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See detailFrench translation and validation of the Cumberland Ankle Instability Tool, an instrument for measuring functional ankle instability
Geerinck, Anton ULiege; Beaudart, Charlotte ULiege; Salvan, Quentin et al

in Foot and Ankle Surgery (in press)

Background: Ankle sprains are one of the most common musculoskeletal injuries, and can lead to chronic ankle instability (CAI). The Cumberland Ankle Instability Tool (CAIT) measures a subset of CAI ... [more ▼]

Background: Ankle sprains are one of the most common musculoskeletal injuries, and can lead to chronic ankle instability (CAI). The Cumberland Ankle Instability Tool (CAIT) measures a subset of CAI, functional ankle instability (FAI).Because no French version existed, we set out to translate and validate the CAIT in French. Methods: The CAIT was translated using a forward-backward methodology. We examined its psychometric properties and calculated a cut-off score for FAI in a sample of 102 subjects (median age 22 years). Results: The CAIT was translated without significant problems. The CAIT-F can discriminate between those with and without FAI (p<0.001), with a cut-off score of ≤23 points. The test-retest reliability is excellent (ICC=0.960), as is the internal consistency (α=0.885). Construct validity was confirmed. No floor or ceiling effects were detected among subjects with FAI. Conclusions: The CAIT is now available in French, and is a valid and reliable instrument. [less ▲]

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See detailPractical guidance for engaging patients in health research, treatment guidelines and regulatory processes: results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)
de Wit, M.; Cooper, Cyrus ULiege; Tugwell, P. et al

in Aging Clinical and Experimental Research (in press)

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients’ needs. However, there is currently little ... [more ▼]

There is increasing emphasis on patient-centred research to support the development, approval and reimbursement of health interventions that best meet patients’ needs. However, there is currently little guidance on how meaningful patient engagement may be achieved. An expert working group, representing a wide range of stakeholders and disciplines, was convened by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO). Through a structured, collaborative process the group generated practical guidance to facilitate optimal patient engagement in clinical development and regulatory decisions. Patient engagement is a relational process. The principles outlined in this report were based on lessons learned through applied experience and on an extensive dialogue among the expert participants. This practice guidance forms a starting point from which tailoring of the approach to suit different chronic diseases may be undertaken. © 2019, The Author(s). [less ▲]

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See detailAssociation between dietary nutrient intake and sarcopenia in the SarcoPhAge study
Beaudart, Charlotte ULiege; Locquet, Médéa ULiege; Touvier, M. et al

in Aging Clinical and Experimental Research (in press)

Background: It has been suggested that a balanced nutritional intake may be useful in preventing or even reversing sarcopenia. Aim: To describe cross-sectional associations between dietary nutrient intake ... [more ▼]

Background: It has been suggested that a balanced nutritional intake may be useful in preventing or even reversing sarcopenia. Aim: To describe cross-sectional associations between dietary nutrient intake and sarcopenia. Methods: Subjects recruited from the SarcoPhAge study population completed a food frequency questionnaire. The micronutrient and macronutrient intake was evaluated in both sarcopenic and non-sarcopenic participants. The Nutritional Belgian Recommendations of 2016 were used, i.e., adequate intake and estimated average requirement (EAR). For micronutrients, the prevalence of insufficient intake was estimated as the proportion of subjects whose intake was below the EAR. Results: A total of 331 subjects (mean age of 74.8 ± 5.9 years, 58.9% women) had complete data and were included in this study. Among them, 51 were diagnosed with sarcopenia (15.4%). In the fully adjusted model, analyses revealed that sarcopenic subjects consumed significantly lower amounts of two macronutrients (proteins, lipids) and five micronutrients (potassium, magnesium, phosphorus, iron, and vitamin K) than non-sarcopenic subjects (all p values < 0.005). A significantly increased prevalence of insufficiency was found for sarcopenic subjects compared to non-sarcopenic subjects for potassium, magnesium, iron, calcium and vitamins E and C (all p values < 0.005). The prevalence of sarcopenic subjects who were also below the Nutritional Belgian Recommendations for protein and lipids was significantly higher than that of non-sarcopenic subjects. Discussion and conclusions: Sarcopenic subjects seem to consume significantly reduced amounts of many micronutrients and macronutrients compared to non-sarcopenic subjects. These results suggest that a poorly balanced diet may be associated with sarcopenia and poor musculoskeletal health, although prospective studies are needed to confirm these findings. © 2019, Springer Nature Switzerland AG. [less ▲]

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See detailImpact of frailty status on the cost of drugs and dietary supplements prescribed to nursing home residents: the SENIOR cohort.
Buckinx, Fanny ULiege; Charles, Alexia ULiege; Quabron, A. et al

in Aging Clinical and Experimental Research (in press)

Background The financial impact associated with drug consumption has been poorly investigated among frail subjects and, specifically, in nursing home settings. Aims To determine the association of the ... [more ▼]

Background The financial impact associated with drug consumption has been poorly investigated among frail subjects and, specifically, in nursing home settings. Aims To determine the association of the average monthly cost of the drugs and dietary supplements consumed by nursing home residents with their frailty status. Methods This is an analysis of the first follow-up year of the SENIOR cohort. All participants were classified into “frail” or “non-frail” categories according to Fried’s criteria at baseline. Monthly bills from the pharmacy were analysed to determine the association between the average monthly cost of the drugs and dietary supplements consumed and frailty status. Results A sample of 87 residents (83.8 ± 9.33 years and 75.9% women) from the SENIOR cohort was included. The prevalence of frailty was 28%. The median number of medications consumed each day was 9 (6–12) (no difference between frail and non-frail subjects; p = 0.15). The overall median monthly cost was € 109.6, of which 49% was covered by Belgian social security and the remaining balance was paid by the patient. When comparing the drug expenses of the frail subjects and the non-frail subjects, the overall average monthly cost did not differ between the 2 groups (p = 0.057). Nevertheless, the expenditure remaining to be paid by the residents, after the Belgian social security intervention, was significantly higher among the frail residents (€ 65.7) than among the non-frail residents (€ 47.6; p = 0.017). Conclusions Frailty status has an impact on the expenditures related to the consumption of drugs. [less ▲]

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See detailEfficacy of chondroitin sulfate in patients with knee osteoarthritis: a comprehensive meta-analysis exploring inconsistencies in randomized, placebo-controlled trials.
Honvo, Germain ULiege; Bruyère, Olivier ULiege; Geerinck, Anton ULiege et al

in Advances in Therapy (in press)

Introduction: There are some controversies about treatment modalities in osteoarthritis (OA), including chondroitin sulfate (CS). The objective of this study was to determine whether CS is effective at ... [more ▼]

Introduction: There are some controversies about treatment modalities in osteoarthritis (OA), including chondroitin sulfate (CS). The objective of this study was to determine whether CS is effective at alleviating pain and improving function in patients with knee OA and to identify the factors that explain inconsistencies in clinical trial results. Methods: We conducted a systematic review of randomized, placebo-controlled trials, searching the databases Medline, Cochrane central register for controlled trials and Scopus. Random effects meta-analysis was then performed, using tau2 and I2 statistics to assess heterogeneity. The pain and Lequesne index (LI) scores were expressed as standardized mean differences (SMDs), with a 95% confidence interval (CI). Heterogeneity was explored by stratifying the analyses according to pre-specified study-level characteristics and assessing the sources of funnel plot asymmetry. Results: The inclusion criteria yielded 18 trials. Overall, CS significantly but inconsistently reduced pain (SMD: - 0.63; 95% CI: - 0.91, - 0.35; I2 = 94%) and improved function (SMD: - 0.82; 95% CI: - 1.31, - 0.33; I2 = 95%). When limiting the analysis to studies with a low risk of bias, the pharmaceutical grade CS of IBSA origin showed a greater reduction in pain (SMD: - 0.25; 95% CI: - 0.34, - 0.16; I2 = 75%) and function (SMD: - 0.33; 95% CI: - 0.47, - 0.20; I2 = 53%, p = 0.07) compared with the other preparations (SMDPain: - 0.08; 95% CI: - 0.19, ? 0.02; I2 = 20%; SMDFunction: - 0.18; 95% CI: - 0.36, ?0.01; I2 = 0%). Assessing funnel plot asymmetry in the studies with a low risk of bias, we found strong correlations between the treatment effects and study size (pain: rS = 0.93; LI: rS = 0.86; p\0.05). Ultimately, there was no residual heterogeneity in the CS effects when the smallest studies were removed from the analyses. Conclusion: This new meta-analysis suggests that CS provides a moderate benefit for pain and has a large effect on function in knee OA, however with large inconsistency. The risks of bias, brand and study size were the factors explaining heterogeneity among the clinical trial results. [less ▲]

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See detailCross-cultural adaptation, translation, and validation of the functional assessment scale for acute hamstring injuries (FASH) questionnaire for French-speaking patients
Locquet, Médéa ULiege; Willems, Tom; Specque, Clément et al

in Disability and Rehabilitation (in press)

Study design: This consisted of a translation and validation study. Background: Acute hamstring injury is a frequent muscle strain in sports that require high explosive strength, impulsion or running ... [more ▼]

Study design: This consisted of a translation and validation study. Background: Acute hamstring injury is a frequent muscle strain in sports that require high explosive strength, impulsion or running phases. Therefore, the Functional Assessment Scale for Hamstring Injury questionnaire was developed to assess pain, physical activity level and ability to perform various exercises in patients with hamstring injuries. The Functional Assessment Scale for Hamstring Injury questionnaire is currently available in English, German, and Greek. Objectives: The goal of this study was to provide a cross-culturally adapted French-translation of the FASH questionnaire and to assess its psychometric performance. Methods: The French-translation and cross-cultural adaptation process were based on international recommendations, following six rigorous steps: (a) two initial translations from English to French; (b) synthesis of the two translations; (c) back-translations; (d) comparisons between the back-translations and the original questionnaire by an expert committee; (e) pretest; and (f) approval of the final French version of the Functional Assessment Scale for Hamstring Injury questionnaire. To validate this French version, 116 subjects (17 pathological patients, 19 patients with other muscle injury, 40 athletes at risk, and 40 healthy control athletes) were recruited to complete the Functional Assessment Scale for Hamstring Injury questionnaire. The Short Form Health Survey (SF-36) was used as a comparative questionnaire. The psychometric properties of the questionnaire were evaluated by determining the test-retest reliability after a 48–60-h interval, internal consistency, construct validity, and floor/ceiling effects. Results: All of the items of the Functional Assessment Scale for Hamstring Injury questionnaire were translated without any major difficulties. The questionnaire showed excellent discriminative power by obtaining significantly different scores from the four groups (p¼0.01). Regarding psychometric performances, the test–retest reliability was excellent (IntraClass Coefficient Correlation of 0.997). Very high internal consistency was also observed (Cronbach’s alpha of 0.969). Correlations with the physical health subscales of the SF-36 were significant and considered to be strong, indicating an excellent convergent validity. The other subscales of the SF-36 (mental health) were weakly correlated with the FASH, reflecting good divergent validity. No floor or ceiling effects were observed. Conclusion: The French-translation of the Functional Assessment Scale for Hamstring Injury questionnaire and its cross-cultural adaptation can be considered to be successful. Functional Assessment Scale for Hamstring Injury-French questionnaire is now a reliable and valid tool for patients suffering from acute hamstring injury, and its application in clinical practice is particularly relevant. IMPLICATIONS FOR REHABILITATION The FASH-F can be considered to be discriminant, reliable and valid for the evaluation of the severity of symptoms and sports ability in individuals with hamstring injuries. FASH-F is now a reliable and valid tool for French-speaking patients suffering from acute hamstring injury, and its application in clinical practice is particularly relevant. A limitation of our study could be that the distribution between the different study groups was not homogeneous implying that our findings may not be fully representative of the general population. [less ▲]

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See detailType 2 diabetes mellitus and osteoarthritis
Veronese, Nicola; Cooper, Cyrus; Reginster, Jean-Yves ULiege et al

in Seminars in Arthritis and Rheumatism (in press)

OBJECTIVES: Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are common diseases that frequently co-exist, along with overweight/obesity. While the mechanical impact of excess body weight on joints ... [more ▼]

OBJECTIVES: Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are common diseases that frequently co-exist, along with overweight/obesity. While the mechanical impact of excess body weight on joints may explain lower limb OA, we sought to explore whether T2DM is linked to OA outside of excess weight and whether T2DM may play a role in OA pathophysiology. The consequence of T2DM on OA outcomes is a question of research interest. METHODS: We conducted a critical review of the literature to explore the association between T2DM and OA, whether any association is site-specific for OA, and whether the presence of T2DM impacts on OA outcomes. We also reviewed the literature to assess the safety of anti-OA treatments in patients with T2DM. RESULTS: T2DM has a pathogenic effect on OA through 2 major pathways involving oxidative stress and low-grade chronic inflammation resulting from chronic hyperglycemia and insulin resistance. T2DM is a risk factor for OA progression and has a negative impact on arthroplasty outcomes. Evidence is mounting for safety concerns with some of the most frequently prescribed anti-OA medications, including paracetamol, non-steroidal anti-inflammatory drugs, and corticosteroid injections, while other anti-OA medications may be safely prescribed in OA patients with T2DM, such as glucosamine and intra-articular hyaluronic acid. CONCLUSIONS: Future research is needed to better understand whether diabetes control and prevention can modulate OA occurrence and progression. The selection of therapy to treat OA symptoms in patients with T2DM may require careful consideration of the evidence based to avoid untoward safety issues. [less ▲]

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See detailFrench translation and validation of the exercise-induced leg pain Questionnaire
Beaudart, Charlotte ULiege; Hagelstein, Thibaut; Van Beveren, Julien et al

in Disability and Rehabilitation (in press)

Objective: The “Exercise-Induced Leg Pain” questionnaire was developed (in German) for the evaluation of the severity of symptoms and sports ability in individuals with exercise-induced leg pain. The ... [more ▼]

Objective: The “Exercise-Induced Leg Pain” questionnaire was developed (in German) for the evaluation of the severity of symptoms and sports ability in individuals with exercise-induced leg pain. The purpose of the present study was to translate and cross-culturally adapt this questionnaire into French and to study the reliability and validity of this French-language version. Methods: The translation and cross-cultural adaptation of the original “Exercise-Induced Leg Pain” was performed according to established guidelines. The translation part was carried out in six stages: (i) two initial translations from German to French; (ii) synthesis of the two translations; (iii) backward translations; (iv) comparison between the backward translations and the original questionnaire by an expert committee; (v) pretest; and (vi) approval of the final version of the French-language “Exercise-Induced Leg Pain” questionnaire. To validate this questionnaire, 84 subjects were recruited (28 pathological patients with a confirmed diagnosis of chronic leg pain, 28 asymptomatic sport students, and 28 healthy control athletes). The discriminative power of the questionnaire was tested, as well as its reliability (internal consistency and test–retest reliability after a 7–10-day interval), construct validity and floor/ceiling effects. Results: The French version of the “Exercise-Induced Leg Pain” questionnaire was generated without any major difficulties. The ability of the questionnaire to discriminate between the three groups of subjects was demonstrated with a total score of 61.0 ± 18.5 for the pathologic group; 93.9 ± 7.57 for the asymptomatic group and 94.1 ± 9.79 for the control group. A high internal consistency (Cronbach's alpha of 0.93) and an excellent test–retest reliability [intraclass coefficient correlation: 0.98 (95% confidence interval: 0.97–0.99, p < 0.001)] indicated that the “Exercise-Induced Leg Pain” is reliable. The questionnaire also demonstrated good construct validity against different subscales of the Short Form-36 questionnaire, a generic quality of life questionnaire, with more than 87% of the prespecified hypotheses confirmed. Finally, no floor effects or ceiling effects were observed. Conclusion: The French version of the « Exercise-Induced Leg Pain » was successfully translated and cross-culturally adapted. The questionnaire is consistent, valid and reliable for evaluating French-speaking patients with chronic exercise-induced leg pain. Implications for rehabilitation The “Exercise-Induced Leg Pain” questionnaire aims to assess the severity of symptoms that impact the function and sports ability of patients with exercise-induced leg pain; The French version of the « Exercise-Induced Leg Pain » was successfully translated and cross-culturally adapted. The questionnaire is consistent, valid and reliable for evaluating French-speaking patients with chronic exercise-induced leg pain. [less ▲]

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See detailThe explicit use of PRISMA and its effect on the reporting completeness of meta-analyses in the field of behavioral and social sciences
Leclercq, Victoria ULiege; Beaudart, Charlotte ULiege; Ajamieh, Sara ULiege et al

Poster (2019, May 14)

Objectives: To investigate the effect of the explicit use of PRISMA, a statement designed to help authors to report meta-analyses (MAs), on the reporting quality of MAs in behavioral and social sciences ... [more ▼]

Objectives: To investigate the effect of the explicit use of PRISMA, a statement designed to help authors to report meta-analyses (MAs), on the reporting quality of MAs in behavioral and social sciences. Methods: We evaluated a random sample of 207 MAs indexed in PsycINFO in 2016; 100 explicitly used PRISMA and 107 did not. Two authors independently checked the 27 PRISMA items and extracted factors that could potentially be associated with reporting quality. Results: From our 207 MAs, perfect adherence to PRISMA was found in less than 4%, of which 87% explicitly used PRISMA. The following items were significantly more frequently encountered in MAs that explicitly used PRISMA: structured summary, protocol and registration, information sources, search strategy, study characteristics, results of individual studies, funding, study selection, risk of bias in individual study and bias across studies. The journals’ impact factors, the endorsement of PRISMA by the journal, the number of authors, the country of the first author, the open access of the article and the design of the studies were significantly and positively associated with the explicit PRISMA use. Conclusions: Even if far from optimal, the explicit use of PRISMA has a positive influence on the reporting completeness of MAs. [less ▲]

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See detailThe methodological quality of meta-analyses in behavioral and social sciences: leads for enhancements according to AMSTAR 2
Leclercq, Victoria ULiege; Beaudart, Charlotte ULiege; Ajamieh, Sara ULiege et al

Poster (2019, May 14)

Objectives: To investigate the methodological quality in meta-analyses (MAs) published in behavioral and social sciences. Methods: We evaluated a random sample of 207 MAs indexed in PsycINFO database in ... [more ▼]

Objectives: To investigate the methodological quality in meta-analyses (MAs) published in behavioral and social sciences. Methods: We evaluated a random sample of 207 MAs indexed in PsycINFO database in 2016. Two authors independently extracted methodologic characteristics of all MAs with the 16 items of AMSTAR2 (A MeaSurement Tool to Assess systematic Reviews 2). AMSTAR2 allows to assess the methodological quality of MAs that classifies them in 4 categories: critically low, low, moderate and high. Results: From the 207 MAs, according to AMSTAR2 criteria, 95% of MAs were rated as critically low. Statistical methods were appropriate and publication bias well evaluated in respectively 87% and 70% of the MAs. However, much improvement is needed in data collection and analysis: Publication of the research protocol (in 11% of MAs), comprehensive literature search strategy (44%), assessment (37%) and interpretation (29%) of risk of bias in individual included studies and presentation of excluded studies (11%). Conclusions: The methodological quality of MAs of our sample was critically low, according to AMSTAR2 criteria. Some efforts could improve tremendously the methodological quality of behavioral and social sciences MAs and thus gain in robustness and reliability. [less ▲]

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See detailFrench translation and validation of the “Anterior Knee Pain Scale” (AKPS)
Buckinx, Fanny ULiege; Bornheim, Stephen ULiege; Remy, Gaël et al

in Disability and Rehabilitation (2019), 41(9), 1089-1094

Purpose: To linguistically and cross-culturally translate the Anterior Knee Pain Scale into French and to evaluate the reliability and validity of this translated version of the questionnaire. Methods ... [more ▼]

Purpose: To linguistically and cross-culturally translate the Anterior Knee Pain Scale into French and to evaluate the reliability and validity of this translated version of the questionnaire. Methods: The translation part was performed in six stages, according to international guidelines: (i) two initial translations from English to French; (ii) synthesis of the two translations; (iii) backward translations into the original language; (iv) expert committee to compare the backward translations with the original questionnaire; (v) pre-final version testing and (VI) expert committee appraisal. To validate the French version of the Anterior Knee Pain Scale, we assessed its validity, reliability and floor/ceiling effects. To do this, volunteer patients from the French part of Belgium and from France, with patellofemoral pain were asked to answer the French version of the Anterior Knee Pain Scale at baseline and after 7 days, as well as the generic SF-36 questionnaire. Results: The Anterior Knee Pain Scale was translated without any major difficulties. A total of 101 subjects aged 34.5 ± 11.4 years (58.4% of women) were included in this study. Results indicated an excellent test-retest reliability (Intra-class correlation coefficient (ICC) = 0.97, 95%CI: 0.96–0.98), a high internal consistency (Cronbach’s alpha = 0.87), a consistent construct validity (high correlations with the SF-36 questionnaire were found with domains related to physical function (r = 0.80), physical role (r = 0.70) and pain (r = 0.64)) and low or moderate correlations with domains related to mental health (r = 0.26), vitality (r = 0.32) and social function (r = 0.41). Moreover, no floor/ceiling effects have been found. Conclusions: A valid French version of the Anterior Knee Pain Scale is now available and can be used with confidence to better assess the disease burden associated with patellofemoral pain. It was successfully cross-culturally adapted into French.Implications for rehabilitationThe results on psychometric properties of the French Anterior Knee Pain Scale are comparable with six validated versions obtained for the Finnish, the Turkish, the Chinese, the Dutch, the Thai and the Persian populations.The French translated version of the Anterior Knee Pain Scale is a reliable and valid instrument for assessing the functional limitations associated with patellofemoral pain.The test–retest reliability of the French Anterior Knee Pain Scale was excellent, the internal consistency was high and the construct validity was consistent. There were no floor/ceiling effects. © 2017 Informa UK Limited, trading as Taylor & Francis Group [less ▲]

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See detailCost-effectiveness evaluation of glucosamine for osteoarthritis based on simulation of individual patient data obtained from aggregated data in published studies.
Bruyère, Olivier ULiege; Reginster, Jean-Yves ULiege; Honvo, Germain ULiege et al

in Aging Clinical and Experimental Research (2019), (Online first),

Background: The economic evaluation of treatments usually requires access to individual patient data, which is difficult to obtain. Moreover, in osteoarthritis, health utility scores are unavailable and ... [more ▼]

Background: The economic evaluation of treatments usually requires access to individual patient data, which is difficult to obtain. Moreover, in osteoarthritis, health utility scores are unavailable and can be assessed only using a validated equation model based on various clinical data. We aimed to develop and validate a methodology to simulate individual health utility scores from aggregated clinical data available in published studies to calculate the cost-effectiveness of different glucosamine preparations (i.e., crystalline glucosamine sulfate, glucosamine sulfate, and glucosamine hydrochloride) used for osteoarthritis. Methods: We developed a method to simulate individual utility values and validated the model by comparing the results obtained with the simulation and the results of one trial where the utility scores are available. Then, we simulated the utility scores of 10 published trials that used different glucosamine preparations. The utility estimates were used to calculate the quality-adjusted life year (QALY) using the area-under-the-curve method. Costs were for the glucosamine product only. The incremental cost/effectiveness ratio (ICER) was then calculated. Results: The values of utility scores calculated from data sources and those simulated with the model were similar. From 10 studies where utility was simulated, four used crystalline glucosamine sulfate, and six used other formulations. The ICER revealed that compared to placebo, crystalline glucosamine sulfate only was cost-effective at all time points and up to 3 years with a median ICER of 5347.2 €/QALY at month 3, 4807.2 €/QALY at month 6 and 11535.5 €/QALY at year 3. The use of other formulations was not cost-effective. Conclusion: Using a new model to simulate individual health utility scores of patients included in ten published trials, ICER analysis showed that the use of crystalline glucosamine sulfate is cost-effective, while other formulations were not. The results confirm the importance of the formulation of glucosamine products. [less ▲]

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See detailPatients’ preferences for osteoarthritis treatment: the value of stated-preference studies.
Hiligsmann, M.; Pinto, D.; Dennison, E et al

in Aging Clinical and Experimental Research (2019), 31(1), 1-3

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See detailRecommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts' consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation
Hiligsmann, Mickaël ULiege; Reginster, Jean-Yves ULiege; Tosteson, A.N.A. et al

in Osteoporosis International (2019), 30(1), 45-57

Summary Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These ... [more ▼]

Summary Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards. Introduction This paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards. Methods A working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted. Results Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed. Conclusion While the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers. [less ▲]

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See detailAssessment of muscle function and physical performance in daily clinical practice: a position paper endorsed by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
Beaudart, Charlotte ULiege; Rolland, Y.; Cruz-Jentoft, A.J. et al

in Calcified Tissue International (2019)

It is well recognized that poor muscle function and poor physical performance are strong predictors of clinically relevant adverse events in older people. Given the large number of approaches to measure ... [more ▼]

It is well recognized that poor muscle function and poor physical performance are strong predictors of clinically relevant adverse events in older people. Given the large number of approaches to measure muscle function and physical performance, clinicians often struggle to choose a tool that is appropriate and validated for the population of older people they deal with. In this paper, an overview of different methods available and applicable in clinical settings is proposed. 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 organized afterwards where the whole group could amend and discuss the recommendations further. Several characteristics should be considered when choosing a tool: (1) purpose of the assessment (intervention, screening, diagnosis); (2) patient characteristics (population, settings, functional ability, etc.); (3) psychometric properties of the tool (test–retest reliability, inter-rater reliability, responsiveness, floor and ceiling effects, etc.); (4) applicability of the tool in clinical settings (overall cost, time required for the examination, level of training, equipment, patient acceptance, etc.); (5) prognostic reliability for relevant clinical outcomes. Based on these criteria and the available evidence, the expert group advises the use of grip strength to measure muscle strength and the use of 4-m gait speed or the Short Physical Performance Battery test to measure physical performance in daily practice. The tools proposed are relevant for the assessment of muscle weakness and physical performance. Subjects with low values should receive additional diagnostic workups to achieve a full diagnosis of the underlying condition responsible (sarcopenia, frailty or other). [less ▲]

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See detailSafety of cyclooxygenase-2 inhibitors in osteoarthritis: outcomes of a systematic review and meta-analysis.
Curtis, E.; Fuggle, N.; Shaw, S. et al

in Drugs and Aging (2019), 36(suppl 1), 25-44

Objective: Our aim was to assess the safety of cyclooxygenase-2 (COX-2) inhibitors in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled ... [more ▼]

Objective: Our aim was to assess the safety of cyclooxygenase-2 (COX-2) inhibitors in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled trials. Methods: A comprehensive literature search was undertaken in the databases MEDLINE, Cochrane Central Register of Controlled Trials (Ovid CENTRAL) and Scopus. Randomized, double-blind, placebo-controlled, parallel-group trials that assessed adverse events (AEs) with COX-2 inhibitors in patients with OA were eligible for inclusion. Two authors appraised titles, abstracts and full-text papers for suitability and then assessed the studies for random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data and selective outcomes reporting. The primary outcomes of interest were gastrointestinal disorders, cardiac disorders, vascular disorders, nervous system disorders, skin and subcutaneous tissue disorders, hepatobiliary disorders, renal and urinary disorders, as well as overall severe and serious AEs, drug-related AEs and mortality. Secondary outcomes were withdrawals due to AEs (i.e. the number of participants who stopped the treatment due to an AE) and total number of AEs (i.e. the number of patients who experienced any AE at least once). Results: Database searches identified 2149 records from which, after exclusions, 40 trials were included in the meta-analysis. The use of COX-2 inhibitors in OA was associated with a significant increased risk of drug-related AEs compared with placebo (relative risk (RR) 1.26, 95% CI 1.09–1.46; I2 = 24%). The risk of upper gastrointestinal complications (including dyspepsia, gastritis and heartburn) was significantly increased with COX-2 inhibitors versus placebo (RR 1.19, 95% CI 1.03–1.38; I2 = 0%), particularly for abdominal pain, which increased by 40% with COX-2 inhibitors (RR 1.40, 95% CI 1.08–1.80; I2 = 0%). The risk of hypertension increased by 45% overall (RR 1.45, 95% CI 1.01–2.10; I2 = 25%); however, when rofecoxib was removed from the analysis the risk of hypertension in the COX-2 inhibitor group was no longer significant (RR 1.21, 95% CI 0.80–1.83; I2 = 20%). The overall risk of heart failure and edema was increased by nearly 70% with COX-2 inhibitors versus placebo (RR 1.68, 95% CI 1.22–2.31; 0%) and this level of risk did not change appreciably when rofecoxib was excluded (RR 1.67, 95% CI 1.21–2.29; 0%). Conclusions: In our analysis, COX-2 inhibitors were associated with an increased risk of upper gastrointestinal AEs, especially abdominal pain. We also found an increased risk of cardiovascular AEs with COX-2 inhibitors, namely hypertension, heart failure and edema. [less ▲]

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