Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU.

Patient experience data (PED), provided by patients/their carers without interpretation by clinicians, directly capture what matters more to patients on their medical condition, treatment and impact of healthcare. PED can be collected through different methodologies and these need to be robust and validated for its intended use. Medicine regulators are increasingly encouraging stakeholders to generate, collect and submit PED to support both scientific advice in development programs and regulatory decisions on the approval and use of these medicines. This article reviews the existing definitions and types of PED and demonstrate the potential for use in different settings of medicines' life cycle, focusing on Patient-Reported Outcomes (PRO) and Patient Preferences (PP). Furthermore, it addresses some challenges and opportunities, alluding to important regulatory guidance that has been published, methodological aspects and digitalization, highlighting the lack of guidance as a key hurdle to achieve more systematic inclusion of PED in regulatory submissions. In addition, the article discusses opportunities at European and global level that could be implemented to leverage PED use. New digital tools that allow patients to collect PED in real time could also contribute to these advances, but it is equally important not to overlook the challenges they entail. The numerous and relevant initiatives being developed by various stakeholders in this field, including regulators, show their confidence in PED's value and create an ideal moment to address challenges and consolidate PED use across medicines' life cycle.

Impact on pulmonary, cardiac, and renal function and long-term quality of life after hospitalization for acute respiratory distress syndrome due to COVID-19: Protocol of the Post-COVID Brazil 3 study.

RATIONALE: Evidence about long-term sequelae after hospitalization for acute respiratory distress syndrome due to COVID-19 is still scarce. PURPOSE: To evaluate changes in pulmonary, cardiac, and renal function and in quality of life after hospitalization for acute respiratory distress syndrome secondary to COVID-19. METHODS: This will be a multicenter case-control study of 220 participants. Eligible are patients who are hospitalized for acute respiratory distress syndrome due to COVID-19. In the control group, individuals with no history of hospitalization in the last 12 months or long-term symptoms of COVID-19 will be selected. All individuals will be subjected to pulmonary spirometry with a carbon monoxide diffusion test, chest tomography, cardiac and renal magnetic resonance imaging with gadolinium, ergospirometry, serum and urinary creatinine, total protein, and urinary microalbuminuria, in addition to quality-of-life questionnaires. Patients will be evaluated 12 months after hospital discharge, and controls will be evaluated within 90 days of inclusion in the study. For all the statistical analyses, p < 0.05 is the threshold for significance. RESULTS: The primary outcome of the study will be the pulmonary diffusing capacity for carbon monoxide measured after 12 months. The other parameters of pulmonary, cardiac, and renal function and quality of life are secondary outcomes. CONCLUSION: This study aims to determine the long-term sequelae of pulmonary, cardiac, and renal function and the quality of life of patients hospitalized for acute respiratory distress syndrome due to COVID-19 in the Brazilian population.

Does kinesio tape alter muscle strength in athletes? - Systematic review and meta-analysis.

BACKGROUND: Kinesio tape (KT) is still a matter of debate and the results of studies that evaluated its effects on muscle strength in athletes are still contradictory and inconclusive. OBJECTIVES: To analyze randomized clinical trials (RCT) to compare the effects of KT on muscle strength with the control/placebo group among athletes with and without musculoskeletal injury. METHOD: The search involved the databases: PubMed, Web of Science, LILACS, PEDro, The Cochrane Library, Medline, Scopus, SPORTDiscus and Embase, without filter and included RCTs evaluating the effects of KT on muscle strength in athletes with or without musculoskeletal injury, comparing it to a control/placebo intervention. The following were excluded: studies with duplicate information; who used instruments for indirect assessment of muscle strength; involving a different population of athletes. Meta-analysis calculations were performed using post-intervention muscle strength data in the Review Manager (RevMan) program. RESULTS: 10 articles were eligible, among which 5 studies were included in the meta-analysis. In the primary analysis, no relevant clinical effect was found (immediate post-intervention <24h: Z = 1.97 CI95% = 0.35[0.00-0.70]; p = 0.05 I2 = 0% and late post-intervention ≥24h: Z = 1.47 CI95% = 0.59[-0.20-1.38]; p = 0.14 I2 = 69%) when comparing the KT group with the control/placebo groups for muscle strength of lower limbs in participants with and without musculoskeletal injury and in the subgroup analysis (including only individuals without injury), there was also no clinical effect (Z = 1.50, 95%CI = 0.31[-0.10-0.71] p = 0.13, I2 = 0%) of KT for muscle strength. CONCLUSIONS: KT does not contribute to muscle strength gain in athletes with and without musculoskeletal injuries. PROSPERO: CRD42020139822. (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=139822) (29 July 2020).

Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol. / Qualidade de Vida em Longo Prazo e Desfechos após Internação por COVID-19 no Brasil: Protocolo do Estudo Pós-COVID Brasil 1.

BACKGROUND: The long-term impact of hospitalization for COVID-19 on patients' physical, mental, and cognitive health still needs further assessment. OBJECTIVES: This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19. METHODS: This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses. RESULTS: The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented. CONCLUSIONS: This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.

FUNDAMENTO: O impacto em longo prazo da hospitalização por COVID-19 sobre a saúde física, mental e cognitiva dos pacientes requer mais investigação. OBJETIVOS: Este artigo visa avaliar os fatores associados com a qualidade de vida e desfechos cardiovasculares e não cardiovasculares 12 meses após a internação hospitalar por COVID-19. MÉTODOS: Este estudo multicêntrico prospectivo pretende incluir 611 pacientes internados por COVID-19 (NCT05165979). Entrevistas telefônicas centralizadas estão programadas para ocorrer em três, seis, nove e 12 meses após a alta hospitalar. O desfecho primário é definido como o escore de utilidade de qualidade de vida relacionada à saúde avaliada pelo questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários são definidos como o EQ-5D-3L aos três, seis e nove meses, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático, eventos cardiovasculares maiores, reinternação, e mortalidade por todas as causas aos três, seis, nove e 12 meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. RESULTADOS: O desfecho primário será apresentado como frequência do escore EQ-5D-3L 12 meses após a internação por COVID-19. Uma subanálise para identificar possíveis associações das variáveis independentes com desfechos do estudo será apresentada. CONCLUSÃO: Este estudo determinará o impacto da COVID-19 sobre a qualidade de vida e de desfechos cardiovasculares e não cardiovasculares de pacientes internados 12 meses após a alta, e fornecerá novas informações ao sistema público de saúde no Brasil.

Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol. / Qualidade de Vida Relacionada à Saúde e Desfechos em Longo Prazo após COVID-19 Sintomática Leve: Protocolo do Estudo Pós-COVID Brasil 2.

BACKGROUND: The long-term effects of mild COVID-19 on physical, cognitive, and mental health are not yet well understood. OBJECTIVE: The purpose of this paper is to describe the protocol for the ongoing "Post-COVID Brazil" study 2, which aims to evaluate the factors associated with health-related quality of life and long-term cardiovascular and non-cardiovascular outcomes one year after a mild episode of symptomatic COVID-19. METHODS: The "Post-COVID Brazil" study 2 is a prospective multicenter study that plans to enroll 1047 patients (NCT05197647). Centralized, structured telephone interviews are conducted at 1, 3, 6, 9, and 12 months after COVID-19 diagnosis. The primary outcome is the health-related quality-of-life utility score, assessed using the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints include the EQ-5D-3L at 3, 6, and 9 months, as well as all-cause mortality, major cardiovascular events, hospitalization, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value < 0.05 will be considered statistically significant for all analyses. RESULTS: The primary endpoint will be presented as the overall frequency of the EQ-5D-3L domains 12 months after SARS-CoV-2 infection. Main analysis will explore the association of independent variables with the study outcomes. CONCLUSION: The "Post-COVID Brazil" study 2 aims to clarify the impact of long COVID on the quality of life and cardiovascular and non-cardiovascular outcomes of Brazilian patients who have had mild COVID-19.

FUNDAMENTO: Os efeitos em longo prazo da COVID-19 leve sobre a saúde física, mental e cognitiva ainda não são bem conhecidos. OBJETIVO: Este artigo visa descrever o protocolo para o estudo em andamento Pós-COVID Brasil 2, o qual tem como objetivo avaliar os fatores associados à qualidade de vida associada à saúde e desfechos cardiovasculares e não cardiovasculares de longo prazo um ano após um episódio de COVID-19 sintomática leve. MÉTODOS: O estudo "Pós-COVID Brasil 2" é um estudo multicêntrico prospectivo que pretende incluir 1047 pacientes (NCT05197647). Entrevistas estruturas, centralizadas são conduzidas em um mês, e aos três, seis, nove e 12 meses após o diagnóstico de COVID-19. O desfecho primário é o escore de utilidade da qualidade de vida relacionada à saúde, avaliado usando o questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários incluem o EQ-5D-3L aos três, seis e nove meses, mortalidade por todas as causas, eventos cardiovasculares maiores, hospitalização, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático as três, seis, nove e doze meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. RESULTADOS: O desfecho primário será apresentado como frequência dos domínios do EQ-5D-3L doze meses após a infecção por SARS-CoV-2. A análise principal explorará a associação das variáveis independentes com os desfechos do estudo. CONCLUSÃO: O estudo "Pós-COVID Brasil 2" tem como objetivo elucidar o impacto da COVID longa sobre a qualidade de vida e desfechos cardiovasculares e não cardiovasculares de brasileiros pacientes que apresentaram COVID-19 leve.

Qualidade de Vida em Longo Prazo e Desfechos após Internação por COVID-19 no Brasil: Protocolo do Estudo Pós-COVID Brasil 1 / Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol

Resumo Fundamento O impacto em longo prazo da hospitalização por COVID-19 sobre a saúde física, mental e cognitiva dos pacientes requer mais investigação. Objetivos Este artigo visa avaliar os fatores associados com a qualidade de vida e desfechos cardiovasculares e não cardiovasculares 12 meses após a internação hospitalar por COVID-19. Métodos Este estudo multicêntrico prospectivo pretende incluir 611 pacientes internados por COVID-19 (NCT05165979). Entrevistas telefônicas centralizadas estão programadas para ocorrer em três, seis, nove e 12 meses após a alta hospitalar. O desfecho primário é definido como o escore de utilidade de qualidade de vida relacionada à saúde avaliada pelo questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários são definidos como o EQ-5D-3L aos três, seis e nove meses, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático, eventos cardiovasculares maiores, reinternação, e mortalidade por todas as causas aos três, seis, nove e 12 meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. Resultados O desfecho primário será apresentado como frequência do escore EQ-5D-3L 12 meses após a internação por COVID-19. Uma subanálise para identificar possíveis associações das variáveis independentes com desfechos do estudo será apresentada. Conclusão Este estudo determinará o impacto da COVID-19 sobre a qualidade de vida e de desfechos cardiovasculares e não cardiovasculares de pacientes internados 12 meses após a alta, e fornecerá novas informações ao sistema público de saúde no Brasil.

Abstract Background The long-term impact of hospitalization for COVID-19 on patients' physical, mental, and cognitive health still needs further assessment. Objectives This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19. Methods This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses. Results The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented. Conclusions This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.

Qualidade de Vida Relacionada à Saúde e Desfechos em Longo Prazo após COVID-19 Sintomática Leve: Protocolo do Estudo Pós-COVID Brasil 2 / Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol

Resumo Fundamento Os efeitos em longo prazo da COVID-19 leve sobre a saúde física, mental e cognitiva ainda não são bem conhecidos. Objetivo Este artigo visa descrever o protocolo para o estudo em andamento Pós-COVID Brasil 2, o qual tem como objetivo avaliar os fatores associados à qualidade de vida associada à saúde e desfechos cardiovasculares e não cardiovasculares de longo prazo um ano após um episódio de COVID-19 sintomática leve. Métodos O estudo "Pós-COVID Brasil 2" é um estudo multicêntrico prospectivo que pretende incluir 1047 pacientes (NCT05197647). Entrevistas estruturas, centralizadas são conduzidas em um mês, e aos três, seis, nove e 12 meses após o diagnóstico de COVID-19. O desfecho primário é o escore de utilidade da qualidade de vida relacionada à saúde, avaliado usando o questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários incluem o EQ-5D-3L aos três, seis e nove meses, mortalidade por todas as causas, eventos cardiovasculares maiores, hospitalização, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático as três, seis, nove e doze meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. Resultados O desfecho primário será apresentado como frequência dos domínios do EQ-5D-3L doze meses após a infecção por SARS-CoV-2. A análise principal explorará a associação das variáveis independentes com os desfechos do estudo. Conclusão O estudo "Pós-COVID Brasil 2" tem como objetivo elucidar o impacto da COVID longa sobre a qualidade de vida e desfechos cardiovasculares e não cardiovasculares de brasileiros pacientes que apresentaram COVID-19 leve.

Abstract Background The long-term effects of mild COVID-19 on physical, cognitive, and mental health are not yet well understood. Objective The purpose of this paper is to describe the protocol for the ongoing "Post-COVID Brazil" study 2, which aims to evaluate the factors associated with health-related quality of life and long-term cardiovascular and non-cardiovascular outcomes one year after a mild episode of symptomatic COVID-19. Methods The "Post-COVID Brazil" study 2 is a prospective multicenter study that plans to enroll 1047 patients (NCT05197647). Centralized, structured telephone interviews are conducted at 1, 3, 6, 9, and 12 months after COVID-19 diagnosis. The primary outcome is the health-related quality-of-life utility score, assessed using the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints include the EQ-5D-3L at 3, 6, and 9 months, as well as all-cause mortality, major cardiovascular events, hospitalization, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value < 0.05 will be considered statistically significant for all analyses. Results The primary endpoint will be presented as the overall frequency of the EQ-5D-3L domains 12 months after SARS-CoV-2 infection. Main analysis will explore the association of independent variables with the study outcomes. Conclusion The "Post-COVID Brazil" study 2 aims to clarify the impact of long COVID on the quality of life and cardiovascular and non-cardiovascular outcomes of Brazilian patients who have had mild COVID-19.

Association of smartphone addiction with pain, sleep, anxiety, and depression in university students / Análise da dependência do uso de smartphone em comparação à dor, sono, ansiedade e depressão em universitários

Abstract Introduction: Smartphone use has become a popular social communication phenomenon worldwide. Its excessive use can compromise daily routines and habits, which is associated with sleep disorders, stress, anxiety and pain. Therefore, the university student stands out, as they has a lifestyle in which it is necessary to reconcile daily activities with curriculum activities, aggravating psychosocial factors. Objective: To investigate whether smartphone addiction influences sleep quality, anxiety, depression and pain in university students. Methods: We carried out an analytical cross-sectional study. For data collection, the following self-administered questionnaires were used: Smartphone Addiction Inventory (SPAI-BR), to assess smartphone dependence; Pittsburgh Sleep Quality Index (PSQI), to evaluate sleep quality; Hospital Anxiety and Depression Scale, to assess anxiety and depression (HADS), where it was subdivided into HADS-A for anxiety and HADS-D for depression; and Numeric Rating Scale (NRS) to determine physical pain intensity. The sample consisted of 301 university students studying physiotherapy and physical education at the State University of Northern Paraná (UENP). They were divided according to the score obtained in the SPAI-BR between the "regular" group (up to 6 points) and "predisposed" to smartphone dependence (7 or more points). Results: The comparisons were statistically significant in favor of the regular group: the predisposed group obtained a higher score for the questionnaires used with an average NRS of 2.37 points, average HADS-D of 9.05 points and average HADS-A of 6.01 points. Differences between groups were statistically significant: NRS, p = 0.018; HADS-A, p = 0.001; HADS-D p = 0.001; and PSQI, p = 0.001. Conclusion: The university students analyzed in this study classified as predisposed were more prone to being addicted to their smartphone, and they were more likely to have anxiety, with a worse quality of sleep and with a greater intensity of pain.

Resumo Introdução: O uso de smartphones se tornou um fenômeno social mundialmente popular de comunicação. Seu uso excessivo pode comprometer as rotinas e hábitos diários, que estão associados aos distúrbios do sono, estresse, ansiedade, algias; logo, destaca-se o universitário, que apresenta um estilo de vida em que é preciso conciliar as atividades diárias com as curriculares, agravando fatores psicossociais. Objetivo: Investigar se a dependência do uso de smartphone influencia a qualidade de sono e os níveis de ansiedade, depressão e dor em universitários. Métodos: Trata-se de um estudo transversal analítico. Para a coleta dos dados foram utilizados os questionários autoaplicáveis Inventário de Dependências do Smartphone (SPAI-BR), Escala de Pittsburgh (PSQI), Escala Hospitalar de Ansiedade e Depressão (HADS), sendo este subdividido em HADS-A (ansiedade) e HADS-D (depressão), e Escala Numérica da Dor (END). A amostra foi composta por 301 universitários da Universidade Estadual do Norte do Paraná, dos cursos de fisioterapia e educação física. Os estudantes foram divididos de acordo com o escore obtido no SPAI-BR entre grupo regular (até 6 pontos) e pré-disposto à dependência do uso de smartphone (7 ou mais pontos). Resultados: As comparações foram estatisticamente significativas a favor do grupo regular; sendo assim, o grupo pré-disposto obteve uma pontuação pior nos questionários utilizados, sendo a média END de 2,37 pontos, a média HADS-D de 9,05 e a média HADS-A de 6,01. Os valores de intensidade de dor entre os grupos foram de p = 0,018; HADS-A: p = 0,001; HADS-D: p = 0,001; PSQI: p= 0,001. Conclusão: Os universitários classificados como pré- dispostos apresentaram uma maior propensão à dependência do smartphone, além de maior chance de terem ansiedade com uma pior qualidade de sono e maior intensidade de dor.

Progressive tension protocol for muscle strength with Kinesio tape in runners - double-blind randomized clinical trial / Protocolo de tensão progressiva para força muscular com Kinesio tape em corredores - ensaio clínico randomizado duplo-cego

Abstract Introduction Kinesio tape (KT), although frequently used in sports, is still a matter of debate, and the results of studies that evaluated its effects on muscle strength (MS) in athletes are still inconclusive and contradictory. Objective To evaluate the effect of a progressive KT tension protocol on knee MS in runners over an eight-week intervention. Methods Clinical trial involving 49 runners of both sexes randomized into two groups: KT (KT with progressive tension protocol) and placebo (KT without tension). The MS of knee flexors and extensors was evaluated by isokinetic dynamometer (60º/s and 90º/s) at four moments: (1) without KT; (2) with KT and without tension; (3) without KT (after 8 weeks after of intervention); (4) with KT and with tension (after 8 weeks after of intervention). Inter- and intra-group comparisons were made. The significance level adopted was 95% (p < 0.05). Results There were no significant differences in MS between the groups at any of the evaluated moments. There was a statistically significant difference in MS (60º/s) in both groups (KT and placebo) when comparing moments 4 and 2 for knee flexors, and in the placebo group between moments 4 and 2 and moments 4 and 3 for knee extensors. Conclusion The progressive tension protocol of KT was not able to intervene in the SM gain of knee flexors and extensors of runners in inter and intragroup comparisons.

Resumo Introdução A Kinesio tape (KT), apesar de muito utilizada na prática esportiva, ainda é motivo de debate e os resultados de estudos que avaliaram seus efeitos na força muscular (FM) em atletas ainda são inconclusivos e contraditórios. Objetivo Avaliar o efeito de um protocolo de tensão progressiva KT na FM do joelho em corredores ao longo de uma intervenção de oito semanas. Métodos Ensaio clínico envolvendo 49 corredores de ambos os sexos randomizados em dois grupos: KT (KT com protocolo de tensão progressiva) e placebo (KT sem tensão). A FM dos flexores e extensores do joelho foi avaliada por dinamômetro isocinético (60º/s e 90º/s) em quatro momentos: (1) sem KT; (2) com KT e sem tensão; (3) sem KT (após 8 semanas); (4) com KT e com tensão (pós-protocolo 8 semanas). Comparações inter e intragrupos foram feitas. O nível de significância adotado foi de 95% (p < 0,05). Resultados Não houve diferenças signi-ficativas na FM entre os grupos em nenhum dos momentos avaliados. Houve diferença estatisticamente significante na FM (60º/s) em ambos os grupos (KT e placebo, quando comparados os momentos 4 e 2 para flexores de joelho, e no grupo placebo entre os momentos 4 e 2 e os momentos 4 e 3 para extensores de joelho. Conclusão O protocolo de tensão progressiva de KT não foi capaz de intervir no ganho de FM de flexores e extensores de joelho de corredores em comparações inter e intragrupos.

Assessing the burden of COVID-19 in developing countries: systematic review, meta-analysis and public policy implications.

INTRODUCTION: The infection fatality rate (IFR) of COVID-19 has been carefully measured and analysed in high-income countries, whereas there has been no systematic analysis of age-specific seroprevalence or IFR for developing countries. METHODS: We systematically reviewed the literature to identify all COVID-19 serology studies in developing countries that were conducted using representative samples collected by February 2021. For each of the antibody assays used in these serology studies, we identified data on assay characteristics, including the extent of seroreversion over time. We analysed the serology data using a Bayesian model that incorporates conventional sampling uncertainty as well as uncertainties about assay sensitivity and specificity. We then calculated IFRs using individual case reports or aggregated public health updates, including age-specific estimates whenever feasible. RESULTS: In most locations in developing countries, seroprevalence among older adults was similar to that of younger age cohorts, underscoring the limited capacity that these nations have to protect older age groups.Age-specific IFRs were roughly 2 times higher than in high-income countries. The median value of the population IFR was about 0.5%, similar to that of high-income countries, because disparities in healthcare access were roughly offset by differences in population age structure. CONCLUSION: The burden of COVID-19 is far higher in developing countries than in high-income countries, reflecting a combination of elevated transmission to middle-aged and older adults as well as limited access to adequate healthcare. These results underscore the critical need to ensure medical equity to populations in developing countries through provision of vaccine doses and effective medications.

Evaluation of the Clinical Profile of Patients with Gynecological Tumors undergoing Antineoplastic Treatment / Avaliação do Perfil Clínico de Pacientes com Tumores Ginecológicos em Tratamento Antineoplásico / Evaluación del Perfil Clinico de Pacientes con Tumores Ginecológicos Sometidos a Tratamiento Antineoplásico

Introduction: The evaluation of the causes of interruption of the antineoplastic therapeutic plan allows the development of strategies that increase adherence and positive treatment outcomes. Objective: Outline the clinical profile of the patients with gynecological tumors under intravenous antineoplastic treatment, identifying the risk of interrupting the therapeutic plan. Method: Retrospective and quantitative study (2011-2018), including patients older than 18 years old, with gynecological tumors undergoing antineoplastic treatment. The database was built from the spreadsheets of antineoplastic drug handling at the Chemotherapy Center. The variables collected were: year of treatment, age, type of tumor, purpose of treatment, protocol, medication, dose, start and end of treatment, and treatment interruption. Results: 6,496 patients over 8 years were evaluated. Fifty two percent of the patients presented cervical cancer. Almost forty eight percent (47.6%) showed a palliative treatment purpose for their tumors. Approximately, twenty three percent (22.6%) interrupted the antineoplastic treatment. For adjuvant, curative, and palliative purposes the age range 18-30 presented the highest interruption, respectively 33%, 36% and 41%. The paclitaxel/carboplatin protocol was the most prescribed with a significant percentage of interruption. Conclusion: The findings suggest that there is an association between treatment discontinuation and patients' age and therapeutic purpose

Introdução: A avaliação das causas de interrupção do plano terapêutico antineoplásico permite a elaboração de estratégias que aumentem a adesão e os desfechos positivos do tratamento. Objetivo: Traçar o perfil clínico das pacientes com tumores ginecológicos, em tratamento antineoplásico intravenoso, identificando o risco de interrupção do plano terapêutico. Método: Estudo retrospectivo e quantitativo (2011-2018), incluindo pacientes maiores de 18 anos, com tumores ginecológicos em tratamento antineoplásico. O banco de dados foi construído a partir das planilhas de controle de antineoplásicos da Central de Quimioterapia. As variáveis coletadas foram ano de tratamento, idade, tipo de tumor, finalidade do tratamento, protocolo, medicamento, dose, início e término do tratamento e interrupção do tratamento. Resultados: Avaliaram-se 6.496 pacientes ao longo de oito anos. Cinquenta e dois por cento das pacientes apresentavam câncer cervical. Quase 48% (47,6%) apresentaram uma finalidade de tratamento paliativo para seus tumores. Aproximadamente 23% (22,6%) interromperam o tratamento antineoplásico. Para fins adjuvantes, curativos e paliativos, a faixa etária de 18 a 30 anos apresentou a maior interrupção, respectivamente 33%, 36% e 41%. O protocolo paclitaxel/carboplatina foi o mais prescrito com percentual significativo de interrupção. Conclusão: Os achados sugerem que exista uma associação entre a suspensão do tratamento e a idade dos pacientes e a finalidade terapêutica

Introducción: La evaluación de las causas de interrupción del plan terapéutico antineoplásico permite el desarrollo de estrategias que aumentan la adherencia y los resultados positivos del tratamiento. Objetivo: Delinear el perfil clínico de las pacientes con tumores ginecológicos, en tratamiento antineoplásico intravenoso, identificando el riesgo de interrupción del plan terapéutico. Método: Estudio retrospectivo y cuantitativo (2011-2018), que incluyó a pacientes mayores de 18 años, con tumores ginecológicos en tratamiento antineoplásico. La base de datos se construyó a partir de las hojas de cálculo del manejo de fármacos antineoplásicos en el Centro de Quimioterapia. Las variables recogidas fueron: año de tratamiento, edad, tipo de tumor, finalidad del tratamiento, protocolo, medicación, dosis, inicio y finalización del tratamiento e interrupción del mismo. Resultados: Se evaluaron 6.496 pacientes durante los ocho años. El 52% de las pacientes presentó cáncer de cuello uterino. Casi el 48% (47,6%) mostró un propósito de tratamiento paliativo para sus tumores. Aproximadamente, el 23% (22,6%) interrumpió el tratamiento antineoplásico. Para fines adyuvantes, curativos y paliativos, el rango de edad de 18 a 30 años presentó la mayor interrupción, respectivamente 33%, 36% y 41%. El paclitaxel/carboplatino fue el más prescrito con un porcentaje significativo de interrupción. Conclusión: Nuestros hallazgos sugieren que existe una asociación entre la interrupción del tratamiento y la edad de los pacientes y el propósito terapéutico

Percepção de cuidados desproporcionais entre médicos seniores, médicos residentes, enfermeiros e técnicos de enfermagem em um centro de terapia intensiva / Perception of disproportionate care among staff physicians, training physicians, nurses, and practical nurses in an intensive care unit

Introdução: O aumento progressivo de medidas avançadas para manutenção da vida em pacientes com pouca expectativa de sobrevida gera percepção de cuidado desproporcional. Objetivamos averiguar a prevalência de cuidado desproporcional em equipe médica e enfermagem que atuam na Unidade de Terapia Intensiva (UTI) em um hospital público do Brasil.Métodos: Estudo transversal envolvendo equipe médica e enfermagem em uma UTI multidisciplinar de 34 leitos de um hospital terciário no sul do Brasil de janeiro a julho de 2019. Ao total 151 profissionais responderam a um questionário eletrônico anônimo.Resultados: A taxa de resposta foi de 49,5%. Cento e dezoito (78,1%) profissionais identificaram cuidado desproporcional no ambiente de trabalho. Enfermeiros e técnicos de enfermagem receberam menos treinamento formal em comunicação de fim de vida do que médicos (10,6% versus 57,6%, p < 0,001). Vinte e nove (28,1%) enfermeiros e técnicos de enfermagem e 4 (0,08%) médicos responderam que não havia discussão sobre terminalidade na UTI (p = 0,006). Quarenta e três (89,5%) médicos afirmaram que havia colaboração entre equipe médica e equipe de enfermagem, ao passo que 58 (56,3%) enfermeiros e técnicos de enfermagem discordaram da assertiva (p < 0,001).Conclusão: Este é o primeiro estudo sobre percepção de cuidado desproporcional conduzido na América Latina, envolvendo residentes e técnicos de enfermagem e um centro de alta complexidade do sistema público de saúde. A vasta maioria dos profissionais percebe a existência de cuidado desproporcional em sua prática diária, independentemente da classe profissional.

Introduction: The increased use of life-sustaining measures in patients with poor long- and middle-term expected survival concerns health care providers regarding disproportionate care. The objective of this study was to report the prevalence of perceived inappropriate care among intensive care unit (ICU) staff physicians, training physicians, nurses, and practical nurses in a Brazilian public hospital.Methods: We conducted a cross-sectional study with the medical and nursing team of a 34-bed multidisciplinary ICU of a tertiary teaching hospital in Southern Brazil from January to July 2019. A total of 151 professionals completed an anonymous electronic survey. Results: The response rate was 49.5%. One hundred and eighteen (78.1%) respondents reported disproportionate care in the work environment. Nurses and practical nurses were less likely to receive formal training on end-of-life communication compared to physicians (10.6% vs. 57.6%, p < 0.001). Twenty-nine (28.1%) nurses and practical nurses vs. 4 (0.08%) physicians claimed that there were no palliative care deliberations in the ICU (p = 0.006). Of 48 senior and junior physicians, 43 (89.5%) believed that collaboration between physicians and nurses was good, whereas 58 out of 103 (56.3%) nurses and practical nurses disagreed (p < 0.001).Conclusion: This is the first survey on the perception of inappropriate care conducted in Latin America. The study included junior physicians and practical nurses working in a high-complexity medical center associated with the Brazilian public health system. Most health care providers perceived disproportionate care in their daily practice, regardless of their professional class.

The Correspondence Between Fluid Balance and Body Weight Change Measurements in Critically Ill Adult Patients.

INTRODUCTION: Positive fluid status has been associated with a worse prognosis in intensive care unit (ICU) patients. Given the potential for errors in the calculation of fluid balance totals and the problem of accounting for indiscernible fluid losses, measurement of body weight change is an alternative non-invasive method commonly used for estimating body fluid status. The objective of the study is to compare the measurements of fluid balance and body weight changes over time and to assess their association with ICU mortality. METHODS: This prospective observational study was conducted in the 34-bed multidisciplinary ICU of a tertiary teaching hospital in southern Brazil. Adult patients were eligible if their expected length of stay was more than 48 hours, and if they were not receiving an oral diet. Clinical demographic data, daily and cumulative fluid balance with and without indiscernible water loss, and daily and total body weight changes were recorded. Agreement between daily fluid balance and body weight change, and between cumulative fluid balance and total body weight change were calculated. RESULTS: Cumulative fluid balance and total body weight change differed significantly among survivors and non survivors respectively, +2.53L versus +5.6L (p= 0.012) and -3.05kg vs -1.1kg (p= 0.008). The average daily difference between measured fluid balance and body weight was +0.864 L/kg with a wide interval: -3.156 to +4.885 L/kg, which remained so even after adjustment for indiscernible losses (mean bias: +0.288; limits of agreement between -3.876 and +4.452 L/kg). Areas under ROC curve for cumulative fluid balance, cumulative fluid balance with indiscernible losses and total body weight change were, respectively, 0.65, 0.56 and 0.65 (p= 0.14). CONCLUSION: The results indicated the absence of correspondence between fluid balance and body weight change, with a more significant discrepancy between cumulative fluid balance and total body weight change. Both fluid balance and body weight changes were significantly different among survivors and non-survivors, but neither measurement discriminated ICU mortality.

A 7-year Experience with Keloid Fillet Flap and Adjuvant Intralesional Corticosteroids.

CONTEXT: Keloids are fibroproliferative scars characterized by excessive collagen deposition beyond the margins of the original wound. Although many treatment modalities were described in the literature, no single first-line therapy is recommended, and its recurrence rate remains high. AIMS: The aim of this study was to investigate the efficacy rate in treating auricle keloids after fillet flap excision combined with adjuvant intralesional steroid injections. SETTINGS AND DESIGN: This was a retrospective study. MATERIALS AND METHODS: Between 2012 and 2019, a total of 16 auricle keloids were treated at our center with fillet flap excision and adjuvant steroid injections. Intralesional steroid injections were given at the end of the first week and then administered at 4-week intervals until the lesions were soft and flat. Postoperative efficacy, complications, recurrence, and patient satisfaction were analyzed. RESULTS: A high improvement of the keloid was observed in 13 (81.2%) lesions. No major complications and no recurrence of the keloid were detected during the follow-up period (mean, 35 months). Regarding patient satisfaction, nine (81.8%) considered their result as excellent. CONCLUSION: This study showed that this approach is effective regardless of the keloid location at the auricle.

Segmental stiff skin syndrome (SSS): Clinical case and a brief review.

Stiff skin syndrome (SSS) is a rare, scleroderma-like condition that is commonly characterised by stony hard skin and limited joint mobility, in the absence of visceral involvement or immunologic abnormalities. Depending on the distribution of the disease, this disorder can be further categorised into classic (widespread) SSS or its newly described segmental variant. Additional features of this syndrome may include hypertrichosis, lipodystrophy, dysmetria and scoliosis. In this report, we present the case of a patient with segmental SSS and we briefly review the current literature about the topic.