Effect of certolizumab pegol over 96 weeks of treatment on inflammation of the spine and sacroiliac joints, as measured by MRI, and the association between clinical and MRI outcomes in patients with axial spondyloarthritis.

Objective: To report MRI outcomes and explore the relationship between clinical remission and MRI inflammation in patients with axial spondyloarthritis (axSpA) from the RAPID-axSpA trial, including radiographic (r-)axSpA and non-radiographic (nr-)axSpA.

Methods: RAPID-axSpA (NCT01087762) was double-blind and placebo-controlled to week 24, dose-blind to week 48 and open-label to week 204. Patients were randomised to certolizumab pegol (CZP) or placebo.

Validation of a novel activity monitor in impaired, slow-walking, crutch-supported patients.

Background: A growing need in clinical practice of rehabilitation and orthopaedic medicine is for objective outcome tools to estimate physical activity. Current techniques show limited validity or are too demanding for routine clinical use. Accelerometer-based activity monitors (AMs) have shown promise for measuring physical activity in healthy people but lack validity in impaired patients.

Association of the different types of radiographic damage with physical function in patients with rheumatoid arthritis: analysis of the RAPID trials.

Objectives: To evaluate the separate effects of erosions (E) (bone damage), joint space narrowing (JSN) (cartilage loss) and (sub)luxation (SLUX) (soft tissue damage) in four different joint groups on physical disability in rheumatoid arthritis (RA).

Methods: 3-year follow-up data from the Rheumatoid Arthritis PreventIon of structural Damage (RAPID) 1 and 2 trials were used. These randomised controlled trials compared certolizumab plus methotrexate (MTX) versus MTX in patients with RA.

Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice.

Background: Seroma formation is a common complication following mastectomy for invasive breast cancer. Mastectomy flap fixation is achieved by reducing dead space volume using interrupted subcutaneous sutures.

Methods: All patients undergoing mastectomy due to invasive breast cancer or ductal carcinoma in situ (DCIS) were eligible for inclusion.

Assessment of physical function following total hip arthroplasty: Inertial sensor based gait analysis is supplementary to patient-reported outcome measures.

Background: Functional outcome assessment after total hip arthroplasty often involves subjective patient-reported outcome measures whereas analysis of gait is more objective. The study's aims were to compare subjective and objective functional outcomes after total hip arthroplasty between patients with low and high self-reported levels of pre-operative physical function.

Methods: Patients undergoing total hip arthroplasty (n=36; m/f=18/18; mean age=63.

Erosions in the foot at baseline are predictive of orthopaedic shoe use after 10 years of treat to target therapy in patients with recent onset rheumatoid arthritis.

The objective of this study is to investigate if foot joint damage due to rheumatoid arthritis (RA) can predict whether patients will start wearing orthopaedic shoes (OS) within 10 years after treatment start. Data from recent onset RA patients with 10 years follow-up from the BeSt (Dutch acronym for treatment strategies) study were used. Treatment was tightly controlled, targeted at disease activity score (DAS) ≤2.

Cardiovascular and selected comorbidities in early arthritis and early spondyloarthritis, a comparative study: results from the ESPOIR and DESIR cohorts.

Objectives: To investigate the prevalence of comorbidities in early rheumatoid arthritis (ERA) and early axial spondyloarthritis (ESpA) versus the general population.

Methods: Baseline data of 689 patients with ERA from the Etude et Suivi des Polyarthrites Indifférenciées Récentes (ESPOIR) cohort (age 48.2±12.

Sponyloarthritis features forecasting the presence of HLA-B27 or sacroiliitis on magnetic resonance imaging in patients with suspected axial spondyloarthritis: results from a cross-sectional study in the ESPeranza Cohort.

Introduction: Chronic back pain (CBP) is frequently the presenting symptom in patients with suspected axial spondyloarthritis (axSpA). Presence of sacroiliitis on magnetic-resonance-imaging (MRI) or HLA-B27 adds to diagnostic certainty. However, these costly tests cannot be applied in all patients with CBP.

Accelerometer-based Physical Activity Monitoring in Patients with Knee Osteoarthritis: Objective and Ambulatory Assessment of Actual Physical Activity During Daily Life Circumstances.

Background: It is important to assess physical activity objectively during daily life circumstances, to understand the association between physical activity and diseases and to determine the effectiveness of interventions. Accelerometer-based physical activity monitoring seems a promising method and could potentially capture all four FITT (i.e.

The Morphology of the Proximal Femoral Canal Continues to Change in the Very Elderly: Implications for Total Hip Arthroplasty.

A shape mismatch between cementless stems and the femoral canal of very elderly patients could partly explain the inferior performance of cementless compared to cemented stems in this age group. Influences of age and gender on canal morphology were investigated by measuring coronal/sagittal dimensions on CT-scans of subjects ≥80 years old (n = 117) and subjects < 80 years old (n = 51). Absolute canal dimensions like width were larger in octogenarians than in younger subjects.

Report from the OMERACT Hand Osteoarthritis Working Group: Set of Core Domains and Preliminary Set of Instruments for Use in Clinical Trials and Observational Studies.

Objective: During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary instruments for each core domain. Finally, an agenda for future research in hand osteoarthritis (OA) was to be proposed.

Patient-reported outcome measures versus inertial performance-based outcome measures: A prospective study in patients undergoing primary total knee arthroplasty.

Background: Outcome assessment of total knee arthroplasty (TKA) by subjective patient reported outcome measures (PROMs) may not fully capture the functional (dis-)abilities of relevance. Objective performance-based outcome measures could provide distinct information. An ambulant inertial measurement unit (IMU) allows kinematic assessment of physical performance and could potentially be used for routine follow-up.

Quality indicators in rheumatoid arthritis: results from the METEOR database.

Objective: To test the feasibility of collecting, storing, retrieving and analysing necessary information to fulfil a preliminary set of quality indicators (QIs) that have been proposed by an international task force in a large multinational clinical practice database of patients with RA.

Methods: Data from all 12 487 patients with 46 005 visits in the Measurement of Efficacy of Treatment in the Era of Outcome in Rheumatology database from January 2008 until January 2012 were analysed to test the feasibility of collecting information on 10 QIs: time to diagnosis; frequency of visits; assessment of autoantibodies and radiographs, disease activity and function; disease remission, low disease activity, normal function; time to first DMARD and type of first DMARD. For each QI, two aspects were assessed: information availability and target achievement.

Metachronous colorectal cancers result from missed lesions and non-compliance with surveillance.

Background: Several studies examined the rate of colorectal cancer (CRC) developed during colonoscopy surveillance after CRC resection (ie, metachronous CRC [mCRC]), yet the underlying etiology is unclear.

Objective: To examine the rate and likely etiology of mCRCs.

Design: Population-based, multicenter study.

Golimumab in patients with active rheumatoid arthritis after treatment with tumor necrosis factor α inhibitors: findings with up to five years of treatment in the multicenter, randomized, double-blind, placebo-controlled, phase 3 GO-AFTER study.

Introduction: The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor-α (TNF)-inhibitor(s).

Methods: Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively.

Optimisation of rheumatic disease assessments in clinical trials, clinical care, and long-term databases.

The assessment of disease in rheumatological diseases is rather complicated, because it may involve different contexts (clinical practice, clinical trials, observational studies, registries, etc.) as well as different domains (disease activity, physical function, radiographic damage, quality of life, etc.).

Can we improve the performance and reporting of investigator-initiated clinical trials? Rheumatoid arthritis as an example.

Investigator-initiated trials, some of which have been referred to as comparative effectiveness trials, pragmatic trials, or strategy trials, are sometimes considered to be of greater clinical importance than industry-driven trials, because they address important but unresolved clinical questions that differ from the questions asked in industry-driven trials. Regulatory authorities have provided methodological guidance for industry-driven trials for the approval of new treatments, but such guidance is less clear for investigator-initiated trials. The European League Against Rheumatism (EULAR) task force for the update of the recommendations for the management of rheumatoid arthritis has critically looked at the methodological quality and conduct of many investigator-initiated trials, and has identified a number of concerns.

Relationship between types of radiographic damage and disability in patients with rheumatoid arthritis in the EURIDISS cohort: a longitudinal study.

Objective: The aim of this study was to assess if any of the different types of radiographic damage [true joint space narrowing (JSN), (sub)luxation and erosions] are preferentially related to disability in patients with RA.

Methods: Longitudinal data from 167 RA patients from the European Research on Incapacitating Diseases and Social Support study over 10 years were analysed to investigate the relationship between the three types of radiographic damage and disability [grip strength, HAQ and the dexterity scale in the Arthritis Impact Measurement Scales (AIMS)]. A longitudinal analysis including separate models per type of damage and joint group and combined models including all information was conducted.

Bone marrow edema on magnetic resonance imaging (MRI) of the sacroiliac joints is associated with development of fatty lesions on MRI over a 1-year interval in patients with early inflammatory low back pain: a 2-year followup study.

Objective: To assess whether bone marrow edema (BME) detected on magnetic resonance imaging (MRI) of the sacroiliac joints (MRI-SIJ) is associated with development of structural changes on both MRI and pelvic radiographs in patients with early inflammatory back pain (IBP).

Methods: Patients with IBP ≤ 2 years were followed for 2 years with annual MRI-SIJ. MRI were scored for BME and structural changes (erosions and fatty lesions).

Updating the OMERACT filter: implications of filter 2.0 to select outcome instruments through assessment of "truth": content, face, and construct validity.

Objective: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets the criteria for content, face, and construct validity.

Methods: Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved.