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1.
Adv Rheumatol ; 64(1): 8, 2024 Jan 17.
Artículo en Inglés | MEDLINE | ID: mdl-38233892

RESUMEN

BACKGROUND: Hip fractures in the older adults lead to increased morbidity and mortality. Although a low bone mineral density is considered the leading risk factor, it is essential to recognize other factors that could affect the risk of hip fractures. This study aims to evaluate the contribution of clinical characteristics, patient-reported outcomes, and muscle and aerobic capacity for hip fractures in community-dwelling older adults. METHODS: This is a retrospective cohort study with real world-data from subjects ≥ 60 years old attending an outpatient clinic in Minas Gerais, Brazil, from May 1, 2019, to August 22, 2022. Data about clinical characteristics (multimorbidity, medications of long-term use, sedative and or tricyclic medications, number of falls), patient-reported outcomes (self-perception of health, self-report of difficulty walking, self-report of vision problems, and self-report of falls) and muscle and aerobic capacity (calf circumference, body mass index, and gait speed) were retrieved from an electronic health record. The association of each potential risk factor and hip fracture was investigated by a multivariable logistic regression analysis adjusted for age and sex. RESULTS: A total of 7,836 older adults were included with a median age of 80 years (IQR 72-86) and 5,702 (72.7%) were female. Hip fractures occurred in 121 (1.54%) patients. Multimorbidity was associated with an increased risk of hip fracture (OR = 1.12, 95%CI 1.06-1.18) and each episode of fall increased the chance of hip fracture by 1.7-fold (OR = 1.69, 95%CI 1.52-1.80). Patient-reported outcomes associated with increased fracture risk were regular or poor self-perception of health (OR = 1.59, 95%CI 1.06-2.37), self-report of walking difficulty (OR = 3.06, 95%CI 1.93-4.84), and self-report of falls (OR = 2.23, 95%CI 1.47-3.40). Body mass index and calf circumference were inversely associated with hip fractures (OR = 0.91, 95%CI 0.87-0.96 and OR = 0.93, 95%CI 0.88-0.97, respectively), while slow gait speed increased the chance of hip fractures by almost two-fold (OR = 1.80, 95%CI 1.22-2.66). CONCLUSION: Our study reinforces the importance of identified risk factors for hip fracture in community-dwelling older adults beyond bone mineral density and available fracture risk assessment tools. Data obtained in primary care can help physicians, other health professionals, and public health policies to identify patients at increased risk of hip fractures.


Asunto(s)
Fracturas de Cadera , Fracturas Osteoporóticas , Humanos , Femenino , Anciano , Anciano de 80 o más Años , Persona de Mediana Edad , Masculino , Vida Independiente , Estudios Retrospectivos , Fracturas de Cadera/epidemiología , Fracturas de Cadera/etiología , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/etiología , Factores de Riesgo
2.
Adv Rheumatol ; 64(1): 5, 2024 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-38167406

RESUMEN

BACKGROUND: Knowledge of patients about Rheumatoid Arthritis (RA) is a necessary aspect to better approach self-management support in a patient-centered manner. The research instrument known as the Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS), consisting of 13 items, is simple, reliable and reproducible, and can be applied in both clinical practice and research protocols. OBJECTIVE: This study aimed to translate and culturally adapt the RAKAS vocabulary into Brazilian Portuguese and to evaluate its concurrent validity. METHODS: The RAKAS was translated into Brazilian Portuguese and administered to 52 elderly women with RA recruited between May 2021 and May 2022. Concurrent validity was assessed using the Spearman's correlation coefficient between RAKAS and Patient Knowledge Questionnaire (PKQ). RESULTS: The participants considered RAKAS-13/BRAZIL easy to understand and did not report any doubts in answering the final version. Concurrent validity of the RAKAS-13/BRAZIL was low compared to the PKQ (ρ = 0.283, p = 0.038). CONCLUSION: The Brazilian Portuguese version of the RAKAS (RAKAS-13/BRASIL) proved to be a questionnaire that was easy and quick to administer to assess patient knowledge about Rheumatoid Arthritis, despite its low correlation with the PKQ in the present study.


Asunto(s)
Artritis Reumatoide , Comparación Transcultural , Humanos , Femenino , Anciano , Brasil , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Artritis Reumatoide/diagnóstico
3.
Adv Rheumatol ; 64: 5, 2024. tab, graf
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1533539

RESUMEN

Abstract Background Knowledge of patients about Rheumatoid Arthritis (RA) is a necessary aspect to better approach self-management support in a patient-centered manner. The research instrument known as the Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS), consisting of 13 items, is simple, reliable and reproducible, and can be applied in both clinical practice and research protocols. Objectives This study aimed to translate and culturally adapt the RAKAS vocabulary into Brazilian Portuguese and to evaluate its concurrent validity. Methods The RAKAS was translated into Brazilian Portuguese and administered to 52 elderly women with RA recruited between May 2021 and May 2022. Concurrent validity was assessed using the Spearman's correlation coefficient between RAKAS and Patient Knowledge Questionnaire (PKQ). Results The participants considered RAKAS-13/BRAZIL easy to understand and did not report any doubts in answering the final version. Concurrent validity of the RAKAS-13/BRAZIL was low compared to the PKQ (ρ = 0.283, p = 0.038). Conclusion The Brazilian Portuguese version of the RAKAS (RAKAS-13/BRASIL) proved to be a questionnaire that was easy and quick to administer to assess patient knowledge about Rheumatoid Arthritis, despite its low correlation with the PKQ in the present study.

4.
Adv Rheumatol ; 64: 8, 2024. tab
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1550007

RESUMEN

Abstract Background Hip fractures in the older adults lead to increased morbidity and mortality. Although a low bone mineral density is considered the leading risk factor, it is essential to recognize other factors that could affect the risk of hip fractures. This study aims to evaluate the contribution of clinical characteristics, patient-reported outcomes, and muscle and aerobic capacity for hip fractures in community-dwelling older adults. Methods This is a retrospective cohort study with real world-data from subjects ≥ 60 years old attending an outpatient clinic in Minas Gerais, Brazil, from May 1, 2019, to August 22, 2022. Data about clinical characteristics (multimorbidity, medications of long-term use, sedative and or tricyclic medications, number of falls), patient-reported outcomes (self-perception of health, self-report of difficulty walking, self-report of vision problems, and self-report of falls) and muscle and aerobic capacity (calf circumference, body mass index, and gait speed) were retrieved from an electronic health record. The association of each potential risk factor and hip fracture was investigated by a multivariable logistic regression analysis adjusted for age and sex. Results A total of 7,836 older adults were included with a median age of 80 years (IQR 72-86) and 5,702 (72.7%) were female. Hip fractures occurred in 121 (1.54%) patients. Multimorbidity was associated with an increased risk of hip fracture (OR = 1.12, 95%CI 1.06-1.18) and each episode of fall increased the chance of hip fracture by 1.7-fold (OR = 1.69, 95%CI 1.52-1.80). Patient-reported outcomes associated with increased fracture risk were regular or poor self-perception of health (OR = 1.59, 95%CI 1.06-2.37), self-report of walking difficulty (OR = 3.06, 95%CI 1.93-4.84), and self-report of falls (OR = 2.23, 95%CI 1.47-3.40). Body mass index and calf circumference were inversely associated with hip fractures (OR = 0.91, 95%CI 0.87-0.96 and OR = 0.93, 95%CI 0.88-0.97, respectively), while slow gait speed increased the chance of hip fractures by almost two-fold (OR = 1.80, 95%CI 1.22-2.66). Conclusion Our study reinforces the importance of identified risk factors for hip fracture in community-dwelling older adults beyond bone mineral density and available fracture risk assessment tools. Data obtained in primary care can help physicians, other health professionals, and public health policies to identify patients at increased risk of hip fractures.

5.
Adv Rheumatol ; 63(1): 12, 2023 03 15.
Artículo en Inglés | MEDLINE | ID: mdl-36922853

RESUMEN

Clinical practice guidelines (CPG) are developed to align standards of health care around the world, aiming to reduce the incidence of misconducts and enabling more effective use of health resources. Considering the complexity, cost, and time involved in formulating CPG, strategies should be used to facilitate and guide authors through each step of this process. The main objective of this document is to present a methodological guide prepared by the Epidemiology Committee of the Brazilian Society of Rheumatology for the elaboration of CPG in rheumatology. Through an extensive review of the literature, this study compiles the main practical recommendations regarding the following steps of CPG drafting: distribution of working groups, development of the research question, search, identification and selection of relevant studies, evidence synthesis and quality assessment of the body of evidence, the Delphi methodology for consensus achievement, presentation and dissemination of the recommendations, CPG quality assessment and updating. This methodological guide serves as an important tool for rheumatologists to develop reliable and high-quality CPG, standardizing clinical practices worldwide.


Asunto(s)
Reumatología , Humanos , Brasil , Consenso
6.
Med Princ Pract ; 32(2): 117-125, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36927744

RESUMEN

OBJECTIVE: There is a lack of studies evaluating the COVID-19 pandemic effect on breast cancer detection according to age-group. This study aimed to assess the pandemic impact on the trend of mammograms, breast biopsies, and breast cancer stage at diagnosis according to age-group. METHODS: This was an ecological time series study by inflection point regression model. We used data from women aged between 30 and 49, 50 and 69, and 70 years or more available in an open-access dataset of the Brazilian public healthcare system (2017-2021). We analyzed the trend of the variables in the pre-pandemic and the pandemic effect on the total time series. RESULTS: The decreasing or stationary trend of mammograms in the pre-pandemic has changed to a decreasing trend in the total time series in all age-groups. Before the pandemic, the increasing trend of breast biopsies has changed to stationary in the total time series in all age-groups. The increasing trend of tumors at stages 0 to II in the pre-pandemic has changed to decreasing or stationary in the total time series. Finally, the increasing trend of tumors at stage III or IV remained increasing in the total time series in all age-groups. CONCLUSION: The pandemic has changed the stationary or increasing trend to a decreasing or stationary trend of mammograms, breast biopsies, and tumors at stages 0 to II but has not influenced the increasing trend of tumors at stages III and IV in all age-groups.


Asunto(s)
Neoplasias de la Mama , COVID-19 , Femenino , Humanos , Adulto , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/patología , Pandemias , Análisis de Series de Tiempo Interrumpido , COVID-19/epidemiología , Mamografía , Prueba de COVID-19
7.
Value Health Reg Issues ; 35: 8-12, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-36796115

RESUMEN

OBJECTIVES: The overload of health services because of the COVID-19 pandemic has reduced the population's access to treatment and prevention of other diseases. This study aimed to identify whether there was a change in the trend of breast biopsies and their direct costs during the COVID-19 pandemic in a developing country's public and universal healthcare system. METHODS: This was an ecological time series study of mammograms and breast biopsies in women aged 30 years or older from an open-access data set of the Public Health System of Brazil from 2017 to July 2021. RESULTS: In 2020, there was a reduction of -40.9% in mammograms and -7.9% in breast biopsies compared with the prepandemic period. From 2017 to 2020, there was an increase in the breast biopsies ratio per mammogram (1.37%-2.55%), the percentage of Breast Imaging-Reporting and Data System (BI-RADS) IV and V mammograms (0.79%-1.14%), and the annual direct cost of breast biopsies (Brazilian Real 3 477 410.00 to Brazilian Real 7 334 910.00). In the time series, the negative impact of the pandemic was lower on BI-RADS IV to V mammograms than on BI-RADS 0 to III. There was an association between the trend of breast biopsies and BI-RADS IV to V mammography. CONCLUSIONS: The COVID-19 pandemic harmed the increasing trend of breast biopsies, their total direct costs, BI-RADS 0 to III and IV to V mammograms, observed in the prepandemic period. Furthermore, there was a tendency to screen women at a higher risk for breast cancer during the pandemic.


Asunto(s)
Neoplasias de la Mama , COVID-19 , Femenino , Humanos , Pandemias , Análisis de Series de Tiempo Interrumpido , COVID-19/epidemiología , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/epidemiología , Biopsia
8.
Adv Rheumatol ; 63: 12, 2023. tab, graf
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1447146

RESUMEN

Abstract Clinical practice guidelines (CPG) are developed to align standards of health care around the world, aiming to reduce the incidence of misconducts and enabling more effective use of health resources. Considering the complexity, cost, and time involved in formulating CPG, strategies should be used to facilitate and guide authors through each step of this process. The main objective of this document is to present a methodological guide prepared by the Epidemiology Committee of the Brazilian Society of Rheumatology for the elaboration of CPG in rheumatology. Through an extensive review of the literature, this study compiles the main practical recommendations regarding the following steps of CPG drafting: distribution of working groups, development of the research question, search, identification and selection of relevant studies, evidence synthesis and quality assessment of the body of evidence, the Delphi methodology for consensus achievement, presentation and dissemination ofthe recommendations, CPG quality assessment and updating. This methodological guide serves as an important tool for rheumatologists to develop reliable and high-quality CPG, standardizing clinical practices worldwide.

9.
BMC Health Serv Res ; 22(1): 1466, 2022 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-36461119

RESUMEN

BACKGROUND: The COVID-19 pandemic has overloaded the healthcare systems of many countries and reduced the population's access to treatment and prevention of other diseases. This study aims to assess whether the COVID-19 pandemic has negatively interfered with the trend and the direct costs of screening and chemotherapy treatment of breast cancer in a public and universal healthcare system. METHOD: This was an ecological time series study using an open database of a public and universal health system from 2017 to 2021. RESULTS: In 2020, there was a 41% reduction in the coverage rate of breast cancer screening in women aged 50 to 69 years (about 1 million mammograms missed). The total direct cost of breast cancer screening reduced proportionally to the number of tests (BRL 67 million). On the other hand, the cost of chemotherapy treatment was higher in 2020, both in advanced (BRL 465 million) and localized (BRL 113 million) diseases. In the time series, mammograms' trend and direct costs changed from stationary to decreasing after the COVID-19 pandemic. The trend of direct costs with chemotherapy treatment for the advanced disease has been increasing and has not changed after the COVID-19 pandemic. On the other hand, in the case of localized disease, there was a trend toward reducing direct costs after the pandemic. CONCLUSION: After COVID-19, there was a downward trend in breast cancer screening and its direct costs, an upward trend in chemotherapy costs for advanced disease, and a downward trend in chemotherapy costs for localized disease.


Asunto(s)
Neoplasias de la Mama , COVID-19 , Femenino , Humanos , Pandemias , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/epidemiología , Detección Precoz del Cáncer , Análisis de Series de Tiempo Interrumpido , COVID-19/epidemiología
10.
Health Res Policy Syst ; 18(1): 69, 2020 Jun 17.
Artículo en Inglés | MEDLINE | ID: mdl-32552692

RESUMEN

In Brazil, governmental and non-governmental organisations develop practice guidelines (PGs) in order to optimise patient care. Although important improvements have been made over the past years, many of these documents still lack transparency and methodological rigour. In order to conduct a critical analysis and define future steps in PG development in Brazil, we carried out a structured assessment of strengths, weaknesses, opportunities and threats (SWOT analysis) for the development of a national guideline programme. Participants consisted of academia, methodologists, medical societies and healthcare system representatives. In summary, the PG development process has improved in Brazil and current investments in methodological research and capacity-building are ongoing. Despite the centralised processes for public PGs, standardised procedures for their development are not well established and human resources are insufficient in number and capacity to develop the amount of trustworthy documents needed. Brazil's capacity could be strengthened and initial efforts have been made such as the adoption of standards proposed by world-renowned institutions in PG development and enhancement of the involvement of key stakeholders. Further steps involve the alignment between health technology assessment and PG processes for synergy and the development of a national network to promote the interaction between groups involved in the development of PGs. The lessons learned from this paper could be used to foster debate on guideline development, especially for countries facing similar threats on this topic.


Asunto(s)
Guías de Práctica Clínica como Asunto , Desarrollo de Programa , Brasil , Creación de Capacidad , Medicina Basada en la Evidencia
11.
Adv Rheumatol ; 59(1): 17, 2019 04 29.
Artículo en Inglés | MEDLINE | ID: mdl-31036077

RESUMEN

BACKGROUND: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. CONCLUSION: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.


Asunto(s)
Enfermedades del Sistema Inmune/tratamiento farmacológico , Huésped Inmunocomprometido , Inmunosupresores/uso terapéutico , Inflamación/tratamiento farmacológico , Vacuna contra la Fiebre Amarilla/efectos adversos , Fiebre Amarilla/prevención & control , Enfermedad Crónica , Contraindicaciones de los Medicamentos , Toma de Decisiones Conjunta , Técnica Delphi , Humanos , Enfermedades del Sistema Inmune/inmunología , Inflamación/inmunología , Medición de Riesgo , Vacunación/efectos adversos , Vacuna contra la Fiebre Amarilla/administración & dosificación
12.
Adv. rheumatol ; 59(1): 17, Apr. 2019. ilus, tab
Artículo en Inglés | Sec. Est. Saúde SP, SESSP-IIERPROD, Sec. Est. Saúde SP | ID: biblio-1017123

RESUMEN

BACKGROUND: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving >/=80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. CONCLUSION: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting Vaccination practices. We recommended a shared decision-making approach on taking or not the YFV


Asunto(s)
Fiebre Amarilla , Vacunación/normas , Estrategias de eSalud
13.
Adv Rheumatol ; 59: 17, 2019. tab, graf
Artículo en Inglés | LILACS | ID: biblio-1088607

RESUMEN

Abstract Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV.


Asunto(s)
Humanos , Fiebre Amarilla/prevención & control , Enfermedad Crónica , Vacuna contra la Fiebre Amarilla/administración & dosificación , Brasil/epidemiología , Eficacia/normas , Resultado del Tratamiento
14.
Drugs Context ; 7: 212543, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30302115

RESUMEN

Biosimilar products are already approved and marketed in several countries. The Food and Drug Administration has approved ten different biosimilars, and the European Medicines Agency has approved 40. Even though this scenario has provided important experience with biosimilar products, there are still challenges and unanswered questions. Up to now, a good amount of knowledge has been gathered in order to support the importance of the totality of evidence and the construction of a biosimilarity exercise for regulatory approval. In addition, the extrapolation of indications has been proved viable when a careful analysis is performed. The models for clinical trials and the use of the most sensible populations have been extensively discussed, and there is apparent homogeneity in manufacturer choices for study designs. However, some challenges remain. The lack of regulatory harmony, especially concerning naming, the marketed intended copies, the interchangeability, and the biosimilars in orphan diseases are some of those and are the focus of discussion in this review.

15.
Clin Rheumatol ; 35(5): 1217-23, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-25963999

RESUMEN

The objective of this study is to describe the prevalence of musculoskeletal symptoms (MSK-S) in the five urban geographical regions of Brazil using the Portuguese version of the Community Oriented Program for Control of Rheumatic Diseases (COPCORD) core questionnaire (CQ)-BRAZCO study. From April to May 2013, a population-based survey was conducted by applying the CQ for 5000 individuals aged over 15 years in 16 capitals of the Brazilian regions. Trained teams assessed the MSK-S and socioeconomic status. The sample consisted of representative quotas of the Brazilian population, proportional to the capitals' population density. It respected the groups' quotas of gender and age and included all socioeconomic classes, educational levels, and occupations. There were 1342 (26.9 %) participants who presented MSK-S unrelated to trauma in 7 days preceding the interview. A higher prevalence of these complaints were in females (65.2 %), elderly people, in the north region of the country (30.7 %), and a lower prevalence was found in single individuals (41.7 %) and in the south (23.3 %). The most frequent pain sites were the spine (76.7 %) and knees (49.6 %), and the mean pain intensity was 6.8 (VAS). The BRAZCO study shows that Brazilian population presents a higher rate of MSK-S unrelated to trauma than many Asian countries. These results can be applied to guide the assessment of prevalence of rheumatic diseases. Additionally, it can help in the design of policies for health care workforce organization and its accessibility, as well as to reduce the risk of rheumatic diseases at the community level.


Asunto(s)
Enfermedades Musculoesqueléticas/epidemiología , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Brasil/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades Musculoesqueléticas/diagnóstico , Prevalencia , Factores Sexuales , Encuestas y Cuestionarios , Adulto Joven
16.
Rev Bras Reumatol ; 52(5): 733-41, 2012 Oct.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-23090373

RESUMEN

OBJECTIVE: To conduct a cross-cultural adaptation of the Bath Ankylosing Spondylitis Functional Index (BASFI) into Brazilian-Portuguese language and to assess its measurement properties. METHODS: The BASFI was translated by four rheumatologists and three English teachers. The translated questionnaire was applied to ankylosing spondylitis patients by trained observers, and self-administered in three moments: days 1, 2, and 14. The validity was assessed analyzing the association of BASFI and functional capacity measures (cervical rotation, intermalleolar distance, Schober's test and occiput-to-wall distance). The internal consistence was tested by Cronbach's α coefficient and the reliability by test-retest (intraclass correlation coefficient - ICC). RESULTS: A total of 60 patients with ankylosing spondylitis was included: 85% male, mean age 47 ± 12 years, and mean disease duration 20 ± 11 years. The intra-observer test-retest (two-week interval) reliability showed a high ICC (0.999, 95% CI: 0.997-0.999) and a high internal consistency (Cronbach's α coefficient: 0.86, CI 95%: 0.80-0.90). Considering the validity, the BASFI indices were correlated with cervical rotation (0.53, P < 0.001) and with intermalleolar distance (0.50, P < 0.001). CONCLUSION: The BASFI Brazilian-Portuguese version is reliable and valid for assessment of patients with ankylosing spondylitis.


Asunto(s)
Espondilitis Anquilosante/diagnóstico , Encuestas y Cuestionarios , Brasil , Características Culturales , Femenino , Humanos , Lenguaje , Masculino , Persona de Mediana Edad , Traducción
17.
Rev. bras. reumatol ; 52(5): 737-741, set.-out. 2012.
Artículo en Portugués | LILACS | ID: lil-653726

RESUMEN

OBJETIVO: Conduzir uma adaptação cultural cruzada do Índice Funcional de Espondilite Anquilosante de Bath (BASFI, Bath Ankylosing Spondylitis Functional Index) para o português do Brasil e avaliar suas propriedades de medição. MéTODOS: O BASFI foi traduzido por quatro reumatologistas e três professores de língua inglesa. O questionário traduzido foi aplicado a pacientes com espondilite anquilosante por observadores treinados e autoaplicado em três momentos, dias 1, 2 e 14. A validade foi estimada analisando-se a associação do BASFI e as medidas de capacidade funcional (rotação cervical, distância intermaleolar, teste de Schober e distância occipito-parede). A consistência interna foi testada pelo coeficiente α de Cronbach, e a confiabilidade pelo teste-reteste (coeficiente de correlação intraclasse [CCI]). RESULTADOS: Foram incluídos 60 pacientes com espondilite anquilosante: 85% do gênero masculino, com idade média de 47 ± 12 anos e duração média da doença de 20 ± 11 anos. A confiabilidade intraobservador no teste-reteste (intervalo de duas semanas) revelou alto ICC (0,999; 95% IC: 0,997-0,999), além de alta consistência interna (coeficiente α de Cronbach: 0,86; 95% IC: 0,80-0,90). Considerando-se a validade, os índices do BASFI foram correlacionados com a rotação cervical (0,53; P < 0,001) e a distância intermaleolar (0,50; P < 0,001). CONCLUSÃO: A versão do BASFI para o português do Brasil é confiável e válida para avaliação de pacientes com espondilite anquilosante.


OBJECTIVE: To conduct a cross-cultural adaptation of the Bath Ankylosing Spondylitis Functional Index (BASFI) into Brazilian-Portuguese language and to assess its measurement properties. METHODS: The BASFI was translated by four rheumatologists and three English teachers. The translated questionnaire was applied to ankylosing spondylitis patients by trained observers, and self-administered in three moments: days 1, 2, and 14. The validity was assessed analyzing the association of BASFI and functional capacity measures (cervical rotation, intermalleolar distance, Schober's test and occiput-to-wall distance). The internal consistence was tested by Cronbach's αcoefficient and the reliability by testretest (intraclass correlation coefficient - ICC). RESULTS: A total of 60 patients with ankylosing spondylitis was included: 85% male, mean age 47 ± 12 years, and mean disease duration 20 ± 11 years. The intra-observer test-retest (two-week interval) reliability showed a high ICC (0.999, 95% CI: 0.997-0.999) and a high internal consistency (Cronbach's α coefficient: 0.86, CI 95%: 0.80-0.90). Considering the validity, the BASFI indices were correlated with cervical rotation (0.53, P < 0.001) and with intermalleolar distance (0.50, P < 0.001). CONCLUSION: The BASFI Brazilian-Portuguese version is reliable and valid for assessment of patients with ankylosing spondylitis.


Asunto(s)
Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Espondilitis Anquilosante/diagnóstico , Brasil , Características Culturales , Lenguaje , Traducción
18.
Rev. bras. geriatr. gerontol ; 14(2): 221-231, abr.-jun. 2011. tab, graf
Artículo en Portugués | LILACS | ID: lil-643584

RESUMEN

Estimar o custo direto dos recursos médico-hospitalares utilizados no tratamento cirúrgico da fratura de fêmur decorrente de quedas durante a hospitalização e pós-operatório até dois meses após a lesão. Método: estudo transversal, descritivo e retrospectivo em pacientes de ambos os sexos, com 60 anos ou mais de idade, no período de janeiro de 2008 a junho de 2009. Os dados foram extraídos das contas hospitalares de um convênio credenciado à rede hospitalar privada da cidade de Brasília. Resultados: a frequência de fratura por quedas para o sexo feminino foi 76,2% (n=16), e no masculino, 23,8%(n=5), sendo que 66,7% (n=14) das lesões resultaram em fratura de fêmur proximal. A média de permanência hospitalar das cirurgias foi de 7,1 dias e 2,7 dias em UTI. Houve 16 pacientes com fratura de fêmur e a média do tratamento cirúrgico foi R$ 39.160,75, totalizando R$ 626.572,06. O custo direto dos recursos médico-hospitalares durante a internação ficou entre R$ 8.293,55 e R$ 139.837,50; já no pós-operatório, corresponderam a 5,7% do custo total da internação. Conclusão: o custo cirúrgico da fratura de fêmur é considerável para os convênios do sistema de saúde suplementar e confirmou a vulnerabilidade do sexo feminino para as fraturas de quadril. As maiores despesas foram com a prótese, material e medicamentos, e variaram em função do tipo de cirurgia, período de hospitalização e faixa etária.


Asunto(s)
Anciano , Accidentes por Caídas , Costos y Análisis de Costo , Fracturas del Fémur , Salud del Anciano , Servicios de Salud para Ancianos , Sector Privado , Servicio de Cirugía en Hospital
19.
J Rheumatol ; 36(6): 1337-42, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-19411396

RESUMEN

OBJECTIVE: To develop a questionnaire for the evaluation of sexuality of male patients with juvenile idiopathic arthritis (JIA). METHODS: A cohort of male patients with rheumatoid factor (RF)-negative polyarticular JIA according to the 2004 revised ILAR criteria and inactive disease was studied. The Health Assessment Questionnaire (HAQ) was applied to all patients. As a control group, 120 age-matched males of the same socioeconomic status were evaluated. A self-administered structured instrument, the Male Sexual Evaluation Questionnaire (MSEQ), was developed by multiprofessional experts to assess sexual life, including satisfaction, practice, and related functional aspects. RESULTS: Thirty-two male patients with RF-negative polyarticular JIA [mean age 20.8+/-3.8 yrs (range 16-26), mean disease duration 15.4+/-3.6 yrs (range 13-20)] were studied. Mean HAQ score was 1.25+/-0.67 (range 0.1-2.1). Masturbation was practiced similarly by patients and controls (87.5% vs 91%; p>0.999), although joint pain was observed in only 2 (7%) patients. Regular sexual intercourse (>or=once/week) was reported by 78% of patients and 62% of controls (p=0.86). Joint pain during intercourse was more frequent in patients (48% vs 3% in controls; p<0.001). The mean HAQ score was higher in the 12 patients with joint pain (hips=3, knees=5, and hips+knees=4) during intercourse compared to the 13 patients without joint pain (1.82+/-0.27 vs 1.43+/-0.32; p<0.05). Preserved desire and satisfaction were universal findings for all JIA patients and controls. CONCLUSION: The MSEQ was applicable to this cohort of male patients with RF-negative polyarticular JIA and showed that sexual life is preserved despite longterm disease, morbidity/functional dysfunction, and joint pain.


Asunto(s)
Artritis Juvenil , Articulaciones/fisiopatología , Sistema Musculoesquelético/fisiopatología , Dolor/fisiopatología , Conducta Sexual , Actividades Cotidianas , Adolescente , Adulto , Artritis Juvenil/complicaciones , Artritis Juvenil/fisiopatología , Artritis Juvenil/psicología , Estudios de Cohortes , Estado de Salud , Humanos , Masculino , Dolor/etiología , Calidad de Vida , Índice de Severidad de la Enfermedad , Conducta Sexual/fisiología , Conducta Sexual/psicología , Encuestas y Cuestionarios , Adulto Joven
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