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1.
Clin Radiol ; 73(8): 759.e1-759.e9, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29759590

RESUMO

AIM: To determine the willingness of women with extremely dense breasts to undergo breast cancer screening with magnetic resonance imaging (MRI) in a research setting, and to examine reasons for women to participate or not. MATERIALS AND METHODS: Between 2011 and 2015, 8,061 women (50-75 years) were invited for supplemental MRI as part of the Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial (ClinicalTrials.gov Identifier: NCT01315015), after a negative screening mammography in the national population-based mammography screening programme. Demographics of participants and non-participants were compared. All invitees were asked to report reasons for (non)participation. Ethical approval was obtained. Participants provided written informed consent. RESULTS: Of the 8,061 invitees, 66% answered that they were interested, and 59% eventually participated. Participants were on average 54-years old (interquartile range: 51-59 years), comparable to women with extremely dense breasts in the population-based screening programme (55 years). Women with higher socio-economic status (SES) were more often interested in participation than women with lower SES (68% versus 59%, p<0.001). The most frequently stated reasons for non-participation were "MRI-related inconveniences and/or self-reported contraindications to MRI" (27%) and "anxiety regarding the result of supplemental screening" (21%). "Expected personal health benefit" (68%) and "contribution to science" (43%) were the most frequent reasons for participation. CONCLUSION: Of women invited for MRI because of extremely dense breasts, 59% participated. Common reasons for non-participation were "MRI-related inconveniences" and "anxiety regarding the result of supplemental screening". In case of future implementation, availability of precise evidence on benefits and harms might reduce this anxiety.


Assuntos
Densidade da Mama , Neoplasias da Mama/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Cooperação do Paciente , Idoso , Neoplasias da Mama/patologia , Detecção Precoce de Câncer , Feminino , Humanos , Interpretação de Imagem Assistida por Computador , Programas de Rastreamento , Pessoa de Meia-Idade , Países Baixos , Fatores de Risco
2.
Clin Exp Rheumatol ; 32(3): 369-76, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24564933

RESUMO

OBJECTIVES: To examine in patients with early rheumatoid arthritis (RA) whether quality of life (QoL), independently of disease activity, is affected by tight control treatment strategy schemes. METHODS: In the Computer Assisted Management in Early RA (CAMERA) trials, patients with early RA, disease duration <1 year, no prior use of DMARDs) had been randomised to a methotrexate (MTX)-based tight control strategy or usual care (CAMERA study) or to 10 mg/d prednisone or placebo both added from start to a MTX-based tight control strategy (CAMERA-II study). In either study, randomisation to the more intensive strategy resulted in lower disease activity. To assess QoL, the 'Influence of Rheumatic Diseases on General Health and Lifestyle' questionnaire (IRGL) was used. Baseline and 1- and/or 2-year measurements were analysed with regression analyses with the IRGL (sub)scales as outcome variables and treatment strategy and disease activity assessing 28 joints (DAS28) as independent variables, correcting for baseline values of each scale and possible confounders (gender, age, rheumatoid factor status). RESULTS: There was no clear association between either of the treatment strategies and QoL, but a decrease in DAS28 was associated with improvement in the majority of QoL (sub)scales. CONCLUSIONS: No independent effect of the specific tight control strategies schemes on QoL was found, while there was a clear disease activity related effect. Thus frequent outpatient visits or the inclusion of prednisone in a tight control strategy did not negatively influence QoL.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/psicologia , Metotrexato/administração & dosagem , Prednisona/administração & dosagem , Qualidade de Vida/psicologia , Adulto , Idoso , Antirreumáticos/administração & dosagem , Quimioterapia Combinada , Feminino , Glucocorticoides/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Placebos , Índice de Gravidade de Doença , Inquéritos e Questionários , Terapia Assistida por Computador , Resultado do Tratamento
3.
Osteoporos Int ; 24(4): 1429-36, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23011680

RESUMO

UNLABELLED: Addition of 10 mg prednisone daily to a methotrexate-based tight control strategy does not lead to bone loss in early rheumatoid arthritis (RA) patients receiving preventive treatment for osteoporosis. A small increase in lumbar bone mineral density (BMD) during the first year of treatment was recorded, regardless of use of glucocorticoids. INTRODUCTION: This study aims to describe effects on BMD of treatment according to EULAR guidelines with a methotrexate-based tight control strategy including 10 mg prednisone daily versus the same strategy without prednisone in early RA patients who received preventive therapy for osteoporosis. METHODS: Early RA patients were included in the CAMERA-II trial: a randomized, placebo-controlled, double-blind 2-year trial, in which effects of addition of 10 mg prednisone daily to a methotrexate-based tight control strategy were studied. All patients received calcium, vitamin D and bisphosphonates. Disease activity was assessed every 4 weeks. Radiographs of hands and feet and dual-energy X-ray absorptiometry of lumbar spine and left hip were performed at baseline and after 1 and 2 years of treatment. RESULTS: BMD increased significantly over time in both treatment groups at the lumbar spine with a mean of 2.6% during the first year (p<0.001), but not at the hip; at none of the time points did BMD differ significantly between the prednisone and placebo group. Higher age and lower weight at baseline and higher disease activity scores during the trial, but not glucocorticoid therapy, were associated with lower BMD at both the lumbar spine and the hip in mixed-model analyses. CONCLUSION: Addition of 10 mg prednisone daily to a methotrexate-based tight control strategy does not lead to bone loss in early RA patients on bisphosphonates. A small increase in lumbar BMD during the first year of treatment was found, regardless of use of glucocorticoids.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Densidade Óssea/efeitos dos fármacos , Glucocorticoides/efeitos adversos , Osteoporose/induzido quimicamente , Prednisona/efeitos adversos , Absorciometria de Fóton/métodos , Adulto , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/fisiopatologia , Conservadores da Densidade Óssea/uso terapêutico , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Glucocorticoides/administração & dosagem , Glucocorticoides/uso terapêutico , Articulação do Quadril/fisiopatologia , Humanos , Vértebras Lombares/fisiopatologia , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Osteoporose/fisiopatologia , Osteoporose/prevenção & controle , Prednisona/administração & dosagem , Prednisona/uso terapêutico , Índice de Gravidade de Doença , Fator de Necrose Tumoral alfa/antagonistas & inibidores
4.
Ann Rheum Dis ; 70(6): 1099-103, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21406458

RESUMO

OBJECTIVE: To investigate the long-term effects of the tight control (TC) and conventional (CT) methotrexate-based strategies of the Computer Assisted Management in Early Rheumatoid Arthritis trial in early rheumatoid arthritis and evaluate the predictive value of an early response to treatment. METHODS: Clinical and radiographic 5-year outcome was compared between initial strategies. Patients were classified according to the EULAR response criteria. The prognostic value of early response to treatment in addition to established predictors was analysed by multiple linear regression analyses. RESULTS: 5 years of data were available for 205 of 299 patients, with no indication for selective drop-out. At 5 years there was no longer any significant difference for clinical and radiographic outcomes between treatment strategies applied during the first 2 years. Good-responders had a mean disease activity score of 2.39 (1.2) and median yearly radiographic progression rate of 0.6 (0.0 to 2.2) at 5 years; significantly lower (both p<0.02) when compared to moderate- and non-responders. Multiple regression analysis showed that early response to treatment is an independent predictor of 5-year outcome, irrespective of treatment strategy. CONCLUSIONS: The difference in disease activity between treatment strategies disappeared over the years. Good-response to treatment independently predicts significantly better 5-year clinical and radiographic outcome. The TC principle probably should be continued in the long-term.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Metotrexato/uso terapêutico , Adulto , Idoso , Antirreumáticos/administração & dosagem , Artrite Reumatoide/sangue , Artrite Reumatoide/diagnóstico por imagem , Biomarcadores/sangue , Sedimentação Sanguínea , Proteína C-Reativa/metabolismo , Progressão da Doença , Quimioterapia Assistida por Computador , Métodos Epidemiológicos , Feminino , Humanos , Masculino , Metotrexato/administração & dosagem , Pessoa de Meia-Idade , Radiografia , Resultado do Tratamento
5.
Ann Rheum Dis ; 69(10): 1849-52, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20511610

RESUMO

OBJECTIVE: To investigate the effects of a switch from oral methotrexate (MTX) to subcutaneous MTX (scMTX) or adding ciclosporin to oral MTX with a simultaneous reduction of the MTX dose, in case of adverse events (AE) or insufficient effect (IE) in rheumatoid arthritis (RA). METHODS: The tight control treatment arm of the Computer Assisted Management in Early RA (CAMERA) trial was evaluated. The change in 28-joint Disease Activity Score (DAS28) after taking scMTX (over 1 month) or adding ciclosporin (over 3 months) was compared to the average monthly change in the preceding 3 months. Analyses were performed separately for strategy steps because of AE or IE. RESULTS: Of 151 patients, 57 needed the scMTX strategy step (21 because of AE, 36 because of IE) and 40 the following ciclosporin strategy step (20 and 20, respectively). The decrease in DAS28 after taking the scMTX strategy step was 0.30 points (p<0.05); no significant change in DAS28 was seen after the ciclosporin strategy step. In both strategy steps for AE or IE, quite similar observations were made. Of the patients who took the scMTX strategy step, 63% showed improvement. CONCLUSION: scMTX seems a useful treatment step after oral MTX in a tight control strategy, whereas the ciclosporin step seems ineffective.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Ciclosporina/uso terapêutico , Metotrexato/administração & dosagem , Administração Oral , Adulto , Idoso , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Ciclosporina/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Injeções Subcutâneas , Masculino , Metotrexato/efeitos adversos , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
6.
Ann Rheum Dis ; 69(6): 1044-8, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19581281

RESUMO

OBJECTIVE: To evaluate toxicity profiles in patients with rheumatoid arthritis (RA) treated either according to an intensive or a conventional treatment strategy approach with methotrexate (MTX) and to study factors associated with MTX-related toxicity. METHODS: Data were used from the Computer-Assisted Management in Early Rheumatoid Arthritis (CAMERA) study, in which clinical efficacy of an intensive treatment strategy with MTX was more beneficial than a conventional treatment strategy approach. In this study, data on adverse events (AEs) were compared between the two strategy groups. Logistic regression analyses were used to identify possible associations between factors assessed at baseline and withdrawal due to MTX-related AEs or liver toxicity at follow-up. RESULTS: Although significantly more patients in the intensive strategy group experienced MTX-related AEs than in the conventional strategy group, all recorded AEs were relatively mild. A higher body mass index (BMI) was significantly associated with withdrawal due to MTX-related AEs in the multiple regression analyses (odds ratio=1.207, 95% confidence interval 1.02 to 1.44, p=0.033). There was a trend towards an association between diminished creatinine clearance and MTX withdrawal. For liver toxicity, increased serum liver enzymes at baseline were associated with liver toxicity during follow-up. CONCLUSION: Although the occurrence of AEs in the intensive strategy group was higher than in the conventional strategy group, the previously observed clinical efficacy of an intensive treatment strategy seems to outweigh the observed toxicity profiles. When starting MTX, attention should be given to patients with a high BMI and those with increased levels of liver enzymes and decreased renal function.


Assuntos
Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Imunossupressores/efeitos adversos , Metotrexato/efeitos adversos , Adulto , Idoso , Antirreumáticos/administração & dosagem , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Esquema de Medicação , Quimioterapia Assistida por Computador/métodos , Métodos Epidemiológicos , Feminino , Humanos , Imunossupressores/administração & dosagem , Masculino , Metotrexato/administração & dosagem , Pessoa de Meia-Idade
7.
Ann Rheum Dis ; 66 Suppl 3: iii56-60, 2007 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-17934098

RESUMO

OBJECTIVE: To evaluate the available evidence on the efficacy and feasibility of the new concept of tight control in randomised trials in patients with rheumatoid arthritis (RA). Tight control is a treatment strategy tailored to the individual patient with RA, which aims to achieve a predefined level of low disease activity or remission within a certain period of time. METHODS: The literature database PubMed was searched and yielded four trials: the FIN-RACo trial, the TICORA study, the BeSt study and the CAMERA study. RESULTS: Tight control resulted in greater improvement and a higher percentage of patients meeting the preset aim of low disease activity or remission when compared to the control intervention. In the FIN-RACo trial, analysing the subset of patients completing the study, 68% in the tight control group achieved remission (DAS28<2.6) verus 41% in the contrast group [corrected] In the TICORA study, 65% of patients in the tight control group versus 16% of the contrast group achieved remission, based on DAS<1.6 (p<0.0001). In the CAMERA study, 50% of patients in the tight control group using a computer decision model achieved remission, versus 37% in the contrast group (p = 0.029). The BeSt study consisted of only tight control groups aimed at a DAS<1.6; remission was achieved in 38-46% of patients. This is higher than the range of remission in earlier trials of 13-36%. CONCLUSION: Tight control aiming for low disease activity or even better still, remission, seems a promising option in treating patients with RA in clinical trials and probably also in daily practice.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Quimioterapia Combinada , Humanos , Metotrexato/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão/métodos , Projetos de Pesquisa , Resultado do Tratamento
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