Artigos e Materiais de Revistas Científicas - LIM/17

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A coleção de Artigos e Materiais de Revistas Científicas engloba artigos originais, artigos de revisão, artigos de atualização, artigos técnicos, relatos de experiências, resenhas, ensaios, editoriais, cartas ao editor, debates, notas científicas e técnicas, depoimentos, entrevistas e pontos de vista. Consideram-se como artigos científicos originais os trabalhos redigidos para divulgação de informações e resultados sobre determinada pesquisa científica, publicados em periódico científico após avaliação por outros pesquisadores.

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  • article 0 Citação(ões) na Scopus
    Data-driven, cross-disciplinary collaboration: lessons learned at the largest academic health center in Latin America during the COVID-19 pandemic
    (2024) RITTO, Ana Paula; ARAUJO, Adriana Ladeira de; CARVALHO, Carlos Roberto Ribeiro de; SOUZA, Heraldo Possolo De; FAVARETTO, Patricia Manga e Silva; SABOYA, Vivian Renata Boldrim; GARCIA, Michelle Louvaes; KULIKOWSKI, Leslie Domenici; KALLAS, Esper Georges; PEREIRA, Antonio Jose Rodrigues; COBELLO JUNIOR, Vilson; SILVA, Katia Regina; ABDALLA, Eidi Raquel Franco; SEGURADO, Aluisio Augusto Cotrim; SABINO, Ester Cerdeira; RIBEIRO JUNIOR, Ulysses; FRANCISCO, Rossana Pulcineli Vieira; MIETHKE-MORAIS, Anna; LEVIN, Anna Sara Shafferman; SAWAMURA, Marcio Valente Yamada; FERREIRA, Juliana Carvalho; SILVA, Clovis Artur; MAUAD, Thais; GOUVEIA, Nelson da Cruz; LETAIF, Leila Suemi Harima; BEGO, Marco Antonio; BATTISTELLA, Linamara Rizzo; DUARTE, Alberto Jose da Silva; SEELAENDER, Marilia Cerqueira Leite; MARCHINI, Julio; FORLENZA, Orestes Vicente; ROCHA, Vanderson Geraldo; MENDES-CORREA, Maria Cassia; COSTA, Silvia Figueiredo; CERRI, Giovanni Guido; BONFA, Eloisa Silva Dutra de Oliveira; CHAMMAS, Roger; BARROS FILHO, Tarcisio Eloy Pessoa de; BUSATTO FILHO, Geraldo
    Introduction The COVID-19 pandemic has prompted global research efforts to reduce infection impact, highlighting the potential of cross-disciplinary collaboration to enhance research quality and efficiency.Methods At the FMUSP-HC academic health system, we implemented innovative flow management routines for collecting, organizing and analyzing demographic data, COVID-related data and biological materials from over 4,500 patients with confirmed SARS-CoV-2 infection hospitalized from 2020 to 2022. This strategy was mainly planned in three areas: organizing a database with data from the hospitalizations; setting-up a multidisciplinary taskforce to conduct follow-up assessments after discharge; and organizing a biobank. Additionally, a COVID-19 curated collection was created within the institutional digital library of academic papers to map the research output.Results Over the course of the experience, the possible benefits and challenges of this type of research support approach were identified and discussed, leading to a set of recommended strategies to enhance collaboration within the research institution. Demographic and clinical data from COVID-19 hospitalizations were compiled in a database including adults and a minority of children and adolescents with laboratory confirmed COVID-19, covering 2020-2022, with approximately 350 fields per patient. To date, this database has been used in 16 published studies. Additionally, we assessed 700 adults 6 to 11 months after hospitalization through comprehensive, multidisciplinary in-person evaluations; this database, comprising around 2000 fields per subject, was used in 15 publications. Furthermore, thousands of blood samples collected during the acute phase and follow-up assessments remain stored for future investigations. To date, more than 3,700 aliquots have been used in ongoing research investigating various aspects of COVID-19. Lastly, the mapping of the overall research output revealed that between 2020 and 2022 our academic system produced 1,394 scientific articles on COVID-19.Discussion Research is a crucial component of an effective epidemic response, and the preparation process should include a well-defined plan for organizing and sharing resources. The initiatives described in the present paper were successful in our aim to foster large-scale research in our institution. Although a single model may not be appropriate for all contexts, cross-disciplinary collaboration and open data sharing should make health research systems more efficient to generate the best evidence.
  • article 0 Citação(ões) na Scopus
    Physically Inactive Undergraduate Students Exhibit More Symptoms of Anxiety, Depression, and Poor Quality of Life than Physically Active Students
    (2023) SANTANA, E. E. S. D.; NEVES, L. M.; SOUZA, K. C. D.; MENDES, T. B.; ROSSI, F. E.; SILVA, A. A. D.; OLIVEIRA, R. D.; PERILHãO, M. S.; ROSCHEL, H.; GIL, S.
    Background: The World Health Organization (WHO) recommends at least 150 min of moderate or vigorous activity (MVPA) per week for health benefits. However, meeting WHO guidelines for physical activity has been shown to be a great challenge for general populations and it may be even more difficult for undergraduate students due to elevated academic demand, thus negatively affecting general health status. Thus, this study investigated whether undergraduate students meeting WHO guidelines for physical activity show greater scores for symptoms of anxiety, depression, and poor quality of life than their counterparts not meeting guideline recommendations. Additionally, symptoms of anxiety, depression, and poor quality of life among academic areas were compared. Methods: This is a cross-sectional study. The participants were recruited through messaging apps or institutional e-mail. The participants filled out an online consent form, questionnaires to assess demographic and academic characteristics, the International Physical Activity Questionnaire, the Beck depression and anxiety inventory, and the short-form 36-item health survey questionnaire. The participants were classified as physically active (MVPA > 150 min/week) or inactive (MVPA < 150 min/week) according to WHO Guidelines. Results: A total of 371 individuals were included in the analysis. Physically inactive students demonstrated higher scores of depression (17.96 vs. 14.62; 95% CI: −5.81 to −0.86; p = 0.0083) than physically active ones. SF-36 analyses revealed that physically inactive students had lower values in mental (45.68 vs. 52.77; 95% CI: 2.10 to 12.06; p = 0.0054) and physical (59.37 vs. 67.14; 95% CI: 3.24 to 12.30; p = 0.0015) domains compared with physically active ones. As for SF-36 subscales, physically inactive students showed lower scores in function capacity (70.45 vs. 79.70; 95% CI: 4.27 to 14.49; p = 0.0003), mental health (45.57 vs. 55.60; 95% CI: 5.28 to 14.76; p < 0.0001), social aspects (48.91 vs. 57.69; 95%CI: 3.47 to 14.08; p = 0.0012), vitality (42.19 vs. 50.61; 95% CI: 3.47 to 13.35; p = 0.0009), pain (61.85 vs. 68.00; 95% CI: 1.27 to 11.02; p = 0.0135), and general health status (53.82 vs. 63.81; 95% CI: 5.21 to 14.75; p < 0.0001) than their physically active peers. Conclusions: The findings suggest that undergraduate students who do not meet WHO guidelines for physical activity display higher scores of anxiety, depression, and poor quality of life in comparison with their counterparts meeting physical activity guidelines. Collectively, these data suggest the need for academic institutions and policy makers to monitor and promote in-campus interventions to encourage physical activity.
  • article 2 Citação(ões) na Scopus
    Demographic, clinical, laboratory data, prognostic, and treatment features of patients with antisynthetase syndrome: An international, two-center cohort study
    (2022) SILVA, L. M. B. Da; RATHORE, U.; AGARWAL, V.; GUPTA, L.; SHINJO, S. K.
    Objectives: To compare clinical, demographic, laboratory data, prognostic and treatment characteristics of patients with antisynthetase syndrome (ASSD) treated in two different centers of India and Brazil. Patients and methods: This international, two-center, retro-prospective cohort study which was conducted at two tertiary rheumatology centers (one in Brazil and one in India) between January 2000 to January 2020 included a total of 115 patients with ASSD (21 males, 94 females; mean age; at disease diagnosis at 40.3; range, 18 to 80 years). Demographic, clinical and laboratory data of the patients were recorded. Clinical involvement was evaluated. Results: Of the patients, 81 were Brazilians and 34 were of Indian origin. The Indian group exhibited a greater delay in diagnosis after the onset of symptoms compared to Brazilian patients (12 vs. 6 months, respectively; p=0.026). Brazilian patients exhibited a significantly higher prevalence of joint and lung involvement, mechanic’s hands, and Raynaud’s phenomenon. Anti-Jo-1 was the most common autoantibodies in both groups. Systemic arterial hypertension, followed by diabetes mellitus were the most prevalent comorbidities. Concerning previously used drugs, the Indian patients had a larger group of patients treated with antimalarials, whereas the Brazilian group used more azathioprine and intravenous immunoglobulin. A higher proportion of Indian patients was treated with one immunosuppressive drug (70.6%), while the Brazilian group were often treated using two immunosuppressive drugs (33%). Comparison between the severity and prognosis showed that Brazilian group had a higher number of relapses, and during follow-up, the global mortality rates were similar in both groups (6.2% for Brazilian vs. 8.8% for Indian). Conclusion: Brazilian and Indian patients with ASSD have comparable epidemiological characteristics such as age at the time of disease diagnosis, and sex distribution, and autoantibodies. Diagnostic delay is seen in Indian patients, and Brazilians exhibit a higher prevalence of joint and lung involvement, mechanic’s hands, Raynaud’s phenomenon with a higher number of relapses, although the mortality rate seems to be similar in both groups.
  • article 0 Citação(ões) na Scopus
    Increased Prolonged Sitting in Patients with Rheumatoid Arthritis during the COVID-19 Pandemic: A Within-Subjects, Accelerometer-Based Study
    (2023) PINTO, A. J.; REZENDE, D.; SIECZKOWSKA, S. M.; MEIRELES, K.; BONFIGLIOLI, K.; RIBEIRO, A. C. D. M.; BONFá, E.; OWEN, N.; DUNSTAN, D. W.; ROSCHEL, H.; GUALANO, B.
    Background: Social distancing measures designed to contain the COVID-19 pandemic can restrict physical activity, a particular concern for high-risk patient groups. We assessed rheumatoid arthritis patients’ physical activity and sedentary behavior level, pain, fatigue, and health-related quality of life prior to and during the social distancing measures implemented in Sao Paulo, Brazil. Methods: Post-menopausal females diagnosed with rheumatoid arthritis were assessed before (from March 2018 to March 2020) and during (from 24 May to 7 July 2020) social distancing measures to contain COVID-19 pandemic, using a within-subjects, repeated-measure design. Physical activity and sedentary behavior were assessed using accelerometry (ActivPAL micro). Pain, fatigue, and health-related quality of life were assessed by questionnaires. Results: Mean age was 60.9 years and BMI was 29.5 Kg/m2. Disease activity ranged from remission to moderate activity. During social distancing, there were reductions in light-intensity activity (13.0% [−0.2 h/day, 95% CI: −0.4 to −0.04; p = 0.016]) and moderate-to-vigorous physical activity (38.8% [−4.5 min/day, 95% CI: −8.1 to −0.9; p = 0.015]), but not in standing time and sedentary time. However, time spent in prolonged bouts of sitting ≥30 min increased by 34% (1.0 h/day, 95% CI: 0.3 to 1.7; p = 0.006) and ≥60 min increased by 85% (1.0 h/day, 95% CI: 0.5 to 1.6). There were no changes in pain, fatigue, and health-related quality of life (all p > 0.050). Conclusions: Imposed social distancing measures to contain the COVID-19 outbreak were associated with decreased physical activity and increased prolonged sedentary behavior, but did not change clinical symptoms sitting among patients with rheumatoid arthritis.
  • article 0 Citação(ões) na Scopus
    COVID-19 vaccine confidence in the post-vaccination era: Perceptions among adults with immune-mediated inflammatory diseases
    (2023) SANTANA, F. M.; REZENDE, R. P. V.; PASCHOAL, N. O. S.; ROCHA, L. F.; LOPES, J. B.; PEREZ, M. O.; BUNJES, B. G.; DORIO, M.; FURQUIM, M. A. D.; COBRA, J. F.; SALES, L. P.; FIGUEIREDO, C. P.
    Objective: Assess the perceived protection afforded by a range of COVID-19 vaccines in immune-mediated in-flammatory diseases patients previously vaccinated against SARS-CoV-2.Study design: Survey.Methods: On-line cross-sectional survey aimed at evaluating the perceived protection (and its determinants) afforded by a range of COVID-19 vaccines among immune-mediated inflammatory diseases previously vacci-nated for COVID-19.Results: Out of 493 eligible respondents who lived in Brazil, 397 (80.5%) were confident that their primary vaccination series would protect them against severe COVID-19. In multivariate analysis, only overlapping immune-mediated inflammatory diseases remained (negatively) associated with the perception of protection.Conclusions: No influence was found between COVID-19 vaccine types and the perception of protection after initial vaccinations.
  • article 9 Citação(ões) na Scopus
    Characteristics associated with poor COVID-19 outcomes in people with psoriasis, psoriatic arthritis and axial spondyloarthritis: data from the COVID-19 PsoProtect and Global Rheumatology Alliance physician-reported registries
    (2023) MACHADO, Pedro M.; SCHAEFER, Martin; MAHIL, Satveer K.; LIEW, Jean; GOSSEC, Laure; DAND, Nick; PFEIL, Alexander; STRANGFELD, Anja; REGIERER, Anne Constanze; FAUTREL, Bruno; ALONSO, Carla Gimena; SAAD, Carla G. S.; GRIFFITHS, Christopher E. M.; LOMATER, Claudia; MICELI-RICHARD, Corinne; WENDLING, Daniel; RODRIGUEZ, Deshire Alpizar; WIEK, Dieter; MATEUS, Elsa F.; SIROTICH, Emily; SORIANO, Enrique R.; RIBEIRO, Francinne Machado; OMURA, Felipe; MARTINS, Frederico Rajao; SANTOS, Helena; DAU, Jonathan; BARKER, Jonathan N.; HAUSMANN, Jonathan; HYRICH, Kimme L.; GENSLER, Lianne; SILVA, Ligia; JACOBSOHN, Lindsay; CARMONA, Loreto; PINHEIRO, Marcelo M.; ZELAYA, Marcos David; SEVERINA, Maria de los Angeles; YATES, Mark; DUBREUIL, Maureen; GORE-MASSY, Monique; ROMEO, Nicoletta; HAROON, Nigil; SUFKA, Paul; GRAINGER, Rebecca; HASSELI, Rebecca; LAWSON-TOVEY, Saskia; BHANA, Suleman; PHAM, Thao; OLOFSSON, Tor; BAUTISTA-MOLANO, Wilson; WALLACE, Zachary S.; YIU, Zenas Z. N.; YAZDANY, Jinoos; ROBINSON, Philip C.; SMITH, Catherine H.
    ObjectivesTo investigate factors associated with severe COVID-19 in people with psoriasis (PsO), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). MethodsDemographic data, clinical characteristics and COVID-19 outcome severity of adults with PsO, PsA and axSpA were obtained from two international physician-reported registries. A three-point ordinal COVID-19 severity scale was defined: no hospitalisation, hospitalisation (and no death) and death. ORs were estimated using multivariable ordinal logistic regression. ResultsOf 5045 cases, 18.3% had PsO, 45.5% PsA and 36.3% axSpA. Most (83.6%) were not hospitalised, 14.6% were hospitalised and 1.8% died. Older age was non-linearly associated with COVID-19 severity. Male sex (OR 1.54, 95% CI 1.30 to 1.83), cardiovascular, respiratory, renal, metabolic and cancer comorbidities (ORs 1.25-2.89), moderate/high disease activity and/or glucocorticoid use (ORs 1.39-2.23, vs remission/low disease activity and no glucocorticoids) were associated with increased odds of severe COVID-19. Later pandemic time periods (ORs 0.42-0.52, vs until 15 June 2020), PsO (OR 0.49, 95% CI 0.37 to 0.65, vs PsA) and baseline exposure to TNFi, IL17i and IL-23i/IL-12+23i (OR 0.57, 95% CI 0.44 to 0.73; OR 0.62, 95% CI 0.45 to 0.87; OR 0.67, 95% CI 0.45 to 0.98; respectively; vs no disease-modifying antirheumatic drug) were associated with reduced odds of severe COVID-19. ConclusionOlder age, male sex, comorbidity burden, higher disease activity and glucocorticoid intake were associated with more severe COVID-19. Later pandemic time periods, PsO and exposure to TNFi, IL17i and IL-23i/IL-12+23i were associated with less severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with PsO, PsA and axSpA during COVID-19 waves or similar future respiratory pandemics.
  • article 0 Citação(ões) na Scopus
    Exposure to air pollution as an environmental determinant of how Sjögren's disease is expressed at diagnosis
    (2023) BRITO-ZERON, P.; FLORES-CHAVEZ, A.; NG, W. -F.; HORVATH, I. Fanny; RASMUSSEN, A.; PRIORI, R.; BALDINI, C.; ARMAGAN, B.; OZKIZILTAS, B.; PRAPROTNIK, S.; SUZUKI, Y.; QUARTUCCIO, L.; HERNANDEZ-MOLINA, G.; ABACAR, K.; BARTOLONI, E.; RISCHMUELLER, M.; OLIVEIRA, F. Reis-de; TREVISANI, V. Fernandes Moca; JURCUT, C.; FUGMANN, C.; CARUBBI, F.; HOFAUER, B.; VALIM, V.; PASOTO, S. G.; RETAMOZO, S.; ATZENI, F.; FONSECA-AIZPURU, E.; LOPEZ-DUPLA, M.; GIACOMELLI, R.; NAKAMURA, H.; AKASBI, M.; THOMPSON, K.; SZANTO, A.; FARRIS, A. D.; VILLA, M.; BOMBARDIERI, S.; KILIC, L.; TUFAN, A.; PIRKMAJER, K. Perdan; FUJISAWA, Y.; VITA, S. De; INANC, N.; RAMOS-CASALS, M.
    ObjectiveTo analyse how the potential exposure to air pollutants can influence the key components at the time of diagnosis of Sjogren's phenotype (epidemiological profile, sicca symptoms, and systemic disease). MethodsFor the present study, the following variables were selected for harmonisation and refinement: age, sex, country, fulfilment of 2002/2016 criteria items, dry eyes, dry mouth, and overall ESSDAI score. Air pollution indexes per country were defined according to the OECD (1990-2021), including emission data of nitrogen and sulphur oxides (NO/SO), particulate matter (PM2.5 and 1.0), carbon monoxide (CO) and volatile organic compounds (VOC) calculated per unit of GDP, Kg per 1000 USD.ResultsThe results of the chi-square tests of independence for each air pollutant with the frequency of dry eyes at diagnosis showed that, except for one, all variables exhibited p-values <0.0001. The most pronounced disparities emerged in the dry eye prevalence among individuals inhabiting countries with the highest NO/SO exposure, a surge of 4.61 percentage points compared to other countries, followed by CO (3.59 points), non-methane (3.32 points), PM2.5 (3.30 points), and PM1.0 (1.60 points) exposures. Concerning dry mouth, individuals residing in countries with worse NO/SO exposures exhibited a heightened frequency of dry mouth by 2.05 percentage points (p<0.0001), followed by non-methane exposure (1.21 percentage points increase, p=0.007). Individuals inhabiting countries with the worst NO/SO, CO, and PM2.5 pollution levels had a higher mean global ESSDAI score than those in lower-risk nations (all p-values <0.0001). When systemic disease was stratified according to DAS into low, moderate, and high systemic activity levels, a heightened proportion of individuals manifesting moderate/severe systemic activity was observed in countries with worse exposures to NO/SO, CO, and PM2.5 pollutant levels. ConclusionFor the first time, we suggest that pollution levels could influence how SjD appears at diagnosis in a large international cohort of patients. The most notable relationships were found between symptoms (dryness and general body symptoms) and NO/SO, CO, and PM2.5 levels.
  • article 2 Citação(ões) na Scopus
    Still's disease continuum from childhood to elderly: data from the international AIDA Network Still's disease registry
    (2023) VITALE, Antonio; CAGGIANO, Valeria; LOPALCO, Giuseppe; GIARDINI, Henrique A. Mayrink; CICCIA, Francesco; ALMAGHLOUTH, Ibrahim A.; RUSCITTI, Piero; SFIKAKIS, Petros P.; TUFAN, Abdurrahman; DAGNA, Lorenzo; GIACOMELLI, Roberto; HINOJOSA-AZAOLA, Andrea; RAGAB, Gafaar; DIRESKENELI, Haner; FOTIS, Lampros; SOTA, Jurgen; IANNONE, Florenzo; MORRONE, Maria; ANTONELLI, Isabele Parente de Brito; DAGOSTIN, Marilia Ambiel; IACONO, Daniela; PATRONE, Martina; ASFINA, Kazi; ALANAZI, Fehaid; COLA, Ilenia Di; GAGGIANO, Carla; TEKTONIDOU, Maria G.; KARDAS, Riza Can; KUCUK, Hamit; CAMPOCHIARO, Corrado; TOMELLERI, Alessandro; NAVARINI, Luca; BERARDICURTI, Onorina; MARTIN-NARES, Eduardo; TORRES-RUIZ, Jiram; MAHMOUD, Ayman Abdel-Monem Ahmed; ALIBAZ-ONER, Fatma; KOURTESI, Katerina; TARSIA, Maria; SFRISO, Paolo; MAKOWSKA, Joanna; GOVONI, Marcello; TORRE, Francesco La; MAGGIO, Maria Cristina; MONTI, Sara; GIUDICE, Emanuela Del; EMMI, Giacomo; BARTOLONI, Elena; HERNANDEZ-RODRIGUEZ, Jose; GOMEZ-CAVERZASCHI, Veronica; MAIER, Armin; SIMONINI, Gabriele; IAGNOCCO, Annamaria; CONTI, Giovanni; OLIVIERI, Alma Nunzia; PAULIS, Amato De; GULLO, Alberto Lo; VIAPIANA, Ombretta; WIESIK-SZEWCZYK, Ewa; ERTEN, Sukran; OGUNJIMI, Benson; CARUBBI, Francesco; THARWAT, Samar; LASKARI, Katerina; COSTI, Stefania; TRIGGIANESE, Paola; KARAMANAKOS, Anastasios; CONFORTI, Alessandro; FRASSI, Micol; SEBASTIANI, Gian Domenico; GIDARO, Antonio; MAURO, Angela; BALISTRERI, Alberto; FABIANI, Claudia; FREDIANI, Bruno; CANTARINI, Luca
    Objective Still's disease is more frequently observed in the paediatric context, but a delayed onset is not exceptional both in the adulthood and in the elderly. However, whether paediatric-onset, adult-onset and elderly-onset Still's disease represent expressions of the same disease continuum or different clinical entities is still a matter of controversy. The aim of this study is to search for any differences in demographic, clinical features and response to treatment between pediatric-onset, adult-onset and elderly-onset Still's disease. Methods Subjects included in this study were drawn from the International AutoInflammatory Disease Alliance Network registry for patients with Still's disease. Results A total of 411 patients suffering from Still's disease were enrolled; the disease occurred in the childhood in 65 (15.8%) patients, in the adult 314 (76.4%) patients and in the elderly in 32 (7.8%) patients. No statistically significant differences at post-hoc analysis were observed in demographic features of the disease between pediatric-onset, adult-onset and elderly-onset Still's disease. The salmon-coloured skin rash (p=0.004), arthritis (p=0.009) and abdominal pain (p=0.007) resulted significantly more frequent among paediatric patients than in adult cases, while pleuritis (p=0.015) and arthralgia (p<0.0001) were significantly more frequent among elderly-onset patients compared with paediatric-onset subjects. Regarding laboratory data, thrombocytosis was significantly more frequent among paediatric patients onset compared with adult-onset subjects (p<0.0001), while thrombocytopenia was more frequent among elderly-onset patients although statistical significance was only bordered. No substantial differences were observed in the response to treatments. Conclusions Despite some minor difference between groups, overall, demographic, clinical, laboratory and treatments aspects of Still's disease were similarly observed in patients at all ages. This supports that pediatric-onset, adult-onset and elderly-onset Still's disease is the same clinical condition arising in different ages.
  • article 56 Citação(ões) na Scopus
    2023 ACR/EULAR antiphospholipid syndrome classification criteria
    (2023) BARBHAIYA, Medha; ZUILY, Stephane; NADEN, Ray; HENDRY, Alison; MANNEVILLE, Florian; AMIGO, Mary-Carmen; AMOURA, Zahir; ANDRADE, Danieli; ANDREOLI, Laura; ARTIM-ESEN, Bahar; ATSUMI, Tatsuya; AVCIN, Tadej; BELMONT, Michael H.; BERTOLACCINI, Maria Laura; BRANCH, D. Ware; CARVALHEIRAS, Graziela; CASINI, Alessandro; CERVERA, Ricard; COHEN, Hannah; COSTEDOAT-CHALUMEAU, Nathalie; CROWTHER, Mark; JESUS, Guilherme de; DELLUC, Aurelien; DESAI, Sheetal; SANCHO, Maria De; DEVREESE, Katrien M.; DIZ-KUCUKKAYA, Reyhan; DUARTE-GARCIA, Ali; FRANCES, Camille; GARCIA, David; GRIS, Jean-Christophe; JORDAN, Natasha; LEAF, Rebecca K.; KELLO, Nina; KNIGHT, Jason S.; LASKIN, Carl; LEE, Alfred I.; LEGAULT, Kimberly; LEVINE, Steve R.; LEVY, Roger A.; LIMPER, Maarten; LOCKSHIN, Michael D.; MAYER-PICKEL, Karoline; MUSIAL, Jack; MERONI, Pier Luigi; ORSOLINI, Giovanni; ORTEL, Thomas L.; PENGO, Vittorio; PETRI, Michelle; PONS-ESTEL, Guillermo; GOMEZ-PUERTA, Jose A.; RAIMBOUG, Quentin; ROUBEY, Robert; SANNA, Giovanni; SESHAN, Surya V.; SCIASCIA, Savino; TEKTONIDOU, Maria G.; TINCANI, Angela; WAHL, Denis; WILLIS, Rohan; YELNIK, Cecile; ZUILY, Catherine; GUILLEMIN, Francis; COSTENBADER, Karen; ERKAN, Doruk
    Objective To develop new antiphospholipid syndrome (APS) classification criteria with high specificity for use in observational studies and trials, jointly supported by the American College of Rheumatology (ACR) and EULAR. Methods This international multidisciplinary initiative included four phases: (1) Phase I, criteria generation by surveys and literature review; (2) Phase II, criteria reduction by modified Delphi and nominal group technique exercises; (3) Phase III, criteria definition, further reduction with the guidance of real-world patient scenarios, and weighting via consensus-based multicriteria decision analysis, and threshold identification; and (4) Phase IV, validation using independent adjudicators' consensus as the gold standard. Results The 2023 ACR/EULAR APS classification criteria include an entry criterion of at least one positive antiphospholipid antibody (aPL) test within 3 years of identification of an aPL-associated clinical criterion, followed by additive weighted criteria (score range 1-7 points each) clustered into six clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and two laboratory domains (lupus anticoagulant functional coagulation assays, and solid-phase enzyme-linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti-beta(2)-glycoprotein I antibodies). Patients accumulating at least three points each from the clinical and laboratory domains are classified as having APS. In the validation cohort, the new APS criteria vs the 2006 revised Sapporo classification criteria had a specificity of 99% vs 86%, and a sensitivity of 84% vs 99%. Conclusion These new ACR/EULAR APS classification criteria were developed using rigorous methodology with multidisciplinary international input. Hierarchically clustered, weighted, and risk-stratified criteria reflect the current thinking about APS, providing high specificity and a strong foundation for future APS research.
  • article 1 Citação(ões) na Scopus
    Efficacy of canakinumab in patients with Still's disease across different lines of biologic therapy: real-life data from the International AIDA Network Registry for Still's Disease
    (2023) VITALE, Antonio; CAGGIANO, Valeria; SFIKAKIS, Petros P.; DAGNA, Lorenzo; LOPALCO, Giuseppe; RAGAB, Gaafar; TORRE, Francesco La; ALMAGHLOUTH, Ibrahim A.; MAGGIO, Maria Cristina; SOTA, Jurgen; TUFAN, Abdurrahman; HINOJOSA-AZAOLA, Andrea; IANNONE, Florenzo; LOCONTE, Roberta; LASKARI, Katerina; DIRESKENELI, Haner; RUSCITTI, Piero; MORRONE, Maria; GIARDINI, Henrique A. Mayrink; PANAGIOTOPOULOS, Alexandros; COLA, Ilenia Di; MARTIN-NARES, Eduardo; MONTI, Sara; STEFANO, Ludovico De; KARDAS, Riza Can; DURAN, Rahime; CAMPOCHIARO, Corrado; TOMELLERI, Alessandro; ALABDULKAREEM, Abdulaziz Mohammed; GAGGIANO, Carla; TARSIA, Maria; BARTOLONI, Elena; ROMEO, Mery; HUSSEIN, Mohamed A.; LAYMOUNA, Ahmed Hatem; ANTONELLI, Isabele Parente de Brito; DAGOSTIN, Marilia Ambiel; FOTIS, Lampros; BINDOLI, Sara; NAVARINI, Luca; ALIBAZ-ONER, Fatma; SEVIK, Gizem; FRASSI, Micol; CICCIA, Francesco; IACONO, Daniela; CRISAFULLI, Francesca; PORTINCASA, Piero; JABER, Nour; KAWAKAMI-CAMPOS, Perla Ayumi; WIESIK-SZEWCZYK, Ewa; IAGNOCCO, Annamaria; SIMONINI, Gabriele; SFRISO, Paolo; BALISTRERI, Alberto; GIACOMELLI, Roberto; CONTI, Giovanni; FREDIANI, Bruno; FABIANI, Claudia; CANTARINI, Luca
    Introduction: The effectiveness of canakinumab may change according to the different times it is used after Still's disease onset. This study aimed to investigate whether canakinumab (CAN) shows differences in short- and long-term therapeutic outcomes, according to its use as different lines of biologic treatment.Methods: Patients included in this study were retrospectively enrolled from the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to Still's disease. Seventy-seven (51 females and 26 males) patients with Still's disease were included in the present study. In total, 39 (50.6%) patients underwent CAN as a first-line biologic agent, and the remaining 38 (49.4%) patients were treated with CAN as a second-line biologic agent or subsequent biologic agent.Results: No statistically significant differences were found between patients treated with CAN as a first-line biologic agent and those previously treated with other biologic agents in terms of the frequency of complete response (p =0.62), partial response (p =0.61), treatment failure (p >0.99), and frequency of patients discontinuing CAN due to lack or loss of efficacy (p =0.2). Of all the patients, 18 (23.4%) patients experienced disease relapse during canakinumab treatment, 9 patients were treated with canakinumab as a first-line biologic agent, and nine patients were treated with a second-line or subsequent biologic agent. No differences were found in the frequency of glucocorticoid use (p =0.34), daily glucocorticoid dosage (p =0.47), or concomitant methotrexate dosage (p =0.43) at the last assessment during CAN treatment.Conclusion: Canakinumab has proved to be effective in patients with Still's disease, regardless of its line of biologic treatment.
  • article 2 Citação(ões) na Scopus
    Musculoskeletal manifestations in children with Behcet's syndrome: data from the AIDA Network Behcet's Syndrome Registry
    (2023) GAGGIANO, Carla; MASELLI, Anna; SFIKAKIS, Petros P.; LASKARI, Katerina; RAGAB, Gaafar; HEGAZY, Mohamed Tharwat; LAYMOUNA, Ahmed Hatem; LOPALCO, Giuseppe; ALMAGHLOUTH, Ibrahim A.; ASFINA, Kazi Nur; ALAHMED, Ohoud; MAYRINK, Henrique Ayres Giardini; ANTONELLI, Isabele Parente de Brito; CATTALINI, Marco; PIGA, Matteo; SOTA, Jurgen; GENTILESCHI, Stefano; MAGGIO, Maria Cristina; OPRIS-BELINSKI, Daniela; HATEMI, Gulen; INSALACO, Antonella; OLIVIERI, Alma Nunzia; TUFAN, Abdurrahman; KARADENIZ, Hazan; KARDAS, Riza Can; TORRE, Francesco La; CARDINALE, Fabio; MARINO, Achille; GUERRIERO, Silvana; RUSCITTI, Piero; TARSIA, Maria; VITALE, Antonio; CAGGIANO, Valeria; TELESCA, Salvatore; IANNONE, Florenzo; PARRETTI, Veronica; FRASSI, Micol; ARAGONA, Emma; CICCIA, Francesco; WIESIK-SZEWCZYK, Ewa; IONESCU, Ruxandra; SAHIN, Ali; AKKOC, Nurullah; HINOJOSA-AZAOLA, Andrea; THARWAT, Samar; HERNANDEZ-RODRIGUEZ, Jose; ESPINOSA, Gerard; CONTI, Giovanni; GIUDICE, Emanuela Del; GOVONI, Marcello; EMMI, Giacomo; FABIANI, Claudia; BALISTRERI, Alberto; FREDIANI, Bruno; RIGANTE, Donato; CANTARINI, Luca
    This study aims to describe musculoskeletal manifestations (MSM) in children with Behcet's syndrome (BS), their association with other disease manifestations, response to therapy, and long-term prognosis. Data were retrieved from the AIDA Network Behcet's Syndrome Registry. Out of a total of 141 patients with juvenile BS, 37 had MSM at disease onset (26.2%). The median age at onset was 10.0 years (IQR 7.7). The median follow-up duration was 21.8 years (IQR 23.3). Recurrent oral (100%) and genital ulcers (67.6%) and pseudofolliculitis (56.8%) were the most common symptoms associated with MSM. At disease onset, 31 subjects had arthritis (83.8%), 33 arthralgia (89.2%), and 14 myalgia (37.8%). Arthritis was monoarticular in 9/31 cases (29%), oligoarticular in 10 (32.3%), polyarticular in 5 (16.1%), axial in 7 (22.6%). Over time, arthritis became chronic-recurrent in 67.7% of cases and 7/31 patients had joint erosions (22.6%). The median Behcet's Syndrome Overall Damage Index was 0 (range 0-4). Colchicine was inefficacious for MSM in 4/14 cases (28.6%), independently from the type of MSM (p = 0.46) or the concomitant therapy (p = 0.30 for cDMARDs, p = 1.00 for glucocorticoids); cDMARDs and bDMARDs were inefficacious for MSM in 6/19 (31.4%) and 5/12 (41.7%) cases. The presence of myalgia was associated with bDMARDs inefficacy (p = 0.014). To conclude, MSM in children with BS are frequently associated with recurrent ulcers and pseudofolliculitis. Arthritis is mostly mono- or oligoarticular, but sacroiliitis is not unusual. Prognosis of this subset of BS is overall favorable, though the presence of myalgia negatively affects response to biologic therapies. ClinicalTrials.gov Identifier: NCT05200715 (registered on December 18, 2021).
  • article 0 Citação(ões) na Scopus
    Influence of exposure to climate-related hazards in the phenotypic expression of primary Sjögren's syndrome
    (2023) FLORES-CHAVEZ, A.; BRITO-ZERON, P.; NG, W. -f.; SZANTO, A.; RASMUSSEN, A.; PRIORI, R.; BALDINI, C.; ARMAGAN, B.; OEZKIZILTAS, B.; PRAPROTNIK, S.; SUZUKI, Y.; QUARTUCCIO, L.; HERNANDEZ-MOLINA, G.; INANC, N.; BARTOLONI, E.; RISCHMUELLER, M.; OLIVEIRA, F. Reis-de; TREVISANI, V. Fernandes Moca; JURCUT, C.; NORDMARK, G.; CARUBBI, F.; HOFAUER, B.; VALIM, V.; PASOTO, S. G.; RETAMOZO, S.; ATZENI, F.; FONSECA-AIZPURU, E.; LOPEZ-DUPLA, M.; GIACOMELLI, R.; NAKAMURA, H.; AKASBI, M.; THOMPSON, K.; HORVATH, I. Fanny; FARRIS, A. D.; SIMONCELLI, E.; BOMBARDIERI, S.; KILIC, L.; TUFAN, A.; PIRKMAJER, K. Perdan; FUJISAWA, Y.; VITA, S. De; ABACAR, K.; RAMOS-CASALS, M.
    Objective To analyse how the key components at the time of diagnosis of the Sjogren's phenotype (epidemiological profile, sicca symptoms, and systemic disease) can be influenced by the potential exposure to climate-related natural hazards. Methods For the present study, the following variables were selected for harmonisation and refinement: age, sex, country, fulfilment of 2002/2016 criteria items, dry eyes, dry mouth, and overall ESSDAI score. Climate-related hazards per country were defined according to the OECD and included seven climate-related hazard types: extreme temperature, extreme precipitation, drought, wildfire, wind threats, river flooding, and coastal flooding. Climatic variables were defined as dichotomous variables according to whether each country is ranked among the ten countries with the most significant exposure. Results After applying data-cleaning techniques and excluding people from countries not included in the OECD climate rankings, the database study analysed 16,042 patients from 23 countries. The disease was diagnosed between 1 and 3 years earlier in people living in countries included among the top 10 worst exposed to extreme precipitation, wildfire, wind threats, river flooding, and coastal flooding. A lower frequency of dry eyes was observed in people living in countries exposed to wind threats, river flooding, and coastal flooding, with a level of statistical association being classified as strong (p<0.0001 for the three variables). The frequency of dry mouth was significantly lower in people living in countries exposed to river flooding (p<0.0001) and coastal flooding (p<0.0001). People living in countries included in the worse climate scenarios for extreme temperature (p<0.0001) and river flooding (p<0.0001) showed a higher mean ESSDAI score in comparison with people living in no-risk countries. In contrast, those living in countries exposed to worse climate scenarios for wind threats (p<0.0001) and coastal flooding (p<0.0001) showed a lower mean ESSDAI score in comparison with people living in no-risk countries. Conclusion Local exposure to extreme climate-related hazards plays a role in modulating the presentation of Sjogren across countries concerning the age at which the disease is diagnosed, the frequency of dryness, and the degree of systemic activity.
  • article 2 Citação(ões) na Scopus
    The Role of MRI in Differentiating Demyelinating and Inflammatory (not Infectious) Myelopathies
    (2023) TAMANINI, Joao Vitor Gerdulli; SABINO, Joao Vitor; CORDEIRO, Rafael Alves; MIZUBUTI, Vanessa; VILLARINHO, Luciano de Lima; DUARTE, Juliana Avila; PEREIRA, Fernanda Veloso; APPENZELLER, Simone; DAMASCENO, Alfredo; REIS, Fabiano
    Demyelinating and inflammatory myelopathies represent a group of diseases with characteristic patterns in neuroimaging and several differential diagnoses. The main imaging patterns of demyelinating myelopathies (multiple sclerosis, neuromyelitis optica spectrum disorder, acute disseminated encephalomyelitis, and myelin oligodendrocyte glycoprotein antibody-related disorder) and inflammatory myelopathies (systemic lupus erythematosusmyelitis, sarcoidosis-myelitis, Sjoeurogren-myelitis, and Beh,cet's-myelitis) will be discussed in this article, highlighting key points to the differential diagnosis. Semin Ultrasound CT MRI 44:469-488 (c) 2023 Elsevier Inc. All rights reserved.
  • article 1 Citação(ões) na Scopus
    Osteoporosis and fracture risk assessment: improving outcomes in postmenopausal women
    (2023) PEREZ, Mariana Ortega; PEDRO, Pedro Paulo de Alcantara; LYRIO, Andre Marun; GRIZZO, Felipe Merchan Ferraz; LOURES, Marco Antonio A. da Rocha
  • article 0 Citação(ões) na Scopus
    Adult-onset Still's disease with ankylosis of the distal interphalangeal joints: beyond psoriatic arthritis
    (2023) CORDEIRO, R. A.; ANTONELLI, I. P. B.; GIARDINI, H. A. M.
  • article 0 Citação(ões) na Scopus
    Using Physiological Laboratory Tests and Neuromuscular Functions to Predict Extreme Ultratriathlon Performance
    (2023) ABAD, Cesar Cavinato Cal; CARMO, Everton Crivoi; PRADO, Danilo Marcelo Leite Do; REIS, Valter; PEREIRA, Lucas; LOTURCO, Irineu; KOEHLE, Michael
    Purpose: This study aims to investigate the relationship between split disciplines and overall extreme ultra-triathlon (EUT) performance and verify the relationship among physiological and neuromuscular measurements with both fractional and total EUT performance while checking which variables could predict partial and overall EUT race time. Methods: Eleven volunteers (37 +/- 6 years; 176.9 +/- 6.1 cm; 77.9 +/- 10.9 kg) performed two maximal graded tests (cycling and running) for physiological measurements and muscle strength/power tests to assess neuromuscular functions. Results: The correlation of swimming split times to predict overall EUT race times was lower than for cycling and running split times (r(2) = 0.005; p > .05; r(2) = 0.949; p r(2) = 0.925; p < .001, respectively). VO2peak obtained during running test (VO2peakrun) and VT power output assessed during cycling test (VTPO) were the highest predictors of cycling performance (r(2) = 0.92; p = .017), whereas VO2peakrun and peakpower output in the cycling test (PPO) were the highest predictors of running performance (r(2) = 0.94; p = .008). Conclusion: VO2peakrun and VTPO, associated to jump height assessed during countermovement jump (CMJ) test were the highest correlated variables to predict total EUT performance (r(2) = 0.99; p = .007). In practical terms, coaches should include the assessment of VO2peakrun, VTPO, and CMJ to evaluate the athletes' status and monitor their performance throughout the season. Future studies should test how the improvement of these variables would affect EUT performance during official races.
  • article 1 Citação(ões) na Scopus
    Maternal plasma transforming growth factor-b1 (TGF-b1) and newborn size: the Araraquara Cohort Study
    (2023) DEJANI, Naiara Naiana; NICOLETTI, Carolina F.; ARGENTATO, Perla Pizzi; PEREIRA, Ludmilla da Silva; SARAIVA, Amanda Correia; ASSIS, Leticia Montanha de; NAKANDAKARE, Patricia Yury; BATISTA, Livia Patricia Rodrigues; TELES, Laisla de Franca da Silva; LEITAO, Maria Paula; LUZIA, Liania Alves; MEDEIROS, Alexandra Ivo de; RONDO, Patricia Helen
    Objective: To investigate associations of maternal and cord blood cytokine patterns with new-born size and body composition. Methods: This cross-sectional study involved 70 pregnant women and their healthy newborns selected from the ""Araraquara Cohort Study"". Newborn anthropometric measurements were recorded at birth. Body composition was evaluated by air displacement plethysmography. Mater -nal blood samples were collected from pregnant women between 30 and 36 weeks of gestation, and umbilical cord blood samples were collected immediately after placenta discharge. The con-centrations of the cytokines were determined in plasma by ELISA. Multiple linear regression mod -els were used to assess associations between maternal and cord blood cytokine concentrations and newborn anthropometry and body composition measurements. Results: Maternal plasma TGF-fi1 concentration was inversely associated with newborn weight (fi =-43.0; p = 0.012), length (fi =-0.16, p = 0.028), head circumference (fi =-0.13, p = 0.004), ponderal index (fi =-0.32, p = 0.011) and fat-free mass (fi =-0.05, p = 0.005). However, the asso-ciation persisted just for head circumference (fi =-0.26; p = 0.030) and ponderal index (fi = - 0.28; p = 0.028), after adjusting for pre-gestational BMI, gestational weight gain, gestational age, hours after delivery, newborn sex, smoking and alcohol consumption. Conclusions: Maternal plasma TGF-b1 concentration may be involved in the regulation of new-born size, mainly head circumference and ponderal index. Further cohort studies are necessary to investigate the role of TGF-b1 in different trimesters of pregnancy and its effect during the early stages of fetal development. (c) 2022 Published by Elsevier Editora Ltda. on behalf of Sociedade Brasileira de Pediatria. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/ by-nc-nd/4.0/).
  • article 0 Citação(ões) na Scopus
    Patients living with HIV have quantitatively inadequate food consumption
    (2023) FERREIRA, Barbara; MOSCARDINI, Izabela Spereta; ESTEVES, Gabriel Perri; BERALDO, Rebeca Antunes
    Objective: The objective of the current study was to estimate energy expenditure and compare it with the usual food consumption of PLWH, and to determine whether duration of high-potency antiretroviral therapy (HAART) influenced nutritional intake and adequacy. Materials and methods: Anthropometric measurements and bioelectrical impedance analysis (BIA) provided data for estimating resting energy expenditure (REE) using Melchior's equations. Dietary Reference Intakes (DRIs) and 24-Hour Recall were used to verify if reported food intake aligned with energy, macro and micronutrient recommendations. Results: Sixty one patients with a mean age of 52 +/- 9.4 years and who had a high frequency of diabetes mellitus (24.5%), hypertension (54%), and dyslipidemia (90.1%) were evaluated. Estimated REE of female and male patients with less than 10 years of HAART was 1791 (1717.5; 1887.2) and 1941 (1808; 2335.6), and their estimated energy intake was 900.5 (847;1221.9) and 2095.4 (1297.5; 2496.4), respectively. The estimated REE for female and male patients with more than 10 years of HAART was 1796.20 (1598.9;1820.7) and 2105 (1913.4; 2308), and their estimated energy intake was 1566 (1353.1; 1764.3) and 1999.7 (1706.5; 2508.1), respectively. Being on HAART for more than 10 years was associated with increased energy intake (533 (95% CI 3; 1063) kcals), but not with meeting energy requirements. Conclusion: Patients had an atherogenic metabolic profile, inadequate dietary pattern, and a similar REE, regardless of HAART duration, contributing even more to the increased risk of cardiovascular diseases.
  • article 0 Citação(ões) na Scopus
    Physical and autonomic functionality in women with breast cancer pre and post chemotherapy: a case control study
    (2024) SOUSA, Bruna Lorena Soares Cavalcante; ROSA, Thiago dos Santos; SILVINO, Valmir Oliveira; BARROS, Esmeralda Maria Lustosa; CORREA, Hugo de Luca; PRADO, Danilo Marcelo Leite do; VERAS-SILVA, Acacio Salvador; SOUZA, Mariana Duarte de; LIMA, Carlos Eduardo Batista de; OLIVEIRA, Luciano Fonseca Lemos de; SANTOS, Marcos Antonio Pereira dos
    Background Breast cancer (BC) is one of the most incident types of cancer among women in the world. Although chemotherapy is an effective way to treat several types of cancer, it may also cause serious complications, including cardiotoxicity. This study aimed to identify the impact of chemotherapy on functional capacity, muscle strength and autonomic function.Methods Ten breast cancer patients in therapeutic follow-up (TG) and ten women without comorbidities (CG) participated in the study (46 +/- 8.87 years old). Both groups were evaluated at two time points, before and 20 weeks after the start of chemotherapy. Functional capacity and muscle strength were assessed by 6-minute walk test (6MWT) and handgrip test, respectively. Autonomic function was assessed by heart rate variability analysis.Results TG presented greater reductions in the handgrip test for the non-dominant hand (TG down arrow 15.2%; CG: up arrow 1.1%, p<0.05) compared to GC. However, no significant differences were found regarding VO(2)max (p>0.05) and 6MWT total distance (p>0.05). Regarding the heart rate variability variables before and after follow-up period, rMSSD (CG= 39.15 +/- 37.66; TG= 14.89 +/- 8.28, p= 0.01) and SDNN (CG= 55.77 +/- 40.03; TG= 26.30 +/- 10.37, p= 0.02) showed effect in the group and time interaction, whereas the LF/HF ratio presented significant difference only in the time analysis (CG= 2.24 +/- 2.30; TG= 2.84 +/- 1.82, p= 0.04).Conclusion Chemotherapy used in the treatment of breast cancer patients resulted in decreased muscle strength and autonomic imbalance. The data suggests that chemotherapy may carry the risk of developing cardiovascular disease.
  • article 0 Citação(ões) na Scopus
    Effect of menstrual cycle and contraceptive pill phase on aspects of exercise physiology and athletic performance in female athletes: protocol for the Feminae international multisite innovative project
    (2023) SALE, Kirsty J. Elliott; FLOOD, Tessa R.; ARENT, Shawn M.; DOLAN, Eimear; SAUNDERS, Bryan; HANSEN, Mette; IHALAINEN, Johanna K.; MIKKONEN, Ritva S.; MINAHAN, Clare; THORNTON, Jane S.; ACKERMAN, Kathryn E.; LEBRUN, Constance M.; SALE, Craig; STELLINGWERFF, Trent; SWINTON, Paul A.; HACKNEY, Anthony C.; Feminae consortium
    The idiom 'more high-quality research is needed' has become the slogan for sport and exercise physiology-based research in female athletes. However, in most instances, it is challenging to address this gap of high-quality research in elite female athletes at a single study site due to challenges in recruiting enough participants with numerous menstrual cycle and contraceptive pill permutations. Accordingly, we have assembled an international multisite team to undertake an innovative project for female athletes, which investigates the effects of changes in endogenous and exogenous oestrogen and progesterone/progestins across the menstrual cycle and in response to second-generation combined monophasic contraceptive pill use, on aspects of exercise physiology and athletic performance. This project will employ the current gold-standard methodologies in this area, resulting in an adequately powered dataset. This protocol paper describes the consortium-based approach we will undertake during this study.