Self-administration of medicines or dietary supplements without any physician’s advice is a widespread behavior and appears to be more frequently practiced by women. Moreover, reasons to self-administer products are often pains and injuries especially among athletes who might also use remedies to improve physical performance. The objective of this study was thus to assess the prevalence of self-administration of medicines and dietary supplements as well as its determinants among female amateur runners.
Our sample was comprised of women who took part in amateur running events. Data regarding self-administration of substances, exclusively aiming at being physically prepared for the running event (i.e., intake the week before), were collected through an anonymous self-administered questionnaire including four specific themes (i.e., general information, self-administered medicines and dietary supplements, context of self-administration of substances and knowledge of the anti-doping regulations).
A total of 136 women, with a median age of 39 years (interquartile range: 27–47), volunteered. Among them, 34.6% reported self-administration of medicines during the period immediately preceding the running event, with the aim to be physically prepared. More than one third (33.8%) also declared self-administration of dietary supplements. Furthermore, we observed that about 8.1% of the sample had consumed a potentially doping substance. After adjustments for confounding variables, the probability of self-administration of products (medicines or supplements) increased significantly with the intensity of the activity and the membership in a sports club.
Our study showed that self-administration of products among female runners seems to be a widespread behavior, where the intensity of the sports practice and the network of runners seem to influence the decision to resort to this behavior.
Amateurs sports; Dietary supplements; Female runners; Self-administration of products; Self-medication; Vitamin and mineral supplements
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.
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.
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.
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.
Sarcopenia; Daily practice; Assessment; Management; Tools
The European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases convened a task force of experts in rheumatoid arthritis (RA) and clinical trial methodology to comment on the new draft ‘Guideline on clinical investigation of medicinal products for the treatment of RA’ released by the European Medicines Agency (EMA). Special emphasis was placed by the group on the development of new drugs for the treatment of early RA. In the absence of a clear definition of early RA, it was suggested that clinical investigations in this condition were conducted in disease-modifying antirheumatic drugs naïve patients with no more than 1 year disease duration. The expert group recommended using an appropriate improvement in disease activity (American College of Rheumatology (ACR) or Simplified/Clinical Disease Activity Index (SDAI/CDAI) response criteria) or low disease activity (by any score) as primary endpoints, with ACR/European League Against Rheumatism remission as a secondary endpoint. Finally, as compelling evidence showed that the Disease Acrivity Score using 28-joint counts (DAS28) might not provide a reliable definition of remission, or sometimes even low disease activity, the group suggested replacing DAS28 as a measurement instrument to evaluate disease activity in RA clinical trials. Proposed alternatives included SDAI, CDAI and Boolean criteria.
Early Rheumatoid Arthritis; Outcomes research; Treatment; DMARDs (biologic); DMARDs (synthetic)
Purpose of review
This article reviews recently published evidence for common pathways explaining bone and muscle wasting in normal ageing and pathological conditions.
Numerous studies support the concept of a bone–muscle unit, where constant cross-talking between the two tissues takes place, involving molecules released by the skeletal muscle secretome, which affects bone, and osteokines secreted by the osteoblasts and osteocytes, which, in turn, impact muscle cells.
New chemical entities aiming at concomitantly treating osteoporosis and sarcopenia could be developed by targeting pathways that centrally regulate bone and muscle or emerging pathways that facilitate the communication between the two tissues.
bone; muscle; myostatin; osteoporosis; sarcopenia
The Hospital for Special Surgery (HSS) Hip Replacement Expectations Survey and Knee Replacement Expectations Survey are validated tools developed to measure patients' preoperative expectations for hip and knee arthroplasty. These instruments have possible uses in both daily practice and research. Our objective was to assess the test-retest reliability and the construct validity of the French version of the surveys.
Patients scheduled for total hip (n = 82) or knee replacement (n = 61) aged 38–90 years were included. All completed the HSS Hip or Knee Replacement Expectations Survey and the Expectation WOMAC to determine concurrent validity.
The test-retest reliability was assessed using the intraclass coefficient correlation (ICC), the Bland and Altman Method and the coefficient of variation; the internal consistency was assessed by the Cronbach α coefficient. The construct validity was investigated using the Pearson correlation coefficient and floor and ceiling effects by percentage frequency of lowest or highest possible score achieved by respondents.
143 patients scheduled for hip or knee arthroplasty were included.
The reliability was excellent between the test and the rested total score, with an ICC of 0.902 (0.853–0.936) and CV of 4.06% for the French Hip Replacement Expectations Survey and 0.865 (0.786–0.917) and CV of 7.7% for the French Knee Replacement Expectations Survey, without bias.
The Cronbach α coefficient was 0.72 for hip Survey and 0.82 for knee Survey showing a good internal consistency.
Pearson correlation coefficients of 0.45 and 0.48 between Expectations WOMAC and HSS, respectively for hip Survey and knee Survey, were observed but with systematic bias.
The lowest possible score was not reported by any patient and only three patients (3.66%) scheduled for hip arthroplasty reported the highest possible score.
The French version of the HSS Hip or Knee Replacement Expectations Survey is a reliable and valid questionnaire and compares favourably with the original English version. Therefore, this new version may help French-speaking clinicians to evaluate expectations before lower limb arthroplasty.
Lower limb arthroplasty; Questionnaire; Psychometric properties; Validity; Reliability
Diacerein is a symptomatic slow-acting drug in osteoarthritis (SYSADOA) with anti-inflammatory, anti-catabolic and pro-anabolic properties on cartilage and synovial membrane. It has also recently been shown to have protective effects against subchondral bone remodelling. Following the end of the revision procedure by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) constituted a panel of 11 experts to better define the real place of diacerein in the armamentarium for treating OA. Based on a literature review of clinical trials and meta-analyses, the ESCEO confirms that the efficacy of diacerein is similar to that of non-steroidal anti-inflammatory drugs (NSAIDs) after the first month of treatment, and superior to that of paracetamol. Additionally, diacerein has shown a prolonged effect on symptoms of several months once treatment was stopped. The use of diacerein is associated with common gastrointestinal disorders such as soft stools and diarrhoea, common mild skin reactions, and, uncommonly, hepatobiliary disorders. However, NSAIDs and paracetamol are known to cause potentially severe hepatic, gastrointestinal, renal, cutaneous and cardiovascular reactions. Therefore, the ESCEO concludes that the benefit–risk balance of diacerein remains positive in the symptomatic treatment of hip and knee osteoarthritis. Furthermore, similarly to other SYSADOAs, the ESCEO positions diacerein as a first-line pharmacological background treatment of osteoarthritis, particularly for patients in whom NSAIDs or paracetamol are contraindicated.
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.
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.
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.
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.
Electronic supplementary material
The online version of this article (doi:10.1007/s40520-015-0517-y) contains supplementary material, which is available to authorized users.
Clinical trials; Sarcopenia; Public health; Preventative health care; Frailty
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.
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.
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 < 0.02) associated with the female gender, the duration of hand OA, the radiological severity of OA (Verbruggen–Veys and Kellgren–Lawrence scales) and pain, disability, or stiffness [Australian Canadian Osteoarthritis Hand Index (AUSCAN) and Functional Index for Hand Osteoarthritis ]. After a stepwise analysis, the parameters correlated to the aesthetic discomfort were the presence of erosive joints (p = 0.0048), the AUSCAN score (p < 0.0001), the number of joints with severe radiological damage (p = 0.023), and gender (p = 0.0009). For aesthetic damage, the parameters associated were AUSCAN score (p < 0.0001), duration of hand OA >10 years (p = 0.001), and presence of erosive joints (p < 0.0001). Compared with patients with low aesthetic discomfort (VAS ≤33 mm), those with the highest discomfort (VAS ≥66 mm) had more erosive OA (p = 0.014), a higher Verbruggen and Veys score (p = 0.0039), and a higher AUSCAN score (p < 0.001).
Aesthetic discomfort and damage are significant complaints in patients with hand OA. The determinants of the magnitude of these are gender, radiological severity, duration of hand OA, presence of erosive joints, and impact on pain, function, and stiffness as assessed with the AUSCAN.
Electronic supplementary material
The online version of this article (doi:10.1186/s13075-015-0807-y) contains supplementary material, which is available to authorized users.
Hand osteoarthritis; Erosive; Aesthetic discomfort; Quality of life
Dairy products provide a package of essential nutrients that is difficult to obtain in low-dairy or dairy-free diets, and for many people it is not possible to achieve recommended daily calcium intakes with a dairy-free diet. Despite the established benefits for bone health, some people avoid dairy in their diet due to beliefs that dairy may be detrimental to health, especially in those with weight management issues, lactose intolerance, osteoarthritis, rheumatoid arthritis, or trying to avoid cardiovascular disease. This review provides information for health professionals to enable them to help their patients make informed decisions about consuming dairy products as part of a balanced diet. There may be a weak association between dairy consumption and a possible small weight reduction, with decreases in fat mass and waist circumference and increases in lean body mass. Lactose intolerant individuals may not need to completely eliminate dairy products from their diet, as both yogurt and hard cheese are well tolerated. Among people with arthritis, there is no evidence for a benefit to avoid dairy consumption. Dairy products do not increase the risk of cardiovascular disease, particularly if low fat. Intake of up to three servings of dairy products per day appears to be safe and may confer a favourable benefit with regard to bone health.
Dairy products; Cardiovascular disease; Osteoporosis; Arthritis; Weight management; Lactose intolerance
The intense sweeteners currently authorised in Europe comprise ten compounds of various chemical natures. Their overall use has sharply risen in the last 20 years. These compounds are mainly used to formulate reduced-calorie products while maintaining sweetness.
This extensive analysis of the literature reviews the data currently available on the potential nutritional benefits and risks related to the consumption of products containing intense sweeteners.
Results and Conclusions
Regarding nutritional benefits, the available studies, while numerous, do not provide proof that the consumption of artificial sweeteners as sugar substitutes is beneficial in terms of weight management, blood glucose regulation in diabetic subjects or the incidence of type 2 diabetes. Regarding nutritional risks (incidence of type 2 diabetes, habituation to sweetness in adults, cancers, etc.), it is not possible based on the available data to establish a link between the occurrence of these risks and the consumption of artificial sweeteners. However, some studies underline the need to improve knowledge of the links between intense sweeteners consumption and certain risks.
Intense sweetener; Aspartame; Acesulfame K; Stevia; Sucralose; Diabetes; Obesity; Energy intakes; Satiety; Eating behaviour; Compensation; Weight
Early mobilization after surgery reduces the incidence of a wide range of complications. Wearable motion sensors measure movements over time and transmit this data wirelessly, which has the potential to monitor patient recovery and encourages patients to engage in their own rehabilitation.
We sought to determine the ability of off-the-shelf activity sensors to remotely monitor patient postoperative mobility.
Consecutive subjects were recruited under the Department of Neurosurgery at Columbia University. Patients were enrolled during physical therapy sessions. The total number of steps counted by the two blinded researchers was compared to the steps recorded on four activity sensors positioned at different body locations.
A total of 148 motion data points were generated. The start time, end time, and duration of each walking session were accurately recorded by the devices and were remotely available for the researchers to analyze. The sensor accuracy was significantly greater when placed over the ankles than over the hips (P<.001). Our multivariate analysis showed that step length was an independent predictor of sensor accuracy. On linear regression, there was a modest positive correlation between increasing step length and increased ankle sensor accuracy (r=.640, r
2=.397) that reached statistical significance on the multivariate model (P=.03). Increased gait speed also correlated with increased ankle sensor accuracy, although less strongly (r=.444, r
2=.197). We did not note an effect of unilateral weakness on the accuracy of left- versus right-sided sensors. Accuracy was also affected by several specific measures of a patient’s level of physical assistance, for which we generated a model to mathematically adjust for systematic underestimation as well as disease severity.
We provide one of the first assessments of the accuracy and utility of widely available and wirelessly connected activity sensors in a postoperative patient population. Our results show that activity sensors are able to provide invaluable information about a patient’s mobility status and can transmit this data wirelessly, although there is a systematic underestimation bias in more debilitated patients.
mobilization; activity tracking; postoperative; physiotherapy; functional recovery; physical therapy; gait; neurorehabilitation
Osteoarthritis (OA), a disease affecting different patient phenotypes, appears as an optimal candidate for personalized healthcare. The aim of the discussions of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) working group was to explore the value of markers of different sources in defining different phenotypes of patients with OA. The ESCEO organized a series of meetings to explore the possibility of identifying patients who would most benefit from treatment for OA, on the basis of recent data and expert opinion. In the first meeting, patient phenotypes were identified according to the number of affected joints, biomechanical factors, and the presence of lesions in the subchondral bone. In the second meeting, summarized in the present article, the working group explored other markers involved in OA. Profiles of patients may be defined according to their level of pain, functional limitation, and presence of coexistent chronic conditions including frailty status. A considerable amount of data suggests that magnetic resonance imaging may also assist in delineating different phenotypes of patients with OA. Among multiple biochemical biomarkers identified, none is sufficiently validated and recognized to identify patients who should be treated. Considerable efforts are also being made to identify genetic and epigenetic factors involved in OA, but results are still limited. The many potential biomarkers that could be used as potential stratifiers are promising, but more research is needed to characterize and qualify the existing biomarkers and to identify new candidates.
The publication outcomes of the abstracts presented during the ECCEO-IOF 2011 reflect a high research productivity, support the robustness of the selection process conducted by the Scientific Advisory Committee and suggest that IOF-ESCEO WCO is successful in its mission to promote and disseminate research.
Background and Objective
The European (now World) Congress on Osteoporosis, Osteoarthritis and Musculo-Skeletal Diseases (IOF-ESCEO WCO, formerly ECCEO-IOF) is the largest worldwide event fully dedicated to the clinical, epidemiological, translational and economic aspects of bone, joint and muscle diseases. The role of the Scientific Advisory Committee is to select abstracts for oral communication or poster presentation based on a short summary of the research. The aim of the present survey was to determine the publication rate in international peer reviewed journals of abstracts accepted at the IOF-ESCEO WCO 2011 Meeting (formerly ECCEO-IOF11), the relationship, if any, between the presentation format of the abstract and its subsequent full publication and the impact factor of the journal in which research was published.
Of 619 abstracts accepted at the 2011 ECCEO-IOF11 annual meeting, 45 were accepted for oral communication and 574 accepted for poster presentation. In the subsequent 3 years (2011–2014), 191 abstracts were published as a full-length manuscript (30.9 %). The publication rate was significantly higher for oral communications (75.6 %) than for poster presentations (27.4 %; p < 0.0001). Publications derived from oral communications were published in journals with a higher impact factor (8.3 ± 10.1) than those arising from poster presentations (4.0 ± 2.3; p < 0.0001), but there was no difference in the time to publication (OC 16.3 [IQR 8.4–23.3] months vs PP 11.3 [IQR 5.3–21.4]; p = 0.14).
These results indicate a high research productivity and an appropriate selection of oral communication by the Scientific Advisory Committee of ESCEO-IOF.
Publication outcomes; ECCEO-IOF Meeting; Oral communication; Poster; Presentation format
Frailty is a major health condition associated with ageing. Although the concept is almost universally accepted, its operational definition remains controversial. Anyway, this geriatric condition represents a huge potential public health issue at both the patient and the societal levels because of its multiple clinical, societal consequences and its dynamic nature. Here, we review existing definitions and assessment tools for frailty, we highlight consequences of this geriatric condition and we discuss the importance of its screening and prevention to limit its public health burden.
Frailty; Elderly; Public health; Prevalence
The editors of Archives of Public Health would like to thank all our reviewers who have contributed to the journal in Volume 72 (2014).
Besides magnetic resonance imaging, dual energy X-ray absorptiometry (DXA) seems the most reliable tool to evaluate body composition and is often considered as the gold standard in clinical practice. Bioelectrical impedance analysis (BIA) could provide a simpler, portative, and less expensive alternative. Because the body composition assessment by BIA is device-dependent, the aim of this study was to appraise the concordance between the specific bioelectrical impedance device InBody S10 and DXA for the body composition evaluation.
Body composition, included appendicular lean mass divided by height squared (ALM/ht2) was measured by DXA (Hologic QDR Discovery device) and by BIA (InBody S10 Biospace device). Agreement between tools was assessed by means of the Bland Altman method and reliability was determined using the IntraClass Coefficient (ICC). ICC was also computed to assess the reliability of the test-retest performed by the same operator or by two different ones.
A total of 219 subjects were enrolled in this study (mean age: 43.7 ± 19.1 years old, 51.6% of women). For the ALM/ht2, reliability of the test-retest of the BIA was high with an ICC of 0.89 (95%CI: 0.86-0.92) when performed by the same operator and an ICC of 0.77 (95%CI: 0.72-0.82) when performed by two different operators. Agreement between ALM/ht2 assessed by DXA and BIA was low (ICC = 0.37 (95%CI: 0.25-0.48)). Mean ALM/ht2 was 9.19 ± 1.39 kg/m2 with BIA and 7.34 ± 1.34 kg/m2 with DXA, (p < 0001). A formula developed using a multiple regression analysis, and taking into account muscle mass assessed by BIA, as well as sex and body mass index, explains 89% of the ALM/ht2 assessed by DXA.
Although our results show that the measure of ALM/ht2 by BIA is reliable, the agreement between DXA and BIA is low. Indeed, BIA seems to overestimate ALM/ht2 compared to DXA and, consequently, it is important to use an adapted formula to obtain measurement of the appendicular lean mass by BIA close to that measured by DXA.
BIA; Muscle mass; Appendicular lean mass; DXA
Osteoarthritis is a syndrome affecting a variety of patient profiles. A European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and the European Union Geriatric Medicine Society working meeting explored the possibility of identifying different patient profiles in osteoarthritis. The risk factors for the development of osteoarthritis include systemic factors (e.g., age, sex, obesity, genetics, race, and bone density) and local biomechanical factors (e.g., obesity, sport, joint injury, and muscle weakness); most also predict disease progression, particularly joint injury, malalignment, and synovitis/effusion. The characterization of patient profiles should help to better orientate research, facilitate trial design, and define which patients are the most likely to benefit from treatment. There are a number of profile candidates. Generalized, polyarticular osteoarthritis and local, monoarticular osteoarthritis appear to be two different profiles; the former is a feature of osteoarthritis co-morbid with inflammation or the metabolic syndrome, while the latter is more typical of post-trauma osteoarthritis, especially in cases with severe malalignment. Other biomechanical factors may also define profiles, such as joint malalignment, loss of meniscal function, and ligament injury. Early- and late-stage osteoarthritis appear as separate profiles, notably in terms of treatment response. Finally, there is evidence that there are two separate profiles related to lesions in the subchondral bone, which may determine benefit from bone-active treatments. Decisions on appropriate therapy should be made considering clinical presentation, underlying pathophysiology, and stage of disease. Identification of patient profiles may lead to more personalized healthcare, with more targeted treatment for osteoarthritis.
Sarcopenia, operationally defined as the loss of muscle mass and muscle function, is a major health condition associated with ageing, and contributes to many components of public health at both the patient and the societal levels. Currently, no consensual definition of sarcopenia exists and therefore it is still a challenge to establish the actual prevalence of sarcopenia or to establish the direct and indirect impacts of sarcopenia on public health. Anyway, this geriatric syndrome represents a huge potential public health issue because of its multiple clinical and societal consequences. Moreover, all these aspects have an impact on healthcare costs both for the patient and the society. Therefore, the implementation of effective and broadly applicable preventive and therapeutic interventions has become a medical and societal challenge for the growing number of older persons affected by sarcopenia and its disabling complications.
Sarcopenia; Public health; Epidemiology; Consequences; Diagnosis
Besides its well-known effect on bone metabolism, recent researches suggest that vitamin D may also play a role in the muscular, immune, endocrine, and central nervous systems. Double-blind RCTs support vitamin D supplementation at a dose of 800 IU per day for the prevention of falls and fractures in the senior population. Ecological, case–control and cohort studies have suggested that high vitamin D levels were associated with a reduced risk of autoimmune diseases, type 2 diabetes, cardio-vascular diseases and cancer but large clinical trials are lacking today to provide solid evidence of a vitamin D benefit beyond bone health. At last, the optimal dose, route of administration, dosing interval and duration of vitamin D supplementation at a specific target dose beyond the prevention of vitamin D deficiency need to be further investigated.
Innovations in mobile and electronic healthcare are revolutionizing the involvement of both doctors and patients in the modern healthcare system by extending the capabilities of physiological monitoring devices. Despite significant progress within the monitoring device industry, the widespread integration of this technology into medical practice remains limited. The purpose of this review is to summarize the developments and clinical utility of smart wearable body sensors.
We reviewed the literature for connected device, sensor, trackers, telemonitoring, wireless technology and real time home tracking devices and their application for clinicians.
Smart wearable sensors are effective and reliable for preventative methods in many different facets of medicine such as, cardiopulmonary, vascular, endocrine, neurological function and rehabilitation medicine. These sensors have also been shown to be accurate and useful for perioperative monitoring and rehabilitation medicine.
Although these devices have been shown to be accurate and have clinical utility, they continue to be underutilized in the healthcare industry. Incorporating smart wearable sensors into routine care of patients could augment physician-patient relationships, increase the autonomy and involvement of patients in regards to their healthcare and will provide for novel remote monitoring techniques which will revolutionize healthcare management and spending.
Sensors; Mobile health; eHealth; Patient education; Quantified patient
Signals of an increased risk of myocardial infarction (MI) have been identified with dabigatran etexilate in randomized controlled trials (RCTs).
Methods and Resules
We conducted searches of the published literature and a clinical trials registry maintained by the drug manufacturer. Criteria for inclusion in our meta‐analysis included all RCTs and the availability of outcome data for MI, other cardiovascular events, major bleeding, and all‐cause mortality. Among the 501 unique references identified, 14 RCTs fulfilled the inclusion criteria. Stratification analyses by comparators and doses of dabigatran etexilate were conducted. Peto odds ratio (ORPETO) values using the fixed‐effect model (FEM) for MI, other cardiovascular events, major bleeding, and all‐cause mortality were 1.34 (95% CI 1.08 to 1.65, P=0.007), 0.93 (95%CI 0.83 to 1.06, P=0.270), 0.88 (95% CI 0.79 to 0.99, P=0.029), and 0.89 (95% CI 0.80 to 1.00, P=0.041). When compared with warfarin, ORPETO values using FEM were 1.41 (95% CI 1.11 to 1.80, P=0.005), 0.94 (95%CI 0.83 to 1.06, P=0.293), 0.85 (95% CI 0.76 to 0.96, P=0.007), and 0.90 (95% CI 0.81 to 1.01, P=0.061), respectively. In RCTs using the 150‐mg BID dosage, the ORPETO values using FEM were 1.45 (95% CI 1.11 to 1.91, P=0.007), 0.95 (95% CI 0.82 to 1.09, P=0.423), 0.92 (95% CI 0.81 to 1.05, P=0.228), and 0.88 (95% CI 0.78 to 1.00, P=0.045), respectively. The results of the 110‐mg BID dosage were mainly driven by the RE‐LY trial.
This meta‐analysis provides evidence that dabigatran etexilate is associated with a significantly increased risk of MI. This increased risk should be considered taking into account the overall benefit in terms of major bleeding and all‐cause mortality.
all‐cause mortality; dabigatran etexilate; major bleeding; myocardial infarction
The reduced muscle mass and impaired muscle performance that defines sarcopenia in older individuals is associated with increased risk of physical limitation and a variety of chronic diseases. It may also contribute to clinical frailty.
A gradual erosion of quality of life (QoL) has been evidenced in these individuals, although much of this research has been done using generic QoL instruments, particularly the SF-36, which may not be ideal in older populations with significant comorbidities.
This review and report of an expert meeting, presents the current definitions of these geriatric syndromes (sarcopenia and frailty). It then briefly summarises QoL concepts and specificities in older populations, examines the relevant domains of QoL and what is known concerning QoL decline with these conditions. It calls for a clearer definition of the construct of disability and argues that a disease-specific QoL instrument for sarcopenia/frailty would be an asset for future research and discusses whether there are available and validated components that could be used to this end and whether the psychometric properties of these instruments are sufficiently tested. It calls also for an approach using utility weighting to provide some cost estimates and suggests that a time trade off study could be appropriate.
Age; aging; muscle weakness; quality of life; malnutrition