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BACKGROUND: Proximal humerus fracture (PHF) is a common fragility fracture in older adults and can have a substantial impact on upper limb function. Although most patients with PHF can be treated nonsurgically, it is unknown whether older adults benefit from supervised exercise therapy after PHF. Therefore, the objective of this trial was to investigate whether 10 weeks of physiotherapist-supervised exercises once a week were superior to 10 weeks of unsupervised home-based exercises in older adults with a nonsurgically treated displaced 2-part PHF. METHODS: This was designed as an assessor-blinded, prospective, randomized controlled trial and took place in 3 Nordic countries. In total, 72 patients (≥60 years) with nonsurgically treated displaced 2-part PHF were randomized to either physiotherapist-supervised exercises once a week for 10 weeks, combined with daily home-based exercises, or to 10 weeks of daily unsupervised home-based exercises. The primary outcome measure was the Disability of the Arm, Shoulder, and Hand (DASH) with a primary endpoint at 3 months. Secondary outcomes were DASH (at 12 months), Constant-Murley Score, the 15D-instrument, Visual Analog Scale, General Self-Efficacy Scale, and Pain Catastrophizing Scale, with follow-up visits after 3 and 12 months. Non-union and patient death within 3 months were counted as complications. RESULTS: The mean age of the patients in both groups was 72 years. At 3 months follow-up, the mean DASH score in the supervised group was 25.9 (SD 16.0) compared to 22.4 (SD 18.9) in the unsupervised group. The mean between-group difference (3.5, 95% CI -5.0 to 12.5) was not clinically relevant. None of the secondary outcome measures presented any clinically relevant or statistically significant between-group differences at 3 or 12 months follow-up. One patient in the supervised group and 3 in the unsupervised group were diagnosed with non-union. One patient from each group died before 3 months follow-up. CONCLUSIONS: This trial provides no evidence that supervised exercises are superior to unsupervised home-based exercises in improving functional outcome or health-related quality of life in older patients with a nonsurgically treated 2-part PHF. Further, our results suggest that most older adults with a nonsurgically treated 2-part PHF can perform home-based exercises without the supervision of a physiotherapist.
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Fraturas do Úmero , Fisioterapeutas , Fraturas do Ombro , Humanos , Idoso , Qualidade de Vida , Estudos Prospectivos , Terapia por Exercício/métodos , Fraturas do Ombro/terapia , Resultado do Tratamento , ÚmeroRESUMO
OBJECTIVE: To investigate if using a hip bandage is more effective than standard care in the prevention of total hip arthroplasty re-dislocation in patients with a previous total hip arthroplasty dislocation. DESIGN: randomized controlled trial. SETTING: Holstebro Regional Hospital and Viborg Regional Hospital. SUBJECTS: A total of 99 patients, 51 women, mean 70.7 (SD 9.9) years were enrolled in an un-blinded, clinical randomized controlled trial. INTERVENTIONS: Participants with at least one previous total hip arthroplasty dislocation were randomized to either wearing a bandage reducing flexion, adduction, and internal rotation of the hip (intervention group) or to standard care (control group). The participants were followed for 12 weeks. Main follow-up measures were as follows: number of re-dislocations (primary outcome), hip disability measured with the Oxford Hip Score (0-48, 48 best), quality of life measured with the 36-Item Short Form Survey (0-100, 100 best), satisfaction with treatment and serious adverse events. Statistical analyses followed the intention-to-treat principle. RESULTS: No significant group differences were observed for the primary outcome re-dislocations (9 versus 15, P = 0.143) or for disability (11.3 versus 14.4, P = 0.161), quality of life (57.7 versus 48.3, P = 0.050) or satisfaction with treatment (P = 0.562). There were 3 serious adverse events leading to total hip arthroplasty revision in the intervention group and 4 in the control group. CONCLUSION: We found that a hip bandage is not superior to standard care in the prevention of total hip arthroplasty re-dislocation in those with a previous total hip arthroplasty dislocation.
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Artroplastia de Quadril , Luxação do Quadril , Prótese de Quadril , Artroplastia de Quadril/efeitos adversos , Bandagens , Feminino , Seguimentos , Luxação do Quadril/etiologia , Luxação do Quadril/prevenção & controle , Luxação do Quadril/cirurgia , Humanos , Masculino , Qualidade de Vida , Estudos RetrospectivosRESUMO
OBJECTIVES: To examine whether MRI assessed inflammation and damage in the wrist of patients with early rheumatoid arthritis (RA) are associated with patient-reported outcomes (PROs). METHODS: Wrist and hand MRIs of 210 patients with early RA from two investigator-initiated, randomised controlled studies (CIMESTRA/OPERA) were assessed according to the Outcome Measures in Rheumatology RA MRI score (RAMRIS) for synovitis, tenosynovitis, osteitis, bone erosions and joint space narrowing (JSN) at baseline, 1 and 5 years follow-up. These features, and changes therein, were assessed for associations with health assessment questionnaires (HAQ), patient global visual analogue scales (VAS-PtGlobal) and VAS-pain using Spearman's correlations, generalised estimating equations and univariate/multivariable linear regression analyses. MRI features were further tested for trends against specific hand-related HAQ items using Jonckheere trend tests. RESULTS: MRI inflammation, but not damage, showed statistically significant associations with HAQ, VAS-PtGlobal and VAS-pain for status and change scores, independently of C reactive protein and swollen joint count. MRI-assessed synovitis was most consistently associated with PROs, particularly VAS-PtGlobal and VAS-pain. MRI-assessed synovitis and tenosynovitis mean scores were positively associated with patient-reported difficulty to cut meat and open a milk carton (p<0.01), and similar patterns were seen for other hand-related HAQ items. Incorporating metacarpophalangeal joints in the analyses did not strengthen the associations between MRI pathology and PROs. CONCLUSIONS: MRI-assessed inflammation, but not damage, in early RA wrists is associated with patient-reported physical impairment, global assessment of disease activity and pain and influences the physical function in the hand. TRIAL REGISTRATION NUMBER: NCT00660647.
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Artrite Reumatoide/diagnóstico por imagem , Inflamação/diagnóstico por imagem , Imageamento por Ressonância Magnética , Articulação do Punho/diagnóstico por imagem , Adulto , Idoso , Artrite Reumatoide/sangue , Artrite Reumatoide/tratamento farmacológico , Proteína C-Reativa/metabolismo , Método Duplo-Cego , Feminino , Inquéritos Epidemiológicos , Humanos , Inflamação/sangue , Estudos Longitudinais , Masculino , Articulação Metacarpofalângica/diagnóstico por imagem , Pessoa de Meia-Idade , Dor Musculoesquelética/diagnóstico por imagem , Osteíte/sangue , Osteíte/diagnóstico por imagem , Medição da Dor , Medidas de Resultados Relatados pelo Paciente , Radiografia , Índice de Gravidade de Doença , Sinovite/sangue , Sinovite/diagnóstico por imagem , Tenossinovite/sangue , Tenossinovite/diagnóstico por imagemRESUMO
INTRODUCTION: Fibroblast growth factor (FGF23), sclerostin, osteocalcin, and osteoprotegerin are important factors that control mineral bone metabolism. End-stage renal disease is associated with the pronounced dysregulation of mineral bone metabolism; however, the impact and clearance of mineral bone metabolism factors during dialysis remain largely undescribed. METHODS: In a cross-sectional study, 10 chronic hemodialysis patients were treated with hemodialysis for 8 h using a high-flux filter and a dialysate bath of 50% calculated total body water continuously recycled at a rate of 500 mL/min. Plasma and dialysate concentrations of FGF23, sclerostin, osteoprotegerin, and osteocalcin were measured at 1, 2, 4, 6, and 8 h permitting the estimation of dialysis clearance. RESULTS: Clearance of FGF23 was 7.7 mL/min, of sclerostin was 7.6 mL/min, of osteoprotegerin was 1.2 mL/min, and of osteocalcin was 19.7 mL/min. Clearance of FGF23 was correlated to sclerostin and osteoprotegerin clearance and also to the ultrafiltration rate. Although, osteocalcin blood concentrations decreased during dialysis, they rebounded within 6 h. Overall, no significant changes in blood concentrations of the measure mineral bone metabolism factors were observed. CONCLUSIONS: The intradialytic clearance of osteocalcin, FGF23, sclerostin, and osteoprotegerin occurs; however, only clearance of FGF23 is directly correlated with the ultrafiltration rate. The effects of dialytic clearance on mineral bone metabolism are, however, uncertain and intradialytic plasma concentrations of the studied substrates remained largely unchanged.
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Proteínas Morfogenéticas Ósseas/sangue , Fatores de Crescimento de Fibroblastos/sangue , Falência Renal Crônica/sangue , Falência Renal Crônica/terapia , Osteocalcina/sangue , Osteoprotegerina/sangue , Diálise Renal , Proteínas Adaptadoras de Transdução de Sinal , Idoso , Feminino , Fator de Crescimento de Fibroblastos 23 , Marcadores Genéticos , Humanos , Masculino , Pessoa de Meia-Idade , Diálise Renal/métodosRESUMO
OBJECTIVES: To investigate whether a treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid injections suppresses MRI inflammation and halts structural damage progression in patients with early rheumatoid arthritis (ERA), and whether adalimumab provides an additional effect. METHODS: In a double-blind, placebo-controlled trial, 85 disease-modifying antirheumatic drug-naïve patients with ERA were randomised to receive methotrexate, intra-articular glucocorticosteroid injections and placebo/adalimumab (43/42). Contrast-enhanced MRI of the right hand was performed at months 0, 6 and 12. Synovitis, osteitis, tenosynovitis, MRI bone erosion and joint space narrowing (JSN) were scored with validated methods. Dynamic contrast-enhanced MRI (DCE-MRI) was carried out in 14 patients. RESULTS: Synovitis, osteitis and tenosynovitis scores decreased highly significantly (p<0.0001) during the 12-months' follow-up, with mean change scores of -3.7 (median -3.0), -2.2 (-1) and -5.3 (-4.0), respectively. No overall change in MRI bone erosion and JSN scores was seen, with change scores of 0.1 (0) and 0.2 (0). The tenosynovitis score at month 6 was significantly lower in the adalimumab group, 1.3 (0), than in the placebo group, 3.9 (2), Mann-Whitney: p<0.035. Furthermore, the osteitis score decreased significantly during the 12-months' follow-up in the adalimumab group, but not in the placebo group, Wilcoxon: p=0.001-0.002 and p=0.062-0.146. DCE-MRI parameters correlated closely with conventional MRI inflammatory parameters. Clinical measures decreased highly significantly during follow-up. CONCLUSIONS: A treat-to-target strategy with methotrexate and intra-articular glucocorticosteroid in patients with ERA effectively decreased synovitis, osteitis and tenosynovitis and halted structural damage progression as judged by MRI. The findings suggest that addition of adalimumab is associated with further suppression of osteitis and tenosynovitis.
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Anti-Inflamatórios/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Metotrexato/uso terapêutico , Triancinolona/uso terapêutico , Adalimumab , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/complicações , Artrite Reumatoide/patologia , Protocolos Clínicos , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Injeções Intra-Articulares , Imageamento por Ressonância Magnética , Masculino , Articulação Metacarpofalângica/patologia , Pessoa de Meia-Idade , Osteíte/tratamento farmacológico , Osteíte/etiologia , Osteíte/patologia , Planejamento de Assistência ao Paciente , Índice de Gravidade de Doença , Sinovite/tratamento farmacológico , Sinovite/etiologia , Sinovite/patologia , Tenossinovite/tratamento farmacológico , Tenossinovite/etiologia , Tenossinovite/patologia , Resultado do Tratamento , Articulação do Punho/patologia , Adulto JovemRESUMO
OBJECTIVES: To explore if the reliability of synovitis assessment by unenhanced MRI is influenced by different MRI field-strengths, coil types and image resolutions in RA patients. METHODS: Forty-one RA patients and 12 healthy controls underwent hand MRI (wrist and 2(nd)--5(th) metacarpophalangeal joints) at 4 different field-strengths (0.23 T/0.6 T/1.5 T/3.0 T) on the same day. Seven protocols using a STIR sequence with different field-strengths, coils (flex coils/dedicated phased-array extremity coils) and resolution were applied and scored blindly for synovitis (OMERACT-RAMRIS method). A 1.5 T post-contrast T1-weighted sequence was used as gold standard reference. RESULTS: Fair-good agreement (ICC=0.38--0.72) between the standard reference and the different STIR protocols (best agreement with extremity coil and small voxel size at 1.5 T). The accuracy for presence/absence of synovitis was very high per person (0.80--1.0), and moderate-high per joint (0.63--0.85), whereas exact agreements on scores were moderate (0.50--0.66). The intrareader agreement (15 patients and 3 controls) on presence/absence of synovitis was very high (0.87--1.0). CONCLUSIONS: Unenhanced MRI using STIR sequence is only moderately reliable for assessing hand synovitis in RA, when contrast-enhanced MRI is considered the gold standard reference. Contrast injection, field strength and coil type influence synovitis assessment, and should be considered before performing MRI in clinical trials and practice. KEY POINTS: ⢠STIR is only moderately reliable for synovitis assessment, compared with post-contrast-T1-w. ⢠Contrast injection, field strength, and coil type influence synovitis assessment. ⢠Contrast injection is recommended for reliable and reproducible hand synovitis assessment.
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Meios de Contraste , Aumento da Imagem , Imageamento por Ressonância Magnética/métodos , Sinovite/diagnóstico , Adolescente , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Adulto JovemRESUMO
BACKGROUND: Multipass hemodialysis (MPHD) is a recently described dialysis modality, involving the use of small volumes of dialysate which are repetitively recycled. Dialysis regimes of 8 hours for six days a week using this device result in an increased removal of small water soluble solutes and middle molecules compared to standard hemodialysis (SHD). Since protein-bound solutes (PBS) exert important pathophysiological effects, we investigated whether MPHD results in improved removal of PBS as well. METHODS: A cross-over study (Clinical Trial NCT01267760) was performed in nine stable HD patients. At midweek a single dialysis session was performed with either 4 hours SHD using a dialysate flow of 500 mL/min or 8 hours MPHD with a dialysate volume of 50% of estimated body water volume. Blood and dialysate samples were taken every hour to determine concentrations of p-cresylglucuronide (PCG), hippuric acid (HA), indole acetic acid (IAA), indoxyl sulfate (IS), and p-cresylsulfate (PCS). Dialyser extraction ratio, reduction ratio, and solute removal were calculated for these solutes. RESULTS: Already at 60 min after dialysis start, the extraction ratio in the hemodialyser was a factor 1.4-4 lower with MPHD versus SHD, resulting in significantly smaller reduction ratios and lower solute removal within a single session. Even when extrapolating our findings to 3 times 4 h SHD and 6 times 8 h MPHD per week, the latter modality was at best similar in terms of total solute removal for most protein-bound solutes, and worse for the highly protein-bound solutes IS and PCS. When efficiency was calculated as solute removal/litre of dialysate used, MPHD was found superior to SHD. CONCLUSION: When high water consumption is a concern, a treatment regimen of 6 times/week 8 h MPHD might be an alternative for 3 times/week 4 h SHD, but at the expense of a lower total solute removal of highly protein-bound solutes.
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Agendamento de Consultas , Soluções para Hemodiálise , Falência Renal Crônica/terapia , Proteínas , Diálise Renal/normas , Idoso , Estudos Cross-Over , Feminino , Humanos , Falência Renal Crônica/diagnóstico , Masculino , Pessoa de Meia-Idade , Prognóstico , Diálise Renal/métodos , Fatores de Tempo , Resultado do Tratamento , Ultrafiltração/métodos , Ultrafiltração/normas , Ureia/análise , Ácido Úrico/análiseRESUMO
OBJECTIVE: The aim of this study was to investigate the ability of whole-body MRI (WBMRI) to visualize inflammation [synovitis, bone marrow oedema (BME) and enthesitis] and structural damage in patients with RA. METHODS: The 3T WBMR images were acquired in a head-to-toe scan in 20 patients with RA and at least one swollen or tender joint. Short Tau Inversion Recovery and pre- and post-contrast T1-weighted images were evaluated for readability and the presence/absence of inflammation (synovitis, BME and enthesitis) and structural damage (erosions and fat infiltrations) in 76 peripheral joints, 30 entheseal sites and in the spine. RESULTS: The readability was >70% for all individual joints, except for the most peripheral joints of the hands and feet. Synovitis was most frequent in the wrist, first tarsometatarsal, first CMC joints and glenohumeral joints (67-61%); BME in the wrist, CMC, acromioclavicular and glenohumeral joints (45-35%) and erosions in the wrist, MTP and CMC joints (19-16%). Enthesitis at ≥ 1 site was registered in 16 patients. BME was frequently seen in the cervical (20%) but not the thoracic and lumbar spine, while fat infiltrations and erosions were rare. The intrareader agreement was high (85-100%) for all pathologies. The agreement between WBMRI and clinical findings was low. CONCLUSION: Peripheral and axial inflammation and structural damage at joints and entheses was frequently identified by WBMRI, and more frequently than by clinical examination. WBMRI is a promising tool for evaluation of the total inflammatory load of inflammation (an MRI joint count) and structural damage in RA patients.
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Artrite Reumatoide/diagnóstico , Artrite Reumatoide/patologia , Articulações/patologia , Imageamento por Ressonância Magnética/métodos , Índice de Gravidade de Doença , Adulto , Idoso , Artrite Reumatoide/epidemiologia , Doenças da Medula Óssea/diagnóstico , Doenças da Medula Óssea/epidemiologia , Doenças da Medula Óssea/patologia , Comorbidade , Edema/diagnóstico , Edema/epidemiologia , Edema/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Reprodutibilidade dos Testes , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/epidemiologia , Doenças Reumáticas/patologia , Sinovite/diagnóstico , Sinovite/epidemiologia , Sinovite/patologiaRESUMO
OBJECTIVE: The aim of this study was to examine the influence of different MRI unit field strengths, coil types and image resolutions on the OMERACT RA MRI scoring system (RAMRIS) of bone marrow oedema (BME) and image quality. METHODS: Forty-one patients and 12 healthy controls participated in this cross-sectional study. Coronal short tau inversion recovery (STIR) and T1-weighted sequences were obtained at 0.23, 0.6, 1.5 and 3T using flex coils (Flex). Additional STIR sequences were obtained with phased array extremity coils (Extr) (at 0.6 and 1.5T) and higher resolution (at 1.5T). In otal, 338 STIR image sets were anonymized and scored according to RAMRIS and parameters of image quality were measured. RESULTS: The BME sum scores were similar overall when comparing the different MRI units, coil types and voxel sizes, yet significantly higher at the higher resolution of 1.5T Extr compared with 0.23T Flex (P = 0.004), 0.6T Flex (P = 0.03), 1.5T Flex (P = 0.05) and 3T Flex (P = 0.001). Mean differences were relatively minor (0-3.5). Intrareader reliability of BME scores was high [intraclass correlation coefficient ≥ 0.90 for all except 0.23T (0.81) and percentage exact agreement 81-88%]. The smallest detectable difference was better at 0.6, 1.5 and 3T (9-29% of maximum value) than at 0.23T (40%). Image quality was lowest at 0.23T. CONCLUSION: No major, consistent differences were found between BME scores using STIR sequences obtained at different field strengths, coil types and image resolutions, suggesting that these are equally suited for assessment of BME in RA. However, parameters of image quality and intrareader reliability (favouring 0.6, 1.5 and 3T) should be considered when selecting the MRI acquisition strategy.
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Artrite Reumatoide/patologia , Doenças da Medula Óssea/patologia , Edema/patologia , Imageamento por Ressonância Magnética/métodos , Articulação Metacarpofalângica/patologia , Articulação do Punho/patologia , Idoso , Medula Óssea/patologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos TestesRESUMO
INTRODUCTION: Most home haemodialysis (HD) modalities are limited to home use since they are based on a single-pass (SP) technique, which requires preparation of large amounts of dialysate. We present a new dialysis method, which requires minimal dialysate volumes, continuously recycled during treatment [multipass HD (MPHD)]. Theoretical calculations suggest that MPHD performed six times weekly for 8 h/night, using a dialysate bath containing 50% of the calculated body water, will achieve urea clearances equivalent to conventional HD 4 h thrice weekly, and a substantial clearance of higher middle molecules. METHODS: Ten stable HD patients were dialyzed for 4 h using standard SPHD (dialysate flow 500 mL/min). Used dialysate was collected. One week later, an 8-h MPHD was performed. The dialysate volume was 50% of the calculated water volume, the dialysate inflow 500 mL/min-0.5 × ultrafiltration/min and the outflow 500 mL/min + 0.5 × ultrafiltration/min. Elimination rates of urea, creatinine, uric acid, phosphate and ß2-microglobulin (B2M) and dialysate saturation were determined hourly. RESULTS: Three hours of MPHD removed 49, 54, 50, 51 and 57%, respectively, of the amounts of urea, creatinine, uric acid, phosphate and B2M that were removed by 4 h conventional HD. The corresponding figures after 8 h MPHD were 63, 78, 74, 78 and 111%. CONCLUSIONS: Clearance of small molecules using MPHD 6 × 8 h/week will exceed traditional HD 3 × 4 h/week. Similarly, clearance of large molecules will significantly exceed traditional HD and HD 5 × 2.5 h/week. This modality will increase patients' freedom of movement compared with traditional home HD. The new method can also be used in the intensive care unit and for automated peritoneal dialysis.
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Biomarcadores/análise , Soluções para Diálise , Falência Renal Crônica/terapia , Diálise Renal , Adolescente , Adulto , Creatinina/análise , Feminino , Seguimentos , Humanos , Falência Renal Crônica/complicações , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Fosfatos/análise , Prognóstico , Ultrafiltração , Ureia/análise , Ácido Úrico/análise , Adulto JovemRESUMO
OBJECTIVE: To test the correlation between assessment of inflammation using dynamic contrast-enhanced MRI (DCE-MRI) analysed by a novel computer-aided approach and semi-quantitative scores of synovitis and bone marrow oedema (BME) using the OMERACT-RA MRI Scoring (RAMRIS) system, in the wrist of patients with RA. METHODS: Fifty-four RA patients had conventional and DCE-MRI of a symptomatic wrist using a low-field 0.2T extremity scanner. RAMRIS synovitis and BME of the wrist joint were done. DCE-MRI data were analysed in three ways: (i) in all images (fully automated approach), (ii) within a large extended region of interest (ROI) placed around the wrist joint (semi-automated approach) and (iii) within a small ROI placed in the area with most visual enhancement (semi-automated approach). Time spent on each procedure was noted. Spearman's rank correlation test was applied to assess the correlation between RAMRIS and the computer-generated dynamic parameters. RESULTS: RAMRIS synovitis (range 2-9), BME (range 0-39) and the dynamic parameters reflecting the number of enhancing voxels were significantly correlated, especially when an extended ROI around the wrist was used (ρ = 0.74; P < 0.01 for synovitis and ρ = 0.82; P < 0.01 for BME). The observer spent on average 20 min (range 12-25 min) to perform RAMRIS, including acquisition of the results in the database, and 8 min (range 7-10 min) to perform all above-mentioned computer-aided analyses. CONCLUSION: Computer-aided analysis of DCE-MRI data correlated with RAMRIS synovitis and BME and was twice as fast to perform. This technique may be useful for quick semi-automated assessment of joint inflammation, but needs further validation.
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Artrite Reumatoide/diagnóstico , Doenças da Medula Óssea/diagnóstico , Edema/diagnóstico , Imageamento por Ressonância Magnética/métodos , Sinovite/diagnóstico , Articulação do Punho/patologia , Adulto , Idoso , Artrite Reumatoide/complicações , Doenças da Medula Óssea/etiologia , Meios de Contraste , Edema/etiologia , Métodos Epidemiológicos , Gadolínio , Humanos , Interpretação de Imagem Assistida por Computador/métodos , Pessoa de Meia-Idade , Sinovite/etiologia , Adulto JovemRESUMO
OBJECTIVE: Whole-body MRI (WBMRI) is a promising technique for monitoring patients' global disease activity in inflammatory joint diseases. The validation of WBMRI is limited; no studies have evaluated the test-retest agreement (interscan agreement) and only a few have assessed the intra- and interreader agreement. Therefore, we first examined the interscan agreement of WBMRI in patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), and healthy controls (HC); and second, we evaluated the intra- and interreader agreement and agreement with conventional hand MRI and determined the distribution of lesions. METHODS: WBMRI was performed twice at a 1-week interval in 14 patients with PsA, 10 with RA, and 16 HC. Images were anonymized and read in pairs with unknown chronological order by experienced readers according to the Outcome Measures in Rheumatology (OMERACT) WBMRI, Canada-Denmark MRI, and the RA MRI scoring system (RAMRIS) and the PsA MRI scoring system (PsAMRIS). Ten image sets were reanonymized for assessment of intra- and interreader agreement. Agreement was calculated on lesion level by percentage exact agreement (PEA) and Cohen κ, and for sum scores by absolute agreement, single-measure intraclass correlation coefficient (ICC). RESULTS: WBMRI of the spine and peripheral joints and entheses generally showed moderate to almost perfect interscan agreement with PEA ranging from 95% to 100%, κ 0.71-1.00, and ICC 0.95 to 1.00. Intra- and interreader data generally showed moderate to almost perfect agreement. Agreement with conventional MRI varied. More lesions were found in patients than in HC. CONCLUSION: WBMRI showed good interscan agreement, implying that repositioning of the patient between examinations does not markedly affect scoring of lesions. Intra- and interreader agreement were moderate to almost perfect.
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Artrite Psoriásica , Artrite Reumatoide , Artrite Psoriásica/diagnóstico por imagem , Artrite Reumatoide/diagnóstico por imagem , Humanos , Imageamento por Ressonância Magnética , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Imagem Corporal TotalRESUMO
INTRODUCTION: Evidence on the effects of structured nutrition education is weak in adults with type 1 diabetes mellitus (T1D) with moderately impaired glycemic control. Objective was to compare the effects of different types of nutrition education programs on glycemic control, cardiovascular risk factors, quality of life, diet quality and food choices in T1D. RESEARCH DESIGN AND METHODS: A 12 months randomized controlled study conducted at nine diabetes specialist centers with three parallel arms: (i) a food-based approach (FBA) including foods with low glycemic index or (ii) carbohydrate counting (CC) according to today's standard practice or (iii) individual sessions according to routine care (RC). The primary end point was difference in glycated hemoglobin A1c (HbA1c) between groups at 12 months. RESULTS: 159 patients were randomized (FBA: 51; CC: 52; RC: 55). Mean (SD) age 48.6 (12.0) years, 57.9% females and mean (SD) HbA1c level 63.9 (7.9) mmol/mol, 8% (0.7%). After 3 months, HbA1c improved in both FBA and CC compared with RC. However, there were no significant differences at 12 months in HbA1c; FBA versus RC (-0.4 mmol/mol (1.3), 0.04% (0.1%)), CC versus RC (-0.8 mmol/mol (1.2), 0.1% (0.1%)), FBA versus CC (0.4 mmol/mol (0.3), 0.04% (0.01%)). At 12 months, intake of legumes, nuts and vegetables was improved in FBA versus CC and RC. FBA also reported higher intake of monounsaturated and polyunsaturated fats compared with RC, and dietary fiber, monounsaturated and polyunsaturated fats compared with CC (all p values <0.05). There were no differences in blood pressure levels, lipids, body weight or quality of life. CONCLUSIONS: Nutrition education using an FBA, CC or RC is equivalent in terms of HbA1c and cardiovascular risk factors in persons with T1D with moderately impaired glycemic control. An FBA had benefits regarding food choices compared with CC and RC.
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Diabetes Mellitus Tipo 1 , Adulto , Glicemia , Diabetes Mellitus Tipo 1/terapia , Carboidratos da Dieta , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de VidaRESUMO
Objective: To compare joint inflammation seen by whole-body magnetic resonance imaging (WBMRI), with "whole-body" ultrasound and clinical assessments, in patients with active rheumatoid arthritis (RA) before and during tumor necrosis factor-inhibitor (TNF-I, adalimumab) treatment. Methods: In 18 patients with RA, clinical assessment for joint tenderness and swelling, WBMRI, and ultrasound were obtained at baseline and week 16. Wrist, metacarpophalangeal (MCP) and proximal interphalangeal (PIP), elbow (except for WBMRI), shoulder, knee, ankle, and metatarsophalangeal joints were examined. Joint inflammation was defined by WBMRI as the presence of synovitis and/or osteitis and by ultrasound as gray-scale synovial hypertrophy grade >2 and/or color Doppler grade >1. On patient level, agreement was assessed by Spearman correlation coefficients (rho) for sum scores for 28 joints (i.e., wrists, MCPs, PIPs, elbows, shoulders, and knees) between clinical examination (DAS28CRP), ultrasound (US28), and WBMRI (WBMRI26; elbows not included). On joint level, agreement on inflammation between WBMRI, ultrasound, and clinical findings was calculated with Cohen's kappa (κ). Results: At patient level, WBMRI26 and US28 sum scores showed good correlation (rho = 0.72; p < 0.01) at baseline, but not at follow-up (rho = 0.25; p = 0.41). At joint level, moderate agreement was seen for hand joints (κ = 0.41-0.44); for other joints κ <0.40. No correlation with DAS28CRP was seen. No statistically significant correlations were observed between changes in WBMRI26, US28, and DAS28CRP during treatment. Conclusions: WBMRI and ultrasound joint inflammation sum scores at patient level showed good agreement in clinically active RA patients before TNF-I initiation, whereas agreement was poorer at joint level, and after treatment.
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BACKGROUND: Many laboratories offer glycemic index (GI) services. OBJECTIVE: We assessed the performance of the method used to measure GI. DESIGN: The GI of cheese-puffs and fruit-leather (centrally provided) was measured in 28 laboratories (n=311 subjects) by using the FAO/WHO method. The laboratories reported the results of their calculations and sent the raw data for recalculation centrally. RESULTS: Values for the incremental area under the curve (AUC) reported by 54% of the laboratories differed from central calculations. Because of this and other differences in data analysis, 19% of reported food GI values differed by >5 units from those calculated centrally. GI values in individual subjects were unrelated to age, sex, ethnicity, body mass index, or AUC but were negatively related to within-individual variation (P=0.033) expressed as the CV of the AUC for repeated reference food tests (refCV). The between-laboratory GI values (mean+/-SD) for cheese-puffs and fruit-leather were 74.3+/-10.5 and 33.2+/-7.2, respectively. The mean laboratory GI was related to refCV (P=0.003) and the type of restrictions on alcohol consumption before the test (P=0.006, r2=0.509 for model). The within-laboratory SD of GI was related to refCV (P<0.001), the glucose analysis method (P=0.010), whether glucose measures were duplicated (P=0.008), and restrictions on dinner the night before (P=0.013, r2=0.810 for model). CONCLUSIONS: The between-laboratory SD of the GI values is approximately 9. Standardized data analysis and low within-subject variation (refCV<30%) are required for accuracy. The results suggest that common misconceptions exist about which factors do and do not need to be controlled to improve precision. Controlled studies and cost-benefit analyses are needed to optimize GI methodology. The trial was registered at clinicaltrials.gov as NCT00260858.
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Técnicas de Laboratório Clínico/normas , Carboidratos da Dieta/metabolismo , Análise de Alimentos/normas , Alimentos/classificação , Índice Glicêmico , Adolescente , Adulto , Idoso , Área Sob a Curva , Glicemia/metabolismo , Estudos Cross-Over , Feminino , Teste de Tolerância a Glucose , Humanos , Masculino , Pessoa de Meia-Idade , Valores de Referência , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Socioeconomic status, origin or demographic attributes shall not determine the quality of healthcare delivery, according to e.g. United Nations and European Union rules. Health equity has been defined as the absence of systematic disparities and unwarranted differences between groups defined by differences in social advantages. A study was performed to investigate whether this was applicable to type 1 diabetes mellitus (T1D) care in a setting with universal, tax-funded healthcare. METHODS: This retrospective registry-study was based on patient-level data from individuals diagnosed with T1D during 2010-2011 (n = 16,367) in any of seven Swedish county councils (covering ~65% of the Swedish population). Health equity in T1D care was analysed through multivariate regression analyses on absolute HbA1c level at one-year follow-up, one-year change in estimated glomerular filtration rate (eGFR) and one-year change in cardiovascular risk score, using selected sociodemographic dimensions as case-mix factors. RESULTS: Higher educational level was consistently associated with lower levels of HbA1c, and so was being married. Never married was associated with worse eGFR development, and lower educational level was associated with higher cardiovascular risk. Women had higher HbA1c levels than men, and glucose control was significantly worse in patients below the age of 25. CONCLUSION: Patients' sociodemographic profile was strongly associated with absolute levels of risk factor control in T1D, but also with an increased annual deterioration in eGFR. Whether these systematic differences stem from patient-related problems or healthcare organisational shortcomings is a matter for further research. The results, though, highlight the need for intensified diabetes management education and secondary prevention directed towards T1D patients, taking sociodemographic characteristics into account.
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Atenção à Saúde , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/terapia , Qualidade da Assistência à Saúde , Sistema de Registros , Adulto , Idoso , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fatores Socioeconômicos , Suécia/epidemiologiaRESUMO
OBJECTIVE: To test the effect of patient-reported outcome (PRO)-based tele-health followup for tight control of disease activity in patients with rheumatoid arthritis (RA), and the differences between tele-health followup performed by rheumatologists or rheumatology nurses. METHODS: A total of 294 patients were randomized (1:1:1) to either PRO-based tele-health followup carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional outpatient followup by physicians. The primary outcome was a change in the Disease Activity Score in 28 joints (DAS28) after week 52. Secondary outcomes were physical function, quality of life, and self-efficacy. The noninferiority margin was a DAS28 score change of 0.6. Mean differences were estimated following per protocol, intent-to-treat (ITT), and multivariate imputation analysis. RESULTS: Overall, patients had low disease activity at baseline and end followup. Demographics and baseline characteristics were similar between groups. Noninferiority was established for the DAS28. In the ITT analysis, mean differences in the DAS28 score between PRO-TR versus control were -0.10 (90% confidence interval [90% CI] -0.30, 0.13) and -0.19 (90% CI -0.41, 0.02) between PRO-TN versus control. When including 1 yearly visit to the outpatient clinic, patients in PRO-TN had mean ± SD 1.72 ± 1.03 visits/year, PRO-TR had 1.75 ± 1.03 visits/year, and controls had 4.15 ± 1.0 visits/year. This included extra visits due to inflammatory flare. CONCLUSION: Among RA patients with low disease activity or remission, a PRO-based tele-health followup for tight control of disease activity in RA can achieve similar disease control as conventional outpatient followup. The degree of disease control did not differ between patients seen by rheumatologists or rheumatology nurses.
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Assistência ao Convalescente/métodos , Artrite Reumatoide/terapia , Telemedicina/métodos , Idoso , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/fisiopatologia , Artrite Reumatoide/psicologia , Dinamarca , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Enfermeiras e Enfermeiros , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Indução de Remissão , Reumatologistas , Autoeficácia , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoAssuntos
Comportamento Alimentar , Nível de Saúde , Atividade Motora , Saúde Pública/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sobrepeso/epidemiologia , Fatores Sexuais , Fatores Socioeconômicos , Suécia/epidemiologia , Adulto JovemRESUMO
The pre-absorptive cephalic phase of insulin secretion is elicited during the first ten min of a meal and before glucose levels rise. Its importance for insulin release during the post-absorptive phase has been well documented in animals but its presence or importance in man has become increasingly controversial. We here examined the presence of an early cephalic phase of insulin release in 31 well matched individuals without (n = 15) or with (n = 16) a known family history of type 2 diabetes (first-degree relatives; FDR). We also examined the potential differences in individuals with or without impaired fasting (IFG) and impaired glucose tolerance (IGT). We here demonstrate that a cephalic phase of insulin secretion was present in all individuals examined and without any differences between control persons and FDR or IFG/IGT. However, the overall importance of the cephalic phase is conjectural since it was unrelated to the subsequent post-absorptive insulin release or glucose tolerance. One of the best predictors of the incremental cephalic phase of insulin release was fasting insulin level and, thus, a relation to degree of insulin sensitivity is likely. In conclusion, an early pre-absorptive and cephalic phase of insulin release is robustly present in man. However, we could not document any relation to family history of Type 2 diabetes nor to the post-absorptive phase and, thus, confirm its importance for subsequent degree of insulin release or glucose tolerance.
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Diabetes Mellitus Tipo 2 , Insulina/metabolismo , Adulto , Peptídeo C/metabolismo , Estudos de Casos e Controles , Ingestão de Alimentos , Jejum/fisiologia , Intolerância à Glucose , Teste de Tolerância a Glucose , Humanos , Secreção de Insulina , Masculino , Refeições , Pessoa de Meia-Idade , LinhagemRESUMO
BACKGROUND: Reduced cardiovascular mortality and morbidity have been shown in persons adhering to Mediterranean-inspired diets (MIDs). Although the underlying mechanisms of this association are poorly understood, the importance of increasing dietary amounts of polyunsaturated fatty acids of the n-3 series has been emphasized. OBJECTIVE: We investigated whether a MID provided to healthy subjects would affect 1) the inflammatory process and endothelial indexes such as vasoregulation and vascular endothelial growth factor (VEGF) and 2) serum phospholipid fatty acid composition. DESIGN: A total of 22 subjects (10 women) received a MID or an ordinary Swedish diet (OSD) for 4 wk in a crossover fashion. Concentrations of lipids and fatty acids, high-sensitivity C-reactive protein, and interleukin 6, both before and after lipopolysaccharide stimulation; the number of leukocytes and platelets; and VEGF and monocyte chemoattractant protein 1 were analyzed. RESULTS: The plasma ratio of n-6 to n-3 fatty acids was substantially lower after the MID than after the OSD (x +/- SEM: 4.72 +/- 0.19 and 2.60 +/- 0.17, respectively; P < 0.0001). Neither C-reactive protein nor interleukin 6 concentrations changed significantly after the MID compared with the OSD. The total number of leukocytes and platelets was 10% (P < 0.05) and 15% (P < 0.001) lower, respectively, after the MID than after the OSD. Serum VEGF concentrations were lower after the MID than after the OSD (237 +/- 30 and 206 +/- 25 pg/mL, respectively; P = 0.0014). CONCLUSIONS: A MID reduces the number of platelets and leukocytes and VEGF concentrations in healthy subjects. This may be linked to higher serum concentrations of n-3 fatty acids, which promote a favorable composition of phospholipids.