Cost-effectiveness analysis of fracture liaison services: a Markov model using Dutch real-world data.

This study assessed the lifetime cost-effectiveness of a fracture liaison service (FLS) compared to no-FLS in the Netherlands from a societal perspective and suggested that FLS was cost-effective in patients with a recent fracture aged 50 years and older. The implementation of FLS could lead to lifetime health-economic benefits. INTRODUCTION: The objective of this study was to investigate the lifetime cost-effectiveness of a fracture liaison service (FLS) compared to no-FLS in the Netherlands from a societal perspective and using real-world data. METHODS: Annual fracture incidence, treatment scenarios as well as treatment initiation in the years 2017-2019 were collected from a large secondary care hospital in the Netherlands. An individual-level, state transition model was designed to simulate lifetime costs and quality-adjusted life years (QALYs). Treatment pathways were differentiated by gender, presence of osteoporosis and/or prevalent vertebral fracture, and treatment status. Results were presented as incremental cost-effectiveness ratios (ICER). Both one-way and probabilistic sensitivity analyses were conducted. RESULTS: For patients with a recent fracture aged 50 years and older, the presence of an FLS was associated with a lifetime €45 higher cost and 0.11 additional QALY gained leading to an ICER of €409 per QALY gained, indicating FLS was cost-effective compared to no-FLS at the Dutch threshold of €20,000/QALY. The FLS remained cost-effectiveness across different age categories. Our findings were robust in all one-way sensitivity analyses, the higher the treatment initiation rate in FLS, the greater the cost-effective of FLS. Probabilistic sensitivity analyses revealed that FLS was cost-effective in 90% of the simulations at the threshold of €20,000/QALY, with women 92% versus men 84% by gender. CONCLUSION: This study provides the first health-economic analysis of FLS in the Netherlands, suggesting the implementation of FLS could lead to lifetime health-economic benefits.

Work-related support for employed and self-employed people with rheumatoid arthritis or axial spondyloarthritis: a cross-sectional online survey of patients.

BACKGROUND: Little is known about the provision of work-related support for (self-)employed people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) by healthcare providers (HCPs) or employers. OBJECTIVE: This study aims to explore the experiences of (self-)employed people with RA or axSpA regarding work-related support from HCPs and employers in the Netherlands. METHODS: This cross-sectional study concerned an online survey for (self-)employed people, aged ≥ 16 years and diagnosed with RA or axSpA. The survey focused on experiences with HCPs and employers' work-related support and included questions on sociodemographic factors, health and work characteristics and work-related problems. RESULTS: The survey was completed by 884 participants, 56% with RA and 44% with axSpA, of whom 65% were employed, 8% self-employed and 27% not employed. In total, 95% (589/617) of (self-)employed participants reported work-related problems. Sixty-five percent of employed and 56% of self-employed participants had discussed these work-related problems with rheumatologists and/or other HCPs. Whereas 69% of employees with their employer. Both employed and self-employed participants reported that work-related advices or actions were more often provided by other HCPs (53%) than rheumatologists (29%). Fifty-six percent of employees reported this work-related support by the employer. CONCLUSION: This survey among (self-)employed people with RA or axSpA found that the majority reported work-related problems, but only half of them received any work-related support for these problems. Discussion of work-related problems with HCPs was more often reported by employed than self-employed participants. More attention from especially rheumatologists and other HCPs is important to identify and address work-related problems promptly.

Development of a Multimodal, Physiotherapist-Led, Vocational Intervention for People with Inflammatory Arthritis and Reduced Work Ability: A Mixed-Methods Design Study.

PURPOSE: Work ability of people with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) is reduced, but underexamined as a clinical treatment target. The evidence on vocational interventions indicates that delivery by a single healthcare professional (HCP) may be beneficial. Physiotherapist (PT)-led interventions have potential because PTs are most commonly consulted by RA/axSpA patients in the Netherlands. The aim was to develop a PT-led, vocational intervention for people with RA/axSpA and reduced work ability. METHODS: Mixed-methods design based on the Medical Research Council (MRC) framework for developing and evaluating complex interventions, combining a rapid literature review and six group meetings with: patient representatives (n = 6 and 10), PTs (n = 12), (occupational) HCPs (n = 9), researchers (n = 6) and a feasibility test in patients (n = 4) and PTs (n = 4). RESULTS: An intervention was developed and evaluated. Patient representatives emphasized the importance of PTs' expertise in rheumatic diseases and work ability. The potential for PTs to support patients was confirmed by PTs and HCPs. The feasibility test confirmed adequate feasibility and underlined necessity of training PTs in delivery. The final intervention comprised work-focussed modalities integrated into conventional PT treatment (10-21 sessions over 12 months), including a personalized work-roadmap to guide patients to other professionals, exercise therapy, patient education and optional modalities. CONCLUSION: A mixed-methods design with stakeholder involvement produced a PT-led, vocational intervention for people with RA/axSpA and reduced work ability, tested for feasibility and ready for effectiveness evaluation.

Health-related quality of life of patients with a recent fracture attending a fracture liaison service: a 3-year follow-up study.

This study explored the course of health state utility value over 3 years in patients with a recent fracture attending a Fracture Liaison Service and suggested that the overall change in health-related quality of life was not significant, although significant improvements were observed at 6 and 12 months compared to baseline. INTRODUCTION: To estimate the 3-year health-related quality of life (HRQoL) of patients with a recent fracture presenting at a Fracture Liaison Service (FLS) and to explore factors associated with health state utility value (HSUV). METHODS: Patients' HSUVs were derived from the EQ-5D-5L and SF-6D and calculated at six time points. Multiple imputation was applied for missing data. Linear mixed-effects regression analysis with random intercept and slope was applied to explore the course of HSUV over 3 years. The impact of subsequent fracture and the length of time between FLS visit and patients' index fracture on HSUV were also investigated. A backward stepwise elimination was applied to identify factors associated with HSUV. RESULTS: A total of 499 patients were included. The change of EQ-5D HSUV was not significant over 3-year follow-up (P = 0.52), although slightly but significantly higher HSUV was captured at 6 months (mean difference (MD): 0.015, P = 0.02) and 12 months (MD: 0.018, P = 0.01). There was no significant difference in the course of EQ-5D HSUV between fracture locations (P = 0.86). A significant increase in HSUV was only captured for patients had shorter time period (< 107 days) between FLS visit and their index fracture. Suffering a subsequent fracture was associated with significant QoL loss (MD: - 0.078, P < 0.001). Subsequent fracture, previous treatment with anti-osteoporosis medication, a prevalent vertebral fracture (grade 2 or 3), use of a walking aid, previous falls, and higher BMI were negatively associated with mean EQ-5D HSUV over 3 years. Comparable results were found using SF-6D HSUV. The lack of HRQoL data immediately after fracture and selection bias were two main limitations. CONCLUSION: The 3-year change in HSUV was not statistically significant, although significant improvements were observed at 6 and 12 months in comparison with baseline. Six factors were negatively associated with EQ-5D HSUV.

Patient preferences for lifestyle behaviours in osteoporotic fracture prevention: a cross-European discrete choice experiment.

Using a discrete choice experiment, we aimed to assess patients' preferences with regard to adopting lifestyle behaviours to prevent osteoporotic fractures. Overall, the 1042 patients recruited from seven European countries were favourable to some lifestyle behaviours (i.e., engaging in moderate physical activity, taking calcium and vitamin D supplements, reducing their alcohol consumption and ensuring a normal body weight). INTRODUCTION: Alongside medical therapy, healthy lifestyle habits are recommended for preventing osteoporotic fractures. In this study, we aimed to assess patients' preferences with regard to adopting lifestyle changes to prevent osteoporotic fractures. METHODS: A discrete choice experiment was conducted in seven European countries. Patients with or at risk of osteoporosis were asked to indicate to what extent they would be motivated to adhere to 16 lifestyle packages that differed in various levels of 6 attributes. The attributes and levels proposed were physical activity (levels: not included, moderate or high), calcium and vitamin D status (levels: not included, taking supplements, improving nutrition and assuring a minimal exposure to sunlight daily), smoking (levels: not included, quit smoking), alcohol (levels: not included, moderate consumption), weight reduction (levels: not included, ensure a healthy body weight) and fall prevention (levels: not included, receiving general advice or following a 1-day fall prevention program). A conditional logit model was used to estimate a patient's relative preferences for the various attributes across all participants and per country. RESULTS: In total, 1042 patients completed the questionnaire. Overall, patients were favourable to lifestyle behaviours for preventing osteoporotic fractures. However, among the lifestyle behaviours proposed, patients were consensually not prone to engage in a high level of physical activity. In addition, in Ireland, Belgium, the Netherlands and Switzerland, patients were also not inclined to participate in a 1-day fall prevention program and Belgian, Swiss and Dutch patients were not prone to adhere to a well-balanced nutritional program. Nevertheless, we observed globally that patients felt positively about reducing their alcohol consumption, engaging in moderate physical activity, taking calcium and vitamin D supplements and ensuring a normal body weight, all measures aimed at preventing fractures. CONCLUSIONS: In a patient-centred approach, fracture prevention should take these considerations and preferences into account.

The impact of fracture liaison services on subsequent fractures and mortality: a systematic literature review and meta-analysis.

This systematic review and meta-analysis suggests that fracture liaison service (FLS) is associated with a significantly lower probability of subsequent fractures and mortality although the latter was only found in studies comparing outcomes before and after the introduction of an FLS. INTRODUCTION: To systematically review and evaluate the impact of fracture liaison services (FLSs) on subsequent fractures and mortality using meta-analysis. METHODS: A literature search was performed within PubMed and Embase to identify original articles published between January 1, 2010, and April 30, 2020, reporting the effect of FLSs on subsequent fractures and/or mortality. Only studies comparing FLS to no-FLS were included. A meta-analysis using random-effects models was conducted. The quality of studies was appraised after combining and modifying criteria of existing quality assessment tools. RESULTS: The search retrieved 955 published studies, of which 16 studies fulfilled the inclusion criteria. Twelve studies compared outcomes before (pre-FLS) and after (post-FLS) FLS implementation, two studies compared outcomes between hospitals with and without FLS, and two other studies performed both comparisons. In total, 18 comparisons of FLS and no-FLS care were reported. Follow-up time varied from 6 months to 4 years. Sixteen comparisons reported on subsequent fractures and 12 on mortality. The quality assessment revealed methodological issues in several criteria. Excluding studies with very high selection bias, the meta-analysis of nine comparisons (in eight papers) revealed that the FLS care was associated with a significantly lower probability of subsequent fractures (odds ratio: 0.70, 95% CI: 0.52-0.93, P=0.01). In studies with a follow-up > 2 years, a significantly lower probability of subsequent fractures was captured for FLS care (odds ratio: 0.57, 95% CI: 0.34-0.94, P=0.03), while in studies ≤ 2 years, there was no difference in the odds of subsequent fractures. No significant difference in the odds of mortality was observed (odds ratio: 0.73, 95% CI: 0.49-1.09, P=0.12) in the meta-analysis of eight comparisons (in seven papers). However, a significantly lower probability of mortality was identified in the six pre-post FLS comparisons (odds ratio: 0.65, 95% CI: 0.44-0.95, P=0.03), but not in studies comparing hospitals with and without FLS. No difference was observed in mortality stratified by follow-up time. CONCLUSION: This systematic review and meta-analysis suggests that FLS care is associated with a significantly lower probability of subsequent fractures and mortality although the latter was only found in studies comparing outcomes before and after the introduction of an FLS. The quality assessment revealed that some important methodological issues were unmet in the currently available studies. Recommendations to guide researchers to design high-quality studies for evaluation of FLS outcomes in the future were provided.

Understanding patients' preferences for osteoporosis treatment: the impact of patients' characteristics on subgroups and latent classes.

This study revealed patterns in osteoporosis patients' treatment preferences, which cannot be related to socio-demographic or clinical characteristics, implicating unknown underlying reasons. Therefore, to improve quality of care and treatment, patients should have an active role in treatment choice, irrespective of their characteristics. INTRODUCTION: Patient centeredness is important to improve the quality of care. Accounting for patient preferences is a key element of patient centeredness, and understanding preferences are important for successful and adherent treatment. This study was designed to identify different preferences profiles and to investigate how patient characteristics influence treatment preferences of patients for anti-osteoporosis drugs. METHODS: Data from a discrete choice experiment among 188 osteoporotic patients were used. The hypothetical treatment options were characterized by three attributes: treatment efficacy, side effects, and mode/frequency of administration. A mixed logit model was used to measure heterogeneity across the sample. Subgroup analyses were conducted to identify potential effect of patient characteristics. Latent class modeling (LCM) was applied. Associations between patients' characteristics and the identified latent classes were explored with chi-square. RESULTS: All treatment options were important for patients' decision regarding osteoporotic treatment. Significant heterogeneity was observed for most attributes. Subgroup analyses revealed that patients with a previous fracture valued efficacy most, and patients with a fear of needles or aged > 65 years preferred oral tablets. Elderly patients disliked intravenous medication. Three latent classes were identified, in which 6-month subcutaneous injection was preferred in two classes (86%), while oral tablets were preferred in the third class (14%). No statistically significant associations between the profiles regarding socio-demographic or clinical characteristics could be found. CONCLUSIONS: This study revealed patterns in patients' preferences for osteoporosis treatment, which cannot be related to specific socio-demographic or clinical characteristics. Therefore, patients should be involved in clinical decision-making to reveal their preferences.

Interventions to improve adherence to anti-osteoporosis medications: an updated systematic review.

An earlier systematic review on interventions to improve adherence and persistence was updated. Fifteen studies investigating the effectiveness of patient education, drug regimen, monitoring and supervision, and interdisciplinary collaboration as a single or multi-component intervention were appraised. Multicomponent interventions with active patient involvement were more effective. INTRODUCTION: This study was conducted to update a systematic literature review on interventions to improve adherence to anti-osteoporosis medications. METHODS: A systematic literature review was carried out in Medline (using PubMed), Embase (using Ovid), Cochrane Library, Current Controlled Trials, ClinicalTrials.gov , NHS Centre for Review and Dissemination, CINHAL, and PsycINFO to search for original studies that assessed interventions to improve adherence (comprising initiation, implementation, and discontinuation) and persistence to anti-osteoporosis medications among patients with osteoporosis, published between July 2012 and December 2018. Quality of included studies was assessed. RESULTS: Of 585 studies initially identified, 15 studies fulfilled the inclusion criteria of which 12 were randomized controlled trials. Interventions were classified as (1) patient education (n = 9), (2) drug regimen (n = 3), (3) monitoring and supervision (n = 2), and (4) interdisciplinary collaboration (n = 1). In most subtypes of interventions, mixed results on adherence (and persistence) were found. Multicomponent interventions based on patient education and counseling were the most effective interventions when aiming to increase adherence and/or persistence to osteoporosis medications. CONCLUSION: This updated review suggests that patient education, monitoring and supervision, change in drug regimen, and interdisciplinary collaboration have mixed results on medication adherence and persistence, with more positive effects for multicomponent interventions with active patient involvement. Compared with the previous review, a shift towards more patient involvement, counseling and shared decision-making, was seen, suggesting that individualized solutions, based on collaboration between the patient and the healthcare provider, are needed to improve adherence and persistence to osteoporosis medications.

Spatially resolved endogenous improved metabolite detection in human osteoarthritis cartilage by matrix assisted laser desorption ionization mass spectrometry imaging.

Osteoarthritis (OA) is one of the most common musculoskeletal diseases, characterized by the progressive deterioration of articular cartilage. Although the disease has been well studied in the past few years, the endogenous metabolic composition and more importantly the spatial information of these molecules in cartilage is still poorly understood. Matrix-assisted laser desorption/ionization (MALDI) mass spectrometry imaging (MSI) has been previously used for the investigation of the bimolecular distribution of proteins and lipids through the in situ analysis of cartilage tissue sections. MALDI-MSI as a tool to detect metabolites remains challenging, as these species have low abundance and degrade rapidly. In this work, we present a complete methodology, from sample preparation to data analysis for the detection of endogenous metabolites on cartilage by MSI. Our results demonstrate for the first time the ability to detect small molecules in fragile, challenging tissues through an optimized protocol, and render MSI as a tool towards a better understanding of OA.

Performance of the Michigan Hand Outcomes Questionnaire in hand osteoarthritis.

OBJECTIVE: To investigate the performance of the Michigan Hand Outcomes Questionnaire (MHQ) in hand osteoarthritis (OA) by evaluating truth, discrimination and feasibility. DESIGN: Symptomatic hand OA patients from the Hand Osteoarthritis in Secondary Care (HOSTAS) cohort completed questionnaires (demographics, MHQ, Australian/Canadian Hand Osteoarthritis Index [AUSCAN], Functional Index for Hand Osteoarthritis [FIHOA] and visual analogue scale [VAS] pain) at baseline (n = 383), 1- and 2-year follow-up (n = 312, n = 293). Anchor questions at follow-up assessed whether pain/function levels were (un)acceptable and had changed compared to baseline. Correlations between MHQ and other pain/function questionnaires were calculated. Validity of unique MHQ domains (work performance, aesthetics, satisfaction), discrimination across disease stages, and responsiveness were assessed by categorizing patients by external anchors (employment, joint deformities, erosions, and anchor questions). Between-group differences were assessed with linear regression, probability plots and comparison of medians. RESULTS: MHQ pain and function subscales correlated moderately-to-good with other instruments (rs 0.63-0.81). Work performance scores were worse in patients with reduced working capacity than in employed patients. Aesthetics scores were worse in patients with more deformities. Patients with unacceptable complaints had worse satisfaction scores. All pain/function instruments discriminated between patients with acceptable vs unacceptable pain/function, while only MHQ activities of daily living (ADL), FIHOA, and MHQ aesthetics could discriminate between erosive and non-erosive disease. MHQ and AUSCAN were most responsive. CONCLUSIONS: MHQ has several unique aspects and advantages justifying its use in hand OA, including the unique assessment of work performance, aesthetics, and satisfaction. However, MHQ, AUSCAN and FIHOA appear to measure different aspects of pain and function.

Disease burden of knee osteoarthritis patients with a joint replacement compared to matched controls: a population-based analysis of a Dutch medical claims database.

OBJECTIVE: On a population level, the incidence of knee prostheses (KPs) has increased, but excess health care costs per patient, compared to matched controls without a KP, in the years surrounding these procedures and their determinants are largely unknown. We therefore aimed to provide estimates of age- and sex-specific incidence of KPs, revision KPs, and prosthesis complications in patients with knee osteoarthritis (OA) and to determine excess health care costs in the years surrounding surgery compared with matched controls. METHODS: All KPs in OA patients in the Achmea Health Database were identified as well as up to four controls. Incidence rates of KPs, revisions, and complications from 2006 to 2013 were determined. Annual health care cost and excess costs (over matched controls) preceding, during, and after surgery were calculated and their determinants were evaluated. RESULTS: The increased incidence of KPs, revisions, and complications was strongest in younger age categories and men. The average costs per patient were relatively stable between 2006 and 2012. KP patient's annual health care costs increased towards the year of surgery. After surgery, costs decreased, but remained higher as compared to costs prior to surgery. High post-surgery costs were mainly associated with subsequent revisions or additional KPs, but costs were also higher in females, lower age categories, and lower social economic status. CONCLUSION: These results underscore the increasing burden and medical need associated with end-stage OA, especially in younger age categories. Improvement of guidelines tailored to individual patient groups aimed at avoiding complications and revisions is required to counteract this increasing burden.

Economic considerations and patients' preferences affect treatment selection for patients with rheumatoid arthritis: a discrete choice experiment among European rheumatologists.

OBJECTIVE: To compare the value that rheumatologists across Europe attach to patients' preferences and economic aspects when choosing treatments for patients with rheumatoid arthritis. METHODS: In a discrete choice experiment, European rheumatologists chose between two hypothetical drug treatments for a patient with moderate disease activity. Treatments differed in five attributes: efficacy (improvement and achieved state on disease activity), safety (probability of serious adverse events), patient's preference (level of agreement), medication costs and cost-effectiveness (incremental cost-effectiveness ratio (ICER)). A Bayesian efficient design defined 14 choice sets, and a random parameter logit model was used to estimate relative preferences for rheumatologists across countries. Cluster analyses and latent class models were applied to understand preference patterns across countries and among individual rheumatologists. RESULTS: Responses of 559 rheumatologists from 12 European countries were included in the analysis (49% females, mean age 48 years). In all countries, efficacy dominated treatment decisions followed by economic considerations and patients' preferences. Across countries, rheumatologists avoided selecting a treatment that patients disliked. Latent class models revealed four respondent profiles: one traded off all attributes except safety, and the remaining three classes disregarded ICER. Among individual rheumatologists, 57% disregarded ICER and these were more likely from Italy, Romania, Portugal or France, whereas 43% disregarded uncommon/rare side effects and were more likely from Belgium, Germany, Hungary, the Netherlands, Norway, Spain, Sweden or UK. CONCLUSIONS: Overall, European rheumatologists are willing to trade between treatment efficacy, patients' treatment preferences and economic considerations. However, the degree of trade-off differs between countries and among individuals.

Clinicians' perspective on key domains in ANCA-associated vasculitis: a Delphi exercise.

OBJECTIVES: The existing set of outcomes for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) needs to incorporate views of outcome measure stakeholders to meet the current standards of outcome measurement proposed by the Outcome Measures in Rheumatology (OMERACT) initiative. This study identifies domains that clinical experts (one group of stakeholders) consider to be important to determining the impact of AAV using the International Classification of Functioning, Disability and Health (ICF), a framework that describes health along four components: body functions, body structures, activities and participation, and contextual factors. METHOD: An international group of clinicians with expertise in the clinical care of patients with vasculitis were identified through consultation with three major vasculitis societies. The relevant domains were determined using a three-round e-mail-based Delphi questionnaire. RESULTS: Eighty-two clinicians were invited to participate in this study and 41 responded. Nineteen domains were identified as important by > 80% of participants: six body functions (energy, seeing, hearing, pain, respiratory, and renal function), seven body structures (peripheral nerves, eye, ear, nose, sinuses, lungs (and airways), and kidneys), three activities and participation (carrying out daily routine, remunerative employment, and recreation and leisure), and three environmental factors (medications, support and relationships, and health services, systems, and policies). CONCLUSIONS: Clinical experts focus on the physiological effects of AAV with less importance given to the effect of AAV on patients' activities and participation in life situations and the role of contextual factors. This study represents a step towards incorporating views of a range of stakeholders into disease assessment in AAV.

The development of a personalized patient education tool for decision making for postmenopausal women with osteoporosis.

UNLABELLED: A personalized patient education tool for decision making (PET) for postmenopausal women with osteoporosis was developed by means of a systematic development approach. A prototype was constructed and refined by involving various professionals and patients. Professionals and patients expressed a positive attitude towards the use of the PET. INTRODUCTION: The purpose was to systematically develop a paper-based personalized PET to assist postmenopausal women with osteoporosis in selecting a treatment in line with their personal values and preferences. METHODS: The development of the PET was based on a systematic process including scope, design, development of a prototype, and alpha testing among professionals and patients by semi-structured interviews. RESULTS: The design and development resulted in a four-page PET prototype together with a one-page fact sheet of the different drug options. The prototype PET provided the personal risk factors, the estimated individualized risk for a future major osteoporotic fracture and potential reduction with drugs, and a summary of advantages and disadvantages whether or not to start drugs. The drug fact sheet presents five attributes of seven drugs in a tabular format. The alpha testing with professionals resulted in some adaptations, e.g., inclusion of the possibility to calculate fracture risk based on various individual risk scoring methods. Important results from the alpha testing with patients were differences in the fracture risk percentage which was seen as worthwhile to start drugs, the importance of an overview of side effects, and of the timing of the PET into the patient pathway. All women indicated that the PET could be helpful for their decision to select a treatment. CONCLUSION: Physicians and patients expressed a positive attitude towards the use of the proposed PET. Further research would be needed to test the effects of the PET on feasibility in clinical workflow and on patient outcomes.

Potential cost-effectiveness for using patient decision aids to guide osteoporosis treatment.

UNLABELLED: We use a model to predict whether using a patient decision aid in patients considering bisphosphonate therapy would be a good use of health resources. We found that if the decision aid improved adherence, and only marginally increased time physicians needed with their patients, then the decision-aid would be cost-effective. INTRODUCTION: Oral bisphosphonates have been shown to reduce the risk of osteoporotic fracture. Adherence is crucial but suboptimal. A recent study suggests that a patient decision aid, which facilitates shared decision-making, could be effective in increasing adherence to bisphosphonates. But decision aids come at a cost in terms of additional time spent with physicians. This study considers the emerging evidence on the role of patient decision aids in improving adherence to bisphosphonates and their potential costs to inform future decision-making and research priorities. METHODS: We estimate the hypothetical cost-effectiveness of a patient decision aid detailing the benefits and risks of bisphosphonates for osteoporotic patients, from a Canadian healthcare perspective. A previously developed and validated Markov microsimulation model was adapted to include use of a patient decision aid to support the decision of whether to initiate bisphosphonate therapy, and subsequent influence on adherence and future fractures. We considered 2014 costs and benefits in terms of quality-adjusted life-years (QALYs). RESULTS: A patient decision aid that could improve treatment initiation rates or persistence (adherence) by 20 %, or a linear combination of the two, in osteoporotic women aged 70+ over a 3-year treatment period was found to have an incremental cost-effectiveness ratio below $50,000/QALY. CONCLUSIONS: Patient decision aids have the potential to be cost-effective in osteoporosis so long as they increase adherence under certain conditions. Funding further research on the long-term effectiveness and costs of a patient decision aid which outlines all treatment options for osteoporosis patients is justified.

Development of a health index in patients with ankylosing spondylitis (ASAS HI): final result of a global initiative based on the ICF guided by ASAS.

OBJECTIVES: The burden of disease in patients with ankylosing spondylitis (AS) can be considerable. However, no agreement has been reached among expert members of Assessment of SpondyloArthritis International Society (ASAS) to define severity of AS. Based on the International Classification of Functioning, Disability and Health (ICF), a core set of items for AS has been selected to represent the entire spectrum of possible problems in functioning. Based on this, the objective of this study was to develop a tool to quantify health in AS, the ASAS Health Index. METHODS: First, based on a literature search, experts' and patients' opinion, a large item pool covering the categories of the ICF core set was generated. In several steps this item pool was reduced based on reliability, Rasch analysis and consensus building after two cross-sectional surveys to come up with the best fitting items representing most categories of the ICF core set for AS. RESULTS: After the first survey with 1754 patients, the item pool of 251 items was reduced to 82. After selection by an expert committee, 50 items remained which were tested in a second cross-sectional survey. The results were used to reduce the number of items to a final set of 17 items. This selection showed the best reliability and fit to the Rasch model, no residual correlation, and absence of consistent differential item function and a Person Separation Index of 0.82. CONCLUSIONS: In this long sequential study, 17 items which cover most of the ICF core set were identified that showed the best representation of the health status of patients with AS. The ASAS Health Index is a linear composite measure which differs from other measures in the public domain.

Pattern of bone erosion and bone proliferation in psoriatic arthritis hands: a high-resolution computed tomography and radiography follow-up study during adalimumab therapy.

OBJECTIVES: To investigate the pattern and development of bone erosion and proliferation in patients with psoriatic arthritis (PsA) during treatment with adalimumab, using high-resolution computed tomography (CT) and conventional radiography. METHOD: Forty-one biologic-naïve PsA patients were initiated with adalimumab 40 mg subcutaneously every other week. CT and radiography of the 2nd-5th metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints were conducted at baseline (n = 41) and after 24 weeks (n = 32). Changes in bone erosion and proliferation are described and the imaging modalities compared. RESULTS: Ninety percent of bone erosions detected by CT were located in the metacarpal heads, and most frequently in the 2nd-3rd MCP joints. Radial (37%) and ulnar (31%) surfaces were more frequently eroded than dorsal (10%) and palmar (22%) sites. Using CT, bone proliferations were located primarily on the sides of the distal part of the DIP joints (43% of all proliferations), but also proximally in DIP (17%) and MCP joints (27%). For bone erosions and proliferations, respectively, radiography showed a low sensitivity (17% and 26%), but a high specificity (98% and 95%) and accuracy (93% and 87%), with CT as the gold standard reference. Neither CT nor radiography revealed statistically significant changes in bone erosion or proliferation scores between baseline and follow-up. CONCLUSIONS: Patterns of bone erosion and proliferation in PsA hands were revealed in more detail by CT than by radiography. No overall progression or repair could be detected during adalimumab treatment with either of the methods.

The ASAS Health Index (ASAS HI) - a new tool to assess the health status of patients with spondyloarthritis.

Within the variable course of ankylosing spondylitis (AS), peripheral arthritis, enthesitis, and involvement of other organs can add to the burden of the disease. The primary complaints of patients with spondyloarthritis (SpA) are pain, stiffness, fatigue, and limitation in activities and social participation. Instruments currently available for the assessment of patients with SpA focus predominantly on specific aspects of health such as pain, disease activity, and physical function and measure specific concepts like physical function and health-related quality of life (HR-QoL). However, the overall picture of impairments, limitations and restrictions in activities or social participation of patients with AS is not adequately assessed in SpA-specific questionnaires. Most of the existing questionnaires are not conceptualised with regard to their underlying construct. The International classification of functioning, disability and health (ICF) Core Set for AS may serve as an appropriate model and underlying construct to develop a health index, since the whole range of functioning and disability of patients with AS is captured. Based on these assumptions, ASAS developed for patients with SpA an instrument assessing health as operationalised by the ICF. The questionnaire was developed by preparing an item pool, linkage of the items to the comprehensive ICF core set for AS and test of the item pool in two cross-sectional studies. The analysis of the questionnaire and the response scale were done with Rasch analysis. Emphasis was on optimal targeting, the capacity of items to differentiate between different levels of health, and optimal coverage of items to the spectrum of ICF categories, so that the final questionnaire could represent as much of the entire range of difficulty levels as possible. The ASAS HI is a linear composite measure and includes 17 items which cover most of the ICF core set. Preliminary validity has been confirmed in a field test in 4 English-speaking countries. The ASAS HI should soon be used in clinical trials and in clinical practice to test its real life performance and to confirm that this new composite index captures relevant information on functioning and health of patients with AS.

Compensation mechanisms for lost productivity: a comparison between four European countries.

OBJECTIVE: Productivity costs are usually estimated by multiplying the wage with the period absent. This can lead to an overestimation if compensation mechanisms occur. Until now only Dutch data are available on the influence of compensation mechanisms on lost productivity, but between-country differences in frequency and type of compensation mechanisms can be expected. The objective of this study was to understand whether compensation mechanisms for days absent from paid work differ in type and frequency across countries and to explore whether this would result in between-country differences in relevant lost productivity. METHODS: Data from a cross-sectional survey among respondents with rheumatic disorders from four countries were the basis for this study. Analyses focused on respondents with paid employment who reported absence in the last 3 months. The different compensation mechanisms are described and the resulting lost productivity in terms of days absent was calculated with and without taking compensation mechanisms into account. Logistic regression analyses were performed to examine which variables influence compensation mechanisms leading to relevant lost productivity. RESULTS: The results indicate that compensation mechanisms occur and are relevant in all four countries. Between-country differences in the type and frequency of compensation mechanisms and relevant lost productivity were observed. The logistic regression analyses indicate that, correcting for other variables, this is also the case for the use of compensation mechanisms leading to relevant lost productivity. CONCLUSIONS: Between-country differences in compensation mechanisms in case of absenteeism exist and could vary to such an extent that foreign relevant lost productivity data should be used with caution.

Effectiveness and cost-effectiveness of a multimodal, physiotherapist-led, vocational intervention in people with inflammatory arthritis: study protocol of the Physiotherapy WORKs trial.

BACKGROUND: Although reduced work ability is a substantial problem among people with inflammatory arthritis (IA), work ability is an underexposed area in clinical practice. Evidence on vocational interventions in IA is limited, but favourable results of delivery by a physiotherapist (PT) warrant the need for further research. Therefore, we aim to evaluate the (cost-)effectiveness of a multimodal, PT-led, vocational intervention in (self-)employed people with IA compared to usual care. METHODS: This randomized controlled trial will include 140 people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who are (self-)employed and have reduced work ability (Work Ability Index - Single Item Scale (WAS) ≤ 7/10) and/or RA/axSpA related sick leave (≤ 6 months). Participants will be randomized 1:1 to the intervention or control condition (usual care). The intervention, delivered by primary care PTs, will be personalized to each patient, consisting of 10 to 21 sessions over 12 months. The intervention will be multimodal, comprising of 1) exercise therapy and a physical activity plan, 2) education/self-management support, 3) work-roadmap to guide participants in finding relevant other care, with optionally 4) online self-management course and 5) workplace examination. Assessments will be performed at baseline and after 3, 6, and 12 months. The primary outcome measure of effectiveness is work ability, as measured with the WAS at 12 months. For the cost-effectiveness analysis, the EuroQol (EQ-5D-5L), self-reported healthcare use, sick leave and productivity while at work will be used to estimate the trial based cost-utility from a societal perspective. A process evaluation, including assessments of adherence and treatment fidelity, will be undertaken using the registrations of the PTs and semi-structured interviews at 12 months follow-up in a random sample of the intervention group. DISCUSSION: The results of this study will provide insights in the (cost-)effectiveness of a multimodal, PT-led, vocational intervention in people with IA and a reduced work ability. TRIAL REGISTRATION: This study is registered in the International Clinical Trial Registry Platform (ICTRP) under number NL9343.