234 results on '"van de Laar MA"'
Search Results
2. A Delphi Exercise to Identify Characteristic Features of Gout - Opinions from Patients and Physicians, the First Stage in Developing New Classification Criteria (vol 40, pg 498, 2013)
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Prowse, RL, Dalbeth, N, Kavanaugh, A, Adebajo, AO, Gaffo, AL, Terkeltaub, R, Mandell, BF, Suryana, BP, Goldenstein-Schainberg, C, Diaz-Torne, C, Khanna, D, Liote, F, McCarthy, G, Kerr, GS, Yamanaka, H, Janssens, H, Baraf, HF, Chen, JH, Vazquez-Mellado, J, Harrold, LR, Stamp, LK, Van De Laar, MA, Janssen, M, Doherty, M, Boers, M, Edwards, NL, Gow, P, Chapman, P, Khanna, P, Helliwell, PS, Grainger, R, Schumacher, HR, Neogi, T, Jansen, TL, Louthrenoo, W, Sivera, F, Taylor, WJ, and Alten, R
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- 2013
3. Cost-Effectiveness of a JAK1/JAK2 Inhibitor vs a Biologic Disease-Modifying Antirheumatic Drug (bDMARD) in a Treat-to-Target Strategy for Rheumatoid Arthritis
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Van De Laar CJ, Oude Voshaar MAH, Fakhouri WKH, Zaremba-Pechmann L, De Leonardis F, De La Torre I, and Van De Laar MAFJ
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markov model ,rheumatoid arthritis ,baricitinib ,cost-effectiveness ,health economic model ,treat-to-target ,Medicine (General) ,R5-920 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Celine J Van De Laar,1 Martijn AH Oude Voshaar,1,2 Walid KH Fakhouri,3 Liliana Zaremba-Pechmann,3 Francesco De Leonardis,3 Inmaculada De La Torre,3 Mart AFJ Van De Laar1,2 1Transparency in Healthcare BV, Hengelo, the Netherlands; 2Department of Psychology and Communication of Health and Risk, Institute for Behavioural Research, University of Twente, Enschede, the Netherlands; 3Eli Lilly & Company, Indianapolis, IN, USACorrespondence: Celine J Van De Laar Tel +31 74-43032645Email c.vandelaar@tihealthcare.nlBackground: Baricitinib is a janus kinase (JAK1/JAK2) inhibitor developed for the treatment of patients suffering from rheumatoid arthritis (RA). Treating RA to the target of remission is current common practice. Cost-effectiveness of different treat-to-target (T2T) strategies, especially ones including new treatments is important for development and preference policy for treatment centers. European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) guidelines are currently unclear about preference between a JAK1/JAK2 versus a biological disease-modifying antirheumatic drug (bDMARD).Objective: The main goal of this paper was to evaluate the cost-effectiveness of baricitinib versus first biological for methotrexate inadequate responders in a T2T strategy using a Markov model that incorporates hospital costs as well as societal costs. Costs and utilities over five years were compared between the two strategies.Methods: A Monte Carlo simulation model was developed to conduct cost–utility analysis from the societal perspective over 5 years. Health states were based on the DAS28-erythrocyte sedimentation rate (ESR) categories. Effectiveness of baricitinib was retrieved from randomized controlled trials. Effectiveness of all other treatments, health state utilities, medical costs, and productivity loss were retrieved from the Dutch RhEumatoid Arthritis Monitoring (DREAM) cohorts. Annual discount rates of 1.5% for utility and 4% for costs were used. Probabilistic sensitivity analysis was employed to incorporate uncertainty and assess robustness of the results.Results: Probabilistic sensitivity analysis results showed the baricitinib strategy yielded lower costs and higher utility over a 5-year period. Scenario analyses showed the baricitinib strategy to be cost-effective in both the moderate and severe RA populations.Conclusion: Results suggest that the use of a JAK1/JAK2 inhibitor instead of a bDMARD in a T2T approach is cost-effective in csDMARD refractory RA patients.Keywords: Markov model, rheumatoid arthritis, baricitinib, cost-effectiveness, health economic model, treat-to-target
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- 2020
4. Development and preliminary evaluation of a short self-report measure of generalized pain hypersensitivity
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van Bemmel PF, Oude Voshaar MAH, ten Klooster PM, Vonkeman HE, and van de Laar MAFJ
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Central sensitization ,Chronic pain ,Nociceptive pain ,Questionnaires ,Medicine (General) ,R5-920 - Abstract
Peter F van Bemmel,1 Martijn AH Oude Voshaar,2 Peter M ten Klooster,2 Harald E Vonkeman,1,2 Mart AFJ van de Laar1,2 1Department of Rheumatology, Medisch Spectrum Twente, Enschede, Netherlands; 2Department of Psychology, Health, and Technology, University of Twente, Enschede, Netherlands Purpose: Generalized pain hypersensitivity is frequently observed in chronic pain conditions. Currently, identification is based on expert clinical opinion, and in very few cases combined with quantitative sensory testing. The objectives of this study were to develop and evaluate a short self-report measure of generalized pain hypersensitivity: a generalized pain questionnaire (GPQ). Methods: Items for the GPQ were developed based on a literature review, followed by an interview study with ten rheumatic patients with suspected pain hypersensitivity. We examined the psychometric properties of the preliminary items in a sample of 212 outpatients suffering from either fibromyalgia (FM; n=98) or rheumatoid arthritis (n=114). Additionally, self-reported data were gathered on sociodemographics, fibromyalgia-survey criteria, health status, and neuropathic-like pain features. Results: Mokken-scale analyses demonstrated a unidimensional seven-item scale with strong homogeneity (H=0.65) and high reliability (ρ=0.90). Correlations between total GPQ scores and relevant external measures, such as the FM-survey criteria and neuropathic-like pain features, were consistent with a priori expectations, supporting its external construct validity. Furthermore, the GPQ had good accuracy in distinguishing between patients with FM (generally assumed to be the result of central nervous system hypersensitization) and patients with RA (assumed to result mostly in local nociceptive or inflammatory pain), with an area under the receiver-operating characteristic curve of 0.89. A cutoff value >10 had the highest combination of sensitivity (82.7%) and specificity (77.2%). Conclusion: The GPQ is psychometrically sound and appears promising for measuring the presence and severity of generalized pain hypersensitivity in chronic pain patients. Keywords: central sensitization, chronic pain, nociceptive pain, questionnaires
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- 2019
5. AR1 PRODUCTIVITY LOSS AT WORK IN PATIENTS WITH EARLY RHEUMATOID ARTHRITIS
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Braakman-Jansen, LM, primary, Taal, E, additional, Kuper, I, additional, and van de Laar, MA, additional
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- 2008
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6. PAR7 PHARMACOECONOMICS OF COX-2-SELECTIVE INHIBITORS VERSUS NON-SELECTIVE NSAIDS AND CONCOMITANT COUMARIN USE: ECONOMIC EVALUATION LINKED TO A CASECONTROL STUDY
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Postma, MJ, primary, Knijff-Dutmer, EA, additional, van der Palen, J, additional, van de Laar, MA, additional, and Brouwers, JR, additional
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- 2003
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7. AB0035 Platelet microparticles in patients with rheumatoid arthritis
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Knijff-Dutmer, EA, primary, Koerts, J, additional, Kalsbeek-Batenburg, EM, additional, and Van de Laar, MA, additional
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- 2001
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8. A randomised controlled trial on the efficacy and tolerability with dose escalation of allopurinol 300-600 mg/day versus benzbromarone 100-200 mg/day in patients with gout.
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Reinders MK, Haagsma C, Jansen TL, van Roon EN, Delsing J, van de Laar MA, and Brouwers JR
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- 2009
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9. Helicobacter pylori eradication in patients on long-term treatment with NSAIDs reduces the severity of gastritis: a randomized controlled trial.
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De Leest HT, Steen KS, Bloemena E, Lems WF, Kuipers EJ, Van de Laar MA, Bijlsma JW, Janssen M, Houben HH, Kostense PJ, Boers M, and Dijkmans BA
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- 2009
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10. Efficacy and tolerability of urate-lowering drugs in gout: a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol.
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Reinders MK, van Roon EN, Jansen TL, Delsing J, Griep EN, Hoekstra M, van de Laar MA, and Brouwers JR
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- 2009
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11. Efficacy of wrist working splints in patients with rheumatoid arthritis: A randomized controlled study.
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Veehof MM, Taal E, Heijnsdijk-Rouwenhorst LM, and van de Laar MA
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- 2008
12. Rasch analysis of the Dutch health assessment questionnaire disability index and the health assessment questionnaire II in patients with rheumatoid arthritis.
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Ten Klooster PM, Taal E, and van de Laar MA
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- 2008
13. Cost-effectiveness of intensive exercise therapy directly following hospital discharge in patients with arthritis: results of a randomized controlled clinical trial.
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Bulthuis Y, Mohammad S, Braakman-Jansen LM, Drossaers-Bakker KW, and van de Laar MA
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- 2008
14. Modern psychometrics applied in rheumatology–A systematic review
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Siemons Liseth, ten Klooster Peter M, Taal Erik, Glas Cees AW, and Van de Laar Mart AFJ
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Clinical measures ,Item response theory ,Modern psychometrics ,Patient-reported outcomes ,Rheumatology ,Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. Methods Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. Results Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. Conclusion IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.
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- 2012
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15. Construct validity of the interview Time Trade-Off and computer Time Trade-Off in patients with rheumatoid arthritis: A cross-sectional observational pilot study
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Buitinga Laurien, Braakman-Jansen Louise MA, Taal Erik, and van de Laar Mart AFJ
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background The Time Trade-Off (TTO) is a widely used instrument for valuing preference-based health-related quality of life (HRQoL). The TTO reveals preferences for own current health (‘utilities’) on a scale anchored between death (0) and perfect health (1). Limited information on the external validity of the TTO is available. Aim of this pilot study was to examine the construct validity of both an interview TTO and a computer-based TTO in patients with rheumatoid arthritis (RA). Methods Thirty patients visiting the outpatient rheumatology clinic participated. Construct validity was assessed by measuring convergent and discriminative validity. Convergent validity was assessed by calculating Spearman’s correlations between the utilities obtained from the TTOs and pain, general health (rating scales), health-related quality of life (SF-36 and SF-6D) and functional status (HAQ-DI). Discriminative power of both TTO measures was determined by comparing median utilities between worse and better health outcomes. Results Correlations of both TTO measures with HRQoL, general health, pain and functional status were poor (absolute values ranging from .05 to .26). Both TTOs appeared to have no discriminative value among groups of RA patients who had a worse or better health status defined by six health outcome measures. About one-third of respondents were zero-traders on each of the TTO measures. After excluding zero-traders from analysis, the correlations improved considerably. Conclusions Both the interview TTO and computer TTO showed poor construct validity in RA patients when using measures of HRQol, general health, pain and functional status as reference measures. Possibly, the validity of the TTO improves when using an anchor that is more realistic to RA patients than the anchor ‘death’.
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- 2012
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16. Measurement properties of physical function scales validated for use in patients with rheumatoid arthritis: A systematic review of the literature
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Oude Voshaar Martijn AH, ten Klooster Peter M, Taal Erik, and van de Laar Mart AFJ
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Physical function ,disability ,rheumatoid arthritis ,psychometric ,validity ,reliability ,responsiveness ,measurement properties ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Abstract Background The aim of this study was to systematically review the content validity and measurement properties of all physical function (PF) scales which are currently validated for use with patients with rheumatoid arthritis (RA). Methods Systematic literature searches were performed in the Scopus and PubMed databases to identify articles on the development or psychometric evaluation of PF scales for patients with RA. The content validity of included scales was evaluated by linking their items to the International Classification of Functioning Disability and Health (ICF). Furthermore, available evidence of the reliability, validity, responsiveness, and interpretability of the included scales was rated according to published quality criteria. Results The search identified 26 questionnaires with PF scales. Ten questionnaires were rated to have adequate content validity. Construct validity, internal consistency, test-retest reliability and responsiveness was rated favourably for respectively 15, 11, 5, and 6 of the investigated scales. Information about the absolute measurement error and minimal important change scores were rarely reported. Conclusion Based on this literature review, the disease-specificHAQ and the generic SF-36 can currently be most confidently recommended to measure PF in RA for most research purposes. The HAQ, however, was frequently associated with considerable ceiling effects while the SF-36 has limited content coverage. Alternative scales that might be better suited for specific research purposes are identified along with future directions for research.
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- 2011
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17. Mapping HIV/STI behavioural surveillance in Europe
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Lert France, Hope Vivian, Elford Jonathan, Graz Bertrand, Gervasoni Jean-Pierre, Spencer Brenda, Jeannin André, Dubois-Arber Françoise, Ward Helen, Haour-Knipe Mary, Low Nicola, and van de Laar Marita
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Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Background Used in conjunction with biological surveillance, behavioural surveillance provides data allowing for a more precise definition of HIV/STI prevention strategies. In 2008, mapping of behavioural surveillance in EU/EFTA countries was performed on behalf of the European Centre for Disease prevention and Control. Method Nine questionnaires were sent to all 31 member States and EEE/EFTA countries requesting data on the overall behavioural and second generation surveillance system and on surveillance in the general population, youth, men having sex with men (MSM), injecting drug users (IDU), sex workers (SW), migrants, people living with HIV/AIDS (PLWHA), and sexually transmitted infection (STI) clinics patients. Requested data included information on system organisation (e.g. sustainability, funding, institutionalisation), topics covered in surveys and main indicators. Results Twenty-eight of the 31 countries contacted supplied data. Sixteen countries reported an established behavioural surveillance system, and 13 a second generation surveillance system (combination of biological surveillance of HIV/AIDS and STI with behavioural surveillance). There were wide differences as regards the year of survey initiation, number of populations surveyed, data collection methods used, organisation of surveillance and coordination with biological surveillance. The populations most regularly surveyed are the general population, youth, MSM and IDU. SW, patients of STI clinics and PLWHA are surveyed less regularly and in only a small number of countries, and few countries have undertaken behavioural surveys among migrant or ethnic minorities populations. In many cases, the identification of populations with risk behaviour and the selection of populations to be included in a BS system have not been formally conducted, or are incomplete. Topics most frequently covered are similar across countries, although many different indicators are used. In most countries, sustainability of surveillance systems is not assured. Conclusion Although many European countries have established behavioural surveillance systems, there is little harmonisation as regards the methods and indicators adopted. The main challenge now faced is to build and maintain organised and functional behavioural and second generation surveillance systems across Europe, to increase collaboration, to promote robust, sustainable and cost-effective data collection methods, and to harmonise indicators.
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- 2010
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18. Flexor Hallucis Longus tendon rupture in RA-patients is associated with MTP 1 damage and pes planus
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Buurke Jaap J, Dubbeldam Rosemary, Drossaers-Bakkers Wiepke K, Baan Henriette, Nene Anand, and van de Laar Martin AFJ
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Abstract Background To assess the prevalence of and relation between rupture or tenosynovitis of the Flexor Hallucis Longus (FHL) tendon and range of motion, deformities and joint damage of the forefoot in RA patients with foot complaints. Methods Thirty RA patients with painful feet were analysed, their feet were examined clinically for the presence of pes planus and range of motion (ROM), radiographs were scored looking for the presence of forefoot damage, and ultrasound examination was performed, examining the presence of tenosyovitis or rupture of the FHL at the level of the medial malleolus. The correlation between the presence or absence of the FHL and ROM, forefoot damage and pes planus was calculated. Results In 11/60(18%) of the feet, a rupture of the FHL was found. This was associated with a limited motion of the MTP1-joint, measured on the JAM (χ2 = 10.4, p = 0.034), a higher prevalence of pes planus (χ2 = 5.77, p = 0.016) and a higher prevalence of erosions proximal at the MTP-1 joint (χ2 = 12.3, p = 0.016), and joint space narrowing of the MTP1 joint (χ2 = 12.7, p = 0.013). Conclusion Rupture of the flexor hallucis longus tendon in RA-patients is associated with limited range of hallux motion, more erosions and joint space narrowing of the MTP-1-joint, as well as with pes planus.
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- 2007
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19. Self-reported differences in empowerment between lurkers and posters in online patient support groups.
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van Uden-Kraan CF, Drossaert CH, Taal E, Seydel ER, van de Laar MA, van Uden-Kraan, Cornelia F, Drossaert, Constance H C, Taal, Erik, Seydel, Erwin R, and van de Laar, Mart A F J
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Background: Patients who visit online support groups benefit in various ways. Results of our earlier study indicated that participation in online support groups had a profound effect on the participants' feelings of "being empowered." However, most studies of online patient support groups have focused on the members of these groups who actively contribute by sending postings (posters). Thus far, little is known about the impact for "lurkers" (ie, those who do not actively participate by sending postings).Objective: In the present study, we explored if lurkers in online patient support groups profit to the same extent as posters do.Methods: We searched the Internet with the search engine Google to identify all Dutch online support groups for patients with breast cancer, fibromyalgia, and arthritis. Invitations to complete an online survey were sent out by the owners of 19 groups. In the online questionnaire, we asked questions about demographic and health characteristics, use of and satisfaction with the online support group, empowering processes, and empowering outcomes. The online questionnaire was completed by 528 individuals, of which 109 (21%) identified themselves as lurkers.Results: Lurkers (mean age 47 years) were slightly older than active participants (mean age 43 years, P = .002), had a shorter disease history (time since diagnosis 3.7 years vs 5.4 years, P = .001), and reported lower mental well-being (SF 12 subscore 37.7 vs 40.5, P = .004). No significant differences were found in other demographic variables. Posters indicated visiting the online support groups significantly more often for social reasons, such as curiosity about how other members were doing, to enjoy themselves, as a part of their daily routine (all P < .001), and because other members expected them to be there (P = .003). Lurkers and posters did not differ in their information-related reasons for visiting the online support group. Lurkers were significantly less satisfied with the online support group compared to posters (P < .001). With regard to empowering processes such as "exchanging information" and "finding recognition," lurkers scored significantly lower than posters. However, lurkers did not differ significantly from posters with regard to most empowering outcomes, such as "being better informed," "feeling more confident in the relationship with their physician," "improved acceptance of the disease," "feeling more confident about the treatment," "enhanced self-esteem," and "increased optimism and control." The exception was "enhanced social well-being," which scored significantly lower for lurkers compared to posters (P < .001).Conclusion: Our study revealed that participation in an online support group had the same profound effect on lurkers' self-reported feelings of being empowered in several areas as it had on posters. Apparently, reading in itself is sufficient to profit from participation in an online patient support group. [ABSTRACT FROM AUTHOR]- Published
- 2008
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20. Further validation of the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale in patients with osteoarthritis.
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Ten Klooster PM, Oostveen JC, Zandbelt LC, Taal E, Drossaert CH, Harmsen EJ, and van de Laar MA
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OBJECTIVE: To examine the structural validity, internal consistency, test-retest reliability, and construct validity of the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale in patients with osteoarthritis (OA). METHODS: A cross-sectional sample of 224 outpatients with OA completed a survey containing the Dutch PEPPI-5 and other standardized measures assessing perceived health-management skills, general self-efficacy, social support, and health-related quality of life. A subsample of 100 patients completed the PEPPI-5 again approximately 3 weeks later. RESULTS: Confirmatory factor analysis demonstrated good fit for a unidimensional model of the PEPPI-5. Additionally, the scale showed high internal consistency ([alpha]=0.92) and fair test-retest reliability (ICC=0.68). As hypothesized, the PEPPI-5 was strongly correlated with perceived health-management skills, moderately with social support and psychosocial aspects of health, and not with physical aspects of health. Contrary to expectations, however, it was not correlated with general self-efficacy. CONCLUSION: The Dutch PEPPI-5 demonstrated adequate validity and reliability in patients with OA. PRACTICE IMPLICATIONS: The PEPPI-5 is a brief and appropriate tool for measuring self-efficacy of patients with OA to interact with their physicians. Additional research into its sensitivity to change is needed before it can be confidently recommended as an outcome measure in intervention studies. [ABSTRACT FROM AUTHOR]
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- 2012
21. Patient involvement in rheumatoid arthritis care to improve disease activity-based management in daily practice: A randomized controlled trial.
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Spijk-de Jonge MJ, Weijers JM, Teerenstra S, Elwyn G, van de Laar MA, van Riel PL, Huis AM, and Hulscher ME
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- Humans, Patient Participation, Severity of Illness Index, Treatment Outcome, Arthritis, Rheumatoid drug therapy, Rheumatology
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Objective: To evaluate the effect of an intervention to improve disease activity-based management of RA in daily clinical practice by addressing patient level barriers., Methods: The DAS-pass strategy aims to increase patients' knowledge about DAS28 and to empower patients to be involved in treatment (decisions). It consists of an informational leaflet, a patient held record and guidance by a specialized rheumatology nurse. In a Randomized Controlled Trial, 199 RA patients were randomized 1:1 to intervention or control group. Outcome measures were patient empowerment (EC-17; primary outcome), attitudes towards medication (BMQ), disease activity (DAS28) and knowledge about DAS28., Results: Our strategy did not affect EC-17, BMQ, or DAS28 use. However it demonstrated a significant improvement of knowledge about DAS28 in the intervention group, compared to the control group. The intervention had an additional effect on patients with low baseline knowledge compared to patients with high baseline knowledge., Conclusion: The DAS-pass strategy educates patients about (the importance of) disease activity-based management, especially patients with low baseline knowledge., Practice Implications: The strategy supports patient involvement in disease activity-based management of RA and can be helpful to reduce inequalities between patients in the ability to be involved in shared decision making., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)
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- 2022
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22. The added value of synovial fluid centrifugation for monosodium urate and calcium pyrophosphate crystal detection.
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Boumans D, Hettema ME, Vonkeman HE, Maatman RG, and van de Laar MA
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- Adult, Aged, Aged, 80 and over, Centrifugation, Female, Humans, Male, Microscopy, Polarization, Middle Aged, Prospective Studies, Young Adult, Calcium Pyrophosphate analysis, Chondrocalcinosis diagnosis, Gout diagnosis, Synovial Fluid chemistry, Uric Acid analysis
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The aim of the study was to assess the added value of synovial fluid (SF) centrifugation for microscopic monosodium urate (MSU) and calcium pyrophosphate (CPP) crystal detection in patients with arthritis. This is a prospective observational study using SF samples from joints of patients undergoing joint arthrocentesis. Two blinded observers assessed the SF smears by polarized light microscopy for the presence of crystals before as well as after centrifugation. SF samples were collected from 98 patients with arthritis. After exclusion, 87 samples were eligible for inclusion. Of each sample, 2 smears before and after centrifugation were prepared and microscopically examined, resulting in 348 smears per observer. Observer 1 identified MSU crystals in 18.4% and CPP in 9.2% of the smears before as well as after centrifugation. No extra MSU crystal-positive smears were identified after centrifugation. However, centrifugation yielded 4 additional CPP crystal-positive smears. Observer 2 identified MSU crystals in 15.5% and CPP crystals in 6.3% of the smears before as well as after centrifugation. Centrifugation yielded 2 additional MSU crystal-positive smears and 4 CPP crystal-positive smears. Monosodium urate crystals were well recognized without centrifugation. Centrifugation of SF had limited additional value for increasing the amount of MSU-positive smears. However, CPP crystals were identified in a higher number of smears after centrifugation than before. Therefore, centrifugation may be of additional value in selected patients with suspected calcium pyrophosphate deposition disease and to a lesser extent for gout.
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- 2017
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23. A mixed-methods process evaluation of a goal management intervention for patients with polyarthritis.
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Arends RY, Bode C, Taal E, and Van de Laar MA
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- Adaptation, Psychological, Adult, Aged, Evaluation Studies as Topic, Female, Group Processes, Humans, Male, Middle Aged, Program Evaluation, Treatment Outcome, Videotape Recording, Young Adult, Arthritis psychology, Arthritis therapy, Goals, Patient Education as Topic methods, Self Care psychology
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Process evaluations of newly developed interventions are necessary to identify effective and less effective intervention components. First aim of this study was to identify key components of a psychosocial goal management intervention from the perspective of participants, and second aim was to evaluate the intervention's fidelity. A mixed-methods approach was applied to 24 interviews with participants post-intervention and 16 audio recordings of random training sessions. Participants experienced three key components: (1) the content, in which specific exercises helped to raise awareness and (intention to) change goal management behaviour, (2) person-focused approach, specifically, the nurse as trainer and personal fit of the approach, and (3) social mechanisms, including facilitating group processes and interpersonal processes. Adherence to the protocol by the trainers was high, while differences were found in the degree to which they were able to apply the intended collaborative approach and psychological communication skills. The applied design provided valuable insights into the processes that took place. Both the effects experienced by participants in relationship to the content, approach and social mechanisms as well as the strengths and weaknesses found with regard to fidelity provide insights that can inform the development and implementation of person-focused interventions.
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- 2017
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24. Evaluation of a patient decision aid for initiating disease modifying anti-rheumatic drugs.
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Nota I, Drossaert CH, Taal E, Vonkeman HE, Haagsma CJ, and van de Laar MA
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- Aged, Female, Humans, Male, Middle Aged, Antirheumatic Agents therapeutic use, Decision Making, Decision Support Techniques, Patient Participation methods, Rheumatic Diseases drug therapy
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Background: According to international guidelines, treatment of inflammatory arthritis should be based on a shared decision between patient and rheumatologist. Furthermore, patients with inflammatory arthritis have high need of information and want to be more actively involved in medical decision-making. To facilitate shared decision-making and support patients in choosing between disease modifying anti-rheumatic drugs (DMARDs), a web-based patient decision aid (PtDA) was developed. This study evaluated use, appreciation and effect of this PtDA., Methods: A post-test only study with a historical comparison group was conducted. In a two-year period, all patients diagnosed with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, who were deciding whether to start a (different) DMARD were invited to participate. In the first year, patients received standard information (comparison group). In the second year, patients were referred to the PtDA (intervention group). In both groups, a questionnaire was sent four weeks after consulting the rheumatologist. Patient characteristics included sociodemographic, health-related and preference-related variables. Process measures were for use and appraisal of the PtDA (intervention group only). The primary outcome measure was patients' perceived role in medical decision-making. Secondary outcome measures comprised satisfaction with the decision-making process and the decision, beliefs about medication, adherence to medication and trust in the physician., Results: We received 158/232 questionnaires (68 %) from the comparison group and 123/200 (61 %) from the intervention group. The PtDA was used by 69/123 patients (57 %) in the intervention group. Patients who used the PtDA highly appreciated it and perceived it as easy to use and helpful. Relative to the comparison group, patients in the intervention group perceived a more active role in medical decision-making and decisions were more in line with patients' personal preferences. Other outcomes showed no significant difference between the two groups., Conclusion: The web-based PtDA was highly appreciated and perceived as helpful for decision-making. Implementation of the PtDA in rheumatology practice was associated with a significantly larger proportion of patients perceiving an active role in medical decision-making and decisions were more in line with patients' personal preferences. The PtDA can be a valuable aid in improving patient participation in decision-making about DMARDs.
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- 2016
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25. Validation of automatic joint space width measurements in hand radiographs in rheumatoid arthritis.
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Schenk O, Huo Y, Vincken KL, van de Laar MA, Kuper IH, Slump KC, Lafeber FP, and Bernelot Moens HJ
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Computerized methods promise quick, objective, and sensitive tools to quantify progression of radiological damage in rheumatoid arthritis (RA). Measurement of joint space width (JSW) in finger and wrist joints with these systems performed comparable to the Sharp-van der Heijde score (SHS). A next step toward clinical use, validation of precision and accuracy in hand joints with minimal damage, is described with a close scrutiny of sources of error. A recently developed system to measure metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints was validated in consecutive hand images of RA patients. To assess the impact of image acquisition, measurements on radiographs from a multicenter trial and from a recent prospective cohort in a single hospital were compared. Precision of the system was tested by comparing the joint space in mm in pairs of subsequent images with a short interval without progression of SHS. In case of incorrect measurements, the source of error was analyzed with a review by human experts. Accuracy was assessed by comparison with reported measurements with other systems. In the two series of radiographs, the system could automatically locate and measure 1003/1088 (92.2%) and 1143/1200 (95.3%) individual joints, respectively. In joints with a normal SHS, the average (SD) size of MCP joints was [Formula: see text] and [Formula: see text] in the two series of radiographs, and of PIP joints [Formula: see text] and [Formula: see text]. The difference in JSW between two serial radiographs with an interval of 6 to 12 months and unchanged SHS was [Formula: see text], indicating very good precision. Errors occurred more often in radiographs from the multicenter cohort than in a more recent series from a single hospital. Detailed analysis of the 55/1125 (4.9%) measurements that had a discrepant paired measurement revealed that variation in the process of image acquisition (exposure in 15% and repositioning in 57%) was a more frequent source of error than incorrect delineation by the software (25%). Various steps in the validation of an automated measurement system for JSW of MCP and PIP joints are described. The use of serial radiographs from different sources, with a short interval and limited damage, is helpful to detect sources of error. Image acquisition, in particular repositioning, is a dominant source of error.
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- 2016
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26. Effectiveness of Tumor Necrosis Factor Inhibitors in Combination with Various csDMARD in the Treatment of Rheumatoid Arthritis: Data from the DREAM Registry.
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Manders SH, Kievit W, Jansen TL, Stolk JN, Visser H, Schilder AM, Vonkeman HE, Adang E, van de Laar MA, and van Riel PL
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- Adult, Aged, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Registries, Treatment Outcome, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Methotrexate therapeutic use, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objective: To analyze and compare the effectiveness and drug survival in patients with rheumatoid arthritis, as measured by 28-joint Disease Activity Score (DAS28) and Health Assessment Questionnaire-Disability Index (HAQ-DI), of tumor necrosis factor inhibitor (TNFi) monotherapy, TNFi + leflunomide (LEF), TNFi + sulfasalazine (SSZ), TNFi + other conventional synthetic disease-modifying antirheumatic drugs (csDMARD), and TNFi + methotrexate (MTX) therapy, in daily practice., Methods: Data were collected from the DREAM registry. Patients beginning their first TNFi treatment were included in the study: TNFi monotherapy (n = 320), TNFi + SSZ (n = 103), TNFi + LEF (n = 80), TNFi + other csDMARD (n = 99), TNFi + MTX alone (n = 919), TNFi + MTX + other csDMARD (n = 412). Treatment effectiveness was analyzed using DAS28 and HAQ-DI with linear mixed models and the TNFi drug survival was analyzed using Kaplan-Meier curves and Cox regression. All analyses have been corrected for confounders., Results: The patients who received TNFi + MTX had significantly better DAS28 and HAQ-DI values over time (both p < 0.001) and longer TNFi drug survival than TNFi monotherapy (p < 0.001). TNFi + SSZ and TNFi + other csDMARD had significantly better DAS28 values over time (p = 0.001) and longer drug survival (p = 0.001) versus TNFi monotherapy. TNFi + LEF was not significantly better compared to monotherapy. Adding other csDMARD to the TNFi + MTX combination provided no added value., Conclusion: Preferably, TNFi should be prescribed together with MTX. If this is not possible, we advise the use of other csDMARD.
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- 2016
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27. Stopping Tumor Necrosis Factor Inhibitor Treatment in Patients With Established Rheumatoid Arthritis in Remission or With Stable Low Disease Activity: A Pragmatic Multicenter, Open-Label Randomized Controlled Trial.
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Ghiti Moghadam M, Vonkeman HE, Ten Klooster PM, Tekstra J, van Schaardenburg D, Starmans-Kool M, Brouwer E, Bos R, Lems WF, Colin EM, Allaart CF, Meek IL, Landewé R, Bernelot Moens HJ, van Riel PL, van de Laar MA, and Jansen TL
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- Female, Humans, Male, Middle Aged, Remission Induction, Severity of Illness Index, Withholding Treatment, Arthritis, Rheumatoid drug therapy, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objective: Tumor necrosis factor inhibitor (TNFi) biologic agents are an effective treatment for rheumatoid arthritis (RA). It is unclear whether patients whose disease is in remission or who have stable low disease activity need to continue use of TNFi or can stop this treatment. This study was undertaken to assess whether patients with established RA who are in remission or have stable low disease activity can effectively and safely stop their TNFi therapy., Methods: The study was designed as a pragmatic multicenter, open-label randomized controlled trial. Inclusion criteria were a diagnosis of RA according to the American College of Rheumatology 1987 classification criteria, as well as use of a TNFi for at least 1 year along with a stable dose of disease-modifying antirheumatic drugs and a Disease Activity Score in 28 joints (DAS28) of <3.2 over the 6 months preceding trial inclusion. Patients were randomized in a 2:1 ratio to either stop or continue treatment with their current TNFi. Flare was defined as a DAS28 of ≥3.2 during the 12-month follow-up period and an increase in score of ≥0.6 compared to the baseline DAS28., Results: In total, 531 patients were allocated to the stop group and 286 to the TNFi continuation group. At 12 months, more patients had experienced a flare in the stop group (272 [51.2%] of 531) than in the continuation group (52 [18.2%] of 286; P < 0.001). The hazard ratio for occurrence of a flare after stopping TNFi was 3.50 (95% confidence interval [95% CI] 2.60-4.72). The mean DAS28 in the stop group was significantly higher during the follow-up period compared to that in the continuation group (P < 0.001). Of the 195 patients who restarted TNFi treatment after experiencing a flare and within 26 weeks after stopping, 165 (84.6%) had regained a DAS28 of <3.2 by 6 months later, and the median time to a regained DAS28 of <3.2 was 12 weeks (95% Cl 10.7-13.3). There were more hospitalizations in the stop group than in the continuation group (6.4% versus 2.4%)., Conclusion: Stopping TNFi treatment results in substantially more flares than does continuation of TNFi in patients with established RA in remission or with stable low disease activity., (© 2016, American College of Rheumatology.)
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- 2016
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28. Further Simplification of the Simple Erosion Narrowing Score With Item Response Theory Methodology.
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Oude Voshaar MA, Schenk O, Ten Klooster PM, Vonkeman HE, Bernelot Moens HJ, Boers M, and van de Laar MA
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- Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy, Double-Blind Method, Drug Therapy, Combination, Humans, Methotrexate administration & dosage, Models, Statistical, Prednisone administration & dosage, Sulfasalazine administration & dosage, Arthritis, Rheumatoid pathology
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Objective: To further simplify the simple erosion narrowing score (SENS) by removing scored areas that contribute the least to its measurement precision according to analysis based on item response theory (IRT) and to compare the measurement performance of the simplified version to the original., Methods: Baseline and 18-month data of the Combinatietherapie Bij Reumatoide Artritis (COBRA) trial were modeled using longitudinal IRT methodology. Measurement precision was evaluated across different levels of structural damage. SENS was further simplified by omitting the least reliably scored areas. Discriminant validity of SENS and its simplification were studied by comparing their ability to differentiate between the COBRA and sulfasalazine arms. Responsiveness was studied by comparing standardized change scores between versions., Results: SENS data showed good fit to the IRT model. Carpal and feet joints contributed the least statistical information to both erosion and joint space narrowing scores. Omitting the joints of the foot reduced measurement precision for the erosion score in cases with below-average levels of structural damage (relative efficiency compared with the original version ranged 35-59%). Omitting the carpal joints had minimal effect on precision (relative efficiency range 77-88%). Responsiveness of a simplified SENS without carpal joints closely approximated the original version (i.e., all Δ standardized change scores were ≤0.06). Discriminant validity was also similar between versions for both the erosion score (relative efficiency = 97%) and the SENS total score (relative efficiency = 84%)., Conclusion: Our results show that the carpal joints may be omitted from the SENS without notable repercussion for its measurement performance., (© 2016, American College of Rheumatology.)
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- 2016
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29. Exploring Fatigue Trajectories in Early Symptomatic Knee and Hip Osteoarthritis: 6-year Results from the CHECK Study.
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Botterman J, Bode C, Siemons L, van de Laar MA, and Dekker J
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- Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Disease Progression, Fatigue diagnosis, Female, Follow-Up Studies, Humans, Male, Middle Aged, Osteoarthritis, Hip drug therapy, Osteoarthritis, Knee drug therapy, Severity of Illness Index, Sex Factors, Fatigue complications, Osteoarthritis, Hip complications, Osteoarthritis, Knee complications
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Objective: To examine whether different groups of fatigue trajectories can be identified among patients with early symptomatic osteoarthritis (OA) of the knee or hip, to describe the level of fatigue severity within each of these fatigue groups, and to investigate the involvement of age, sex, use of medication, comorbidity, and OA severity in relation to group membership., Methods: Six years of followup data on fatigue (Medical Outcomes Study Short Form-36 Vitality scale) came from the Cohort Hip and Cohort Knee (CHECK) cohort. Growth mixture modeling was applied to identify distinct fatigue trajectories as well as to take into account the effects of the patient characteristics., Results: Three fatigue trajectories were identified: low fatigue, low-to-high fatigue, and high fatigue. Latter trajectories showed considerable overlap from years 2 to 6, but differed in some patient characteristics in comparison with each other and in comparison with the low fatigue group. Comorbidity, medication use, and sex were significantly associated with the identified trajectories. Women, individuals with a comorbid disease, and those who used medication were more likely to follow a high fatigue trajectory., Conclusion: These findings suggest heterogeneous development of fatigue in the early OA population associated with varying patient characteristics. Further, this study shows that a considerable number of patients with OA already experience elevated levels of fatigue at an early stage of OA. While these findings need to be replicated, the identification of these trajectories with differing patient characteristics may warrant tailored psychosocial interventions for patients with elevated levels of fatigue.
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- 2016
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30. The longitudinal relation between patterns of goal management and psychological health in people with arthritis: The need for adaptive flexibility.
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Arends RY, Bode C, Taal E, and van de Laar MA
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- Adult, Affect, Aged, Aged, 80 and over, Anxiety Disorders complications, Arthritis complications, Chronic Disease, Cluster Analysis, Depressive Disorder complications, Female, Humans, Longitudinal Studies, Male, Middle Aged, Motivation, Quality of Life psychology, Social Behavior, Surveys and Questionnaires, Young Adult, Adaptation, Psychological, Anxiety Disorders psychology, Arthritis psychology, Attitude to Health, Depressive Disorder psychology, Goals
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Objectives: Due to their disease, patients with polyarthritis face the task of reconciling their threatened personal goals with their capabilities. Previous cross-sectional research on patients with chronic disease related higher levels of goal management strategies to lower levels of distress and higher levels of well-being. This study was the first to focus longitudinally on goal management patterns that combined strategies originating from different goal management theories. Our first study objective was to identify patterns that consisted of various strategies of goal management among patients with polyarthritis. Subsequently, the cross-sectional and longitudinal relationships between these patterns and the psychological health of the patients were studied., Methods: A longitudinal questionnaire study with three measurements of goal management and psychological health was conducted among 331 patients with polyarthritis. Stability of goal management over time was analysed with ANOVAs. Patterns were identified using cluster analysis at baseline, based on the following strategies: Goal maintenance, goal adjustment, goal disengagement, and goal reengagement. Longitudinal relationships between the patterns and psychological health (specifically: Depression, anxiety, purpose in life, positive affect, and social participation) were analysed using a generalized estimating equations analysis., Results: Three goal management patterns were found: 'Moderate engagement', 'Broad goal management repertoire', and 'Holding on'. Patients with the 'Broad goal management repertoire' pattern had the highest level of psychological health. The 'Holding on' pattern was identified as the most unfavourable in terms of psychological health. Over time, stable differences in levels of psychological health between the patterns were found., Conclusions: This study was the first to reveal patterns of several goal management strategies and their longitudinal relationship to psychological health. Psychosocial support for arthritis patients with lower psychological health should focus on helping patients to become familiar with a broad range of goal management strategies when dealing with threatened goals., Statement of Contribution: What is already known on this subject? Polyarthritis is a collective term for a variety of disorders associated with autoimmune pathologies that may affect all aspects of a person's physical, psychological, and social functioning. Patients often experience difficulties in maintaining and achieving goals in several domains of life due to disease symptoms. The process of emotional adaptation to polyarthritis is characterized by searching equilibrium between desires and constraints and reacting constructive to stressors. Goal management strategies are ways to minimize the perceived disparity between the actual and the preferred situation with regard to personal goals and are applied both consciously and unconsciously. Cross-sectional, higher levels of goal management strategies have been related to lower levels of distress and higher levels of well-being both in patients with polyarthritis and in other patient groups. What does this study add? Contributes to our understanding of how combinations of goal management strategies relate to psychological health. Identifies patterns of goal management that are longitudinally related to psychological health. Provides clear guidance for improving psychological health of people with polyarthritis., (© 2016 The British Psychological Society.)
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- 2016
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31. Arthritis patients' motives for (not) wanting to be involved in medical decision-making and the factors that hinder or promote patient involvement.
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Nota I, Drossaert CH, Taal E, and van de Laar MA
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- Adolescent, Adult, Aged, Arthritis, Rheumatoid therapy, Attitude of Health Personnel, Female, Humans, Male, Middle Aged, Physician-Patient Relations, Young Adult, Arthritis, Rheumatoid psychology, Clinical Decision-Making, Decision Making, Motivation, Patient Participation psychology, Patient Preference
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The aim of this study is to gain insight into arthritis patients' motives for (not) wanting to be involved in medical decision-making (MDM) and the factors that hinder or promote patient involvement. In-depth semi-structured interviews were conducted with 29 patients suffering from Rheumatoid Arthritis (RA). Many patients perceived the questions about involvement in MDM as difficult, mostly because they were unaware of having a choice. Shared decision-making (SDM) was generally preferred, but the preferred level of involvement varied between and within individuals. Preference regarding involvement may vary according to the type of treatment and the severity of the complaints. A considerable group of respondents would have liked more participation than they had experienced in the past. Perceived barriers could be divided into doctor-related (e.g. a paternalistic attitude), patient-related (e.g. lack of knowledge) and context-related (e.g. too little time to decide) factors. This study demonstrates the complexity of predicting patients' preferences regarding involvement in MDM: most RA patients prefer SDM, but their preference may vary according to the situation they are in and the extent to which they experience barriers in getting more involved. Unawareness of having a choice is still a major barrier for patient participation. The attending physician seems to have an important role as facilitator in enhancing patient participation by raising awareness and offering options, but implementing SDM is a shared responsibility; all parties need to be involved and educated.
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- 2016
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32. Initial combination therapy versus step-up therapy in treatment to the target of remission in daily clinical practice in early rheumatoid arthritis patients: results from the DREAM registry.
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Steunebrink LM, Versteeg GA, Vonkeman HE, Ten Klooster PM, Kuper HH, Zijlstra TR, van Riel PL, and van de Laar MA
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- Adult, Aged, Case-Control Studies, Cohort Studies, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Methotrexate administration & dosage, Middle Aged, Registries, Remission Induction, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy
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Background: Treat to target (T2T) is widely accepted as the standard of care for patients with rheumatoid arthritis (RA) and has been shown to be more effective than traditional routine care. The objective of this study was to compare the effectiveness of two T2T strategies in patients with early RA: a step-up approach starting with methotrexate (MTX) monotherapy (cohort I) versus an initial disease-modifying antirheumatic drug combination approach (cohort II)., Methods: A total of 128 patients from cohort II were case-control-matched with 128 patients from cohort I on gender, age, and baseline disease activity. Twelve-month follow-up data were available for 121 patients in both cohorts. The primary outcome was the proportion of patients having reached at least one 28-joint Disease Activity Score (DAS28) score <2.6 (remission) during 12 months of follow-up. Secondary outcomes were time until remission was achieved and mean DAS28 scores at 6- and 12-month follow-up., Results: After 12 months of follow-up, remission was reached at least once in 77.3 % of the patients in cohort II versus 71.9 % in cohort I (P = 0.31). Median time until first remission was 17 weeks in cohort II versus 27 weeks in cohort I (P = 0.04). A significant time by strategy interaction was found in mean DAS28 scores. Post hoc analysis revealed a significant difference in mean DAS28 scores between both cohorts at 6 months (P = 0.04), but not at 12 months (P = 0.36)., Conclusions: The initial combination strategy resulted in a comparable remission rate after 1 year but a significantly shorter time until remission. At 6 months, mean DAS28 scores were lower in patients with initial combination treatment than in those with step-up therapy. At 12 months, no significant differences remained in mean DAS28 scores or the proportion of patients in remission.
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- 2016
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33. Recently diagnosed rheumatoid arthritis patients benefit from a treat-to-target strategy: results from the DREAM registry.
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Steunebrink LM, Vonkeman HE, ten Klooster PM, Hoekstra M, van Riel PL, and van de Laar MA
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- Adult, Aged, Arthritis, Rheumatoid diagnosis, Cohort Studies, Female, Humans, Male, Middle Aged, Registries, Severity of Illness Index, Treatment Outcome, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Methotrexate therapeutic use, Remission Induction methods
- Abstract
Despite considerable evidence on the efficacy and safety of early aggressive treat-to-target (T2T) strategies in early rheumatoid arthritis (RA), a proportion of patients still fail to reach remission. The goal of this study is to examine remission rates and predictors of remission in a real life T2T cohort of consecutive patients with a recent diagnosis of RA. Baseline demographics, clinical, laboratory and patient-reported variables and 1-year follow-up disease activity data were used from patients with early RA included in the DREAM remission induction cohort II study. Survival analyses and simple and multivariable logistic regression analyses were used to examine remission rates and significant predictors of achieving remission. A total of 137 recently diagnosed consecutive RA patients were available for this study. During the first year after inclusion, DAS28 remission was achieved at least once in 77.2 % of the patients and the median time to first remission was 17 weeks. None of the examined baseline variables were robustly associated with achieving remission within 1 year and in the multivariable analysis only lower ESR (p = 0.005) remained significantly associated with achieving fast remission within 17 weeks. During the first year of their disease a high proportion of recently diagnosed RA patient achieved remission, with only a small percentage of patients needing bDMARD therapy. Combined with the absence of baseline predictors of remission, this suggests that clinicians in daily clinical practice may focus on DAS28 scores only, without needing to take other patients characteristics into account.
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- 2016
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34. Construct Validation of a Multidimensional Computerized Adaptive Test for Fatigue in Rheumatoid Arthritis.
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Nikolaus S, Bode C, Taal E, Vonkeman HE, Glas CA, and van de Laar MA
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- Adult, Aged, Aged, 80 and over, Computers, Female, Humans, Male, Middle Aged, Reproducibility of Results, Surveys and Questionnaires, Young Adult, Arthritis, Rheumatoid pathology, Fatigue diagnosis, Psychometrics methods, Self Report
- Abstract
Objective: Multidimensional computerized adaptive testing enables precise measurements of patient-reported outcomes at an individual level across different dimensions. This study examined the construct validity of a multidimensional computerized adaptive test (CAT) for fatigue in rheumatoid arthritis (RA)., Methods: The 'CAT Fatigue RA' was constructed based on a previously calibrated item bank. It contains 196 items and three dimensions: 'severity', 'impact' and 'variability' of fatigue. The CAT was administered to 166 patients with RA. They also completed a traditional, multidimensional fatigue questionnaire (BRAF-MDQ) and the SF-36 in order to examine the CAT's construct validity. A priori criterion for construct validity was that 75% of the correlations between the CAT dimensions and the subscales of the other questionnaires were as expected. Furthermore, comprehensive use of the item bank, measurement precision and score distribution were investigated., Results: The a priori criterion for construct validity was supported for two of the three CAT dimensions (severity and impact but not for variability). For severity and impact, 87% of the correlations with the subscales of the well-established questionnaires were as expected but for variability, 53% of the hypothesised relations were found. Eighty-nine percent of the items were selected between one and 137 times for CAT administrations. Measurement precision was excellent for the severity and impact dimensions, with more than 90% of the CAT administrations reaching a standard error below 0.32. The variability dimension showed good measurement precision with 90% of the CAT administrations reaching a standard error below 0.44. No floor- or ceiling-effects were found for the three dimensions., Conclusion: The CAT Fatigue RA showed good construct validity and excellent measurement precision on the dimensions severity and impact. The dimension variability had less ideal measurement characteristics, pointing to the need to recalibrate the CAT item bank with a two-dimensional model, solely consisting of severity and impact.
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- 2015
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35. Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures.
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Oude Voshaar MA, Ten Klooster PM, Glas CA, Vonkeman HE, Taal E, Krishnan E, Bernelot Moens HJ, Boers M, Terwee CB, van Riel PL, and van de Laar MA
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- Activities of Daily Living, Adult, Aged, Arthritis, Rheumatoid rehabilitation, Disability Evaluation, Female, Humans, Male, Middle Aged, Reproducibility of Results, Severity of Illness Index, Arthritis, Rheumatoid physiopathology, Motor Activity physiology, Patient Outcome Assessment
- Abstract
Objective: To evaluate the content validity and measurement properties of the Patient-Reported Outcome Measurement Information System (PROMIS) physical function item bank and a 20-item short form in patients with RA in comparison with the HAQ disability index (HAQ-DI) and 36-item Short Form Health Survey (SF-36) physical functioning scale (PF-10)., Methods: The content validity of the instruments was evaluated by linking their items to the International Classification of Functioning, Disability and Health (ICF) core set for RA. The measures were administered to 690 RA patients enrolled in the Dutch Rheumatoid Arthritis Monitoring registry. Measurement precision was evaluated using item response theory methods and construct validity was evaluated by correlating physical function scores with other clinical and patient-reported outcome measures., Results: All 207 health concepts identified in the physical function measures referred to activities that are featured in the ICF. Twenty-three of 26 ICF RA core set domains are featured in the full PROMIS physical function item bank compared with 13 and 8 for the HAQ-DI and PF-10, respectively. As hypothesized, all three physical function instruments were highly intercorrelated (r 0.74-0.84), moderately correlated with disease activity measures (r 0.44-0.63) and weakly correlated with age (rs 0.07-0.14). Item response theory-based analysis revealed that a 20-item PROMIS physical function short form covered a wider range of physical function levels than the HAQ-DI or PF-10., Conclusion: The PROMIS physical function item bank demonstrated excellent measurement properties in RA. A content-driven 20-item short form may be a useful tool for assessing physical function in RA., (© The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2015
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36. Estimation of heritability of different outcomes for genetic studies of TNFi response in patients with rheumatoid arthritis.
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Umićević Mirkov M, Janss L, Vermeulen SH, van de Laar MA, van Riel PL, Guchelaar HJ, Brunner HG, Albers CA, and Coenen MJ
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- Adult, Aged, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid metabolism, Female, Genotype, Humans, Male, Middle Aged, Phenotype, Severity of Illness Index, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid genetics, DNA genetics, Genome-Wide Association Study, Polymorphism, Genetic, Tumor Necrosis Factor-alpha antagonists & inhibitors
- Abstract
Objectives: Pharmacogenetic studies of tumour necrosis factor inhibitors (TNFi) response in patients with rheumatoid arthritis (RA) have largely relied on the changes in complex disease scores, such as disease activity score 28 (DAS28), as a measure of treatment response. It is expected that genetic architecture of such complex score is heterogeneous and not very suitable for pharmacogenetic studies. We aimed to select the most optimal phenotype for TNFi response using heritability estimates., Methods: Using two linear mixed-modelling approaches (Bayz and GCTA), we estimated heritability, together with genomic and environmental correlations for the TNFi drug-response phenotype ΔDAS28 and its separate components: Δ swollen joint count (SJC), Δ tender joint count (TJC), Δ erythrocyte sedimentation rate (ESR) and Δ visual-analogue scale of general health (VAS-GH). For this, we used genome-wide single nucleotide polymorphism (SNP) data from 878 TNFi-treated Dutch patients with RA. Furthermore, a multivariate genome-wide association study (GWAS) approach was implemented, analysing separate DAS28 components simultaneously., Results: The highest heritability estimates were found for ΔSJC (h(2)gbayz=0.76 and h(2)gGCTA=0.87) and ΔTJC (h(2)gbayz=0.62 and h(2)gGCTA=0.82); lower heritability was found for ΔDAS28 (h(2)gbayz=0.59 and h(2)gGCTA=0.71) while estimates for ΔESR and ΔVASGH were near or equal to zero. The highest genomic correlations were observed for ΔSJC and ΔTJC (0.49), and the highest environmental correlation was seen between ΔTJC and ΔVASGH (0.62). The multivariate GWAS did not generate excess of low p values as compared with a univariate analysis of ΔDAS28., Conclusions: Our results indicate that multiple SNPs together explain a substantial portion of the variation in change in joint counts in TNFi-treated patients with RA. In conclusion, of the outcomes studied, the joint counts are most suitable for TNFi pharmacogenetics in RA., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)
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- 2015
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37. Exploring preferences for domain-specific goal management in patients with polyarthritis: what to do when an important goal becomes threatened?
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Arends RY, Bode C, Taal E, and Van de Laar MA
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- Activities of Daily Living, Adaptation, Psychological, Adult, Aged, Aged, 80 and over, Arthritis diagnosis, Arthritis psychology, Cost of Illness, Female, Health Knowledge, Attitudes, Practice, Humans, Male, Middle Aged, Perception, Reproducibility of Results, Treatment Outcome, Arthritis therapy, Patient Care Planning, Patient Preference, Patient-Centered Care, Surveys and Questionnaires
- Abstract
Usually priorities in goal management--intended to minimize discrepancies between a given and desired situation--are studied as person characteristics, neglecting possible domain-specific aspects. However, people may make different decisions in different situations depending on the importance of the personal issues at stake. Aim of the present study therefore was to develop arthritis-related vignettes to examine domain-specific goal management and to explore patients' preferences. Based on interviews and literature, situation-specific hypothetical stories were developed in which the main character encounters a problem with a valued goal due to arthritis. Thirty-one patients (61 % female, mean age 60 years) evaluated the face validity of the newly developed vignettes. Secondly, 262 patients (60 % female, mean age 63 years) were asked to come up with possible solutions for the problems with attaining a goal described in a subset of the vignettes. Goal management strategies within the responses and the preference for the various strategies were identified. The 11 developed vignettes in three domains were found to be face-valid. In 90 % of the responses, goal management strategies were identified (31 % goal maintenance, 29 % goal adjustment, 21 % goal disengagement, and 10 % goal re-engagement). Strategy preference was related to domains. Solutions containing goal disengagement were the least preferred. Using vignettes for measuring domain-specific goal management appears as valuable addition to the existing questionnaires. The vignettes can be used to study how patients with arthritis cope with threatened goals in specific domains from a patient's perspective. Domain-specific strategy preference emphasizes the importance of a situation-specific instrument.
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- 2015
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38. Tapering and discontinuation of methotrexate in patients with RA treated with TNF inhibitors: data from the DREAM registry.
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Manders SH, van de Laar MA, Rongen-van Dartel SA, Bos R, Visser H, Brus HL, Jansen T, Vonkeman HE, van Riel PL, and Kievit W
- Abstract
Objectives: To study the number of patients that taper or discontinue concomitant methotrexate (MTX) in daily practice in patients with rheumatoid arthritis (RA) treated with tumour necrosis factor inhibitor (TNFi) and to analyse the effects of that adaption on disease activity and drug survival., Methods: Data were collected from the Dutch Rheumatoid Arthritis Monitoring (DREAM) registry. Patients who started their first TNFi were included in the study. Treatment effectiveness after MTX tapering or discontinuation was analysed using Disease Activity Score of 28 joints (DAS28). Drug survival of the TNFi was analysed using the Cox proportional hazard model with a time-dependent covariate., Results: In 458 patients (34%), MTX was tapered, 126 patients (10%) discontinued MTX and 747 patients (56%) continued MTX at the same dose. On average, DAS28 improved after tapering MTX (-0.40, -0.45) and after stopping MTX (-0.28, -0.12) at 6 and 12 months. In the taper group, 21% of the patients relapsed (DAS28 increase >0.6), and in the discontinuation group this was 21% and 24% at 6 and 12 months, respectively. Patients who taper and discontinue MTX have a similar DAS28 score over time as patients who continue MTX. Moreover, there was no influence of tapering or discontinuation of MTX on long-term drug survival of TNFi., Conclusions: In daily practice, tapering or discontinuation of concomitant MTX in patients with RA treated with TNFi frequently occurs and it does not seem to influence the average DAS28 over time or the long-term TNFi drug survival. It appears that in daily clinical practice the correct patients are selected to taper or discontinue MTX.
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- 2015
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39. Impact on total population health and societal cost, and the implication on the actual cost-effectiveness of including tumour necrosis factor-α antagonists in management of ankylosing spondylitis: a dynamic population modelling study.
- Author
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Tran-Duy A, Boonen A, van de Laar MA, and Severens JL
- Abstract
Background: Sequential treatment of ankylosing spondylitis (AS) that includes tumour necrosis factor-α antagonists (anti-TNF agents) has been applied in most of the Western countries. Existing cost-effectiveness (CE) models almost exclusively presented the incremental CE of anti-TNF agents using a closed cohort while budget impact studies are mainly lacking. Notwithstanding, information on impact on total population health and societal budget as well as on actual incremental CE for a given decision time span are important for decision makers. This study aimed at quantifying, for different decision time spans starting from January 1, 2014 in the Dutch society, (1) impact of sequential drug treatment strategies without and with inclusion of anti-TNF agents (Strategies 1 and 2, respectively) on total population health and societal cost, and (2) the actual incremental CE of Strategy 2 compared to Strategy 1., Methods: Dynamic population modelling was used to capture total population health and cost, and the actual incremental CE. Distinguishing the prevalent AS population on January 1, 2014 and the incident AS cohorts in the subsequent 20 years, the model tracked individually an actual number of AS patients until death or end of the simulation time. During the simulation, data on patient characteristics, history of drug use, costs and health at discrete time points were generated. In Strategy 1, five nonsteroidal anti-inflammatory drugs (NSAIDs) were available but anti-TNF agents withdrawn. In Strategy 2, five NSAIDs and two anti-TNF agents continued to be available., Results: The predicted size of the prevalent AS population in the Dutch society varied within the range of 67,145-69,957 with 44-46 % of the patients receiving anti-TNF agents over the period 2014-2034. The use of anti-TNF agents resulted in an increase in the annual drug costs (168.54-205.28 million Euros), but at the same time caused a decrease in the annual productivity costs (12.58-31.21 million Euros) and in annual costs of healthcare categories other than drugs (7.23-11.90 million Euros). Incremental cost (Euros) per QALY gained in Strategy 2 compared to Strategy 1 corresponding to decision time spans of 5, 10, 15 and 20 years improved slightly from 75,379 to 67,268, 63,938 and 61,129, respectively. At willingness-to-pay thresholds of 118,656, 112,067, 110,188 and 110,512 Euros, it was 99 % certain that Strategy 2 was cost-effective for decision time spans of 5, 10, 15 and 20, respectively., Conclusions: Using the dynamic population approach, the present model can project real-time data to inform a healthcare system decision that affects all actual number of AS patients eligible for anti-TNF agents within different decision time spans. The predicted total population costs of different categories in the present study can help plan the organization of the healthcare resources based on the national budget for the disease.
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- 2015
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40. The Human and Economic Burden of Difficult-to-Treat Gouty Arthritis.
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Bardin T, Voshaar MA, and van de Laar MA
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- Arthritis, Gouty drug therapy, Comorbidity, Humans, Prevalence, Severity of Illness Index, Arthritis, Gouty economics, Arthritis, Gouty epidemiology, Cost of Illness, Quality of Life
- Abstract
Gouty arthritis, one of the most painful and common forms of adult arthritis, is caused by monosodium urate crystal deposits in joints, most often in the lower extremities. Crystals trigger an inflammatory response leading to acute flares characterized by a rapid onset of pain, warmth, swelling, and redness in involved joints. Over time, continued monosodium urate crystal deposits and inflammation can lead to chronic tophaceous gout that result in bone erosion, progressing to joint destruction and significant disability. The goal of therapy in an acute gout flare is prompt and safe termination of pain and inflammation. Acute gouty arthritis is usually treated with nonsteroidal anti-inflammatory drugs, colchicine, or corticosteroids. However, for a growing number of patients, current standard treatments are ineffective or are contraindicated, largely due to the presence of comorbidities. Gouty arthritis can have a major negative impact of health-related quality of life, especially in patients with difficult-to-treat disease, as revealed by recent studies comparing health-related quality of life with that of the general population. Additionally, gouty arthritis also constitutes an important economic burden through absence from work and medical costs. This burden is even greater in patients with difficult-to-treat disease., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
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- 2015
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41. Comparison of 2 Dosages of Intraarticular Triamcinolone for the Treatment of Knee Arthritis: Results of a 12-week Randomized Controlled Clinical Trial.
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Popma JW, Snel FW, Haagsma CJ, Brummelhuis-Visser P, Oldenhof HG, van der Palen J, and van de Laar MA
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- Adult, Aged, Arthritis, Psoriatic drug therapy, Arthritis, Psoriatic pathology, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid pathology, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Follow-Up Studies, Glucocorticoids adverse effects, Humans, Injections, Intra-Articular, Male, Middle Aged, Osteoarthritis drug therapy, Osteoarthritis pathology, Pain Measurement, Prospective Studies, Range of Motion, Articular physiology, Time Factors, Treatment Outcome, Triamcinolone Acetonide adverse effects, Arthritis drug therapy, Arthritis pathology, Glucocorticoids administration & dosage, Range of Motion, Articular drug effects, Triamcinolone Acetonide administration & dosage
- Abstract
Objective: To determine whether a double dose of intraarticular triamcinolone acetonide is more effective for knee arthritis than a 40-mg dose., Methods: In this 12-week randomized controlled clinical trial, 40 mg and 80 mg of intraarticular triamcinolone acetonide were compared in patients with knee arthritis. Evaluated variables included a Likert burden scale, visual analog scale pain scale, degree of arthritis activity, presence of swelling, and presence of functional limitation., Results: Ninety-seven patients were randomized. No significant differences were observed between the groups regarding any outcomes., Conclusion: An 80-mg dose of triamcinolone acetonide had no additional benefit compared with 40 mg as treatment for knee arthritis., Trial Registration: Nederlands Trial Register; trial registration number: NTR2298.
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- 2015
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42. The Way Forward: Practical Clinical Considerations for the Use of Canakinumab in Patients With Difficult-to-Treat Gouty Arthritis.
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Bardin T and van de Laar MA
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- Antibodies, Monoclonal, Humanized, Arthritis, Gouty diagnosis, Arthritis, Gouty immunology, Contraindications, Humans, Severity of Illness Index, Antibodies, Monoclonal therapeutic use, Arthritis, Gouty drug therapy, Gout Suppressants therapeutic use, Interleukin-1beta antagonists & inhibitors
- Abstract
Canakinumab is indicated for patients with frequent gouty arthritis attacks who cannot be managed with standard-of-care medication, and should be used according to the labeled indication. Given its mechanism of action, physicians need to be aware of the potential contraindications and precautions with its use. When deciding as to whether a patient with gouty arthritis is an appropriate candidate for canakinumab treatment, several key clinical considerations should be kept in mind, which are discussed herein., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
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- 2015
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43. Foreword.
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Bardin T and van de Laar MA
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- Antibodies, Monoclonal, Humanized, Arthritis, Gouty immunology, Cost of Illness, Humans, Antibodies, Monoclonal therapeutic use, Arthritis, Gouty drug therapy, Gout Suppressants therapeutic use, Interleukin-1beta antagonists & inhibitors
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- 2015
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44. Neuropathic-like pain features and cross-sectional associations in rheumatoid arthritis.
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Koop SM, ten Klooster PM, Vonkeman HE, Steunebrink LM, and van de Laar MA
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- Aged, Analgesics therapeutic use, Cohort Studies, Cross-Sectional Studies, Female, Fibromyalgia diagnosis, Fibromyalgia drug therapy, Humans, Logistic Models, Male, Mass Screening methods, Mass Screening statistics & numerical data, Middle Aged, Multivariate Analysis, Netherlands, Neuralgia diagnosis, Neuralgia drug therapy, Pain Measurement statistics & numerical data, Severity of Illness Index, Surveys and Questionnaires, Arthritis, Rheumatoid complications, Fibromyalgia complications, Neuralgia complications, Pain Measurement methods
- Abstract
Introduction: Increasing evidence indicates that features suggestive of neuropathic pain may also be present in patients with common rheumatic conditions. The objective of this study was to examine neuropathic-like pain symptoms and associated factors in patients with rheumatoid arthritis., Methods: We used the painDETECT screening tool to identify possible or likely neuropathic pain in 159 outpatients with rheumatoid arthritis. Patients additionally completed other self-reported measures, while clinical measures were assessed to calculate the 28-joint Disease Activity Score. Univariate analyses and multivariable logistic regression were used to identify factors associated with neuropathic pain features., Results: According to the painDETECT, 27 patients (17.0 %) were classified as having likely neuropathic pain and 34 patients (21.4 %) as having possible neuropathic pain. Besides reporting more severe pain, patients with likely or possible neuropathic pain were more likely to meet the diagnostic criteria for fibromyalgia, to use analgesics, and to have more tender joints and a worse physical and mental health status as measured by the 36-item Short-Form health survey. In multivariable analysis, physical (P < 0.001) and mental health status (P = 0.006) remained significantly associated with neuropathic pain features, even after controlling for pain severity., Conclusions: These findings suggest that a sizeable proportion of patients with relatively well-controlled rheumatoid arthritis report symptoms suggestive of neuropathic pain. Neuropathic-like pain symptoms are independently associated with worse self-reported physical and mental health.
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- 2015
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45. Patient-centred care in established rheumatoid arthritis.
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Voshaar MJ, Nota I, van de Laar MA, and van den Bemt BJ
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- Chronic Disease, Decision Making, Emotions, Humans, Medication Adherence, Patient Education as Topic, Patient Participation, Self Care, Social Support, Arthritis, Rheumatoid therapy, Patient-Centered Care
- Abstract
Review of the evidence on patient-centred care (PCC) in rheumatoid arthritis (RA) shows that involving the patient as an individual - with unique needs, concerns and preferences - has a relevant impact on treatment outcomes (safety, effectiveness and costs). This approach empowers patients to take personal responsibility for their treatment. Because clinicians are only able to interact personally with their patients just a few hours per year, patients with a chronic condition such as RA should be actively involved in the management of their disease. To stimulate this active role, five different PCC activities can be distinguished: (1) patient education, (2) patient involvement/shared decision-making, (3) patient empowerment/self-management, (4) involvement of family and friends and (5) physical and emotional support. This article reviews the existing knowledge on these five PCC activities in the context of established RA management, especially focused on opportunities to increase medication adherence in established RA., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
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- 2015
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46. Patients' considerations in the decision-making process of initiating disease-modifying antirheumatic drugs.
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Nota I, Drossaert CH, Taal E, and van de Laar MA
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- Adult, Aged, Aged, 80 and over, Arthritis, Rheumatoid psychology, Female, Humans, Male, Middle Aged, Patient Participation psychology, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy, Arthritis, Rheumatoid epidemiology, Decision Making, Patient Participation methods, Surveys and Questionnaires
- Abstract
Objective: To explore what considerations patients have when deciding about disease-modifying antirheumatic drugs (DMARDs) and what information patients need to participate in the decision-making process., Methods: In-depth face-to-face interviews were conducted with 32 patients with inflammatory arthritis who recently consulted their rheumatologist and discussed initiating DMARDs., Results: Beliefs in the necessity of DMARDs, either for relief of symptoms or prevention of future joint damage, were reasons to initiate DMARDs. Furthermore, trust in the rheumatologist and the health care system was important in this respect. Patients expressed many concerns about initiating DMARDS. These related to the perceived aggressive and harmful nature of DMARDs, potential (or unknown) side effects, influence on fertility and pregnancy, combination with other medicines, time to benefit, and manner of administration. Participants also worried about the future regarding long-term medication use and drug dependency, and if a medicine proved to be ineffective, about the risks of future treatments and running out of options. To decrease uncertainty, participants wanted to be informed about multiple treatment options, both current and future. They not only wanted clinical information but also information on how the medications could affect their daily lives., Conclusion: Health education should inform patients about multiple treatment options, for the present as well as for the future. It should enable patients to compare treatments with regard to both clinical aspects as well as possible consequences for their daily lives., (© 2015, American College of Rheumatology.)
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- 2015
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47. Predictors of satisfactory improvements in pain for patients with early rheumatoid arthritis in a treat-to-target study.
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Ten Klooster PM, Vonkeman HE, Oude Voshaar MA, Siemons L, van Riel PL, and van de Laar MA
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- Adult, Aged, Female, Humans, Logistic Models, Male, Middle Aged, Pain Measurement, Prognosis, Risk Factors, Severity of Illness Index, Surveys and Questionnaires, Time Factors, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Pain drug therapy, Pain Management statistics & numerical data, Patient Satisfaction
- Abstract
Objective: The aim of this study was to identify baseline predictors of achieving patient-perceived satisfactory improvement (PPSI) in pain after 6 months of treat to target in patients with early RA., Methods: Baseline and 6 month data were used from patients included in the Dutch Rheumatoid Arthritis Monitoring remission induction cohort study. Simple and multivariable logistic regression analyses were used to identify significant predictors of achieving an absolute improvement of 30 mm or a relative improvement of 50% on a visual analogue scale for pain., Results: At 6 months, 125 of 209 patients (59.8%) achieved an absolute PPSI and 130 patients (62.2%) achieved a relative PPSI in pain. Controlling for baseline pain, having symmetrical arthritis was the strongest independent predictor of achieving an absolute [odds ratio (OR) 3.17, P = 0.03] or relative (OR 3.44, P = 0.01) PPSI. Additionally, anti-CCP positivity (OR 2.04, P = 0.04) and having ≤12 tender joints (OR 0.29, P = 0.01) were predictive of achieving a relative PPSI. The total explained variance of baseline predictors was 30% for absolute and 18% for relative improvements, respectively., Conclusion: Symmetrical joint involvement, anti-CCP positivity and fewer tender joints at baseline are prognostic signs for achieving satisfactory improvement in pain after 6 months of treat to target in patients with early RA., (© The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
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- 2015
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48. Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial.
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Manders SH, Kievit W, Adang E, Brus HL, Moens HJ, Hartkamp A, Hendriks L, Brouwer E, Visser H, Vonkeman HE, Hendrikx J, Jansen TL, Westhovens R, van de Laar MA, and van Riel PL
- Subjects
- Abatacept economics, Antirheumatic Agents economics, Drug Resistance, Female, Humans, Male, Middle Aged, Rituximab economics, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Abatacept therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Cost-Benefit Analysis, Rituximab therapeutic use
- Abstract
Introduction: For patients with rheumatoid arthritis (RA) whose treatment with a tumour necrosis factor inhibitor (TNFi) is failing, several biological treatment options are available. Often, another TNFi or a biological with another mode of action is prescribed. The objective of this study was to compare the effectiveness and cost-effectiveness of three biologic treatments with different modes of action in patients with RA whose TNFi therapy is failing., Methods: We conducted a pragmatic, 1-year randomised trial in a multicentre setting. Patients with active RA despite previous TNFi treatment were randomised to receive abatacept, rituximab or a different TNFi. The primary outcome (Disease Activity Score in 28 joints) and the secondary outcomes (Health Assessment Questionnaire Disability Index and 36-item Short Form Health Survey scores) were analysed using linear mixed models. Cost-effectiveness was analysed on the basis of incremental net monetary benefit, which was based on quality-adjusted life-years (calculated using EQ-5D scores), and all medication expenditures consumed in 1 year. All analyses were also corrected for possible confounders., Results: Of 144 randomised patients, 5 were excluded and 139 started taking abatacept (43 patients), rituximab (46 patients) or a different TNFi (50 patients). There were no significant differences between the three groups with respect to multiple measures of RA outcomes. However, our analysis revealed that rituximab therapy is significantly more cost-effective than both abatacept and TNFi over a willingness-to-pay range of 0 to 80,000 euros., Conclusions: All three treatment options were similarly effective; however, when costs were factored into the treatment decision, rituximab was the best option available to patients whose first TNFi treatment failed. However, generalization of these costs to other countries should be undertaken carefully., Trial Registration: Netherlands Trial Register number NTR1605. Registered 24 December 2008.
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- 2015
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49. Effectiveness of TNF inhibitor treatment with various methotrexate doses in patients with rheumatoid arthritis: results from clinical practice.
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Manders SH, Kievit W, Adang E, Jansen TJ, Stolk JN, Visser H, Schilder AM, Vonkeman HE, van de Laar MA, and van Riel PL
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- Adalimumab, Adult, Aged, Drug Therapy, Combination, Female, Humans, Linear Models, Male, Middle Aged, Treatment Outcome, Tumor Necrosis Factor-alpha antagonists & inhibitors, Antibodies, Monoclonal, Humanized therapeutic use, Antirheumatic Agents therapeutic use, Arthritis, Rheumatoid drug therapy, Methotrexate administration & dosage, Registries
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- 2015
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50. Assessment of fatigue in rheumatoid arthritis: a psychometric comparison of single-item, multiitem, and multidimensional measures.
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Oude Voshaar MA, Ten Klooster PM, Bode C, Vonkeman HE, Glas CA, Jansen T, van Albada-Kuipers I, van Riel PL, and van de Laar MA
- Subjects
- Aged, Arthritis, Rheumatoid psychology, Fatigue complications, Fatigue psychology, Female, Humans, Male, Middle Aged, Psychometrics, Reproducibility of Results, Severity of Illness Index, Surveys and Questionnaires, Arthritis, Rheumatoid complications, Fatigue diagnosis
- Abstract
Objective: To compare the psychometric functioning of multidimensional disease-specific, multiitem generic, and single-item measures of fatigue in patients with rheumatoid arthritis (RA)., Methods: Confirmatory factor analysis (CFA) and longitudinal item response theory (IRT) modeling were used to evaluate the measurement structure and local reliability of the Bristol RA Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ), the Medical Outcomes Study Short Form-36 (SF-36) vitality scale, and the BRAF Numerical Rating Scales (BRAF-NRS) in a sample of 588 patients with RA., Results: A 1-factor CFA model yielded a similar fit to a 5-factor model with subscale-specific dimensions, and the items from the different instruments adequately fit the IRT model, suggesting essential unidimensionality in measurement. The SF-36 vitality scale outperformed the BRAF-MDQ at lower levels of fatigue, but was less precise at moderate to higher levels of fatigue. At these levels of fatigue, the living, cognition, and emotion subscales of the BRAF-MDQ provide additional precision. The BRAF-NRS showed a limited measurement range with its highest precision centered on average levels of fatigue., Conclusion: The different instruments appear to access a common underlying domain of fatigue severity, but differ considerably in their measurement precision along the continuum. The SF-36 vitality scale can be used to measure fatigue severity in samples with relatively mild fatigue. For samples expected to have higher levels of fatigue, the multidimensional BRAF-MDQ appears to be a better choice. The BRAF-NRS are not recommended if precise assessment is required, for instance in longitudinal settings.
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- 2015
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