Maarten Boers

VU University Medical Center, Amsterdamo, North Holland, Netherlands

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Publications (359)1937.45 Total impact

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    ABSTRACT: Treatment with initial high-dose prednisolone and a combination of methotrexate (MTX) and sulfasalazine (SSZ) according to the COBRA regimen (Dutch acronym for combinatietherapie bij reumatoide artritis, 'combination therapy for rheumatoid arthritis'), has repeatedly been demonstrated to be very effective in early rheumatoid arthritis (RA). COBRA combination therapy is superior to initial monotherapy of SSZ and MTX, is also associated with a good long-term outcome, is as safe as other treatment regimes, and performs as well as the combination of high-dose MTX and the tumor necrosis factor antagonist infliximab. A pilot study with an intensified version of the COBRA combination therapy showed that strict monitoring and aggressive treatment intensification based on the Disease Activity Score can result in a remission rate of 90% in patients with active early RA. Also, the first results indicate that an attenuated variation on COBRA combination therapy, called 'COBRA-light', is effective in decreasing disease activity and is generally well tolerated. Based on these results, we conclude that initial high-dose prednisolone in combination with MTX and SSZ could or should be the first choice in early active RA since it is effective and safe, and the cost price of the drugs is low. © 2014 S. Karger AG, Basel.
    NeuroImmunoModulation 09/2014; 22(1-2):51-56. · 1.84 Impact Factor
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    ABSTRACT: The Cohort Hip and Cohort Knee (CHECK) study included participants with early symptomatic osteoarthritis (OA) of the hip or knee and evaluated clinical, radiographic and biochemical variables in order to establish the course, prognosis and underlying mechanisms of early symptomatic osteoarthritis. A total of 1002 participants aged 45-65 years, with symptomatic OA characterized by pain of knee and/ or hip, entered the cohort in the period October 2002 to September 2005. They were included at or within 6 months of their first visit to the general practitioner for these symptoms. An overview of measures that are included in the study can be found on the website [www.check-research.com]. On the basis of their presenting symptoms, participants were divided into two groups. Participants with mild symptoms visited the research centre at years 0, 2, 5, 8 and 10 (variable visiting group) and participants with more serious symptoms visited the research centre each year (annual visiting group). After 7 years, only 105 participants (10%) had dropped out; their baseline characteristics did not differ significantly from those of other participants. CHECK is a valuable source of information on early symptomatic OA, that allows the examination of high-quality data on clinical, radiographic and biochemical variables. The CHECK steering group welcomes collaboration with national and international colleagues. Requests for collaboration or access to data can be sent to [checkreu@umcutrecht.nl].
    International journal of epidemiology. 08/2014;
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    ABSTRACT: Serum 14-3-3η is a novel joint-derived proinflammatory mediator implicated in the pathogenesis of rheumatoid arthritis (RA). In our study, we assessed the diagnostic utility of 14-3-3η and its association with standard clinical and serological measures.
    The Journal of rheumatology. 08/2014;
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    ABSTRACT: This study aims to investigate how well the Assessment of SpondyloArthritis international Society (ASAS)/Outcome Measures in Rheumatology Clinical Trials (OMERACT) core set and response criteria for ankylosing spondylitis (AS) have been implemented in randomized controlled trials (RCTs) testing pharmacological and non-pharmacological interventions. A systematic literature search was performed up to June 2013 looking for RCTs in patients with axial spondyloarthritis (SpA) (AS and non-radiographic axial SpA). The assessed domains and instruments belonging to the core sets for disease-controlling anti-rheumatic therapy (DC-ART) and symptom-modifying anti-rheumatic drugs (SMARDs) were extracted. Results were reported separately for those trials published until 2 years after the publication of the core set (1 April 2001; 'control trials') and those trials published at least 2 years after the publication date ('implementation trials'). One hundred twenty-three articles from 99 RCTs were included in the analysis, comparing 48 'control trials' and 51 'implementation trials'. Regarding DC-ART core set, the following domains were significantly more frequently assessed in the 'implementation group' in comparison to the 'control group': 'physical function' (100 vs 41.7 %; p ≤ 0.001), 'peripheral joints/entheses' (100 vs 33.3 %; p ≤ 0.001) and 'fatigue' (100 vs 0 %; p ≤ 0.001). Three instruments were significantly more used in the 'implementation group': Bath Ankylosing Spondylitis Functional Index (BASFI) (100 vs 8.3 %; p = ≤ 0.001), CRP (92.3 vs 58.3 %; p = 0.01) and Bath Ankylosing Spondylitis Metrology Index (BASMI) (53.8 vs 0 %; p = 0.001). Regarding SMARD core set domains, physical function (92 vs 23 %; p ≤ 0.001) and fatigue (84 vs 17 %; p ≤ 0.001), as well as the instruments BASFI (88 vs 14 %; p ≤ 0.001) and BASMI (52 vs 0 %; p ≤ 0.001), increased significantly in the 'implementation group'. Twenty per cent of trials from the 'implementation group' but none from the 'control group' included all domains of the core set. In conclusion, this study provides evidence for the implementation of the ASAS/OMERACT core set in RCTs of both DC-ART and SMARD. This applies to the use of the domains and, to a lesser extent, to the specific instruments.
    Clinical rheumatology. 06/2014;
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    ABSTRACT: General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in methodological approach.
    Seminars in arthritis and rheumatism. 06/2014;
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    ABSTRACT: Objective To develop an Animated Activity Questionnaire (AAQ), based on video animations, for assessing activity limitations in patients with hip/knee osteoarthritis (OA), which combines the advantages of self-reported questionnaires and performance-based tests, without many of their limitations, and to preliminary assess its reliability and validity. We hypothesize that the AAQ correlates highly with performance-based tests, and moderately with self-reports. Methods Item selection was based on 1) the pilot AAQ; 2) pre-specified conditions; 3) the International Classification of Functioning core set for OA, 4) existing measurement instruments, and 5) focus groups of patients. Test-retest reliability was assessed in 30/110 patients. In 110 patients correlations were calculated between AAQ and self-reported Hip disability and Knee injury Osteoarthritis Outcome ADL subscale (H/KOOS). In 45/110 patients correlations with performance-based tests (Stair Climbing Test , Timed Up and Go test, 30 second Chair Stand Test ) were calculated. Results 17 basic daily activities were chosen for the AAQ. Video animations were made showing a person performing each activity with 3 to 5 different levels of difficulty. Patients were asked to select the level that best matched their own performance. Reliability was high (Intraclass Correlation Coefficient 0.97 (CI 0.93-0.98)). The AAQ correlated highly with performance-based tests (0.62), but higher with H/KOOS ADL (0.76) than expected. Conclusions A computerized AAQ for assessing activity limitations was developed. Content validity was considered good. Preliminary validation results showed high reliability, but construct validity needs further study with larger sample size. Continuing research will focus on construct validity and cross-cultural validity. © 2014 American College of Rheumatology.
    Arthritis care & research. 06/2014;
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    ABSTRACT: Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.
    Annals of the rheumatic diseases 05/2014; · 8.11 Impact Factor
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    ABSTRACT: Recently, we documented the likely non-inferiority of Combinatietherapie Bij Reumatoïde Artritis (COBRA)-light therapy (methotrexate increased to 25 mg/week with initial prednisolone 30 mg/day) compared with the original COBRA therapy (methotrexate 7.5 mg/week, sulfasalazine 2 g/day, with initial prednisolone 60 mg/day) after 26 weeks in patients with early active rheumatoid arthritis (RA). To assess the non-inferiority of COBRA-light versus COBRA after 1 year in terms of disease activity (DAS44), functional outcome (Health Assessment Questionnaire (HAQ)) and radiographic progression (Sharp/van der Heijde score (SHS)), and to assess the effect of adding etanercept. An open-label, randomised controlled, non-inferiority trial of 162 patients with active early RA, following a treat-to-target protocol incorporating the addition of etanercept if DAS44 ≥1.6 at weeks 26 or 39. Both groups showed major improvements in DAS44 after 52 weeks: mean (SD) -2.41 (1.2) in the COBRA and -2.02 (1.0) in the COBRA-light group (p=ns). In both groups, functional ability improved and radiological progression of joints was minimal. At least one adverse event was reported in 96% of the patients in both groups. In total, 25 serious adverse events occurred: 9 vs 16 in COBRA and COBRA-light, respectively. Treatment actually instituted was often less intensive than required by the protocol: of the total population, 108 patients (67%) required etanercept (more in the COBRA-light group), but only 67 of these (62%) actually received it. Intensive COBRA or COBRA-light therapy has major, comparably favourable effects on disease activity, functional ability and radiological outcome after 1 year in patients with early RA. Protocolised addition of etanercept was often not implemented by treating rheumatologists, and patients receiving it appeared to have limited added benefit, probably because of low disease activity levels at its initiation. ISRCTN55552928.
    Annals of the rheumatic diseases 05/2014; · 8.11 Impact Factor
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    John R Kirwan, Maarten Boers, Peter Tugwell
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) community strives to develop core outcome sets for rheumatologic conditions to specify, for each condition, the minimum set of outcomes necessary to provide consistent estimates of the benefits of an intervention. The original and successful OMERACT filter of "truth, discrimination, and feasibility" requires development and updating because of application to a widening range of conditions by an expanding group, particularly patients. It should more explicitly identify the relevant core outcomes that might be universal to all randomized controlled trials within rheumatology. Working from first principles, comparing proposals against actual procedures adopted by OMERACT working groups, and seeking a broad consensus over several major sessions at the OMERACT 11 meeting, a new version has emerged, OMERACT Filter 2.0, which will form the central theme of the intended OMERACT handbook and offers an approach to core outcome set development in many areas of healthcare.
    The Journal of Rheumatology 05/2014; 41(5):975-977. · 3.26 Impact Factor
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    ABSTRACT: Objectives: An estimated 55-90% of patients with rheumatoid arthritis have foot problems. Therapeutic footwear is frequently prescribed as part of usual care, but data on its use and effect is incomplete. This study aimed to investigate the use and effects of therapeutic footwear. Methods: Patients with rheumatoid arthritis receiving custom-made therapeutic footwear for the first time formed an inception cohort. Patients reported their therapeutic footwear use on 3 consecutive days in activity diaries 14 and 20 weeks after delivery of the footwear. The Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) was used as the primary outcome of lower-extremity-related pain and activity limitations, and the Health Assessment Questionnaire (HAQ) as a secondary outcome measure of activity limitations, both at baseline and 26 weeks after therapeutic footwear delivery. Results: The cohort comprised 114 rheumatoid arthritis patients (median disease duration 10 years). Mean (standard deviation) therapeutic footwear use was 54 (25)% of the time patients were out of bed. The median (interquartile range) WOMAC score improved from 41 (27-59) to 31 (16-45) (p < 0.001). Secondary outcome measures improved significantly. Conclusion: Therapeutic footwear was used with moderate intensity by most rheumatoid arthritis patients and was associated with a substantial decrease in pain and activity limitations. Therapeutic footwear is a relevant treatment option for patients with rheumatoid arthritis and foot problems.
    Journal of rehabilitation medicine: official journal of the UEMS European Board of Physical and Rehabilitation Medicine 04/2014; · 1.88 Impact Factor
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    ABSTRACT: 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. 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. The case studies showed that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. These issues will require resolution to reach consensus on how Truth will be assessed for the proposed Filter 2.0 framework, for instruments to be endorsed by OMERACT.
    The Journal of Rheumatology 04/2014; · 3.26 Impact Factor
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    ABSTRACT: The "Discrimination" part of the OMERACT Filter asks whether a measure discriminates between situations that are of interest. "Feasibility" in the OMERACT Filter encompasses the practical considerations of using an instrument, including its ease of use, time to complete, monetary costs, and interpretability of the question(s) included in the instrument. Both the Discrimination and Reliability parts of the filter have been helpful but were agreed on primarily by consensus of OMERACT participants rather than through explicit evidence-based guidelines. In Filter 2.0 we wanted to improve this definition and provide specific guidance and advice to participants.
    The Journal of Rheumatology 04/2014; · 3.26 Impact Factor
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    ABSTRACT: 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 presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed "OMERACT Filter 2.0." Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework. After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas ("core domain set"). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final "core outcome measurement set." At final vote, 96% of participants agreed "The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook." Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: At a previous Outcome Measures in Rheumatology (OMERACT) meeting, participants reflected on the underlying methods of patient-reported outcome (PRO) instrument development. The participants requested proposals for more explicit instrument development protocols that would contribute to an enhanced version of the "Truth" statement in the OMERACT Filter, a widely used guide for outcome validation. In the present OMERACT session, we explored to what extent these new Filter 2.0 proposals were practicable, feasible, and already being applied. Following overview presentations, discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed PRO development framework, whether these observations had a more general application, and what issues remained to be resolved. Several aspects of PRO development were recognized as particularly important, and the need to directly involve patients at every stage of an iterative PRO development program was endorsed. This included recognition that patients contribute as partners in the research and not merely as subjects. Correct communication of concepts with the words used in questionnaires was central to their performance as measuring instruments, and ensuring this understanding crossed cultural and linguistic boundaries was important in international studies or comparisons. Participants recognized, endorsed, and were generally already putting into practice the principles of PRO development presented in the plenary session. Further work is needed on some existing instruments and on establishing widespread good practice for working in close collaboration with patients.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference. We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology. The draft framework comprises 4 core "areas": death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed. In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product. This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.
    The Journal of Rheumatology 03/2014; · 3.26 Impact Factor
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    ABSTRACT: The aim of rheumatoid arthritis (RA) treatment is remission. As treatment should be targeted at outcomes relevant to patients, it is important to understand how patients perceive remission, and to assess whether the current definition of remission adequately reflects these perceptions. The objective of this study is to explore the patient perspective on remission in RA. Nine focus-group discussions in Austria, The Netherlands and UK were conducted, including patients in American College of Rheumatology (ACR)/ European League of Rheumatology (EULAR) remission, self-declared remission and in moderate/high disease activity. Moderators employed a prespecified interview guide helped to engage patients in a discussion on their experience with remission. Inductive thematic analysis was performed within each country, and identified themes were discussed across countries. 47 RA patients (66% women, disease duration 9 years) participated. Three major themes of patient-perceived remission emerged: (1) symptoms would either be absent or strongly reduced, (2) impact of the disease on daily life would diminish by increased independence, ability to do valued activities, improved mood and ability to cope; (3) leading to a return to normality, including work, family role and perception of others. Patients felt the concept of remission was influenced by ageing, side effects of medication, comorbidities, accrued damage to joints and disease duration. Opinions on duration of state, the role of medication and measurement instruments varied widely. Patients characterise remission by the absence or reduction of symptoms, but more directly by decreased daily impact of their condition and the feeling of a return to normality. The next step is to study whether an additional patient-perceived measure of remission may add value to the ACR/EULAR definition of remission.
    Annals of the rheumatic diseases 02/2014; · 8.11 Impact Factor
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    ABSTRACT: Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology.
    The Journal of Rheumatology 02/2014; · 3.26 Impact Factor

Publication Stats

12k Citations
1,937.45 Total Impact Points

Institutions

  • 2001–2014
    • VU University Medical Center
      • • Department of Epidemiology and Biostatistics
      • • Department of Rheumatology
      • • Department of Medical Psychology
      Amsterdamo, North Holland, Netherlands
    • Stanford University
      • Division of Immunology
      Stanford, CA, United States
  • 2013
    • University of Liège
      • Department of Public Health, Epidemiology and Health Economics
      Luik, Walloon Region, Belgium
    • University of Bristol
      Bristol, England, United Kingdom
  • 2008–2013
    • University Medical Center Utrecht
      Utrecht, Utrecht, Netherlands
  • 1994–2011
    • University of Massachusetts Boston
      Boston, Massachusetts, United States
  • 2001–2010
    • University of Amsterdam
      • Department of Clinical Epidemiology and Biostatistics
      Amsterdamo, North Holland, Netherlands
  • 2009
    • Harvard Medical School
      Boston, Massachusetts, United States
  • 2006–2009
    • CIET
      New York City, New York, United States
    • Hospitais da Universidade de Coimbra
      Coímbra, Coimbra, Portugal
  • 1993–2009
    • University of Ottawa
      • • Department of Epidemiology and Community Medicine
      • • Department of Medicine
      Ottawa, Ontario, Canada
    • McMaster University
      • Department of Clinical Epidemiology and Biostatistics
      Hamilton, Ontario, Canada
  • 1992–2009
    • Maastricht University
      • Interne Geneeskunde
      Maastricht, Provincie Limburg, Netherlands
  • 2007
    • University of Queensland 
      • Faculty of Health Sciences
      Brisbane, Queensland, Australia
    • University of Washington Seattle
      Seattle, Washington, United States
    • Ludwig-Maximilian-University of Munich
      • Department of Physical Medicine and Rehabilitation
      München, Bavaria, Germany
  • 1999–2006
    • Maastricht Universitair Medisch Centrum
      Maestricht, Limburg, Netherlands
    • Children's Hospital of Eastern Ontario
      Ottawa, Ontario, Canada
  • 1998–2006
    • VU University Amsterdam
      • Department of Epidemiology and Biostatistics
      Amsterdamo, North Holland, Netherlands
  • 2005
    • University of Toronto
      • Department of Surgery
      Toronto, Ontario, Canada
  • 2001–2004
    • Academisch Medisch Centrum Universiteit van Amsterdam
      • Department of Clinical Epidemiology and Biostatistics
      Amsterdamo, North Holland, Netherlands
  • 1999–2003
    • Mayo Clinic - Rochester
      • Department of Health Science Research
      Rochester, MN, United States
  • 2002
    • Humboldt-Universität zu Berlin
      Berlín, Berlin, Germany
  • 2001–2002
    • Claude Bernard University Lyon 1
      Villeurbanne, Rhône-Alpes, France
  • 1995
    • The University of Western Ontario
      • Department of Medicine
      London, Ontario, Canada