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Secular trends of use of anti-osteoporotic treatments in Spain: A population-based cohort study including over 1.5million people and more than 12years of follow-up.
25 December 2017
OBJECTIVE: Different regulatory actions for anti-osteoporotic medication (AOM) were taken during the last years, including marketing of new drugs, safety warnings, or restrictions on the indications. We aimed to characterise the secular trends of AOM use in Spain from 2001 to 2013. METHODS: A cohort study using the Spanish Database for Pharmacoepidemiological Research in Primary Care (BIFAP), was performed. BIFAP includes anonym records for 4million patients. Participants entered the study when aged ≥50years in 2001-2013 and after 1year of data available, and were followed to an AOM prescription (including alendronate, other bisphosphonates, SERM (selective estrogen receptor modulators), strontium ranelate, teriparatide or denosumab), death, lost or the end of December 2013. Prevalence (%) and incidence rate (IR/1000person-years (py)) of AOM users were computed by years and sex. RESULTS: Out of 1.5million participants, 135,410 received AOM treatment during 2001-2013. Prevalence was 6.1% (women) and 1.1% (men), that increased from 2001 (2.0%) to 2009 (7.6%) to decrease thereafter. Out of them, 95,057 were incident. The IR was 24.90 (women) and 2.77 (men), that increased from 2001 (21.25 and 1.96) to 2007 (35.84 and 3.64), and decreased to 12.48 and 1.81 (2013). IRs were highest for bisphosphonates along the years (ranging 3.70-14.73 and 0.57-1.75 in women and men respectively), followed by SERM up to 2005 (6.51-9.02 and 0.06-0.07), and strontium ranelate from 2006 (4.66 and 0.45) to 2012 (2.05 and 0.26). IR for teriparatide increased from marketing in 2004 (0.10-1.01 and 0.02-0.29), as was denosumab from marketing in 2011 (0.03-2.64 and 0.09-0.15). CONCLUSIONS: Population-based estimates of AOM use in Spain peaked in 2007-2009 and decreased thereafter, irrespective of age and sex. New treatments were ten times higher in women than men. Bisphosphonates were the most frequently prescribed class, followed by SERM in women before 2006, strontium otherwise till 2012, and denosumab in women or teriparatide in men in 2013. Changes in the osteoporosis criteria, fracture risk assessment strategies, and regulatory actions for AOM around the time, may explain that trend.
Prevention of Falls Network Europe: a thematic network aimed at introducing good practice in effective falls prevention across Europe.
26 December 2017
The Prevention of Falls Network Europe (ProFaNE) aims to improve quality of life of the ageing population by focussing on a major cause of disability and distress: falls. The thematic network is funded by the European Commission and brings together scientists, clinicians and other health professionals from around Europe to focus on four main themes: taxonomy and coordination of trials, clinical assessment and management of falls, assessment of balance function, and psychological aspects of falling. There are 24 members across Europe as well as network associates who contribute expertise at workshops and meetings. ProFaNE, a 4-year project which started in January 2003, aims to improve and standardise health care processes, introducing and promoting good practice widely across Europe. ProFaNE undertakes workshops that bring together experts and observers around specific topics to exchange knowledge, expertise and resources on interventions that reduce falls. A key document for policy makers around Europe, written by ProFaNE members, was published by the World Health Organisation in March 2004. ProFaNE's website has both public and private areas with resources (web links to falls prevention, useful documents for policy makers, researchers and practitioners) and a discussion board to encourage informal networking between members and the public. The ultimate aim of ProFaNE is to submit a collaborative bid to undertake a multi-centre, randomised controlled trial of a multi-factorial fall prevention intervention with peripheral fracture as the primary outcome. The success of the networking and relationship building in the first year and a half of ProFaNE's work makes this an achievable goal.
Development and delivery of an exercise programme for falls prevention: the Prevention of Falls Injury Trial (PreFIT).
9 January 2018
OBJECTIVE: This paper describes the development and implementation of an exercise intervention to prevent falls within The Prevention of Fall Injury Trial (PreFIT), which is a large multi-centred randomised controlled trial based in the UK National Health Service (NHS). DESIGN: Using the template for intervention description and replication (TIDieR) checklist, to describe the rationale and processes for treatment selection and delivery of the PreFIT exercise intervention. PARTICIPANTS: Based on the results of a validated falls and balance survey, participants were eligible for the exercise intervention if they were at moderate or high risk of falling. INTERVENTIONS: Intervention development was informed using the current evidence base, published guidelines, and pre-existing surveys of clinical practice, a pilot study and consensus work with therapists and practitioners. The exercise programme targets lower limb strength and balance, which are known, modifiable risk factors for falling. Treatment was individually tailored and progressive, with seven recommended contacts over a six-month period. Clinical Trials Registry (ISCTRN 71002650).
Exploring physiotherapists' experiences of implementing a cognitive behavioural approach for managing low back pain and identifying barriers to long-term implementation.
12 January 2018
OBJECTIVES: Our objectives were two-fold: (i) to describe physiotherapists' experiences of implementing a cognitive behavioural approach (CBA) for managing low back pain (LBP) after completing an extensive online training course (iBeST), and (ii) to identify how iBeST could be enhanced to support long-term implementation before scale up for widespread use. DESIGN: We conducted semi-structured interviews with 11 physiotherapists from six National Health Service departments in the Midlands, Oxfordshire and Derbyshire. Questions centred on (i) using iBeST to support implementation, (ii) what barriers they encountered to implementation and (iii) what of information or resources they required to support sustained implementation. Interviews were transcribed and thematically analysed using NVivo. Themes were categorised using the Theoretical Domains Framework (TDF). Evidence-based techniques were identified using the behaviour change technique taxonomy to target relevant TDF domains. RESULTS: Three themes emerged from interviews: anxieties about using a CBA, experiences of implementing a CBA, and sustainability for future implementation of a CBA. Themes crossed multiple TDF domains and indicated concerns with knowledge, beliefs about capabilities and consequences, social and professional roles, social influences, emotion, and environmental context and resources. We identified evidence-based strategies that may support sustainable implementation of a CBA for LBP in a physiotherapy setting. CONCLUSIONS: This study highlighted potential challenges for physiotherapists in the provision of evidence-based LBP care within the current UK NHS. Using the TDF provided the foundation to develop a tailored, evidence-based, implementation intervention to support long term use of a CBA by physiotherapists managing LBP within UK NHS outpatient departments.
Current practice in methodology and reporting of the sample size calculation in randomised trials of hip and knee osteoarthritis: a protocol for a systematic review.
8 January 2018
BACKGROUND: A key aspect of the design of randomised controlled trials (RCTs) is determining the sample size. It is important that the trial sample size is appropriately calculated. The required sample size will differ by clinical area, for instance, due to the prevalence of the condition and the choice of primary outcome. Additionally, it will depend upon the choice of target difference assumed in the calculation. Focussing upon the hip and knee osteoarthritis population, this study aims to systematically review how the trial size was determined for trials of osteoarthritis, on what basis, and how well these aspects are reported. METHODS: Several electronic databases (Medline, Cochrane library, CINAHL, EMBASE, PsycINFO, PEDro and AMED) will be searched to identify articles on RCTs of hip and knee osteoarthritis published in 2016. Articles will be screened for eligibility and data extracted independently by two reviewers. Data will be extracted on study characteristics (design, population, intervention and control treatments), primary outcome, chosen sample size and justification, parameters used to calculate the sample size (including treatment effect in control arm, level of variability in primary outcome, loss to follow-up rates). Data will be summarised across the studies using appropriate summary statistics (e.g. n and %, median and interquartile range). The proportion of studies which report each key component of the sample size calculation will be presented. The reproducibility of the sample size calculation will be tested. DISCUSSION: The findings of this systematic review will summarise the current practice for sample size calculation in trials of hip and knee osteoarthritis. It will also provide evidence on the completeness of the reporting of the sample size calculation, reproducibility of the chosen sample size and the basis for the values used in the calculation. TRIAL REGISTRATION: As this review was not eligible to be registered on PROSPERO, the summary information was uploaded to Figshare to make it publicly accessible in order to avoid unnecessary duplication amongst other benefits ( https://doi.org/10.6084/m9.figshare.5009027.v1) ; Registered January 17, 2017.
Development and validation of a prediction rule for psychiatric hospital readmissions of patients with a diagnosis of psychosis
20 November 2017
Multiple studies of psychosis have demonstrated an association between a variety of clinical and demographic patient characteristics and psychiatric hospital readmission. Our aim is to investigate whether these potential predictors retain their predictive value when put together to create a prediction tool for hospital readmission that clinicians could use to guide best care practice for patients with psychosis when discharged from hospital. A prediction model for psychiatric hospital readmission will be developed using data from an existing single-outcome, parallel arm, non-blinded randomised trial (OCTET). The trial recruited patients aged between 18-65 years, diagnosed with psychosis, registered in one of 60 NHS Trusts providing mental health services in England. Recruitment took place from 10 November, 2008 to 22 February, 2011. A total of 119/336 (35%) patients were readmitted to hospital in the 12-month follow-up after discharge at baseline (60/167 patients were re-admitted in the control group only). A set of 17 potential predictors has been identified from those found in the literature. Univariate and multivariate logistic regression models will be fitted using a smooth supersaturated polynomial technique which allows for correlations between the predictors. No variable selection will be done and multiple imputation will be used to account for missing values. The final multivariate prediction model will be internally and externally validated, using bootstrap and applying the model to an independent dataset to evaluate its performance, respectively. We will present the final model and describe any challenges we encounter to obtain it, both clinical and methodological. We will report the independent and adjusted prediction value for each of the pre-selected predictors; the multivariate model’s discrimination and calibration, the latter adjusted for optimism; and the model’s sensitivity, specificity and area under the receiving operating curve. Findings from the external validation analysis will also be presented.
Health amongst former rugby union players: A cross-sectional study of morbidity and health-related quality of life.
22 December 2017
In the general population, physical activity is associated with improved health outcomes. However, long-term sports participation may be associated with adverse outcomes, particularly at the elite level. The aims of this study were to assess morbidity and health-related quality of life (HrQoL) amongst former rugby players, compared to an age-standardised general population sample. A cross-sectional study of former elite, male, rugby players (n = 259) was undertaken, and standardised morbidity ratios (SMR) calculated, assessing morbidity prevalence relative to English Longitudinal Study of Aging participants (ELSA, n = 5186). HrQoL, measured using the EQ-5D, was compared to a Health Survey for England (HSE, n = 2981) sample. In SMR analyses of participants aged 50+, diabetes was significantly lower amongst former players, (0.28, 95% CI 0.11-0.66), whereas osteoarthritis (4.00, 95% CI 3.32-4.81), joint replacement (6.02, 95% CI 4.66-7.77), osteoporosis (2.69, 95% CI 1.35-5.38), and anxiety (2.00, 95% CI 1.11-3.61) were significantly higher. More problems in HrQoL were reported amongst former players within the domains of mobility (p < 0.001), self-care (p = 0.041), usual activities (p < 0.001) and pain/discomfort (p < 0.001). Morbidity and HrQoL differ between players and the general population, with higher musculoskeletal morbidity and lower diabetes amongst former players. The magnitude of musculoskeletal morbidity may warrant proactive osteoarthritis management within this population.
Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris: An External Multicenter Validation Study of Birmingham Hip Resurfacing and Corail-Pinnacle Implants.
18 January 2018
BACKGROUND: The authors of recent studies have reported newly devised implant-specific blood metal ion thresholds to predict adverse reactions to metal debris (ARMD) in patients who have undergone unilateral or bilateral metal-on-metal (MoM) hip arthroplasty. These thresholds were most effective for identifying patients at low risk of ARMD. We investigated whether these newly devised blood metal ion thresholds could effectively identify patients at risk of ARMD after MoM hip arthroplasty in an external cohort of patients. METHODS: We performed a validation study involving 803 MoM hip arthroplasties (323 unilateral Birmingham Hip Resurfacing [BHR], 93 bilateral BHR, and 294 unilateral Corail-Pinnacle implants) performed in 710 patients at 3 European centers. All patients underwent whole-blood metal ion sampling, and were divided into 2 groups: those with ARMD (leading to revision or identified on imaging; n = 75) and those without ARMD (n = 635). Previously devised implant-specific blood metal ion thresholds (2.15 μg/L of cobalt for unilateral BHR; 5.5 μg/L for the maximum of either cobalt or chromium for bilateral BHR; and 3.57 μg/L of cobalt for unilateral Corail-Pinnacle implants) were applied to the validation cohort, and receiver operating characteristic curve analysis was used to establish the discriminatory characteristics of each threshold. RESULTS: The area under the curve, sensitivity, specificity, and positive and negative predictive values for the ability of each implant-specific threshold to distinguish between patients with and without ARMD were, respectively, 89.4% (95% confidence interval [CI] = 82.8% to 96.0%), 78.9%, 86.7%, 44.1%, and 96.9% for unilateral BHR; 89.2% (CI = 81.3% to 97.1%), 70.6%, 86.8%, 54.5%, and 93.0% for bilateral BHR; and 76.9% (CI = 63.9% to 90.0%), 65.0%, 85.4%, 24.5%, and 97.1% for unilateral Corail-Pinnacle implants. Using the implant-specific thresholds, we missed 20 patients with ARMD (2.8% of the patients in this series). We missed more patients with ARMD when we used the fixed thresholds proposed by regulatory authorities: 35 (4.9%) when we used the U.K. threshold of 7 μg/L for both cobalt and chromium (p = 0.0003), 21 (3.0%) when we used the U.S. threshold of 3 μg/L for both cobalt and chromium (p = 1.0), and 46 (6.5%) when we used the U.S. threshold of 10 μg/L for both cobalt and chromium (p < 0.0001). CONCLUSIONS: This external multicenter validation study confirmed that patients with blood metal ion levels below new implant-specific thresholds have a low risk of ARMD after MoM hip arthroplasty. Using these implant-specific thresholds, we missed fewer patients with ARMD compared with when the thresholds currently proposed by regulatory authorities were used. We therefore recommend using implant-specific blood metal ion thresholds when managing patients who have undergone MoM hip arthroplasty. LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.
The Influence of Arthritis in Other Major Joints and the Spine on the One-Year Outcome of Total Hip Replacement: A Prospective, Multicenter Cohort Study (EUROHIP) Measuring the Influence of Musculoskeletal Morbidity.
10 January 2018
BACKGROUND: Although arthritis in other affected major joints and back pain are known to lead to worse outcomes following total hip replacement, to our knowledge, these risk factors have not previously been operationalized as a musculoskeletal morbidity profile. The aim of this study was to measure the influence of other major joints and the spine (as grades of musculoskeletal morbidity) on the 1-year outcome of primary total hip replacement. METHODS: The EUROHIP study consists of 1,327 patients undergoing primary total hip replacement for arthritis across 20 European orthopaedic centers. The primary outcome was the responder rate at 12 months calculated with the relative effect per patient for total hip replacement using the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The primary predictor of interest was different combinations of arthritis of major joints and the spine grouped into 4 musculoskeletal morbidity grades: 1 (single major joint), 2 (multiple major joints), 3 (single major joint and spine), and 4 (multiple major joints and spine). The confounders adjusted for were age, sex, body mass index, living situation, years of hip pain, American Society of Anesthesiologists (ASA) class, anxiety or depression, and preoperative WOMAC subscales. RESULTS: For this analysis, 845 patients were included with complete 12-month follow-up WOMAC scores. The mean patient age was 65.7 years, and 55.2% of patients were female. CONCLUSIONS: The involvement of other major joints and the spine assessed as 1 of 4 musculoskeletal morbidity grades had a strong influence on the 1-year outcome after total hip replacement. The effect size was large compared with other risk factors. Even so, the majority of patients in musculoskeletal morbidity grade 4 had favorable outcomes from the surgical procedure (>74% response to surgical procedures). LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.