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BACKGROUND: Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. OBJECTIVE: To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. METHODS: This data are from the study "Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases," a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. RESULTS: A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. CONCLUSION: In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.
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Artrite Reumatoide , Vacinas contra COVID-19 , COVID-19 , ChAdOx1 nCoV-19 , Humanos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/complicações , Feminino , Masculino , Brasil/epidemiologia , Pessoa de Meia-Idade , COVID-19/prevenção & controle , COVID-19/complicações , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/administração & dosagem , ChAdOx1 nCoV-19/efeitos adversos , Estudos Prospectivos , Adulto , SARS-CoV-2/imunologia , Idoso , Cefaleia/induzido quimicamente , Cefaleia/etiologia , Mialgia/induzido quimicamente , Mialgia/etiologia , Artralgia/etiologia , Vacinas de Produtos InativadosRESUMO
BACKGROUND AND AIM: Hughes-Stovin syndrome (HSS) is a rare systemic vasculitis with widespread venous/arterial thrombosis and pulmonary vasculitis. Distinguishing between pulmonary embolism (PE) and in-situ thrombosis in the early stages of HSS is challenging. The aim of the study is to compare clinical, laboratory, and computed tomography pulmonary angiography (CTPA) characteristics in patients diagnosed with PE versus those with HSS. METHODS: This retrospective study included 40 HSS patients with complete CTPA studies available, previously published by the HSS study group, and 50 patients diagnosed with PE from a single center. Demographics, clinical and laboratory findings, vascular thrombotic events, were compared between both groups. The CTPA findings were reviewed, with emphasis on the distribution, adherence to the mural wall, pulmonary infarction, ground glass opacification, and intra-alveolar hemorrhage. Pulmonary artery aneurysms (PAAs) in HSS were assessed and classified. RESULTS: The mean age of HSS patients was 35 ± 12.3 years, in PE 58.4 ± 17 (p < 0.0001). Among PE 39(78 %) had co-morbidities, among HSS none. In contrast to PE, in HSS both major venous and arterial thrombotic events are seen.. Various patterns of PAAs were observed in the HSS group, which were entirely absent in PE. Parenchymal hemorrhage was also more frequent in HSS compared to PE (P < 0.001). CONCLUSION: Major vascular thrombosis with arterial aneurysms formation are characteristic of HSS. PE typically appear loosely-adherent and mobile whereas "in-situ thrombosis" seen in HSS is tightly-adherent to the mural wall. Mural wall enhancement and PAAs are distinctive pulmonary findings in HSS. The latter findings have significant therapeutic ramifications.
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Angiografia por Tomografia Computadorizada , Embolia Pulmonar , Humanos , Embolia Pulmonar/diagnóstico por imagem , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Estudos Retrospectivos , Angiografia por Tomografia Computadorizada/métodos , Vasculite/diagnóstico por imagem , Vasculite/complicações , Idoso , Artéria Pulmonar/diagnóstico por imagem , Artéria Pulmonar/patologiaRESUMO
Adequate sodium and potassium intake, along with adherence to the Mediterranean diet (MedDiet), are key factors for preventing hypertension and cerebrovascular diseases. However, data on the consumption of these nutrients within the MedDiet are scarce. This cross-sectional study aims to assess the association between MedDiet adherence and sodium/potassium intake in the MIND-Matosinhos randomized controlled trial, targeting Portuguese adults at a high risk of dementia. Good adherence to the MedDiet was defined using the Portuguese Mediterranean Diet Adherence Screener questionnaire (≥10 points), and both sodium/potassium intakes were estimated from 24-hour urine collections. The association between MedDiet adherence and these nutrients' intake (dichotomized by the median) was quantified by calculating odds ratios (OR) and respective 95% confidence intervals (95% CI) using a logistic regression. A total of 169 individuals (60.9% female; median age: 70 years; range: 36-85 years) were included. Good adherence to the MedDiet was observed among 18.3% of the sample. After adjusting for sex, age, education and using antihypertensive drugs, good MedDiet adherence was associated with higher sodium (OR = 3.11; 95% CI: 1.27-7.65) and potassium intake (OR = 9.74; 95% CI: 3.14-30.26). Increased adherence to the MedDiet may contribute to a higher potassium intake but seems to have limited effects on the adequacy of sodium levels.
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Demência , Dieta Mediterrânea , Potássio na Dieta , Sódio na Dieta , Humanos , Feminino , Masculino , Idoso , Demência/prevenção & controle , Pessoa de Meia-Idade , Potássio na Dieta/administração & dosagem , Estudos Transversais , Sódio na Dieta/administração & dosagem , Idoso de 80 Anos ou mais , Adulto , Fatores de Risco , Cooperação do Paciente/estatística & dados numéricos , PortugalRESUMO
BACKGROUND: Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied. METHODS: We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death. RESULTS: A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days. CONCLUSIONS: Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.).
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Hemorragia Cerebral , Inibidores do Fator Xa , Fator Xa , Hematoma , Proteínas Recombinantes , Humanos , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Idoso , Masculino , Feminino , Hemorragia Cerebral/tratamento farmacológico , Hemorragia Cerebral/induzido quimicamente , Pessoa de Meia-Idade , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/efeitos adversos , Fator Xa/uso terapêutico , Fator Xa/efeitos adversos , Hematoma/induzido quimicamente , Hematoma/tratamento farmacológico , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Doença AgudaRESUMO
BACKGROUND: Stroke burden challenges global health, and social and economic policies. Although stroke recovery encompasses a wide range of care, including in-hospital, outpatient, and community-based rehabilitation, there are no published cost-effectiveness studies of integrated post-stroke pathways. OBJECTIVE: To determine the most cost-effective rehabilitation pathway during the first 12 months after a first-ever stroke. METHODS: A cohort of people in the acute phase of a first stroke was followed after hospital discharge; 51 % women, mean (SD) age 74.4 (12.9) years, mean National Institute of Health Stroke Scale score 11.7 (8.5) points, and mode modified Rankin Scale score 3 points. We developed a decision tree model of 9 sequences of rehabilitation care organised in 3 stages (3, 6 and 12 months) through a combination of public, semi-public and private entities, considering both the individual and healthcare service perspectives. Health outcomes were expressed as quality-adjusted life years (QALY) over a 1-year time horizon. Costs included healthcare, social care, and productivity losses. Sensitivity analyses were conducted on model input values. RESULTS: From the individual perspective, pathway 3 (Short-term Inpatient Unit ¼ Community Clinic) was the most cost-effective, followed by pathway 1 (Rehabilitation Centre ¼ Community Clinic). From the healthcare service perspective, pathway 3 was the most cost-effective followed by pathway 7 (Outpatient Hospital ¼ Private Clinic). All other pathways were considered strongly dominated and excluded from the analysis. The total 1-year mean cost ranged between 12104 and 23024 from the individual's perspective and between 10992 and 31319 from the healthcare service perspective. CONCLUSION: Assuming a willingness-to-pay threshold of one times the national gross domestic product (20633/QALY), pathway 3 (Short-term Inpatient Unit ¼ Community Clinic) was the most cost-effective strategy from both the individual and healthcare service perspectives. Rehabilitation pathway data contribute to the development of a future integrated care system adapted to different stroke profiles.
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Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Reabilitação do Acidente Vascular Cerebral , Humanos , Reabilitação do Acidente Vascular Cerebral/economia , Reabilitação do Acidente Vascular Cerebral/métodos , Reabilitação do Acidente Vascular Cerebral/estatística & dados numéricos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Árvores de Decisões , Estudos de Coortes , Procedimentos Clínicos/economia , Acidente Vascular Cerebral/economia , Análise de Custo-EfetividadeRESUMO
Computerized cognitive tests have the potential to cost-effectively detect and monitor cognitive impairments and thereby facilitate treatment for these conditions. However, relatively few of these tests have been validated in a variety of populations. Brain on Track, a self-administered web-based test, has previously been shown to have a good ability to differentiate between healthy individuals and patients with cognitive impairment in Portuguese populations. The objective of this study was to validate the differential ability and evaluate the usability of Brain on Track in a Swedish memory clinic setting. Brain on Track was administered to 30 patients with mild cognitive impairment/mild dementia and 30 healthy controls, all scheduled to perform the test from home after one week and after three months. To evaluate the usability, the patient group was interviewed after completion of the testing phase. Patients scored lower than healthy controls at both the first (median score 42.4 vs 54.1, p<0.001) and the second test (median score 42.3 vs 55.0, p<0.001). The test-retest intra-class correlation was 0.87. A multiple logistic regression model accounting for effects of age, gender and education rendered an ability of Brain on Track to differentiate between the groups with an area under the receiver operation characteristics curve of 0.90 for the first and 0.88 for the second test. In the subjective evaluation, nine patients left positive comments, nine were negative whereas five left mixed comments regarding the test experience. Sixty percent of patients had received help from relatives to log on to the platform. In conclusion, Brain on Track performed well in differentiating healthy controls from patients with cognitive impairment and showed a high test-retest reliability, on par with results from previous studies. However, the substantial proportion of patients needing help to log in could to some extent limit an independent use of the platform.
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Disfunção Cognitiva , Humanos , Idoso , Reprodutibilidade dos Testes , Suécia , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/psicologia , Testes Neuropsicológicos , Cognição , InternetRESUMO
Patient characteristics may influence access and acceptance of Prostate Specific Antigen test, and therefore, the timing of prostate cancer (PCa) diagnosis. A group of 361 patients from a cohort (nâ =â 451) diagnosed with PCa in 2018-2020 at the Portuguese Institute of Oncology of Porto was evaluated before treatment, using a structured interview, the Medical Term Recognition Test, and the EORTC Quality of Life Questionnaire QLQ-PR25. PCa prognostic stages (I, II, III, IV) were attributed according to the American Joint Committee on Cancer eighth edition. Multinomial logistic regression was used to compute the odds ratio and 95% confidence interval (OR [95% CI]), considering PCa stage II, the most frequent, as reference. Older age (ORâ =â 4.21 [2.24-7.93]), living outside the Porto Metropolitan Area while having low income (ORâ =â 6.25 [1.53-25.62]), and erectile dysfunction (ORâ =â 2.22 [0.99-4.99]) were associated with stage III, while urination during the night (ORâ =â 3.02 [1.42-6.41]) was associated with stage IV. Urine leakage was less frequent in stage III (ORâ =â 0.23 [0.08-0.68]), and living with a partner (ORâ =â 0.41 [0.19-0.88]) and family history of cancer (ORâ =â 0.25 [0.07-0.86]) in stage IV. Health literacy was not associated with PCa stage but lower education was less frequent in stage I (ORâ =â 0.27 [0.11-0.69]). Patient sociodemographic and clinical characteristics should be considered as targets to improve PCa early detection and prognosis.
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Letramento em Saúde , Neoplasias da Próstata , Masculino , Humanos , Prognóstico , Qualidade de Vida , Comportamentos Relacionados com a SaúdeRESUMO
This study aims to estimate the prevalence and to identify the determinants of cancer-related neuropathic pain (CRNP), chemotherapy-induced peripheral neuropathy (CIPN) and cognitive decline among patients with breast cancer over five years after diagnosis. Women with an incident breast cancer (n = 462) and proposed for surgery were recruited at the Portuguese Institute of Oncology-Porto in 2012 and underwent systematic neurological examinations and evaluations with the Montreal Cognitive Assessment (MoCA) before treatment and after one, three, and five years. Multivariate logistic regression was used to assess the determinants of CRNP and CIPN, and multivariate linear regression for the variation in MoCA scores. Prevalence of CRNP and CIPN decreased from the first to the fifth year after diagnosis (CRNP: from 21.1% to 16.2%, p = 0.018; CIPN: from 22.0% to 16.0% among those undergoing chemotherapy, p = 0.007). Cognitive impairment was observed in at least one assessment in 17.7% of the women. Statistically significant associations were observed between: cancer stage III and both CRNP and CIPN; triple negative breast cancer, chemotherapy, axillary node dissection, older age, higher education, and being single and CRNP; taxanes and fruit and vegetable consumption and CIPN. Anxiety, depression and poor sleep quality at baseline were associated with decreases in MoCA values from pre- to post-treatment and with CRNP. Follow-up protocols should consider the persistence of CRNP, CIPN, and cognitive impairment for several years following diagnosis.
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Leprosy is an infectious and contagious disease of slow evolution, triggered by Mycobacterium leprae. Arthritis is its third most common manifestation, after cutaneous and peripheral nerve involvement. Since musculoskeletal symptoms may be the initial presentation of the disease, it is important for health professionals to recognize its rheumatic manifestations for early diagnosis and appropriate treatment, especially in endemic areas. In addition, cases of leprosy have increased globally, notably in patients undergoing treatment with TNF-α blockers and due to the increase in migration and travel of people from developing countries to developed countries. This review proposes to discuss the main scenarios of mimicry of different rheumatic diseases by leprosy, as well as the role of immunosuppressive drugs used in rheumatology practice in the treatment of reactional states and in the risk of developing the infection.
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A avaliação das salas de vacina se faz necessária pelos diversos fatores que podem interferir na qualidade dos imunobiológicos presentes no local e assim comprometer sua eficácia, por meio da identificação de problemas que comprometem a concretização dos protocolos determinados pelo Programa Nacional de Imunizações (PNI). Com isso, é possível obter resultados satisfatórios e reordenar a execução e a oferta de serviços de qualidade. O presente estudo objetivou avaliar as salas de imunização da cidade de São Luís, Maranhão. Trata-se de estudo avaliativo realizado no município de São Luís MA, em 65 salas que administram vacinas através do Instrumento de Supervisão em Sala de Vacinação (PAISSV). Nenhuma sala foi considerada como ideal, mas 58,46% obtiveram o escore bom. Contudo, 67,69% das salas apresentaram temperatura diferente de 18ºC a 20ºC, 75,38% não realizava o registro de data e hora de abertura do frasco, 70,77% não organizava os cartões de controle por data de retorno, em 60,00% não era realizada a busca ativa de faltosos, o informativo não desligar o disjuntor na caixa de distribuição elétrica não estava presente em 78,46% e o programa de manutenção preventiva e/ou corretiva para o refrigerador era inexistente em 64,62%. As salas de vacinas dos serviços de saúde pública de São Luís foram consideradas como boas, porém não exime a necessidade de fiscalização e avaliação, juntamente com estratégias de qualificação dos profissionais.
The evaluation of vaccine rooms is necessary due to the various factors that can interfere with the quality of the immunobiologicals present in the place and thus compromise their effectiveness, through the identification of problems that compromise the implementation of the protocols determined by the National Immunization Program (PNI). With this, it is possible to obtain satisfactory results and reorganize the execution and provision of quality services. The present study aimed to evaluate the immunization rooms in the city of São Luís, Maranhão. This is an evaluative study carried out in the city of São Luís MA, in 65 rooms that administer vaccines through the Instrument of Supervision in the Vaccination Room (PAISSV). No room was considered ideal, but 58.46% had a good score. However, 67.69% of the rooms had a temperature different from 18ºC to 20ºC, 75.38% did not record the date and time of opening the bottle, 70.77% did not organize the control cards by return date, in 60 .00% the active search for faults was not carried out, the information not to turn off the circuit breaker in the electrical distribution box was not present in 78.46% and the preventive and/or corrective maintenance program for the refrigerator was non-existent in 64.62 %. Vaccination rooms at public health services in São Luís were considered good, but this does not exempt the need for inspection and evaluation, along with professional qualification strategies.
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Programas de Imunização , Pesquisa sobre Serviços de SaúdeRESUMO
BACKGROUND: Evidence suggests an association between SARS-CoV-2 infection and worse performance on cognitive tests, and a higher risk of Parkinson's disease (PD) and dementia up to 6 and 12 months after infection, respectively. Longer follow-ups with comparison groups are needed to clarify the potentially increased risk of neurodegenerative diseases in COVID-19 survivors, namely those infected before mass vaccination. METHODS: A prospective study started in July 2022 with four cohorts of 150 individuals each, defined according to SARS-CoV-2 infection and hospitalisation status between March 2020 and February 2021: cohort 1-hospitalised due to SARS-CoV-2 infection; cohort 2-hospitalised, COVID-19-free; cohort 3-infected, not hospitalised; cohort 4-not infected, not hospitalised. Cohort 2 will be matched to cohort 1 according to age, sex, level of hospitalisation care and length of stay; cohort 4 will be age-matched and sex-matched to cohort 3. Baseline, 1-year and 2-year follow-up evaluations will include: cognitive performance assessed with the Montreal Cognitive Assessment (MoCA) and neuropsychological tests; the assessment of prodromal markers of PD with Rapid Eye Movement Sleep Behaviour Disorder single-question Screen and self-reported olfactory and gustative alterations; screening of PD with the 9-item PD screening questionnaire; gait evaluation with Timed Up&Go test. Suspected cases of cognitive impairment and PD will undergo a clinical evaluation by a neurologist. Frequency measures of neurological complications, prodromal markers and diagnoses of dementia and PD, will be presented. The occurrence of cognitive decline-the difference between baseline and 1-year MoCA scores 1.5 SD below the mean of the distribution of the variation-will be compared between cohorts 1 and 2, and cohorts 3 and 4 with OR estimated using multivariate logistic regression. ETHICS AND DISSEMINATION: This study received ethics approval from the Ethics Committees of the health units Unidade Local de Saúde de Matosinhos and Centro Hospitalar de Entre Douro e Vouga, and informed consent is signed for participating. Results will be disseminated among the scientific community and the public.
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COVID-19 , Demência , Doença de Parkinson , Humanos , COVID-19/complicações , Estudos Prospectivos , SARS-CoV-2 , Doença de Parkinson/complicações , Doença de Parkinson/diagnóstico , Demência/complicaçõesRESUMO
BACKGROUND: An individual's personal values strongly influence their immediate and long-term decisions. Psychological heterogeneity in clinical trial populations contributes to selection bias and may affect treatment outcomes and inevitably trial results. OBJECTIVES: The objective of this study was to characterize for the first time the main interpersonal values of patients who participated in Phase II and III clinical trials. METHODS: This multicenter observational study included 200 participants from 4 different hospitals who participated in a Phase II or III clinical trial. Patients from different therapeutic areas were included in this study. The patients' interpersonal values were studied using the Survey of Interpersonal Values (SIV). The SIV scale is grouped into six subscales that assess specific personal values: (1) support, the need to be treated with kindness and to receive encouragement from other people; (2) conformity, the extent to which one does what is acceptable and considered socially correct; (3) recognition, the need to be highly regarded and admired, to be considered important and recognized by others; (4) independence, the extent to which individuals feel free to make their own decisions; (5) benevolence, the capacity to understand and show generosity towards the less fortunate; and (6) leadership, the value ascribed to coordinating the work of others, being selected for a leadership position, and being in a position to tell others what to do. The results obtained from the patient population were classified using the following categories: "very high" (P95-P99), "high" (P70-90), "medium" (P35-65) low" (P10-30), or "very low" (P1-5), and subsequently compared with those of the Portuguese normative population. RESULTS: Compared with the normative population, regardless of the patient's underlying disease, the percentile frequency distributions were significantly higher for the independence (p < 0.001) and benevolence (p < 0.001) subscales, and significantly lower for the leadership (p < 0.001) and recognition (p < 0.001) subscales in the patient population. Patient distribution according to underlying disease differed significantly relative differences in distribution relative to the normative population for the majority of subscales. Non-alcoholic steatohepatitis (NASH), heart failure, myocardial infarction, lung cancer, and rheumatoid arthritis patients were those for which the greatest differences were observed across diseases, while stroke, multiple sclerosis, and HIV patients showed the least differences relative to the normative population. CONCLUSIONS: This novel analysis of the interpersonal values of patients that participate in Phase II and III clinical trials revealed that the patients' interpersonal values largely differed from those of the Portuguese normative population. Better understanding the implications of these findings for clinical trial representativeness and outcomes is of crucial importance.
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Infecções por HIV , Hepatopatia Gordurosa não Alcoólica , Humanos , LiderançaRESUMO
Cardiovascular (CV) guidelines stress the need for global intervention to manage risk factors and reduce the risk of major vascular events. Growing evidence supports the use of polypill as a strategy to prevent cerebral and cardiovascular disease, however it is still underused in clinical practice. This paper presents an expert consensus aimed to summarize the data regarding polypill use. The authors consider the benefits of polypill and the significant claims for clinical applicability. Potential advantages and disadvantages, data regarding several populations in primary and secondary prevention, and pharmacoeconomic data are also addressed.
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INTRODUCTION: Transient ischaemic attack (TIA) and minor stroke are frequently assumed as temporary or non-disabling events. However, evidence suggests that these patients can experience relevant impairment and functional disability. Therefore, the present study aims to evaluate the feasibility and effectiveness of a 3-month multidomain intervention programme, composed of five non-pharmacological strategies, aimed at accelerating return to pre-event level of functionality in patients with TIA or minor stroke. METHODS AND ANALYSIS: Patients diagnosed with a TIA or a minor stroke are being recruited at the emergency or neurology departments of the Hospital Pedro Hispano, located in Matosinhos, Portugal (n=70). Those who accept to participate will be randomly allocated to two groups (1:1): (a) Intervention-receives a 3 months combined approach, initiating early post-event, composed of cognitive training, physical exercise, nutrition, psychoeducation and assessment/correction of hearing loss; (b) Control-participants will not be subject to any intervention. Both groups will receive the usual standard of care provided to these diseases. Recruitment began in May 2022 and is expected to continue until March 2023. Socio-demographic characteristics, lifestyles, health status, cognitive function, symptoms of anxiety and depression and quality of life will be assessed; as well as anthropometry, blood pressure and physical condition. Time to complete or partial recovery of instrumental activities of daily living will be assessed using an adapted version of the Frenchay Activities Index. All participants will be evaluated before the intervention and after 3 months. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. TRIAL REGISTRATION NUMBER: NCT05369637.
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Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Ataque Isquêmico Transitório/prevenção & controle , Qualidade de Vida , Estudos de Viabilidade , Projetos Piloto , Atividades Cotidianas , Acidente Vascular Cerebral/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The nature and quality of stroke survivor rehabilitation varies throughout Europe, including in Portugal, having not been widely monitored or benchmarked. OBJECTIVES: This study analyses the stroke care pathway from three perspectives: healthcare system, process, and patient. METHODS: The study uses data from a one-year single-center prospective cohort of first stroke patients, assessed at baseline, 3, 6, and 12 months. Care pathways and settings were described in terms of organizational model, funding, patient involvement, frequency and intensity and multidisciplinary team. Patient-level information and satisfaction were evaluated using a 10-point numeric rating scale. Kruskal - Wallis and post-hoc tests were used to compare EQ-5D-3 L, National Institute of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index, Mini-Mental State Examination scores between pathways and settings. RESULTS: A total of 391 acute stroke patients, with a mean disability of 3.7 (mRS) and severity of 11.7 (NIHSS) participated. Six pathways and eight settings were described. A lack of compliance between guidelines and care was identified. There were significant differences in the four outcomes between the six pathways (p-values 0.007 to 0.020) suggesting inefficiency and inequalities, with an inadequate level of information and patient satisfaction. After post-hoc analysis, pathways 1 and 2 showed highest outcomes (p-values 0.001 to 0.002). Within settings, short-term units showed high scores, followed by rehabilitation center, outpatient hospital, and community clinic (p-values 0.001 to 0.040). CONCLUSION: A multilevel characterization of the post-stroke rehabilitation pathway showed a more complete perspective on stroke management which may contribute to future rehabilitation and stroke policies.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/diagnóstico , Portugal , Estudos Prospectivos , Qualidade de Vida , Satisfação do Paciente , Satisfação PessoalRESUMO
This study aimed to identify and assess the evidence on the association between idiopathic chronic low back pain (LBP) and cognitive function in individuals with LBP. A secondary aim was to explore whether changes in cognitive function are associated with pain characteristics and psychological factors (eg, catastrophizing and fear of movement). Eleven studies were included in this systematic review, and four meta-analyses were conducted. Low to very low-quality evidence suggests impaired cognitive function in individuals with LBP compared to asymptomatic controls for problem solving (k = 5; d = 0.33; CI = 0.16-0.50; z = 3.85 p = 0.0001), speed of information processing (k = 5; d = 0.44; CI = 0.22-0.65; z = 4.02 p < 0.0001), working memory (k = 6; d = 0.50; CI = 0.34-0.66; z = 6.09 p < 0.0001), and delayed memory (k = 3; d = 0.34; CI = 0.07-0.6, z = 2.49 p = 0.02). The association between LBP intensity and psychological factors and cognitive function was inconclusive. More studies are needed to explore these associations and improve evidence in this field. The results of this study suggest that cognitive aspects should be considered during the rehabilitation process of patients with LBP and raise further questions, including whether individuals with LBP are at a greater risk of developing dementia or whether targeting cognitive function will increase the probability of success of LBP treatment. These questions should, also, be considered in future studies.
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Dor Lombar , Humanos , Dor Lombar/terapia , CogniçãoRESUMO
BACKGROUND/AIMS: Clinical trials are fundamental for the development of new medicines and patient participation is based on free consent. Our study sought to identify psychological characteristics that may influence patient willingness to participate in a clinical trial. METHODS: A total of 100 participants were invited to participate with 80% positive response rate. The psychological characteristics of each patient were evaluated using the following validated psychometric scales: Self-Efficacy Scale, Curiosity, Exploration Inventory-Trait, Social Support Satisfaction, State-Trait Anxiety Inventory and Social Avoidance and Distress, and Fear of Negative Evaluation. RESULTS: Patients who agreed to participate in the clinical trial were significantly younger than those who refused (p=0.028). There were no differences in sex, lifestyle, employment status, monthly income or education. After adjusting for age and sex, patients who agreed to participate scored significantly higher in the following: self-efficacy total score (p<0.001), effectiveness in adversity (p<0.001), social effectiveness (p<0.001) and initiation and persistence (p<0.001); social support total score (p<0.001), family satisfaction (p=0.015), friendship satisfaction (p<0.001), social activities satisfaction (p=0.002) and intimacy (p<0.001); total curiosity score (p<0.001), absorption (p<0.001) and exploration (p<0.001). Compared with patients who agreed to participate, those who refused scored significantly higher for both state (p<0.001) and trait anxiety (p<0.001), fear of negative evaluation (p<0.001) and social avoidance and distress (p<0.001). CONCLUSIONS: Patients who were willing to participate in clinical trials exhibited different psychological characteristics to patients who refused. Specifically, they were more curious and self-efficacious, less anxious and reported a higher level of social support than patients who declined to participate. Identifying characteristics that condition the individual's decision to participate in a clinical trial has important implications for the development of patient-focused communication strategies and improved recruitment approaches.
Assuntos
Ensaios Clínicos como Assunto , Participação do Paciente , Humanos , Ansiedade , Autoeficácia , Participação do Paciente/psicologia , Fatores SociodemográficosRESUMO
BACKGROUND: The ATN scheme was proposed as an unbiased biological characterization of the Alzheimer's disease (AD) spectrum, grouping biomarkers into three categories: brain Amyloidosis-A, Tauopathy-T, Neurodegeneration-N. Although this scheme was mainly recommended for research, it is relevant for diagnosis. OBJECTIVE: To evaluate the ATN scheme performance in real-life cohorts reflecting the inflow of patients with cognitive complaints and different underlying disorders in general neurological centers. METHODS: We included patients (nâ=â1,128) from six centers with their core cerebrospinal fluid-AD biomarkers analyzed centrally. A was assessed through Aß42/Aß40, T through pTau-181, and N through tTau. Association between demographic features, clinical diagnosis at baseline/follow-up and ATN profiles was assessed. RESULTS: The prevalence of ATN categories was: A-T-N-: 28.3%; AD continuum (Aâ+âT-/+N-/+): 47.8%; non-AD (A- plus T or/and N+): 23.9%. ATN profiles prevalence was strongly influenced by age, showing differences according to gender, APOE genotype, and cognitive status. At baseline, 74.6% of patients classified as AD fell in the AD continuum, decreasing to 47.4% in mild cognitive impairment and 42.3% in other neurodegenerative conditions. At follow-up, 41% of patients changed diagnosis, and 92% of patients that changed to AD were classified within the AD continuum. Aâ+âwas the best individual marker for predicting a final AD diagnosis, and the combinations Aâ+âT+ (irrespective of N) and Aâ+âT+N+ had the highest overall accuracy (83%). CONCLUSION: The ATN scheme is useful to guide AD diagnosis in real-life neurological centers settings. However, it shows a lack of accuracy for patients with other types of dementia. In such cases, the inclusion of other markers specific for non-AD proteinopathies could be an important aid to the differential diagnosis.
Assuntos
Doença de Alzheimer , Amiloidose , Disfunção Cognitiva , Humanos , Doença de Alzheimer/diagnóstico , Peptídeos beta-Amiloides , Proteínas tau , Disfunção Cognitiva/diagnóstico , Biomarcadores , Proteínas Amiloidogênicas , Fragmentos de PeptídeosRESUMO
To explore the association between the user's cognitive function and usability reported by the evaluator. A cross-sectional study was conducted with a community-based sample. Data about participants' age, sex, education, sleep quantity, subjective memory complaints, and cognitive function were collected. A usability session was conducted to evaluate a digital solution called Brain on Track. Independent linear-regression analyses were used to explore univariable and multivariable associations between evaluator-reported usability assessment and the users' cognitive function, age, sex, education, sleep quantity, and subjective memory complaints. A total of 238 participants entered this study, of which 161 (67.6%) were females and the mean age was 42 (SD 12.9) years old. All variables (age, education, sleep quantity, subjective memory complaints and cognitive function) except sex were significantly associated with evaluator-reported usability in the univariable analysis (p < 0.05). Cognitive function, age, education, and subjective memory complaints remained significant in the multivariable model (F = 38.87, p < 0.001) with an adjusted R2 of 0.391. Cognition scores alone showed an adjusted R2 of 0.288. This work suggests that cognitive function impacts evaluator reported usability, alongside other users' characteristics and needs to be considered in the usability evaluation.