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1.
Front Immunol ; 12: 615656, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33841398

RESUMO

Purpose: The prevalence of peripheral nervous system (PNS) involvement in primary Sjögren's syndrome (pSS) has been reported to range from 2% to over 50%. Bias in study designs, including low number of patients and unclearly defined rheumatological and neurological diagnosis could explain such variability. Consequently, the exact depiction of PNS involvement in pSS is still lacking. This study aimed at analyzing the prevalence and the clinical and laboratory factors associated with PNS involvement in a very large cohort of well-characterized pSS patients with a clearly defined neurological diagnosis. Methods: Clinical and serological data of 1,695 pSS patients with specific and accurate information on PNS involvement were analyzed. Comparisons between patients with and without PNS involvement and between patients with distinct subsets of PNS manifestations were performed. Results: Prevalence of PNS involvement was 3.7%. The most frequent types observed were pure sensory neuropathies and axonal sensorimotor polyneuropathies (SMP). Patients with PNS involvement exhibited a more active disease profile and were more frequently treated with immunosuppressants. Intriguingly, clinical and serological negative prognostic factors, including purpura, extra-glandular manifestations, leukopenia, low complement and cryoglobulinemia, principally characterized patients with SMP, while subjects with pure sensory neuropathy displayed a milder phenotype. Conclusion: Our results highlight that PNS involvement is rather rare, but prognostically relevant in pSS. Main adverse prognostic features characterize patients with SMP, while pure sensory neuropathies are usually associated with a mild clinical picture. These findings, useful for patient stratification, may suggest protean pathogenic pathways underlying different types of PNS manifestations in pSS.

3.
Pharmaceuticals (Basel) ; 14(3)2021 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-33803847

RESUMO

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a wide spectrum of clinical manifestations. The respiratory system can be involved in up to 50-70% of patients and be the presenting manifestation of the disease in 4-5% of cases. Every part of the respiratory part can be involved, and the severity can vary from mild self-limiting to life threatening forms. Respiratory involvement can be primary (caused by SLE itself) or secondary (e.g., infections or drug toxicity), acute or chronic. The course, treatment and prognosis vary greatly depending on the specific pattern of the disease. This review article aims at providing an overview of respiratory manifestations in SLE along with an update about therapeutic approaches including novel biologic therapies.

4.
BMC Musculoskelet Disord ; 22(1): 227, 2021 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-33641666

RESUMO

In recent years, technological improvements allowed imaging modalities to become increasingly essential in achieving early and precise diagnoses in the field of rheumatic and musculoskeletal diseases (RMDs). To date, imaging examinations are routinely used in all steps of diagnostic and therapeutic care pathways of patients affected by RMDs. The articles published in this Article Collection clearly show the efforts of researchers to find innovative applications of musculoskeletal imaging in clinical practice and to face the crucial challenges that remain in the interpretation and quality control of images. Highly performing diagnostic technologies are currently available to early diagnose and accurately monitor several musculoskeletal disorders, but also to guide personalized interventional therapeutic procedures tailored to the individual patients in the emerging process of precision medicine. Among these new modalities, some are particularly promising and thereby subject to several lines of research in RMDs, including SPECT-CT and dual-energy CT, MRI sequences, high and ultra-high frequency ultrasound with effective tools like shear wave elastography.


Assuntos
Técnicas de Imagem por Elasticidade , Doenças Musculoesqueléticas , Humanos , Imagem por Ressonância Magnética , Doenças Musculoesqueléticas/diagnóstico por imagem , Doenças Musculoesqueléticas/terapia , Cintilografia , Ultrassonografia
5.
Nutrients ; 13(3)2021 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-33673487

RESUMO

In recent years, an increasing interest in the influence of diet in rheumatic and musculoskeletal diseases (RMDs) led to the publication of several articles exploring the role of food/nutrients in both the risk of developing these conditions in normal subjects and the natural history of the disease in patients with established RMDs. Diet may be a possible facilitator of RMDs due to both the direct pro-inflammatory properties of some nutrients and the indirect action on insulin resistance, obesity and associated co-morbidities. A consistent body of research has been conducted in rheumatoid arthritis (RA), while studies in systemic lupus erythematosus (SLE) are scarce and have been conducted mainly on experimental models of the disease. This review article aims to outline similarities and differences between RA and SLE based on the existing literature.

6.
Panminerva Med ; 2021 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-33765764

RESUMO

Uric acid has long been considered responsible for a single specific disease, namely gout. In recent years, novel knowledge has emerged linking serum uric acid with a variety of conditions and related risk factors, from hypertension, metabolic syndrome, and type 2 diabetes, to fatal/nonfatal cardiovascular diseases and all-cause death, with the underlying mechanisms involving disrupted neurohormonal and metabolic signaling as well as oxidative stress and inflammation. Importantly, the cut-off value of serum uric acid predicting the risk of incident events is within the range of normality and below the threshold for increased risk of gout. A large contribution to the advancement in knowledge in the cardiovascular implications of uric acid derives from the Italian study URic acid Right for heArt Health (URRAH). This review summarizes the mechanisms linking uric acid with cardiovascular risk and the major findings of the URRAH study. The need for a reappraisal of the definition of range of normality for uric acid is discussed.

7.
Sci Rep ; 11(1): 4863, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33649408

RESUMO

The coronavirus 2019 disease (COVID-19) is characterised by a heterogeneous clinical presentation, a complex pathophysiology and a wide range of imaging findings, depending on disease severity and time course. We conducted a retrospective evaluation of hospitalized patients with proven SARS-CoV-2 infection, clinical signs of COVID-19 and computed tomography (CT) scan-proven pulmonary involvement, in order to identify relationships between clinical, serological, imaging data and disease outcomes in patients with COVID-19. Clinical and serological records of patients admitted to two COVID-19 Units of the Abruzzo region in Italy with proven SARS-CoV-2 pulmonary involvement investigated with CT scan, assessed at the time of admission to the hospital, were retrospectively evaluated. Sixty-one patients (22 females and 39 males) of median age 65 years were enrolled. Fifty-six patients were discharged while death occurred in 5 patients. None of the lung abnormalities detected by CT was different between discharged and deceased patients. No differences were observed in the features and extent of pulmonary involvement according to age and gender. Logistic regression analysis with age and gender as covariates demonstrated that ferritin levels over the 25th percentile were associated with the involvement of all 5 pulmonary lobes (OR = 14.5, 95% CI 2.3-90.9, p = 0.004), the presence of septal thickening (OR = 8.2, 95% CI 1.6-40.9, p = 0.011) and the presence of mediastinal lymph node enlargement (OR = 12.0, 95% CI 1.1-127.5, p = 0.039) independently of age and gender. We demonstrated that ferritin levels over the 25th percentile are associated with a more severe pulmonary involvement, independently of age and gender and not associated with disease outcomes. The identification of reliable biomarkers in patients with COVID-19 may help guiding clinical decision, tailoring therapeutic approaches and ultimately improving the care and prognosis of patients with this disease.


Assuntos
Ferritinas/sangue , Pulmão/diagnóstico por imagem , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Adulto , Idoso , Idoso de 80 Anos ou mais , /diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
8.
Ann Rheum Dis ; 2021 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-33547062

RESUMO

OBJECTIVES: Severe systemic inflammation associated with some stages of COVID-19 and in fatal cases led therapeutic agents developed or used frequently in Rheumatology being at the vanguard of experimental therapeutics strategies. The aim of this project was to elaborate EULAR Points to consider (PtCs) on COVID-19 pathophysiology and immunomodulatory therapies. METHODS: PtCs were developed in accordance with EULAR standard operating procedures for endorsed recommendations, led by an international multidisciplinary Task Force, including rheumatologists, translational immunologists, haematologists, paediatricians, patients and health professionals, based on a systemic literature review up to 15 December 2020. Overarching principles (OPs) and PtCs were formulated and consolidated by formal voting. RESULTS: Two OPs and fourteen PtCs were developed. OPs highlight the heterogeneous clinical spectrum of SARS-CoV-2 infection and the need of a multifaceted approach to target the different pathophysiological mechanisms. PtCs 1-6 encompass the pathophysiology of SARS-CoV-2 including immune response, endothelial dysfunction and biomarkers. PtCs 7-14 focus on the management of SARS-CoV-2 infection with immunomodulators. There was evidence supporting the use of glucocorticoids, especially dexamethasone, in COVID-19 cases requiring oxygen therapy. No other immunomodulator demonstrated efficacy on mortality to date, with however inconsistent results for tocilizumab. Immunomodulatory therapy was not associated with higher infection rates. CONCLUSIONS: Multifactorial pathophysiological mechanisms, including immune abnormalities, play a key role in COVID-19. The efficacy of glucocorticoids in cases requiring oxygen therapy suggests that immunomodulatory treatment might be effective in COVID-19 subsets. Involvement of rheumatologists, as systemic inflammatory diseases experts, should continue in ongoing clinical trials delineating optimal immunomodulatory therapy utilisation in COVID-19.

9.
Artigo em Inglês | MEDLINE | ID: mdl-33493333

RESUMO

OBJECTIVES: To characterize the phenotypic presentation at diagnosis of childhood-onset primary Sjögren syndrome (SjS). METHODS: The Big Data Sjögren Project Consortium is an international, multicentre registry using worldwide data-sharing cooperative merging of pre-existing clinical SjS databases from the five continents. For this study, we selected those patients in whom the disease was diagnosed below the age of 19 according to the fulfilment of the 2002/2016 classification criteria. RESULTS: Among the 12 083 patients included in the Sjögren Big Data Registry, 158 (1.3%) patients had a childhood-onset diagnosis (136 girls, mean age of 14.2 years): 126 (80%) reported dry mouth, 111 (70%) dry eyes, 52 (33%) parotid enlargement, 118/122 (97%) positive minor salivary gland biopsy and 60/64 (94%) abnormal salivary ultrasound study, 140/155 (90%) positive antinuclear antibody, 138/156 (89%) anti-Ro/La antibodies and 86/142 (68%) positive rheumatoid factor. The systemic ESSDAI domains containing the highest frequencies of active patients included the glandular (47%), articular (26%) and lymphadenopathy (25%) domains. Patients with childhood-onset primary SjS showed the highest mean ESSDAI score and the highest frequencies of systemic disease in 5 (constitutional, lymphadenopathy, glandular, cutaneous and haematological) of the 12 ESSDAI domains, and the lowest frequencies in 4 (articular, pulmonary, peripheral nerve and central nervous system) in comparison with patients with adult-onset disease. CONCLUSIONS: Childhood-onset primary SjS involves around 1% of patients with primary SjS, with a clinical phenotype dominated by sicca features, parotid enlargement and systemic disease. Age at diagnosis plays a key role on modulating the phenotypic expression of the disease.

10.
Autoimmun Rev ; 20(2): 102738, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33326854

RESUMO

Autoimmune diseases (AIDs) share similar serological, clinical, and radiological findings, but, behind these common features, there are different pathogenic mechanisms, immune cells dysfunctions, and targeted organs. In this context, multiple lines of evidence suggest the application of precision medicine principles to AIDs to reduce the treatment failure. Precision medicine refers to the tailoring of therapeutic strategies to the individual characteristics of each patient, thus it could be a new approach for management of AIDS which considers individual variability in genes, environmental exposure, and lifestyle. Precision medicine would also assist physicians in choosing the right treatment, the best timing of administration, consequently trying to maximize drug efficacy, and, possibly, reducing adverse events. In this work, the growing body of evidence is summarized regarding the predictive factors for drug response in patients with AIDs, applying the precision medicine principles to provide high-quality evidence for therapeutic opportunities in improving the management of these patients.


Assuntos
Doenças Autoimunes , Lúpus Eritematoso Sistêmico , Síndrome de Sjogren , Doenças Autoimunes/terapia , Consenso , Humanos , Medicina de Precisão
11.
Panminerva Med ; 2020 Dec 04.
Artigo em Inglês | MEDLINE | ID: mdl-33274907

RESUMO

INTRODUCTION: Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by a chronic inflammatory process mainly affecting the exocrine glands but also burdened by a wide range of extraglandular manifestations. Non-Hodgkin lymphoma (NHL) is the most severe pSS complication worsening disease prognosis. EVIDENCE ACQUISITION: We summarized original articles published between April 2018 and May 2020 on this topic aiming to highlight novelties on lymphoma and lymphomagenesis. EVIDENCE SYNTHESIS: Results have been grouped by epidemiology, etiopathogenesis and predictors of lymphoma. CONCLUSIONS: NHL is the most severe complication of pSS and occurs in around 5-10% of patients. Over the last two years, several clinical, serological, and histopathological features have been proposed as predictive for lymphoma in pSS patients, allowing early diagnosis and consequently, better management and prognosis. Individual monitoring for disease activity and possible lymphoma development is a central clue in the evaluation of pSS patients.

12.
Artigo em Inglês | MEDLINE | ID: mdl-33316070

RESUMO

OBJECTIVE: To analyse the prognosis and outcomes of SARS-CoV-2 infection in patients with primary SS. METHODS: We searched for patients with primary SS presenting with SARS-CoV-2 infection (defined following and according to the European Centre for Disease Prevention and Control guidelines) among those included in the Big Data Sjögren Registry, an international, multicentre registry of patients diagnosed according to the 2002/2016 classification criteria. RESULTS: A total of 51 patients were included in the study (46 women, mean age at diagnosis of infection of 60 years). According to the number of patients with primary SS evaluated in the Registry (n = 8211), the estimated frequency of SARS-CoV-2 infection was 0.62% (95% CI 0.44, 0.80). All but two presented with symptoms suggestive of COVID-19, including fever (82%), cough (57%), dyspnoea (39%), fatigue/myalgias (27%) and diarrhoea (24%), and the most frequent abnormalities included raised lactate dehydrogenase (LDH) (88%), CRP (81%) and D-dimer (82%) values, and lymphopenia (70%). Infection was managed at home in 26 (51%) cases and 25 (49%) required hospitalization (five required admission to ICU, four died). Compared with patients managed at home, those requiring hospitalization had higher odds of having lymphopenia as laboratory abnormality (adjusted OR 21.22, 95% CI 2.39, 524.09). Patients with comorbidities had an older age (adjusted OR 1.05, 95% CI 1.00, 1.11) and showed a risk for hospital admission six times higher than those without (adjusted OR 6.01, 95% CI 1.72, 23.51) in the multivariate analysis. CONCLUSION: Baseline comorbidities were a key risk factor for a more complicated COVID-19 in patients with primary SS, with higher rates of hospitalization and poor outcomes in comparison with patients without comorbidities.

13.
Clin Exp Rheumatol ; 38 Suppl 126(4): 166-173, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33025895

RESUMO

OBJECTIVES: Articular manifestations (AMs) are observed in a large proportion of patients with primary Sjögren's syndrome (pSS) and can occur at the time of pSS diagnosis or during the disease course. Although in the majority of cases AMs are mild and self-limiting, some patients may experience chronic polyarthritis requiring treatment with DMARDs. Ultrasonography (US) and magnetic resonance imaging (MRI) can help assessing the extent of articular involvement and guide the treatment. The aim of this study was to describe clinical, serological, and histological picture of a cohort of pSS patients with AMs. METHODS: Clinical and serological records were retrospectively evaluated and either US or MRI were performed to evaluate AMs and their features were described according to the OMERACT scoring systems. RESULTS: One hundred and thirty-three pSS patients were enrolled, of whom 115 (86%) with articular involvement. In particular, 91 patients (68%) displayed AMs at the time of pSS diagnosis while 24 patients (32%) during the course of the disease. Patients with AMs during the disease course were diagnosed with pSS at a younger age and reported a higher VAS dryness compared to patients displaying AMs at pSS onset. Hands and wrists were the most frequently involved sites followed by knees, shoulders and ankles. Overall, a consistent number of abnormalities were detected, more by MRI than US. Hands and wrists were the most frequently evaluated sites and the prevalence of all MRI abnormalities was similar between the different sites and comparable between the groups. CONCLUSIONS: pSS AMs encompass a wide disease spectrum ranging from arthralgia to erosive arthritis resembling RA and therefore represent an important determinant of patients' quality of life. Imaging techniques such as US and MRI may be useful in the follow-up of pSS patients for prompt identification of AMs, for the quantification of their extent and ultimately for providing guidance on treatment and improving patient care.


Assuntos
Síndrome de Sjogren , Humanos , Articulações , Qualidade de Vida , Estudos Retrospectivos , Síndrome de Sjogren/diagnóstico por imagem , Ultrassonografia
14.
Clin Exp Rheumatol ; 38 Suppl 126(4): 53-56, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33095137

RESUMO

OBJECTIVES: Immunological parameters exert a relevant diagnostic and prognostic role in primary Sjögren's syndrome (pSS) and may identify specific disease phenotypes. Among disease-associated immunological features, anti-La/SSB are rarely found without concomitant anti-Ro/SSA and their clinical significance in patients with pSS has been poorly investigated. Thus, we aimed to characterise the value of anti-La/SSB analysing clinical and serologic features of a wide cohort of pSS patients with both circulating anti-Ro/SSA and positive salivary gland biopsy (SGB). METHODS: Clinical and serological data of 600 pSS patients with both anti-Ro/SSA and SGB positivity and categorised according to anti-La/SSB status were retrospectively analysed. Comparisons between patients with and without circulating anti-La/SSB were performed. RESULTS: Among the whole cohort, 319 (53%) of patients were anti-La/SSB negative and 281 (47%) were anti-La/SSB positive. Anti-La/SSB positive patients were younger at disease diagnosis and had a longer disease duration. Moreover, anti-La/SSB positive patients had a higher prevalence of hypergammaglobulinaemia and circulating rheumatoid factor and of lymphoproliferative disorders in comparison to seronegative group. At multivariate analysis, hypergammaglobulinaemia (OR=1,7; 95% CI 1.17, 2.43), rheumatoid factor (OR=2.3; 95% CI 1.6, 3.3) and lymphoma (OR=2.6; 95% CI 1.12, 5.96) were identified as independent variables significantly associated with anti-La/SSB positivity. CONCLUSIONS: In patients with pSS and concomitant anti-Ro/SSA and SGB positivity, the presence of anti-La/SSB may help in identifying a disease subset with distinct prognostic features, especially in terms of higher risk of lymphoproliferative complications.


Assuntos
Síndrome de Sjogren , Anticorpos Antinucleares , Biópsia , Humanos , Estudos Retrospectivos , Glândulas Salivares , Síndrome de Sjogren/diagnóstico
15.
Front Med (Lausanne) ; 7: 534, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33015092

RESUMO

Introduction: Over the last two decades, rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren's syndrome (pSS). Several studies reported that B lymphocyte depletion with RTX is effective to treat some aspects within the disease spectrum, by reducing disease activity and affecting the inflammation and lymphoid organization that occur in target tissues. Notwithstanding, randomized controlled trials failed to confirm such evidence. With the recent release of several RTX biosimilars on the market, their efficacy and safety compared to the originator must be ascertained across different indications. This study aimed at comparing efficacy and safety of RTX originator and CT-P10 RTX biosimilar in pSS patients in a real-life setting. Methods: Clinical and laboratory records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least two courses of either RTX originator or CT-P10 with complete data at baseline and after 12, 24, 36, and 48 weeks of treatment were enrolled. Disease activity was assessed with the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) and its clinical version without the biological domain (clinESSDAI). Patient-reported symptoms were assessed with the EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI). Adverse events (AEs) occurring during the study period were also recorded. Results: Nine patients who received RTX originator and eight patients who received CT-P10 were enrolled. Baseline clinical and serological features, including ESSDAI and ESSPRI, were similar in the two treatment groups. An efficient depletion of circulating CD19+ B lymphocytes was achieved in both treatment arms. Both RTX originator and CT-P10 significantly reduced ESSDAI and clinESSDAI by week 24, and no difference between the groups was observed at any timepoint. Conversely, changes of ESSPRI overtime did not differ between the two treatment arms and were not statistically significant compared to corresponding baseline values. With regard to safety, at 48 weeks of follow-up, only four mild AEs (two in the RTX originator and two in the CT-P10 group) were observed. Conclusion: Our study provides the first evidence that, at 48 weeks of follow-up, RTX originator and CT-P10 display similar efficacy and safety profiles in pSS.

16.
BMC Rheumatol ; 4: 51, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32974609

RESUMO

Background: Hepatitis E virus (HEV) represents the most common cause of acute hepatitis and jaundice in the world. About 2 million of infection cases occur each year in Europe, mainly as autochthonous anthropozoonosis, and HEV can be transmitted through undercooked pork meat. This infection has been linked to various extra-hepatic manifestations, while chronic infections with a rapid development of liver failure have been described in heavily immunosuppressed patients undergoing solid organ transplantations (SOTs), in patients with hematological diseases or with immunodeficiency virus infection. Main body of abstract: The purpose of this review article is to describe rheumatic manifestations related to HEV infection and their implications for rheumatologists in the daily clinical practice. Despite recent accumulating literature in this field, little is known about the course of the infection in patients with rheumatic diseases (RDs) and about the impact of immunosuppressive drugs. Moreover, HEV infection can mimic RDs' manifestations or drugs toxicity. Specific guidelines on management are lacking and the majority of data are referred to SOTs receivers. Conclusions: More studies are needed to better understand the real impact of HEV infection in patients with RDs, regarding both clinical outcomes and their management.

18.
Clin Exp Rheumatol ; 2020 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-32940209

RESUMO

OBJECTIVES: The AQUEOUS (Anti-phospholipid syndrome: a QUEstionnaire for yOUng patientS) study aimed to assess how the diagnosis of primary anti-phospholipid syndrome (PAPS) affects the psychosocial status of young patients. METHODS: Subjects with PAPS aged 18-45 years were invited to compile an ad hoc designed questionnaire and the Short Form-12 to assess quality of life (QoL). RESULTS: Ninety-two patients (83.7% females) were recruited in 10 Italian centres. Vascular and obstetric manifestations were equally represented. Nearly half of the patients perceived the need for psychological support, 89.2% when considering women after pregnancy complications. Social activities and working efficiency were reduced in APS patients, also intimacy was threatened. In all cases, fatigue appeared to be the main determinant. PAPS affected family planning, due to fears of treatment side-effects, disease hereditariness, inability to care for the newborn child. Fertility appeared to be conserved: the median time to pregnancy was 2 months; assisted reproduction techniques were pursued by 5 women. Our survey documented significantly lower rates of hospitalisation and learning disabilities in 51 children born after APS diagnosis as compared to 48 children born before. PAPS patients displayed lower QoL in physical and, to a greater extent, mental scores compared to the general Italian population. Both components were significantly lower in women and in patients with fatigue. CONCLUSIONS: The AQUEOUS study assessed for the first time the unmet needs of young PAPS patients, enabling the development of a future "youth-focused" strategy to reduce disease burden.

20.
Artigo em Inglês | MEDLINE | ID: mdl-32793982

RESUMO

OBJECTIVE: To establish optimal cut-off values for the scores of the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromialgia Assessment Scale (FAS 2019mod), and the Polysymptomatic Distress Scale (PDS) in order to distinguish five levels of FM disease severity. METHODS: Consecutive FM patients were evaluated with the three clinimetric indices, and each patient was required to answer the anchor question: 'In general, would you say your health is 1 = very good, 2 = good, 3 = fair, 4 = poor, or 5 = very poor?'-which represented the external criterion. Cut-off points were established through the interquartile reconciliation approach. RESULTS: The study sample consisted of 2181 women (93.2%) and 158 men (6.8%), with a mean age of 51.9 (11.5) years, and mean disease duration was 7.3 (6.9) years. The overall median FIQR, FAS 2019 mod and PDS scores (25th-75th percentiles) were respectively 61.16 (41.16-77.00), 27.00 (19.00-32.00) and 19.0 (13.00-24.00). Reconciliation of the mean 75th and 25th percentiles of adjacent categories defined the severity states for FIQR: 0-23 for remission, 24-40 for mild disease, 41-63 for moderate disease, 64-82 for severe disease and >83 for very severe disease; FAS 2019 mod: 0-12 for remission, 13-20 for mild disease, 21-28 for moderate disease, 29-33 for severe disease and >33 for very severe disease; PDS: 0-5 for remission, 6-15 for mild disease, 16-20 for moderate disease, 21-25 for severe disease and >25 for very severe disease. CONCLUSIONS: Disease severity cut-offs can represent an important improvement in interpreting FM.

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