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
Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.
Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) 2.5–5 mm) were randomly allocated to strontium ranelate 1 g/day (n=558), 2 g/day (n=566) or placebo (n=559). The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment) over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee pain. The trial is registered (ISRCTN41323372).
The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: −0.23 (SD 0.56) mm; 2 g/day: −0.27 (SD 0.63) mm; placebo: −0.37 (SD 0.59) mm); treatment-placebo differences were 0.14 (SE 0.04), 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04), 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed with strontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day). There were greater reductions in total WOMAC score (p=0.045), pain subscore (p=0.028), physical function subscore (p=0.099) and knee pain (p=0.065) with strontium ranelate 2 g/day. Strontium ranelate was well tolerated.
Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.
Knee Osteoarthritis; Osteoarthritis; Outcomes research
The leading treatments for postmenopausal osteoporosis are the nitrogen-containing bisphosphonates, which are required long term for optimal benefit. Oral bisphosphonates have proven efficacy in postmenopausal osteoporosis in clinical trials, but in practice the therapeutic benefits are often compromised by patients’ low adherence. Nonadherence to bisphosphonate therapy negatively impacts outcomes such as fracture rate; fractures are in turn associated with decreased quality of life. The most common reason cited by patients for their nonadherence is that the strict dosing instructions for bisphosphonates are difficult to follow. One aspect of bisphosphonate administration that can be changed is dosing frequency and several studies have evaluated patient preferences for different dosing schedules. Studies have shown a preference for a weekly bisphosphonate regimen versus daily dosing and it has been demonstrated that this preference for reduced dosing frequency impacts on adherence. Ibandronate is the first nitrogen-containing oral bisphosphonate for osteoporosis that can be administered in a monthly regimen and two robust clinical studies demonstrated a strong patient preference for this monthly regimen versus a weekly regimen. It is important that physicians consider patient preference when prescribing treatment for osteoporosis to ensure that the disease is effectively managed for the long-term benefit of the patient.
postmenopausal osteoporosis; bisphosphonates; preference; adherence; ibandronate
Preference for and acceptability of a drug are crucial for complianceand hence optimal treatment of diseases that require long-term management (eg, osteoporosis). The preference for and acceptability of a chewable tablet containing calcium and vitamin D3 and a dose-comparable effervescent powder were assessed in a Phase 4, randomized, open-label, crossover trial in 5 European countries (Sweden, Finland, Belgium, the Netherlands, and Greece).
The aim of the present analysis was to compare the preference for and acceptability, including tolerability, of these 2 formulations based on the Belgian results of the previously mentioned study.
Patients were recruited from 3 osteoporosis units and universityhospitals in Brussels, Liege, and Ghent, Belgium. Adult patients at risk for calcium and vitamin D deficiencies were enrolled. The study drugs included 2 formulations of a dietary supplement containing a combination of calcium plus vitamin D3: chewable tablets (calcium carbonate, 1250 mg; vitamin D3, 400 IU) (A) and effervescent powder (calcium carbonate, 1250 mg; vitamin D3, 440 IU) (B). Patients were randomly assigned to receive 1 of 2 treatment sequences: AB or BA. Both formulations were given PO BID for 14 days, with a switch to the alternate formulation occurring on day 15 of the study. Preference and acceptability were assessed using 2 questionnaires: one assessed 5 variables of acceptability using 11-point scales, and the other assessed preference using yes/no questions. Compliance and tolerability were recorded throughout the study, with unused dose counts and recording of adverse events (AEs), respectively.
The study comprised 200 patients, 199 of whom received at least 1 dose of study medication and were included in the intent-to-treat analysis (174 women, 25 men; mean age, 66 years [range, 30–87 years]). Preference data were available in 178 patients, 129 of whom (72.5%) preferred the chewable tablet compared with 34 (19.1%) who preferred the effervescent powder and 15 (8.4%) who had no preference (both, P < 0.001 vs tablet). The preference for the tablet was based on consistently and significantly higher mean scores on all 5 variables of acceptability (all, P < 0.001). The most common AEs were gastrointestinal (tablet, 27/192 patients [14.1%]; powder, 31/190 patients [16.3%]). Eighteen patients (9.0%) discontinued the trial due to ≥1 AE (12 receiving the tablet and 6 receiving the powder).
In this study of preference for and acceptability of 2 formulations (chewable tablet and effervescent powder) of a dietary supplement containing a combination of calcium plus vitamin D3 in Belgian adults at risk for calcium and vitamin D deficiencies, the chewable tablet was preferred by a significant majority. Based on 5 variables, the tablet was found to be significantly more acceptable than the powder. Tolerability was similar between the 2 formulations.
acceptance; calcium; elderly; formulation; osteoporosis; preference; vitamin D3
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.
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.
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.
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.
Osteoporosis; Cost-effectiveness; Dairy products; Vitamin D; Fracture; Osteoporosis
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
Background: the impact of sarcopenia on quality of life is currently assessed by generic tools. However, these tools may not detect subtle effects of this specific condition on quality of life.
Objective: the aim of this study was to develop a sarcopenia-specific quality of life questionnaire (SarQoL, Sarcopenia Quality of Life) designed for community-dwelling elderly subjects aged 65 years and older.
Settings: participants were recruited in an outpatient clinic in Liège, Belgium.
Subjects: sarcopenic subjects aged 65 years or older.
Methods: the study was articulated in the following four stages: (i) Item generation—based on literature review, sarcopenic subjects' opinion, experts' opinion, focus groups; (ii) Item reduction—based on sarcopenic subjects' and experts' preferences; (iii) Questionnaire generation—developed during an expert meeting; (iv) Pretest of the questionnaire—based on sarcopenic subjects' opinion.
Results: the final version of the questionnaire consists of 55 items translated into 22 questions rated on a 4-point Likert scale. These items are organised into seven domains of dysfunction: Physical and mental health, Locomotion, Body composition, Functionality, Activities of daily living, Leisure activities and Fears. In view of the pretest, the SarQoL is easy to complete, independently, in ∼10 min.
Conclusions: the first version of the SarQoL, a specific quality of life questionnaire for sarcopenic subjects, has been developed and has been shown to be comprehensible by the target population. Investigations are now required to test the psychometric properties (internal consistency, test–retest reliability, divergent and convergent validity, discriminant validity, floor and ceiling effects) of this questionnaire.
sarcopenia; quality of life; questionnaire; older people
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
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
The patient’s perspective is becoming increasingly important in clinical and policy decisions. In this study, we aimed to evaluate the preferences of patients with, or at risk of, osteoporosis for medication attributes, and to establish how patients trade between these attributes.
A discrete choice experiment survey was designed and patients were asked to choose between two hypothetical unlabelled drug treatments (and an opt-out option) that vary in five attributes: efficacy in reducing the risk of fracture, type of potential common side-effects, mode and frequency of administration and out-of-pocket costs. An efficient experimental design was used to construct the treatment option choice sets and a mixed logit panel data model was used to estimate patients’ preferences and trade-offs between attributes.
A total of 257 patients with, or at risk of, osteoporosis completed the experiment. As expected, patients preferred treatment with higher effectiveness and lower cost. They also preferred either an oral monthly tablet or 6-month subcutaneous injection above weekly oral tablets, 3-month subcutaneous, 3-month intravenous or yearly intravenous injections. Patients disliked being at risk of gastro-intestinal disorders more than being at risk of skin reactions and flu-like symptoms. There was significant variation in preferences across the sample for all attributes except subcutaneous injection.
This study revealed that osteoporotic patients preferred 6-month subcutaneous injection and oral monthly tablet, and disliked gastro-intestinal disorders. Moreover, patients were willing to pay a personal contribution or to trade treatment efficacy for better levels of other attributes. Preferences for treatment attributes varied across patients and this highlights the importance of clinical decision-making taking individual preferences into account to improve osteoporosis care.
We review the various aspects of health technology assessment in osteoporosis, including epidemiology and burden of disease, and assessment of the cost-effectiveness of recent advances in the treatment of osteoporosis and the prevention of fracture, in the context of the allocation of healthcare resources by decision-makers in osteoporosis. This article was prepared on the basis of a symposium held by the Belgian Bone Club and the discussions surrounding that meeting, and is based on a review and critical appraisal of the literature. Epidemiological studies confirm the immense burden of osteoporotic fractures for patients and society with lifetime risks of any fracture of the hip, spine and forearm of around 40% for women and 13% for men. The economic impact is also large, for example, Europe’s six largest countries spent €31 billion on osteoporotic fractures in 2010. Moreover, the burden is expected to increase in the future with demographic changes and increasing life expectancy. Recent advances in the management of osteoporosis include novel treatments, better fracture risk assessment notably via fracture risk algorithms, and improved adherence to medication. Economic evaluation can inform decision-makers in healthcare on the cost-effectiveness of the various interventions. Cost-effectiveness analyses suggest that the recent advances in the prevention and treatment of osteoporosis may constitute an efficient basis for the allocation of scarce healthcare resources. In summary, health technology assessment is increasingly used in the field of osteoporosis and could be very useful to help decision-makers efficiently allocate healthcare resources.
Burden of disease; cost-effectiveness; economic evaluation; health technology assessment; osteoporosis
Osteoarthritis is a clinical syndrome of failure of the joint accompanied by varying degrees of joint pain, functional limitation, and reduced quality of life due to deterioration of articular cartilage and involvement of other joint structures.
Regulatory agencies require relevant clinical benefit on symptoms and structure modification for registration of a new therapy as a disease-modifying osteoarthritis drug (DMOAD). An international Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and International Osteoporosis Foundation was convened to explore the current burden of osteoarthritis, review current regulatory guidelines for the conduct of clinical trials, and examine the concept of responder analyses for improving drug evaluation in osteoarthritis.
The ESCEO considers that the major challenges in DMOAD development are the absence of a precise definition of the disease, particularly in the early stages, and the lack of consensus on how to detect structural changes and link them to clinically meaningful endpoints. Responder criteria should help identify progression of disease and be clinically meaningful. The ideal criterion should be sensitive to change over time and should predict disease progression and outcomes such as joint replacement.
The ESCEO considers that, for knee osteoarthritis, clinical trial data indicate that radiographic joint space narrowing >0.5 mm over 2 or 3 years might be a reliable surrogate measure for total joint replacement. On-going research using techniques such as magnetic resonance imaging and biochemical markers may allow the identification of these patients earlier in the disease process.
magnetic resonance imaging; osteoarthritis; X-ray; responder; structure-modifying drug; pain
Osteoarthritis is a primary cause of disability and functional incapacity. Pharmacological treatment is currently limited to symptomatic management, and in advanced stages, surgery remains the only solution. The therapeutic armamentarium for osteoarthritis remains poor in treatments with an effect on joint structure, that is, disease-modifying osteoarthritis drugs (DMOADs). Glucosamine sulfate and chondroitin sulfate are the only medications for which some conclusive evidence for a disease-modifying effect is available. Strontium ranelate is currently indicated for the prevention of fracture in severe osteoporosis. Its efficacy and safety as a DMOAD in knee osteoarthritis has recently been explored in the SEKOIA trial, a 3-year randomized, double-blind, placebo-controlled trial. Outpatients with knee osteoarthritis, Kellgren and Lawrence grade 2 or 3, and joint space width (JSW) of 2.5–5 mm received strontium ranelate 1 g/day (n = 558) or 2 g/day (n = 566), or placebo (n = 559). This sizable population was aged 62.9 years and had a JSW of 3.50 ± 0.84 mm. Treatment with strontium ranelate led to significantly less progression of knee osteoarthritis: estimates for annual difference in joint space narrowing versus placebo were 0.14 mm [95% confidence interval (CI) 0.05–0.23 mm; p < 0.001] for 1 g/day and 0.10 mm (95% CI 0.02–0.19 mm; p = 0.018) for 2 g/day, with no difference between strontium ranelate groups. Radiological progression was less frequent with strontium ranelate (22% with 1 g/day and 26% with 2 g/day versus 33% with placebo, both p < 0.05), as was radioclinical progression (8% and 7% versus 12%, both p < 0.05). Symptoms also improved with strontium ranelate 2 g/day only in terms of total WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score (p = 0.045), and its components for pain (p = 0.028) and physical function (p = 0.099). Responder analyses using a range of criteria for symptoms indicated that the effect of strontium ranelate 2 g/day on pain and physical function was clinically meaningful. Strontium ranelate was well tolerated. The observation of both structure and symptom modification with strontium ranelate 2 g/day makes SEKOIA a milestone in osteoarthritis research and treatment.
joint space narrowing; osteoarthritis; strontium ranelate; symptoms; treatment
The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.
The objective of the study was to report results from the first 3 years of the extension, representing up to 6 years of denosumab exposure.
Design, Setting, and Participants:
This was a multicenter, international, open-label study of 4550 women.
Women from the FREEDOM denosumab group received 3 more years of denosumab for a total of 6 years (long-term) and women from the FREEDOM placebo group received 3 years of denosumab (crossover).
Main Outcome Measures:
Bone turnover markers (BTMs), bone mineral density (BMD), fracture, and safety data are reported.
Reductions in BTMs were maintained (long-term) or achieved rapidly (crossover) after denosumab administration. In the long-term group, BMD further increased for cumulative 6-year gains of 15.2% (lumbar spine) and 7.5% (total hip). During the first 3 years of denosumab treatment, the crossover group had significant gains in lumbar spine (9.4%) and total hip (4.8%) BMD, similar to the long-term group during the 3-year FREEDOM trial. In the long-term group, fracture incidences remained low and below the rates projected for a virtual placebo cohort. In the crossover group, 3-year incidences of new vertebral and nonvertebral fractures were similar to those of the FREEDOM denosumab group. Incidence rates of adverse events did not increase over time. Six participants had events of osteonecrosis of the jaw confirmed by adjudication. One participant had a fracture adjudicated as consistent with atypical femoral fracture.
Denosumab treatment for 6 years remained well tolerated, maintained reduced bone turnover, and continued to increase BMD. Fracture incidence remained low.
Fatigue, lack of motivation and low compliance can be observed in nursing home residents during the practice of physical activity. Because exercises should not be too vigorous, whole body vibration could potentially be an effective alternative. The objective of this randomized controlled trial was to assess the impact of 3-month training by whole body vibration on the risk of falls among nursing home residents.
Patients were randomized into two groups: the whole body vibration group which received 3 training sessions every week composed of 5 series of only 15 seconds of vibrations at 30 Hz frequency and a control group with normal daily life for the whole study period. The impact of this training on the risk of falls was assessed blindly by three tests: the Tinetti Test, the Timed Up and Go test and a quantitative evaluation of a 10-second walk performed with a tri-axial accelerometer.
62 subjects (47 women and 15 men; mean age 83.2 ± 7.99 years) were recruited for the study. No significant change in the studied parameters was observed between the treated (n=31) and the control group (n=31) after 3 months of training by controlled whole-body-vibrations. Actually, the Tinetti test increased of + 0.93 ± 3.14 points in the treated group against + 0.88 ± 2.33 points in the control group (p = 0.89 when adjusted). The Timed Up and Go test showed a median evolution of - 1.14 (− 4.75-3.73) seconds in the treated group against + 0.41 (− 3.57- 2.41) seconds in the control group (p = 0.06). For the quantitative evaluation of the walk, no significant change was observed between the treated and the control group in single task as well as in dual task conditions.
The whole body vibration training performed with the exposition settings such as those used in this research was feasible but seems to have no impact on the risk of falls among nursing home residents. Further investigations, in which, for example, the exposure parameters would be changed, seem necessary.
Trial registration number: NCT01759680
Whole-body-vibration; Nursing home; Falls