0.001] respectively. In females, MetS was inversely related to high income [OR 0.70 (CI 0.46, 1.1); p < 0.09] and education level [OR 0.38 (CI 0.26, 0.56); p < 0.001], and was significantly higher in the unemployed class [OR 1.6 (CI 1.2, 2.2); p < 0.004]. CONCLUSIONS: The prevalence of MetS is significantly high among retired, married and high-earning Saudi males while in females, high earners and high education seem to confer a protective effect against MetS.

Selected dietary nutrients and the prevalence of metabolic syndrome in adult males and females in Saudi Arabia: a pilot study.

During the last decade, the rapid economic development in Saudi Arabia resulted in an unbalanced dietary intake pattern within the general population. Consequently, metabolic syndrome was also documented to be highly prevalent in the Middle-East region. We aimed to examine the relationship between selected dietary nutrient intakes and the prevalence of metabolic syndrome in the general adult population of Riyadh, Saudi Arabia. In this cross-sectional study, 185 adult Saudis aged 19 to 60 years (87 males and 98 females (mean age 35.6 ± 13.2 and 37.6 ± 11.7 years, respectively)) were included. The criteria for metabolic syndrome were based on the International Diabetes Foundation (IDF) criteria, and the dietary food intake was assessed by two 24-h dietary recall methods. The odd ratios (ORs) of metabolic syndrome risk across quartiles of selected dietary nutrients were significantly lower for carbohydrates and proteins, as well as for vitamins A, C, E and K, calcium, zinc and magnesium (p < 0.05 for all) in the female group with metabolic syndrome than those without. The pattern of daily dietary intake of selected nutrients among the general population of Saudi Arabia raises concern, and this dietary imbalance could increase the risk of metabolic syndrome, particularly in adult Saudi females.

Assessment of selected nutrient intake and adipocytokine profile among Saudi children and adults.

We report the dietary intake of selected nutrients in apparently healthy adults and children and its correlation with circulating levels of serum leptin and resistin. In this observational study, 47 Saudi children (mean age 13.1 ± 2.8 year) and 47 adults (mean age 45.7 ± 10.5 year) were recruited. Anthropometric data and lipid profile were obtained. Food intake was assessed by a food questionnaire and a 24-hour diet recall method. The dietary intake of selected nutrients was compared with the estimated average requirement (EAR) or adequate intake (AI) for establishing nutritional status. Results demonstrated that the levels of choline and calcium intake were significantly lower than the EAR in adults (p= 0.01 and 0.04, respectively) and relatively low in children. The level of manganese in adults was significantly higher (p= 0.02) than their AI level. The increasing levels of dietary vitamin B6 and B12 were associated with a significant increase in serum concentrations of leptin in adults and children (p=0.02). Overall, the dietary intakes of selected nutrients in Saudi adults and children were not adequate with most of them below cut-off EAR values except for essential amino acids.